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More Young Women Being Diagnosed With Breast Cancer Than Ever Before
This transcript has been edited for clarity.
From the year 2000 until around 2016, the incidence of breast cancer among young women — those under age 50 — rose steadily, if slowly.
And then this happened:
I look at a lot of graphs in my line of work, and it’s not too often that one actually makes me say “What the hell?” out loud. But this one did. Why are young women all of a sudden more likely to get breast cancer?
The graph comes from this paper, Breast cancer incidence among us women aged 20 to 49 years by race, stage, and hormone receptor status, appearing in JAMA Network Open
Researchers from Washington University in St. Louis utilized SEER registries to conduct their analyses. SEER is a public database from the National Cancer Institute with coverage of 27% of the US population and a long track record of statistical backbone to translate the data from SEER to numbers that are representative of the population at large.
From 2000 to 2019, more than 200,000 women were diagnosed with primary invasive breast cancer in the dataset, and I’ve already given you the top-line results. Of course, when you see a graph like this, the next question really needs to be why?
Fortunately, the SEER dataset contains a lot more information than simply whether someone was diagnosed with cancer. In the case of breast cancer, there is information about the patient’s demographics, the hormone status of the cancer, the stage, and so on. Using those additional data points can help the authors, and us, start to formulate some hypotheses as to what is happening here.
Let’s start with something a bit tricky about this kind of data. We see an uptick in new breast cancer diagnoses among young women in recent years. We need to tease that uptick apart a bit. It could be that it is the year that is the key factor here. In other words, it is simply that more women are getting breast cancer since 2016 and so more young women are getting breast cancer since 2016. These are known as period effects.
Or is there something unique to young women — something about their environmental exposures that put them at higher risk than they would have been had they been born at some other time? These are known as cohort effects.
The researchers teased these two effects apart, as you can see here, and concluded that, well, it’s both.
Stage of cancer at diagnosis can give us some more insight into what is happening. These results are pretty interesting. These higher cancer rates are due primarily to stage I and stage IV cancers, not stage II and stage III cancers.
The rising incidence of stage I cancers could reflect better detection, though many of the women in this cohort would not have been old enough to quality for screening mammograms. That said, increased awareness about genetic risk and family history might be leading younger women to get screened, picking up more early cancers. Additionally, much of the increased incidence was with estrogen receptor–positive tumors, which might reflect the fact that women in this cohort are tending to have fewer children, and children later in life.
So why the rise in stage IV breast cancer? Well, precisely because younger women are not recommended to get screening mammograms; those who detect a lump on their own are likely to be at a more advanced stage. But I’m not sure why that would be changing recently. The authors argue that an increase in overweight and obesity in the country might be to blame here. Prior studies have shown that higher BMI is associated with higher stage at breast cancer diagnosis.
Of course, we can speculate as to multiple other causes as well: environmental toxins, pollution, hormone exposures, and so on. Figuring this out will be the work of multiple other studies. In the meantime, we should remember that the landscape of cancer is continuously changing. And that means we need to adapt to it. If these trends continue, national agencies may need to reconsider their guidelines for when screening mammography should begin — at least in some groups of young women.
Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
From the year 2000 until around 2016, the incidence of breast cancer among young women — those under age 50 — rose steadily, if slowly.
And then this happened:
I look at a lot of graphs in my line of work, and it’s not too often that one actually makes me say “What the hell?” out loud. But this one did. Why are young women all of a sudden more likely to get breast cancer?
The graph comes from this paper, Breast cancer incidence among us women aged 20 to 49 years by race, stage, and hormone receptor status, appearing in JAMA Network Open
Researchers from Washington University in St. Louis utilized SEER registries to conduct their analyses. SEER is a public database from the National Cancer Institute with coverage of 27% of the US population and a long track record of statistical backbone to translate the data from SEER to numbers that are representative of the population at large.
From 2000 to 2019, more than 200,000 women were diagnosed with primary invasive breast cancer in the dataset, and I’ve already given you the top-line results. Of course, when you see a graph like this, the next question really needs to be why?
Fortunately, the SEER dataset contains a lot more information than simply whether someone was diagnosed with cancer. In the case of breast cancer, there is information about the patient’s demographics, the hormone status of the cancer, the stage, and so on. Using those additional data points can help the authors, and us, start to formulate some hypotheses as to what is happening here.
Let’s start with something a bit tricky about this kind of data. We see an uptick in new breast cancer diagnoses among young women in recent years. We need to tease that uptick apart a bit. It could be that it is the year that is the key factor here. In other words, it is simply that more women are getting breast cancer since 2016 and so more young women are getting breast cancer since 2016. These are known as period effects.
Or is there something unique to young women — something about their environmental exposures that put them at higher risk than they would have been had they been born at some other time? These are known as cohort effects.
The researchers teased these two effects apart, as you can see here, and concluded that, well, it’s both.
Stage of cancer at diagnosis can give us some more insight into what is happening. These results are pretty interesting. These higher cancer rates are due primarily to stage I and stage IV cancers, not stage II and stage III cancers.
The rising incidence of stage I cancers could reflect better detection, though many of the women in this cohort would not have been old enough to quality for screening mammograms. That said, increased awareness about genetic risk and family history might be leading younger women to get screened, picking up more early cancers. Additionally, much of the increased incidence was with estrogen receptor–positive tumors, which might reflect the fact that women in this cohort are tending to have fewer children, and children later in life.
So why the rise in stage IV breast cancer? Well, precisely because younger women are not recommended to get screening mammograms; those who detect a lump on their own are likely to be at a more advanced stage. But I’m not sure why that would be changing recently. The authors argue that an increase in overweight and obesity in the country might be to blame here. Prior studies have shown that higher BMI is associated with higher stage at breast cancer diagnosis.
Of course, we can speculate as to multiple other causes as well: environmental toxins, pollution, hormone exposures, and so on. Figuring this out will be the work of multiple other studies. In the meantime, we should remember that the landscape of cancer is continuously changing. And that means we need to adapt to it. If these trends continue, national agencies may need to reconsider their guidelines for when screening mammography should begin — at least in some groups of young women.
Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
From the year 2000 until around 2016, the incidence of breast cancer among young women — those under age 50 — rose steadily, if slowly.
And then this happened:
I look at a lot of graphs in my line of work, and it’s not too often that one actually makes me say “What the hell?” out loud. But this one did. Why are young women all of a sudden more likely to get breast cancer?
The graph comes from this paper, Breast cancer incidence among us women aged 20 to 49 years by race, stage, and hormone receptor status, appearing in JAMA Network Open
Researchers from Washington University in St. Louis utilized SEER registries to conduct their analyses. SEER is a public database from the National Cancer Institute with coverage of 27% of the US population and a long track record of statistical backbone to translate the data from SEER to numbers that are representative of the population at large.
From 2000 to 2019, more than 200,000 women were diagnosed with primary invasive breast cancer in the dataset, and I’ve already given you the top-line results. Of course, when you see a graph like this, the next question really needs to be why?
Fortunately, the SEER dataset contains a lot more information than simply whether someone was diagnosed with cancer. In the case of breast cancer, there is information about the patient’s demographics, the hormone status of the cancer, the stage, and so on. Using those additional data points can help the authors, and us, start to formulate some hypotheses as to what is happening here.
Let’s start with something a bit tricky about this kind of data. We see an uptick in new breast cancer diagnoses among young women in recent years. We need to tease that uptick apart a bit. It could be that it is the year that is the key factor here. In other words, it is simply that more women are getting breast cancer since 2016 and so more young women are getting breast cancer since 2016. These are known as period effects.
Or is there something unique to young women — something about their environmental exposures that put them at higher risk than they would have been had they been born at some other time? These are known as cohort effects.
The researchers teased these two effects apart, as you can see here, and concluded that, well, it’s both.
Stage of cancer at diagnosis can give us some more insight into what is happening. These results are pretty interesting. These higher cancer rates are due primarily to stage I and stage IV cancers, not stage II and stage III cancers.
The rising incidence of stage I cancers could reflect better detection, though many of the women in this cohort would not have been old enough to quality for screening mammograms. That said, increased awareness about genetic risk and family history might be leading younger women to get screened, picking up more early cancers. Additionally, much of the increased incidence was with estrogen receptor–positive tumors, which might reflect the fact that women in this cohort are tending to have fewer children, and children later in life.
So why the rise in stage IV breast cancer? Well, precisely because younger women are not recommended to get screening mammograms; those who detect a lump on their own are likely to be at a more advanced stage. But I’m not sure why that would be changing recently. The authors argue that an increase in overweight and obesity in the country might be to blame here. Prior studies have shown that higher BMI is associated with higher stage at breast cancer diagnosis.
Of course, we can speculate as to multiple other causes as well: environmental toxins, pollution, hormone exposures, and so on. Figuring this out will be the work of multiple other studies. In the meantime, we should remember that the landscape of cancer is continuously changing. And that means we need to adapt to it. If these trends continue, national agencies may need to reconsider their guidelines for when screening mammography should begin — at least in some groups of young women.
Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Chemo-Free Maintenance Strategies May Boost Survival in TNBC
TOPLINE:
METHODOLOGY:
- First-line standard therapy for advanced TNBC generally includes taxane- or platinum-based chemotherapy which poses challenging toxicities. Exploring chemotherapy-free maintenance strategies may provide adequate disease control and improve patient quality of life.
- The researchers evaluated 45 patients, at five sites in the Republic of Korea, the United States, and Singapore, with TNBC who had ongoing stable disease or complete/partial response from first- or second-line platinum-based chemotherapy.
- The patients were randomized 1:1 to receive olaparib 300 mg twice daily with or without durvalumab 1500 mg on day 1 every 4 weeks.
- The authors compared PFS with a historical control of continued platinum-based therapy. An improvement to 4 months with maintenance therapy was considered clinically significant.
TAKEAWAY:
- After a follow-up of 9.8 months, patients who received olaparib alone demonstrated median PFS of 4.0 months, and those who received the combination therapy had median PFS of 6.1 months.
- Clinical benefit rates, defined as stable disease for at least 24 weeks or complete/partial response, were reported in 44% of the monotherapy group and 36% of the combination therapy group.
- Sustained clinical benefit was evident irrespective of germline BRCA mutation or programmed death-ligand 1 status, although it tended to be associated with complete or partial response to prior platinum.
- Grade 3-4 adverse events were reported in nine patients (39%) in the olaparib arm and eight patients (36%) in the combination arm. No treatment-related deaths or new safety signals were observed.
IN PRACTICE:
“Maintenance regimens are rarely used in [triple-negative breast cancer] but offer the possibility of more tolerable long-term treatment avoiding some of the chemotherapy-related side effects of more aggressive regimens, as is standard in the first-line treatment of HER2-positive advanced breast cancer,” the researchers concluded.
SOURCE:
This study, led by Tira J. Tan from Duke-NUS Medical School, Singapore, was published online on January 18, 2024, in Clinical Cancer Research.
LIMITATIONS:
The main limitations were the small sample size and lack of a standard control arm. Most patients (76%) were Asian, limiting generalizability. The trial was not designed to compare olaparib monotherapy and olaparib plus durvalumab regimens.
DISCLOSURES:
AstraZeneca Pharmaceuticals LP supported this study. Several authors reported financial support from various sources.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- First-line standard therapy for advanced TNBC generally includes taxane- or platinum-based chemotherapy which poses challenging toxicities. Exploring chemotherapy-free maintenance strategies may provide adequate disease control and improve patient quality of life.
- The researchers evaluated 45 patients, at five sites in the Republic of Korea, the United States, and Singapore, with TNBC who had ongoing stable disease or complete/partial response from first- or second-line platinum-based chemotherapy.
- The patients were randomized 1:1 to receive olaparib 300 mg twice daily with or without durvalumab 1500 mg on day 1 every 4 weeks.
- The authors compared PFS with a historical control of continued platinum-based therapy. An improvement to 4 months with maintenance therapy was considered clinically significant.
TAKEAWAY:
- After a follow-up of 9.8 months, patients who received olaparib alone demonstrated median PFS of 4.0 months, and those who received the combination therapy had median PFS of 6.1 months.
- Clinical benefit rates, defined as stable disease for at least 24 weeks or complete/partial response, were reported in 44% of the monotherapy group and 36% of the combination therapy group.
- Sustained clinical benefit was evident irrespective of germline BRCA mutation or programmed death-ligand 1 status, although it tended to be associated with complete or partial response to prior platinum.
- Grade 3-4 adverse events were reported in nine patients (39%) in the olaparib arm and eight patients (36%) in the combination arm. No treatment-related deaths or new safety signals were observed.
IN PRACTICE:
“Maintenance regimens are rarely used in [triple-negative breast cancer] but offer the possibility of more tolerable long-term treatment avoiding some of the chemotherapy-related side effects of more aggressive regimens, as is standard in the first-line treatment of HER2-positive advanced breast cancer,” the researchers concluded.
SOURCE:
This study, led by Tira J. Tan from Duke-NUS Medical School, Singapore, was published online on January 18, 2024, in Clinical Cancer Research.
LIMITATIONS:
The main limitations were the small sample size and lack of a standard control arm. Most patients (76%) were Asian, limiting generalizability. The trial was not designed to compare olaparib monotherapy and olaparib plus durvalumab regimens.
DISCLOSURES:
AstraZeneca Pharmaceuticals LP supported this study. Several authors reported financial support from various sources.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- First-line standard therapy for advanced TNBC generally includes taxane- or platinum-based chemotherapy which poses challenging toxicities. Exploring chemotherapy-free maintenance strategies may provide adequate disease control and improve patient quality of life.
- The researchers evaluated 45 patients, at five sites in the Republic of Korea, the United States, and Singapore, with TNBC who had ongoing stable disease or complete/partial response from first- or second-line platinum-based chemotherapy.
- The patients were randomized 1:1 to receive olaparib 300 mg twice daily with or without durvalumab 1500 mg on day 1 every 4 weeks.
- The authors compared PFS with a historical control of continued platinum-based therapy. An improvement to 4 months with maintenance therapy was considered clinically significant.
