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
Authors
Barlesi, F.Wolf, J.
Ahn, M. J.
Doebele, R. C.
Paz-Ares, L.
Rolfo, C.
Siena, S.
Seto, T.
Ohe, Y.
Ou, S. H. I.
Krebs, Matthew G
Kapre, A.
Piault-Louis, E.
McCallum, S.
Osborne, S.
Aziez, A.
Drilon, A.
Affiliation
Multidisciplinary Oncology & Therapeutic Innovations Department, Aix Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France;Issue Date
2020
Metadata
Show full item recordAbstract
Background: 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.Citation
Barlesi 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.Journal
Annals of OncologyDOI
10.1016/j.annonc.2020.10.379Additional Links
https://dx.doi.org/10.1016/j.annonc.2020.10.379Type
Meetings and ProceedingsLanguage
enae974a485f413a2113503eed53cd6c53
10.1016/j.annonc.2020.10.379