Phase II trial of cisplatin, etoposide, and 5-fluorouracil in advanced non-small-cell lung cancer - An Eastern Cooperative Oncology Group study (PB586)

Advanced non-small-cell lung cancer (NSCLC) remains an incurable disease de spite significant progress in chemotherapy. We conducted a phase II clinica l trial to investigate the efficacy and toxicity of a cisplatin, etoposide, and 5-fluorouracil (5-FU) combination in advanced metastatic and/or recurr ent NSCLC. Forty patients with advanced, recurrent, or metastatic, measurab le NSCLC were treated with cisplatin, 60 mg/m(2) intravenously (i.v.) on da y 1; etoposide, 120 mg/m(2)/day i.v. on days 1, 2, and 3; and 5-FU, 1,000 m g/m(2)/day i.v. continuous infusion on days 1 through 5. Treatment was admi nistered in 4-week cycles. Thirty patients had distant metastases and were previously untreated, and 10 patients had recurrent disease after prior tre atment with either surgery (1 patient), radiation therapy (5 patients), or both treatments (4 patients). Twenty-nine patients were evaluable for respo nse. Seven (24%) patients achieved a partial remission (PR), 18 (62%) had s table disease (SD), and 8 (14%) had progressive disease (PD). Overall media n survival was 7.9 months (range, 0.4-27.4 months). Patients who achieved a PR had a median survival of 23.5 months (9.3-27.4 months). In contrast, pa tients with SD had a median survival of 9.9 months (2.5-25.3 months), and p atients with PD had a median survival of 2.1 months (1-9.3 months). Median duration of response of 27.1 weeks (4.9-76.5 weeks) for patients with PR, a nd time to progression was 13.4 weeks (3.7-54.5 weeks) for patients with SD . Toxicity was primarily hematologic and gastrointestinal, and there were t hree deaths due to infection. The combination of cisplatin, 5-FU, and etopo side as administered in this study appears to have considerable toxicity an d does not appear to be superior to other cisplatin-containing regimens use d for the treatment of advanced NSCLC.