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Hair dye and cancer study ‘offers some reassurance’
Findings limited to White women in United States
The largest study of its kind has found no positive association between personal use of permanent hair dye and the risk for most cancers and cancer mortality.
The findings come from the Nurses’ Health Study, an ongoing prospective cohort study of more than 117,000 women who have been followed for 36 years and who did not have cancer at baseline.
The findings were published online on September 2 in the BMJ.
The results “offer some reassurance against concerns that personal use of permanent hair dyes might be associated with increased cancer risk or mortality,” write the investigators, with first author Yin Zhang, PhD, of Harvard Medical School, Boston.
The findings, which are limited to White women in the United States, indicate correlation, not causation, the authors emphasize.
Nevertheless, the researchers found an increased risk for some cancers among hair dye users, especially with greater cumulative dose (200 or more uses during the study period). The risk was increased for basal cell carcinoma, breast cancer (specifically, estrogen receptor negative [ER–], progesterone receptor negative [PR–], and hormone receptor negative [ER–, PR–]), and ovarian cancer.
A British expert not involved in the study dismissed these findings. “The reported associations are very weak, and, given the number of associations reported in this manuscript, they are very likely to be chance findings,” commented Paul Pharoah, PhD, professor of cancer epidemiology at the University of Cambridge (England).
“For the cancers where an increase in risk is reported, the results are not compelling. Even if they were real findings, the associations may not be cause-and-effect, and, even if they were causal associations, the magnitude of the effects are so small that any risk would be trivial.
“In short, none of the findings reported in this manuscript suggest that women who use hair dye are putting themselves at increased risk of cancer,” he stated.
A U.S. researcher who has previously coauthored a study suggesting an association between hair dye and breast cancer agreed that the increases in risk reported in this current study are “small.” But they are “of interest,” especially for breast and ovarian cancer, said Alexandra White, PhD, of the National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, N.C.
Hair dyes include compounds that “are not just potential carcinogens but also act as endocrine disruptors,” she said in an interview.
“In both breast and ovarian cancer, we know that hormones play an important part in the etiology ... so it’s biologically plausible that you would see [these associations in the current study],” added Dr. White, who was approached for comment.
However, she added that, even with the “modest” 20%-28% increase in the relative risk for certain breast cancers linked to a heavy cumulative dose of dyes in the current study, “there doesn’t seem to be any strong association with any cancer type.”
But she also pointed out that the most outstanding risk association was among ER–/PR– breast cancers, which are the “most aggressive and difficult to treat,” and thus the new findings are “important.”
Dr. White is the lead author of a 2019 study that received a lot of media attention because it rang an alarm bell about hair dyes and breast cancer risk.
That study concluded that ever using permanent hair dye or hair straighteners was associated with a higher risk for breast cancer than never using them and that this higher risk was especially associated with Black women. However, the study participants were from the prospective Sister Study. The participants in that study had no history of breast cancer, but they each had at least one sister who did. This family history of breast cancer may represent selection bias.
With changes in the 1980s, even safer now?
The study of hair dyes and cancer has “major public health implications” because the use of hair dye is widespread, Dr. Zhang and colleagues write in their article. They estimate that 50% to 80% of women and 10% of men aged 40 years and older in the United States and Europe use hair dye.
Permanent hair dyes “pose the greatest potential concern,” they stated, adding that these account for approximately 80% of hair dyes used in the United States and Europe and an even higher percentage in Asia.
The International Agency for Research on Cancer classifies occupational exposure to hair dyes as probably carcinogenic, but the carcinogenicity resulting from personal use of hair dyes is not classifiable – thus, there is no warning about at-home usage.
Notably, there was “a huge and very important” change in hair dye ingredients in the 1980s after the Food and Drug Administration warned about some chemicals in permanent hair dyes and the cosmetic industry altered their formulas, lead author Dr. Zhang said.
However, the researchers could not analyze use before and after the changes because not enough women reported first use of permanent hair dye after 1980 (only 1890 of 117,200 participants).
“We could expect that the current ingredients should make it safer,” Dr. Zhang said.
Study details
The researchers report that ever-users of permanent hair dyes had no significant increases in risk for solid cancers (n = 20,805; hazard ratio, 0.98, 95% confidence interval, 0.96-1.01) or hematopoietic cancers overall (n = 1,807; HR, 1.00; 95% CI, 0.91-1.10) compared with nonusers.
Additionally, ever-users did not have an increased risk for most specific cancers or cancer-related death (n = 4,860; HR, 0.96; 95% CI, 0.91-1.02).
As noted above, there were some exceptions.
Basal cell carcinoma risk was slightly increased for ever-users (n = 22,560; HR, 1.05; 95% CI, 1.02-1.08). Cumulative dose (a calculation of duration and frequency) was positively associated with risk for ER– breast cancer, PR– breast cancer, ER–/PR– breast cancer, and ovarian cancer, with risk rising in accordance with the total amount of dye.
Notably, at a cumulative dose of ≥200 uses, there was a 20% increase in the relative risk for ER- breast cancer (n = 1521; HR, 1.20; 95% CI, 1.02-1.41; P value for trend, .03). At the same cumulative dose, there was a 28% increase in the relative risk for ER-/PR- breast cancer (n = 1287; HR, 1.28, 95% CI, 1.08-1.52; P value for trend, .006).
In addition, an increased risk for Hodgkin lymphoma was observed, but only for women with naturally dark hair (the calculation was based on 70 women, 24 of whom had dark hair).
In a press statement, senior author Eva Schernhammer, PhD, of Harvard and the Medical University of Vienna, said the results “justify further prospective validation.”
She also explained that there are many variables to consider in this research, including different populations and countries, different susceptibility genotypes, different exposure settings (personal use vs. occupational exposure), and different colors of the permanent hair dyes used (dark dyes vs. light dyes).
Geographic location is a particularly important variable, suggested the study authors.
They pointed out that Europe, but not the United States, banned some individual hair dye ingredients that were considered carcinogenic during both the 1980s and 2000s. One country has even tighter oversight: “The most restrictive regulation of hair dyes exists in Japan, where cosmetic products are considered equivalent to drugs.”
The study was funded by the Centers for Disease Control and Prevention and the National Institute for Occupational Safety and Health. The study authors and Dr. White have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Findings limited to White women in United States
Findings limited to White women in United States
The largest study of its kind has found no positive association between personal use of permanent hair dye and the risk for most cancers and cancer mortality.
The findings come from the Nurses’ Health Study, an ongoing prospective cohort study of more than 117,000 women who have been followed for 36 years and who did not have cancer at baseline.
The findings were published online on September 2 in the BMJ.
The results “offer some reassurance against concerns that personal use of permanent hair dyes might be associated with increased cancer risk or mortality,” write the investigators, with first author Yin Zhang, PhD, of Harvard Medical School, Boston.
The findings, which are limited to White women in the United States, indicate correlation, not causation, the authors emphasize.
Nevertheless, the researchers found an increased risk for some cancers among hair dye users, especially with greater cumulative dose (200 or more uses during the study period). The risk was increased for basal cell carcinoma, breast cancer (specifically, estrogen receptor negative [ER–], progesterone receptor negative [PR–], and hormone receptor negative [ER–, PR–]), and ovarian cancer.
A British expert not involved in the study dismissed these findings. “The reported associations are very weak, and, given the number of associations reported in this manuscript, they are very likely to be chance findings,” commented Paul Pharoah, PhD, professor of cancer epidemiology at the University of Cambridge (England).
“For the cancers where an increase in risk is reported, the results are not compelling. Even if they were real findings, the associations may not be cause-and-effect, and, even if they were causal associations, the magnitude of the effects are so small that any risk would be trivial.
“In short, none of the findings reported in this manuscript suggest that women who use hair dye are putting themselves at increased risk of cancer,” he stated.
A U.S. researcher who has previously coauthored a study suggesting an association between hair dye and breast cancer agreed that the increases in risk reported in this current study are “small.” But they are “of interest,” especially for breast and ovarian cancer, said Alexandra White, PhD, of the National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, N.C.
Hair dyes include compounds that “are not just potential carcinogens but also act as endocrine disruptors,” she said in an interview.
“In both breast and ovarian cancer, we know that hormones play an important part in the etiology ... so it’s biologically plausible that you would see [these associations in the current study],” added Dr. White, who was approached for comment.
However, she added that, even with the “modest” 20%-28% increase in the relative risk for certain breast cancers linked to a heavy cumulative dose of dyes in the current study, “there doesn’t seem to be any strong association with any cancer type.”
But she also pointed out that the most outstanding risk association was among ER–/PR– breast cancers, which are the “most aggressive and difficult to treat,” and thus the new findings are “important.”
Dr. White is the lead author of a 2019 study that received a lot of media attention because it rang an alarm bell about hair dyes and breast cancer risk.
That study concluded that ever using permanent hair dye or hair straighteners was associated with a higher risk for breast cancer than never using them and that this higher risk was especially associated with Black women. However, the study participants were from the prospective Sister Study. The participants in that study had no history of breast cancer, but they each had at least one sister who did. This family history of breast cancer may represent selection bias.
With changes in the 1980s, even safer now?
The study of hair dyes and cancer has “major public health implications” because the use of hair dye is widespread, Dr. Zhang and colleagues write in their article. They estimate that 50% to 80% of women and 10% of men aged 40 years and older in the United States and Europe use hair dye.
Permanent hair dyes “pose the greatest potential concern,” they stated, adding that these account for approximately 80% of hair dyes used in the United States and Europe and an even higher percentage in Asia.
The International Agency for Research on Cancer classifies occupational exposure to hair dyes as probably carcinogenic, but the carcinogenicity resulting from personal use of hair dyes is not classifiable – thus, there is no warning about at-home usage.
Notably, there was “a huge and very important” change in hair dye ingredients in the 1980s after the Food and Drug Administration warned about some chemicals in permanent hair dyes and the cosmetic industry altered their formulas, lead author Dr. Zhang said.
However, the researchers could not analyze use before and after the changes because not enough women reported first use of permanent hair dye after 1980 (only 1890 of 117,200 participants).
“We could expect that the current ingredients should make it safer,” Dr. Zhang said.
