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Overall Survival Benefit of Crizotinib in Patients With ALK-Positive NSCLC

By: Joseph Fanelli
Posted: Monday, July 23, 2018

Based on the final overall survival results of the phase III PROFILE 1014 trial, first-line crizotinib showed a survival benefit in patients with advanced ALK-positive non–small cell lung cancer (NSCLC) versus chemotherapy. The study, published in the Journal of Clinical Oncology, supports the prior primary analysis findings showing prolonged progression-free survival with crizotinib.

“The final analysis of the PROFILE 1014 study provides a new benchmark for [overall survival] in patients with ALK-rearranged non–small cell lung cancer and highlights the benefit of crizotinib for prolonging survival in this patient population,” concluded lead author Benjamin J. Solomon, MBBS, PhD, of the Peter MacCallum Cancer Centre in Melbourne, Australia, and colleagues.

In the phase III trial, 172 patients were randomized to receive 250 mg of crizotinib twice daily, and 171 patients received chemotherapy with pemetrexed plus cisplatin or carboplatin. Crossover to crizotinib was permitted after disease progression.

The median follow-up for overall survival was about 46 months for both arms. After 4 years, overall survival in the crizotinib cohort was 56.6% and 49.1% in the chemotherapy group. After adjustment for crossover to crizotinib treatment, the former group displayed an overall survival benefit (hazard ratio of 0.346). The median overall survival was not reached for 57 patients in the crizotinib population who received at least one ALK inhibitor in subsequent treatment.

Finally, before first-line therapy is started, Dr. Solomon and colleagues noted the importance of screening all patients with nonsquamous NSCLC for ALK rearrangement status, given their study data.



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