Breast Cancer

Key clinical point: Patients with human epidermal growth factor receptor 2-positive (ERBB2+) and triple-negative breast cancer (TNBC) are more likely to need radiation for brain metastasis (BRM) than those with other BC subtypes.

Major finding: At the 3-year timepoint, the cumulative incidences of BRM was highest in patients with ERBB2+/hormone receptor-negative (HR−) BC (25.3%). TNBC (hazard ratio 4.25), ERBB2+/HR+ BC (hazard ratio 1.94), and ERBB2+/HR− BC (hazard ratio 2.81; all P < .001) were associated with a shorter time from BC diagnosis to brain radiotherapy than HR+/ERBB2− BC. Patients who received radiotherapy for BRM were more likely to have TNBC or ERBB2+ BC than HR+/ERBB2− BC (P < .001).

Study details: Findings are from a retrospective, observational population-based cohort study including 3916 patients with metastatic BC, of which 31.0% had HR+/ERBB2− BC, 7.9% had ERBB2+/HR+ BC, 5.1% had ERBB2+/HR− BC, and 6.6% had TNBC.

Disclosures: This research was supported by Eli Lilly. Some authors declared serving as consultants, board members, or speakers or receiving grants or personal fees from several sources, including Eli Lilly.

Source: Wang XY et al. Analysis of rates of brain metastases and association with breast cancer subtypes in Ontario, Canada. JAMA Netw Open. 2022;5(8):e2225424 (Aug 12). Doi: 10.1001/jamanetworkopen.2022.25424

Key clinical point: Patients with human epidermal growth factor receptor 2-positive (ERBB2+) and triple-negative breast cancer (TNBC) are more likely to need radiation for brain metastasis (BRM) than those with other BC subtypes.

Major finding: At the 3-year timepoint, the cumulative incidences of BRM was highest in patients with ERBB2+/hormone receptor-negative (HR−) BC (25.3%). TNBC (hazard ratio 4.25), ERBB2+/HR+ BC (hazard ratio 1.94), and ERBB2+/HR− BC (hazard ratio 2.81; all P < .001) were associated with a shorter time from BC diagnosis to brain radiotherapy than HR+/ERBB2− BC. Patients who received radiotherapy for BRM were more likely to have TNBC or ERBB2+ BC than HR+/ERBB2− BC (P < .001).

Study details: Findings are from a retrospective, observational population-based cohort study including 3916 patients with metastatic BC, of which 31.0% had HR+/ERBB2− BC, 7.9% had ERBB2+/HR+ BC, 5.1% had ERBB2+/HR− BC, and 6.6% had TNBC.

Disclosures: This research was supported by Eli Lilly. Some authors declared serving as consultants, board members, or speakers or receiving grants or personal fees from several sources, including Eli Lilly.

Source: Wang XY et al. Analysis of rates of brain metastases and association with breast cancer subtypes in Ontario, Canada. JAMA Netw Open. 2022;5(8):e2225424 (Aug 12). Doi: 10.1001/jamanetworkopen.2022.25424

Key clinical point: Patients with human epidermal growth factor receptor 2-positive (ERBB2+) and triple-negative breast cancer (TNBC) are more likely to need radiation for brain metastasis (BRM) than those with other BC subtypes.

Major finding: At the 3-year timepoint, the cumulative incidences of BRM was highest in patients with ERBB2+/hormone receptor-negative (HR−) BC (25.3%). TNBC (hazard ratio 4.25), ERBB2+/HR+ BC (hazard ratio 1.94), and ERBB2+/HR− BC (hazard ratio 2.81; all P < .001) were associated with a shorter time from BC diagnosis to brain radiotherapy than HR+/ERBB2− BC. Patients who received radiotherapy for BRM were more likely to have TNBC or ERBB2+ BC than HR+/ERBB2− BC (P < .001).

Study details: Findings are from a retrospective, observational population-based cohort study including 3916 patients with metastatic BC, of which 31.0% had HR+/ERBB2− BC, 7.9% had ERBB2+/HR+ BC, 5.1% had ERBB2+/HR− BC, and 6.6% had TNBC.

Disclosures: This research was supported by Eli Lilly. Some authors declared serving as consultants, board members, or speakers or receiving grants or personal fees from several sources, including Eli Lilly.

Source: Wang XY et al. Analysis of rates of brain metastases and association with breast cancer subtypes in Ontario, Canada. JAMA Netw Open. 2022;5(8):e2225424 (Aug 12). Doi: 10.1001/jamanetworkopen.2022.25424

Key clinical point: Lapatinib demonstrated excellent survival outcomes in patients with small, node-negative, human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC), when used in combination with trastuzumab, but not when used as a substitute for trastuzumab.

Major finding: The 7-year disease-free survival (DFS) rate in the overall cohort was excellent (88.1%), with improved DFS outcomes observed in the trastuzumab (89.6%), trastuzumab followed by lapatinib (89.0%), and trastuzumab+lapatinib (89.1%) arms, but not as much in the lapatinib-only arm (84.3%; stratified log-rank P   =   .031).

Study details: Findings are from a subanalysis of the phase 3 ALTTO trial including 2821 patients with small (pathological tumor size ≤ 3 cm), lymph node-negative, early HER2+ BC who were randomly assigned to receive adjuvant therapy with trastuzumab, lapatinib, trastuzumab followed by lapatinib, or trastuzumab+lapatinib.

Disclosures: The ALTTO trial received funding from GlaxoSmithKline, Novartis Pharma AG, and other sources. Two authors declared being employees of and owning stocks in Novartis. The other authors reported ties with several sources, including Novartis.

Source: Nader-Marta G et al. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy-a sub-analysis of the ALTTO study. Br J Cancer. 2022 (Sep 1). Doi: 10.1038/s41416-022-01963-8

Key clinical point: Lapatinib demonstrated excellent survival outcomes in patients with small, node-negative, human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC), when used in combination with trastuzumab, but not when used as a substitute for trastuzumab.