Study details
The researchers report that ever-users of permanent hair dyes had no significant increases in risk for solid cancers (n = 20,805; hazard ratio, 0.98, 95% confidence interval, 0.96-1.01) or hematopoietic cancers overall (n = 1,807; HR, 1.00; 95% CI, 0.91-1.10) compared with nonusers.
Additionally, ever-users did not have an increased risk for most specific cancers or cancer-related death (n = 4,860; HR, 0.96; 95% CI, 0.91-1.02).
As noted above, there were some exceptions.
Basal cell carcinoma risk was slightly increased for ever-users (n = 22,560; HR, 1.05; 95% CI, 1.02-1.08). Cumulative dose (a calculation of duration and frequency) was positively associated with risk for ER– breast cancer, PR– breast cancer, ER–/PR– breast cancer, and ovarian cancer, with risk rising in accordance with the total amount of dye.
Notably, at a cumulative dose of ≥200 uses, there was a 20% increase in the relative risk for ER- breast cancer (n = 1521; HR, 1.20; 95% CI, 1.02-1.41; P value for trend, .03). At the same cumulative dose, there was a 28% increase in the relative risk for ER-/PR- breast cancer (n = 1287; HR, 1.28, 95% CI, 1.08-1.52; P value for trend, .006).
In addition, an increased risk for Hodgkin lymphoma was observed, but only for women with naturally dark hair (the calculation was based on 70 women, 24 of whom had dark hair).
In a press statement, senior author Eva Schernhammer, PhD, of Harvard and the Medical University of Vienna, said the results “justify further prospective validation.”
She also explained that there are many variables to consider in this research, including different populations and countries, different susceptibility genotypes, different exposure settings (personal use vs. occupational exposure), and different colors of the permanent hair dyes used (dark dyes vs. light dyes).
Geographic location is a particularly important variable, suggested the study authors.
They pointed out that Europe, but not the United States, banned some individual hair dye ingredients that were considered carcinogenic during both the 1980s and 2000s. One country has even tighter oversight: “The most restrictive regulation of hair dyes exists in Japan, where cosmetic products are considered equivalent to drugs.”
The study was funded by the Centers for Disease Control and Prevention and the National Institute for Occupational Safety and Health. The study authors and Dr. White have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
The largest study of its kind has found no positive association between personal use of permanent hair dye and the risk for most cancers and cancer mortality.
The findings come from the Nurses’ Health Study, an ongoing prospective cohort study of more than 117,000 women who have been followed for 36 years and who did not have cancer at baseline.
The findings were published online on September 2 in the BMJ.
The results “offer some reassurance against concerns that personal use of permanent hair dyes might be associated with increased cancer risk or mortality,” write the investigators, with first author Yin Zhang, PhD, of Harvard Medical School, Boston.
The findings, which are limited to White women in the United States, indicate correlation, not causation, the authors emphasize.
Nevertheless, the researchers found an increased risk for some cancers among hair dye users, especially with greater cumulative dose (200 or more uses during the study period). The risk was increased for basal cell carcinoma, breast cancer (specifically, estrogen receptor negative [ER–], progesterone receptor negative [PR–], and hormone receptor negative [ER–, PR–]), and ovarian cancer.
A British expert not involved in the study dismissed these findings. “The reported associations are very weak, and, given the number of associations reported in this manuscript, they are very likely to be chance findings,” commented Paul Pharoah, PhD, professor of cancer epidemiology at the University of Cambridge (England).
“For the cancers where an increase in risk is reported, the results are not compelling. Even if they were real findings, the associations may not be cause-and-effect, and, even if they were causal associations, the magnitude of the effects are so small that any risk would be trivial.
“In short, none of the findings reported in this manuscript suggest that women who use hair dye are putting themselves at increased risk of cancer,” he stated.
A U.S. researcher who has previously coauthored a study suggesting an association between hair dye and breast cancer agreed that the increases in risk reported in this current study are “small.” But they are “of interest,” especially for breast and ovarian cancer, said Alexandra White, PhD, of the National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, N.C.
Hair dyes include compounds that “are not just potential carcinogens but also act as endocrine disruptors,” she said in an interview.
“In both breast and ovarian cancer, we know that hormones play an important part in the etiology ... so it’s biologically plausible that you would see [these associations in the current study],” added Dr. White, who was approached for comment.
However, she added that, even with the “modest” 20%-28% increase in the relative risk for certain breast cancers linked to a heavy cumulative dose of dyes in the current study, “there doesn’t seem to be any strong association with any cancer type.”
But she also pointed out that the most outstanding risk association was among ER–/PR– breast cancers, which are the “most aggressive and difficult to treat,” and thus the new findings are “important.”
Dr. White is the lead author of a 2019 study that received a lot of media attention because it rang an alarm bell about hair dyes and breast cancer risk.
That study concluded that ever using permanent hair dye or hair straighteners was associated with a higher risk for breast cancer than never using them and that this higher risk was especially associated with Black women. However, the study participants were from the prospective Sister Study. The participants in that study had no history of breast cancer, but they each had at least one sister who did. This family history of breast cancer may represent selection bias.
With changes in the 1980s, even safer now?
The study of hair dyes and cancer has “major public health implications” because the use of hair dye is widespread, Dr. Zhang and colleagues write in their article. They estimate that 50% to 80% of women and 10% of men aged 40 years and older in the United States and Europe use hair dye.
Permanent hair dyes “pose the greatest potential concern,” they stated, adding that these account for approximately 80% of hair dyes used in the United States and Europe and an even higher percentage in Asia.
The International Agency for Research on Cancer classifies occupational exposure to hair dyes as probably carcinogenic, but the carcinogenicity resulting from personal use of hair dyes is not classifiable – thus, there is no warning about at-home usage.
Notably, there was “a huge and very important” change in hair dye ingredients in the 1980s after the Food and Drug Administration warned about some chemicals in permanent hair dyes and the cosmetic industry altered their formulas, lead author Dr. Zhang said.
However, the researchers could not analyze use before and after the changes because not enough women reported first use of permanent hair dye after 1980 (only 1890 of 117,200 participants).
“We could expect that the current ingredients should make it safer,” Dr. Zhang said.
Study details
The researchers report that ever-users of permanent hair dyes had no significant increases in risk for solid cancers (n = 20,805; hazard ratio, 0.98, 95% confidence interval, 0.96-1.01) or hematopoietic cancers overall (n = 1,807; HR, 1.00; 95% CI, 0.91-1.10) compared with nonusers.
Additionally, ever-users did not have an increased risk for most specific cancers or cancer-related death (n = 4,860; HR, 0.96; 95% CI, 0.91-1.02).
As noted above, there were some exceptions.
Basal cell carcinoma risk was slightly increased for ever-users (n = 22,560; HR, 1.05; 95% CI, 1.02-1.08). Cumulative dose (a calculation of duration and frequency) was positively associated with risk for ER– breast cancer, PR– breast cancer, ER–/PR– breast cancer, and ovarian cancer, with risk rising in accordance with the total amount of dye.
Notably, at a cumulative dose of ≥200 uses, there was a 20% increase in the relative risk for ER- breast cancer (n = 1521; HR, 1.20; 95% CI, 1.02-1.41; P value for trend, .03). At the same cumulative dose, there was a 28% increase in the relative risk for ER-/PR- breast cancer (n = 1287; HR, 1.28, 95% CI, 1.08-1.52; P value for trend, .006).
In addition, an increased risk for Hodgkin lymphoma was observed, but only for women with naturally dark hair (the calculation was based on 70 women, 24 of whom had dark hair).
In a press statement, senior author Eva Schernhammer, PhD, of Harvard and the Medical University of Vienna, said the results “justify further prospective validation.”
She also explained that there are many variables to consider in this research, including different populations and countries, different susceptibility genotypes, different exposure settings (personal use vs. occupational exposure), and different colors of the permanent hair dyes used (dark dyes vs. light dyes).
Geographic location is a particularly important variable, suggested the study authors.
They pointed out that Europe, but not the United States, banned some individual hair dye ingredients that were considered carcinogenic during both the 1980s and 2000s. One country has even tighter oversight: “The most restrictive regulation of hair dyes exists in Japan, where cosmetic products are considered equivalent to drugs.”
The study was funded by the Centers for Disease Control and Prevention and the National Institute for Occupational Safety and Health. The study authors and Dr. White have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Napabucasin suppressed tumor growth in DLBCL cell lines
The STAT3 pathway is important to the development of many cancers, but so far, no Food and Drug Administration–approved drugs are ready for clinical use. Napabucasin, a novel oral small-molecule inhibitor of signal transducer and activator of transcription 3 (STAT3), blocks tumor growth and resists metastasis in a broad spectrum of solid tumors. Napabucasin was now found to be effective in inhibiting diffuse large beta cell lymphoma (DLBCL) in cell lines and in in vitro testing, as reported by Xue Li of the West China Hospital, Sichuan (China) University, and colleagues.
In addition, the effects of napabucasin were found to be synergistic with the use of doxorubicin, a standard DLBCL therapy agent, according to the report, published online in Cancer Letters.
‘Dramatic’ results
The researchers found that 34% (23/69) of DLBCL patients expressed STAT3 in tumor tissues. When they tested napabucasin in a variety of DLBCL cell lines they found that the drug exhibited potent cytotoxicity in a dose-dependent manner. In addition, they found that napabucasin induced intrinsic and extrinsic cell apoptosis, downregulated the expression of STAT3 target genes, including the antiapoptotic protein Mcl-1, and regulated the mitogen-activated protein kinase (MAPK) pathway, all important indicators of antitumor effectiveness in vitro.
In cells treated with napabucasin and doxorubicin alone and in combination, napabucasin alone significantly suppressed tumor growth, compared with that of the control (P < .01), achieving tumor growth inhibition (TGI) of 78.8%. The combination treatment, “with a dramatic TGI of 98.2%,” was more effective than doxorubicin monotherapy (TGI = 63.2%; P < .05), according to the researchers.
“Our study provided evidence that napabucasin is an attractive candidate drug either as a monotherapy or in combination therapies for DLBCL treatment. Further work studying the clinical efficacy and combination treatment schedule should be performed for personalized therapy,” the researchers concluded.
The work was supported by grants from the Chinese government. The authors stated that they had no conflicts of interest.
SOURCE: Li X et al. Cancer Lett. 2020 Aug 14. doi: 10.1016/j.canlet.2020.07.032.
