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Clinical Trial
. 2021 Aug;6(4):100189.
doi: 10.1016/j.esmoop.2021.100189. Epub 2021 Aug 7.

Quality of life with first-line pembrolizumab for PD-L1-positive advanced gastric/gastroesophageal junction adenocarcinoma: results from the randomised phase III KEYNOTE-062 study

E Van Cutsem  1 , A Valderrama  2 , Y-J Bang  3 , C S Fuchs  4 , K Shitara  5 , Y Y Janjigian  6 , S Qin  7 , T G Larson  8 , V Shankaran  9 , S Stein  4 , J M Norquist  2 , U Kher  10 , S Shah  10 , M Alsina  11
Affiliations
Clinical Trial

Quality of life with first-line pembrolizumab for PD-L1-positive advanced gastric/gastroesophageal junction adenocarcinoma: results from the randomised phase III KEYNOTE-062 study

E Van Cutsem et al. ESMO Open. 2021 Aug.

Abstract

Background: In the randomised phase III KEYNOTE-062 study, pembrolizumab was non-inferior to chemotherapy for overall survival in patients with programmed death-ligand 1 (PD-L1)-positive [combined positive score (CPS) ≥1] advanced gastric/gastroesophageal junction (GEJ) cancer. We present findings of prespecified health-related quality-of-life (HRQOL) analyses for pembrolizumab versus chemotherapy in this population.

Materials and methods: HRQOL, a secondary endpoint, was measured in patients who received ≥1 dose of study treatment and completed ≥1 HRQOL questionnaire [European Organisation for the Research and Treatment of Cancer (EORTC) 30-question quality-of-life (QLQ-C30), EORTC 22-question quality-of-life gastric-cancer-specific module (QLQ-STO22)]. Least squares mean (LSM) change (baseline to week 18) in global health status/quality of life (GHS/QOL; EORTC QLQ-C30) and time to deterioration (TTD) in GHS/QOL, nausea/vomiting and appetite loss scores (EORTC QLQ-C30) and abdominal pain/discomfort scores (EORTC QLQ-STO22) were evaluated.

Results: The HRQOL population comprised 495 patients with CPS ≥1 (pembrolizumab, 252; chemotherapy, 243). Compliance rates at week 18 were similar for pembrolizumab and chemotherapy (EORTC QLQ-C30, 87.9% and 81.9%; EORTC QLQ-STO22, 87.9% and 81.3%, respectively). There was no between-arm difference in LSM score change in GHS/QOL [-0.16; 95% confidence interval (CI) -5.01 to 4.69; P = 0.948]. The LSM score change for most subscales showed comparable worsening in both arms. TTD for GHS/QOL [hazard ratio (HR), 0.96; 95% CI, 0.67-1.38; P = 0.826], appetite loss (HR, 0.83; 95% CI, 0.58-1.20; P = 0.314) and pain (HR, 1.22; 95% CI, 0.78-1.91; P = 0.381) were similar between arms. Longer TTD was observed for pembrolizumab versus chemotherapy for nausea/vomiting (HR, 0.61; 95% CI, 0.44-0.85; P = 0.003).

Conclusions: HRQOL was maintained with first-line treatment with pembrolizumab in patients with PD-L1-positive advanced gastric/GEJ cancer and was similar between pembrolizumab and chemotherapy in this population.

Keywords: gastric cancer; gastroesophageal cancer; patient-reported outcomes; pembrolizumab; quality of life.

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Conflict of interest statement

Disclosure EVC reports advisory/consultancy fees from Array, AstraZeneca, Bayer, BioPharma, Bristol Myers Squibb, Celgene, Halozyme, Lilly, Merck KGaA, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Novartis, Roche and Servier; and researching grant/funding (institution) from Amgen, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Ipsen, Lilly, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA., Merck KGaA, Novartis, Roche and Servier. AV is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Y-JB reports consulting/advisory role for Astellas, AstraZeneca, Bayer, BeiGene, Bristol Myers Squibb, Daichii-Sankyo, Eli Lilly, Genentech/Roche, Genexine, Green Cross, Hanmi, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Merck Serono, Novartis, Samyang Biopharmaceuticals and Taiho; and grants (to the institution for clinical trials) from Astellas, AstraZeneca, Bayer, BeiGene, Bristol Myers Squibb, Boehringer Ingelheim, Boston Biomedical, CKD Pharma, Curis, Daiichi Sankyo, Eli Lilly, Five Prime, Genentech/Roche, Genexine, Green Cross, GSK, MacroGenics, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Merck Serono, Novartis, Ono, Pfizer, Taiho and Takeda. CSF reports consulting role for Agios, Amylin Pharmaceuticals, Bain Capital, CytomX Therapeutics, Daiichi Sankyo, Eli Lilly, Entrinsic Health, EvolveImmune Therapeutics, Genentech, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Taiho and Unum Therapeutics. He also serves as a director for CytomX Therapeutics and owns unexercised stock options for CytomX and Entrinsic Health. He is a co-founder of EvolveImmune Therapeutics and has equity in this private company. KS reports grants and personal fees from Astellas Pharma, Eli Lilly and Company, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Ono Pharmaceutical and Taiho Pharmaceutical; personal fees from AbbVie, Bristol Myers Squibb, GlaxoSmithKline, Novartis, Pfizer Inc., Takeda Pharmaceuticals and Yakult; and grants from Chugai Pharma, Daiichi Sankyo, Dainippon Sumitomo Pharma and Medi Science. YYJ reports advisory fees from Bristol Myers Squibb, Lilly, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Merck Serono and Pfizer; and research expenses from Amgen, Bayer, Boehringer Ingelheim, Genentech, Lilly and Roche. VS reports research funding from Bristol Myers Squibb, EMD-Serono and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. SSt reports advisory/consultancy role for Bayer, Bristol Myers Squibb, Exelixis, Genentech, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and QED. JMN is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. UK is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. SSh is an employee and a stockholder of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. MA reports scientific consultancy role for Bristol Myers Squibb, Lilly, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Servier; and honoraria for speaking for Bristol Myers Squibb, Lilly, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Servier. All other authors have declared no conflicts of interest.

