Journal of Clinical Oncology, Vol 22, No 9 (May 1), 2004: pp. 1589-1597
© 2004 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2004.08.163
Randomized Phase III Trial of Pemetrexed Versus Docetaxel in Patients With Non–Small-Cell Lung Cancer Previously Treated With Chemotherapy
Nasser Hanna,
Frances A. Shepherd,
Frank V. Fossella,
Jose R. Pereira,
Filippo De Marinis,
Joachim von Pawel,
Ulrich Gatzemeier,
Thomas Chang Yao Tsao,
Miklos Pless,
Thomas Muller,
Hong-Liang Lim,
Christopher Desch,
Klara Szondy,
Radj Gervais,
Shaharyar,
Christian Manegold,
Sofia Paul,
Paolo Paoletti,
Lawrence Einhorn,
Paul A. Bunn, Jr.
From Indiana University and the Hoosier Oncology Group; Eli Lilly and Company, Indianapolis, IN; The University of Texas M.D. Anderson Cancer Center, Houston, TX; University of Colorado Cancer Center, Denver, CO; Virginia Cancer Institute, Richmond, VA; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Instituto Arnaldo Vieira de Carvalho, Sao Paolo, Brazil; San Camillo-Forlanini Hospitals, Rome, Italy; Chang Gung Memorial Hospital, Taoyuan, Taiwan; University Hospital Basel, Petersgraben Switzerland; Fachklinik München, Gauting; Hospital Grosshansdorf, Grosshansdorf; Krankenhaus Hofheim Am Taunus, Hofheim; Thoraxklinik-Heidelberg, Heidelberg, Germany; National University Hospital, Singapore; Semmelweis Medical University Diosarok, Budapest, Hungary; Centre Francois Baclesse, Caen, France; Mayo Hospital, Lahore, Pakistan.
Address reprint requests to Nasser Hanna, MD, Indiana University, 535 Barnhill Dr, Room 473, Indianapolis, IN 46202; e-mail: nhanna{at}iupui.edu
PURPOSE: To compare the efficacy and toxicity of pemetrexed versus docetaxel in patients with advanced non—small-cell lung cancer (NSCLC) previously treated with chemotherapy.
PATIENTS AND METHODS: Eligible patients had a performance status 0 to 2, previous treatment with one prior chemotherapy regimen for advanced NSCLC, and adequate organ function. Patients received pemetrexed 500 mg/m2 intravenously (IV) day 1 with vitamin B12, folic acid, and dexamethasone or docetaxel 75 mg/m2 IV day 1 with dexamethasone every 21 days. The primary end point was overall survival.
RESULTS: Five hundred seventy-one patients were randomly assigned. Overall response rates were 9.1% and 8.8% (analysis of variance P = .105) for pemetrexed and docetaxel, respectively. Median progression-free survival was 2.9 months for each arm, and median survival time was 8.3 versus 7.9 months (P = not significant) for pemetrexed and docetaxel, respectively. The 1-year survival rate for each arm was 29.7%. Patients receiving docetaxel were more likely to have grade 3 or 4 neutropenia (40.2% v 5.3%; P < .001), febrile neutropenia (12.7% v 1.9%; P < .001), neutropenia with infections (3.3% v 0.0%; P = .004), hospitalizations for neutropenic fever (13.4% v 1.5%; P < .001), hospitalizations due to other drug related adverse events (10.5% v 6.4%; P = .092), use of granulocyte colony-stimulating factor support (19.2% v 2.6%, P < .001) and all grade alopecia (37.7% v 6.4%; P < .001) compared with patients receiving pemetrexed.
CONCLUSION: Treatment with pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer side effects compared with docetaxel in the second-line treatment of patients with advanced NSCLC and should be considered a standard treatment option for second-line NSCLC when available.
Supported by Eli Lilly and Company, Indianapolis, IN.
Presented in part at the 39th annual meeting of the American Society of Clinical Oncology, Chicago, IL, June 2003, and the 10th World Conference on Lung Cancer meeting of the International Association for the Study of Lung Cancer, Vancouver, Canada, August 2003.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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