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

• Published in: The oncologist (Dayton, Ohio) Ohio), 2005-10, Vol.10 (9), p.728-733
• Main Authors: Greco, F. Anthony, Thompson, Dana S., Morrissey, Lisa H., Erland, Joan B., Burris, Howard A., Spigel, David R., Joseph, Geetha, Corso, Steven W., Spremulli, Ellen, Hainsworth, John D.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carboplatin - administration & dosage; Carboplatin - adverse effects; Carcinoma, Small Cell - drug therapy; Carcinoma, Small Cell - mortality; Chemotherapy; Etoposide - administration & dosage; Etoposide - adverse effects; Etoposide - analogs & derivatives; Female; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Male; Middle Aged; Nonplatinum doublet; Organophosphorus Compounds - administration & dosage; Organophosphorus Compounds - adverse effects; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Randomized study; Small cell lung cancer; Topotecan - administration & dosage; Topotecan - adverse effects
• ISSN: 1083-7159; 1549-490X
• DOI: 10.1634/theoncologist.10-9-728

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.