DETROIT--A regimen combining vinorelbine (Navelbine) with cisplatin(Drug information on cisplatin) (Platinol) improved survival in patients with advanced non-small-cell lung cancer (NSCLC) over that achieved with cisplatin alone, said Antoinette Wozniak, MD, associate professor of clinical oncology, Wayne State University Medical School, Karmanos Cancer Institute.
The phase III randomized study, conducted by Dr. Wozniak and her colleagues with the Southwest Oncology Group (SWOG), included 415 stage IV NSCLC patients (92%) and selected stage IIIB NSCLC patients (those with malignant pleural effusion and/or multiple ipsilateral lung nodules) (8%).
Patients were randomized to cisplatin, 100 mg/m² every 4 weeks, or cisplatin every 4 weeks plus vinorelbine, 25 mg/m² weekly. Patients had received no previous chemotherapy.
Response Rate of 26%
Response rates were 12%, with no complete responders, in the cisplatin- alone group vs 26%, with 2% complete responders, in the combination arm.
Patients on the combination arm had significantly improved progression-free survival (median, 2 months vs 4 months) and overall survival (median, 6 months vs 8 months).
Survival rates at 1 and 2 years are 20% and 6%, respectively, for the single-agent group vs 36% and 12% for the combination arm, Dr. Wozniak said in her presentation of the data at the annual meeting of the American Society of Clinical Oncology (ASCO).
The most frequent toxicity was hematologic, with 120 episodes of grade IV granulocytopenia in the combination arm, compared with only 3 such episodes in the cisplatin-only arm. Two patients receiving cisplatin/vinorelbine died of neutropenic sepsis.
"These results support the conclusion that cisplatin and vinorelbine is a superior treatment than cisplatin alone," Dr. Wozniak said, adding that this regimen will serve as the basis for further SWOG trials.