TAKEAWAY:
- After a follow-up of 9.8 months, patients who received olaparib alone demonstrated median PFS of 4.0 months, and those who received the combination therapy had median PFS of 6.1 months.
- Clinical benefit rates, defined as stable disease for at least 24 weeks or complete/partial response, were reported in 44% of the monotherapy group and 36% of the combination therapy group.
- Sustained clinical benefit was evident irrespective of germline BRCA mutation or programmed death-ligand 1 status, although it tended to be associated with complete or partial response to prior platinum.
- Grade 3-4 adverse events were reported in nine patients (39%) in the olaparib arm and eight patients (36%) in the combination arm. No treatment-related deaths or new safety signals were observed.
IN PRACTICE:
“Maintenance regimens are rarely used in [triple-negative breast cancer] but offer the possibility of more tolerable long-term treatment avoiding some of the chemotherapy-related side effects of more aggressive regimens, as is standard in the first-line treatment of HER2-positive advanced breast cancer,” the researchers concluded.
SOURCE:
This study, led by Tira J. Tan from Duke-NUS Medical School, Singapore, was published online on January 18, 2024, in Clinical Cancer Research.
LIMITATIONS:
The main limitations were the small sample size and lack of a standard control arm. Most patients (76%) were Asian, limiting generalizability. The trial was not designed to compare olaparib monotherapy and olaparib plus durvalumab regimens.
DISCLOSURES:
AstraZeneca Pharmaceuticals LP supported this study. Several authors reported financial support from various sources.
A version of this article appeared on Medscape.com.
Treatment Sequence May Impact Pancreatic Cancer Survival
TOPLINE:
METHODOLOGY:
- Despite therapeutic advances, survival among patients with unresectable and/or metastatic pancreatic ductal adenocarcinoma has not markedly improved in recent years.
- In the current analysis, researchers evaluated whether treatment sequence could affect survival outcomes in this patient population.
- To this end , researchers conducted a single institution, retrospective analysis of patients who received different lines of treatment between January 2015 and December 2021.
- The most common first-line therapy was nab-paclitaxel plus S-1 (58%), followed by FOLFIRINOX (10%), nab-paclitaxel plus gemcitabine (8%), gemcitabine alone (7%), gemcitabine plus oxaliplatin (6%); second-line therapies, in order of frequency, included gemcitabine combination therapy (48%), nab-paclitaxel combination therapy (19%), FOLFIRINOX (10%), and gemcitabine alone (7%); third-line treatments consisted of FOLFIRINOX (31%), irinotecan or oxaliplatin combination therapy (23%), immunotherapy (19%), and gemcitabine combination therapy (10%).
TAKEAWAY:
- Overall, progression occurred in 90% of patients, and the median overall survival was 12.0 months, with only 48% of patients able to start a third-line therapy.
- The researchers focused on three common therapy sequences: nab-paclitaxel plus gemcitabine or nab-paclitaxel combination therapy as first-line and FOLFIRINOX as second-line (line A); nab-paclitaxel combination therapy to gemcitabine combination therapy to FOLFIRINOX (line B); and nab-paclitaxel combination therapy, to gemcitabine combination therapy, to oxaliplatin or irinotecan combination therapy (line C).
- Overall, the researchers observed a median overall survival of 14 months among patients receiving line A and C sequences and 18 months with line B.
- Patients receiving line B therapy demonstrated a 52% lower risk for death compared with those receiving line A treatment (hazard ratio [HR], 0.48; P = .018) and a 75% reduced risk for death compared with those on the line C sequence (HR, 0.25; P = .040).
IN PRACTICE:
“Our study provides real-world evidence for the effectiveness of different treatment sequences and underscores the [impact of] treatment sequences on survival outcome when considering the entire management in advanced pancreatic ductal adenocarcinoma,” the authors concluded.
SOURCE:
The study, led by Guanghai Dai, MD, from the Chinese People’s Liberation Army General Hospital, Beijing, was published in BMC Cancer on January 12, 2024.
LIMITATIONS:
The study was a single-center, retrospective analysis.
DISCLOSURES:
The paper was funded by Beijing natural science foundation. The authors did not declare any relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Despite therapeutic advances, survival among patients with unresectable and/or metastatic pancreatic ductal adenocarcinoma has not markedly improved in recent years.
- In the current analysis, researchers evaluated whether treatment sequence could affect survival outcomes in this patient population.
- To this end , researchers conducted a single institution, retrospective analysis of patients who received different lines of treatment between January 2015 and December 2021.
- The most common first-line therapy was nab-paclitaxel plus S-1 (58%), followed by FOLFIRINOX (10%), nab-paclitaxel plus gemcitabine (8%), gemcitabine alone (7%), gemcitabine plus oxaliplatin (6%); second-line therapies, in order of frequency, included gemcitabine combination therapy (48%), nab-paclitaxel combination therapy (19%), FOLFIRINOX (10%), and gemcitabine alone (7%); third-line treatments consisted of FOLFIRINOX (31%), irinotecan or oxaliplatin combination therapy (23%), immunotherapy (19%), and gemcitabine combination therapy (10%).
TAKEAWAY:
- Overall, progression occurred in 90% of patients, and the median overall survival was 12.0 months, with only 48% of patients able to start a third-line therapy.
- The researchers focused on three common therapy sequences: nab-paclitaxel plus gemcitabine or nab-paclitaxel combination therapy as first-line and FOLFIRINOX as second-line (line A); nab-paclitaxel combination therapy to gemcitabine combination therapy to FOLFIRINOX (line B); and nab-paclitaxel combination therapy, to gemcitabine combination therapy, to oxaliplatin or irinotecan combination therapy (line C).
- Overall, the researchers observed a median overall survival of 14 months among patients receiving line A and C sequences and 18 months with line B.
- Patients receiving line B therapy demonstrated a 52% lower risk for death compared with those receiving line A treatment (hazard ratio [HR], 0.48; P = .018) and a 75% reduced risk for death compared with those on the line C sequence (HR, 0.25; P = .040).
IN PRACTICE:
“Our study provides real-world evidence for the effectiveness of different treatment sequences and underscores the [impact of] treatment sequences on survival outcome when considering the entire management in advanced pancreatic ductal adenocarcinoma,” the authors concluded.
SOURCE:
The study, led by Guanghai Dai, MD, from the Chinese People’s Liberation Army General Hospital, Beijing, was published in BMC Cancer on January 12, 2024.
LIMITATIONS:
The study was a single-center, retrospective analysis.
DISCLOSURES:
The paper was funded by Beijing natural science foundation. The authors did not declare any relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Despite therapeutic advances, survival among patients with unresectable and/or metastatic pancreatic ductal adenocarcinoma has not markedly improved in recent years.
- In the current analysis, researchers evaluated whether treatment sequence could affect survival outcomes in this patient population.
- To this end , researchers conducted a single institution, retrospective analysis of patients who received different lines of treatment between January 2015 and December 2021.
- The most common first-line therapy was nab-paclitaxel plus S-1 (58%), followed by FOLFIRINOX (10%), nab-paclitaxel plus gemcitabine (8%), gemcitabine alone (7%), gemcitabine plus oxaliplatin (6%); second-line therapies, in order of frequency, included gemcitabine combination therapy (48%), nab-paclitaxel combination therapy (19%), FOLFIRINOX (10%), and gemcitabine alone (7%); third-line treatments consisted of FOLFIRINOX (31%), irinotecan or oxaliplatin combination therapy (23%), immunotherapy (19%), and gemcitabine combination therapy (10%).
TAKEAWAY:
- Overall, progression occurred in 90% of patients, and the median overall survival was 12.0 months, with only 48% of patients able to start a third-line therapy.
- The researchers focused on three common therapy sequences: nab-paclitaxel plus gemcitabine or nab-paclitaxel combination therapy as first-line and FOLFIRINOX as second-line (line A); nab-paclitaxel combination therapy to gemcitabine combination therapy to FOLFIRINOX (line B); and nab-paclitaxel combination therapy, to gemcitabine combination therapy, to oxaliplatin or irinotecan combination therapy (line C).
- Overall, the researchers observed a median overall survival of 14 months among patients receiving line A and C sequences and 18 months with line B.
- Patients receiving line B therapy demonstrated a 52% lower risk for death compared with those receiving line A treatment (hazard ratio [HR], 0.48; P = .018) and a 75% reduced risk for death compared with those on the line C sequence (HR, 0.25; P = .040).
IN PRACTICE:
“Our study provides real-world evidence for the effectiveness of different treatment sequences and underscores the [impact of] treatment sequences on survival outcome when considering the entire management in advanced pancreatic ductal adenocarcinoma,” the authors concluded.
SOURCE:
The study, led by Guanghai Dai, MD, from the Chinese People’s Liberation Army General Hospital, Beijing, was published in BMC Cancer on January 12, 2024.
LIMITATIONS:
The study was a single-center, retrospective analysis.
DISCLOSURES:
The paper was funded by Beijing natural science foundation. The authors did not declare any relevant financial relationships.
A version of this article appeared on Medscape.com.
ALL: When Should MRD Trigger Stem Cell Transplants?
Allogeneic hematopoietic stem cell transplants (HSCT) are still part of the hematology armamentarium for relapsed/refractory (R/R) patients with Ph-negative ALL who are MRD positive. However, when asked about the best treatment strategy for patients who are MRD-negative, hematologist Mark R. Litzow, MD, of the Mayo Clinic in Rochester, Minnesota, said in an interview, “There is no firm consensus about that.”
Discussing how medicine has evolved over the past 20 to 30 years, Dr. Litzow recalled that HSCT used to be standard treatment for adult patients with ALL. “We felt that in most instances, chemotherapy alone was not going to be effective in curing them. A vast majority would relapse,” he said. Nowadays, however, specialists differ on the use of HSCT in patients with Ph-negative, MRD-negative ALL.
A pair of commentaries in the January issue of The Lancet Hematology tackle this topic from different perspectives. On one hand, hematologist Patrice Chevallier, MD, of the University of Nantes in France, argues that for such patients, HSCT “remains a valid option,”and MRD status shouldn’t be the sole factor used for a decision.
However, hematologist Nicolas Boissel, MD, PhD, of Paris Cité University, contends that detectable early MRD is the “only robust predictor” of HSCT benefit in patients under 60 with Ph-negative ALL, and it has “unproven” benefit in older patients.
As Dr. Chevallier notes, “allogeneic HSCT is indicated in patients defined as having a high risk of relapse. Currently, a high level of residual leukemic cells after treatment is recognized as the strongest, and sometimes sole, criterion defining high-risk patients.”
As first- and second-line therapy in pediatric patients and as first-line therapy in adults, the “rule” is to offer HSCT to MRD-positive patients but not MRD-negative ones, he writes. “In older patients and those who are relapsed or refractory, the recent demonstration of efficient immunotherapies and cell therapies has launched the debate on the role of MRD status and the question of whether or not to transplant patients who are MRD-negative in both settings.”
Dr. Chevallier notes that “there is no standard definition of an MRD-negative status,” and the best timing for evaluation is unknown. Further, he adds, a “variable proportion of MRD-negative patients still relapse after treatment — up to 25% of patients who respond early and more than 50% of patients who respond late.”
He also points out that there’s an 80% chance that patients will convert from MRD negative to MRD positive after blinatumomab therapy, and he highlights the low long-term survival rate (20%) after brexucabtagene autoleucel (Tecartus), a CAR T-cell therapy.
As for older patients, Dr. Chevallier observes that improved chemo-immunotherapy and conditioning regimens could spark a rethinking of the feasibility of HSCT. However, for now, in those patients, “MRD is not decisional, and allogeneic HSCT is not a routine practice,” he writes.
In his commentary, Dr. Boissel points out that there have been no controlled studies of HSCT in the first-remission setting, although he writes that some data suggests that HSCT may be helpful for patients in high-risk genetic subgroups, regardless of MRD status. On the other hand, “converging observations suggest no benefit of HSCT in MRD-positive patients treated with blinatumomab in the front-line setting.”
If MRD monitoring is unavailable, Dr. Boissel adds, “it seems reasonable to use early blast clearance or other baseline high-risk features to indicate HSCT.”
How can hematologists make the best decision about HSCT?
In an interview, City of Hope Medical Center (Duarte, California) hematologist-oncologist Ibrahim T. Aldoss, MD, said that chemotherapy — with or without immunotherapy — can often be enough to treat younger patients without high-risk genetic factors. “Potentially, these patients can be spared from transplants,” he said, although patients with resistant MRD “clearly need transplants.”
The risks of transplants are significant, he noted. While they can reduce the risk of relapse, the risk of dying during remission is higher vs chemotherapy. “So you have to balance the risks that you’re willing to take,” he said, keeping in mind that some patients can be cured with chemotherapy.
In addition, Dr. Aldoss said, acute graft-versus-host disease in the first few months after transplant can become chronic. “Many years later, patients can be struggling to where it actually impacts their daily activity. And unfortunately, patients can die from it.”
In the big picture, “you cannot have a generalized statement about whether you shouldn’t do transplants in every MRD-negative patient,” he said. However, “if you do achieve MRD negativity, most patients likely don’t need transplants.”
The Mayo Clinic’s Dr. Litzow urged colleagues to consider several factors when making decisions. Do patients have a high level of comorbidities that would raise the risk of death from HSCT? He noted that there’s nearly a 20% risk of death from HSCT, and comorbidities can boost the risk to 40%-50%.
Also, does the patient have a suitable donor? While advances have boosted the number of eligible donors, he said, “not everybody has an ideal donor.”
If a patient is MRD-negative but not a good candidate for a transplant, Dr. Litzow said consolidation therapy followed by maintenance therapy may be indicated. “Continue to check their bone marrow and their blood periodically as they’re going through treatment and reassess their MRD status to make sure they’re staying negative. If they turn MRD-positive during the course of their therapy, then we have to step back and rethink the role of transplant.”
As for cost, Dr. Litzow points out that HSCT is very expensive, although ALL is an accepted indication for HSCT. However, “if someone doesn’t have medical insurance, then it can be difficult to consider them having a transplant.”
