Annals of Oncology 14:1549-1554, 2003
© 2003 European Society for Medical Oncology
Original Paper |
Sequential dose-dense paclitaxel followed by topotecan in untreated extensive-stage small-cell lung cancer: a Spanish Lung Cancer Group phase II study
1 Vall d’Hebron University Hospital, Barcelona; 2 Hospital Germans Trias i Pujol, Badalona, Barcelona; 3 Fundación Jiménez Díaz, Madrid; 4 Hospital Ramón y Cajal, Madrid; 5 Hospital General de Elche, Alicante; 6 Hospital Son Dureta, Palma de Mallorca; 7 Hospital del Mar, Barcelona; 8 Hospital de Cruces, Baracaldo, Spain
Received 5 March 2003; revised 30 April 2003; accepted 4 June 2003
Background:
Poor survival rates in extensive-stage small-cell lung cancer (SCLC) patients prompted us to evaluate a sequential dose-dense schedule of paclitaxel followed by topotecan.
Patients and methods:
Forty-three patients with previously untreated, extensive-stage SCLC received three cycles of paclitaxel 250 mg/m2 over 3 h every 14 days followed by three cycles of topotecan 2.5 mg/m2 for 5 days every 21 days. Granulocyte colony-stimulating factor was given after every cycle. Patients progressing at any time and those not achieving complete response (CR) subsequently received four cycles of standard-dose etoposide–cisplatin.
Results:
A total of 118 cycles of paclitaxel were administered with minimal hematological toxicity. Grade 2/3 peripheral neuropathy was observed in 21% of patients. Response rate to paclitaxel was 48.8%, and 25.6% had stable disease (SD). Thirty-two patients achieving SD or response to paclitaxel subsequently received a total of 90 topotecan cycles. Topotecan-related toxicities included febrile neutropenia in 15.6% of patients with one toxic death, grade 3/4 anemia in 25% of patients and grade 3/4 thrombocytopenia in 31.3%. Non-hematological toxicities were mild. At completion of sequential paclitaxel–topotecan treatment the overall response rate was 55.8% (22 partial response, two CRs). Median survival for all patients was 10.5 months and median progression-free survival was 8.5 months.
Conclusions:
Sequential treatment with dose-dense paclitaxel followed by topotecan is feasible despite significant hematological toxicity during topotecan treatment. This schedule is an active regimen in extensive-stage SCLC and merits further investigation.
Key words: dose-dense, paclitaxel, sequential treatment, small-cell lung cancer, topotecan
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