Comparing Patient-Reported Outcomes in the CROWN Study

Comparing Patient-Reported Outcomes in the CROWN Study

Patient Advocacy
Jan 30, 2021
ALK Positive Medical Committee

The abstract “Patient-reported outcomes from the randomized Phase 3 CROWN study of first-line lorlatinib versus crizotinib in ALK+ NSCLC” by Mazieres et al., presents a welcome analysis of symptoms and health-related quality of life (QOL) in those patients receiving the ALK inhibitors crizotinib vs. lorlatinib. We at ALK Positive, a patient-directed support and advocacy group, are grateful to the authors for presenting this research. 

The U.S. Food and Drug Administration approval of crizotinib in 2011 was a ground-breaking development for those with lung cancer harboring the ALK gene mutation. People with advanced and metastatic lung cancer, some highly symptomatic at diagnosis, were able to enter treatment with an oral drug and avoid the side effects and lifestyle changes associated with chemotherapy. At the time, perhaps the gratitude for this life-extending drug overshadowed most associated QOL concerns. With the advent of multiple ALK TKIs, and research showing median overall survival for stage IV ALK-positive NSCLC approaching seven years, our group has developed an understandable interest in quality of life and symptom management while being treated with the various ALK inhibitors. 

The abstract suggests that multiple measures of health-related quality of life while taking lorlatinib and crizotinib are not meaningfully different. We are pleased that those receiving lorlatinib do not have to sacrifice quality of life to achieve prolonged progression-free survival. The longer median time to worsening of global QOL of lorlatinib in comparison to crizotinib is a reassuring finding that we suspect is associated with the prolonged PFS associated with lorlatinib. As we share our treatment stories in the ALK Positive Support Group, we find our experiences are consistent with the results presented here. Our group members report the ALK inhibitors are generally well-tolerated, and lorlatinib is no exception.

The recording and analysis of patient-reported outcome tools has an important role in ALK-positive NSCLC research. We can imagine that patient-reported outcomes could even be a deciding factor in choosing between two otherwise equally effective treatments. We look forward to the authors’ additional analysis of this data. 

ALK Positive, through fundraising partnerships with LUNGevity and GO2, has, within the past 3 years, awarded $2,800,000 in grants to fund pre-clinical and clinical research. In our next venture, ALK Positive will be launching an IRB-approved, longitudinal, real-world, patient-reported outcomes survey.  The survey will generate data from QOL validated instruments that will be correlated with various ALK-positive NSCLC treatments and medications.