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TOPLINE:
The combination shows consistent benefits across patient subgroups with a manageable safety profile.
METHODOLOGY:
- A randomized, double-blind, phase 3 trial enrolled 441 females (median age, 48 years) with early or locally advanced triple-negative breast cancer from 40 hospitals in China between November 2020 and May 2023.
- Participants were randomized 1:1 to receive either camrelizumab 200 mg (n = 222) or placebo (n = 219) combined with chemotherapy every 2 weeks, with median follow-up period of 14.4 months.
- Treatment included nab-paclitaxel (100 mg/m²) plus carboplatin (area under curve, 1.5) on days 1, 8, and 15 in 28-day cycles for 16 weeks, followed by epirubicin (90 mg/m²) and cyclophosphamide (500 mg/m²) every 2 weeks for 8 weeks.
- The primary endpoint was pathological complete response, defined as no invasive tumor in breast and lymph nodes.
TAKEAWAY:
- Pathological complete response was achieved in 56.8% (95% CI, 50.0%-63.4%) of patients in the camrelizumab-chemotherapy group vs 44.7% (95% CI, 38.0%-51.6%) in the placebo-chemotherapy group (rate difference, 12.2%; 95% CI, 3.3%-21.2%; P = .004).
- Grade 3 or higher adverse events occurred in 89.2% of camrelizumab-chemotherapy group vs 83.1% in placebo-chemotherapy group, with serious adverse events in 34.7% vs 22.8%, respectively.
- Event-free survival rate at 18 months was 86.6% (95% CI, 79.9%-91.1%) with camrelizumab-chemotherapy vs 83.6% (95% CI, 76.2%-88.9%) with placebo-chemotherapy (hazard ratio [HR], 0.80; 95% CI, 0.46-1.42).
- Disease-free survival rate at 12 months reached 91.9% (95% CI, 85.5%-95.5%) with camrelizumab-chemotherapy compared with 87.8% (95% CI, 80.3%-92.6%) with placebo-chemotherapy (HR, 0.58; 95% CI, 0.27-1.24).
IN PRACTICE:
“The addition of camrelizumab to neoadjuvant chemotherapy significantly improved pathological complete response... The benefits of camrelizumab-chemotherapy with respect to pCR were generally consistent across subgroups,” wrote the authors of the study.
SOURCE:
The study was led by Zhi-Ming Shao, MD, Fudan University Shanghai Cancer Center in Shanghai, China. It was published online on December 13 in JAMA.
LIMITATIONS:
According to the authors, the study’s limitations include short follow-up duration preventing assessment of mature survival data and long-term safety profile, uncertainty about optimal duration of adjuvant camrelizumab treatment, small sample sizes in some subgroups warranting cautious interpretation, and potential limited generalizability as the study was conducted only in Chinese patients with triple-negative breast cancer.
DISCLOSURES:
The study was supported by Jiangsu Hengrui Pharmaceuticals. The authors and funder were involved in data collection, analysis, and interpretation and guaranteed the accuracy, completeness of the data, writing of the report, and the decision to submit the manuscript for publication.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
The combination shows consistent benefits across patient subgroups with a manageable safety profile.
METHODOLOGY:
- A randomized, double-blind, phase 3 trial enrolled 441 females (median age, 48 years) with early or locally advanced triple-negative breast cancer from 40 hospitals in China between November 2020 and May 2023.
- Participants were randomized 1:1 to receive either camrelizumab 200 mg (n = 222) or placebo (n = 219) combined with chemotherapy every 2 weeks, with median follow-up period of 14.4 months.
- Treatment included nab-paclitaxel (100 mg/m²) plus carboplatin (area under curve, 1.5) on days 1, 8, and 15 in 28-day cycles for 16 weeks, followed by epirubicin (90 mg/m²) and cyclophosphamide (500 mg/m²) every 2 weeks for 8 weeks.
- The primary endpoint was pathological complete response, defined as no invasive tumor in breast and lymph nodes.
TAKEAWAY:
- Pathological complete response was achieved in 56.8% (95% CI, 50.0%-63.4%) of patients in the camrelizumab-chemotherapy group vs 44.7% (95% CI, 38.0%-51.6%) in the placebo-chemotherapy group (rate difference, 12.2%; 95% CI, 3.3%-21.2%; P = .004).
- Grade 3 or higher adverse events occurred in 89.2% of camrelizumab-chemotherapy group vs 83.1% in placebo-chemotherapy group, with serious adverse events in 34.7% vs 22.8%, respectively.