What’s next? In his commentary, Dr. Boissel writes that his team aims to study whether HSCT is helpful in patients with high-risk B-cell ALL “who reach MRD negativity after a consolidation phase including blinatumomab.”
Dr. Aldoss discloses relationships with Amgen, Kite, Pfizer, Jazz, AbbVie, Sobi, Agios, Autolus, and MacroGenics. Dr. Litzow reports ties with Amgen. Dr. Boissel declares relationships with Amgen, Pfizer, Novartis, and Servier. Dr. Chevallier has no disclosures.
Allogeneic hematopoietic stem cell transplants (HSCT) are still part of the hematology armamentarium for relapsed/refractory (R/R) patients with Ph-negative ALL who are MRD positive. However, when asked about the best treatment strategy for patients who are MRD-negative, hematologist Mark R. Litzow, MD, of the Mayo Clinic in Rochester, Minnesota, said in an interview, “There is no firm consensus about that.”
Discussing how medicine has evolved over the past 20 to 30 years, Dr. Litzow recalled that HSCT used to be standard treatment for adult patients with ALL. “We felt that in most instances, chemotherapy alone was not going to be effective in curing them. A vast majority would relapse,” he said. Nowadays, however, specialists differ on the use of HSCT in patients with Ph-negative, MRD-negative ALL.
A pair of commentaries in the January issue of The Lancet Hematology tackle this topic from different perspectives. On one hand, hematologist Patrice Chevallier, MD, of the University of Nantes in France, argues that for such patients, HSCT “remains a valid option,”and MRD status shouldn’t be the sole factor used for a decision.
However, hematologist Nicolas Boissel, MD, PhD, of Paris Cité University, contends that detectable early MRD is the “only robust predictor” of HSCT benefit in patients under 60 with Ph-negative ALL, and it has “unproven” benefit in older patients.
As Dr. Chevallier notes, “allogeneic HSCT is indicated in patients defined as having a high risk of relapse. Currently, a high level of residual leukemic cells after treatment is recognized as the strongest, and sometimes sole, criterion defining high-risk patients.”
As first- and second-line therapy in pediatric patients and as first-line therapy in adults, the “rule” is to offer HSCT to MRD-positive patients but not MRD-negative ones, he writes. “In older patients and those who are relapsed or refractory, the recent demonstration of efficient immunotherapies and cell therapies has launched the debate on the role of MRD status and the question of whether or not to transplant patients who are MRD-negative in both settings.”
Dr. Chevallier notes that “there is no standard definition of an MRD-negative status,” and the best timing for evaluation is unknown. Further, he adds, a “variable proportion of MRD-negative patients still relapse after treatment — up to 25% of patients who respond early and more than 50% of patients who respond late.”
He also points out that there’s an 80% chance that patients will convert from MRD negative to MRD positive after blinatumomab therapy, and he highlights the low long-term survival rate (20%) after brexucabtagene autoleucel (Tecartus), a CAR T-cell therapy.
As for older patients, Dr. Chevallier observes that improved chemo-immunotherapy and conditioning regimens could spark a rethinking of the feasibility of HSCT. However, for now, in those patients, “MRD is not decisional, and allogeneic HSCT is not a routine practice,” he writes.
In his commentary, Dr. Boissel points out that there have been no controlled studies of HSCT in the first-remission setting, although he writes that some data suggests that HSCT may be helpful for patients in high-risk genetic subgroups, regardless of MRD status. On the other hand, “converging observations suggest no benefit of HSCT in MRD-positive patients treated with blinatumomab in the front-line setting.”
If MRD monitoring is unavailable, Dr. Boissel adds, “it seems reasonable to use early blast clearance or other baseline high-risk features to indicate HSCT.”
How can hematologists make the best decision about HSCT?
In an interview, City of Hope Medical Center (Duarte, California) hematologist-oncologist Ibrahim T. Aldoss, MD, said that chemotherapy — with or without immunotherapy — can often be enough to treat younger patients without high-risk genetic factors. “Potentially, these patients can be spared from transplants,” he said, although patients with resistant MRD “clearly need transplants.”
The risks of transplants are significant, he noted. While they can reduce the risk of relapse, the risk of dying during remission is higher vs chemotherapy. “So you have to balance the risks that you’re willing to take,” he said, keeping in mind that some patients can be cured with chemotherapy.
In addition, Dr. Aldoss said, acute graft-versus-host disease in the first few months after transplant can become chronic. “Many years later, patients can be struggling to where it actually impacts their daily activity. And unfortunately, patients can die from it.”
In the big picture, “you cannot have a generalized statement about whether you shouldn’t do transplants in every MRD-negative patient,” he said. However, “if you do achieve MRD negativity, most patients likely don’t need transplants.”
The Mayo Clinic’s Dr. Litzow urged colleagues to consider several factors when making decisions. Do patients have a high level of comorbidities that would raise the risk of death from HSCT? He noted that there’s nearly a 20% risk of death from HSCT, and comorbidities can boost the risk to 40%-50%.
Also, does the patient have a suitable donor? While advances have boosted the number of eligible donors, he said, “not everybody has an ideal donor.”
If a patient is MRD-negative but not a good candidate for a transplant, Dr. Litzow said consolidation therapy followed by maintenance therapy may be indicated. “Continue to check their bone marrow and their blood periodically as they’re going through treatment and reassess their MRD status to make sure they’re staying negative. If they turn MRD-positive during the course of their therapy, then we have to step back and rethink the role of transplant.”
As for cost, Dr. Litzow points out that HSCT is very expensive, although ALL is an accepted indication for HSCT. However, “if someone doesn’t have medical insurance, then it can be difficult to consider them having a transplant.”
What’s next? In his commentary, Dr. Boissel writes that his team aims to study whether HSCT is helpful in patients with high-risk B-cell ALL “who reach MRD negativity after a consolidation phase including blinatumomab.”
Dr. Aldoss discloses relationships with Amgen, Kite, Pfizer, Jazz, AbbVie, Sobi, Agios, Autolus, and MacroGenics. Dr. Litzow reports ties with Amgen. Dr. Boissel declares relationships with Amgen, Pfizer, Novartis, and Servier. Dr. Chevallier has no disclosures.
Allogeneic hematopoietic stem cell transplants (HSCT) are still part of the hematology armamentarium for relapsed/refractory (R/R) patients with Ph-negative ALL who are MRD positive. However, when asked about the best treatment strategy for patients who are MRD-negative, hematologist Mark R. Litzow, MD, of the Mayo Clinic in Rochester, Minnesota, said in an interview, “There is no firm consensus about that.”
Discussing how medicine has evolved over the past 20 to 30 years, Dr. Litzow recalled that HSCT used to be standard treatment for adult patients with ALL. “We felt that in most instances, chemotherapy alone was not going to be effective in curing them. A vast majority would relapse,” he said. Nowadays, however, specialists differ on the use of HSCT in patients with Ph-negative, MRD-negative ALL.
A pair of commentaries in the January issue of The Lancet Hematology tackle this topic from different perspectives. On one hand, hematologist Patrice Chevallier, MD, of the University of Nantes in France, argues that for such patients, HSCT “remains a valid option,”and MRD status shouldn’t be the sole factor used for a decision.
However, hematologist Nicolas Boissel, MD, PhD, of Paris Cité University, contends that detectable early MRD is the “only robust predictor” of HSCT benefit in patients under 60 with Ph-negative ALL, and it has “unproven” benefit in older patients.
As Dr. Chevallier notes, “allogeneic HSCT is indicated in patients defined as having a high risk of relapse. Currently, a high level of residual leukemic cells after treatment is recognized as the strongest, and sometimes sole, criterion defining high-risk patients.”
As first- and second-line therapy in pediatric patients and as first-line therapy in adults, the “rule” is to offer HSCT to MRD-positive patients but not MRD-negative ones, he writes. “In older patients and those who are relapsed or refractory, the recent demonstration of efficient immunotherapies and cell therapies has launched the debate on the role of MRD status and the question of whether or not to transplant patients who are MRD-negative in both settings.”
Dr. Chevallier notes that “there is no standard definition of an MRD-negative status,” and the best timing for evaluation is unknown. Further, he adds, a “variable proportion of MRD-negative patients still relapse after treatment — up to 25% of patients who respond early and more than 50% of patients who respond late.”
He also points out that there’s an 80% chance that patients will convert from MRD negative to MRD positive after blinatumomab therapy, and he highlights the low long-term survival rate (20%) after brexucabtagene autoleucel (Tecartus), a CAR T-cell therapy.
As for older patients, Dr. Chevallier observes that improved chemo-immunotherapy and conditioning regimens could spark a rethinking of the feasibility of HSCT. However, for now, in those patients, “MRD is not decisional, and allogeneic HSCT is not a routine practice,” he writes.
In his commentary, Dr. Boissel points out that there have been no controlled studies of HSCT in the first-remission setting, although he writes that some data suggests that HSCT may be helpful for patients in high-risk genetic subgroups, regardless of MRD status. On the other hand, “converging observations suggest no benefit of HSCT in MRD-positive patients treated with blinatumomab in the front-line setting.”
If MRD monitoring is unavailable, Dr. Boissel adds, “it seems reasonable to use early blast clearance or other baseline high-risk features to indicate HSCT.”
How can hematologists make the best decision about HSCT?
In an interview, City of Hope Medical Center (Duarte, California) hematologist-oncologist Ibrahim T. Aldoss, MD, said that chemotherapy — with or without immunotherapy — can often be enough to treat younger patients without high-risk genetic factors. “Potentially, these patients can be spared from transplants,” he said, although patients with resistant MRD “clearly need transplants.”
The risks of transplants are significant, he noted. While they can reduce the risk of relapse, the risk of dying during remission is higher vs chemotherapy. “So you have to balance the risks that you’re willing to take,” he said, keeping in mind that some patients can be cured with chemotherapy.
In addition, Dr. Aldoss said, acute graft-versus-host disease in the first few months after transplant can become chronic. “Many years later, patients can be struggling to where it actually impacts their daily activity. And unfortunately, patients can die from it.”
In the big picture, “you cannot have a generalized statement about whether you shouldn’t do transplants in every MRD-negative patient,” he said. However, “if you do achieve MRD negativity, most patients likely don’t need transplants.”
The Mayo Clinic’s Dr. Litzow urged colleagues to consider several factors when making decisions. Do patients have a high level of comorbidities that would raise the risk of death from HSCT? He noted that there’s nearly a 20% risk of death from HSCT, and comorbidities can boost the risk to 40%-50%.
Also, does the patient have a suitable donor? While advances have boosted the number of eligible donors, he said, “not everybody has an ideal donor.”
If a patient is MRD-negative but not a good candidate for a transplant, Dr. Litzow said consolidation therapy followed by maintenance therapy may be indicated. “Continue to check their bone marrow and their blood periodically as they’re going through treatment and reassess their MRD status to make sure they’re staying negative. If they turn MRD-positive during the course of their therapy, then we have to step back and rethink the role of transplant.”
As for cost, Dr. Litzow points out that HSCT is very expensive, although ALL is an accepted indication for HSCT. However, “if someone doesn’t have medical insurance, then it can be difficult to consider them having a transplant.”
What’s next? In his commentary, Dr. Boissel writes that his team aims to study whether HSCT is helpful in patients with high-risk B-cell ALL “who reach MRD negativity after a consolidation phase including blinatumomab.”
Dr. Aldoss discloses relationships with Amgen, Kite, Pfizer, Jazz, AbbVie, Sobi, Agios, Autolus, and MacroGenics. Dr. Litzow reports ties with Amgen. Dr. Boissel declares relationships with Amgen, Pfizer, Novartis, and Servier. Dr. Chevallier has no disclosures.
Two-Step Strategy Improves Early-Stage Ovarian Cancer Detection
TOPLINE:
a new analysis with a 21-year follow-up found.
METHODOLOGY:
- Detecting ovarian cancer at stage I or II could significantly reduce ovarian cancer-related deaths, but only 25%-30% of patients are diagnosed at an early stage.
- In this single-arm prospective analysis, 7,856 healthy postmenopausal women received annual screening for ovarian cancer between 2011 and 2022. Screening involved an annual blood test to detect levels of cancer antigen 125 and track these levels over time.
- Investigators used the Risk of Ovarian Cancer Algorithm (ROCA) to determine whether ovarian cancer risk was normal, intermediate, or high. Those with elevated ROCA scores were referred for transvaginal sonography; those with intermediate scores received follow-up blood tests every 3 months.
- Overall, 92.3% of women were normal risk, 5.7% were intermediate, and 2% were high risk and recommended for transvaginal sonography.
TAKEAWAY:
- Most women (95.5%) referred for transvaginal ultrasound had one. Of these ultrasounds, most (90%) were negative or revealed benign findings, 5.2% required a repeat ultrasound, and 4.8% (34 patients) showed suspicious findings.
- Of 34 patients with suspicious findings and recommended for surgery, 15 had ovarian cancer and two had borderline tumors, indicating a positive predictive value of 50% (17 of 34 patients) for ovarian cancer. Of these 17 patients, 12 (70.6%) had stage I or II disease.
- Following abnormal ROCA results, seven other women were diagnosed with endometrial tumors (six of which were stage I), indicating a positive predictive value of 74% (25 of 34) for any cancer.
- The specificity for elevated risk ROCA prompting ultrasound was 98%, and the specificity of the ROCA and ultrasound prompting surgery was 99.8%. The sensitivity for detecting ovarian and borderline cancer was 74% (17 of 23).
IN PRACTICE:
“Remarkably, 70% of ovarian cancers detected by the ROCA” were early stage,” the authors concluded. Although the trial was not powered to detect reduced mortality, the high specificity, positive predictive value, and shift to identifying earlier-stage cancers “support further development of this strategy,” the investigators said.
LIMITATIONS:
This trial was not powered to detect mortality benefit. Six ovarian cancers and borderline tumors were missed. Only 80% of ovarian cancers express cancer antigen 125, potentially limiting the sensitivity of the algorithm.
SOURCE:
This study, led by Chae Young Han from the University of Texas MD Anderson Cancer Center, Houston, was published online on January 12 in the Journal of Clinical Oncology.
