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 language | English |
|---|---|
| Pages (from-to) | 1-8 |
| Number of pages | 8 |
| Journal | Gastric Cancer |
| DOIs | |
| Publication status | Accepted/In press - 2017 Aug 16 |
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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 journal › Article
}
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 -