Major finding: The 7-year disease-free survival (DFS) rate in the overall cohort was excellent (88.1%), with improved DFS outcomes observed in the trastuzumab (89.6%), trastuzumab followed by lapatinib (89.0%), and trastuzumab+lapatinib (89.1%) arms, but not as much in the lapatinib-only arm (84.3%; stratified log-rank P   =   .031).

Study details: Findings are from a subanalysis of the phase 3 ALTTO trial including 2821 patients with small (pathological tumor size ≤ 3 cm), lymph node-negative, early HER2+ BC who were randomly assigned to receive adjuvant therapy with trastuzumab, lapatinib, trastuzumab followed by lapatinib, or trastuzumab+lapatinib.

Disclosures: The ALTTO trial received funding from GlaxoSmithKline, Novartis Pharma AG, and other sources. Two authors declared being employees of and owning stocks in Novartis. The other authors reported ties with several sources, including Novartis.

Source: Nader-Marta G et al. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy-a sub-analysis of the ALTTO study. Br J Cancer. 2022 (Sep 1). Doi: 10.1038/s41416-022-01963-8

Key clinical point: Lapatinib demonstrated excellent survival outcomes in patients with small, node-negative, human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC), when used in combination with trastuzumab, but not when used as a substitute for trastuzumab.

Major finding: The 7-year disease-free survival (DFS) rate in the overall cohort was excellent (88.1%), with improved DFS outcomes observed in the trastuzumab (89.6%), trastuzumab followed by lapatinib (89.0%), and trastuzumab+lapatinib (89.1%) arms, but not as much in the lapatinib-only arm (84.3%; stratified log-rank P   =   .031).

Study details: Findings are from a subanalysis of the phase 3 ALTTO trial including 2821 patients with small (pathological tumor size ≤ 3 cm), lymph node-negative, early HER2+ BC who were randomly assigned to receive adjuvant therapy with trastuzumab, lapatinib, trastuzumab followed by lapatinib, or trastuzumab+lapatinib.

Disclosures: The ALTTO trial received funding from GlaxoSmithKline, Novartis Pharma AG, and other sources. Two authors declared being employees of and owning stocks in Novartis. The other authors reported ties with several sources, including Novartis.

Source: Nader-Marta G et al. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy-a sub-analysis of the ALTTO study. Br J Cancer. 2022 (Sep 1). Doi: 10.1038/s41416-022-01963-8

Key clinical point: Neratinib as monotherapy or in combination with capecitabine showed good survival outcomes and was well tolerated in a real-world setting of patients with advanced human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with or without brain metastases (BM).

Major finding: The median progression-free survival (PFS) and overall survival (OS) for all patients were 5.9 months (95% CI 4.9-7.4) and 15.0 months (95% CI 10.4-22.2), respectively, with survival outcomes being similar in patients with vs without BM. PFS and OS were significantly longer with neratinib+capecitabine vs neratinib (P ≤ .001). Diarrhea was the major adverse event (64%) with 10% being grade 3.

Study details: Findings are from a single-center retrospective study including 72 patients with advanced HER2+ BC who received neratinib (n = 27) or neratinib+capecitabine (n = 45). Thirty-eight patients had BM.

Disclosures: This study was supported by the Royal Marsden National Institute for Health and Care Research Biomedical Research Centre for Cancer, UK. The authors declared receiving research funding, speaker’s fees, honoraria, or travel support from several sources.

Source: Cunningham N et al. Neratinib in advanced HER2-positive breast cancer: Experience from the Royal Marsden Hospital. Breast Cancer Res Treat. 2022;195(3):333-340 (Aug 17). Doi: 10.1007/s10549-022-06703-3

Key clinical point: Neratinib as monotherapy or in combination with capecitabine showed good survival outcomes and was well tolerated in a real-world setting of patients with advanced human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with or without brain metastases (BM).

Major finding: The median progression-free survival (PFS) and overall survival (OS) for all patients were 5.9 months (95% CI 4.9-7.4) and 15.0 months (95% CI 10.4-22.2), respectively, with survival outcomes being similar in patients with vs without BM. PFS and OS were significantly longer with neratinib+capecitabine vs neratinib (P ≤ .001). Diarrhea was the major adverse event (64%) with 10% being grade 3.

Study details: Findings are from a single-center retrospective study including 72 patients with advanced HER2+ BC who received neratinib (n = 27) or neratinib+capecitabine (n = 45). Thirty-eight patients had BM.

Disclosures: This study was supported by the Royal Marsden National Institute for Health and Care Research Biomedical Research Centre for Cancer, UK. The authors declared receiving research funding, speaker’s fees, honoraria, or travel support from several sources.

Source: Cunningham N et al. Neratinib in advanced HER2-positive breast cancer: Experience from the Royal Marsden Hospital. Breast Cancer Res Treat. 2022;195(3):333-340 (Aug 17). Doi: 10.1007/s10549-022-06703-3

Key clinical point: Neratinib as monotherapy or in combination with capecitabine showed good survival outcomes and was well tolerated in a real-world setting of patients with advanced human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with or without brain metastases (BM).

Major finding: The median progression-free survival (PFS) and overall survival (OS) for all patients were 5.9 months (95% CI 4.9-7.4) and 15.0 months (95% CI 10.4-22.2), respectively, with survival outcomes being similar in patients with vs without BM. PFS and OS were significantly longer with neratinib+capecitabine vs neratinib (P ≤ .001). Diarrhea was the major adverse event (64%) with 10% being grade 3.

Study details: Findings are from a single-center retrospective study including 72 patients with advanced HER2+ BC who received neratinib (n = 27) or neratinib+capecitabine (n = 45). Thirty-eight patients had BM.

Disclosures: This study was supported by the Royal Marsden National Institute for Health and Care Research Biomedical Research Centre for Cancer, UK. The authors declared receiving research funding, speaker’s fees, honoraria, or travel support from several sources.

