Overall survival was significantly longer with nedaplatin plus docetaxel than with cisplatin plus docetaxel in previously untreated patients with advanced or relapsed squamous cell lung carcinoma, a new study published online ahead of print in the journal The Lancet Oncology has shown.1
Because nedaplatin, a derivative of cisplatin, in combination with docetaxel, has shown promising activity for advanced squamous cell lung carcinoma in a previous phase 1/2 study, researchers sought to compare nedaplatin with cisplatin plus docetaxel to investigate the impact on overall survival.
For the multicenter, open-label, phase 3 study, researchers enrolled 355 patients with pathologically proven squamous cell lung cancer with stage 3B/4 or postoperative recurrence who had not received previous chemotherapy or developed recurrent disease more than 1 year after previous adjuvant chemotherapy.
Patients were randomly assigned 1:1 to nedaplatin 100 mg/m2 plus docetaxel 60 mg/m2 intravenously or cisplatin 80 mg/m2 and docetaxel 60 mg/m2 every 3 weeks for 4 to 6 cycles.
Results showed that among 349 evaluable patients, median overall survival was 13.6 months (95% CI, 11.6 – 15.6) with nedaplatin and 11.4 months (95% CI, 10.2 – 12.2) with cisplatin (HR, 0.81; 95% CI, 0.65 – 1.02; P = .037), demonstrating a significant difference between the 2 treatment arms.
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In regard to safety, grade 3 or higher nausea, fatigue, hyponatremia, and hypokalemia were more common in the cisplatin treatment arm than the nedaplatin group; however, grade 3 or higher leukopenia, neutropenia, and thrombocytopenia were more frequent in the nedaplatin arm. Of note, 4 treatment-related deaths occurred in the nedaplatin group and 3 occurred in the cisplatin group.
“Nedaplatin plus docetaxel could be a new treatment option for advanced or relapsed squamous cell lung cancer,” the authors concluded.
- Shukuya T, Yamanaka T, Seto T, et al. Nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung (WJOG5208L): a randomised, open-label, phase 3 trial [published online ahead of print October 27, 2015]. Lancet Oncol. doi: 10.1016/S1470-2045(15)00305-8.