Health-related quality of life associated with regorafenib treatment in refractory advanced gastric adenocarcinoma

On Behalf Of The Integrate I Investigators

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: The INTEGRATE phase II multinational randomized controlled trial demonstrated the activity of regorafenib on progression-free survival (PFS) in patients with refractory advanced gastric adenocarcinoma. We sought to evaluate whether these PFS gains had the potential to be offset by quality of life (QoL) impacts from treatment side effects and to thereby determine the appropriateness of continuing development to phase III. Methods: QoL was assessed in INTEGRATE at baseline and at each 4 weeks thereafter, until discontinuation of study treatment, using the QLQ-C30, STO22, and EQ-5D questionnaires. The patient disease and treatment assessment (PTDATA) form was also provided to English-speaking participants. Randomized groups were compared on the QLQ-C30, STO22, and EQ-5D scales using a repeated-measures model; the frequency of troublesome symptoms and side effects measured by the PTDATA form; and deterioration-free survival (DFS). The prognostic value of baseline QoL information was also evaluated. Results: Of the 147 eligible randomized patients, 142 consented to participate in the QoL substudy, 136 completed a baseline QoL assessment, and 95 completed at least one post-baseline QoL assessment. The DFS rate was significantly improved with regorafenib, and there was no compelling statistical evidence that regorafenib had a broad negative effect across the spectrum of QoL indices evaluated. Fatigue, anxiety, appetite loss, and pain were among the issues most commonly reported for both randomized groups. Baseline levels of pain, appetite, constipation, and physical functioning were prognostic factors for survival. Conclusions: Regorafenib improved DFS without an excessively negative effect on QoL. Progressing development to the phase III setting is warranted.

Original languageEnglish
Pages (from-to)1-8
Number of pages8
JournalGastric Cancer
DOIs
Publication statusAccepted/In press - 2017 Aug 16

Fingerprint

Stomach
Adenocarcinoma
Quality of Life
Appetite
Therapeutics
Disease-Free Survival
Survival
Pain
regorafenib
Constipation
Fatigue
Survival Rate
Anxiety
Randomized Controlled Trials

Keywords

  • Antineoplastic agents/therapeutic use
  • Protein kinase inhibitors/therapeutic use
  • Quality of life
  • Stomach neoplasms

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology
  • Cancer Research

Cite this

Health-related quality of life associated with regorafenib treatment in refractory advanced gastric adenocarcinoma. / On Behalf Of The Integrate I Investigators.

In: Gastric Cancer, 16.08.2017, p. 1-8.

Research output: Contribution to journalArticle

@article{5454589284b1406b8c5f60a0030ee64d,
title = "Health-related quality of life associated with regorafenib treatment in refractory advanced gastric adenocarcinoma",
abstract = "Background: The INTEGRATE phase II multinational randomized controlled trial demonstrated the activity of regorafenib on progression-free survival (PFS) in patients with refractory advanced gastric adenocarcinoma. We sought to evaluate whether these PFS gains had the potential to be offset by quality of life (QoL) impacts from treatment side effects and to thereby determine the appropriateness of continuing development to phase III. Methods: QoL was assessed in INTEGRATE at baseline and at each 4 weeks thereafter, until discontinuation of study treatment, using the QLQ-C30, STO22, and EQ-5D questionnaires. The patient disease and treatment assessment (PTDATA) form was also provided to English-speaking participants. Randomized groups were compared on the QLQ-C30, STO22, and EQ-5D scales using a repeated-measures model; the frequency of troublesome symptoms and side effects measured by the PTDATA form; and deterioration-free survival (DFS). The prognostic value of baseline QoL information was also evaluated. Results: Of the 147 eligible randomized patients, 142 consented to participate in the QoL substudy, 136 completed a baseline QoL assessment, and 95 completed at least one post-baseline QoL assessment. The DFS rate was significantly improved with regorafenib, and there was no compelling statistical evidence that regorafenib had a broad negative effect across the spectrum of QoL indices evaluated. Fatigue, anxiety, appetite loss, and pain were among the issues most commonly reported for both randomized groups. Baseline levels of pain, appetite, constipation, and physical functioning were prognostic factors for survival. Conclusions: Regorafenib improved DFS without an excessively negative effect on QoL. Progressing development to the phase III setting is warranted.",
keywords = "Antineoplastic agents/therapeutic use, Protein kinase inhibitors/therapeutic use, Quality of life, Stomach neoplasms",
author = "{On Behalf Of The Integrate I Investigators} and Martin, {Andrew J.} and Emma Gibbs and Katrin Sjoquist and Nick Pavlakis and John Simes and Tim Price and Jenny Shannon and Sanjeev Gill and Vikram Jain and Geoffrey Liu and George Kannourakis and Kim, {Yeul Hong} and Kim, {Jin Won} and David Goldstein",
year = "2017",
month = "8",
day = "16",
doi = "10.1007/s10120-017-0754-1",
language = "English",
pages = "1--8",
journal = "Gastric Cancer",
issn = "1436-3291",
publisher = "Springer Japan",

}

TY - JOUR

T1 - Health-related quality of life associated with regorafenib treatment in refractory advanced gastric adenocarcinoma

AU - On Behalf Of The Integrate I Investigators

AU - Martin, Andrew J.