DISCLOSURES:
This study was supported by funds from the NCI Early Detection Research Network, the MD Anderson Ovarian SPOREs, the National Cancer Institute, the Department of Health and Human Services, and others. The authors reported receiving research funding, grants, consulting, and personal fees from various companies, including Curio Science, Fujirebio Diagnostics, GlaxoSmithKline, AstraZeneca, and Genentech.
A version of this article appeared on Medscape.com.
TOPLINE:
a new analysis with a 21-year follow-up found.
METHODOLOGY:
- Detecting ovarian cancer at stage I or II could significantly reduce ovarian cancer-related deaths, but only 25%-30% of patients are diagnosed at an early stage.
- In this single-arm prospective analysis, 7,856 healthy postmenopausal women received annual screening for ovarian cancer between 2011 and 2022. Screening involved an annual blood test to detect levels of cancer antigen 125 and track these levels over time.
- Investigators used the Risk of Ovarian Cancer Algorithm (ROCA) to determine whether ovarian cancer risk was normal, intermediate, or high. Those with elevated ROCA scores were referred for transvaginal sonography; those with intermediate scores received follow-up blood tests every 3 months.
- Overall, 92.3% of women were normal risk, 5.7% were intermediate, and 2% were high risk and recommended for transvaginal sonography.
TAKEAWAY:
- Most women (95.5%) referred for transvaginal ultrasound had one. Of these ultrasounds, most (90%) were negative or revealed benign findings, 5.2% required a repeat ultrasound, and 4.8% (34 patients) showed suspicious findings.
- Of 34 patients with suspicious findings and recommended for surgery, 15 had ovarian cancer and two had borderline tumors, indicating a positive predictive value of 50% (17 of 34 patients) for ovarian cancer. Of these 17 patients, 12 (70.6%) had stage I or II disease.
- Following abnormal ROCA results, seven other women were diagnosed with endometrial tumors (six of which were stage I), indicating a positive predictive value of 74% (25 of 34) for any cancer.
- The specificity for elevated risk ROCA prompting ultrasound was 98%, and the specificity of the ROCA and ultrasound prompting surgery was 99.8%. The sensitivity for detecting ovarian and borderline cancer was 74% (17 of 23).
IN PRACTICE:
“Remarkably, 70% of ovarian cancers detected by the ROCA” were early stage,” the authors concluded. Although the trial was not powered to detect reduced mortality, the high specificity, positive predictive value, and shift to identifying earlier-stage cancers “support further development of this strategy,” the investigators said.
LIMITATIONS:
This trial was not powered to detect mortality benefit. Six ovarian cancers and borderline tumors were missed. Only 80% of ovarian cancers express cancer antigen 125, potentially limiting the sensitivity of the algorithm.
SOURCE:
This study, led by Chae Young Han from the University of Texas MD Anderson Cancer Center, Houston, was published online on January 12 in the Journal of Clinical Oncology.
DISCLOSURES:
This study was supported by funds from the NCI Early Detection Research Network, the MD Anderson Ovarian SPOREs, the National Cancer Institute, the Department of Health and Human Services, and others. The authors reported receiving research funding, grants, consulting, and personal fees from various companies, including Curio Science, Fujirebio Diagnostics, GlaxoSmithKline, AstraZeneca, and Genentech.
A version of this article appeared on Medscape.com.
TOPLINE:
a new analysis with a 21-year follow-up found.
METHODOLOGY:
- Detecting ovarian cancer at stage I or II could significantly reduce ovarian cancer-related deaths, but only 25%-30% of patients are diagnosed at an early stage.
- In this single-arm prospective analysis, 7,856 healthy postmenopausal women received annual screening for ovarian cancer between 2011 and 2022. Screening involved an annual blood test to detect levels of cancer antigen 125 and track these levels over time.
- Investigators used the Risk of Ovarian Cancer Algorithm (ROCA) to determine whether ovarian cancer risk was normal, intermediate, or high. Those with elevated ROCA scores were referred for transvaginal sonography; those with intermediate scores received follow-up blood tests every 3 months.
- Overall, 92.3% of women were normal risk, 5.7% were intermediate, and 2% were high risk and recommended for transvaginal sonography.
TAKEAWAY:
- Most women (95.5%) referred for transvaginal ultrasound had one. Of these ultrasounds, most (90%) were negative or revealed benign findings, 5.2% required a repeat ultrasound, and 4.8% (34 patients) showed suspicious findings.
- Of 34 patients with suspicious findings and recommended for surgery, 15 had ovarian cancer and two had borderline tumors, indicating a positive predictive value of 50% (17 of 34 patients) for ovarian cancer. Of these 17 patients, 12 (70.6%) had stage I or II disease.
- Following abnormal ROCA results, seven other women were diagnosed with endometrial tumors (six of which were stage I), indicating a positive predictive value of 74% (25 of 34) for any cancer.
- The specificity for elevated risk ROCA prompting ultrasound was 98%, and the specificity of the ROCA and ultrasound prompting surgery was 99.8%. The sensitivity for detecting ovarian and borderline cancer was 74% (17 of 23).
IN PRACTICE:
“Remarkably, 70% of ovarian cancers detected by the ROCA” were early stage,” the authors concluded. Although the trial was not powered to detect reduced mortality, the high specificity, positive predictive value, and shift to identifying earlier-stage cancers “support further development of this strategy,” the investigators said.
LIMITATIONS:
This trial was not powered to detect mortality benefit. Six ovarian cancers and borderline tumors were missed. Only 80% of ovarian cancers express cancer antigen 125, potentially limiting the sensitivity of the algorithm.
SOURCE:
This study, led by Chae Young Han from the University of Texas MD Anderson Cancer Center, Houston, was published online on January 12 in the Journal of Clinical Oncology.
DISCLOSURES:
This study was supported by funds from the NCI Early Detection Research Network, the MD Anderson Ovarian SPOREs, the National Cancer Institute, the Department of Health and Human Services, and others. The authors reported receiving research funding, grants, consulting, and personal fees from various companies, including Curio Science, Fujirebio Diagnostics, GlaxoSmithKline, AstraZeneca, and Genentech.
A version of this article appeared on Medscape.com.
Europe Is Facing a Pancreatic Cancer Emergency
“It’s a health emergency for society, with mortality rates at over 90%,” warned Professor Alfredo Carrato, MD, PhD, the chairperson of Pancreatic Cancer Europe.
There are many challenges with pancreatic cancer: Lack of awareness, difficult to diagnose, no screening programs for the general population, poor survival rate, and limited treatment options.
Life expectancy at the time of diagnosis is just 4.6 months. Only 3% of people diagnosed with pancreatic cancer will survive for 5 years.
A 2024 systematic analysis in The Lancet suggested that people living in Western Europe are more likely to develop pancreatic cancer than those living anywhere else in the world.
Dr. Carrato, emeritus professor of medical oncology at the University of Alcalá, Madrid, Spain, wasn’t surprised. He told this news organization: “I think the lifestyle in Europe plays a part. We have all of the risk factors in society like obesity, our sedentary behavior, too much red meat consumption, and excess alcohol intake.”
Other risk factors include smoking, diabetes, chronic pancreatitis, and a family history.
The incidence of pancreatic cancer increases with age, so the longer life expectancy in Western Europe could also contribute to the region’s high rates.
A Silent Killer
Pancreatic cancer is difficult to identify. It is often asymptomatic. Symptoms that do show themselves, like back pain, weight loss, and nausea, are nonspecific and make early diagnosis challenging.
Professor Mattias Löhr from the Karolinska Institutet, Stockholm, Sweden, told this news organization: “It’s a dismal disease. It’s not accessible for any easy screening or surveillance. Even early diagnosis is too late with pancreatic cancer.”
There have been few advancements in patient outcomes over the past few decades.
Only about 20% of patients are suitable candidates for surgery that could prolong their lives.
Also, cancer reoccurs in two thirds of surgical candidates, said Dr. Carrato, and oncologists don’t know how to identify them in advance. “I have patients who survive 3 months and others who survive 4 or 5 years, so there’s a need to identify these subtypes at a molecular level for personalized, clinical, and translational research and therapies.”
Dr. Löhr agreed: “All of the medical therapies are not really working well enough for pancreatic cancer in sharp contrast to other cancers.”
How Can Rates Be Reduced?
“Pancreatic Cancer Europe is working in every EU state to try to raise awareness,” said Dr. Carrato. “We should have primary prevention programs to modify lifestyle risks. We also need funds for translational and clinical research. Secondary prevention isn’t possible yet as we haven’t identified the higher-risk population who would be the target for screening.”
Screening programs are available for the 10% of people who have a family history of pancreatic cancer. But, for the vast majority, there are no tests or screenings that allow for earlier detection.
“We need blood or stool tests that have high specificity and sensitivity that are cost-effective,” said Dr. Carrato.
“It’s a type of cancer with a particular and very aggressive biology. There is a lack of pancreatic tumor tissue for research, as many patients are diagnosed by fine-needle aspiration cytology. It’s a challenge for researchers. We have no biomarkers available to direct our decisions; no precision oncology,” he added.
Still, there are some encouraging developments.
The European PANCAID project (pancreatic cancer initial detection via liquid biopsy) is trying to find biomarkers to screen at-risk groups for earlier diagnosis via a blood test.
Also, the European Union (EU)-funded PANCAIM project (pancreatic cancer artificial intelligence [AI] for genomics and personalized medicine) has developed an AI algorithm that detects small cancers in CT scans that even experienced radiologists might easily overlook.
The project’s head, Henkjan Huisman, is professor of medical imaging AI at Radboud University Medical Center, Nijmegen, the Netherlands. He told this news organization: “It’s an extremely important step, as 20% of people with pancreas cancer have the ability to undergo surgery, which means they might live substantially longer. We believe if the tumors are found earlier, thanks to the algorithm, they are smaller and more contained, and so substantially more than 20% of patients would be suitable for surgery, which would be a breakthrough.”
Dr. Löhr added that a messenger RNA vaccine is being developed in the United States to prevent pancreatic cancer from returning after surgery and is demonstrating encouraging results in its early trials.
The Road Toward Better Care
To improve cancer care in Europe, Dr. Carrato said: “Reference centers should be a requirement in health policy programs because the outcomes are much better than in centers which only perform fewer surgeries, and Pancreatic Cancer Europe is working with the EU in this direction.”
Finland is a country that appears to have succeeded in this regard. Its 2005 Health Care Act, for example, ensures that cancer patients are able to receive care in one of its five specialized hospitals.
More research funding is also needed. According to Pancreatic Cancer Europe, only 2% of EU funding on cancer is spent on pancreatic cancer.
The American Cancer Society’s Cancer Facts & Figures 2024 makes room for some optimism, with the 5-year survival rate in the United States jumping to 13% from 6% in the society’s 2014 report, as a result of earlier diagnoses and more personalized treatment. But, even with potentially longer survival rates, said Dr. Löhr, “we are still on the trajectory of pancreatic cancer being number two for cancer deaths by 2030.”
“We need more money on research, centralized surgery, and networking between European countries,” said Dr. Carrato. “This networking would need more money for prevention, better diagnosis, and treatment. The problem is pancreatic cancer incidence is increasing and mortality is also in parallel, and we are not making real progress in this scenario.”
A version of this article appeared on Medscape.com.
“It’s a health emergency for society, with mortality rates at over 90%,” warned Professor Alfredo Carrato, MD, PhD, the chairperson of Pancreatic Cancer Europe.
There are many challenges with pancreatic cancer: Lack of awareness, difficult to diagnose, no screening programs for the general population, poor survival rate, and limited treatment options.
Life expectancy at the time of diagnosis is just 4.6 months. Only 3% of people diagnosed with pancreatic cancer will survive for 5 years.
A 2024 systematic analysis in The Lancet suggested that people living in Western Europe are more likely to develop pancreatic cancer than those living anywhere else in the world.
Dr. Carrato, emeritus professor of medical oncology at the University of Alcalá, Madrid, Spain, wasn’t surprised. He told this news organization: “I think the lifestyle in Europe plays a part. We have all of the risk factors in society like obesity, our sedentary behavior, too much red meat consumption, and excess alcohol intake.”
Other risk factors include smoking, diabetes, chronic pancreatitis, and a family history.
The incidence of pancreatic cancer increases with age, so the longer life expectancy in Western Europe could also contribute to the region’s high rates.
A Silent Killer
Pancreatic cancer is difficult to identify. It is often asymptomatic. Symptoms that do show themselves, like back pain, weight loss, and nausea, are nonspecific and make early diagnosis challenging.
Professor Mattias Löhr from the Karolinska Institutet, Stockholm, Sweden, told this news organization: “It’s a dismal disease. It’s not accessible for any easy screening or surveillance. Even early diagnosis is too late with pancreatic cancer.”
There have been few advancements in patient outcomes over the past few decades.
Only about 20% of patients are suitable candidates for surgery that could prolong their lives.
Also, cancer reoccurs in two thirds of surgical candidates, said Dr. Carrato, and oncologists don’t know how to identify them in advance. “I have patients who survive 3 months and others who survive 4 or 5 years, so there’s a need to identify these subtypes at a molecular level for personalized, clinical, and translational research and therapies.”
Dr. Löhr agreed: “All of the medical therapies are not really working well enough for pancreatic cancer in sharp contrast to other cancers.”
How Can Rates Be Reduced?
“Pancreatic Cancer Europe is working in every EU state to try to raise awareness,” said Dr. Carrato. “We should have primary prevention programs to modify lifestyle risks. We also need funds for translational and clinical research. Secondary prevention isn’t possible yet as we haven’t identified the higher-risk population who would be the target for screening.”
Screening programs are available for the 10% of people who have a family history of pancreatic cancer. But, for the vast majority, there are no tests or screenings that allow for earlier detection.
“We need blood or stool tests that have high specificity and sensitivity that are cost-effective,” said Dr. Carrato.
“It’s a type of cancer with a particular and very aggressive biology. There is a lack of pancreatic tumor tissue for research, as many patients are diagnosed by fine-needle aspiration cytology. It’s a challenge for researchers. We have no biomarkers available to direct our decisions; no precision oncology,” he added.
