Nedaplatin Plus Docetaxel Versus Cisplatin Plus Docetaxel as First-Line Chemotherapy for Advanced Squamous Cell Carcinoma of the Lung — A Multicenter, Open-label, Randomized, Phase III Trial

摘要

IntroductionThis 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. MethodsThis 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. ResultsIn 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 andp?=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 (allp <0.05). ConclusionsThere 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(NCT02088515atClinicalTrials.gov).