Research Article

Patient-reported outcomes and quality of life in advanced ALK+ non-small-cell lung cancer trial of brigatinib (ALTA)

*Author for correspondence: Tel.: +1 781 960 0239; Fax: +1 781 960 0373;

E-mail Address: william.lenderking@evidera.com

Division of Patient-Centered Research, Evidera, Bethesda, MD 20814, USA

Global Outcomes Research Oncology, Millennium Pharmaceuticals, Inc., Cambridge, MA, 02139, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd, Cambridge, MA, USA

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Rebecca M Speck

Division of Patient-Centered Research, Evidera, Bethesda, MD 20814, USA

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Yanyan Zhu

Global Outcomes Research Oncology, Millennium Pharmaceuticals, Inc., Cambridge, MA, 02139, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd, Cambridge, MA, USA

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Hui Huang

Global Outcomes Research Oncology, Millennium Pharmaceuticals, Inc., Cambridge, MA, 02139, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd, Cambridge, MA, USA

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Joice Huang

Global Outcomes Research Oncology, Millennium Pharmaceuticals, Inc., Cambridge, MA, 02139, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd, Cambridge, MA, USA

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David Kerstein

Global Outcomes Research Oncology, Millennium Pharmaceuticals, Inc., Cambridge, MA, 02139, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd, Cambridge, MA, USA

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Corey J Langer

Global Outcomes Research Oncology, Millennium Pharmaceuticals, Inc., Cambridge, MA, 02139, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd, Cambridge, MA, USA

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Published Online:31 Jul 2019https://doi.org/10.2217/fon-2019-0185

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Abstract

Aim: Patient-reported outcomes (PRO) can support clinically relevant primary end points. Materials & methods: The ALTA trial, an open-label, Phase II, randomized dose-comparison study, evaluated the safety and efficacy of brigatinib in ALK+ non-small-cell lung cancer. PRO data collection included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30). A linear mixed model for repeated measures was used to analyze change from baseline in the Global Health Status/Quality of Life subscale (GHS/QOL), with a change of greater than or equal to ten points deemed meaningful. Results: Improvement in mean GHS/QOL scores was statistically significant in the majority of treatment cycles; <10% of patients experienced a meaningful worsening of their GHS/QOL and symptom scores. Conclusion: PRO-measured benefits are consistent with objective response benefits associated with brigatinib.

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Papers of special note have been highlighted as: • of interest

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Vol. 15, No. 24

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Received 29 March 2019

Accepted 27 June 2019

Published online 31 July 2019

Published in print August 2019

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Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.futuremedicine.com/doi/suppl/10.2217/fon-2019-0185

Author contributions

WR Lenderking, RM Speck, H Huang, J Huang and D Kerstein did conception or design of the work; WR Lenderking, HM Lin, RM Speck, Y Zhu and CJ Langer did acquisition, analysis or interpretation of data for the work; drafting of the work or revising it critically for important intellectual content was done by WR Lenderking, HM Lin, RM Speck, Y Zhu, H Huang, J Huang, D Kerstein and CJ Langer; final approval of the version to be published was given by WR Lenderking, HM Lin, RM Speck, Y Zhu, H Huang, J Huang, D Kerstein and CJ Langer.

Financial & competing interests disclosure

This work was funded by Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd. WR Lenderking and RM Speck are full-time employees of Evidera, which is an outcomes research specialty firm with pharmaceutical and medical device clients. H Lin, Y Zhu, H Huang and J Huang are employees of Millennium Pharmaceuticals, and received restricted stock units. D Kerstein was employed at Millennium Pharmaceuticals at the time of this work. CJ Langer is an employee of the Hospital of the University of Pennsylvania, which has received funding from Takeda Pharmaceuticals to conduct clinical trials. He has received remuneration from Takeda Pharmaceuticals for participation in advisory boards. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The protocol was approved by the local institutional review board or ethics committee at each site, and the study was conducted in accordance with the Declaration of Helsinki and International Council for Harmonisation guidelines for good clinical practice. All patients provided written informed consent.

Data sharing statement

The authors certify that this manuscript reports the secondary analysis of clinical trial data that have been shared with them, and that the use of this shared data is in accordance with the terms (if any) agreed upon their receipt. The source of this data is: NCT02094573

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