The STAT3 pathway is important to the development of many cancers, but so far, no Food and Drug Administration–approved drugs are ready for clinical use. Napabucasin, a novel oral small-molecule inhibitor of signal transducer and activator of transcription 3 (STAT3), blocks tumor growth and resists metastasis in a broad spectrum of solid tumors. Napabucasin was now found to be effective in inhibiting diffuse large beta cell lymphoma (DLBCL) in cell lines and in in vitro testing, as reported by Xue Li of the West China Hospital, Sichuan (China) University, and colleagues.
In addition, the effects of napabucasin were found to be synergistic with the use of doxorubicin, a standard DLBCL therapy agent, according to the report, published online in Cancer Letters.
‘Dramatic’ results
The researchers found that 34% (23/69) of DLBCL patients expressed STAT3 in tumor tissues. When they tested napabucasin in a variety of DLBCL cell lines they found that the drug exhibited potent cytotoxicity in a dose-dependent manner. In addition, they found that napabucasin induced intrinsic and extrinsic cell apoptosis, downregulated the expression of STAT3 target genes, including the antiapoptotic protein Mcl-1, and regulated the mitogen-activated protein kinase (MAPK) pathway, all important indicators of antitumor effectiveness in vitro.
In cells treated with napabucasin and doxorubicin alone and in combination, napabucasin alone significantly suppressed tumor growth, compared with that of the control (P < .01), achieving tumor growth inhibition (TGI) of 78.8%. The combination treatment, “with a dramatic TGI of 98.2%,” was more effective than doxorubicin monotherapy (TGI = 63.2%; P < .05), according to the researchers.
“Our study provided evidence that napabucasin is an attractive candidate drug either as a monotherapy or in combination therapies for DLBCL treatment. Further work studying the clinical efficacy and combination treatment schedule should be performed for personalized therapy,” the researchers concluded.
The work was supported by grants from the Chinese government. The authors stated that they had no conflicts of interest.
SOURCE: Li X et al. Cancer Lett. 2020 Aug 14. doi: 10.1016/j.canlet.2020.07.032.
The STAT3 pathway is important to the development of many cancers, but so far, no Food and Drug Administration–approved drugs are ready for clinical use. Napabucasin, a novel oral small-molecule inhibitor of signal transducer and activator of transcription 3 (STAT3), blocks tumor growth and resists metastasis in a broad spectrum of solid tumors. Napabucasin was now found to be effective in inhibiting diffuse large beta cell lymphoma (DLBCL) in cell lines and in in vitro testing, as reported by Xue Li of the West China Hospital, Sichuan (China) University, and colleagues.
In addition, the effects of napabucasin were found to be synergistic with the use of doxorubicin, a standard DLBCL therapy agent, according to the report, published online in Cancer Letters.
‘Dramatic’ results
The researchers found that 34% (23/69) of DLBCL patients expressed STAT3 in tumor tissues. When they tested napabucasin in a variety of DLBCL cell lines they found that the drug exhibited potent cytotoxicity in a dose-dependent manner. In addition, they found that napabucasin induced intrinsic and extrinsic cell apoptosis, downregulated the expression of STAT3 target genes, including the antiapoptotic protein Mcl-1, and regulated the mitogen-activated protein kinase (MAPK) pathway, all important indicators of antitumor effectiveness in vitro.
In cells treated with napabucasin and doxorubicin alone and in combination, napabucasin alone significantly suppressed tumor growth, compared with that of the control (P < .01), achieving tumor growth inhibition (TGI) of 78.8%. The combination treatment, “with a dramatic TGI of 98.2%,” was more effective than doxorubicin monotherapy (TGI = 63.2%; P < .05), according to the researchers.
“Our study provided evidence that napabucasin is an attractive candidate drug either as a monotherapy or in combination therapies for DLBCL treatment. Further work studying the clinical efficacy and combination treatment schedule should be performed for personalized therapy,” the researchers concluded.
The work was supported by grants from the Chinese government. The authors stated that they had no conflicts of interest.
SOURCE: Li X et al. Cancer Lett. 2020 Aug 14. doi: 10.1016/j.canlet.2020.07.032.
FROM CANCER LETTERS
Rate of Clinical Trial Enrollment in Patients Treated for DLBCL Within the Veterans Health Administration
BACKGROUND: Diffuse large B cell lymphoma (DLBCL) is curable in most patients, however this high cure rate is mostly reserved for those who achieve a complete remission with first line treatment. In patients who have relapsed/refractory disease the cure rate is significantly lower. There are limited studies that have previously investigated the rate of clinical trial discussion and enrollment among DLBCL patients. Our aim, as part of a larger study, was to determine the rate of clinical trial enrollment for patients diagnosed with DLBCL at the Veterans Health Administration system (VHA), a population that traditionally experiences poorer outcomes when compared to the community and academic centers.
METHODS: We performed a retrospective chart review of patients diagnosed with DLBCL in the VHA nationwide from 01/01/2011 to 12/31/2017. Patients treated outside of the VHA and patients with primary DLBCL of the CNS were excluded. During our inclusion period, we randomly selected patients and evaluated the number of patients that engaged in discussions with their providers about clinical trials and the number of patients that eventually enrolled in trials.
RESULTS: In total, 721 patients met our inclusion criteria. Median age was 67 and the majority of patients were white (74.5%), male (96.8%), had an ECOG of 2 (83.7%) and presented with advanced stage disease (stage IV: 40.3% and stage III: 26.5%). Of all the patients included in our study 3.7% engaged in discussion about clinical trials and amongst relapsed/ refractory patients (N=182), 12.6% engaged in discussion. The rate of clinical trial enrollment was 1.8% in all patients and 6% in relapsed/refractory patients.
CONCLUSION: Our results show a low rate of 1.8% of DLBCL patients enrolling in clinical trials. These rates are improved but remain low at 6% in relapsed/ refractory patients with only 12.6 % of all relapsed/refractory patients engaging in discussions with their provider about clinical trials, despite NCCN’s recommendation for clinical trial consideration in this subset of DLBCL patients. These results are concerning and show a need to identify and understand the barriers to enrollment in this population in addition to the implementation of mitigation practices.
BACKGROUND: Diffuse large B cell lymphoma (DLBCL) is curable in most patients, however this high cure rate is mostly reserved for those who achieve a complete remission with first line treatment. In patients who have relapsed/refractory disease the cure rate is significantly lower. There are limited studies that have previously investigated the rate of clinical trial discussion and enrollment among DLBCL patients. Our aim, as part of a larger study, was to determine the rate of clinical trial enrollment for patients diagnosed with DLBCL at the Veterans Health Administration system (VHA), a population that traditionally experiences poorer outcomes when compared to the community and academic centers.
METHODS: We performed a retrospective chart review of patients diagnosed with DLBCL in the VHA nationwide from 01/01/2011 to 12/31/2017. Patients treated outside of the VHA and patients with primary DLBCL of the CNS were excluded. During our inclusion period, we randomly selected patients and evaluated the number of patients that engaged in discussions with their providers about clinical trials and the number of patients that eventually enrolled in trials.
RESULTS: In total, 721 patients met our inclusion criteria. Median age was 67 and the majority of patients were white (74.5%), male (96.8%), had an ECOG of 2 (83.7%) and presented with advanced stage disease (stage IV: 40.3% and stage III: 26.5%). Of all the patients included in our study 3.7% engaged in discussion about clinical trials and amongst relapsed/ refractory patients (N=182), 12.6% engaged in discussion. The rate of clinical trial enrollment was 1.8% in all patients and 6% in relapsed/refractory patients.
CONCLUSION: Our results show a low rate of 1.8% of DLBCL patients enrolling in clinical trials. These rates are improved but remain low at 6% in relapsed/ refractory patients with only 12.6 % of all relapsed/refractory patients engaging in discussions with their provider about clinical trials, despite NCCN’s recommendation for clinical trial consideration in this subset of DLBCL patients. These results are concerning and show a need to identify and understand the barriers to enrollment in this population in addition to the implementation of mitigation practices.
BACKGROUND: Diffuse large B cell lymphoma (DLBCL) is curable in most patients, however this high cure rate is mostly reserved for those who achieve a complete remission with first line treatment. In patients who have relapsed/refractory disease the cure rate is significantly lower. There are limited studies that have previously investigated the rate of clinical trial discussion and enrollment among DLBCL patients. Our aim, as part of a larger study, was to determine the rate of clinical trial enrollment for patients diagnosed with DLBCL at the Veterans Health Administration system (VHA), a population that traditionally experiences poorer outcomes when compared to the community and academic centers.
METHODS: We performed a retrospective chart review of patients diagnosed with DLBCL in the VHA nationwide from 01/01/2011 to 12/31/2017. Patients treated outside of the VHA and patients with primary DLBCL of the CNS were excluded. During our inclusion period, we randomly selected patients and evaluated the number of patients that engaged in discussions with their providers about clinical trials and the number of patients that eventually enrolled in trials.
RESULTS: In total, 721 patients met our inclusion criteria. Median age was 67 and the majority of patients were white (74.5%), male (96.8%), had an ECOG of 2 (83.7%) and presented with advanced stage disease (stage IV: 40.3% and stage III: 26.5%). Of all the patients included in our study 3.7% engaged in discussion about clinical trials and amongst relapsed/ refractory patients (N=182), 12.6% engaged in discussion. The rate of clinical trial enrollment was 1.8% in all patients and 6% in relapsed/refractory patients.
CONCLUSION: Our results show a low rate of 1.8% of DLBCL patients enrolling in clinical trials. These rates are improved but remain low at 6% in relapsed/ refractory patients with only 12.6 % of all relapsed/refractory patients engaging in discussions with their provider about clinical trials, despite NCCN’s recommendation for clinical trial consideration in this subset of DLBCL patients. These results are concerning and show a need to identify and understand the barriers to enrollment in this population in addition to the implementation of mitigation practices.
Diagnosis and Treatment of an Anaplastic Large Cell Primary Central Nervous System Lymphoma
BACKGROUND: Primary central nervous system lymphoma (PCNSL) is a rare and aggressive malignancy of predominantly B-cell origins. Where tolerated, strong sensitivity is seen with induction regimens containing high-dose methotrexate and rituximab. However, little is known regarding ideal therapy for T-cell variants, especially anaplastic large cell lymphoma.