- Event-free survival rate at 18 months was 86.6% (95% CI, 79.9%-91.1%) with camrelizumab-chemotherapy vs 83.6% (95% CI, 76.2%-88.9%) with placebo-chemotherapy (hazard ratio [HR], 0.80; 95% CI, 0.46-1.42).
- Disease-free survival rate at 12 months reached 91.9% (95% CI, 85.5%-95.5%) with camrelizumab-chemotherapy compared with 87.8% (95% CI, 80.3%-92.6%) with placebo-chemotherapy (HR, 0.58; 95% CI, 0.27-1.24).
IN PRACTICE:
“The addition of camrelizumab to neoadjuvant chemotherapy significantly improved pathological complete response... The benefits of camrelizumab-chemotherapy with respect to pCR were generally consistent across subgroups,” wrote the authors of the study.
SOURCE:
The study was led by Zhi-Ming Shao, MD, Fudan University Shanghai Cancer Center in Shanghai, China. It was published online on December 13 in JAMA.
LIMITATIONS:
According to the authors, the study’s limitations include short follow-up duration preventing assessment of mature survival data and long-term safety profile, uncertainty about optimal duration of adjuvant camrelizumab treatment, small sample sizes in some subgroups warranting cautious interpretation, and potential limited generalizability as the study was conducted only in Chinese patients with triple-negative breast cancer.
DISCLOSURES:
The study was supported by Jiangsu Hengrui Pharmaceuticals. The authors and funder were involved in data collection, analysis, and interpretation and guaranteed the accuracy, completeness of the data, writing of the report, and the decision to submit the manuscript for publication.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
The combination shows consistent benefits across patient subgroups with a manageable safety profile.
METHODOLOGY:
- A randomized, double-blind, phase 3 trial enrolled 441 females (median age, 48 years) with early or locally advanced triple-negative breast cancer from 40 hospitals in China between November 2020 and May 2023.
- Participants were randomized 1:1 to receive either camrelizumab 200 mg (n = 222) or placebo (n = 219) combined with chemotherapy every 2 weeks, with median follow-up period of 14.4 months.
- Treatment included nab-paclitaxel (100 mg/m²) plus carboplatin (area under curve, 1.5) on days 1, 8, and 15 in 28-day cycles for 16 weeks, followed by epirubicin (90 mg/m²) and cyclophosphamide (500 mg/m²) every 2 weeks for 8 weeks.
- The primary endpoint was pathological complete response, defined as no invasive tumor in breast and lymph nodes.
TAKEAWAY:
- Pathological complete response was achieved in 56.8% (95% CI, 50.0%-63.4%) of patients in the camrelizumab-chemotherapy group vs 44.7% (95% CI, 38.0%-51.6%) in the placebo-chemotherapy group (rate difference, 12.2%; 95% CI, 3.3%-21.2%; P = .004).
- Grade 3 or higher adverse events occurred in 89.2% of camrelizumab-chemotherapy group vs 83.1% in placebo-chemotherapy group, with serious adverse events in 34.7% vs 22.8%, respectively.
- Event-free survival rate at 18 months was 86.6% (95% CI, 79.9%-91.1%) with camrelizumab-chemotherapy vs 83.6% (95% CI, 76.2%-88.9%) with placebo-chemotherapy (hazard ratio [HR], 0.80; 95% CI, 0.46-1.42).
- Disease-free survival rate at 12 months reached 91.9% (95% CI, 85.5%-95.5%) with camrelizumab-chemotherapy compared with 87.8% (95% CI, 80.3%-92.6%) with placebo-chemotherapy (HR, 0.58; 95% CI, 0.27-1.24).
IN PRACTICE:
“The addition of camrelizumab to neoadjuvant chemotherapy significantly improved pathological complete response... The benefits of camrelizumab-chemotherapy with respect to pCR were generally consistent across subgroups,” wrote the authors of the study.
SOURCE:
The study was led by Zhi-Ming Shao, MD, Fudan University Shanghai Cancer Center in Shanghai, China. It was published online on December 13 in JAMA.
LIMITATIONS:
According to the authors, the study’s limitations include short follow-up duration preventing assessment of mature survival data and long-term safety profile, uncertainty about optimal duration of adjuvant camrelizumab treatment, small sample sizes in some subgroups warranting cautious interpretation, and potential limited generalizability as the study was conducted only in Chinese patients with triple-negative breast cancer.
DISCLOSURES:
The study was supported by Jiangsu Hengrui Pharmaceuticals. The authors and funder were involved in data collection, analysis, and interpretation and guaranteed the accuracy, completeness of the data, writing of the report, and the decision to submit the manuscript for publication.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.