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A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer

Author

Listed:
  • Biyun Wang

    (Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University)

  • Tao Sun

    (Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute)

  • Yannan Zhao

    (Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University)

  • Shusen Wang

    (Sun Yat-Sen University Cancer Center, The State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine)

  • Jian Zhang

    (Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University)

  • Zhonghua Wang

    (Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University)

  • Yue-E Teng

    (The First Hospital of China Medical University)

  • Li Cai

    (Harbin Medical University Cancer Hospital)

  • Min Yan

    (Henan Breast Cancer Center, The affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Xiaojia Wang

    (Zhejiang Cancer Hospital)

  • Zefei Jiang

    (The Fifth Medical Center of Chinese PLA General Hospital)

  • Yueyin Pan

    (The First Hospital, Anhui Medical University)

  • Jianfeng Luo

    (Fudan University)

  • Zhimin Shao

    (Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University)

  • Jiong Wu

    (Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University)

  • Xiaomao Guo

    (Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University)

  • Xichun Hu

    (Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University)

Abstract

Platinum is recommended in combination with gemcitabine in the treatment of metastatic triple-negative breast cancer (mTNBC). We conduct a randomized phase 3, controlled, open-label trial to compare nab-paclitaxel/cisplatin (AP) with gemcitabine/cisplatin (GP) in mTNBC patients (ClinicalTrials.gov NCT02546934). 254 patients with untreated mTNBC randomly receive AP (nab-paclitaxel 125 mg/m² on day 1, 8 and cisplatin 75 mg/m² on day 1) or GP (gemcitabine 1250 mg/m² on day 1, 8 and cisplatin 75 mg/m² on day 1) intravenously every 3 weeks until progression disease, intolerable toxicity or withdrawal of consent. The primary endpoint is progression-free survival (PFS); secondary endpoints are objective response rate (ORR), safety and overall survival (OS). The trial has met pre-specified endpoints. The median PFS is 9.8 months with AP as compared to 7.4 months with GP (stratified HR, 0.67; 95% CI, 0.50–0.88; P = 0.004). AP significantly increases ORR (81.1% vs. 56.3%, P

Suggested Citation

  • Biyun Wang & Tao Sun & Yannan Zhao & Shusen Wang & Jian Zhang & Zhonghua Wang & Yue-E Teng & Li Cai & Min Yan & Xiaojia Wang & Zefei Jiang & Yueyin Pan & Jianfeng Luo & Zhimin Shao & Jiong Wu & Xiaoma, 2022. "A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer," Nature Communications, Nature, vol. 13(1), pages 1-7, December.
    • Handle: RePEc:nat:natcom:v:13:y:2022:i:1:d:10.1038_s41467-022-31704-7
    DOI: 10.1038/s41467-022-31704-7
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