Source: Cunningham N et al. Neratinib in advanced HER2-positive breast cancer: Experience from the Royal Marsden Hospital. Breast Cancer Res Treat. 2022;195(3):333-340 (Aug 17). Doi: 10.1007/s10549-022-06703-3

Key clinical point: Addition of durvalumab to neoadjuvant chemotherapy (NACT) improved survival in women with early triple-negative breast cancer (TNBC) although improvement in the pathological complete response (pCR) rate was nonsignificant.

Major finding: In the overall cohort, durvalumab vs placebo improved 3-year invasive disease-free survival (hazard ratio [HR] 0.48; log-rank P   =   .036), distant disease-free survival (HR 0.31; log-rank P   =   .005), and overall survival (HR 0.24; log-rank P   =   .006) rates, despite no adjuvant component of durvalumab.

Study details: Findings are from the phase 2 GeparNuevo study including 174 patients with primary nonmetastatic TNBC who were randomly assigned to receive NACT with durvalumab or placebo.

Disclosures: This study was funded by AstraZeneca and Celgene. The authors declared receiving grants, personal fees, nonfinancial support, or other support from several sources.

Source: Loibl S et al. Neoadjuvant durvalumab improves survival in early triple-negative breast cancer independent of pathological complete response. Ann Oncol. 2022 (Aug 9). Doi: 10.1016/j.annonc.2022.07.1940

Key clinical point: Addition of durvalumab to neoadjuvant chemotherapy (NACT) improved survival in women with early triple-negative breast cancer (TNBC) although improvement in the pathological complete response (pCR) rate was nonsignificant.

Major finding: In the overall cohort, durvalumab vs placebo improved 3-year invasive disease-free survival (hazard ratio [HR] 0.48; log-rank P   =   .036), distant disease-free survival (HR 0.31; log-rank P   =   .005), and overall survival (HR 0.24; log-rank P   =   .006) rates, despite no adjuvant component of durvalumab.

Study details: Findings are from the phase 2 GeparNuevo study including 174 patients with primary nonmetastatic TNBC who were randomly assigned to receive NACT with durvalumab or placebo.

Disclosures: This study was funded by AstraZeneca and Celgene. The authors declared receiving grants, personal fees, nonfinancial support, or other support from several sources.

Source: Loibl S et al. Neoadjuvant durvalumab improves survival in early triple-negative breast cancer independent of pathological complete response. Ann Oncol. 2022 (Aug 9). Doi: 10.1016/j.annonc.2022.07.1940

Key clinical point: Addition of durvalumab to neoadjuvant chemotherapy (NACT) improved survival in women with early triple-negative breast cancer (TNBC) although improvement in the pathological complete response (pCR) rate was nonsignificant.

Major finding: In the overall cohort, durvalumab vs placebo improved 3-year invasive disease-free survival (hazard ratio [HR] 0.48; log-rank P   =   .036), distant disease-free survival (HR 0.31; log-rank P   =   .005), and overall survival (HR 0.24; log-rank P   =   .006) rates, despite no adjuvant component of durvalumab.

Study details: Findings are from the phase 2 GeparNuevo study including 174 patients with primary nonmetastatic TNBC who were randomly assigned to receive NACT with durvalumab or placebo.

Disclosures: This study was funded by AstraZeneca and Celgene. The authors declared receiving grants, personal fees, nonfinancial support, or other support from several sources.

Source: Loibl S et al. Neoadjuvant durvalumab improves survival in early triple-negative breast cancer independent of pathological complete response. Ann Oncol. 2022 (Aug 9). Doi: 10.1016/j.annonc.2022.07.1940

Key clinical point: Sacituzumab govitecan (SG) was more effective than chemotherapy in improving progression-free survival (PFS) and showed a manageable safety profile in patients with heavily pretreated, endocrine-resistant, hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: SG vs chemotherapy significantly improved PFS (hazard ratio [HR] 0.66; P   =   .0003), with PFS rates being 46% vs 30% at 6 months and 21% vs 7% at 12 months, respectively. The most common grade ≥3 treatment-related adverse events with SG vs chemotherapy were neutropenia (51% vs 38%) and diarrhea (9% vs 1%).

Study details: Findings are the primary results of the phase 3 TROPiCS-02 trial including 543 patients with HR+/HER2− locally recurrent inoperable/metastatic BC who had received prior cyclin-dependent kinase 4/6 inhibitor with 2-4 lines of chemotherapy and were randomly assigned to receive SG or chemotherapy.

Disclosures: This study was supported by Gilead Sciences Inc. Four authors declared being employees of or stockowners in Gilead Sciences. The other authors reported ties with several sources, including Gilead.

Source: Rugo HS et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022 (Aug 26). Doi: 10.1200/JCO.22.01002

Key clinical point: Sacituzumab govitecan (SG) was more effective than chemotherapy in improving progression-free survival (PFS) and showed a manageable safety profile in patients with heavily pretreated, endocrine-resistant, hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: SG vs chemotherapy significantly improved PFS (hazard ratio [HR] 0.66; P   =   .0003), with PFS rates being 46% vs 30% at 6 months and 21% vs 7% at 12 months, respectively. The most common grade ≥3 treatment-related adverse events with SG vs chemotherapy were neutropenia (51% vs 38%) and diarrhea (9% vs 1%).

Study details: Findings are the primary results of the phase 3 TROPiCS-02 trial including 543 patients with HR+/HER2− locally recurrent inoperable/metastatic BC who had received prior cyclin-dependent kinase 4/6 inhibitor with 2-4 lines of chemotherapy and were randomly assigned to receive SG or chemotherapy.

Disclosures: This study was supported by Gilead Sciences Inc. Four authors declared being employees of or stockowners in Gilead Sciences. The other authors reported ties with several sources, including Gilead.