Still, there are some encouraging developments.
The European PANCAID project (pancreatic cancer initial detection via liquid biopsy) is trying to find biomarkers to screen at-risk groups for earlier diagnosis via a blood test.
Also, the European Union (EU)-funded PANCAIM project (pancreatic cancer artificial intelligence [AI] for genomics and personalized medicine) has developed an AI algorithm that detects small cancers in CT scans that even experienced radiologists might easily overlook.
The project’s head, Henkjan Huisman, is professor of medical imaging AI at Radboud University Medical Center, Nijmegen, the Netherlands. He told this news organization: “It’s an extremely important step, as 20% of people with pancreas cancer have the ability to undergo surgery, which means they might live substantially longer. We believe if the tumors are found earlier, thanks to the algorithm, they are smaller and more contained, and so substantially more than 20% of patients would be suitable for surgery, which would be a breakthrough.”
Dr. Löhr added that a messenger RNA vaccine is being developed in the United States to prevent pancreatic cancer from returning after surgery and is demonstrating encouraging results in its early trials.
The Road Toward Better Care
To improve cancer care in Europe, Dr. Carrato said: “Reference centers should be a requirement in health policy programs because the outcomes are much better than in centers which only perform fewer surgeries, and Pancreatic Cancer Europe is working with the EU in this direction.”
Finland is a country that appears to have succeeded in this regard. Its 2005 Health Care Act, for example, ensures that cancer patients are able to receive care in one of its five specialized hospitals.
More research funding is also needed. According to Pancreatic Cancer Europe, only 2% of EU funding on cancer is spent on pancreatic cancer.
The American Cancer Society’s Cancer Facts & Figures 2024 makes room for some optimism, with the 5-year survival rate in the United States jumping to 13% from 6% in the society’s 2014 report, as a result of earlier diagnoses and more personalized treatment. But, even with potentially longer survival rates, said Dr. Löhr, “we are still on the trajectory of pancreatic cancer being number two for cancer deaths by 2030.”
“We need more money on research, centralized surgery, and networking between European countries,” said Dr. Carrato. “This networking would need more money for prevention, better diagnosis, and treatment. The problem is pancreatic cancer incidence is increasing and mortality is also in parallel, and we are not making real progress in this scenario.”
A version of this article appeared on Medscape.com.
“It’s a health emergency for society, with mortality rates at over 90%,” warned Professor Alfredo Carrato, MD, PhD, the chairperson of Pancreatic Cancer Europe.
There are many challenges with pancreatic cancer: Lack of awareness, difficult to diagnose, no screening programs for the general population, poor survival rate, and limited treatment options.
Life expectancy at the time of diagnosis is just 4.6 months. Only 3% of people diagnosed with pancreatic cancer will survive for 5 years.
A 2024 systematic analysis in The Lancet suggested that people living in Western Europe are more likely to develop pancreatic cancer than those living anywhere else in the world.
Dr. Carrato, emeritus professor of medical oncology at the University of Alcalá, Madrid, Spain, wasn’t surprised. He told this news organization: “I think the lifestyle in Europe plays a part. We have all of the risk factors in society like obesity, our sedentary behavior, too much red meat consumption, and excess alcohol intake.”
Other risk factors include smoking, diabetes, chronic pancreatitis, and a family history.
The incidence of pancreatic cancer increases with age, so the longer life expectancy in Western Europe could also contribute to the region’s high rates.
A Silent Killer
Pancreatic cancer is difficult to identify. It is often asymptomatic. Symptoms that do show themselves, like back pain, weight loss, and nausea, are nonspecific and make early diagnosis challenging.
Professor Mattias Löhr from the Karolinska Institutet, Stockholm, Sweden, told this news organization: “It’s a dismal disease. It’s not accessible for any easy screening or surveillance. Even early diagnosis is too late with pancreatic cancer.”
There have been few advancements in patient outcomes over the past few decades.
Only about 20% of patients are suitable candidates for surgery that could prolong their lives.
Also, cancer reoccurs in two thirds of surgical candidates, said Dr. Carrato, and oncologists don’t know how to identify them in advance. “I have patients who survive 3 months and others who survive 4 or 5 years, so there’s a need to identify these subtypes at a molecular level for personalized, clinical, and translational research and therapies.”
Dr. Löhr agreed: “All of the medical therapies are not really working well enough for pancreatic cancer in sharp contrast to other cancers.”
How Can Rates Be Reduced?
“Pancreatic Cancer Europe is working in every EU state to try to raise awareness,” said Dr. Carrato. “We should have primary prevention programs to modify lifestyle risks. We also need funds for translational and clinical research. Secondary prevention isn’t possible yet as we haven’t identified the higher-risk population who would be the target for screening.”
Screening programs are available for the 10% of people who have a family history of pancreatic cancer. But, for the vast majority, there are no tests or screenings that allow for earlier detection.
“We need blood or stool tests that have high specificity and sensitivity that are cost-effective,” said Dr. Carrato.
“It’s a type of cancer with a particular and very aggressive biology. There is a lack of pancreatic tumor tissue for research, as many patients are diagnosed by fine-needle aspiration cytology. It’s a challenge for researchers. We have no biomarkers available to direct our decisions; no precision oncology,” he added.
Still, there are some encouraging developments.
The European PANCAID project (pancreatic cancer initial detection via liquid biopsy) is trying to find biomarkers to screen at-risk groups for earlier diagnosis via a blood test.
Also, the European Union (EU)-funded PANCAIM project (pancreatic cancer artificial intelligence [AI] for genomics and personalized medicine) has developed an AI algorithm that detects small cancers in CT scans that even experienced radiologists might easily overlook.
The project’s head, Henkjan Huisman, is professor of medical imaging AI at Radboud University Medical Center, Nijmegen, the Netherlands. He told this news organization: “It’s an extremely important step, as 20% of people with pancreas cancer have the ability to undergo surgery, which means they might live substantially longer. We believe if the tumors are found earlier, thanks to the algorithm, they are smaller and more contained, and so substantially more than 20% of patients would be suitable for surgery, which would be a breakthrough.”
Dr. Löhr added that a messenger RNA vaccine is being developed in the United States to prevent pancreatic cancer from returning after surgery and is demonstrating encouraging results in its early trials.
The Road Toward Better Care
To improve cancer care in Europe, Dr. Carrato said: “Reference centers should be a requirement in health policy programs because the outcomes are much better than in centers which only perform fewer surgeries, and Pancreatic Cancer Europe is working with the EU in this direction.”
Finland is a country that appears to have succeeded in this regard. Its 2005 Health Care Act, for example, ensures that cancer patients are able to receive care in one of its five specialized hospitals.
More research funding is also needed. According to Pancreatic Cancer Europe, only 2% of EU funding on cancer is spent on pancreatic cancer.
The American Cancer Society’s Cancer Facts & Figures 2024 makes room for some optimism, with the 5-year survival rate in the United States jumping to 13% from 6% in the society’s 2014 report, as a result of earlier diagnoses and more personalized treatment. But, even with potentially longer survival rates, said Dr. Löhr, “we are still on the trajectory of pancreatic cancer being number two for cancer deaths by 2030.”
“We need more money on research, centralized surgery, and networking between European countries,” said Dr. Carrato. “This networking would need more money for prevention, better diagnosis, and treatment. The problem is pancreatic cancer incidence is increasing and mortality is also in parallel, and we are not making real progress in this scenario.”
A version of this article appeared on Medscape.com.
High-dose RT and long-term ADT improve survival in high-risk prostate cancer
For patients with high-risk prostate cancer, treatment with long-term androgen deprivation therapy (ADT) and high-dose radiation was associated with significantly better progression-free, cancer-specific, and overall survival compared with ADT and standard-dose radiation.
The investigators also found that the patients taking long-term ADT and high-dose radiation did not experience additional late urinary tract or gastrointestinal toxicities. Christophe Hennequin, MD, PhD, reported these and other findings of the Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18) trial, at the 2024 American Society for Clinical Oncology (ASCO) Genitourinary Cancers Symposium.
Among 505 patients randomly assigned to be treated with radiation therapy (RT) at either the standard 70 Gy dose or a high, 80 Gy dose followed by 3 years of adjuvant ADT, the 10-year progression-free survival (PFS) rate was 83.6% for patients who had received the 80 Gy dose, vs. 72.2% for patients who had received the 70 Gy dose. This translated into a hazard ratio (HR) for biochemical or clinical progression of 0.56 (P = .0005).
This PFS advantage for high-dose radiation was also reflected by an overall survival (OS) advantage, with 10-year OS rates of 77% vs. 65.9%, respectively, translating into a 39% reduction in risk of death (HR 0.61, P = .0039) for patients who had received the higher radiation dose, reported Dr. Hennequin, of the Hospital Saint Louis in Paris, France.
"We have now Level 1 evidence that high-dose RT with long-term ADT must be the standard of care in high-risk prostate cancer patients," he said at the meeting.
Dr. Hennequin noted that significantly more patients assigned to high-dose RT were treated with intensity modulated radiation therapy (IMRT) rather than conventional beam radiation, and emphasized that the superior results seen with the higher dose is likely due to the use of IMRT.
Prior evidence
Dr. Hennequin pointed to a meta-analysis published in The Lancet in 2022 which showed that among nearly 11,000 patients with a median follow-up of 11.4 years the addition of ADT to RT significantly improved metastasis-free survival, and that longer ADT reduced the risk of metastases by 16% compared with standard schedule ADT.
He also cited the DART 01/05 trial results, which were published in 2022 in The Lancet: Oncology, which found a clinically relevant benefit for 24 months vs. 4 months of adjuvant ADT following a minimum of 76 Gy radiation in patients with high-risk disease, but not among patients with intermediate-risk disease.
The GETUG-AFU 18 trial was designed to address the question of whether 80 Gy of radiation could improve outcomes compared with 70 Gy in patients treated with long-term ADT.
Study details and results
The investigators enrolled men with high-risk prostate cancer defined as either a prostate-specific antigen (PSA) level 20 ng/ml or greater, Gleason score 8 or higher, or clinical stage T3 or T4 disease, and after stratification by treatment center and lymph node resection randomly assigned them to receive either 70 Gy or 80 Gy RT followed by 3 years of ADT.
Approximately two-thirds of the patients in each study arm had one risk factor and about one-fourth had two risk factors. The remaining patients had all three high-risk defining factors.
Approximately 16.5% of patients in each arm had undergone lymph node dissection.
The median ADT duration was 33.4 months. In all, 82.9% of patients underwent pelvic lymph node radiation; lymph node radiation was not performed in those patients who had negative node dissection results.
Significantly more patients assigned to the 80 Gy dose were treated with IMRT (80.6% vs. 58.6%, P < .001).
The cancer-specific survival rate was also higher for the group receiving the 80 Gy dose, with a 10 year rate of 95.6% vs. 90% for patients treated with 70 Gy. This difference translated into a HR of 0.48 (P = .0090).
Comparable safety
The safety analysis, which included 248 patients who received 80 Gy and 251 who received 70 Gy, showed that the incidence rates of both late genitourinary and gastrointestinal toxicities were low and comparable between the groups. Grade 3 or greater late genitourinary toxicities were seen in 2.0% of patients treated with 80 Gy and 3.2% of those treated with 70 Gy. In both arms, only 1.6% of patients had grade 3 or greater later GI toxicities.
There were also no differences between the study arms in patient-reported quality of life measures related to either bowel or urinary symptoms.
Invited discussant Neha Vapiwala, MD, FACR, from Penn Medicine in Philadelphia commented that the results of the GETUG-AFU 18 trial suggest that "if you had even lower-dose systemic therapy that the radiation control at the local level - local-regional level in this case - can in fact contribute to the prevention of distant metastases and can contribute to cancer-specific survival."
She said that with the efficacy results and the comparable toxicity and quality of life measures, dose-escalated radiation therapy and long-term ADT appear to offer a synergistic benefit.
The results are "practice-affirming for many, perhaps practice-changing for some if you're not already offering this," she said.
For patients with high-risk prostate cancer, treatment with long-term androgen deprivation therapy (ADT) and high-dose radiation was associated with significantly better progression-free, cancer-specific, and overall survival compared with ADT and standard-dose radiation.
The investigators also found that the patients taking long-term ADT and high-dose radiation did not experience additional late urinary tract or gastrointestinal toxicities. Christophe Hennequin, MD, PhD, reported these and other findings of the Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18) trial, at the 2024 American Society for Clinical Oncology (ASCO) Genitourinary Cancers Symposium.
Among 505 patients randomly assigned to be treated with radiation therapy (RT) at either the standard 70 Gy dose or a high, 80 Gy dose followed by 3 years of adjuvant ADT, the 10-year progression-free survival (PFS) rate was 83.6% for patients who had received the 80 Gy dose, vs. 72.2% for patients who had received the 70 Gy dose. This translated into a hazard ratio (HR) for biochemical or clinical progression of 0.56 (P = .0005).
This PFS advantage for high-dose radiation was also reflected by an overall survival (OS) advantage, with 10-year OS rates of 77% vs. 65.9%, respectively, translating into a 39% reduction in risk of death (HR 0.61, P = .0039) for patients who had received the higher radiation dose, reported Dr. Hennequin, of the Hospital Saint Louis in Paris, France.
"We have now Level 1 evidence that high-dose RT with long-term ADT must be the standard of care in high-risk prostate cancer patients," he said at the meeting.
Dr. Hennequin noted that significantly more patients assigned to high-dose RT were treated with intensity modulated radiation therapy (IMRT) rather than conventional beam radiation, and emphasized that the superior results seen with the higher dose is likely due to the use of IMRT.
Prior evidence
Dr. Hennequin pointed to a meta-analysis published in The Lancet in 2022 which showed that among nearly 11,000 patients with a median follow-up of 11.4 years the addition of ADT to RT significantly improved metastasis-free survival, and that longer ADT reduced the risk of metastases by 16% compared with standard schedule ADT.
He also cited the DART 01/05 trial results, which were published in 2022 in The Lancet: Oncology, which found a clinically relevant benefit for 24 months vs. 4 months of adjuvant ADT following a minimum of 76 Gy radiation in patients with high-risk disease, but not among patients with intermediate-risk disease.
