Le presentamos resumen de:
The Lancet Oncology Published Online: 27 October 2015
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
Takehito Shukuya, MD,Prof Takeharu Yamanaka, PhD,Takashi Seto, MD, Haruko Daga, MD,Koichi Goto, MD, Hideo Saka, MD, Dr Prof Nobuyuki Yamamoto, MD nbyamamo@wakayama-med.ac.jp
Summary
Background
The combination of nedaplatin, a cisplatin derivative, and docetaxel showed promising activity for advanced squamous cell lung carcinoma in a previous phase 1–2 study. We compared nedaplatin plus docetaxel with cisplatin plus docetaxel in patients with previously untreated advanced or relapsed squamous cell lung carcinoma to determine effects on overall survival.
Methods
We did a randomised, open-label, phase 3 study at 53 institutions in Japan. Eligibility criteria included pathologically proven squamous cell lung cancer with stage IIIB/IV or postoperative recurrence, age 20–74 years, Eastern Cooperative Oncology Group performance status of 0–1, no previous chemotherapy or recurrence more than a year after previous adjuvant chemotherapy, and adequate organ function. Patients were randomly assigned (1:1) to 100 mg/m2 nedaplatin and 60 mg/m2 docetaxel intravenously, or 80 mg/m2 cisplatin and 60 mg/m2 docetaxel, every 3 weeks for four to six cycles (at the treating oncologist’s discretion). Randomisation was done centrally at the West Japan Oncology Group data centre via a computer-generated allocation sequence with dynamic minimisation that balanced stage (IIIB/IV or postoperative recurrent), sex, and institution. The primary endpoint was overall survival in the modified intention-to-treat population (ie, all patients who were randomly assigned and met the inclusion criteria). Safety analyses were done in all randomly assigned patients who received at least one dose of the study regimen. This trial is registered with the UMIN Clinical Trials Registry, number UMIN000002015, and is closed to new participants. Read more on 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…