CASE REPORT: A 20-year-old male with no past medical history developed progressive positional headaches, nausea, and dizziness over several months. Between several hospital visits, he was found to have enhancing lesions of his right caudate, left cerebellum, and right frontal lobe. A lumbar puncture demonstrated pleocytosis (152 WBC, 97% lymphocytes) and a small population of atypical CD5- T-cells on flow cytometry. Preliminary biopsy of the right caudate lesion was inconclusive, significant only for demyelination and a subset of LGL-like T-cells expressing CD3 and TIA-1. Neurology was consulted and he was given high-dose methylprednisolone with significant improvement in his symptoms. However, several months later he returned to the emergency department with new headaches, vomiting, and bilateral nystagmus. A repeat brian MRI showed lesion progression and evidence of hydrocephalus. He received hypertonic saline prior to external ventricular drain placement. Once stabilized, he underwent an uncomplicated left retrosigmoid craniotomy with resection of his cerebellar lesion. Histopathology demonstrated strong CD30 and ALK1 expression, with atypical mature T-cells on flow cytometry (CD4+, CD8+, CD5-). PET/CT imaging, bone marrow biopsy, and an ophthalmologic slit lamp exam were without evidence of systemic disease. He was given a diagnosis of PCNSL of T-cell origin (ALK+ anaplastic large cell subtype) and discharged on a dexamethasone taper. After surgical recovery he was started on induction chemotherapy with high-dose methotrexate, procarbazine, and vincristine (MPV). Interval MR imaging demonstrated marked decrease in the size of his intracranial lesions. He was subsequently transitioned to consolidation with HiDAC with the intent to undergo autologous hematopoietic cell transplant.
CONCLUSIONS: Incidence of ALK-positive anaplastic large cell PCNSL is extremely rare, and thus consensus data regarding optimal treatment is lacking. For younger patients with good functional status and renal clearance, induction therapy containing high-dose methotrexate (i.e. MPV) can provide an effective bridge to consolidation and autologous hematopoietic cell transplant.
BACKGROUND: Primary central nervous system lymphoma (PCNSL) is a rare and aggressive malignancy of predominantly B-cell origins. Where tolerated, strong sensitivity is seen with induction regimens containing high-dose methotrexate and rituximab. However, little is known regarding ideal therapy for T-cell variants, especially anaplastic large cell lymphoma.
CASE REPORT: A 20-year-old male with no past medical history developed progressive positional headaches, nausea, and dizziness over several months. Between several hospital visits, he was found to have enhancing lesions of his right caudate, left cerebellum, and right frontal lobe. A lumbar puncture demonstrated pleocytosis (152 WBC, 97% lymphocytes) and a small population of atypical CD5- T-cells on flow cytometry. Preliminary biopsy of the right caudate lesion was inconclusive, significant only for demyelination and a subset of LGL-like T-cells expressing CD3 and TIA-1. Neurology was consulted and he was given high-dose methylprednisolone with significant improvement in his symptoms. However, several months later he returned to the emergency department with new headaches, vomiting, and bilateral nystagmus. A repeat brian MRI showed lesion progression and evidence of hydrocephalus. He received hypertonic saline prior to external ventricular drain placement. Once stabilized, he underwent an uncomplicated left retrosigmoid craniotomy with resection of his cerebellar lesion. Histopathology demonstrated strong CD30 and ALK1 expression, with atypical mature T-cells on flow cytometry (CD4+, CD8+, CD5-). PET/CT imaging, bone marrow biopsy, and an ophthalmologic slit lamp exam were without evidence of systemic disease. He was given a diagnosis of PCNSL of T-cell origin (ALK+ anaplastic large cell subtype) and discharged on a dexamethasone taper. After surgical recovery he was started on induction chemotherapy with high-dose methotrexate, procarbazine, and vincristine (MPV). Interval MR imaging demonstrated marked decrease in the size of his intracranial lesions. He was subsequently transitioned to consolidation with HiDAC with the intent to undergo autologous hematopoietic cell transplant.
CONCLUSIONS: Incidence of ALK-positive anaplastic large cell PCNSL is extremely rare, and thus consensus data regarding optimal treatment is lacking. For younger patients with good functional status and renal clearance, induction therapy containing high-dose methotrexate (i.e. MPV) can provide an effective bridge to consolidation and autologous hematopoietic cell transplant.
BACKGROUND: Primary central nervous system lymphoma (PCNSL) is a rare and aggressive malignancy of predominantly B-cell origins. Where tolerated, strong sensitivity is seen with induction regimens containing high-dose methotrexate and rituximab. However, little is known regarding ideal therapy for T-cell variants, especially anaplastic large cell lymphoma.
CASE REPORT: A 20-year-old male with no past medical history developed progressive positional headaches, nausea, and dizziness over several months. Between several hospital visits, he was found to have enhancing lesions of his right caudate, left cerebellum, and right frontal lobe. A lumbar puncture demonstrated pleocytosis (152 WBC, 97% lymphocytes) and a small population of atypical CD5- T-cells on flow cytometry. Preliminary biopsy of the right caudate lesion was inconclusive, significant only for demyelination and a subset of LGL-like T-cells expressing CD3 and TIA-1. Neurology was consulted and he was given high-dose methylprednisolone with significant improvement in his symptoms. However, several months later he returned to the emergency department with new headaches, vomiting, and bilateral nystagmus. A repeat brian MRI showed lesion progression and evidence of hydrocephalus. He received hypertonic saline prior to external ventricular drain placement. Once stabilized, he underwent an uncomplicated left retrosigmoid craniotomy with resection of his cerebellar lesion. Histopathology demonstrated strong CD30 and ALK1 expression, with atypical mature T-cells on flow cytometry (CD4+, CD8+, CD5-). PET/CT imaging, bone marrow biopsy, and an ophthalmologic slit lamp exam were without evidence of systemic disease. He was given a diagnosis of PCNSL of T-cell origin (ALK+ anaplastic large cell subtype) and discharged on a dexamethasone taper. After surgical recovery he was started on induction chemotherapy with high-dose methotrexate, procarbazine, and vincristine (MPV). Interval MR imaging demonstrated marked decrease in the size of his intracranial lesions. He was subsequently transitioned to consolidation with HiDAC with the intent to undergo autologous hematopoietic cell transplant.
CONCLUSIONS: Incidence of ALK-positive anaplastic large cell PCNSL is extremely rare, and thus consensus data regarding optimal treatment is lacking. For younger patients with good functional status and renal clearance, induction therapy containing high-dose methotrexate (i.e. MPV) can provide an effective bridge to consolidation and autologous hematopoietic cell transplant.
Clinical and Economic Burden of Mantle Cell Lymphoma in the Veteran Health Administration Population
BACKGROUND: Mantle cell lymphoma (MCL) is an incurable B-cell non-Hodgkin lymphoma. There is limited data on MCL burden to US veterans. OBJECTIVE: This retrospective cohort analysis aims to examine the clinical burden, costs and healthcare resource utilization of MCL to veterans.
METHODS: Adults who were newly diagnosed with MCL and initiated treatment were identified in the Veteran Health Administration (VHA) dataset (2014-2018). Treatment regimens are mutually exclusive and categorized as: bendamustine-based (alone or in combination); BTK-based (Bruton’s tyrosine kinase inhibitors: ibrutinib or acalabrutinib, alone or in combination); RCHOP-based; rituximab-monotherapy; and other regimen. Treatment discontinuation is defined as no MCL treatment for 60 days from the last day of supply. Treatment regimens, costs and hospitalizations are examined by 1st, 2nd, and 3rd lines of therapy.
RESULTS: Prevalence and incidence of MCL among the VHA population ranged from 8-11 cases, and 0.6-2.6 cases per 100,000 persons, respectively. A total of 390 patients (mean age: 70 years, 85% white) received 1st line (mean duration: 243 days), 146 (37%) patients received 2nd line (mean duration: 259 days), and 47 (12%) received 3rd line (mean duration: 154 days) therapy. Bendamustine-based regimen was the most common 1st line MCL treatment (43%), with lower utilization later (2nd line: 18%; 3rd line: 2%). BTK-based regimen was the second most common 1st line MCL treatment (23%), and the most common MCL treatment in later settings (2nd line: 34%, 3rd line 28%). RCHOP-based regimens were seldomly used in any setting (<5%). The overall treatment discontinuation rate was 82%. Approximately 38% of MCL patients had a hospitalization, with mean length-of-stay (LOS) of 5.6 days. The hospitalization rate was 29% (mean LOS: 3.5), 36% (mean LOS: 4.4), and 26% (mean LOS: 3.1) during 1st, 2nd, and 3rd line, respectively. Per-patient-per-month costs were $19,338 overall, and $19,239, $20,064, and $27,663 respectively, during 1st, 2nd, and 3rd line of therapy.
CONCLUSION: This study showed that bendamustine- based and BTK-based regimens were the common frontline treatments among newly diagnosed MCL patients in the VHA population. Future studies are warranted to understand factors associated with treatment selection, discontinuation and clinical benefits among these MCL Veteran patients.
BACKGROUND: Mantle cell lymphoma (MCL) is an incurable B-cell non-Hodgkin lymphoma. There is limited data on MCL burden to US veterans. OBJECTIVE: This retrospective cohort analysis aims to examine the clinical burden, costs and healthcare resource utilization of MCL to veterans.
METHODS: Adults who were newly diagnosed with MCL and initiated treatment were identified in the Veteran Health Administration (VHA) dataset (2014-2018). Treatment regimens are mutually exclusive and categorized as: bendamustine-based (alone or in combination); BTK-based (Bruton’s tyrosine kinase inhibitors: ibrutinib or acalabrutinib, alone or in combination); RCHOP-based; rituximab-monotherapy; and other regimen. Treatment discontinuation is defined as no MCL treatment for 60 days from the last day of supply. Treatment regimens, costs and hospitalizations are examined by 1st, 2nd, and 3rd lines of therapy.