The GETUG-AFU 18 trial was designed to address the question of whether 80 Gy of radiation could improve outcomes compared with 70 Gy in patients treated with long-term ADT.
Study details and results
The investigators enrolled men with high-risk prostate cancer defined as either a prostate-specific antigen (PSA) level 20 ng/ml or greater, Gleason score 8 or higher, or clinical stage T3 or T4 disease, and after stratification by treatment center and lymph node resection randomly assigned them to receive either 70 Gy or 80 Gy RT followed by 3 years of ADT.
Approximately two-thirds of the patients in each study arm had one risk factor and about one-fourth had two risk factors. The remaining patients had all three high-risk defining factors.
Approximately 16.5% of patients in each arm had undergone lymph node dissection.
The median ADT duration was 33.4 months. In all, 82.9% of patients underwent pelvic lymph node radiation; lymph node radiation was not performed in those patients who had negative node dissection results.
Significantly more patients assigned to the 80 Gy dose were treated with IMRT (80.6% vs. 58.6%, P < .001).
The cancer-specific survival rate was also higher for the group receiving the 80 Gy dose, with a 10 year rate of 95.6% vs. 90% for patients treated with 70 Gy. This difference translated into a HR of 0.48 (P = .0090).
Comparable safety
The safety analysis, which included 248 patients who received 80 Gy and 251 who received 70 Gy, showed that the incidence rates of both late genitourinary and gastrointestinal toxicities were low and comparable between the groups. Grade 3 or greater late genitourinary toxicities were seen in 2.0% of patients treated with 80 Gy and 3.2% of those treated with 70 Gy. In both arms, only 1.6% of patients had grade 3 or greater later GI toxicities.
There were also no differences between the study arms in patient-reported quality of life measures related to either bowel or urinary symptoms.
Invited discussant Neha Vapiwala, MD, FACR, from Penn Medicine in Philadelphia commented that the results of the GETUG-AFU 18 trial suggest that "if you had even lower-dose systemic therapy that the radiation control at the local level - local-regional level in this case - can in fact contribute to the prevention of distant metastases and can contribute to cancer-specific survival."
She said that with the efficacy results and the comparable toxicity and quality of life measures, dose-escalated radiation therapy and long-term ADT appear to offer a synergistic benefit.
The results are "practice-affirming for many, perhaps practice-changing for some if you're not already offering this," she said.
For patients with high-risk prostate cancer, treatment with long-term androgen deprivation therapy (ADT) and high-dose radiation was associated with significantly better progression-free, cancer-specific, and overall survival compared with ADT and standard-dose radiation.
The investigators also found that the patients taking long-term ADT and high-dose radiation did not experience additional late urinary tract or gastrointestinal toxicities. Christophe Hennequin, MD, PhD, reported these and other findings of the Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18) trial, at the 2024 American Society for Clinical Oncology (ASCO) Genitourinary Cancers Symposium.
Among 505 patients randomly assigned to be treated with radiation therapy (RT) at either the standard 70 Gy dose or a high, 80 Gy dose followed by 3 years of adjuvant ADT, the 10-year progression-free survival (PFS) rate was 83.6% for patients who had received the 80 Gy dose, vs. 72.2% for patients who had received the 70 Gy dose. This translated into a hazard ratio (HR) for biochemical or clinical progression of 0.56 (P = .0005).
This PFS advantage for high-dose radiation was also reflected by an overall survival (OS) advantage, with 10-year OS rates of 77% vs. 65.9%, respectively, translating into a 39% reduction in risk of death (HR 0.61, P = .0039) for patients who had received the higher radiation dose, reported Dr. Hennequin, of the Hospital Saint Louis in Paris, France.
"We have now Level 1 evidence that high-dose RT with long-term ADT must be the standard of care in high-risk prostate cancer patients," he said at the meeting.
Dr. Hennequin noted that significantly more patients assigned to high-dose RT were treated with intensity modulated radiation therapy (IMRT) rather than conventional beam radiation, and emphasized that the superior results seen with the higher dose is likely due to the use of IMRT.
Prior evidence
Dr. Hennequin pointed to a meta-analysis published in The Lancet in 2022 which showed that among nearly 11,000 patients with a median follow-up of 11.4 years the addition of ADT to RT significantly improved metastasis-free survival, and that longer ADT reduced the risk of metastases by 16% compared with standard schedule ADT.
He also cited the DART 01/05 trial results, which were published in 2022 in The Lancet: Oncology, which found a clinically relevant benefit for 24 months vs. 4 months of adjuvant ADT following a minimum of 76 Gy radiation in patients with high-risk disease, but not among patients with intermediate-risk disease.
The GETUG-AFU 18 trial was designed to address the question of whether 80 Gy of radiation could improve outcomes compared with 70 Gy in patients treated with long-term ADT.
Study details and results
The investigators enrolled men with high-risk prostate cancer defined as either a prostate-specific antigen (PSA) level 20 ng/ml or greater, Gleason score 8 or higher, or clinical stage T3 or T4 disease, and after stratification by treatment center and lymph node resection randomly assigned them to receive either 70 Gy or 80 Gy RT followed by 3 years of ADT.
Approximately two-thirds of the patients in each study arm had one risk factor and about one-fourth had two risk factors. The remaining patients had all three high-risk defining factors.
Approximately 16.5% of patients in each arm had undergone lymph node dissection.
The median ADT duration was 33.4 months. In all, 82.9% of patients underwent pelvic lymph node radiation; lymph node radiation was not performed in those patients who had negative node dissection results.
Significantly more patients assigned to the 80 Gy dose were treated with IMRT (80.6% vs. 58.6%, P < .001).
The cancer-specific survival rate was also higher for the group receiving the 80 Gy dose, with a 10 year rate of 95.6% vs. 90% for patients treated with 70 Gy. This difference translated into a HR of 0.48 (P = .0090).
Comparable safety
The safety analysis, which included 248 patients who received 80 Gy and 251 who received 70 Gy, showed that the incidence rates of both late genitourinary and gastrointestinal toxicities were low and comparable between the groups. Grade 3 or greater late genitourinary toxicities were seen in 2.0% of patients treated with 80 Gy and 3.2% of those treated with 70 Gy. In both arms, only 1.6% of patients had grade 3 or greater later GI toxicities.
There were also no differences between the study arms in patient-reported quality of life measures related to either bowel or urinary symptoms.
Invited discussant Neha Vapiwala, MD, FACR, from Penn Medicine in Philadelphia commented that the results of the GETUG-AFU 18 trial suggest that "if you had even lower-dose systemic therapy that the radiation control at the local level - local-regional level in this case - can in fact contribute to the prevention of distant metastases and can contribute to cancer-specific survival."
She said that with the efficacy results and the comparable toxicity and quality of life measures, dose-escalated radiation therapy and long-term ADT appear to offer a synergistic benefit.
The results are "practice-affirming for many, perhaps practice-changing for some if you're not already offering this," she said.
FROM ASCO GU 2024
Dana-Farber Moves to Retract, Correct Dozens of Cancer Papers Amid Allegations
News of the investigation follows a blog post by British molecular biologist Sholto David, MD, who flagged almost 60 papers published between 1997 and 2017 that contained image manipulation and other errors. Some of the papers were published by Dana-Farber’s chief executive officer, Laurie Glimcher, MD, and chief operating officer, William Hahn, MD, on topics including multiple myeloma and immune cells.
Mr. David, who blogs about research integrity, highlighted numerous errors and irregularities, including copying and pasting images across multiple experiments to represent different days within the same experiment, sometimes rotating or stretching images.
In one case, Mr. David equated the manipulation with tactics used by “hapless Chinese papermills” and concluded that “a swathe of research coming out of [Dana-Farber] authored by the most senior researchers and managers appears to be hopelessly corrupt with errors that are obvious from just a cursory reading the papers.”
“Imagine what mistakes might be found in the raw data if anyone was allowed to look!” he wrote.
Barrett Rollins, MD, PhD, Dana-Farber Cancer Institute’s research integrity officer, declined to comment on whether the errors represent scientific misconduct, according to STAT. Rollins told ScienceInsider that the “presence of image discrepancies in a paper is not evidence of an author’s intent to deceive.”
Access to new artificial intelligence tools is making it easier for data sleuths, like Mr. David, to unearth data manipulation and errors.
The current investigation closely follows two other investigations into the published work of Harvard University’s former president, Claudine Gay, and Stanford University’s former president, Marc Tessier-Lavigne, which led both to resign their posts.
A version of this article appeared on Medscape.com.
News of the investigation follows a blog post by British molecular biologist Sholto David, MD, who flagged almost 60 papers published between 1997 and 2017 that contained image manipulation and other errors. Some of the papers were published by Dana-Farber’s chief executive officer, Laurie Glimcher, MD, and chief operating officer, William Hahn, MD, on topics including multiple myeloma and immune cells.
Mr. David, who blogs about research integrity, highlighted numerous errors and irregularities, including copying and pasting images across multiple experiments to represent different days within the same experiment, sometimes rotating or stretching images.
In one case, Mr. David equated the manipulation with tactics used by “hapless Chinese papermills” and concluded that “a swathe of research coming out of [Dana-Farber] authored by the most senior researchers and managers appears to be hopelessly corrupt with errors that are obvious from just a cursory reading the papers.”
“Imagine what mistakes might be found in the raw data if anyone was allowed to look!” he wrote.
Barrett Rollins, MD, PhD, Dana-Farber Cancer Institute’s research integrity officer, declined to comment on whether the errors represent scientific misconduct, according to STAT. Rollins told ScienceInsider that the “presence of image discrepancies in a paper is not evidence of an author’s intent to deceive.”
Access to new artificial intelligence tools is making it easier for data sleuths, like Mr. David, to unearth data manipulation and errors.
The current investigation closely follows two other investigations into the published work of Harvard University’s former president, Claudine Gay, and Stanford University’s former president, Marc Tessier-Lavigne, which led both to resign their posts.
A version of this article appeared on Medscape.com.
News of the investigation follows a blog post by British molecular biologist Sholto David, MD, who flagged almost 60 papers published between 1997 and 2017 that contained image manipulation and other errors. Some of the papers were published by Dana-Farber’s chief executive officer, Laurie Glimcher, MD, and chief operating officer, William Hahn, MD, on topics including multiple myeloma and immune cells.
Mr. David, who blogs about research integrity, highlighted numerous errors and irregularities, including copying and pasting images across multiple experiments to represent different days within the same experiment, sometimes rotating or stretching images.
In one case, Mr. David equated the manipulation with tactics used by “hapless Chinese papermills” and concluded that “a swathe of research coming out of [Dana-Farber] authored by the most senior researchers and managers appears to be hopelessly corrupt with errors that are obvious from just a cursory reading the papers.”
“Imagine what mistakes might be found in the raw data if anyone was allowed to look!” he wrote.
Barrett Rollins, MD, PhD, Dana-Farber Cancer Institute’s research integrity officer, declined to comment on whether the errors represent scientific misconduct, according to STAT. Rollins told ScienceInsider that the “presence of image discrepancies in a paper is not evidence of an author’s intent to deceive.”
Access to new artificial intelligence tools is making it easier for data sleuths, like Mr. David, to unearth data manipulation and errors.
The current investigation closely follows two other investigations into the published work of Harvard University’s former president, Claudine Gay, and Stanford University’s former president, Marc Tessier-Lavigne, which led both to resign their posts.
A version of this article appeared on Medscape.com.
Cancer Identified as a New Cardiovascular Risk Factor
A history of cancer is an independent predictor of major cardiovascular events in patients undergoing coronary angioplasty. Cancer should be considered a new cardiovascular risk factor in primary and secondary prevention, according to a study presented at the 2023 American Heart Association Congress in Philadelphia.
, for example, equating it to the situation of a patient with diabetes or chronic renal failure,” said lead author Renzo Melchiori, MD, a cardiologist at the University Hospital Austral in Pilar, Argentina.
The researchers also advocate for intensifying cardiovascular control measures in secondary prevention for these patients, reconsidering goals, and ensuring compliance with prescribed pharmacological regimens and healthy lifestyle habits.
“Previously, when a patient had oncological pathology, thinking about associated cardiovascular risk seemed somewhat superfluous. But today, oncological diseases are treated so effectively, increasing survival and life expectancy, that we begin to focus on what happens with the arteries of these patients after treatment,” said Dr. Melchiori.
Higher Incidence Density
The retrospective analysis included 937 patients of both sexes aged 18 years and older who underwent coronary angioplasty for acute coronary syndrome between 2008 and 2022 at a university hospital. Of these participants, 89 (9.5%) had a history of cancer, with a median time since oncologic diagnosis of around 2 years for solid and hematologic tumors. Most participants had treated and resolved cancer.
Over a median follow-up of 45 months (range, 14-72 months), the cumulative incidence rates of a major cardiovascular event (nonfatal stroke, nonfatal acute myocardial infarction, cardiovascular death, or new angioplasty) were 22.2% (155/698) and 28.4% (25/88) in the groups without and with a history of cancer, respectively. The incidence density was significantly higher in the group with an oncologic history than in the group without such a history: 0.78 events/100 patients/month vs 0.48 events/100 patients/month (P = .01).
Kaplan-Meier analysis showed a higher probability of a major cardiovascular event in the group of patients with cancer or a history of cancer (P = .0086). In multivariate Cox regression analysis, cancer history was an independent predictor of major cardiovascular events adjusted for other risk factors such as age, hypertension, diabetes, smoking, sedentary lifestyle, and family history (hazard ratio, 1.66; P = .025).
Dr. Melchiori clarified that the increased incidence of cardiovascular events in patients with cancer or a history of cancer cannot be attributed to differences in percutaneous intervention or the indication or compliance of post-treatment pharmacological therapy.
In addition, the specialist acknowledged that due to the sample size, discrimination by cancer type, disease stage, or therapeutic strategies couldn’t be performed. A subanalysis, which has not been presented, indicated that the effect could not be explained solely by the application of radiotherapy or chemotherapy in the 90 days before angioplasty — two factors that cause arterial inflammation.
