Patients with untreated extensive small cell lung cancer (SCLC) with CALGB performance scores 0-2 were treated with etoposide 200 mg/m2/day on days 1-3 and cisplatin doses of 20, 30, or 35 mg/m2/day days 1-3 in a Phase I/II format. Of the nine patients treated at the 35 mg/m2/day cisplatin dose in the Phase I portion of the study, Grade 4 leukopenia occurred in five patients and Grade 4 thrombocytopenia in four. There were two deaths due to myelosuppression and sepsis. This dose was thus considered the maximum tolerated dose (MTD), and a Phase II trial was then conducted using this treatment program. In the Phase II trial of 39 patients, the objective response rate was 67% (95% confidence interval, 50-81%) with 21% complete responses (CI 9-36%). Median survival was 10.5 months. Grade 4-5 leukopenia was seen in 57% and Grade 4-5 thrombocytopenia in 56%. The MTD defined by this Phase I trial represents a 67-100% increase in etoposide and a 33-42% increase in cisplatin dosage compared to prior studies. The observed objective response rates with this regimen are comparable to studies using conventional doses, but hematological toxicity was higher.
|Original language||English (US)|
|Number of pages||9|
|State||Published - Sep 1996|
Bibliographical noteFunding Information:
EPM and MCP were supported by CA12046; SDL was supported by CA16450; DAVE was supported by CA31983; JEH and CTC were supported by CA33601; LHM was supported by CA04326; GC was supported by CA47692; MRG was supported by CA1 1789; The following institutions participated in the study: Univ. of Minnesota; Dartmouth; Columbia University; Massachusetts General Hospital; Univ. of Missouri; Univ. of Iowa Hospitals; New York Hospital; SUNY-Syracuse; Univ. of Maryland Cancer Center; McGill; Walter Reed Army Medical Center; Univ. of California-San Diego; Univ. of Alabama; Mt. Sinai; SUNY-Maimonides; Univ. of North Carolina-Chapel Hill; Univ. of Massachusetts; Rhode Island Hosp.
This study 8631 was conducted by Cancer and Leukemia Group B (0. Ross McIntyre, Chairman) and was supported by Public Health Service grants (CA) from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services and by a grant from the T.J. Martell Foundation.
- Dose intensity
- Small cell lung cancer