Source: Rugo HS et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022 (Aug 26). Doi: 10.1200/JCO.22.01002

Key clinical point: Sacituzumab govitecan (SG) was more effective than chemotherapy in improving progression-free survival (PFS) and showed a manageable safety profile in patients with heavily pretreated, endocrine-resistant, hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: SG vs chemotherapy significantly improved PFS (hazard ratio [HR] 0.66; P   =   .0003), with PFS rates being 46% vs 30% at 6 months and 21% vs 7% at 12 months, respectively. The most common grade ≥3 treatment-related adverse events with SG vs chemotherapy were neutropenia (51% vs 38%) and diarrhea (9% vs 1%).

Study details: Findings are the primary results of the phase 3 TROPiCS-02 trial including 543 patients with HR+/HER2− locally recurrent inoperable/metastatic BC who had received prior cyclin-dependent kinase 4/6 inhibitor with 2-4 lines of chemotherapy and were randomly assigned to receive SG or chemotherapy.

Disclosures: This study was supported by Gilead Sciences Inc. Four authors declared being employees of or stockowners in Gilead Sciences. The other authors reported ties with several sources, including Gilead.

Source: Rugo HS et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022 (Aug 26). Doi: 10.1200/JCO.22.01002

Key clinical point: De-escalation of locoregional radiotherapy, according to a predefined consensus-based study guideline, was oncologically safe in women with cT1-2N1 breast cancer (BC) who received primary chemotherapy.

Major finding: The 5-year locoregional recurrence rate was 2.2% (95% CI 1.4%-3.4%) in the overall cohort, with the rates being similar in the low- vs intermediate-risk group (P   =   .89), low- vs high-risk group (P   =   .75), and intermediate- vs high-risk group (P   =   .83) and the 5-year locoregional recurrence rate remaining < 4% as per the study guideline.

Study details: Findings are from a prospective registry study including 838 patients with cT1-2N1 invasive BC who were treated with ≥3 cycles of primary chemotherapy and surgery of the breast and axillary and were categorized into three predefined risk categorized based on axillary lymph node status.

Disclosures: This study was funded by the Dutch Cancer Society. Some authors declared holding patents, serving as the chair of a committee, or receiving grants, consulting fees, or financial and nonfinancial support from several sources.

Source: de Wild SR et al. De-escalation of radiotherapy after primary chemotherapy in cT1-2N1 breast cancer (RAPCHEM; BOOG 2010-03): 5-year follow-up results of a Dutch, prospective, registry study. Lancet Oncol. 2022;23(9):1201-1210 (Aug 8). Doi: 10.1016/S1470-2045(22)00482-X

Key clinical point: De-escalation of locoregional radiotherapy, according to a predefined consensus-based study guideline, was oncologically safe in women with cT1-2N1 breast cancer (BC) who received primary chemotherapy.

Major finding: The 5-year locoregional recurrence rate was 2.2% (95% CI 1.4%-3.4%) in the overall cohort, with the rates being similar in the low- vs intermediate-risk group (P   =   .89), low- vs high-risk group (P   =   .75), and intermediate- vs high-risk group (P   =   .83) and the 5-year locoregional recurrence rate remaining < 4% as per the study guideline.

Study details: Findings are from a prospective registry study including 838 patients with cT1-2N1 invasive BC who were treated with ≥3 cycles of primary chemotherapy and surgery of the breast and axillary and were categorized into three predefined risk categorized based on axillary lymph node status.

Disclosures: This study was funded by the Dutch Cancer Society. Some authors declared holding patents, serving as the chair of a committee, or receiving grants, consulting fees, or financial and nonfinancial support from several sources.

Source: de Wild SR et al. De-escalation of radiotherapy after primary chemotherapy in cT1-2N1 breast cancer (RAPCHEM; BOOG 2010-03): 5-year follow-up results of a Dutch, prospective, registry study. Lancet Oncol. 2022;23(9):1201-1210 (Aug 8). Doi: 10.1016/S1470-2045(22)00482-X

Key clinical point: De-escalation of locoregional radiotherapy, according to a predefined consensus-based study guideline, was oncologically safe in women with cT1-2N1 breast cancer (BC) who received primary chemotherapy.

Major finding: The 5-year locoregional recurrence rate was 2.2% (95% CI 1.4%-3.4%) in the overall cohort, with the rates being similar in the low- vs intermediate-risk group (P   =   .89), low- vs high-risk group (P   =   .75), and intermediate- vs high-risk group (P   =   .83) and the 5-year locoregional recurrence rate remaining < 4% as per the study guideline.

Study details: Findings are from a prospective registry study including 838 patients with cT1-2N1 invasive BC who were treated with ≥3 cycles of primary chemotherapy and surgery of the breast and axillary and were categorized into three predefined risk categorized based on axillary lymph node status.

Disclosures: This study was funded by the Dutch Cancer Society. Some authors declared holding patents, serving as the chair of a committee, or receiving grants, consulting fees, or financial and nonfinancial support from several sources.

Source: de Wild SR et al. De-escalation of radiotherapy after primary chemotherapy in cT1-2N1 breast cancer (RAPCHEM; BOOG 2010-03): 5-year follow-up results of a Dutch, prospective, registry study. Lancet Oncol. 2022;23(9):1201-1210 (Aug 8). Doi: 10.1016/S1470-2045(22)00482-X

Time to diagnosis is a crucial factor in cancer. Delays can lead to diagnosis at later stages and prevent optimal therapeutic strategies, both of which have the potential to reduce survival. An estimated 63%-82% of cancers get diagnosed as a result of symptom presentation, and delays in diagnosis can hamper treatment efforts. Diagnosis can be challenging because common symptoms – such as weight loss, weakness, poor appetite, and shortness of breath – are nonspecific.

A new analysis of U.S.-based data shows that the average time to diagnosis is 5.2 months for patients with solid tumors. The authors of the study call for better cancer diagnosis pathways in the U.S.

