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Annals of Oncology 15:247-251, 2004
© 2004 European Society for Medical Oncology

Original Paper

Phase II study of topotecan and paclitaxel for patients with previously untreated extensive stage small-cell lung cancer

Received 23 July 2003; revised 22 September 2003; accepted 3 October 2003

Background:

This phase II study was conducted to evaluate the safety and efficacy of the combination of paclitaxel and topotecan for patients with extensive stage small-cell lung cancer (ED-SCLC).

Patients and methods:

Previously untreated ED-SCLC patients with Eastern Coperative Oncology Group performance status <2 were eligible. Treatment consisted of topotecan 1 mg/m2 (first three patients received 1.25 mg/m2), on days 1–5, and paclitaxel 135 mg/m2 over 24 h on day 5, every 4 weeks. Prophylactic granulocyte colony-stimulating factor was administered to all patients.

Results:

Thirty-two patients received a median of four cycles of chemotherapy. Grade 4 anemia, neutropenia and thrombocytopenia occurred in 13, 31 and 18 patients, respectively. Thirty episodes of febrile neutropenia occurred in 22 patients. Grade 3 fatigue, esophagitis, stomatitis and hypotension occurred in one patient each. Of 26 patients eligible for response evaluation, there were six complete and 12 partial responses (overall response rate 69%). The median survival was 54 weeks. The 1-, 2- and 3-year survival rates were 50%, 10% and 3%, respectively.

Conclusions:

The combination of topotecan and paclitaxel is active as initial therapy in SCLC, but the efficacy is similar to ‘standard therapy’. This combination was associated with a high incidence of myelosuppression and febrile neutropenia, at the doses evaluated.

S. Ramalingam1, C. P. Belani1,*, R. Day1, B. A. Zamboni1, S. A. Jacobs1 and J. R. Jett1,2

1 University of Pittsburgh Cancer Institute, Pittsburgh, PA; 2 Mayo Clinic, Rochester, MN, USA

Key words: small-cell lung cancer, paclitaxel, topotecan


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