Patient-reported results from the Phase III CROWN trial showed that the time to treatment deterioration (TTD) for chest pain, shortness of breath, and cough was comparable between those taking lorlatinib and those taking crizotinib. The research was presented today at the International Association for the Study of Lung Cancer's 2020 World Conference in Singapore.
Lorlatinib, a third generation ALK inhibitor, significantly improved progression-free survival compared to crizotinib in patients with previously untreated advanced ALK-positive NSCLC.
Dr. Julien Mazieres from Toulouse University Hospital in Toulouse, France presented the detailed results of the Patient Reported Results (PROs) from the same study.
CROWN enrolled 296 patients with ALK + NSCLC and randomly assigned each to receive either lorlatinib or crizotinib. PROs were assessed using the EORTC QLQ-C30 and QLQ-LC13, and EQ-5D-5L – ratings used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. Each patient completed an assessment on the first day of each cycle (28 days) until the end of treatment. Dr. Mazieres and her team measured the time to treatment worsening (TTD) for chest pain, shortness of breath and cough and compared these results between the two treatment arms.
Graduation rates were 100% at the start of the course and remained high (
According to Dr. Mazieres showed statistically significant but not clinically meaningful differences that favored lorlatinib in symptoms of fatigue, nausea and vomiting, insomnia, loss of appetite, and constipation. In diarrhea, there was both a clinically meaningful and a statistically significant difference in favor of lorlatinib.
Lung cancer symptoms improved from baseline in both treatment arms, with clinically meaningful improvements in cough already occurring in cycle 2 and sustained through cycle 18. The TTD on the composite endpoint of lung cancer symptoms (cough, shortness of breath, or chest pain) was similar between these treatment arms (HR 1.09; 95% CI: 0.82-1.44; 2-sided p = 0.5415). The median time to global quality of life deterioration was 24.0 months for lorlatinib and 12.0 months for crizotinib (HR 0.92; 95% CI 0.65-1.29).
"The time to treatment for lung cancer symptoms worsening was comparable between the treatment arms. (Patients receiving lorlatinib) had early improvements in lung cancer symptoms and clinically meaningful improvements in cough," said Dr. Mazieres.
"Phase III CROWN patient reported results support the improved PFS and are consistent with the safety / tolerability of lorlatinib compared to crizotinib."
Early treatment with lorlatinib improves the survival of some lung cancer patients
International Association for Research into Lung Cancer
Patient-reported results from Phase III randomized CROWN study of first-choice lorlatinib versus ALK + NSCLC (2021, Jan 31)
accessed on January 31, 2021
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