Gemcitabine versus the combination of cisplatin and etoposide in patients with inoperable non-small-cell lung cancer in a phase II randomized study.

PURPOSE: A phase II randomized study was conducted to evaluate the efficacy and toxicity of gemcitabine (GEM) versus the combination of cisplatin and etoposide (EP) in Chinese patients with inoperable (stage III or IV) non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: From March 1995 to February 1996, 53 patients were enrolled onto the study: 27 onto the GEM arm and 26 onto the EP arm. In the GEM arm, gemcitabine 1,250 mg/m2 was given as a 30-minute intravenous (i.v.) infusion on days 1, 8, and 15 of each 28-day cycle. In the EP arm, cisplatin 80 mg/m2 was given on day 1 and etoposide 80 mg/m2 was given on days 1, 2, and 3 of each 28-day cycle.
RESULTS: Twenty-six patients are assessable for treatment response on the GEM arm and 24 on the EP arm. Five patients (19.2%) on the GEM arm and five patients (20.8%) on the EP arm achieved a partial response (PR). No complete responses were attained on either treatment arm. All patients enrolled onto the study were eligible for toxicity assessment. The main toxicities were myelosuppression and vomiting, which included World Health Organization (WHO) grade 3 or 4 leukopenia (3.7%), thrombocytopenia (7.4%), anemia (7.4%), and nausea/vomiting (3.7%) on the GEM arm, and WHO grade 3 or 4 leukopenia (30.8%), thrombocytopenia (7.7%), anemia (15.4%), and nausea/vomiting (34.6%) on the EP arm. The median survival time was 37 weeks on the GEM arm and 48 weeks on the EP arm.
CONCLUSION: Gemcitabine is a well-tolerated chemotherapeutic agent for NSCLC. The antitumor activity was promising, with a 19.2% single-drug response rate, when compared with EP combination chemotherapy, which had a response rate of 20.8%. The safety profile is better than that of EP treatment.

RCT Entities:   Population Interventions Outcomes