Breast Cancer

TOPLINE:

A recent study suggests that younger breast cancer survivors with a germline pathogenic variant or those with an initial diagnosis of in situ vs invasive primary breast cancer have a significantly higher risk for a second primary breast cancer.

METHODOLOGY:

• Women who are diagnosed with breast cancer at age 40 or younger are about two to three times more likely to develop second primary breast cancer compared with women who are older when first diagnosed.
• However, data are lacking on whether certain factors increase a woman’s risk for a second primary breast cancer.
• To classify the risk of developing a second primary breast cancer, the researchers evaluated a main cohort of 685 patients with stages 0-III breast cancer who were diagnosed at age 40 years or younger and had undergone unilateral mastectomy or lumpectomy as primary surgery between August 2006 and June 2015. The team also analyzed data on 547 younger women who had a bilateral mastectomy.
• The researchers assessed various breast cancer risk factors, including self-reported ethnicity, race, age, family history of breast or ovarian cancer, germline genetics, tumor stage, grade, and receptor status.
• The primary outcome was the diagnosis of a second primary breast cancer that occurred at least 6 months after the initial diagnosis of primary breast cancer.

TAKEAWAY:

• Among the 685 main study participants, 17 (2.5%) developed a second primary breast cancer (15 contralateral and 2 ipsilateral) over a median of 4.2 years since their primary diagnosis. The 5- and 10-year cumulative incidence of a second primary breast cancer was 1.5% and 2.6%, respectively.
• Overall, only 33 women were positive for a germline pathogenic variant, and having a pathogenic variant was associated with a fourfold higher risk for second primary breast cancer compared with noncarriers at 5 years (5.5% vs 1.3%) and at 10 years (8.9% vs 2.2%). These findings were held in multivariate models.
• Patients initially diagnosed with in situ disease had more than a fivefold higher risk for second primary breast cancer compared with those initially diagnosed with invasive disease — 6.2% vs 1.2% at 5 years and 10.4% vs 2.1% at 10 years (hazard ratio, 5.25; P = .004). These findings were held in multivariate models (adjusted sub-hazard ratio [sHR], 5.61; 95% CI, 1.52-20.70) and among women without a pathogenic variant (adjusted sHR, 5.67; 95% CI, 1.54-20.90).
• The researchers also found a low risk for contralateral breast cancer among women without pathogenic variants, which could inform surgical decision-making.

IN PRACTICE:

Although the number of women positive for a germline pathogenic variant was small (n = 33) and “results should be interpreted cautiously,” the analysis signals “the importance of genetic testing” in younger breast cancer survivors to gauge their risk for a second primary breast cancer, the authors concluded. The authors added that their “finding of a higher risk of [second primary breast cancer] among those diagnosed with in situ primary [breast cancer] merits further investigation.”

SOURCE:

This study, led by Kristen D. Brantley, PhD, from Harvard T. H. Chan School of Public Health, Boston, was published online in JAMA Oncology.

LIMITATIONS:

A small number of second breast cancer events limited the authors’ ability to assess the effects of multiple risk factors together. Data on risk factors might be incomplete. About 9% of participants completed abbreviated questionnaires that did not include information on body mass index, alcohol, smoking, and family history. Frequencies of pathogenic variants besides BRCA1 and BRCA2 may be underestimated.

DISCLOSURES:

This study received no external funding. Four authors reported receiving grants or royalties outside this work. Other reported no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

A recent study suggests that younger breast cancer survivors with a germline pathogenic variant or those with an initial diagnosis of in situ vs invasive primary breast cancer have a significantly higher risk for a second primary breast cancer.

METHODOLOGY:

• Women who are diagnosed with breast cancer at age 40 or younger are about two to three times more likely to develop second primary breast cancer compared with women who are older when first diagnosed.
• However, data are lacking on whether certain factors increase a woman’s risk for a second primary breast cancer.
• To classify the risk of developing a second primary breast cancer, the researchers evaluated a main cohort of 685 patients with stages 0-III breast cancer who were diagnosed at age 40 years or younger and had undergone unilateral mastectomy or lumpectomy as primary surgery between August 2006 and June 2015. The team also analyzed data on 547 younger women who had a bilateral mastectomy.
• The researchers assessed various breast cancer risk factors, including self-reported ethnicity, race, age, family history of breast or ovarian cancer, germline genetics, tumor stage, grade, and receptor status.
• The primary outcome was the diagnosis of a second primary breast cancer that occurred at least 6 months after the initial diagnosis of primary breast cancer.

