HAMBURG, GermanyGLOB-1 trial results, reported at the 25th Congress of the European Society of Medical Oncology (ESMO), have confirmed the combination of vinorelbine (Navelbine) and cisplatin(Drug information on cisplatin) (Platinol) as a chemotherapy reference standard in metastatic non-small-cell lung cancer (NSCLC), raising questions about the role of three-drug combinations in this setting.
GLOB-1 investigators in 16 countries randomized 257 chemotherapy-naïve patients with stage IV or relapsing NSCLC to vinorelbine (30 mg/m² on days 1, 8, and 15) plus cisplatin (80 mg/m² on day 1) or vinorelbine (25 mg/m² on days 1 and 8) plus cisplatin (75 mg/m² on day 1) plus ifosfamide(Drug information on ifosfamide) (Ifex) (30 g/m² on day 1), given every 21 days.
The addition of ifosfamide failed to enhance the objective response rate (36% with triple-drug therapy vs 36% with two drugs) or disease control (60% vs 65%), reported Pierre-Jean Souquet, MD, of South Lyon Hospital Center, Pierre-Benite, France. Although the two-drug combination appeared to result in prolonged survival (43 weeks vs 36 weeks), Dr. Souquet cautioned that this difference did not reach statistical significance.
The absence of gain with ifosfamide might have been attributable to the lesser dose intensity of vinorelbine achieved with the three-drug regimen, suggested discussant Nicholas Thatcher, MD, of Christie Hospital, Manchester, UK.
Dr. Thatcher underscored the need to identify two-drug combinations for NSCLC that are less toxic, less expensive, can be given weekly in lower doses, and perhaps eliminate the need for platinum altogether. The time has come to use newer drugs such as gemcitabine(Drug information on gemcitabine) [Gemzar], taxanes, oral vinorelbine, and topotecan(Drug information on topotecan) [Hycamtin], he urged.