Phase II study of paclitaxel in patients with extensive-disease small-cell lung cancer

An eastern cooperative oncology group study

David S. Ettinger, Dianne M. Finkelstein, Ravi P. Sarma, David H. Johnson

Research output: Contribution to journalArticle

162 Citations (Scopus)

Abstract

Purpose: To evaluate the efficacy and safety of paclitaxel (Taxol; Bristol-Myers Squibb Co, Princeton, NJ), a novel diterpene plant product in the treatment of previously untreated patients with extensive-disease small-cell lung cancer (SCLC). Patients and Methods: Patients with extensive-disease SCLC received paclitaxel 250 mg/m2 intravenously over 24 hours every 3 weeks. Nonresponders or partial responders, who received the maximum number of cycles (n = 4) of paclitaxel received salvage chemotherapy that consisted of etoposide (VP-16) 120 mg/m2 intravenously over 45 minutes on days 1, 2, and 3, and cisplatin 60 mg/m2 intravenously as a short infusion on day 1. Cycles were repeated every 3 weeks. Results: Of 36 patients entered onto the study, 34 and 32 patients were assessable for toxicity and response, respectively. No complete responses (CRs) were observed. Eleven patients (34%) had a partial response (PR) and six (19%) had stable disease (SD). In three of six patients categorized as having SD, there was greater than 50% tumor shrinkage. However, no 4-week follow-up measurements were made, so these could not be considered PRs, in part because patients received salvage chemotherapy by study design. In this trial, induction and salvage chemotherapy resulted in a response (two CRs and 15 PRs) (53%) in 17 patients. The estimated median survival duration was 43 weeks. Dose-limiting toxicity was leukopenia, with 19 patients (56%) having grade 4 leukopenia. The numbers of patients who experienced other grade 4 toxicities were as follows: pulmonary, three (9%); liver, two (6%); cardiac, one (3%); thrombocytopenia, one (3%); metabolic, one (3%); stomatitis, one (3%); and allergic reaction, one (3%). Four additional patients had grade 3 leukopenia and one patient (3%) died of sepsis (grade 5 toxicity). Conclusion: Paclitaxel is an active new agent in the treatment of SCLC. Further investigation of this agent in combination with other active agents is appropriate.

Original languageEnglish (US)
Pages (from-to)1430-1435
Number of pages6
JournalJournal of Clinical Oncology
Volume13
Issue number6
StatePublished - Jun 1995

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Small Cell Lung Carcinoma
Paclitaxel
Leukopenia
Etoposide
Drug Therapy
Stomatitis
Induction Chemotherapy
Diterpenes
Cisplatin
Sepsis
Hypersensitivity

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase II study of paclitaxel in patients with extensive-disease small-cell lung cancer : An eastern cooperative oncology group study. / Ettinger, David S.; Finkelstein, Dianne M.; Sarma, Ravi P.; Johnson, David H.

In: Journal of Clinical Oncology, Vol. 13, No. 6, 06.1995, p. 1430-1435.

Research output: Contribution to journalArticle

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title = "Phase II study of paclitaxel in patients with extensive-disease small-cell lung cancer: An eastern cooperative oncology group study",
abstract = "Purpose: To evaluate the efficacy and safety of paclitaxel (Taxol; Bristol-Myers Squibb Co, Princeton, NJ), a novel diterpene plant product in the treatment of previously untreated patients with extensive-disease small-cell lung cancer (SCLC). Patients and Methods: Patients with extensive-disease SCLC received paclitaxel 250 mg/m2 intravenously over 24 hours every 3 weeks. Nonresponders or partial responders, who received the maximum number of cycles (n = 4) of paclitaxel received salvage chemotherapy that consisted of etoposide (VP-16) 120 mg/m2 intravenously over 45 minutes on days 1, 2, and 3, and cisplatin 60 mg/m2 intravenously as a short infusion on day 1. Cycles were repeated every 3 weeks. Results: Of 36 patients entered onto the study, 34 and 32 patients were assessable for toxicity and response, respectively. No complete responses (CRs) were observed. Eleven patients (34{\%}) had a partial response (PR) and six (19{\%}) had stable disease (SD). In three of six patients categorized as having SD, there was greater than 50{\%} tumor shrinkage. However, no 4-week follow-up measurements were made, so these could not be considered PRs, in part because patients received salvage chemotherapy by study design. In this trial, induction and salvage chemotherapy resulted in a response (two CRs and 15 PRs) (53{\%}) in 17 patients. The estimated median survival duration was 43 weeks. Dose-limiting toxicity was leukopenia, with 19 patients (56{\%}) having grade 4 leukopenia. The numbers of patients who experienced other grade 4 toxicities were as follows: pulmonary, three (9{\%}); liver, two (6{\%}); cardiac, one (3{\%}); thrombocytopenia, one (3{\%}); metabolic, one (3{\%}); stomatitis, one (3{\%}); and allergic reaction, one (3{\%}). Four additional patients had grade 3 leukopenia and one patient (3{\%}) died of sepsis (grade 5 toxicity). Conclusion: Paclitaxel is an active new agent in the treatment of SCLC. Further investigation of this agent in combination with other active agents is appropriate.",
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