TAKEAWAY:

• Among the 685 main study participants, 17 (2.5%) developed a second primary breast cancer (15 contralateral and 2 ipsilateral) over a median of 4.2 years since their primary diagnosis. The 5- and 10-year cumulative incidence of a second primary breast cancer was 1.5% and 2.6%, respectively.
• Overall, only 33 women were positive for a germline pathogenic variant, and having a pathogenic variant was associated with a fourfold higher risk for second primary breast cancer compared with noncarriers at 5 years (5.5% vs 1.3%) and at 10 years (8.9% vs 2.2%). These findings were held in multivariate models.
• Patients initially diagnosed with in situ disease had more than a fivefold higher risk for second primary breast cancer compared with those initially diagnosed with invasive disease — 6.2% vs 1.2% at 5 years and 10.4% vs 2.1% at 10 years (hazard ratio, 5.25; P = .004). These findings were held in multivariate models (adjusted sub-hazard ratio [sHR], 5.61; 95% CI, 1.52-20.70) and among women without a pathogenic variant (adjusted sHR, 5.67; 95% CI, 1.54-20.90).
• The researchers also found a low risk for contralateral breast cancer among women without pathogenic variants, which could inform surgical decision-making.

IN PRACTICE:

Although the number of women positive for a germline pathogenic variant was small (n = 33) and “results should be interpreted cautiously,” the analysis signals “the importance of genetic testing” in younger breast cancer survivors to gauge their risk for a second primary breast cancer, the authors concluded. The authors added that their “finding of a higher risk of [second primary breast cancer] among those diagnosed with in situ primary [breast cancer] merits further investigation.”

SOURCE:

This study, led by Kristen D. Brantley, PhD, from Harvard T. H. Chan School of Public Health, Boston, was published online in JAMA Oncology.

LIMITATIONS:

A small number of second breast cancer events limited the authors’ ability to assess the effects of multiple risk factors together. Data on risk factors might be incomplete. About 9% of participants completed abbreviated questionnaires that did not include information on body mass index, alcohol, smoking, and family history. Frequencies of pathogenic variants besides BRCA1 and BRCA2 may be underestimated.

DISCLOSURES:

This study received no external funding. Four authors reported receiving grants or royalties outside this work. Other reported no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

A recent study suggests that younger breast cancer survivors with a germline pathogenic variant or those with an initial diagnosis of in situ vs invasive primary breast cancer have a significantly higher risk for a second primary breast cancer.

METHODOLOGY:

• Women who are diagnosed with breast cancer at age 40 or younger are about two to three times more likely to develop second primary breast cancer compared with women who are older when first diagnosed.
• However, data are lacking on whether certain factors increase a woman’s risk for a second primary breast cancer.
• To classify the risk of developing a second primary breast cancer, the researchers evaluated a main cohort of 685 patients with stages 0-III breast cancer who were diagnosed at age 40 years or younger and had undergone unilateral mastectomy or lumpectomy as primary surgery between August 2006 and June 2015. The team also analyzed data on 547 younger women who had a bilateral mastectomy.
• The researchers assessed various breast cancer risk factors, including self-reported ethnicity, race, age, family history of breast or ovarian cancer, germline genetics, tumor stage, grade, and receptor status.
• The primary outcome was the diagnosis of a second primary breast cancer that occurred at least 6 months after the initial diagnosis of primary breast cancer.

TAKEAWAY:

• Among the 685 main study participants, 17 (2.5%) developed a second primary breast cancer (15 contralateral and 2 ipsilateral) over a median of 4.2 years since their primary diagnosis. The 5- and 10-year cumulative incidence of a second primary breast cancer was 1.5% and 2.6%, respectively.
• Overall, only 33 women were positive for a germline pathogenic variant, and having a pathogenic variant was associated with a fourfold higher risk for second primary breast cancer compared with noncarriers at 5 years (5.5% vs 1.3%) and at 10 years (8.9% vs 2.2%). These findings were held in multivariate models.
• Patients initially diagnosed with in situ disease had more than a fivefold higher risk for second primary breast cancer compared with those initially diagnosed with invasive disease — 6.2% vs 1.2% at 5 years and 10.4% vs 2.1% at 10 years (hazard ratio, 5.25; P = .004). These findings were held in multivariate models (adjusted sub-hazard ratio [sHR], 5.61; 95% CI, 1.52-20.70) and among women without a pathogenic variant (adjusted sHR, 5.67; 95% CI, 1.54-20.90).
• The researchers also found a low risk for contralateral breast cancer among women without pathogenic variants, which could inform surgical decision-making.