“Several countries, including the UK, Denmark, Sweden, Canada and Australia, have identified the importance and potential impact of more timely diagnosis by establishing national guidelines, special programs, and treatment pathways. However, in the U.S., there’s relatively little research and effort focused on streamlining the diagnostic pathway. Currently, the U.S. does not have established cancer diagnostic pathways that are used consistently,” Matthew Gitlin, PharmD, said during a presentation at the annual meeting of the European Society for Medical Oncology.

Diagnostic delays can lead to diagnosis at more advanced stages. “That is often associated with worse clinical outcomes, increased economic burden, and decreased health related quality of life,” said Dr. Gitlin, founder and managing director of the health economics consulting firm BluePath Solutions, which conducted the analysis.

The study retrospectively examined administrative billing data drawn from the Clinformatics for Managed Markets longitudinal database. The data represent individuals in Medicare Advantage and a large, U.S.-based private insurance plan. Between 2018 and 2019, there were 458,818 cancer diagnoses. The mean age was 70.6 years and 49.6% of the patients were female. Sixty-five percent were White, 11.1% Black, 8.3% Hispanic, and 2.5% Asian. No race data were available for 13.2%. Medicare Advantage was the primary insurance carrier for 74.0%, and 24.0% had a commercial plan.

The mean time to diagnosis across all tumors was 5.2 months (standard deviation, 5.5 months). There was significant variation across different tumor types, as well as within the same tumor type. The median value was 3.9 months (interquartile range, 1.1-7.2 months).

Mean time to diagnosis ranged from 121.6 days for bladder cancer to as high as 229 days for multiple myeloma. Standard deviations were nearly as large or even larger than the mean values. The study showed that 15.8% of patients waited 6 months or longer for a diagnosis. Delays were most common in kidney cancer, colorectal cancer, gallbladder cancer, esophageal cancer, stomach cancer, lymphoma, and multiple myeloma: More than 25% of patients had a time to diagnosis of at least 6 months in these tumors.

“Although there is limited research in the published literature, our findings are consistent with that literature that does exist. Development or modification of policies, guidelines or medical interventions that streamline the diagnostic pathway are needed to optimize patient outcomes and reduce resource burden and cost to the health care system,” Dr. Gitlin said.

Previous literature on this topic has seen wide variation in how time to diagnosis is defined, and most research is conducted in high-income countries, according to Felipe Roitberg, PhD, who served as a discussant during the session. “Most of the countries and patients in need are localized in low- and middle-income countries, so that is a call to action (for more research),” said Dr. Roitberg, a clinical oncologist at Hospital Sírio Libanês in São Paulo, Brazil.

The study did not look at the associations between race and time to diagnosis. “This is a source of analysis could further be explored,” said Dr. Roitberg.

He noted that the ABC-DO prospective cohort study in sub-Saharan Africa found large variations in breast cancer survival by country, and its authors predicted that downstaging and improvements in treatment could prevent up to one-third of projected breast cancer deaths over the next decade. “So these are the drivers of populational gain in terms of overall survival – not more drugs, not more services available, but coordination of services and making sure the patient has a right pathway (to diagnosis and treatment),” Dr. Roitberg said.

Dr. Gitlin has received consulting fees from GRAIL LLC, which is a subsidiary of Illumina. Dr. Roitberg has received honoraria from Boehringer Ingelheim, Sanofi, Roche, MSD Oncology, AstraZeneca, Nestle Health Science, Dr Reddy’s, and Oncologia Brazil. He has consulted for MSD Oncology. He has received research funding from Roche, Boehringer Ingelheim, MSD, Bayer, AstraZeneca, and Takeda.

Time to diagnosis is a crucial factor in cancer. Delays can lead to diagnosis at later stages and prevent optimal therapeutic strategies, both of which have the potential to reduce survival. An estimated 63%-82% of cancers get diagnosed as a result of symptom presentation, and delays in diagnosis can hamper treatment efforts. Diagnosis can be challenging because common symptoms – such as weight loss, weakness, poor appetite, and shortness of breath – are nonspecific.

A new analysis of U.S.-based data shows that the average time to diagnosis is 5.2 months for patients with solid tumors. The authors of the study call for better cancer diagnosis pathways in the U.S.

“Several countries, including the UK, Denmark, Sweden, Canada and Australia, have identified the importance and potential impact of more timely diagnosis by establishing national guidelines, special programs, and treatment pathways. However, in the U.S., there’s relatively little research and effort focused on streamlining the diagnostic pathway. Currently, the U.S. does not have established cancer diagnostic pathways that are used consistently,” Matthew Gitlin, PharmD, said during a presentation at the annual meeting of the European Society for Medical Oncology.

Diagnostic delays can lead to diagnosis at more advanced stages. “That is often associated with worse clinical outcomes, increased economic burden, and decreased health related quality of life,” said Dr. Gitlin, founder and managing director of the health economics consulting firm BluePath Solutions, which conducted the analysis.

The study retrospectively examined administrative billing data drawn from the Clinformatics for Managed Markets longitudinal database. The data represent individuals in Medicare Advantage and a large, U.S.-based private insurance plan. Between 2018 and 2019, there were 458,818 cancer diagnoses. The mean age was 70.6 years and 49.6% of the patients were female. Sixty-five percent were White, 11.1% Black, 8.3% Hispanic, and 2.5% Asian. No race data were available for 13.2%. Medicare Advantage was the primary insurance carrier for 74.0%, and 24.0% had a commercial plan.

The mean time to diagnosis across all tumors was 5.2 months (standard deviation, 5.5 months). There was significant variation across different tumor types, as well as within the same tumor type. The median value was 3.9 months (interquartile range, 1.1-7.2 months).

Mean time to diagnosis ranged from 121.6 days for bladder cancer to as high as 229 days for multiple myeloma. Standard deviations were nearly as large or even larger than the mean values. The study showed that 15.8% of patients waited 6 months or longer for a diagnosis. Delays were most common in kidney cancer, colorectal cancer, gallbladder cancer, esophageal cancer, stomach cancer, lymphoma, and multiple myeloma: More than 25% of patients had a time to diagnosis of at least 6 months in these tumors.