RESULTS: Prevalence and incidence of MCL among the VHA population ranged from 8-11 cases, and 0.6-2.6 cases per 100,000 persons, respectively. A total of 390 patients (mean age: 70 years, 85% white) received 1st line (mean duration: 243 days), 146 (37%) patients received 2nd line (mean duration: 259 days), and 47 (12%) received 3rd line (mean duration: 154 days) therapy. Bendamustine-based regimen was the most common 1st line MCL treatment (43%), with lower utilization later (2nd line: 18%; 3rd line: 2%). BTK-based regimen was the second most common 1st line MCL treatment (23%), and the most common MCL treatment in later settings (2nd line: 34%, 3rd line 28%). RCHOP-based regimens were seldomly used in any setting (<5%). The overall treatment discontinuation rate was 82%. Approximately 38% of MCL patients had a hospitalization, with mean length-of-stay (LOS) of 5.6 days. The hospitalization rate was 29% (mean LOS: 3.5), 36% (mean LOS: 4.4), and 26% (mean LOS: 3.1) during 1st, 2nd, and 3rd line, respectively. Per-patient-per-month costs were $19,338 overall, and $19,239, $20,064, and $27,663 respectively, during 1st, 2nd, and 3rd line of therapy.
CONCLUSION: This study showed that bendamustine- based and BTK-based regimens were the common frontline treatments among newly diagnosed MCL patients in the VHA population. Future studies are warranted to understand factors associated with treatment selection, discontinuation and clinical benefits among these MCL Veteran patients.
BACKGROUND: Mantle cell lymphoma (MCL) is an incurable B-cell non-Hodgkin lymphoma. There is limited data on MCL burden to US veterans. OBJECTIVE: This retrospective cohort analysis aims to examine the clinical burden, costs and healthcare resource utilization of MCL to veterans.
METHODS: Adults who were newly diagnosed with MCL and initiated treatment were identified in the Veteran Health Administration (VHA) dataset (2014-2018). Treatment regimens are mutually exclusive and categorized as: bendamustine-based (alone or in combination); BTK-based (Bruton’s tyrosine kinase inhibitors: ibrutinib or acalabrutinib, alone or in combination); RCHOP-based; rituximab-monotherapy; and other regimen. Treatment discontinuation is defined as no MCL treatment for 60 days from the last day of supply. Treatment regimens, costs and hospitalizations are examined by 1st, 2nd, and 3rd lines of therapy.
RESULTS: Prevalence and incidence of MCL among the VHA population ranged from 8-11 cases, and 0.6-2.6 cases per 100,000 persons, respectively. A total of 390 patients (mean age: 70 years, 85% white) received 1st line (mean duration: 243 days), 146 (37%) patients received 2nd line (mean duration: 259 days), and 47 (12%) received 3rd line (mean duration: 154 days) therapy. Bendamustine-based regimen was the most common 1st line MCL treatment (43%), with lower utilization later (2nd line: 18%; 3rd line: 2%). BTK-based regimen was the second most common 1st line MCL treatment (23%), and the most common MCL treatment in later settings (2nd line: 34%, 3rd line 28%). RCHOP-based regimens were seldomly used in any setting (<5%). The overall treatment discontinuation rate was 82%. Approximately 38% of MCL patients had a hospitalization, with mean length-of-stay (LOS) of 5.6 days. The hospitalization rate was 29% (mean LOS: 3.5), 36% (mean LOS: 4.4), and 26% (mean LOS: 3.1) during 1st, 2nd, and 3rd line, respectively. Per-patient-per-month costs were $19,338 overall, and $19,239, $20,064, and $27,663 respectively, during 1st, 2nd, and 3rd line of therapy.
CONCLUSION: This study showed that bendamustine- based and BTK-based regimens were the common frontline treatments among newly diagnosed MCL patients in the VHA population. Future studies are warranted to understand factors associated with treatment selection, discontinuation and clinical benefits among these MCL Veteran patients.
Assessing Risk for and Management of Secondary CNS Involvement in Patients With DLBCL Within the Veterans Health Administration (VHA)
INTRODUCTION: In diffuse large B-cell lymphoma (DLBCL), approximately 5-10% of patients develop secondary central nervous system (CNS) involvement. CNS disease is associated with very poor outcomes. Therefore, it is important to identify patients at risk, via the CNS International Prognostic Index (IPI), in order to initiate appropriate interventions. Additional independent risk factors for CNS involvement include HIV-related lymphoma and high-grade B-cell lymphomas. The purpose of this study was to assess for appropriate CNS evaluation and prophylaxis in DLBCL patients within the Veterans Health Administration (VHA).
METHODS: We performed a retrospective chart review of 1,605 randomly selected patients seen in the VHA nationwide who were diagnosed with lymphoma between January 1, 2011 and December 31, 2017. We included patients diagnosed with DLBCL and excluded patients diagnosed or treated outside the VHA. We evaluated CNS IPI score, HIV status, pathology reports to identify high-grade lymphomas, performance of lumbar puncture (LP), and administration of CNS prophylaxis.
RESULTS: A total of 725 patients met our inclusion criteria. Patients were predominantly male (96.8%), white (74.5%), had a median age of 67, and presented with advanced disease (stage III 26.5%, stage IV 40.3%). From the included population, 190 (26.2%) had a highrisk CNS IPI score. Of those with high-risk CNS IPI scores, 64 (33.7%) underwent LP and 46 (24.2%) were treated with CNS prophylaxis. 23 (3.2%) were HIV positive; of those, 14 (60.8%) underwent LP and 4 (17.4%) were treated with CNS prophylaxis. FISH results were available in only 242 (33.4%) of patients and of these, 25 (10.3%) met criteria for high-grade lymphoma. Of those with high-grade lymphoma, 9 (36%) underwent LP and 7 (28%) were treated with CNS prophylaxis.
CONCLUSIONS: The National Comprehensive Cancer Network guidelines recommend that patients at high risk for CNS involvement undergo LP and treatment with CNS prophylaxis. This study found that within the VHA, patients with DLBCL at high risk for CNS involvement are not being evaluated with LPs or treated with CNS prophylaxis as often as indicated, based on CNS IPI, HIV status, and high-grade pathology. We demonstrate a need for improvement in the evaluation and treatment of these patients in order to improve outcomes.
INTRODUCTION: In diffuse large B-cell lymphoma (DLBCL), approximately 5-10% of patients develop secondary central nervous system (CNS) involvement. CNS disease is associated with very poor outcomes. Therefore, it is important to identify patients at risk, via the CNS International Prognostic Index (IPI), in order to initiate appropriate interventions. Additional independent risk factors for CNS involvement include HIV-related lymphoma and high-grade B-cell lymphomas. The purpose of this study was to assess for appropriate CNS evaluation and prophylaxis in DLBCL patients within the Veterans Health Administration (VHA).
METHODS: We performed a retrospective chart review of 1,605 randomly selected patients seen in the VHA nationwide who were diagnosed with lymphoma between January 1, 2011 and December 31, 2017. We included patients diagnosed with DLBCL and excluded patients diagnosed or treated outside the VHA. We evaluated CNS IPI score, HIV status, pathology reports to identify high-grade lymphomas, performance of lumbar puncture (LP), and administration of CNS prophylaxis.
RESULTS: A total of 725 patients met our inclusion criteria. Patients were predominantly male (96.8%), white (74.5%), had a median age of 67, and presented with advanced disease (stage III 26.5%, stage IV 40.3%). From the included population, 190 (26.2%) had a highrisk CNS IPI score. Of those with high-risk CNS IPI scores, 64 (33.7%) underwent LP and 46 (24.2%) were treated with CNS prophylaxis. 23 (3.2%) were HIV positive; of those, 14 (60.8%) underwent LP and 4 (17.4%) were treated with CNS prophylaxis. FISH results were available in only 242 (33.4%) of patients and of these, 25 (10.3%) met criteria for high-grade lymphoma. Of those with high-grade lymphoma, 9 (36%) underwent LP and 7 (28%) were treated with CNS prophylaxis.
CONCLUSIONS: The National Comprehensive Cancer Network guidelines recommend that patients at high risk for CNS involvement undergo LP and treatment with CNS prophylaxis. This study found that within the VHA, patients with DLBCL at high risk for CNS involvement are not being evaluated with LPs or treated with CNS prophylaxis as often as indicated, based on CNS IPI, HIV status, and high-grade pathology. We demonstrate a need for improvement in the evaluation and treatment of these patients in order to improve outcomes.
INTRODUCTION: In diffuse large B-cell lymphoma (DLBCL), approximately 5-10% of patients develop secondary central nervous system (CNS) involvement. CNS disease is associated with very poor outcomes. Therefore, it is important to identify patients at risk, via the CNS International Prognostic Index (IPI), in order to initiate appropriate interventions. Additional independent risk factors for CNS involvement include HIV-related lymphoma and high-grade B-cell lymphomas. The purpose of this study was to assess for appropriate CNS evaluation and prophylaxis in DLBCL patients within the Veterans Health Administration (VHA).
METHODS: We performed a retrospective chart review of 1,605 randomly selected patients seen in the VHA nationwide who were diagnosed with lymphoma between January 1, 2011 and December 31, 2017. We included patients diagnosed with DLBCL and excluded patients diagnosed or treated outside the VHA. We evaluated CNS IPI score, HIV status, pathology reports to identify high-grade lymphomas, performance of lumbar puncture (LP), and administration of CNS prophylaxis.
RESULTS: A total of 725 patients met our inclusion criteria. Patients were predominantly male (96.8%), white (74.5%), had a median age of 67, and presented with advanced disease (stage III 26.5%, stage IV 40.3%). From the included population, 190 (26.2%) had a highrisk CNS IPI score. Of those with high-risk CNS IPI scores, 64 (33.7%) underwent LP and 46 (24.2%) were treated with CNS prophylaxis. 23 (3.2%) were HIV positive; of those, 14 (60.8%) underwent LP and 4 (17.4%) were treated with CNS prophylaxis. FISH results were available in only 242 (33.4%) of patients and of these, 25 (10.3%) met criteria for high-grade lymphoma. Of those with high-grade lymphoma, 9 (36%) underwent LP and 7 (28%) were treated with CNS prophylaxis.
CONCLUSIONS: The National Comprehensive Cancer Network guidelines recommend that patients at high risk for CNS involvement undergo LP and treatment with CNS prophylaxis. This study found that within the VHA, patients with DLBCL at high risk for CNS involvement are not being evaluated with LPs or treated with CNS prophylaxis as often as indicated, based on CNS IPI, HIV status, and high-grade pathology. We demonstrate a need for improvement in the evaluation and treatment of these patients in order to improve outcomes.