IN PRACTICE:

Although the number of women positive for a germline pathogenic variant was small (n = 33) and “results should be interpreted cautiously,” the analysis signals “the importance of genetic testing” in younger breast cancer survivors to gauge their risk for a second primary breast cancer, the authors concluded. The authors added that their “finding of a higher risk of [second primary breast cancer] among those diagnosed with in situ primary [breast cancer] merits further investigation.”

SOURCE:

This study, led by Kristen D. Brantley, PhD, from Harvard T. H. Chan School of Public Health, Boston, was published online in JAMA Oncology.

LIMITATIONS:

A small number of second breast cancer events limited the authors’ ability to assess the effects of multiple risk factors together. Data on risk factors might be incomplete. About 9% of participants completed abbreviated questionnaires that did not include information on body mass index, alcohol, smoking, and family history. Frequencies of pathogenic variants besides BRCA1 and BRCA2 may be underestimated.

DISCLOSURES:

This study received no external funding. Four authors reported receiving grants or royalties outside this work. Other reported no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

An analysis of molecular-targeted cancer drug therapies recently approved in the United States found that fewer than one-third demonstrated substantial clinical benefits at the time of approval.

METHODOLOGY:

• The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
• Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
• In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
• The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
• The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).

TAKEAWAY:

• The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
• Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
• Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
• Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.

IN PRACTICE:

“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”

SOURCE:

The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.

DISCLOSURES:

The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

An analysis of molecular-targeted cancer drug therapies recently approved in the United States found that fewer than one-third demonstrated substantial clinical benefits at the time of approval.

METHODOLOGY:

• The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
• Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
• In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
• The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
• The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).

TAKEAWAY:

• The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
• Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
• Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
• Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.

IN PRACTICE:

“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”

SOURCE:

The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.

DISCLOSURES:

The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

An analysis of molecular-targeted cancer drug therapies recently approved in the United States found that fewer than one-third demonstrated substantial clinical benefits at the time of approval.

METHODOLOGY:

• The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
• Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
• In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
• The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
• The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).

TAKEAWAY:

• The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
• Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
• Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
• Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.

IN PRACTICE:

“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”

SOURCE:

The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.

DISCLOSURES:

The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.

Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.

Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.

Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.

Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source

Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.

Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.

Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.

Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.

Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source

Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.

Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.

Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.

Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.

Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source

Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.

Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio  0.76; 95% CI 0.38-1.33) or tamoxifen  + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).

Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).

Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.

Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source

Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.

Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio  0.76; 95% CI 0.38-1.33) or tamoxifen  + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).

Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).

Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.

Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source

Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.

Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio  0.76; 95% CI 0.38-1.33) or tamoxifen  + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).

Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).

Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.

Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source

Key clinical point: Among patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), adjuvant chemotherapy failed to improve survival outcomes in older women (age ≥ 80 years) but improved prognosis in women age 65-79 years.

Major finding: Adjuvant chemotherapy did not significantly improve overall survival (OS; P = .79) and cancer-specific survival (CSS; P = .091) outcomes in patients age 80 years and older. However, in patients age 65-79 years, adjuvant chemotherapy was effective in improving OS (P < .001) but not CSS (P = .092).

Study details: This retrospective cohort study included 45,762 women with HR+/HER2− BC, age 65-79 years (n = 38,128) or 80 years and older (n = 7634) from the Surveillance, Epidemiology, and End Results (SEER) database, of whom 20.7% and 3.8%, respectively, received adjuvant chemotherapy.

Disclosures: This study was supported by the Project '100 Foreign Experts Plan of Hebei Province,' China. The authors did not declare any conflicts of interest.

Source: Ma X, Wu S, Zhang X, et al. Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: A propensity score-matched retrospective cohort study using the SEER database. BMJ Open. 2024;14:e078782. doi: 10.1136/bmjopen-2023-078782 Source

Key clinical point: Among patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), adjuvant chemotherapy failed to improve survival outcomes in older women (age ≥ 80 years) but improved prognosis in women age 65-79 years.