“Although there is limited research in the published literature, our findings are consistent with that literature that does exist. Development or modification of policies, guidelines or medical interventions that streamline the diagnostic pathway are needed to optimize patient outcomes and reduce resource burden and cost to the health care system,” Dr. Gitlin said.

Previous literature on this topic has seen wide variation in how time to diagnosis is defined, and most research is conducted in high-income countries, according to Felipe Roitberg, PhD, who served as a discussant during the session. “Most of the countries and patients in need are localized in low- and middle-income countries, so that is a call to action (for more research),” said Dr. Roitberg, a clinical oncologist at Hospital Sírio Libanês in São Paulo, Brazil.

The study did not look at the associations between race and time to diagnosis. “This is a source of analysis could further be explored,” said Dr. Roitberg.

He noted that the ABC-DO prospective cohort study in sub-Saharan Africa found large variations in breast cancer survival by country, and its authors predicted that downstaging and improvements in treatment could prevent up to one-third of projected breast cancer deaths over the next decade. “So these are the drivers of populational gain in terms of overall survival – not more drugs, not more services available, but coordination of services and making sure the patient has a right pathway (to diagnosis and treatment),” Dr. Roitberg said.

Dr. Gitlin has received consulting fees from GRAIL LLC, which is a subsidiary of Illumina. Dr. Roitberg has received honoraria from Boehringer Ingelheim, Sanofi, Roche, MSD Oncology, AstraZeneca, Nestle Health Science, Dr Reddy’s, and Oncologia Brazil. He has consulted for MSD Oncology. He has received research funding from Roche, Boehringer Ingelheim, MSD, Bayer, AstraZeneca, and Takeda.

Time to diagnosis is a crucial factor in cancer. Delays can lead to diagnosis at later stages and prevent optimal therapeutic strategies, both of which have the potential to reduce survival. An estimated 63%-82% of cancers get diagnosed as a result of symptom presentation, and delays in diagnosis can hamper treatment efforts. Diagnosis can be challenging because common symptoms – such as weight loss, weakness, poor appetite, and shortness of breath – are nonspecific.

A new analysis of U.S.-based data shows that the average time to diagnosis is 5.2 months for patients with solid tumors. The authors of the study call for better cancer diagnosis pathways in the U.S.

“Several countries, including the UK, Denmark, Sweden, Canada and Australia, have identified the importance and potential impact of more timely diagnosis by establishing national guidelines, special programs, and treatment pathways. However, in the U.S., there’s relatively little research and effort focused on streamlining the diagnostic pathway. Currently, the U.S. does not have established cancer diagnostic pathways that are used consistently,” Matthew Gitlin, PharmD, said during a presentation at the annual meeting of the European Society for Medical Oncology.

Diagnostic delays can lead to diagnosis at more advanced stages. “That is often associated with worse clinical outcomes, increased economic burden, and decreased health related quality of life,” said Dr. Gitlin, founder and managing director of the health economics consulting firm BluePath Solutions, which conducted the analysis.

The study retrospectively examined administrative billing data drawn from the Clinformatics for Managed Markets longitudinal database. The data represent individuals in Medicare Advantage and a large, U.S.-based private insurance plan. Between 2018 and 2019, there were 458,818 cancer diagnoses. The mean age was 70.6 years and 49.6% of the patients were female. Sixty-five percent were White, 11.1% Black, 8.3% Hispanic, and 2.5% Asian. No race data were available for 13.2%. Medicare Advantage was the primary insurance carrier for 74.0%, and 24.0% had a commercial plan.

The mean time to diagnosis across all tumors was 5.2 months (standard deviation, 5.5 months). There was significant variation across different tumor types, as well as within the same tumor type. The median value was 3.9 months (interquartile range, 1.1-7.2 months).

Mean time to diagnosis ranged from 121.6 days for bladder cancer to as high as 229 days for multiple myeloma. Standard deviations were nearly as large or even larger than the mean values. The study showed that 15.8% of patients waited 6 months or longer for a diagnosis. Delays were most common in kidney cancer, colorectal cancer, gallbladder cancer, esophageal cancer, stomach cancer, lymphoma, and multiple myeloma: More than 25% of patients had a time to diagnosis of at least 6 months in these tumors.

“Although there is limited research in the published literature, our findings are consistent with that literature that does exist. Development or modification of policies, guidelines or medical interventions that streamline the diagnostic pathway are needed to optimize patient outcomes and reduce resource burden and cost to the health care system,” Dr. Gitlin said.

Previous literature on this topic has seen wide variation in how time to diagnosis is defined, and most research is conducted in high-income countries, according to Felipe Roitberg, PhD, who served as a discussant during the session. “Most of the countries and patients in need are localized in low- and middle-income countries, so that is a call to action (for more research),” said Dr. Roitberg, a clinical oncologist at Hospital Sírio Libanês in São Paulo, Brazil.

The study did not look at the associations between race and time to diagnosis. “This is a source of analysis could further be explored,” said Dr. Roitberg.

He noted that the ABC-DO prospective cohort study in sub-Saharan Africa found large variations in breast cancer survival by country, and its authors predicted that downstaging and improvements in treatment could prevent up to one-third of projected breast cancer deaths over the next decade. “So these are the drivers of populational gain in terms of overall survival – not more drugs, not more services available, but coordination of services and making sure the patient has a right pathway (to diagnosis and treatment),” Dr. Roitberg said.

Dr. Gitlin has received consulting fees from GRAIL LLC, which is a subsidiary of Illumina. Dr. Roitberg has received honoraria from Boehringer Ingelheim, Sanofi, Roche, MSD Oncology, AstraZeneca, Nestle Health Science, Dr Reddy’s, and Oncologia Brazil. He has consulted for MSD Oncology. He has received research funding from Roche, Boehringer Ingelheim, MSD, Bayer, AstraZeneca, and Takeda.

The Food and Drug Administration has issued a safety alert, warning of a rare but concerning potential risk of squamous cell carcinoma (SCC) and various lymphomas in the scar tissue around breast implants.

