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Annals of Oncology 12:89-94, 2001
© 2001 European Society for Medical Oncology


research-article

Second-line chemotherapy for non-small-cell lung cancer with monthly docetaxel and weekly gemcitabine: A phase II trial

C.H. Spiridonidis1, L.R. Laufman1, L. Carman2, T. Moore3, S. Blair4, J. Jones5, Ch. George4, T. Patel3, R. Roach3, R. Rupert6, J. Zangmeister3, D. Colborn2 and J.Ph. Kuebler4

1Hematology Oncology Consultants Incorporated Columbus, Ohio Newark
2Columbus Community Clinical Oncology Program Columbus, Ohio Newark
3Mid-Ohio Oncologv Group Columbus, Ohio Newark
4Columbus Oncology Associates Columbus, Ohio Newark
5Licking Memorial Hospital Professional Corporation Newark
6University Hospitals East Columbus, Ohio, USA

C H Spiridomdis, MD Hematology Oncology Consultants Incorporated 393 East TownStreet, Suite 109 Columbus, OH 43215 USA E-mail hspindom{at}aol.com

BACKGROUND: Docetaxel and gemcitabine are active against chemotherapy-pretreated non-small-cell lung cancer (NSCLC). The purpose of this phase II study was to evaluate the efficacy and safety of monthly docetaxel combined with weekly gemcitabine in NSCLC patients failing one prior regimen

PATIENTS AND METHODS: Forty patients were enrolled Prior chemotherapy was a platinum-based combination in 36 patients, using vinorelbine in 26 patients and etoposide in 10 patients The other four patients had prior single agents Tumors were refractory or resistant to front-line therapy in 80%of patients Treatment was gemcitabine 800 mg/m2days I, 8, 15 and docetaxel 100 mg/m2 day 1, with cycles repeated every four weeks

RESULTS: Thirteen patients responded (32 5% 95%confidence interval CI) 19%—49%), including one complete and 12partial responses. Responses were observed at all metastatic sites, with similar response frequencies in platinum-sensitive and platinum-resistant/refractory tumors The median time to progression for responders was nine months,with two responses lasting longer than a year Median survival was 8.1 months Hematologic toxicities included grade 4 neutropenia in 23 patients, with 4 episodes of febrile neutropenia, grade3–4 thrombocytopenia in 9 patients, and anemia requiring red cell transfusions in 9 patients. With the exception of asthenia, severe non-hematologic toxicities were infrequent

CONCLUSIONS: Monthly docetaxel, combined with weekly gemcitabine,is an active and safe second-line therapy for NSCLC patients

docetaxel for NSCLC, second-line gemcitabine


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