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Adding Gemcitabine to Paclitaxel/Carboplatin Combination Increases Survival in Advanced Non–Small-Cell Lung Cancer: Results of a Phase II-III Study

From the Medical Oncology Department, Venezia; Medical Oncology Department, Centro Riferimento Oncologico, Aviano; Medical Oncology Department, Azienda Ospedaliera, Padova; Medical Oncology Department, San Giuseppe Hospital, Milano; Medical Oncology Department, Policlinico Universitario Modena; General Medicine Department, Pavia; Cardio-Thoracic Department, Universita di Pisa, Pisa; Oncology Department, Istituto di Ricerca e Cura a Caratiere Scientifico San Raffaele, Milano; Medical Oncology Department, Pordenone; Medical Oncology Department, Forlì; Institute for Scientific Intercharge Foundation, Torino, Italy; for the Gruppo di Studio Tumori Polmonari del Veneto (GSTPV)

Address reprint requests to Adriano Paccagnella, MD, Medical Oncology Department, SS Giovanni and Paolo Hospital, Via Circonvallazione 50, 30174 Mestre-Venezia, Italy; e-mail: adriano.paccagnella{at}ulss12.ve.it

PURPOSE: Paclitaxel/carboplatin (PC) is one of the reference combinations in the treatment of non–small-cell lung cancer (NSCLC). No triplet novel agent combination has until now shown superiority over a two-drug combination for advanced NSCLC. We therefore conducted a clinical trial to test if paclitaxel/carboplatin/gemcitabine (PCG) increases overall survival (OS) and response rate (RR) over PC.

METHODS: Stage IIIB patients not suitable for radical radiation treatment and stage IV chemotherapy-naive patients with measurable disease and performance status of 0 to 2 were randomly assigned to PC arm (paclitaxel 200 mg/m² and carboplatin area under the concentration-time curve 6 day 1/q21 days) or the PCG arm (paclitaxel 200 mg/m² and carboplatin area under the concentration-time curve 6 day 1, and gemcitabine 1,000 mg/m² days 1 and 8 every 21 days).

RESULTS: A total of 324 patients were randomly assigned to the two arms. The RR for PC arm and PCG arm were 20.2% and 46% (P < .0001). The median time to the progression was 5.1 months in the PC group and 7.6 months in the PCG group (P = .012; hazard ratio [HR] 1.34; 95% CI: 1.06 to 1.72). Median OS was 8.3 months and 10.8 months (P = .032; HR 1.309; 95% CI: 1.03 to 1.67) in favor of the PCG arm. One-year survival was 34% (PC arm) and 45% (PCG arm; P = .032). Only hematologic toxicity (neutropenia, thrombocytopenia, and anemia) was significantly increased in the PCG arm and the experimental arm required more platelet and red blood cell transfusions, and more granulocyte colony-stimulating factor usage. No toxic/early deaths were observed.

CONCLUSION: The PCG regimen offers a significant survival advantage over PC in advanced NSCLC, making PCG a treatment option for advanced NSCLC patients.

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

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