Wilner, Pfizer Oncology, La Jolla, CA and Fiona Blackhall, Manchester University, and Christie Hospital National Health Service Foundation Trust, Manchester, United Kingdom. Mok, The Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China Kazuhiko Nakagawa, Kindai University Faculty of Medicine, Osaka, Japan Tarek Mekhail, Florida Hospital, Orlando, FL Enriqueta Felip, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain Federico Cappuzzo, Azienda Unità Sanitaria Locale Della Romagna, Ravenna Jolanda Paolini and Tiziana Usari, Pfizer Oncology, Milan, Italy Yiyun Tang and Keith D. Solomon, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia Dong-Wan Kim, Seoul National University Hospital, Seoul, Republic of Korea Yi-Long Wu, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou Tony S.
Conclusion The final analysis of the PROFILE 1014 study provides a new benchmark for OS in patients with ALK-rearranged non-small-cell lung cancer and highlights the benefit of crizotinib for prolonging survival in this patient population. The longest OS was observed in crizotinib-treated patients who received a subsequent ALK tyrosine kinase inhibitor.
After crossover adjustment, there was an improvement in OS that favored crizotinib (hazard ratio, 0.346 95% bootstrap CI, 0.081 to 0.718). Median OS was not reached (NR) with crizotinib (95% CI, 45.8 months to NR) and 47.5 months with chemotherapy (95% CI, 32.2 months to NR). In the chemotherapy arm, 144 patients (84.2%) received crizotinib in subsequent lines. Results Median follow-up duration for OS was approximately 46 months for both arms. OS was analyzed using a stratified log-rank test and a prespecified rank-preserving structural failure time model to account for crossover. Crossover to crizotinib was permitted after disease progression.
Patients and Methods Patients were randomly assigned to receive oral crizotinib 250 mg twice daily (n = 172) or intravenous pemetrexed 500 mg/m 2 plus cisplatin 75 mg/m 2 or carboplatin (area under the concentration-time curve of 5 to 6 mg
Here, we report the final overall survival (OS) results.
Purpose The phase III PROFILE 1014 trial compared crizotinib with chemotherapy as first-line treatment in patients with anaplastic lymphoma kinase (ALK) -positive advanced nonsquamous non-small-cell lung cancer.