DETROIT--A regimen combining vinorelbine (Navelbine) with
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
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.