A phase I/II trial of etoposide and cisplatin in extensive small cell lung cancer. A cancer and Leukemia Group B study

Edith P. Mitchell, Michael C. Perry, Sharon D. Luikart, Constance T. Cirrincione, David A. Van Echo, James E. Herndon, L. Herbert Maurer, Gerald Clamon, Mark R. Green

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5 Scopus citations


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 languageEnglish (US)
Pages (from-to)215-223
Number of pages9
JournalLung Cancer
Issue number2
StatePublished - Sep 1996

Bibliographical note

Funding 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.

Funding Information:
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.


  • Cisplatin
  • Dose intensity
  • Etoposide
  • Small cell lung cancer


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