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

S. Ramalingam, Chandra Belani, R. Day, B. A. Zamboni, S. A. Jacobs, J. R. Jett

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)247-251
Number of pages5
JournalAnnals of Oncology
Volume15
Issue number2
DOIs
StatePublished - Feb 1 2004

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Topotecan
Small Cell Lung Carcinoma
Paclitaxel
Febrile Neutropenia
Stomatitis
Esophagitis
Granulocyte Colony-Stimulating Factor
Neutropenia
Thrombocytopenia
Hypotension
Fatigue
Anemia
Therapeutics
Survival Rate

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

Cite this

Ramalingam, S. ; Belani, Chandra ; Day, R. ; Zamboni, B. A. ; Jacobs, S. A. ; Jett, J. R. / Phase II study of topotecan and paclitaxel for patients with previously untreated extensive stage small-cell lung cancer. In: Annals of Oncology. 2004 ; Vol. 15, No. 2. pp. 247-251.
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Phase II study of topotecan and paclitaxel for patients with previously untreated extensive stage small-cell lung cancer. / Ramalingam, S.; Belani, Chandra; Day, R.; Zamboni, B. A.; Jacobs, S. A.; Jett, J. R.

In: Annals of Oncology, Vol. 15, No. 2, 01.02.2004, p. 247-251.

Research output: Contribution to journalArticle

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AU - Belani, Chandra

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