Yan Sun1, Wei Guo2, Yuxian Bai3, Minghua Ge4, Chaosu Hu5, Shaoxiong Wu6, Junfang Hao7, Ming Gao8, Jianji Pan9, Pin Dong10, Yunong Wu11, Houjie Liang12, Qichun Wei13, Meizuo Zhong14, Taixiang Lu6. 1. Department of Radiotherapy, Peking University Cancer Hospital & Institute, Beijing, China. 2. Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. 3. Department of Medicine, Affiliated Tumor Hospital of Harbin Medical University, Harbin, China. 4. Department of Head and Neck Surgery, Zhejiang Cancer Hospital, Hangzhou, China. 5. Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. 6. Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China. 7. Department of Radiology, Shandong Tumor Hospital & Institute, Jinan, China. 8. Department of Head and Neck Tumor, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. 9. Department of Radiation Oncology, Fujian Provincial Cancer Hospital, Fuzhou, China. 10. Department of Otolaryngology, Head and Neck Surgery, Shanghai Jiao Tong University Affiliated to Shanghai First People's Hospital, Shanghai, China. 11. Department of Oral and Maxillofacial Surgery, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China. 12. Department of Oncology and Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing, China. 13. Department of Radiation Oncology, The Second Affiliated Hospital, Cancer Institute, Zhejiang University School of Medicine, Hangzhou, China. 14. Department of Oncology, Xiangya Hospital, Central South University, Changsha, China.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of dose-modified docetaxel plus cisplatin and 5-fluorouracil (TPF) in Chinese patients with squamous cell carcinoma of the head and neck (SCCHN). MATERIALS AND METHODS: This Phase III, open-label, multi-center study included Chinese adults with previously untreated TNM Stage III or IV SCCHN (NCT00995293). Patients were randomized (1:1) to induction chemotherapy with TPF (docetaxel 60 mg/m2 and cisplatin 60 mg/m2 on day 1 and 5-FU 750 mg/m2 per day continuous IV infusion on days 1-5) or PF (cisplatin 75 mg/m2 on day 1 and 5-FU 750 mg/m2 per day on days 1-5) every 3 weeks for 3-4 cycles. The primary endpoint was progression-free survival (PFS). RESULTS:Median PFS in the TPF (n = 108) and PF (n = 111) groups was 400 days and 342 days (HR = 0.75; 95% CI, 0.53─1.06; p = .227), respectively. Overall response rate was higher for TPF versus PF (76.3% vs. 52.9%; p = .001), although this equalized following radiotherapy (75.0% vs. 73.9%). In the TPF and PF groups, ≥1 treatment-emergent adverse event was experienced by 104 (94.5%) and 110 (93.2%) patients, respectively. CONCLUSION: Adding dose-modified docetaxel to PF did not significantly improve PFS but may increase anti-tumor activity in Chinese patients with locally advanced SCCHN.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of dose-modified docetaxel plus cisplatin and 5-fluorouracil (TPF) in Chinese patients with squamous cell carcinoma of the head and neck (SCCHN). MATERIALS AND METHODS: This Phase III, open-label, multi-center study included Chinese adults with previously untreated TNM Stage III or IV SCCHN (NCT00995293). Patients were randomized (1:1) to induction chemotherapy with TPF (docetaxel 60 mg/m2 and cisplatin 60 mg/m2 on day 1 and 5-FU 750 mg/m2 per day continuous IV infusion on days 1-5) or PF (cisplatin 75 mg/m2 on day 1 and 5-FU 750 mg/m2 per day on days 1-5) every 3 weeks for 3-4 cycles. The primary endpoint was progression-free survival (PFS). RESULTS: Median PFS in the TPF (n = 108) and PF (n = 111) groups was 400 days and 342 days (HR = 0.75; 95% CI, 0.53─1.06; p = .227), respectively. Overall response rate was higher for TPF versus PF (76.3% vs. 52.9%; p = .001), although this equalized following radiotherapy (75.0% vs. 73.9%). In the TPF and PF groups, ≥1 treatment-emergent adverse event was experienced by 104 (94.5%) and 110 (93.2%) patients, respectively. CONCLUSION: Adding dose-modified docetaxel to PF did not significantly improve PFS but may increase anti-tumor activity in Chinese patients with locally advanced SCCHN.
Authors: Ambika Parmar; Michaelina Macluskey; Niall Mc Goldrick; David I Conway; Anne-Marie Glenny; Janet E Clarkson; Helen V Worthington; Kelvin Kw Chan Journal: Cochrane Database Syst Rev Date: 2021-12-20