Patient reported outcomes (PROs) analysis for patients with ROS1 fusion-positive (ROS1+) non-small cell lung cancer (NSCLC) receiving entrectinib in the global phase II STARTRK-2 study
Ahn, M. J.
Doebele, R. C.
Ou, S. H. I.
Krebs, Matthew G
AffiliationMultidisciplinary Oncology & Therapeutic Innovations Department, Aix Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France;
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AbstractBackground: In the ongoing STARTRK-2 study (NCT02568267), entrectinib demonstrated a favourable efficacy and safety profile in patients with locally advanced/ metastatic ROS1+ NSCLC. We present the results of a pre-specified PRO analysis in an updated dataset with longer follow-up. Methods: The European Organization for Research and Treatment of Cancer quality of life questionnaire (QLQ-C30), and lung cancer module (QLQ-LC13) were completed prior to entrectinib dosing on Day 1 of every treatment cycle, and at end of treatment. The safety analysis set (SAS; patients received 1 entrectinib dose) was used to assess treatment-related symptoms. The efficacy analysis set (EAS; SAS patients with measurable baseline disease) was used to assess tumor-related symptoms, functioning and global health status (GHS). Results: At the data cut-off (1 May 2019), the SAS and EAS included 180 and 145 patients, respectively. GHS and functioning scores were maintained or improved during treatment, with the exception of cognitive functioning (Table). Tumor-related symptoms remained stable or trended towards improvement over time. For treatment- related symptoms, insomnia and appetite loss improved, while constipation and diarrhea worsened. Conclusions:Among ROS1+ NSCLC patients, the treatment burden associated with entrectinib was minimal. There was a trend towards improved physical and role functioning, GHS, and tumor-related symptoms (particularly cough) while receiving entrectinib.
CitationBarlesi F, Wolf J, Ahn MJ, Doebele RC, Paz-Ares L, Rolfo C, et al. 385P Patient reported outcomes (PROs) analysis for patients with ROS1 fusion-positive (ROS1+) non-small cell lung cancer (NSCLC) receiving entrectinib in the global phase II STARTRK-2 study. Annals of Oncology. 2020;31:S1391-S2.
JournalAnnals of Oncology
TypeMeetings and Proceedings