Phase III Study Comparing Cisplatin Plus Gemcitabine With Cisplatin Plus Pemetrexed in Chemotherapy-Naive Patients With Advanced-Stage Non–Small-Cell Lung Cancer

Author:

Scagliotti Giorgio Vittorio1,Parikh Purvish1,von Pawel Joachim1,Biesma Bonne1,Vansteenkiste Johan1,Manegold Christian1,Serwatowski Piotr1,Gatzemeier Ulrich1,Digumarti Raghunadharao1,Zukin Mauro1,Lee Jin S.1,Mellemgaard Anders1,Park Keunchil1,Patil Shehkar1,Rolski Janusz1,Goksel Tuncay1,de Marinis Filippo1,Simms Lorinda1,Sugarman Katherine P.1,Gandara David1

Affiliation:

1. From the University of Torino, Orbassano; San Camillo-Forlanini Hospitals, Rome, Italy; Tata Memorial Hospital, Mumbai; Nizam's Institute of Medical Sciences, Hyderabad; Bangalore Institute of Oncology, Bangalore, India; Asklepios-Fachkliniken Munchen, Gauting; Heidelberg University Medical Center, Mannheim; Hospital Grosshansdorf, Grosshansdorf, Germany; Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, the Netherlands; University Hospital Gasthuisberg, Leuven, Belgium; Specjalistyczny Szpital Im, Szczecin;...

Abstract

PurposeCisplatin plus gemcitabine is a standard regimen for first-line treatment of advanced non–small-cell lung cancer (NSCLC). Phase II studies of pemetrexed plus platinum compounds have also shown activity in this setting.Patients and MethodsThis noninferiority, phase III, randomized study compared the overall survival between treatment arms using a fixed margin method (hazard ratio [HR] < 1.176) in 1,725 chemotherapy-naive patients with stage IIIB or IV NSCLC and an Eastern Cooperative Oncology Group performance status of 0 to 1. Patients received cisplatin 75 mg/m2on day 1 and gemcitabine 1,250 mg/m2on days 1 and 8 (n = 863) or cisplatin 75 mg/m2and pemetrexed 500 mg/m2on day 1 (n = 862) every 3 weeks for up to six cycles.ResultsOverall survival for cisplatin/pemetrexed was noninferior to cisplatin/gemcitabine (median survival, 10.3 v 10.3 months, respectively; HR = 0.94; 95% CI, 0.84 to 1.05). Overall survival was statistically superior for cisplatin/pemetrexed versus cisplatin/gemcitabine in patients with adenocarcinoma (n = 847; 12.6 v 10.9 months, respectively) and large-cell carcinoma histology (n = 153; 10.4 v 6.7 months, respectively). In contrast, in patients with squamous cell histology, there was a significant improvement in survival with cisplatin/gemcitabine versus cisplatin/pemetrexed (n = 473; 10.8 v 9.4 months, respectively). For cisplatin/pemetrexed, rates of grade 3 or 4 neutropenia, anemia, and thrombocytopenia (P ≤ .001); febrile neutropenia (P = .002); and alopecia (P < .001) were significantly lower, whereas grade 3 or 4 nausea (P = .004) was more common.ConclusionIn advanced NSCLC, cisplatin/pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. This is the first prospective phase III study in NSCLC to show survival differences based on histologic type.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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