Major finding: Adjuvant chemotherapy did not significantly improve overall survival (OS; P = .79) and cancer-specific survival (CSS; P = .091) outcomes in patients age 80 years and older. However, in patients age 65-79 years, adjuvant chemotherapy was effective in improving OS (P < .001) but not CSS (P = .092).

Study details: This retrospective cohort study included 45,762 women with HR+/HER2− BC, age 65-79 years (n = 38,128) or 80 years and older (n = 7634) from the Surveillance, Epidemiology, and End Results (SEER) database, of whom 20.7% and 3.8%, respectively, received adjuvant chemotherapy.

Disclosures: This study was supported by the Project '100 Foreign Experts Plan of Hebei Province,' China. The authors did not declare any conflicts of interest.

Source: Ma X, Wu S, Zhang X, et al. Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: A propensity score-matched retrospective cohort study using the SEER database. BMJ Open. 2024;14:e078782. doi: 10.1136/bmjopen-2023-078782 Source

Key clinical point: Among patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), adjuvant chemotherapy failed to improve survival outcomes in older women (age ≥ 80 years) but improved prognosis in women age 65-79 years.

Major finding: Adjuvant chemotherapy did not significantly improve overall survival (OS; P = .79) and cancer-specific survival (CSS; P = .091) outcomes in patients age 80 years and older. However, in patients age 65-79 years, adjuvant chemotherapy was effective in improving OS (P < .001) but not CSS (P = .092).

Study details: This retrospective cohort study included 45,762 women with HR+/HER2− BC, age 65-79 years (n = 38,128) or 80 years and older (n = 7634) from the Surveillance, Epidemiology, and End Results (SEER) database, of whom 20.7% and 3.8%, respectively, received adjuvant chemotherapy.

Disclosures: This study was supported by the Project '100 Foreign Experts Plan of Hebei Province,' China. The authors did not declare any conflicts of interest.

Source: Ma X, Wu S, Zhang X, et al. Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: A propensity score-matched retrospective cohort study using the SEER database. BMJ Open. 2024;14:e078782. doi: 10.1136/bmjopen-2023-078782 Source

Key clinical point: Exposure to antibiotics during neoadjuvant pembrolizumab treatment was associated with a high residual cancer burden (RCB) in patients with human epidermal growth factor receptor 2-negative (HER2−), stage II or III breast cancer (BC).

Major finding: During pembrolizumab treatment, antibiotic use was significantly correlated with RCB index (RCB index-coefficient 0.86; P = .01) and was associated with a higher mean RCB index compared with no use of antibiotics (1.80 vs 1.08).

Study details: This secondary analysis of the phase 2 I-SPY2 trial included 66 patients with HER2− stage II or III BC treated with pembrolizumab plus paclitaxel followed by doxorubicin plus cyclophosphamide, of which 27% of patients concurrently used antibiotics.

Disclosures: This study did not receive any funding. Amit A. Kulkarni declared receiving institutional research funding and serving on advisory boards for various sources. The other authors declared no competing interests.

Source: Kulkarni AA, Jain A, Jewett PI, et al, and the ISPY2 Consortium. Association of antibiotic exposure with residual cancer burden in HER2-negative early stage breast cancer. NPJ Breast Cancer. 2024;10:24 (Mar 26). doi: 10.1038/s41523-024-00630-w  Source

Key clinical point: Exposure to antibiotics during neoadjuvant pembrolizumab treatment was associated with a high residual cancer burden (RCB) in patients with human epidermal growth factor receptor 2-negative (HER2−), stage II or III breast cancer (BC).

Major finding: During pembrolizumab treatment, antibiotic use was significantly correlated with RCB index (RCB index-coefficient 0.86; P = .01) and was associated with a higher mean RCB index compared with no use of antibiotics (1.80 vs 1.08).

Study details: This secondary analysis of the phase 2 I-SPY2 trial included 66 patients with HER2− stage II or III BC treated with pembrolizumab plus paclitaxel followed by doxorubicin plus cyclophosphamide, of which 27% of patients concurrently used antibiotics.

Disclosures: This study did not receive any funding. Amit A. Kulkarni declared receiving institutional research funding and serving on advisory boards for various sources. The other authors declared no competing interests.

