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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
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.
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.
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Abstract
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.
Description
Date
2020
Publisher
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Keywords
Type
Meetings and Proceedings
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.