aShanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, ChinabDepartment of Respiratory, Xiangya Hospital, Central South University, Changsha, ChinacDepartment of Respiratory, Xijing Hospital, the First Affiliated Hospital of the Fourth Military University, Xi-an, ChinadDivision of Thoracic Tumor, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, ChinaeDepartment of Respiratory, Nanjing Military General Hospital, Nanjing, ChinafDivision of Thoracic Tumor, the First Affiliated Hospital, Zhejiang University, Hangzhou, ChinagDepartment of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, ChinahDepartment of Medical Oncology, Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, ChinaiDivision of Thoracic Tumor, Henan Cancer Hospital, Zhengzhou University, Zhengzhou, ChinajDivision of Thoracic Tumor, Beijing Cancer Hospital, Beijing University, Beijing, ChinakDivision of Thoracic Tumor, Guangxi Cancer Hospital, Nanning, ChinalDivision of Thoracic Tumor, Beijing Chest Hospital, Capital Medical University, Beijing, China
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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).