The FDA safety communication is based on several dozen reports of these cancers occurring in the capsule or scar tissue around breast implants. This issue differs from breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) – a known risk among implant recipients.

“After preliminary review of published literature as part of our ongoing monitoring of the safety of breast implants, the FDA is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant,” the agency’s alert explains.

One avenue through which the FDA has identified cases is via medical device reports. As of Sept. 1, the FDA has received 10 medical device reports about SCC related to breast implants and 12 about various lymphomas.

The incidence rate and risk factors for these events are currently unknown, but reports of SCC and various lymphomas in the capsule around the breast implants have been reported for both textured and smooth breast implants, as well as for both saline and silicone breast implants. In some cases, the cancers were diagnosed years after breast implant surgery.

Reported signs and symptoms included swelling, pain, lumps, or skin changes. 

Although the risks of SCC and lymphomas in the tissue around breast implants appears rare, “when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices, FDA Center for Devices and Radiological Health, explained in a press release.

Patients and providers are strongly encouraged to report breast implant–related problems and cases of SCC or lymphoma of the breast implant capsule to MedWatch, the FDA’s adverse event reporting program.

The FDA plans to complete “a thorough literature review” as well as “identify ways to collect more detailed information regarding patient cases.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has issued a safety alert, warning of a rare but concerning potential risk of squamous cell carcinoma (SCC) and various lymphomas in the scar tissue around breast implants.

The FDA safety communication is based on several dozen reports of these cancers occurring in the capsule or scar tissue around breast implants. This issue differs from breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) – a known risk among implant recipients.

“After preliminary review of published literature as part of our ongoing monitoring of the safety of breast implants, the FDA is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant,” the agency’s alert explains.

One avenue through which the FDA has identified cases is via medical device reports. As of Sept. 1, the FDA has received 10 medical device reports about SCC related to breast implants and 12 about various lymphomas.

The incidence rate and risk factors for these events are currently unknown, but reports of SCC and various lymphomas in the capsule around the breast implants have been reported for both textured and smooth breast implants, as well as for both saline and silicone breast implants. In some cases, the cancers were diagnosed years after breast implant surgery.

Reported signs and symptoms included swelling, pain, lumps, or skin changes. 

Although the risks of SCC and lymphomas in the tissue around breast implants appears rare, “when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices, FDA Center for Devices and Radiological Health, explained in a press release.

Patients and providers are strongly encouraged to report breast implant–related problems and cases of SCC or lymphoma of the breast implant capsule to MedWatch, the FDA’s adverse event reporting program.

The FDA plans to complete “a thorough literature review” as well as “identify ways to collect more detailed information regarding patient cases.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has issued a safety alert, warning of a rare but concerning potential risk of squamous cell carcinoma (SCC) and various lymphomas in the scar tissue around breast implants.

The FDA safety communication is based on several dozen reports of these cancers occurring in the capsule or scar tissue around breast implants. This issue differs from breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) – a known risk among implant recipients.

“After preliminary review of published literature as part of our ongoing monitoring of the safety of breast implants, the FDA is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant,” the agency’s alert explains.

One avenue through which the FDA has identified cases is via medical device reports. As of Sept. 1, the FDA has received 10 medical device reports about SCC related to breast implants and 12 about various lymphomas.

The incidence rate and risk factors for these events are currently unknown, but reports of SCC and various lymphomas in the capsule around the breast implants have been reported for both textured and smooth breast implants, as well as for both saline and silicone breast implants. In some cases, the cancers were diagnosed years after breast implant surgery.

Reported signs and symptoms included swelling, pain, lumps, or skin changes. 

Although the risks of SCC and lymphomas in the tissue around breast implants appears rare, “when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices, FDA Center for Devices and Radiological Health, explained in a press release.

Patients and providers are strongly encouraged to report breast implant–related problems and cases of SCC or lymphoma of the breast implant capsule to MedWatch, the FDA’s adverse event reporting program.

The FDA plans to complete “a thorough literature review” as well as “identify ways to collect more detailed information regarding patient cases.”

A version of this article first appeared on Medscape.com.

An Italian study of women diagnosed with breast cancer reported that around 50% experienced body image disturbance and 20% noted a negative impact on their sex life. And while meeting with a specialist in psycho-oncology was universally viewed as an acceptable option, only one out of four patients considered consulting a sexologist. All these women should be encouraged to face and address issues related to sexuality so that they can truly regain a good quality of life, the study suggests.

The study, which was conducted at the breast unit of Santa Maria Goretti Hospital in Latina, Italy, enrolled 141 patients who had undergone breast cancer surgery. Participants were asked to complete a questionnaire that included questions regarding self-image, sexual activity, and sexual satisfaction, and it analyzed these aspects before and after treatment. The participants were then asked whether they felt that they needed to see a sexologist or a specialist in psycho-oncology.

The findings clearly showed a worsening in terms of body image perception. When the women were asked about the relationship they had with their body, femininity, and beauty prior to being diagnosed, 37.4% characterized it as very good and 58.9% as “normal,” with ups and downs but nothing that they would term “conflictual.” After diagnosis, 48.9% noted that the disease had an impact on their body image with a partial conditioning about their femininity and beauty. However, 7.2% had difficulty when it came to recognizing their own body, and their relationship with femininity also became difficult.

On the topic of sexuality, 71.2% of patients were completely satisfied with their sex life before they were diagnosed with breast cancer, 23.7% were partially satisfied, and 5.0% were unsatisfied. As for their sex life after diagnosis and surgery, 20.1% stated that it continued to be fulfilling and 55.4% said that it had gotten worse; 18.8% reported significant sexual dissatisfaction.

The participants were asked whether consulting a professional would be warranted, and whether that would provide useful support for overcoming the difficulties and challenges arising from the disease and the related treatments. In response, 97.1% said they would go to a specialist in psycho-oncology, but only 27.3% would seek help from a sexologist.

