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Effect of Adjuvant Paclitaxel and Carboplatin on Survival in Women With Triple-Negative Breast Cancer

  • Yu, Ke-Da1
  • Ye, Fu-Gui1
  • He, Min1
  • Fan, Lei1
  • Ma, Ding1
  • Mo, Miao2
  • Wu, Jiong1
  • Liu, Guang-Yu1
  • Di, Gen-Hong1
  • Zeng, Xiao-Hua3
  • He, Ping-Qing4
  • Wu, Ke-Jin5
  • Hou, Yi-Feng1
  • Wang, Jie6
  • Wang, Cheng7
  • Zhuang, Zhi-Gang8
  • Song, Chuan-Gui9
  • Lin, Xiao-Yan10
  • Toss, Angela11
  • Ricci, Francesco12
  • And 2 more
  • 1 Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China
  • 2 Department of Cancer Prevention & Clinical Statistics Center, Fudan University Shanghai Cancer Center, Shanghai, China
  • 3 Breast Center, Chongqing Cancer Hospital, Chongqing University, Chongqing, China
  • 4 Department of Breast Surgery, Shanghai Sixth People’s Hospital, Shanghai Jiao Tong University, Shanghai, China
  • 5 Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.
  • 6 & Child Health Hospital of China Welfare Institute, Shanghai Jiao Tong University, Shanghai, China
  • 7 Department of Breast Surgery, Shanghai Ninth People’s Hospital Huangpu Branch, Shanghai Jiao Tong University, Shanghai, China.
  • 8 Department of Breast Surgery, Shanghai First Maternity and Infant Hospital, Shanghai Tongji University, Shanghai, China
  • 9 Department of Breast Surgery, Fujian Medical University Union Hospital, Fuzhou, China
  • 10 Department of Breast Surgery, Tongji University School of Medicine Yangpu Hospital, Shanghai, China
  • 11 Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy
  • 12 & Saint-Cloud, France
  • 13 Key Laboratory of Breast Cancer in Shanghai, Shanghai, China
Published Article
JAMA Oncology
American Medical Association
Publication Date
Aug 13, 2020
DOI: 10.1001/jamaoncol.2020.2965
PMID: 32789480
PMCID: PMC7426881
PubMed Central
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Importance The value of platinum-based adjuvant chemotherapy in patients with triple-negative breast cancer (TNBC) remains controversial, as does whether BRCA1 and BRCA2 ( BRCA1/2 ) germline variants are associated with platinum treatment sensitivity. Objective To compare 6 cycles of paclitaxel plus carboplatin (PCb) with a standard-dose regimen of 3 cycles of cyclophosphamide, epirubicin, and fluorouracil followed by 3 cycles of docetaxel (CEF-T). Design, Setting, and Participants This phase 3 randomized clinical trial was conducted at 9 cancer centers and hospitals in China. Between July 1, 2011, and April 30, 2016, women aged 18 to 70 years with operable TNBC after definitive surgery (having pathologically confirmed regional node-positive disease or node-negative disease with tumor diameter >10 mm) were screened and enrolled. Exclusion criteria included having metastatic or locally advanced disease, having non-TNBC, or receiving preoperative anticancer therapy. Data were analyzed from December 1, 2019, to January 31, 2020, from the intent-to-treat population as prespecified in the protocol. Interventions Participants were randomized to receive PCb (paclitaxel 80 mg/m2 and carboplatin [area under the curve = 2] on days 1, 8, and 15 every 28 days for 6 cycles) or CEF-T (cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2, and fluorouracil 500 mg/m2 every 3 weeks for 3 cycles followed by docetaxel 100 mg/m2 every 3 weeks for 3 cycles). Main Outcomes and Measures The primary end point was disease-free survival (DFS). Secondary end points included overall survival, distant DFS, relapse-free survival, DFS in patients with germline variants in BRCA1/2 or homologous recombination repair (HRR)–related genes, and toxicity. Results A total of 647 patients (mean [SD] age, 51 [44-57] years) with operable TNBC were randomized to receive CEF-T (n = 322) or PCb (n = 325). At a median follow-up of 62 months, DFS time was longer in those assigned to PCb compared with CEF-T (5-year DFS, 86.5% vs 80.3%, hazard ratio [HR] = 0.65; 95% CI, 0.44-0.96; P = .03). Similar outcomes were observed for distant DFS and relapse-free survival. There was no statistically significant difference in overall survival between the groups (HR = 0.71; 95% CI, 0.42-1.22, P = .22). In the exploratory and hypothesis-generating subgroup analyses of PCb vs CEF-T, the HR for DFS was 0.44 (95% CI, 0.15-1.31; P = .14) in patients with the BRCA1/2 variant and 0.39 (95% CI, 0.15-0.99; P = .04) in those with the HRR variant. Safety data were consistent with the known safety profiles of relevant drugs. Conclusions and Relevance These findings suggest that a paclitaxel-plus-carboplatin regimen is an effective alternative adjuvant chemotherapy choice for patients with operable TNBC. In the era of molecular classification, subsets of TNBC sensitive to PCb should be further investigated. Trial Registration Identifier: NCT01216111

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