Assessing Pathologic Evaluation in Patients with DLBCL Within the Veterans Health Administration
INTRODUCTION: Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma. Patients with DLBCL refractory to initial treatment or who experience relapse have low rates of prolonged disease-free survival. Fluorescence in situ hybridization (FISH) revealing rearrangements in the MYC gene along with either the BCL2 or BCL6 genes (double- and triple-hit lymphomas) demonstrate inferior outcomes when treated with standard front-line chemoimmunotherapy. Immunohistochemistry (IHC) testing for MUM1, CD10, BCL6, and MYC also provides important prognostic information and is used in the Hans algorithm to determine the cell of origin. We assessed how frequently these crucial tests were performed on DLBCL patients within the Veterans Health Administration (VHA).
METHODS: We performed a retrospective chart review of 1,605 randomly selected records of patients diagnosed with lymphoma seen within the VHA nationwide between 1/1/2011 and 12/31/2017. We included patients diagnosed with DLBCL. We excluded patients whose workup and treatment were outside of the VHA system, and patients with primary CNS lymphoma. We analyzed pathology reports. The proportion of patients who had IHC and FISH testing for each marker was assessed.
RESULTS: 725 patients were included in the study. Our patients were predominantly male (96.8%), with a median age of 67 years. Out of the patients analyzed, IHC to determine cell of origin was performed in 481 (66.3%). Out of those tested, 316 (65.7%) were of germinal center B-cell (GCB) origin, and 165 (34.3%) were non-GCB origin. FISH testing was performed in only 242 patients (33.4%). Out of the population tested, 25 (10.3%) were double- or triple-hit.
CONCLUSION: Pathological characterization is key to the diagnosis, prognosis, and treatment of DLBCL. It is recommended by the National Comprehensive Cancer Network (NCCN) to obtain IHC testing for MUM1, BCL6, CD10, and MYC, and FISH testing for MYC (with BCL2 and BCL6 if MYC is positive) in all patients with DLBCL. Our study shows that more than one half of patients did not have FISH testing, and that cell of origin was not determined in about one third of patients, indicating a need for improved testing of these protein expressions and gene rearrangements within the VHA.
INTRODUCTION: Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma. Patients with DLBCL refractory to initial treatment or who experience relapse have low rates of prolonged disease-free survival. Fluorescence in situ hybridization (FISH) revealing rearrangements in the MYC gene along with either the BCL2 or BCL6 genes (double- and triple-hit lymphomas) demonstrate inferior outcomes when treated with standard front-line chemoimmunotherapy. Immunohistochemistry (IHC) testing for MUM1, CD10, BCL6, and MYC also provides important prognostic information and is used in the Hans algorithm to determine the cell of origin. We assessed how frequently these crucial tests were performed on DLBCL patients within the Veterans Health Administration (VHA).
METHODS: We performed a retrospective chart review of 1,605 randomly selected records of patients diagnosed with lymphoma seen within the VHA nationwide between 1/1/2011 and 12/31/2017. We included patients diagnosed with DLBCL. We excluded patients whose workup and treatment were outside of the VHA system, and patients with primary CNS lymphoma. We analyzed pathology reports. The proportion of patients who had IHC and FISH testing for each marker was assessed.
RESULTS: 725 patients were included in the study. Our patients were predominantly male (96.8%), with a median age of 67 years. Out of the patients analyzed, IHC to determine cell of origin was performed in 481 (66.3%). Out of those tested, 316 (65.7%) were of germinal center B-cell (GCB) origin, and 165 (34.3%) were non-GCB origin. FISH testing was performed in only 242 patients (33.4%). Out of the population tested, 25 (10.3%) were double- or triple-hit.
CONCLUSION: Pathological characterization is key to the diagnosis, prognosis, and treatment of DLBCL. It is recommended by the National Comprehensive Cancer Network (NCCN) to obtain IHC testing for MUM1, BCL6, CD10, and MYC, and FISH testing for MYC (with BCL2 and BCL6 if MYC is positive) in all patients with DLBCL. Our study shows that more than one half of patients did not have FISH testing, and that cell of origin was not determined in about one third of patients, indicating a need for improved testing of these protein expressions and gene rearrangements within the VHA.
INTRODUCTION: Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma. Patients with DLBCL refractory to initial treatment or who experience relapse have low rates of prolonged disease-free survival. Fluorescence in situ hybridization (FISH) revealing rearrangements in the MYC gene along with either the BCL2 or BCL6 genes (double- and triple-hit lymphomas) demonstrate inferior outcomes when treated with standard front-line chemoimmunotherapy. Immunohistochemistry (IHC) testing for MUM1, CD10, BCL6, and MYC also provides important prognostic information and is used in the Hans algorithm to determine the cell of origin. We assessed how frequently these crucial tests were performed on DLBCL patients within the Veterans Health Administration (VHA).
METHODS: We performed a retrospective chart review of 1,605 randomly selected records of patients diagnosed with lymphoma seen within the VHA nationwide between 1/1/2011 and 12/31/2017. We included patients diagnosed with DLBCL. We excluded patients whose workup and treatment were outside of the VHA system, and patients with primary CNS lymphoma. We analyzed pathology reports. The proportion of patients who had IHC and FISH testing for each marker was assessed.
RESULTS: 725 patients were included in the study. Our patients were predominantly male (96.8%), with a median age of 67 years. Out of the patients analyzed, IHC to determine cell of origin was performed in 481 (66.3%). Out of those tested, 316 (65.7%) were of germinal center B-cell (GCB) origin, and 165 (34.3%) were non-GCB origin. FISH testing was performed in only 242 patients (33.4%). Out of the population tested, 25 (10.3%) were double- or triple-hit.
CONCLUSION: Pathological characterization is key to the diagnosis, prognosis, and treatment of DLBCL. It is recommended by the National Comprehensive Cancer Network (NCCN) to obtain IHC testing for MUM1, BCL6, CD10, and MYC, and FISH testing for MYC (with BCL2 and BCL6 if MYC is positive) in all patients with DLBCL. Our study shows that more than one half of patients did not have FISH testing, and that cell of origin was not determined in about one third of patients, indicating a need for improved testing of these protein expressions and gene rearrangements within the VHA.
VTE, sepsis risk increased among COVID-19 patients with cancer
, according to data from a registry study.
Researchers analyzed data on 5,556 patients with COVID-19 who had an inpatient or emergency encounter at Mount Sinai Health System (MSHS) in New York between March 1 and May 27, 2020. Patients were included in an anonymous MSHS COVID-19 registry.
There were 421 patients who had cancer: 96 with a hematologic malignancy and 325 with solid tumors.
After adjustment for age, gender, and number of comorbidities, the odds ratios for acute VTE and sepsis for patients with cancer (versus those without cancer) were 1.77 and 1.34, respectively. The adjusted odds ratio for mortality in cancer patients was 1.02.
The results remained “relatively consistent” after stratification by solid and nonsolid cancer types, with no significant difference in outcomes between those two groups, and results remained consistent in a propensity-matched model, according to Naomi Alpert, a biostatistician at Icahn School of Medicine at Mount Sinai, New York.
Ms. Alpert reported these findings at the AACR virtual meeting: COVID-19 and Cancer.
She noted that the cancer patients were older than the noncancer patients (mean age, 69.2 years vs. 63.8 years), and cancer patients were more likely to have two or more comorbid conditions (48.2% vs. 30.4%). Cancer patients also had significantly lower hemoglobin levels and red blood cell, platelet, and white blood cell counts (P < .01 for all).
“Low white blood cell count may be one of the reasons for higher risk of sepsis in cancer patients, as it may lead to a higher risk of infection,” Ms. Alpert said. “However, it’s not clear what role cancer therapies play in the risks of COVID-19 morbidity and mortality, so there is still quite a bit to learn.”
In fact, the findings are limited by a lack of information about cancer treatment, as the registry was not designed for that purpose, she noted.
Another study limitation is the short follow-up of a month or less in most patients, due, in part, to the novelty of COVID-19, but also to the lack of information on patients after they left the hospital.
“However, we had a very large sample size, with more than 400 cancer patients included, and, to our knowledge, this is the largest analysis of its kind to be done so far,” Ms. Alpert said. “In the future, it’s going to be very important to assess the effect of cancer therapies on COVID-19 complications and to see if prior therapies had any effect on outcomes.”
Longer follow-up would also be helpful for assessing the chronic effects of COVID-19 on cancer patients over time, she said. “It would be important to see whether some of these elevated risks of venous thromboembolism and sepsis are associated with longer-term mortality risks than what we were able to measure here,” she added.
Asked about the discrepancy between mortality in this study and those of larger registries, such as the COVID-19 and Cancer Consortium (CCC19) and TERAVOLT, Ms. Alpert noted that the current study included only patients who required hospitalization or emergency care.
“Our mortality rate was actually a bit higher than what was reported in some of the other studies,” she said. “We had about a 30% mortality rate in the cancer patients and about 25% for the noncancer patients, so ... we’re sort of looking at a subset of patients who we know are the sickest of the sick, which may explain some of the higher mortality that we’re seeing.”
Ms. Alpert reported having no disclosures.
SOURCE: Alpert N et al. AACR COVID-19 and Cancer, Abstract S12-02.
, according to data from a registry study.
Researchers analyzed data on 5,556 patients with COVID-19 who had an inpatient or emergency encounter at Mount Sinai Health System (MSHS) in New York between March 1 and May 27, 2020. Patients were included in an anonymous MSHS COVID-19 registry.
There were 421 patients who had cancer: 96 with a hematologic malignancy and 325 with solid tumors.
After adjustment for age, gender, and number of comorbidities, the odds ratios for acute VTE and sepsis for patients with cancer (versus those without cancer) were 1.77 and 1.34, respectively. The adjusted odds ratio for mortality in cancer patients was 1.02.
The results remained “relatively consistent” after stratification by solid and nonsolid cancer types, with no significant difference in outcomes between those two groups, and results remained consistent in a propensity-matched model, according to Naomi Alpert, a biostatistician at Icahn School of Medicine at Mount Sinai, New York.
Ms. Alpert reported these findings at the AACR virtual meeting: COVID-19 and Cancer.