Intensifying Prevention Measures
Two independent experts told this news organization that the new study is "interesting" and reinforces the close connection between oncologic and cardiovascular pathology.
Andrés Daniele, MD, cardiologist and president of the Argentine Cardio-Oncology Association, a local chapter of the International Cardio-Oncology Society, emphasized that the study “reiterates an observation seen in other works: A higher rate of atherosclerotic pathology and cardiovascular events in patients with a history of cancer. And that has a reason to be: Both pathologies present common risk factors, and on the other hand, there is greater endothelial dysfunction secondary to the inflammatory syndrome and oncologic therapies.”
“There needs to be a continuum in the intensification of measures in primary and secondary cardiovascular prevention in cancer survivors, whether in remission or with chronic disease. We need to be very aggressive in managing risk factors and insist that patients who have had a cardiovascular event enter cardiovascular rehabilitation therapies,” said Dr. Daniele, who also heads the Cardio-Oncology Department at the centenary Roffo Institute of Oncology at the University of Buenos Aires, Argentina.
The study provides a valuable contribution because “we need to understand the epidemiology and natural history of patients with cancer at risk of developing cardiovascular complications to implement personalized cardiovascular prevention strategies,” said Teresa López Fernández, MD, cardiologist, coordinator of the Cardio-Oncology Program at La Paz University Hospital in Madrid, member of the Cardio-Oncology Working Group of the Spanish Society of Cardiology, member of the board of the International Cardio-Oncology Society, and cochair of the first clinical practice guidelines in cardio-oncology of the European Society of Cardiology.
“We have to be aware that perhaps we should not guide ourselves in these patients with the usual risk stratification scores as cancer or cardiotoxic treatment are not included as variables. However, they require our attention and effort to improve their quality and quantity of life, avoiding potentially preventable cardiovascular events that could negatively impact the survival achieved thanks to advances in cancer treatments,” said Dr. López Fernández.
Dr. Melchiori and Dr. Daniele declared no relevant economic conflicts of interest. Dr. López Fernández reported relationships with Daiichi Sankyo, Almirall España, Janssen-Cilag, Bayer, Roche, Philips, and Incyte.
This article was translated from the Medscape Spanish edition. A version of this article appeared on Medscape.com.
A history of cancer is an independent predictor of major cardiovascular events in patients undergoing coronary angioplasty. Cancer should be considered a new cardiovascular risk factor in primary and secondary prevention, according to a study presented at the 2023 American Heart Association Congress in Philadelphia.
, for example, equating it to the situation of a patient with diabetes or chronic renal failure,” said lead author Renzo Melchiori, MD, a cardiologist at the University Hospital Austral in Pilar, Argentina.
The researchers also advocate for intensifying cardiovascular control measures in secondary prevention for these patients, reconsidering goals, and ensuring compliance with prescribed pharmacological regimens and healthy lifestyle habits.
“Previously, when a patient had oncological pathology, thinking about associated cardiovascular risk seemed somewhat superfluous. But today, oncological diseases are treated so effectively, increasing survival and life expectancy, that we begin to focus on what happens with the arteries of these patients after treatment,” said Dr. Melchiori.
Higher Incidence Density
The retrospective analysis included 937 patients of both sexes aged 18 years and older who underwent coronary angioplasty for acute coronary syndrome between 2008 and 2022 at a university hospital. Of these participants, 89 (9.5%) had a history of cancer, with a median time since oncologic diagnosis of around 2 years for solid and hematologic tumors. Most participants had treated and resolved cancer.
Over a median follow-up of 45 months (range, 14-72 months), the cumulative incidence rates of a major cardiovascular event (nonfatal stroke, nonfatal acute myocardial infarction, cardiovascular death, or new angioplasty) were 22.2% (155/698) and 28.4% (25/88) in the groups without and with a history of cancer, respectively. The incidence density was significantly higher in the group with an oncologic history than in the group without such a history: 0.78 events/100 patients/month vs 0.48 events/100 patients/month (P = .01).
Kaplan-Meier analysis showed a higher probability of a major cardiovascular event in the group of patients with cancer or a history of cancer (P = .0086). In multivariate Cox regression analysis, cancer history was an independent predictor of major cardiovascular events adjusted for other risk factors such as age, hypertension, diabetes, smoking, sedentary lifestyle, and family history (hazard ratio, 1.66; P = .025).
Dr. Melchiori clarified that the increased incidence of cardiovascular events in patients with cancer or a history of cancer cannot be attributed to differences in percutaneous intervention or the indication or compliance of post-treatment pharmacological therapy.
In addition, the specialist acknowledged that due to the sample size, discrimination by cancer type, disease stage, or therapeutic strategies couldn’t be performed. A subanalysis, which has not been presented, indicated that the effect could not be explained solely by the application of radiotherapy or chemotherapy in the 90 days before angioplasty — two factors that cause arterial inflammation.
Intensifying Prevention Measures
Two independent experts told this news organization that the new study is "interesting" and reinforces the close connection between oncologic and cardiovascular pathology.
Andrés Daniele, MD, cardiologist and president of the Argentine Cardio-Oncology Association, a local chapter of the International Cardio-Oncology Society, emphasized that the study “reiterates an observation seen in other works: A higher rate of atherosclerotic pathology and cardiovascular events in patients with a history of cancer. And that has a reason to be: Both pathologies present common risk factors, and on the other hand, there is greater endothelial dysfunction secondary to the inflammatory syndrome and oncologic therapies.”
“There needs to be a continuum in the intensification of measures in primary and secondary cardiovascular prevention in cancer survivors, whether in remission or with chronic disease. We need to be very aggressive in managing risk factors and insist that patients who have had a cardiovascular event enter cardiovascular rehabilitation therapies,” said Dr. Daniele, who also heads the Cardio-Oncology Department at the centenary Roffo Institute of Oncology at the University of Buenos Aires, Argentina.
The study provides a valuable contribution because “we need to understand the epidemiology and natural history of patients with cancer at risk of developing cardiovascular complications to implement personalized cardiovascular prevention strategies,” said Teresa López Fernández, MD, cardiologist, coordinator of the Cardio-Oncology Program at La Paz University Hospital in Madrid, member of the Cardio-Oncology Working Group of the Spanish Society of Cardiology, member of the board of the International Cardio-Oncology Society, and cochair of the first clinical practice guidelines in cardio-oncology of the European Society of Cardiology.
“We have to be aware that perhaps we should not guide ourselves in these patients with the usual risk stratification scores as cancer or cardiotoxic treatment are not included as variables. However, they require our attention and effort to improve their quality and quantity of life, avoiding potentially preventable cardiovascular events that could negatively impact the survival achieved thanks to advances in cancer treatments,” said Dr. López Fernández.
Dr. Melchiori and Dr. Daniele declared no relevant economic conflicts of interest. Dr. López Fernández reported relationships with Daiichi Sankyo, Almirall España, Janssen-Cilag, Bayer, Roche, Philips, and Incyte.
This article was translated from the Medscape Spanish edition. A version of this article appeared on Medscape.com.
A history of cancer is an independent predictor of major cardiovascular events in patients undergoing coronary angioplasty. Cancer should be considered a new cardiovascular risk factor in primary and secondary prevention, according to a study presented at the 2023 American Heart Association Congress in Philadelphia.
, for example, equating it to the situation of a patient with diabetes or chronic renal failure,” said lead author Renzo Melchiori, MD, a cardiologist at the University Hospital Austral in Pilar, Argentina.
The researchers also advocate for intensifying cardiovascular control measures in secondary prevention for these patients, reconsidering goals, and ensuring compliance with prescribed pharmacological regimens and healthy lifestyle habits.
“Previously, when a patient had oncological pathology, thinking about associated cardiovascular risk seemed somewhat superfluous. But today, oncological diseases are treated so effectively, increasing survival and life expectancy, that we begin to focus on what happens with the arteries of these patients after treatment,” said Dr. Melchiori.
Higher Incidence Density
The retrospective analysis included 937 patients of both sexes aged 18 years and older who underwent coronary angioplasty for acute coronary syndrome between 2008 and 2022 at a university hospital. Of these participants, 89 (9.5%) had a history of cancer, with a median time since oncologic diagnosis of around 2 years for solid and hematologic tumors. Most participants had treated and resolved cancer.
Over a median follow-up of 45 months (range, 14-72 months), the cumulative incidence rates of a major cardiovascular event (nonfatal stroke, nonfatal acute myocardial infarction, cardiovascular death, or new angioplasty) were 22.2% (155/698) and 28.4% (25/88) in the groups without and with a history of cancer, respectively. The incidence density was significantly higher in the group with an oncologic history than in the group without such a history: 0.78 events/100 patients/month vs 0.48 events/100 patients/month (P = .01).
Kaplan-Meier analysis showed a higher probability of a major cardiovascular event in the group of patients with cancer or a history of cancer (P = .0086). In multivariate Cox regression analysis, cancer history was an independent predictor of major cardiovascular events adjusted for other risk factors such as age, hypertension, diabetes, smoking, sedentary lifestyle, and family history (hazard ratio, 1.66; P = .025).
Dr. Melchiori clarified that the increased incidence of cardiovascular events in patients with cancer or a history of cancer cannot be attributed to differences in percutaneous intervention or the indication or compliance of post-treatment pharmacological therapy.
In addition, the specialist acknowledged that due to the sample size, discrimination by cancer type, disease stage, or therapeutic strategies couldn’t be performed. A subanalysis, which has not been presented, indicated that the effect could not be explained solely by the application of radiotherapy or chemotherapy in the 90 days before angioplasty — two factors that cause arterial inflammation.
Intensifying Prevention Measures
Two independent experts told this news organization that the new study is "interesting" and reinforces the close connection between oncologic and cardiovascular pathology.
Andrés Daniele, MD, cardiologist and president of the Argentine Cardio-Oncology Association, a local chapter of the International Cardio-Oncology Society, emphasized that the study “reiterates an observation seen in other works: A higher rate of atherosclerotic pathology and cardiovascular events in patients with a history of cancer. And that has a reason to be: Both pathologies present common risk factors, and on the other hand, there is greater endothelial dysfunction secondary to the inflammatory syndrome and oncologic therapies.”
“There needs to be a continuum in the intensification of measures in primary and secondary cardiovascular prevention in cancer survivors, whether in remission or with chronic disease. We need to be very aggressive in managing risk factors and insist that patients who have had a cardiovascular event enter cardiovascular rehabilitation therapies,” said Dr. Daniele, who also heads the Cardio-Oncology Department at the centenary Roffo Institute of Oncology at the University of Buenos Aires, Argentina.
The study provides a valuable contribution because “we need to understand the epidemiology and natural history of patients with cancer at risk of developing cardiovascular complications to implement personalized cardiovascular prevention strategies,” said Teresa López Fernández, MD, cardiologist, coordinator of the Cardio-Oncology Program at La Paz University Hospital in Madrid, member of the Cardio-Oncology Working Group of the Spanish Society of Cardiology, member of the board of the International Cardio-Oncology Society, and cochair of the first clinical practice guidelines in cardio-oncology of the European Society of Cardiology.
“We have to be aware that perhaps we should not guide ourselves in these patients with the usual risk stratification scores as cancer or cardiotoxic treatment are not included as variables. However, they require our attention and effort to improve their quality and quantity of life, avoiding potentially preventable cardiovascular events that could negatively impact the survival achieved thanks to advances in cancer treatments,” said Dr. López Fernández.
Dr. Melchiori and Dr. Daniele declared no relevant economic conflicts of interest. Dr. López Fernández reported relationships with Daiichi Sankyo, Almirall España, Janssen-Cilag, Bayer, Roche, Philips, and Incyte.
This article was translated from the Medscape Spanish edition. A version of this article appeared on Medscape.com.
Bladder Cancer: Is Active Surveillance the Way Forward?
PARIS — Should clinicians promote active surveillance for non–muscle-invasive bladder tumors (NMIBT) and establish it as a comprehensive management approach, as with prostate and kidney cancers?
During the 117th congress of the French Association of Urology (AFU), Benjamin Pradère, MD, urologic surgeon at Croix du Sud Clinic in Quint-Fonsegrives, France, advocated for this approach, suggesting that the use of biomarkers could enhance its effectiveness.
However, it requires careful patient selection, proper information, and relevant follow-up,” said Dr. Pradère, who is a member of the AFU Cancer Committee (CCAFU).
Low-Grade Tumors
NMIBTs are precancerous lesions and constitute 70%-80% of diagnosed bladder tumors. The remaining tumors are more severe invasive tumors that infiltrate deep tissues. NMIBTs, however, entail a high risk for recurrence (reaching 80% after endoscopic resection), as well as a high risk for progression.
As a result, the diagnosis of NMIBT involves follow-up that significantly impacts patients’ quality of life due to repeated cystoscopies and endovesical treatments. “Tumors with the most impact are low-grade Ta tumors”, with longer-term monitoring required for these low-risk tumors.
Hematuria is the most frequent clinical sign. NMIBT diagnosis occurs after endoscopic tumor resection via transurethral resection, followed by an anatomopathological analysis to determine cell grade and tumor stage. Treatment depends on the risk of recurrence and progression, as well as the risk of therapeutic failure after the initial resection.
Risk stratification distinguishes the following four levels:
- Low-risk tumors: Low-grade pTa urothelial tumors, unifocal, < 3 cm, no history of bladder tumors. Low risk of recurrence and progression.
- Intermediate-risk tumors: Other low-grade pTa urothelial tumors with no high-risk criteria. Low risk of progression but high risk of recurrence.
- High-risk tumors: Tumors with at least one risk factor: Stage pT1, high grade, presence of carcinoma in situ. High risks of progression and recurrence.
- Very high-risk tumors: Tumors combining all risk factors (pT1 grade with carcinoma in situ). Very high and early risk of progression.
“We know that low-grade NMIBTs have no impact on survival,” said Dr. Pradère. For these tumors, which represent 60% of diagnosed NMIBTs, or approximately 250,000 new cases annually in France, specific survival is > 99%, meaning that most diagnosed patients will not die of bladder cancer.