Source: Kulkarni AA, Jain A, Jewett PI, et al, and the ISPY2 Consortium. Association of antibiotic exposure with residual cancer burden in HER2-negative early stage breast cancer. NPJ Breast Cancer. 2024;10:24 (Mar 26). doi: 10.1038/s41523-024-00630-w  Source

Key clinical point: Exposure to antibiotics during neoadjuvant pembrolizumab treatment was associated with a high residual cancer burden (RCB) in patients with human epidermal growth factor receptor 2-negative (HER2−), stage II or III breast cancer (BC).

Major finding: During pembrolizumab treatment, antibiotic use was significantly correlated with RCB index (RCB index-coefficient 0.86; P = .01) and was associated with a higher mean RCB index compared with no use of antibiotics (1.80 vs 1.08).

Study details: This secondary analysis of the phase 2 I-SPY2 trial included 66 patients with HER2− stage II or III BC treated with pembrolizumab plus paclitaxel followed by doxorubicin plus cyclophosphamide, of which 27% of patients concurrently used antibiotics.

Disclosures: This study did not receive any funding. Amit A. Kulkarni declared receiving institutional research funding and serving on advisory boards for various sources. The other authors declared no competing interests.

Source: Kulkarni AA, Jain A, Jewett PI, et al, and the ISPY2 Consortium. Association of antibiotic exposure with residual cancer burden in HER2-negative early stage breast cancer. NPJ Breast Cancer. 2024;10:24 (Mar 26). doi: 10.1038/s41523-024-00630-w  Source

Key clinical point: Patients with newly diagnosed breast cancer (BC) who underwent radiation therapy were at a significantly higher risk of developing nonkeratinocyte skin cancers, particularly melanoma and hemangiosarcoma.

Major finding: Compared with the general population, the risk for nonkeratinocyte skin cancer in the skin of the breast or trunk was 57% higher (standardized incidence ratio [SIR] 1.57; 95% CI 1.45-1.7) after BC treatment with radiation therapy, with a 1.37-fold higher risk for melanoma (SIR 1.37; 95% CI 1.25-1.49) and 27.11-fold higher risk for hemangiosarcoma (SIR 27.11; 95% CI 21.6-33.61).

Study details: This population-based cohort study included 875,880 patients with newly diagnosed BC from the Surveillance, Epidemiology, and End Results (SEER) database of which 50.3% of patients received radiation therapy.

Disclosures: This study did not declare any specific funding. Shawheen J. Rezaei declared being supported by Stanford University School of Medicine. Bernice Y. Kwong declared receiving personal fees from Novocure, Genentech, and Novartis. No other conflicts of interest were reported.

Source: Rezaei SJ, Eid E, Tang JY, et al. Incidence of nonkeratinocyte skin cancer after breast cancer radiation therapy. JAMA Netw Open. 2024;7(3):e241632 (Mar 8). doi: 10.1001/jamanetworkopen.2024.1632 Source

Key clinical point: Patients with newly diagnosed breast cancer (BC) who underwent radiation therapy were at a significantly higher risk of developing nonkeratinocyte skin cancers, particularly melanoma and hemangiosarcoma.

Major finding: Compared with the general population, the risk for nonkeratinocyte skin cancer in the skin of the breast or trunk was 57% higher (standardized incidence ratio [SIR] 1.57; 95% CI 1.45-1.7) after BC treatment with radiation therapy, with a 1.37-fold higher risk for melanoma (SIR 1.37; 95% CI 1.25-1.49) and 27.11-fold higher risk for hemangiosarcoma (SIR 27.11; 95% CI 21.6-33.61).

Study details: This population-based cohort study included 875,880 patients with newly diagnosed BC from the Surveillance, Epidemiology, and End Results (SEER) database of which 50.3% of patients received radiation therapy.

Disclosures: This study did not declare any specific funding. Shawheen J. Rezaei declared being supported by Stanford University School of Medicine. Bernice Y. Kwong declared receiving personal fees from Novocure, Genentech, and Novartis. No other conflicts of interest were reported.

Source: Rezaei SJ, Eid E, Tang JY, et al. Incidence of nonkeratinocyte skin cancer after breast cancer radiation therapy. JAMA Netw Open. 2024;7(3):e241632 (Mar 8). doi: 10.1001/jamanetworkopen.2024.1632 Source

Key clinical point: Patients with newly diagnosed breast cancer (BC) who underwent radiation therapy were at a significantly higher risk of developing nonkeratinocyte skin cancers, particularly melanoma and hemangiosarcoma.