She noted that the cancer patients were older than the noncancer patients (mean age, 69.2 years vs. 63.8 years), and cancer patients were more likely to have two or more comorbid conditions (48.2% vs. 30.4%). Cancer patients also had significantly lower hemoglobin levels and red blood cell, platelet, and white blood cell counts (P < .01 for all).
“Low white blood cell count may be one of the reasons for higher risk of sepsis in cancer patients, as it may lead to a higher risk of infection,” Ms. Alpert said. “However, it’s not clear what role cancer therapies play in the risks of COVID-19 morbidity and mortality, so there is still quite a bit to learn.”
In fact, the findings are limited by a lack of information about cancer treatment, as the registry was not designed for that purpose, she noted.
Another study limitation is the short follow-up of a month or less in most patients, due, in part, to the novelty of COVID-19, but also to the lack of information on patients after they left the hospital.
“However, we had a very large sample size, with more than 400 cancer patients included, and, to our knowledge, this is the largest analysis of its kind to be done so far,” Ms. Alpert said. “In the future, it’s going to be very important to assess the effect of cancer therapies on COVID-19 complications and to see if prior therapies had any effect on outcomes.”
Longer follow-up would also be helpful for assessing the chronic effects of COVID-19 on cancer patients over time, she said. “It would be important to see whether some of these elevated risks of venous thromboembolism and sepsis are associated with longer-term mortality risks than what we were able to measure here,” she added.
Asked about the discrepancy between mortality in this study and those of larger registries, such as the COVID-19 and Cancer Consortium (CCC19) and TERAVOLT, Ms. Alpert noted that the current study included only patients who required hospitalization or emergency care.
“Our mortality rate was actually a bit higher than what was reported in some of the other studies,” she said. “We had about a 30% mortality rate in the cancer patients and about 25% for the noncancer patients, so ... we’re sort of looking at a subset of patients who we know are the sickest of the sick, which may explain some of the higher mortality that we’re seeing.”
Ms. Alpert reported having no disclosures.
SOURCE: Alpert N et al. AACR COVID-19 and Cancer, Abstract S12-02.
, according to data from a registry study.
Researchers analyzed data on 5,556 patients with COVID-19 who had an inpatient or emergency encounter at Mount Sinai Health System (MSHS) in New York between March 1 and May 27, 2020. Patients were included in an anonymous MSHS COVID-19 registry.
There were 421 patients who had cancer: 96 with a hematologic malignancy and 325 with solid tumors.
After adjustment for age, gender, and number of comorbidities, the odds ratios for acute VTE and sepsis for patients with cancer (versus those without cancer) were 1.77 and 1.34, respectively. The adjusted odds ratio for mortality in cancer patients was 1.02.
The results remained “relatively consistent” after stratification by solid and nonsolid cancer types, with no significant difference in outcomes between those two groups, and results remained consistent in a propensity-matched model, according to Naomi Alpert, a biostatistician at Icahn School of Medicine at Mount Sinai, New York.
Ms. Alpert reported these findings at the AACR virtual meeting: COVID-19 and Cancer.
She noted that the cancer patients were older than the noncancer patients (mean age, 69.2 years vs. 63.8 years), and cancer patients were more likely to have two or more comorbid conditions (48.2% vs. 30.4%). Cancer patients also had significantly lower hemoglobin levels and red blood cell, platelet, and white blood cell counts (P < .01 for all).
“Low white blood cell count may be one of the reasons for higher risk of sepsis in cancer patients, as it may lead to a higher risk of infection,” Ms. Alpert said. “However, it’s not clear what role cancer therapies play in the risks of COVID-19 morbidity and mortality, so there is still quite a bit to learn.”
In fact, the findings are limited by a lack of information about cancer treatment, as the registry was not designed for that purpose, she noted.
Another study limitation is the short follow-up of a month or less in most patients, due, in part, to the novelty of COVID-19, but also to the lack of information on patients after they left the hospital.
“However, we had a very large sample size, with more than 400 cancer patients included, and, to our knowledge, this is the largest analysis of its kind to be done so far,” Ms. Alpert said. “In the future, it’s going to be very important to assess the effect of cancer therapies on COVID-19 complications and to see if prior therapies had any effect on outcomes.”
Longer follow-up would also be helpful for assessing the chronic effects of COVID-19 on cancer patients over time, she said. “It would be important to see whether some of these elevated risks of venous thromboembolism and sepsis are associated with longer-term mortality risks than what we were able to measure here,” she added.
Asked about the discrepancy between mortality in this study and those of larger registries, such as the COVID-19 and Cancer Consortium (CCC19) and TERAVOLT, Ms. Alpert noted that the current study included only patients who required hospitalization or emergency care.
“Our mortality rate was actually a bit higher than what was reported in some of the other studies,” she said. “We had about a 30% mortality rate in the cancer patients and about 25% for the noncancer patients, so ... we’re sort of looking at a subset of patients who we know are the sickest of the sick, which may explain some of the higher mortality that we’re seeing.”
Ms. Alpert reported having no disclosures.
SOURCE: Alpert N et al. AACR COVID-19 and Cancer, Abstract S12-02.
FROM AACR: COVID-19 AND CANCER
Immunotherapy should not be withheld because of sex, age, or PS
The improvement in survival in many cancer types that is seen with immune checkpoint inhibitors (ICIs), when compared to control therapies, is not affected by the patient’s sex, age, or Eastern Cooperative Oncology Group (ECOG) performance status (PS), according to a new meta-analysis.
Therefore, treatment with these immunotherapies should not be withheld on the basis of these factors, the authors concluded.
Asked whether there have been such instances of withholding ICIs, lead author Yucai Wang, MD, PhD, Mayo Clinic, Rochester, Minnesota, told Medscape Medical News: “We did this study solely based on scientific questions we had and not because we were seeing any bias at the moment in the use of ICIs.
“And we saw that the survival benefits were very similar across all of the categories [we analyzed], with a survival benefit of about 20% from immunotherapy across the board, which is clinically meaningful,” he added.
The study was published online August 7 in JAMA Network Open.
“The comparable survival advantage between patients of different sex, age, and ECOG PS may encourage more patients to receive ICI treatment regardless of cancer types, lines of therapy, agents of immunotherapy, and intervention therapies,” the authors commented.
Wang noted that there have been conflicting reports in the literature suggesting that male patients may benefit more from immunotherapy than female patients and that older patients may benefit more from the same treatment than younger patients.
However, there are also suggestions in the literature that women experience a stronger immune response than men and that, with aging, the immune system generally undergoes immunosenescence.
In addition, the PS of oncology patients has been implicated in how well patients respond to immunotherapy.
Wang noted that the findings of past studies have contradicted each other.
Findings of the Meta-Analysis
The meta-analysis included 37 randomized clinical trials that involved a total of 23,760 patients with a variety of advanced cancers. “Most of the trials were phase 3 (n = 34) and conduced for subsequent lines of therapy (n = 22),” the authors explained.
The most common cancers treated with an ICI were non–small cell lung cancer and melanoma.
Pooled overall survival (OS) hazard ratios (HRs) were calculated on the basis of sex, age (younger than 65 years and 65 years and older), and an ECOG PS of 0 and 1 or higher.
Responses were stratified on the basis of cancer type, line of therapy, the ICI used, and the immunotherapy strategy used in the ICI arm.
Most of the drugs evaluated were PD-1 and PD-L1 inhibitors. The specific drugs assessed included ipilimumab, tremelimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, and avelumab.
A total of 32 trials that involved more than 20,000 patients reported HRs for death according to the patients’ sex. Thirty-four trials that involved more than 21,000 patients reported HRs for death according to patients’ age, and 30 trials that involved more than 19,000 patients reported HRs for death according to patients’ ECOG PS.
No significant differences in OS benefit were seen by cancer type, line of therapy, agent of immunotherapy, or intervention strategy, the investigators pointed out.
There were also no differences in survival benefit associated with immunotherapy vs control therapies for patients with an ECOG PS of 0 and an ECOG PS of 1 or greater. The OS benefit was 0.81 for those with an ECOG PS of 0 and 0.79 for those with an ECOG PS of 1 or greater.
Wang has disclosed no relevant financial relationships.
This article first appeared on Medscape.com .
The improvement in survival in many cancer types that is seen with immune checkpoint inhibitors (ICIs), when compared to control therapies, is not affected by the patient’s sex, age, or Eastern Cooperative Oncology Group (ECOG) performance status (PS), according to a new meta-analysis.
Therefore, treatment with these immunotherapies should not be withheld on the basis of these factors, the authors concluded.
Asked whether there have been such instances of withholding ICIs, lead author Yucai Wang, MD, PhD, Mayo Clinic, Rochester, Minnesota, told Medscape Medical News: “We did this study solely based on scientific questions we had and not because we were seeing any bias at the moment in the use of ICIs.
“And we saw that the survival benefits were very similar across all of the categories [we analyzed], with a survival benefit of about 20% from immunotherapy across the board, which is clinically meaningful,” he added.
The study was published online August 7 in JAMA Network Open.
“The comparable survival advantage between patients of different sex, age, and ECOG PS may encourage more patients to receive ICI treatment regardless of cancer types, lines of therapy, agents of immunotherapy, and intervention therapies,” the authors commented.
Wang noted that there have been conflicting reports in the literature suggesting that male patients may benefit more from immunotherapy than female patients and that older patients may benefit more from the same treatment than younger patients.
However, there are also suggestions in the literature that women experience a stronger immune response than men and that, with aging, the immune system generally undergoes immunosenescence.
In addition, the PS of oncology patients has been implicated in how well patients respond to immunotherapy.
Wang noted that the findings of past studies have contradicted each other.
Findings of the Meta-Analysis
The meta-analysis included 37 randomized clinical trials that involved a total of 23,760 patients with a variety of advanced cancers. “Most of the trials were phase 3 (n = 34) and conduced for subsequent lines of therapy (n = 22),” the authors explained.
The most common cancers treated with an ICI were non–small cell lung cancer and melanoma.
Pooled overall survival (OS) hazard ratios (HRs) were calculated on the basis of sex, age (younger than 65 years and 65 years and older), and an ECOG PS of 0 and 1 or higher.
Responses were stratified on the basis of cancer type, line of therapy, the ICI used, and the immunotherapy strategy used in the ICI arm.
Most of the drugs evaluated were PD-1 and PD-L1 inhibitors. The specific drugs assessed included ipilimumab, tremelimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, and avelumab.
