BACKGROUND: Weekly administration of irinotecan plus cisplatin was evaluated for untreated patients with non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Sixty mg/m(2) of irinotecan plus 30 mg/m(2) of cisplatin were administered on days 1, 8 and 15 every 4 weeks. Patients with no evidence of disease progression were treated with at least two cycles (8 weeks). Of the 39 patients, 29 were provided an antidiarrheal program consisting of sodium bicarbonate and magnesium oxide. RESULTS: There were 13 partial responses and an overall response rate of 33.3% [95% CI: 20%-50%]. The median time to progression and survival were 64 days and 12.8 months, respectively. Grade 4 neutropenia occurred in 15.4% of the patients, and Grade 3 and 4 diarrhea was observed in 12.8% and 2.6%, respectively. The incidence of leukopenia of grade 3-4 was significantly lower in patients provided with the antidiarrheal program due to lack of decrease in the lymphocyte count. CONCLUSION: This phase II study indicated that weekly irinotecan plus cisplatin administration was a promising treatment for untreated NSCLC.
BACKGROUND: Weekly administration of irinotecan plus cisplatin was evaluated for untreated patients with non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Sixty mg/m(2) of irinotecan plus 30 mg/m(2) of cisplatin were administered on days 1, 8 and 15 every 4 weeks. Patients with no evidence of disease progression were treated with at least two cycles (8 weeks). Of the 39 patients, 29 were provided an antidiarrheal program consisting of sodium bicarbonate and magnesium oxide. RESULTS: There were 13 partial responses and an overall response rate of 33.3% [95% CI: 20%-50%]. The median time to progression and survival were 64 days and 12.8 months, respectively. Grade 4 neutropenia occurred in 15.4% of the patients, and Grade 3 and 4 diarrhea was observed in 12.8% and 2.6%, respectively. The incidence of leukopenia of grade 3-4 was significantly lower in patients provided with the antidiarrheal program due to lack of decrease in the lymphocyte count. CONCLUSION: This phase II study indicated that weekly irinotecan plus cisplatin administration was a promising treatment for untreated NSCLC.