“Despite the negative impact on body image and on sexuality, few patients would seek the help of a sexologist; nearly all of the patients, however, would seek the help of a specialist in psycho-oncology. This was very surprising to us,” write the authors. They went on to note that they are carrying out another project to understand the reason for this disparity.

In addition, they advised clinicians to encourage communication about sexuality – a topic that is regularly overlooked and not included in discussions with patients, mostly because of cultural barriers. Often, physicians aren’t comfortable talking about sexuality, as they don’t feel they have the proper training to do so. Patients who are experiencing issues related to sexuality also often have difficulty asking for help. And so, in their conclusion, the authors point out that “collaborating together in the right direction is the basis of change and good communication.”

This article was translated from Univadis Italy and appeared on Medscape.com.

An Italian study of women diagnosed with breast cancer reported that around 50% experienced body image disturbance and 20% noted a negative impact on their sex life. And while meeting with a specialist in psycho-oncology was universally viewed as an acceptable option, only one out of four patients considered consulting a sexologist. All these women should be encouraged to face and address issues related to sexuality so that they can truly regain a good quality of life, the study suggests.

The study, which was conducted at the breast unit of Santa Maria Goretti Hospital in Latina, Italy, enrolled 141 patients who had undergone breast cancer surgery. Participants were asked to complete a questionnaire that included questions regarding self-image, sexual activity, and sexual satisfaction, and it analyzed these aspects before and after treatment. The participants were then asked whether they felt that they needed to see a sexologist or a specialist in psycho-oncology.

The findings clearly showed a worsening in terms of body image perception. When the women were asked about the relationship they had with their body, femininity, and beauty prior to being diagnosed, 37.4% characterized it as very good and 58.9% as “normal,” with ups and downs but nothing that they would term “conflictual.” After diagnosis, 48.9% noted that the disease had an impact on their body image with a partial conditioning about their femininity and beauty. However, 7.2% had difficulty when it came to recognizing their own body, and their relationship with femininity also became difficult.

On the topic of sexuality, 71.2% of patients were completely satisfied with their sex life before they were diagnosed with breast cancer, 23.7% were partially satisfied, and 5.0% were unsatisfied. As for their sex life after diagnosis and surgery, 20.1% stated that it continued to be fulfilling and 55.4% said that it had gotten worse; 18.8% reported significant sexual dissatisfaction.

The participants were asked whether consulting a professional would be warranted, and whether that would provide useful support for overcoming the difficulties and challenges arising from the disease and the related treatments. In response, 97.1% said they would go to a specialist in psycho-oncology, but only 27.3% would seek help from a sexologist.

“Despite the negative impact on body image and on sexuality, few patients would seek the help of a sexologist; nearly all of the patients, however, would seek the help of a specialist in psycho-oncology. This was very surprising to us,” write the authors. They went on to note that they are carrying out another project to understand the reason for this disparity.

In addition, they advised clinicians to encourage communication about sexuality – a topic that is regularly overlooked and not included in discussions with patients, mostly because of cultural barriers. Often, physicians aren’t comfortable talking about sexuality, as they don’t feel they have the proper training to do so. Patients who are experiencing issues related to sexuality also often have difficulty asking for help. And so, in their conclusion, the authors point out that “collaborating together in the right direction is the basis of change and good communication.”

This article was translated from Univadis Italy and appeared on Medscape.com.

An Italian study of women diagnosed with breast cancer reported that around 50% experienced body image disturbance and 20% noted a negative impact on their sex life. And while meeting with a specialist in psycho-oncology was universally viewed as an acceptable option, only one out of four patients considered consulting a sexologist. All these women should be encouraged to face and address issues related to sexuality so that they can truly regain a good quality of life, the study suggests.

The study, which was conducted at the breast unit of Santa Maria Goretti Hospital in Latina, Italy, enrolled 141 patients who had undergone breast cancer surgery. Participants were asked to complete a questionnaire that included questions regarding self-image, sexual activity, and sexual satisfaction, and it analyzed these aspects before and after treatment. The participants were then asked whether they felt that they needed to see a sexologist or a specialist in psycho-oncology.

The findings clearly showed a worsening in terms of body image perception. When the women were asked about the relationship they had with their body, femininity, and beauty prior to being diagnosed, 37.4% characterized it as very good and 58.9% as “normal,” with ups and downs but nothing that they would term “conflictual.” After diagnosis, 48.9% noted that the disease had an impact on their body image with a partial conditioning about their femininity and beauty. However, 7.2% had difficulty when it came to recognizing their own body, and their relationship with femininity also became difficult.

On the topic of sexuality, 71.2% of patients were completely satisfied with their sex life before they were diagnosed with breast cancer, 23.7% were partially satisfied, and 5.0% were unsatisfied. As for their sex life after diagnosis and surgery, 20.1% stated that it continued to be fulfilling and 55.4% said that it had gotten worse; 18.8% reported significant sexual dissatisfaction.

The participants were asked whether consulting a professional would be warranted, and whether that would provide useful support for overcoming the difficulties and challenges arising from the disease and the related treatments. In response, 97.1% said they would go to a specialist in psycho-oncology, but only 27.3% would seek help from a sexologist.

“Despite the negative impact on body image and on sexuality, few patients would seek the help of a sexologist; nearly all of the patients, however, would seek the help of a specialist in psycho-oncology. This was very surprising to us,” write the authors. They went on to note that they are carrying out another project to understand the reason for this disparity.

In addition, they advised clinicians to encourage communication about sexuality – a topic that is regularly overlooked and not included in discussions with patients, mostly because of cultural barriers. Often, physicians aren’t comfortable talking about sexuality, as they don’t feel they have the proper training to do so. Patients who are experiencing issues related to sexuality also often have difficulty asking for help. And so, in their conclusion, the authors point out that “collaborating together in the right direction is the basis of change and good communication.”

This article was translated from Univadis Italy and appeared on Medscape.com.