medwireNews: More than half of the latest evaluated participants from the ongoing phase II PROFILE 1005 trial of crizotinib against ALK (anaplastic lymphoma kinase gene)-positive advanced non-small-cell lung cancer (NSCLC), achieved an objective tumor response, report researchers.
After a median 25 weeks of twice-daily crizotinib 250 mg in 3-week cycles, 53% of the 255 patients in the study who were evaluable for tumor response as of June 2011 had achieved this milestone according to Response Evaluation Criteria in Solid Tumors (RECIST), report the researchers.
The first-in-class, oral, small-molecule competitive ALK-inhibitor also had a good tolerability profile, said co-author Gregory Riely (Memorial Sloan-Kettering Cancer Center, New York, USA), in a statement to the press. Just over 6% of the 439 NSCLC patients with available safety data experienced a serious adverse event such as dyspnea.
"Crizotinib continued to show a good safety profile in patients with previously treated ALK-positive advanced NSCLC," said Riely. "Quality-of-life data showed clinically meaningful improvement in global quality of life and in lung cancer symptoms, such as fatigue, cough, dyspnea, and chest pain," he added.
Riely presented the findings at the 2012 Multidisciplinary Symposium in Thoracic Oncology in Chicago, Illinois, USA.
The PROFILE 1055 cohort is aged a median of 53 years and each patient has undergone at least two failed chemotherapy regimens prior to entry into the trial. Riley and colleagues observed a median 11 months duration of response, with a median disease progression-free survival of just over 8 months at this latest follow up.
The majority of treatment-related adverse effects reported were low-grade 1 or 2 (on the Common Terminology Criteria for Adverse Events scale), with visual effects the most commonly reported, at 50%, followed by nausea, at 46%, vomiting, at 39%, and diarrhea, at 35%.
In all, 12 patients experienced serious adverse events, including dyspnea (n=4), pneumonitis (n=4), febrile neutropenia (n=2), and renal cysts (n=2).
"These results provide strong evidence for crizotinib as a standard of care for advanced ALK-positive NSCLC," concludes the research team.
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