Originally published as JCO Early Release 10.1200/JCO.2008.20.9114 on May 11 2009

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Phase III Study by the Norwegian Lung Cancer Study Group: Pemetrexed Plus Carboplatin Compared With Gemcitabine Plus Carboplatin As First-Line Chemotherapy in Advanced Non–Small-Cell Lung Cancer

From the Departments of Cancer Research and Molecular Medicine and Circulation and Medical Imaging, Norwegian University of Science and Technology; Departments of Oncology and Pulmonology, St Olavs Hospital, Trondheim; Departments of Oncology and Pulmonology, University Hospital of North Norway; Institute of Clinical Medicine, University of Tromsø, Tromsø; Department of Thoracic Medicine, Haukeland University Hospital; Institute of Medicine, University of Bergen, Bergen; Cancer Clinic, Rikshospitalet – Radiumhospitalet Medical Center, University of Oslo; Department of Pulmonology, Ullevål University Hospital, Oslo; Department of Internal Medicine, Bodø Hospital, Bodø; and Department of Internal Medicine, Ålesund Hospital, Ålesund, Norway.

Corresponding author: Bjørn H. Grønberg, MD, 3. etg, Gastro Sør, St. Olavs Hospital, NO-7006 Trondheim, Norway; e-mail: bjorn.h.gronberg{at}gmail.com.

Purpose To compare pemetrexed/carboplatin with a standard regimen as first-line therapy in advanced non–small-cell lung cancer NSCLC.

Patients and Methods Patients with stage IIIB or IV NSCLC and performance status of 0 to 2 were randomly assigned to receive pemetrexed 500 mg/m² plus carboplatin area under the curve (AUC) = 5 (Calvert's formula) on day 1 or gemcitabine 1,000 mg/m² on days 1 and 8 plus carboplatin AUC = 5 on day 1 every 3 weeks for up to four cycles. The primary end point was health-related quality of life (HRQoL) defined as global quality of life, nausea/vomiting, dyspnea, and fatigue reported on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and the lung cancer–specific module LC13 during the first 20 weeks. Secondary end points were overall survival and toxicity.

Results Four hundred thirty-six eligible patients were enrolled from April 2005 to July 2006. Patients who completed the baseline questionnaire were analyzed for HRQoL (n = 427), and those who received one cycle of chemotherapy were analyzed for toxicity (n = 423). Compliance of HRQoL questionnaires was 87%. There were no significant differences for the primary HRQoL end points or in overall survival between the two treatment arms (pemetrexed/carboplatin, 7.3 months; gemcitabine/carboplatin, 7.0 months; P = .63). The patients who received gemcitabine/carboplatin had more grade 3 to 4 hematologic toxicity than patients who received pemetrexed/carboplatin, including leukopenia (46% v 23%, respectively; P < .001), neutropenia (51% v 40%, respectively; P = .024), and thrombocytopenia (56% v 24%, respectively; P < .001). More patients on the gemcitabine/carboplatin arm received transfusions of RBCs and platelets, whereas the frequencies of neutropenic infections and thrombocytopenic bleedings were similar on both arms.

Conclusion Pemetrexed/carboplatin provides similar HRQoL and survival when compared with gemcitabine/carboplatin with less hematologic toxicity and less need for supportive care.

Supported in part by an unrestricted grant from Eli Lilly.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL; and the International Association for the Study of Lung Cancer 12th World Conference on Lung Cancer, September 2-6, 2007, Seoul, Korea.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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