Figures

Figure 1
Figure 1
LSM (95% CI) change from baseline to week 18 in (A) EORTC QLQ-C30 GHS/QOL and functional subscale scores, (B) EORTC QLQ-C30 symptom subscale scores and (C) EORTC QLQ-STO22 symptom subscale scores. CI, confidence interval; GHS, global health status; LSM, least squares mean; EORTC QLQ-C30, European Organisation for the Research and Treatment of Cancer core 30 quality-of-life questionnaire; EORTC QLQ-STO22, European Organisation for the Research and Treatment of Cancer 22-question quality-of-life gastric cancer-specific module; QOL, quality of life.
Figure 2
Figure 2
Mean (±SE) change from baseline by study visit in (A) EORTC QLQ-C30 GHS/QOL scores, (B) EORTC QLQ-C30 symptom subscale nausea/vomiting scores, (C) EORTC QLQ-C30 subscale appetite loss scores and (D) EORTC QLQ-STO22 symptom pain subscale scores. Parts C and D are continued on next page. GHS, global health status; EORTC QLQ-C30, European Organisation for the Research and Treatment of Cancer core 30 quality-of-life questionnaire; EORTC QLQ-STO22, European Organisation for the Research and Treatment of Cancer 22-question quality-of-life gastric cancer-specific module; QOL, quality of life; SE, standard error.
Figure 2
Figure 2
Mean (±SE) change from baseline by study visit in (A) EORTC QLQ-C30 GHS/QOL scores, (B) EORTC QLQ-C30 symptom subscale nausea/vomiting scores, (C) EORTC QLQ-C30 subscale appetite loss scores and (D) EORTC QLQ-STO22 symptom pain subscale scores. Parts C and D are continued on next page. GHS, global health status; EORTC QLQ-C30, European Organisation for the Research and Treatment of Cancer core 30 quality-of-life questionnaire; EORTC QLQ-STO22, European Organisation for the Research and Treatment of Cancer 22-question quality-of-life gastric cancer-specific module; QOL, quality of life; SE, standard error.
Figure 3
Figure 3
Proportion of patients with deteriorated EORTC QLQ-C30 and EORTC QLQ-STO22 scores at week 18. GHS, global health status; EORTC QLQ-C30, European Organisation for the Research and Treatment of Cancer core 30 quality-of-life questionnaire; EORTC QLQ-STO22, European Organisation for the Research and Treatment of Cancer 22-question quality-of-life gastric cancer-specific module; QOL, quality of life.
Figure 4
Figure 4
TTD in (A) EORTC QLQ-C30 GHS/QOL, (B) EORTC QLQ-C30 nausea/vomiting subscale, (C) EORTC QLQ-C30 appetite loss subscale and (D) EORTC QLQ-STO22 pain subscale. Parts C and D are continued on next page. CI, confidence interval; GHS, global health status; NR, not reached; EORTC QLQ-C30, European Organisation for the Research and Treatment of Cancer core 30 quality-of-life questionnaire; EORTC QLQ-STO22, European Organisation for the Research and Treatment of Cancer 22-question quality-of-life gastric cancer-specific module; QOL, quality of life; TTD, time to deterioration; -, the median was not reached. a From product-limit (Kaplan–Meier) method for censored data. b Based on stratified Cox regression model with treatment as a covariate. c Two-sided P value based on stratified log-rank test.
Figure 4
Figure 4
TTD in (A) EORTC QLQ-C30 GHS/QOL, (B) EORTC QLQ-C30 nausea/vomiting subscale, (C) EORTC QLQ-C30 appetite loss subscale and (D) EORTC QLQ-STO22 pain subscale. Parts C and D are continued on next page. CI, confidence interval; GHS, global health status; NR, not reached; EORTC QLQ-C30, European Organisation for the Research and Treatment of Cancer core 30 quality-of-life questionnaire; EORTC QLQ-STO22, European Organisation for the Research and Treatment of Cancer 22-question quality-of-life gastric cancer-specific module; QOL, quality of life; TTD, time to deterioration; -, the median was not reached. a From product-limit (Kaplan–Meier) method for censored data. b Based on stratified Cox regression model with treatment as a covariate. c Two-sided P value based on stratified log-rank test.
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References

    1. Bray F., Ferlay J., Soerjomataram I., Siegel R.L., Torre L.A., Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68:394–424. - PubMed
    1. Casamayor M., Morlock R., Maeda H., Ajani J. Targeted literature review of the global burden of gastric cancer. Ecancermedicalscience. 2018;12:883. - PMC - PubMed
    1. National Comprehensive Cancer Network NCCN clinical practice guidelines in oncology (NCCN guidelines): gastric cancer (Version 4.2020) https://www.nccn.org/professionals/physician_gls/pdf/gastric.pdf Available at. - PubMed
    1. Smyth E.C., Verheij M., Allum W., Cunningham D., Cervantes A., Arnold D. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl 5):v38–v49. - PubMed
    1. Japanese Gastric Cancer Association Japanese gastric cancer treatment guidelines 2018 (5th ed.) Gastric Cancer. 2021;24:1–21. - PMC - PubMed

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