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Paclitaxel/Carboplatin/Etoposide Versus Paclitaxel/Topotecan for Extensive-Stage Small Cell Lung Cancer: A Minnie Pearl Cancer Research Network Randomized, Prospective Phase II Trial

^a Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, Tennessee, USA; ^b Consultants in Blood Disorders and Cancer, Louisville, Kentucky, USA; ^c Upstate Carolina CCOP, Spartanburg, South Carolina, USA; ^d Northeast Alabama Regional Medical Center, Anniston, Alabama, USA

Key Words. Small cell lung cancer • Chemotherapy • Randomized study • Nonplatinum doublet

Correspondence: F. Anthony Greco, M.D., Sarah Cannon Research Institute, 250 25th Avenue North, Suite 110, Nashville, Tennessee 37203, USA. Telephone: 615-329-7274; Fax: 615-986-0029; e-mail fgreco{at}tnonc.com

Purpose. To compare the combination of paclitaxel (Taxol^®; Bristol-Myers Squibb, Princeton, NJ, http://www.bms.com) and topotecan (Hycamtin^®; Glaxo SmithKline, Philadelphia, http://www.gsk.com) with paclitaxel, carboplatin (Paraplatin^®; Bristol-Myers Squibb), and etoposide (Etopophos^®, VePesid^®; Bristol-Myers Squibb) in patients with previously untreated extensive-stage small cell lung cancer.

Patients and Methods. In this phase II trial, 120 patients were randomly allocated to receive either topotecan (1.5 mg/m² i.v. days 1, 2, and 3) and paclitaxel (175 mg/m² i.v. day 1) every 21 days orpaclitaxe l (200mg/m² i.v. day 1), carboplatin (area under the concentration–time curve 6 i.v. day 1), and etoposide (50 mg/100 mg alternating daily by mouth days 1–10) every 21 days, each regimen for a maximum of eight cycles. The primary end points were objective response rate and time to progression.

Results. The paclitaxel–carboplatin–etoposide combination produced a significantly higher overall response rate (78% versus 48%), longer median time to progression (7.6 months versus 5.5 months), and greater number of patients free from progression at 1 year (14% versus 8%) compared with paclitaxel plus topotecan. There was no difference in overall survival. Toxicities were similar in the two treatment arms.

Conclusions. The paclitaxel–carboplatin–etoposide combination produced a superior overall response rate and time to progression in patients with extensive-stage small cell lung cancer compared with paclitaxel plus topotecan. The platinum compounds continue to be a necessary component of the initial therapy for these patients.

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