AU - Gibbs, Emma

AU - Sjoquist, Katrin

AU - Pavlakis, Nick

AU - Simes, John

AU - Price, Tim

AU - Shannon, Jenny

AU - Gill, Sanjeev

AU - Jain, Vikram

AU - Liu, Geoffrey

AU - Kannourakis, George

AU - Kim, Yeul Hong

AU - Kim, Jin Won

AU - Goldstein, David

PY - 2017/8/16

Y1 - 2017/8/16

N2 - Background: The INTEGRATE phase II multinational randomized controlled trial demonstrated the activity of regorafenib on progression-free survival (PFS) in patients with refractory advanced gastric adenocarcinoma. We sought to evaluate whether these PFS gains had the potential to be offset by quality of life (QoL) impacts from treatment side effects and to thereby determine the appropriateness of continuing development to phase III. Methods: QoL was assessed in INTEGRATE at baseline and at each 4 weeks thereafter, until discontinuation of study treatment, using the QLQ-C30, STO22, and EQ-5D questionnaires. The patient disease and treatment assessment (PTDATA) form was also provided to English-speaking participants. Randomized groups were compared on the QLQ-C30, STO22, and EQ-5D scales using a repeated-measures model; the frequency of troublesome symptoms and side effects measured by the PTDATA form; and deterioration-free survival (DFS). The prognostic value of baseline QoL information was also evaluated. Results: Of the 147 eligible randomized patients, 142 consented to participate in the QoL substudy, 136 completed a baseline QoL assessment, and 95 completed at least one post-baseline QoL assessment. The DFS rate was significantly improved with regorafenib, and there was no compelling statistical evidence that regorafenib had a broad negative effect across the spectrum of QoL indices evaluated. Fatigue, anxiety, appetite loss, and pain were among the issues most commonly reported for both randomized groups. Baseline levels of pain, appetite, constipation, and physical functioning were prognostic factors for survival. Conclusions: Regorafenib improved DFS without an excessively negative effect on QoL. Progressing development to the phase III setting is warranted.

AB - Background: The INTEGRATE phase II multinational randomized controlled trial demonstrated the activity of regorafenib on progression-free survival (PFS) in patients with refractory advanced gastric adenocarcinoma. We sought to evaluate whether these PFS gains had the potential to be offset by quality of life (QoL) impacts from treatment side effects and to thereby determine the appropriateness of continuing development to phase III. Methods: QoL was assessed in INTEGRATE at baseline and at each 4 weeks thereafter, until discontinuation of study treatment, using the QLQ-C30, STO22, and EQ-5D questionnaires. The patient disease and treatment assessment (PTDATA) form was also provided to English-speaking participants. Randomized groups were compared on the QLQ-C30, STO22, and EQ-5D scales using a repeated-measures model; the frequency of troublesome symptoms and side effects measured by the PTDATA form; and deterioration-free survival (DFS). The prognostic value of baseline QoL information was also evaluated. Results: Of the 147 eligible randomized patients, 142 consented to participate in the QoL substudy, 136 completed a baseline QoL assessment, and 95 completed at least one post-baseline QoL assessment. The DFS rate was significantly improved with regorafenib, and there was no compelling statistical evidence that regorafenib had a broad negative effect across the spectrum of QoL indices evaluated. Fatigue, anxiety, appetite loss, and pain were among the issues most commonly reported for both randomized groups. Baseline levels of pain, appetite, constipation, and physical functioning were prognostic factors for survival. Conclusions: Regorafenib improved DFS without an excessively negative effect on QoL. Progressing development to the phase III setting is warranted.

KW - Antineoplastic agents/therapeutic use

KW - Protein kinase inhibitors/therapeutic use

KW - Quality of life

KW - Stomach neoplasms

UR - http://www.scopus.com/inward/record.url?scp=85027508431&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85027508431&partnerID=8YFLogxK

U2 - 10.1007/s10120-017-0754-1

DO - 10.1007/s10120-017-0754-1

M3 - Article

C2 - 28815316

AN - SCOPUS:85027508431

SP - 1

EP - 8

JO - Gastric Cancer

JF - Gastric Cancer

SN - 1436-3291

ER -