Major finding: Compared with the general population, the risk for nonkeratinocyte skin cancer in the skin of the breast or trunk was 57% higher (standardized incidence ratio [SIR] 1.57; 95% CI 1.45-1.7) after BC treatment with radiation therapy, with a 1.37-fold higher risk for melanoma (SIR 1.37; 95% CI 1.25-1.49) and 27.11-fold higher risk for hemangiosarcoma (SIR 27.11; 95% CI 21.6-33.61).

Study details: This population-based cohort study included 875,880 patients with newly diagnosed BC from the Surveillance, Epidemiology, and End Results (SEER) database of which 50.3% of patients received radiation therapy.

Disclosures: This study did not declare any specific funding. Shawheen J. Rezaei declared being supported by Stanford University School of Medicine. Bernice Y. Kwong declared receiving personal fees from Novocure, Genentech, and Novartis. No other conflicts of interest were reported.

Source: Rezaei SJ, Eid E, Tang JY, et al. Incidence of nonkeratinocyte skin cancer after breast cancer radiation therapy. JAMA Netw Open. 2024;7(3):e241632 (Mar 8). doi: 10.1001/jamanetworkopen.2024.1632 Source

Key clinical point: MRI response can be used to identify patients with hormone receptor-negative (HR−), human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who may only require three cycles of neoadjuvant chemotherapy to achieve pathological complete response (pCR).

Major finding: After one to three cycles of chemotherapy, nearly one third of patients with HR−/HER2+ BC achieved radiological complete response (36%; 95% CI 30%-43%), of whom the majority of patients achieved pCR (88%; 95% CI 79%-94%). No treatment-related deaths were reported.

Study details: This phase 2 TRAIN-3 trial included 235 and 232 patients with stages II-III HR−/HER2+ and HR+/HER2+ BC, respectively, who received neoadjuvant chemotherapy once every 3 weeks for up to nine cycles and whose response was monitored using breast MRI after every three cycles and lymph node biopsy.

Disclosures: This study received unrestricted financial support from Roche Netherlands. Two authors declared receiving institutional research funding from or having other ties with various sources, including Roche.

Source: van der Voort A, Louis FM, van Ramshorst MS, et al, on behalf of the Dutch Breast Cancer Research Group. MRI-guided optimisation of neoadjuvant chemotherapy duration in stage II–III HER2-positive breast cancer (TRAIN-3): A multicentre, single-arm, phase 2 study. Lancet Oncol. 2024 (Apr 5). doi: 10.1016/S1470-2045(24)00104-9 Source

Key clinical point: MRI response can be used to identify patients with hormone receptor-negative (HR−), human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who may only require three cycles of neoadjuvant chemotherapy to achieve pathological complete response (pCR).

Major finding: After one to three cycles of chemotherapy, nearly one third of patients with HR−/HER2+ BC achieved radiological complete response (36%; 95% CI 30%-43%), of whom the majority of patients achieved pCR (88%; 95% CI 79%-94%). No treatment-related deaths were reported.

Study details: This phase 2 TRAIN-3 trial included 235 and 232 patients with stages II-III HR−/HER2+ and HR+/HER2+ BC, respectively, who received neoadjuvant chemotherapy once every 3 weeks for up to nine cycles and whose response was monitored using breast MRI after every three cycles and lymph node biopsy.

Disclosures: This study received unrestricted financial support from Roche Netherlands. Two authors declared receiving institutional research funding from or having other ties with various sources, including Roche.

Source: van der Voort A, Louis FM, van Ramshorst MS, et al, on behalf of the Dutch Breast Cancer Research Group. MRI-guided optimisation of neoadjuvant chemotherapy duration in stage II–III HER2-positive breast cancer (TRAIN-3): A multicentre, single-arm, phase 2 study. Lancet Oncol. 2024 (Apr 5). doi: 10.1016/S1470-2045(24)00104-9 Source

Key clinical point: MRI response can be used to identify patients with hormone receptor-negative (HR−), human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who may only require three cycles of neoadjuvant chemotherapy to achieve pathological complete response (pCR).

Major finding: After one to three cycles of chemotherapy, nearly one third of patients with HR−/HER2+ BC achieved radiological complete response (36%; 95% CI 30%-43%), of whom the majority of patients achieved pCR (88%; 95% CI 79%-94%). No treatment-related deaths were reported.