The recurrence rate for low-grade tumors is 50%, but recurrences are “almost always low-grade and rarely invade the basement membrane,” said Pradère. Implementing active surveillance to limit surgical intervention to more advanced forms seems to be relevant for these tumors.
Cystoscopy Every 3 Months
According to CCAFU recommendations, “active surveillance is a therapeutic alternative that can be proposed for patients with recurrent low-risk NMIBT after the initial diagnosis.” Criteria include low-grade pTa, fewer than five tumors, size ≤ 15 mm, negative urinary cytology, asymptomatic nature, and the patient’s acceptance of closer monitoring.
While active surveillance has become the standard treatment for low-risk prostate cancer, this therapeutic option remains marginal in bladder cancer, as in kidney cancer. The goal is to defer or avoid surgical treatment by closely monitoring the natural progression of the disease.
For NMIBTs, follow-up modalities are not yet specifically recommended because of a lack of data, said Dr. Pradère. According to a consensus, cystoscopy should be repeated every 3 months for a year and then every 6 months. Unlike standard follow-up, it includes cytology “to not miss the transition to high grade.”
CCAFU recommends discontinuing active surveillance if any of the following criteria are present:
- More than 10 lesions
- Size > 30 mm
- Positive cytology
- Symptoms (hematuria, micturition disorders, and recurring infections).
Literature on the benefits of active surveillance in bladder tumors is still limited. Only seven studies are available. Overall, for nearly 600 included patients, tumors progressed in about 12% of cases. Progression to invasive tumors occurred in 0.8% of patients (n = 5).
13 Months’ Surveillance
According to a long-term study (median follow-up of 38 months), patients mostly exit active surveillance in the first year. The median duration of active surveillance is 13 months. Active surveillance is discontinued to surgically treat tumors that turn out to be low-grade Ta tumors in 70% of cases.
The following factors predicting recurrence and progression of tumors have been identified: Multiple tumors, early recurrence (within a year of initial diagnosis), frequent recurrence (more than one recurrence per year), tumors > 3 cm, and failure of previous endovesical treatment.
Recent studies have shown that with at least three of these recurrence and progression factors, the median duration under active surveillance is 15 months compared with 28 months in the absence of such factors. “Considering these factors, it is possible to assess the benefit of active surveillance for the patient,” said Dr. Pradère.
If active surveillance for bladder tumors is still not widely practiced, then the contribution of imaging (MRI and ultrasound) and biomarkers could promote its adoption. “The use of biomarkers should change the game and encourage active surveillance in patients with small polyps,” said Dr. Pradère.
ADXBladder Test Utility
A study highlighted the importance of evaluating minichromosome maintenance protein 5 expression during active surveillance using the ADXBladder ELISA test on a urine sample. This test is usually used in bladder cancer diagnosis.
“This study showed that a negative result in two consecutive tests during active surveillance is associated with an almost zero recurrence risk. After two negative tests, most patients do not exit active surveillance,” said Dr. Pradère. But the positive predictive value of biomarkers remains low for low-grade tumors.
The future of active surveillance in bladder cancer should involve better patient selection that relies on risk factors, enhanced modalities through imaging and biomarkers, and the advent of artificial intelligence to analyze cystoscopy results, concluded Dr. Pradère.
This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.
PARIS — Should clinicians promote active surveillance for non–muscle-invasive bladder tumors (NMIBT) and establish it as a comprehensive management approach, as with prostate and kidney cancers?
During the 117th congress of the French Association of Urology (AFU), Benjamin Pradère, MD, urologic surgeon at Croix du Sud Clinic in Quint-Fonsegrives, France, advocated for this approach, suggesting that the use of biomarkers could enhance its effectiveness.
However, it requires careful patient selection, proper information, and relevant follow-up,” said Dr. Pradère, who is a member of the AFU Cancer Committee (CCAFU).
Low-Grade Tumors
NMIBTs are precancerous lesions and constitute 70%-80% of diagnosed bladder tumors. The remaining tumors are more severe invasive tumors that infiltrate deep tissues. NMIBTs, however, entail a high risk for recurrence (reaching 80% after endoscopic resection), as well as a high risk for progression.
As a result, the diagnosis of NMIBT involves follow-up that significantly impacts patients’ quality of life due to repeated cystoscopies and endovesical treatments. “Tumors with the most impact are low-grade Ta tumors”, with longer-term monitoring required for these low-risk tumors.
Hematuria is the most frequent clinical sign. NMIBT diagnosis occurs after endoscopic tumor resection via transurethral resection, followed by an anatomopathological analysis to determine cell grade and tumor stage. Treatment depends on the risk of recurrence and progression, as well as the risk of therapeutic failure after the initial resection.
Risk stratification distinguishes the following four levels:
- Low-risk tumors: Low-grade pTa urothelial tumors, unifocal, < 3 cm, no history of bladder tumors. Low risk of recurrence and progression.
- Intermediate-risk tumors: Other low-grade pTa urothelial tumors with no high-risk criteria. Low risk of progression but high risk of recurrence.
- High-risk tumors: Tumors with at least one risk factor: Stage pT1, high grade, presence of carcinoma in situ. High risks of progression and recurrence.
- Very high-risk tumors: Tumors combining all risk factors (pT1 grade with carcinoma in situ). Very high and early risk of progression.
“We know that low-grade NMIBTs have no impact on survival,” said Dr. Pradère. For these tumors, which represent 60% of diagnosed NMIBTs, or approximately 250,000 new cases annually in France, specific survival is > 99%, meaning that most diagnosed patients will not die of bladder cancer.
The recurrence rate for low-grade tumors is 50%, but recurrences are “almost always low-grade and rarely invade the basement membrane,” said Pradère. Implementing active surveillance to limit surgical intervention to more advanced forms seems to be relevant for these tumors.
Cystoscopy Every 3 Months
According to CCAFU recommendations, “active surveillance is a therapeutic alternative that can be proposed for patients with recurrent low-risk NMIBT after the initial diagnosis.” Criteria include low-grade pTa, fewer than five tumors, size ≤ 15 mm, negative urinary cytology, asymptomatic nature, and the patient’s acceptance of closer monitoring.
While active surveillance has become the standard treatment for low-risk prostate cancer, this therapeutic option remains marginal in bladder cancer, as in kidney cancer. The goal is to defer or avoid surgical treatment by closely monitoring the natural progression of the disease.
For NMIBTs, follow-up modalities are not yet specifically recommended because of a lack of data, said Dr. Pradère. According to a consensus, cystoscopy should be repeated every 3 months for a year and then every 6 months. Unlike standard follow-up, it includes cytology “to not miss the transition to high grade.”
CCAFU recommends discontinuing active surveillance if any of the following criteria are present:
- More than 10 lesions
- Size > 30 mm
- Positive cytology
- Symptoms (hematuria, micturition disorders, and recurring infections).
Literature on the benefits of active surveillance in bladder tumors is still limited. Only seven studies are available. Overall, for nearly 600 included patients, tumors progressed in about 12% of cases. Progression to invasive tumors occurred in 0.8% of patients (n = 5).
13 Months’ Surveillance
According to a long-term study (median follow-up of 38 months), patients mostly exit active surveillance in the first year. The median duration of active surveillance is 13 months. Active surveillance is discontinued to surgically treat tumors that turn out to be low-grade Ta tumors in 70% of cases.
The following factors predicting recurrence and progression of tumors have been identified: Multiple tumors, early recurrence (within a year of initial diagnosis), frequent recurrence (more than one recurrence per year), tumors > 3 cm, and failure of previous endovesical treatment.
Recent studies have shown that with at least three of these recurrence and progression factors, the median duration under active surveillance is 15 months compared with 28 months in the absence of such factors. “Considering these factors, it is possible to assess the benefit of active surveillance for the patient,” said Dr. Pradère.
If active surveillance for bladder tumors is still not widely practiced, then the contribution of imaging (MRI and ultrasound) and biomarkers could promote its adoption. “The use of biomarkers should change the game and encourage active surveillance in patients with small polyps,” said Dr. Pradère.
ADXBladder Test Utility
A study highlighted the importance of evaluating minichromosome maintenance protein 5 expression during active surveillance using the ADXBladder ELISA test on a urine sample. This test is usually used in bladder cancer diagnosis.
“This study showed that a negative result in two consecutive tests during active surveillance is associated with an almost zero recurrence risk. After two negative tests, most patients do not exit active surveillance,” said Dr. Pradère. But the positive predictive value of biomarkers remains low for low-grade tumors.
The future of active surveillance in bladder cancer should involve better patient selection that relies on risk factors, enhanced modalities through imaging and biomarkers, and the advent of artificial intelligence to analyze cystoscopy results, concluded Dr. Pradère.
This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.
PARIS — Should clinicians promote active surveillance for non–muscle-invasive bladder tumors (NMIBT) and establish it as a comprehensive management approach, as with prostate and kidney cancers?
During the 117th congress of the French Association of Urology (AFU), Benjamin Pradère, MD, urologic surgeon at Croix du Sud Clinic in Quint-Fonsegrives, France, advocated for this approach, suggesting that the use of biomarkers could enhance its effectiveness.
However, it requires careful patient selection, proper information, and relevant follow-up,” said Dr. Pradère, who is a member of the AFU Cancer Committee (CCAFU).
Low-Grade Tumors
NMIBTs are precancerous lesions and constitute 70%-80% of diagnosed bladder tumors. The remaining tumors are more severe invasive tumors that infiltrate deep tissues. NMIBTs, however, entail a high risk for recurrence (reaching 80% after endoscopic resection), as well as a high risk for progression.
As a result, the diagnosis of NMIBT involves follow-up that significantly impacts patients’ quality of life due to repeated cystoscopies and endovesical treatments. “Tumors with the most impact are low-grade Ta tumors”, with longer-term monitoring required for these low-risk tumors.
Hematuria is the most frequent clinical sign. NMIBT diagnosis occurs after endoscopic tumor resection via transurethral resection, followed by an anatomopathological analysis to determine cell grade and tumor stage. Treatment depends on the risk of recurrence and progression, as well as the risk of therapeutic failure after the initial resection.
Risk stratification distinguishes the following four levels:
- Low-risk tumors: Low-grade pTa urothelial tumors, unifocal, < 3 cm, no history of bladder tumors. Low risk of recurrence and progression.
- Intermediate-risk tumors: Other low-grade pTa urothelial tumors with no high-risk criteria. Low risk of progression but high risk of recurrence.
- High-risk tumors: Tumors with at least one risk factor: Stage pT1, high grade, presence of carcinoma in situ. High risks of progression and recurrence.
- Very high-risk tumors: Tumors combining all risk factors (pT1 grade with carcinoma in situ). Very high and early risk of progression.
“We know that low-grade NMIBTs have no impact on survival,” said Dr. Pradère. For these tumors, which represent 60% of diagnosed NMIBTs, or approximately 250,000 new cases annually in France, specific survival is > 99%, meaning that most diagnosed patients will not die of bladder cancer.
The recurrence rate for low-grade tumors is 50%, but recurrences are “almost always low-grade and rarely invade the basement membrane,” said Pradère. Implementing active surveillance to limit surgical intervention to more advanced forms seems to be relevant for these tumors.
Cystoscopy Every 3 Months
According to CCAFU recommendations, “active surveillance is a therapeutic alternative that can be proposed for patients with recurrent low-risk NMIBT after the initial diagnosis.” Criteria include low-grade pTa, fewer than five tumors, size ≤ 15 mm, negative urinary cytology, asymptomatic nature, and the patient’s acceptance of closer monitoring.
While active surveillance has become the standard treatment for low-risk prostate cancer, this therapeutic option remains marginal in bladder cancer, as in kidney cancer. The goal is to defer or avoid surgical treatment by closely monitoring the natural progression of the disease.
For NMIBTs, follow-up modalities are not yet specifically recommended because of a lack of data, said Dr. Pradère. According to a consensus, cystoscopy should be repeated every 3 months for a year and then every 6 months. Unlike standard follow-up, it includes cytology “to not miss the transition to high grade.”
CCAFU recommends discontinuing active surveillance if any of the following criteria are present:
- More than 10 lesions
- Size > 30 mm
- Positive cytology
- Symptoms (hematuria, micturition disorders, and recurring infections).
Literature on the benefits of active surveillance in bladder tumors is still limited. Only seven studies are available. Overall, for nearly 600 included patients, tumors progressed in about 12% of cases. Progression to invasive tumors occurred in 0.8% of patients (n = 5).
13 Months’ Surveillance
According to a long-term study (median follow-up of 38 months), patients mostly exit active surveillance in the first year. The median duration of active surveillance is 13 months. Active surveillance is discontinued to surgically treat tumors that turn out to be low-grade Ta tumors in 70% of cases.
The following factors predicting recurrence and progression of tumors have been identified: Multiple tumors, early recurrence (within a year of initial diagnosis), frequent recurrence (more than one recurrence per year), tumors > 3 cm, and failure of previous endovesical treatment.
Recent studies have shown that with at least three of these recurrence and progression factors, the median duration under active surveillance is 15 months compared with 28 months in the absence of such factors. “Considering these factors, it is possible to assess the benefit of active surveillance for the patient,” said Dr. Pradère.
If active surveillance for bladder tumors is still not widely practiced, then the contribution of imaging (MRI and ultrasound) and biomarkers could promote its adoption. “The use of biomarkers should change the game and encourage active surveillance in patients with small polyps,” said Dr. Pradère.
ADXBladder Test Utility
A study highlighted the importance of evaluating minichromosome maintenance protein 5 expression during active surveillance using the ADXBladder ELISA test on a urine sample. This test is usually used in bladder cancer diagnosis.
“This study showed that a negative result in two consecutive tests during active surveillance is associated with an almost zero recurrence risk. After two negative tests, most patients do not exit active surveillance,” said Dr. Pradère. But the positive predictive value of biomarkers remains low for low-grade tumors.
The future of active surveillance in bladder cancer should involve better patient selection that relies on risk factors, enhanced modalities through imaging and biomarkers, and the advent of artificial intelligence to analyze cystoscopy results, concluded Dr. Pradère.
This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.