Shun Lu1, Zhiwei Chen2, Chengping Hu3, Jian Zhang4, Yuan Chen5, Yong Song6, Qiong Zhao7, Yun Fan8, Gang Wu9, Zhiyong Ma10, Jian Fang11, Qitao Yu12, Zhe Liu13. 1. Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China. Electronic address: shun_lu@hotmail.com. 2. Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China. 3. Department of Respiratory, Xiangya Hospital, Central South University, Changsha, China. 4. Department of Respiratory, Xijing Hospital, the First Affiliated Hospital of the Fourth Military University, Xi-an, China. 5. Division of Thoracic Tumor, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China. 6. Department of Respiratory, Nanjing Military General Hospital, Nanjing, China. 7. Division of Thoracic Tumor, the First Affiliated Hospital, Zhejiang University, Hangzhou, China. 8. Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China. 9. Department of Medical Oncology, Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China. 10. Division of Thoracic Tumor, Henan Cancer Hospital, Zhengzhou University, Zhengzhou, China. 11. Division of Thoracic Tumor, Beijing Cancer Hospital, Beijing University, Beijing, China. 12. Division of Thoracic Tumor, Guangxi Cancer Hospital, Nanning, China. 13. Division of Thoracic Tumor, Beijing Chest Hospital, Capital Medical University, Beijing, China.
Abstract
INTRODUCTION: This study aimed to compare the efficacy of first-line nedaplatin (80 mg/m2) plus docetaxel (75 mg/m2) (ND) versus cisplatin (75 mg/m2) plus docetaxel (75 mg/m2) (CD) in patients with advanced squamous cell lung carcinoma. METHODS: This open-label randomized controlled phase III trial was performed at 12 hospitals in China. Patients with squamous cell lung carcinoma were randomized to four cycles of ND or CD. The primary endpoint was progression-free survival (PFS). Secondary endpoints included time to progression, best overall response, and adverse events. RESULTS: In the intent-to-treat analysis set (ND: n = 141; CD: n = 139), median PFS was 4.63 months (95% confidence interval: 4.43-5.10) for the ND and 4.23 months (95% confidence interval: 3.37-4.53) for CD groups (p = 0.056). No significant difference in time to progression was observed between the two groups. Best overall responses and disease control rate were better with ND 51.5%, than with CD 38.1% (p = 0.033 and p = 0.0004, respectively). Grade III or IV adverse events and grade 3-4 nausea and fatigue were more frequent in the CD group compared with the ND group (all p < 0.05). CONCLUSIONS: There is no improvement in PFS with the nedaplatin and docetaxel combination in the intent-to-treat analysis. More hematologic toxicities were observed in the ND group (compared with CD), whereas more nonhematologic toxicities were observed in the CD group. ND could be a new treatment option for advanced or relapsed squamous cell lung cancer (NCT02088515 at ClinicalTrials.gov).
RCT Entities:
INTRODUCTION: This study aimed to compare the efficacy of first-line nedaplatin (80 mg/m2) plus docetaxel (75 mg/m2) (ND) versus cisplatin (75 mg/m2) plus docetaxel (75 mg/m2) (CD) in patients with advanced squamous cell lung carcinoma. METHODS: This open-label randomized controlled phase III trial was performed at 12 hospitals in China. Patients with squamous cell lung carcinoma were randomized to four cycles of ND or CD. The primary endpoint was progression-free survival (PFS). Secondary endpoints included time to progression, best overall response, and adverse events. RESULTS: In the intent-to-treat analysis set (ND: n = 141; CD: n = 139), median PFS was 4.63 months (95% confidence interval: 4.43-5.10) for the ND and 4.23 months (95% confidence interval: 3.37-4.53) for CD groups (p = 0.056). No significant difference in time to progression was observed between the two groups. Best overall responses and disease control rate were better with ND 51.5%, than with CD 38.1% (p = 0.033 and p = 0.0004, respectively). Grade III or IV adverse events and grade 3-4 nausea and fatigue were more frequent in the CD group compared with the ND group (all p < 0.05). CONCLUSIONS: There is no improvement in PFS with the nedaplatin and docetaxel combination in the intent-to-treat analysis. More hematologic toxicities were observed in the ND group (compared with CD), whereas more nonhematologic toxicities were observed in the CD group. ND could be a new treatment option for advanced or relapsed squamous cell lung cancer (NCT02088515 at ClinicalTrials.gov).
Authors: Ina Dormuth; Tiantian Liu; Jin Xu; Menggang Yu; Markus Pauly; Marc Ditzhaus Journal: BMC Med Res Methodol Date: 2022-01-30 Impact factor: 4.615