Study details: This phase 2 TRAIN-3 trial included 235 and 232 patients with stages II-III HR−/HER2+ and HR+/HER2+ BC, respectively, who received neoadjuvant chemotherapy once every 3 weeks for up to nine cycles and whose response was monitored using breast MRI after every three cycles and lymph node biopsy.

Disclosures: This study received unrestricted financial support from Roche Netherlands. Two authors declared receiving institutional research funding from or having other ties with various sources, including Roche.

Source: van der Voort A, Louis FM, van Ramshorst MS, et al, on behalf of the Dutch Breast Cancer Research Group. MRI-guided optimisation of neoadjuvant chemotherapy duration in stage II–III HER2-positive breast cancer (TRAIN-3): A multicentre, single-arm, phase 2 study. Lancet Oncol. 2024 (Apr 5). doi: 10.1016/S1470-2045(24)00104-9 Source

Key clinical point: In patients with breast cancer (BC), premastectomy radiotherapy (PreMRT) followed by mastectomy and immediate breast reconstruction (IMBR) is feasible, safe, and shortens the time required for breast reconstruction.

Major finding: At a median follow-up of 29.7 months, there were no complete flap losses, locoregional recurrences, distant metastases, or deaths in the 48 patients who completed mastectomy with IMBR. Patients could undergo mastectomy with IMBR as early as 3 weeks (median 23 days) after completing radiotherapy. No grade 3-4 radiotherapy-related toxic effect or discontinuation of radiotherapy was reported.

Study details: The study enrolled 49 patients with T0-T3, N0-N3b, M0 BC from the phase 2 SAPHIRE trial who received PreMRT and were randomly assigned to receive hypofractionated or conventionally fractionated regional nodal irradiation, followed by mastectomy and IMBR.

Disclosures: This study was supported by the National Cancer Institute of the US National Institutes of Health and others. Five authors declared receiving grants from or having other ties with various sources.

Source: Schaverien MV, Singh P, Smith BD, et al. Premastectomy radiotherapy and immediate breast reconstruction: A randomized clinical trial. JAMA Netw Open. 2024;7(4):e245217 (Apr 5). doi: 10.1001/jamanetworkopen.2024.5217 Source

Key clinical point: In patients with breast cancer (BC), premastectomy radiotherapy (PreMRT) followed by mastectomy and immediate breast reconstruction (IMBR) is feasible, safe, and shortens the time required for breast reconstruction.

Major finding: At a median follow-up of 29.7 months, there were no complete flap losses, locoregional recurrences, distant metastases, or deaths in the 48 patients who completed mastectomy with IMBR. Patients could undergo mastectomy with IMBR as early as 3 weeks (median 23 days) after completing radiotherapy. No grade 3-4 radiotherapy-related toxic effect or discontinuation of radiotherapy was reported.

Study details: The study enrolled 49 patients with T0-T3, N0-N3b, M0 BC from the phase 2 SAPHIRE trial who received PreMRT and were randomly assigned to receive hypofractionated or conventionally fractionated regional nodal irradiation, followed by mastectomy and IMBR.

Disclosures: This study was supported by the National Cancer Institute of the US National Institutes of Health and others. Five authors declared receiving grants from or having other ties with various sources.

Source: Schaverien MV, Singh P, Smith BD, et al. Premastectomy radiotherapy and immediate breast reconstruction: A randomized clinical trial. JAMA Netw Open. 2024;7(4):e245217 (Apr 5). doi: 10.1001/jamanetworkopen.2024.5217 Source

Key clinical point: In patients with breast cancer (BC), premastectomy radiotherapy (PreMRT) followed by mastectomy and immediate breast reconstruction (IMBR) is feasible, safe, and shortens the time required for breast reconstruction.

Major finding: At a median follow-up of 29.7 months, there were no complete flap losses, locoregional recurrences, distant metastases, or deaths in the 48 patients who completed mastectomy with IMBR. Patients could undergo mastectomy with IMBR as early as 3 weeks (median 23 days) after completing radiotherapy. No grade 3-4 radiotherapy-related toxic effect or discontinuation of radiotherapy was reported.

Study details: The study enrolled 49 patients with T0-T3, N0-N3b, M0 BC from the phase 2 SAPHIRE trial who received PreMRT and were randomly assigned to receive hypofractionated or conventionally fractionated regional nodal irradiation, followed by mastectomy and IMBR.