A total of 32 trials that involved more than 20,000 patients reported HRs for death according to the patients’ sex. Thirty-four trials that involved more than 21,000 patients reported HRs for death according to patients’ age, and 30 trials that involved more than 19,000 patients reported HRs for death according to patients’ ECOG PS.
No significant differences in OS benefit were seen by cancer type, line of therapy, agent of immunotherapy, or intervention strategy, the investigators pointed out.
There were also no differences in survival benefit associated with immunotherapy vs control therapies for patients with an ECOG PS of 0 and an ECOG PS of 1 or greater. The OS benefit was 0.81 for those with an ECOG PS of 0 and 0.79 for those with an ECOG PS of 1 or greater.
Wang has disclosed no relevant financial relationships.
This article first appeared on Medscape.com .
The improvement in survival in many cancer types that is seen with immune checkpoint inhibitors (ICIs), when compared to control therapies, is not affected by the patient’s sex, age, or Eastern Cooperative Oncology Group (ECOG) performance status (PS), according to a new meta-analysis.
Therefore, treatment with these immunotherapies should not be withheld on the basis of these factors, the authors concluded.
Asked whether there have been such instances of withholding ICIs, lead author Yucai Wang, MD, PhD, Mayo Clinic, Rochester, Minnesota, told Medscape Medical News: “We did this study solely based on scientific questions we had and not because we were seeing any bias at the moment in the use of ICIs.
“And we saw that the survival benefits were very similar across all of the categories [we analyzed], with a survival benefit of about 20% from immunotherapy across the board, which is clinically meaningful,” he added.
The study was published online August 7 in JAMA Network Open.
“The comparable survival advantage between patients of different sex, age, and ECOG PS may encourage more patients to receive ICI treatment regardless of cancer types, lines of therapy, agents of immunotherapy, and intervention therapies,” the authors commented.
Wang noted that there have been conflicting reports in the literature suggesting that male patients may benefit more from immunotherapy than female patients and that older patients may benefit more from the same treatment than younger patients.
However, there are also suggestions in the literature that women experience a stronger immune response than men and that, with aging, the immune system generally undergoes immunosenescence.
In addition, the PS of oncology patients has been implicated in how well patients respond to immunotherapy.
Wang noted that the findings of past studies have contradicted each other.
Findings of the Meta-Analysis
The meta-analysis included 37 randomized clinical trials that involved a total of 23,760 patients with a variety of advanced cancers. “Most of the trials were phase 3 (n = 34) and conduced for subsequent lines of therapy (n = 22),” the authors explained.
The most common cancers treated with an ICI were non–small cell lung cancer and melanoma.
Pooled overall survival (OS) hazard ratios (HRs) were calculated on the basis of sex, age (younger than 65 years and 65 years and older), and an ECOG PS of 0 and 1 or higher.
Responses were stratified on the basis of cancer type, line of therapy, the ICI used, and the immunotherapy strategy used in the ICI arm.
Most of the drugs evaluated were PD-1 and PD-L1 inhibitors. The specific drugs assessed included ipilimumab, tremelimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, and avelumab.
A total of 32 trials that involved more than 20,000 patients reported HRs for death according to the patients’ sex. Thirty-four trials that involved more than 21,000 patients reported HRs for death according to patients’ age, and 30 trials that involved more than 19,000 patients reported HRs for death according to patients’ ECOG PS.
No significant differences in OS benefit were seen by cancer type, line of therapy, agent of immunotherapy, or intervention strategy, the investigators pointed out.
There were also no differences in survival benefit associated with immunotherapy vs control therapies for patients with an ECOG PS of 0 and an ECOG PS of 1 or greater. The OS benefit was 0.81 for those with an ECOG PS of 0 and 0.79 for those with an ECOG PS of 1 or greater.
Wang has disclosed no relevant financial relationships.
This article first appeared on Medscape.com .
Age, other risk factors predict length of MM survival
Younger age of onset and the use of autologous hematopoietic stem cell transplant (ASCT) treatment were key factors improving the length of survival of newly diagnosed, active multiple myeloma (MM) patients, according to the results of a retrospective analysis.
In addition, multivariable analysis showed that a higher level of blood creatinine, the presence of extramedullary disease, a lower level of partial remission, and the use of nonautologous hematopoietic stem cell transplantation were independent risk factors for shorter survival, according to Virginia Bove, MD, of the Asociación Espanola Primera en Socorros Mutuos, Montevideo, Uruguay and colleagues.
Dr. Bove and colleagues retrospectively analyzed clinical characteristics, response to treatment, and survival of 282 patients from multiple institutions who had active newly-diagnosed multiple myeloma. They compared the results between patients age 65 years or younger (53.2%) with those older than 65 years and assessed clinical risk factors, as reported online in Hematology, Transfusion, and Cell Therapy.
The main cause of death in all patients was MM progression and the early mortality rate was not different between the younger and older patients. The main cause of early death in older patients was infection, according to the researchers.
Multiple risk factors
“Although MM patients younger than 66 years of age have an aggressive presentation with an advanced stage, high rate of renal failure and extramedullary disease, this did not translate into an inferior [overall survival] and [progression-free survival],” the researchers reported.
The overall response rate was similar between groups (80.6% vs. 81.4%; P = .866), and the overall survival was significantly longer in young patients (median, 65 months vs. 41 months; P = .001) and higher in those who received autologous hematopoietic stem cell transplantation.
Multivariate analysis was performed on data from the younger patients. The results showed that a creatinine level of less than or equal to 2 mg/dL (P = .048), extramedullary disease (P = .001), a lower VGPR (P = .003) and the use of nonautologous hematopoietic stem cell transplantation (P = .048) were all independent risk factors for shorter survival.
“Older age is an independent adverse prognostic factor. Adequate risk identification, frontline treatment based on novel drugs and ASCT are the best strategies to improve outcomes, both in young and old patients,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Bove V et al. Hematol Transfus Cell Ther. 2020 Aug 20. doi: 10.1016/j.htct.2020.06.014.
Younger age of onset and the use of autologous hematopoietic stem cell transplant (ASCT) treatment were key factors improving the length of survival of newly diagnosed, active multiple myeloma (MM) patients, according to the results of a retrospective analysis.
In addition, multivariable analysis showed that a higher level of blood creatinine, the presence of extramedullary disease, a lower level of partial remission, and the use of nonautologous hematopoietic stem cell transplantation were independent risk factors for shorter survival, according to Virginia Bove, MD, of the Asociación Espanola Primera en Socorros Mutuos, Montevideo, Uruguay and colleagues.
Dr. Bove and colleagues retrospectively analyzed clinical characteristics, response to treatment, and survival of 282 patients from multiple institutions who had active newly-diagnosed multiple myeloma. They compared the results between patients age 65 years or younger (53.2%) with those older than 65 years and assessed clinical risk factors, as reported online in Hematology, Transfusion, and Cell Therapy.
The main cause of death in all patients was MM progression and the early mortality rate was not different between the younger and older patients. The main cause of early death in older patients was infection, according to the researchers.
Multiple risk factors
“Although MM patients younger than 66 years of age have an aggressive presentation with an advanced stage, high rate of renal failure and extramedullary disease, this did not translate into an inferior [overall survival] and [progression-free survival],” the researchers reported.
The overall response rate was similar between groups (80.6% vs. 81.4%; P = .866), and the overall survival was significantly longer in young patients (median, 65 months vs. 41 months; P = .001) and higher in those who received autologous hematopoietic stem cell transplantation.
Multivariate analysis was performed on data from the younger patients. The results showed that a creatinine level of less than or equal to 2 mg/dL (P = .048), extramedullary disease (P = .001), a lower VGPR (P = .003) and the use of nonautologous hematopoietic stem cell transplantation (P = .048) were all independent risk factors for shorter survival.
“Older age is an independent adverse prognostic factor. Adequate risk identification, frontline treatment based on novel drugs and ASCT are the best strategies to improve outcomes, both in young and old patients,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Bove V et al. Hematol Transfus Cell Ther. 2020 Aug 20. doi: 10.1016/j.htct.2020.06.014.
Younger age of onset and the use of autologous hematopoietic stem cell transplant (ASCT) treatment were key factors improving the length of survival of newly diagnosed, active multiple myeloma (MM) patients, according to the results of a retrospective analysis.
In addition, multivariable analysis showed that a higher level of blood creatinine, the presence of extramedullary disease, a lower level of partial remission, and the use of nonautologous hematopoietic stem cell transplantation were independent risk factors for shorter survival, according to Virginia Bove, MD, of the Asociación Espanola Primera en Socorros Mutuos, Montevideo, Uruguay and colleagues.
Dr. Bove and colleagues retrospectively analyzed clinical characteristics, response to treatment, and survival of 282 patients from multiple institutions who had active newly-diagnosed multiple myeloma. They compared the results between patients age 65 years or younger (53.2%) with those older than 65 years and assessed clinical risk factors, as reported online in Hematology, Transfusion, and Cell Therapy.
The main cause of death in all patients was MM progression and the early mortality rate was not different between the younger and older patients. The main cause of early death in older patients was infection, according to the researchers.
Multiple risk factors
“Although MM patients younger than 66 years of age have an aggressive presentation with an advanced stage, high rate of renal failure and extramedullary disease, this did not translate into an inferior [overall survival] and [progression-free survival],” the researchers reported.
The overall response rate was similar between groups (80.6% vs. 81.4%; P = .866), and the overall survival was significantly longer in young patients (median, 65 months vs. 41 months; P = .001) and higher in those who received autologous hematopoietic stem cell transplantation.
Multivariate analysis was performed on data from the younger patients. The results showed that a creatinine level of less than or equal to 2 mg/dL (P = .048), extramedullary disease (P = .001), a lower VGPR (P = .003) and the use of nonautologous hematopoietic stem cell transplantation (P = .048) were all independent risk factors for shorter survival.
“Older age is an independent adverse prognostic factor. Adequate risk identification, frontline treatment based on novel drugs and ASCT are the best strategies to improve outcomes, both in young and old patients,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Bove V et al. Hematol Transfus Cell Ther. 2020 Aug 20. doi: 10.1016/j.htct.2020.06.014.
FROM HEMATOLOGY, TRANSFUSION, AND CELL THERAPY