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Updated: Jul 31, 2025
Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer
Published on: February 12, 2017
Phase III Study Comparing Cisplatin Plus Gemcitabine With Cisplatin Plus Pemetrexed in Chemotherapy-Naive Patients
Giorgio Vittorio Scagliotti1, Purvish Parikh1, Joachim von Pawel1
1From 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; Maria Sklodowska-Curie Memorial Institute, Krakow, Poland; National Cancer Institute-Brazil, Rio de Janeiro, Brazil; National Cancer Center, Goyang; Samsung Medical Center, Seoul, South Korea; Herlev University Hospital, Herlev, Denmark; Ege University, Izmir, Turkey; Eli Lilly & Co, Canada, Toronto, Ontario Canada; Eli Lilly & Co, Indianapolis, IN; University of California Davis Cancer Center, Sacramento, CA.
Purpose:
Cisplatin 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 Methods:
This 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/m2 on day 1 and gemcitabine 1,250 mg/m2 on days 1 and 8 (n = 863) or cisplatin 75 mg/m2 and pemetrexed 500 mg/m2 on day 1 (n = 862) every 3 weeks for up to six cycles.
Results:
Overall 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.
Conclusion:
In 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.