Disclosures: This study was supported by the National Cancer Institute of the US National Institutes of Health and others. Five authors declared receiving grants from or having other ties with various sources.

Source: Schaverien MV, Singh P, Smith BD, et al. Premastectomy radiotherapy and immediate breast reconstruction: A randomized clinical trial. JAMA Netw Open. 2024;7(4):e245217 (Apr 5). doi: 10.1001/jamanetworkopen.2024.5217 Source

Key clinical point: Higher levels of tumor-infiltrating lymphocytes (TIL) in breast cancer tissue was associated with improved survival outcomes in patients with early-stage triple-negative breast cancer (TNBC) who received locoregional therapy but no adjuvant or neoadjuvant chemotherapy.

Major finding: At a median follow-up of 18 years, each 10% increase in TIL levels was associated with significantly improved invasive disease-free survival (adjusted hazard ratio [aHR] 0.92; 95% CI 0.89-0.94), overall survival (aHR 0.88; 95% CI 0.85-0.91), and recurrence-free survival outcomes (aHR 0.90; 95% CI 0.87-0.92).

Study details: This retrospective pooled analysis included 1966 patients with early-stage TNBC (stage I TNBC, 55%) who underwent surgery with or without radiotherapy but no adjuvant or neoadjuvant chemotherapy.

Disclosures: This study was partly supported by grants from the Breast Cancer Research Foundation and others. Several authors declared ties with various sources.

Source: Leon-Ferre RA, Jonas SF, Salgado R, et al, for the International Immuno-Oncology Biomarker Working Group. Tumor-infiltrating lymphocytes in triple-negative breast cancer. JAMA. 2024;331:1135-1144 (Apr 2). doi: 10.1001/jama.2024.3056 Source

Key clinical point: Higher levels of tumor-infiltrating lymphocytes (TIL) in breast cancer tissue was associated with improved survival outcomes in patients with early-stage triple-negative breast cancer (TNBC) who received locoregional therapy but no adjuvant or neoadjuvant chemotherapy.

Major finding: At a median follow-up of 18 years, each 10% increase in TIL levels was associated with significantly improved invasive disease-free survival (adjusted hazard ratio [aHR] 0.92; 95% CI 0.89-0.94), overall survival (aHR 0.88; 95% CI 0.85-0.91), and recurrence-free survival outcomes (aHR 0.90; 95% CI 0.87-0.92).

Study details: This retrospective pooled analysis included 1966 patients with early-stage TNBC (stage I TNBC, 55%) who underwent surgery with or without radiotherapy but no adjuvant or neoadjuvant chemotherapy.

Disclosures: This study was partly supported by grants from the Breast Cancer Research Foundation and others. Several authors declared ties with various sources.

Source: Leon-Ferre RA, Jonas SF, Salgado R, et al, for the International Immuno-Oncology Biomarker Working Group. Tumor-infiltrating lymphocytes in triple-negative breast cancer. JAMA. 2024;331:1135-1144 (Apr 2). doi: 10.1001/jama.2024.3056 Source

Key clinical point: Higher levels of tumor-infiltrating lymphocytes (TIL) in breast cancer tissue was associated with improved survival outcomes in patients with early-stage triple-negative breast cancer (TNBC) who received locoregional therapy but no adjuvant or neoadjuvant chemotherapy.

Major finding: At a median follow-up of 18 years, each 10% increase in TIL levels was associated with significantly improved invasive disease-free survival (adjusted hazard ratio [aHR] 0.92; 95% CI 0.89-0.94), overall survival (aHR 0.88; 95% CI 0.85-0.91), and recurrence-free survival outcomes (aHR 0.90; 95% CI 0.87-0.92).

Study details: This retrospective pooled analysis included 1966 patients with early-stage TNBC (stage I TNBC, 55%) who underwent surgery with or without radiotherapy but no adjuvant or neoadjuvant chemotherapy.

Disclosures: This study was partly supported by grants from the Breast Cancer Research Foundation and others. Several authors declared ties with various sources.

Source: Leon-Ferre RA, Jonas SF, Salgado R, et al, for the International Immuno-Oncology Biomarker Working Group. Tumor-infiltrating lymphocytes in triple-negative breast cancer. JAMA. 2024;331:1135-1144 (Apr 2). doi: 10.1001/jama.2024.3056 Source