(Singapore – January 31, 2021 2:40 pm SPT 1:40 am EST) – Patient-reported results from a phase III CROWN study showed that there was time to treat a decline (TTD) in chest pain, dyspnea , and cough compared those who received lorlatinib and patients who took crizotinib. The research was presented today at the 2020 International Conference of the International Association for the Study of Lung Cancer in Singapore Lung Cancer.
Lorlatinib, a third-generation ALK inhibitor, significantly improved survival without improvement compared with crizotinib in patients with ALK-positive progressive NSCLC.
Dr. Julien Mazieres, of Toulouse University Hospital, in Toulouse, France presented detailed results of patient-reported outcomes (PROs) from his same study.
CROWN enrolled 296 patients with ALK + NSCLC and all were randomly assigned to receive lorlatinib or crizotinib. PROs were evaluated using EORTC QLQ-C30 and QLQ-LC13, and the EQ-5D-5L – assessments used to measure health-related quality of life (QOL) of cancer patients participating in the international clinical trials. All patients completed an evaluation on the first day of each cycle (28 days) through the end of treatment. Dr. Mazieres and her team measured time to treat dementia (TTD) in chest pain, dyspnea, and cough and compared these results between the two treatment arms.
Baseline completion rates were 100% and remained high (? 96%) through a circle of 18 in each treatment arm. There were no clinically or statistically significant differences between manipulative arms in any functional area, with numerical improvements favoring lorlatinib in the physical, occupational, emotional, and social activity scales, and numerical improvement in favor of crizotinib for activity mental.
According to Dr. Mazieres, differences were statistically significant, but not clinically significant, favoring lorlatinib in symptoms of obesity, nausea and vomiting, insomnia, loss of appetite, and constipation. For diarrhea there was both a clinically significant and statistically significant difference in favor of lorlatinib.
Baseline lung cancer symptoms improved in both treatment arms, with clinical improvements in cough as early as Cycle 2 and maintained through Circle 18. TTD was at the end of lung cancer symptoms (cough, dyspnea, or chest pain) similar between manipulative arms (HR 1.09; 95% CI: 0.82–1.44; 2-sided p = 0.5415). The median time to worsen global QOL was 24.0 months for lorlatinib and 12.0 months for crizotinib (HR 0.92; 95% CI 0.65–1.29).
“The time to treat a decline for lung cancer symptoms was comparable to treatment arms. Improvements in lung cancer symptoms were seen early and clinical improvements in cough were found in [patients who received] lorlatinib, “Dr. Mazieres reported.
“Outcomes reported by patients in CROWN phase III support the improved PFS and are consistent with the safety / tolerability of lorlatinib compared with crizotinib.”
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The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association’s membership includes nearly 7,500 lung cancer specialists across all disciplines in more than 100 countries, creating a global network working together to overcome lung and thoracic cancers all over the world. The association also publishes the Journal of Thoracic Oncology, the leading educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancy. Visit http: // www.
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