VIENNA--Although the majority of patients with advanced non-small-cell lung cancer (NSCLC) are too ill to tolerate platinum therapy, the more benign safety profile of gemcitabine(Drug information on gemcitabine) (Gemzar) is opening up the possibility of palliative chemotherapy for a wider group of NSCLC patients.
"Gemcitabine is at least as effective as and much less toxic than the standard two-drug combination chemotherapy of cisplatin(Drug information on cisplatin) [Platinol] and etoposide(Drug information on etoposide)," said Dr. Christian Manegold in his report of the results of a European multicenter trial at the 21st Congress of the European Society for Medical Oncology (ESMO).
This phase II study randomized patients with stage III or IV NSCLC to receive either gemcita-bine (1,000 mg/m2 as a 30-minute IV infusion on days 1, 8, and 15 of a 28-day cycle) or cisplatin (100 mg/m2 on day 1) plus etoposide (100 mg/m2 on days 1, 2, and 3 of a 28-day cycle). None of the 150 participants had undergone prior chemotherapy or previous irradiation of the measured lesion, and none had CNS metastases.
The two regimens yielded entirely comparable response rates (18% with gemcitabine and 15% with cisplatin-etoposide), times to progression (4.2 months and 4.9 months, respectively), and median survival durations (6.6 months and 7.6 months, respectively).
No Serious Hematologic Toxicity
Neither chemotherapy regimen was seriously compromised by hematologic toxicity, with roughly three quarters of patients in both arms maintaining normal neutrophil counts.
Nausea and vomiting were common in the cisplatin-etoposide group, reaching severe proportions in more than a quarter of patients. Nearly half of the gemcitabine-treated patients were free of nausea and vomiting.
An especially striking contrast, Dr. Manegold emphasized, was in the incidence of alopecia, which afflicted more than 80% of patients in the combination arm but only 3% of gemcitabine-treated patients.