Health-related quality of life (HRQoL) impact of pembrolizumab (P) versus chemotherapy (C) as first-line (1L) treatment in PD-L1–positive advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma

Cutsem, Éric Van; Valderrama, Adriana; Bang, Yung‐Jue; Fuchs, Christiane; Shitara, K.; Janjigian, Yelena Y.; Qin, Shukui; Larson, T. A.; Shankaran, Veena; Stein, Steven; Norquist, Josephine M.; Kher, Uma; Shah, Shimul A.; Alsina, María

doi:10.1093/annonc/mdz394.036

Cited by 6 publications

(13 citation statements)

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“…Thirty-four RCTs, enrolling a total of 18 709 patients, were included in the analysis (eFigure in the Supplement; Table ). Twenty-one studies 22,25,30,31,34,40,41,[43][44][45][46][47][48][49][50][51][52][53][54][55][56][57] investigated PROs in the first-line setting, and 13 studies 23,24,[26][27][28][29]32,33,[35][36][37][38][39]42 explored PROs in lines beyond first. Nineteen trials tested ICIs as monotherapy, 8 trials [43][44][45][46][47][48][49][50] evaluated the combination of ICIs with chemotherapy, and 8 trials [51][52][53][54]…”

Section: Resultsmentioning

confidence: 99%

“…Thirty-four RCTs, enrolling a total of 18 709 patients, were included in the analysis (eFigure in the Supplement ; Table ). 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 Twenty-one studies 22 , 25 , 30 , 31 , 34 , 40 , 41 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 investigated PROs in the first-line settin...…”

Section: Resultsmentioning

confidence: 99%

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Association of Anticancer Immune Checkpoint Inhibitors With Patient-Reported Outcomes Assessed in Randomized Clinical Trials

et al. 2022

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ImportanceThe association of immune checkpoint inhibitors (ICIs) with patient quality of life has been poorly explored.ObjectiveTo evaluate patient-reported outcomes (PROs) assessed in randomized clinical trials (RCTs) of immunotherapy-based treatments.Data SourcesThis systematic review and random-effects meta-analysis used RCTs identified in PubMed, MEDLINE, Embase, and Scopus from database inception to June 1, 2021.Study SelectionA total of 2259 RCTs were identified that assessed ICIs as monotherapy or in combination with chemotherapy or combined with another ICI and/or targeted therapy vs control groups not containing immunotherapy in patients with advanced solid tumors. Studies were reviewed independently by 2 authors.Data Extraction and SynthesisThis meta-analysis followed the PRISMA guidelines and recommendations of the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium.Main Outcomes and MeasuresThe coprimary aims of the meta-analysis were (1) pooled differences between treatment groups in the mean change of PRO score from baseline to 12 and 24 weeks of follow-up and (2) pooled differences between treatment groups in the time to deterioration of PRO score. For each end point, RCTs have been analyzed according to the type of treatment administered in the experimental group: ICIs given as monotherapy, ICIs combined with chemotherapy, or ICIs in association with another ICI and/or with targeted therapies.ResultsOf the 2259 identified RCTs, 34 (18 709 patients) met the selection criteria and were analyzed. In the group of 19 RCTs testing ICIs as monotherapy, the pooled between-groups difference of mean change from baseline to 12 weeks of follow-up was 4.6 (95% CI, 2.8-6.4), and the mean change from baseline to 24 weeks of follow-up was 6.1 (95% CI, 4.2-8.1), significantly favoring ICIs. The pooled difference was 1.4 (95% CI, −0.4 to 3.2) at week 12 and 2.5 (95% CI, −0.8 to 5.9) at week 24 in the group of 8 RCTs testing ICIs combined with chemotherapy and 2.1 (95% CI, −0.8 to 5.0) at week 12 and 2.1 (95% CI, −0.4 to 4.5) at week 24 in the group of 8 RCTs testing other ICI-containing combinations. The time to deterioration was significantly longer in the immunotherapy-containing groups compared with control groups in all 3 groups of RCTs evaluated (hazard ratios of 0.80 [95% CI, 0.70-0.91] for ICIs as monotherapy, 0.89 [95% CI, 0.78-1.00] for ICIs plus chemotherapy, and 0.78 [95% CI, 0.63-0.96] for other ICI-containing combinations).Conclusions and RelevanceImmune checkpoint inhibitors as monotherapy appear to have a favorable association with patient-reported quality of life and can be combined with other classes of anticancer drugs without worsening this quality of life.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Association of Anticancer Immune Checkpoint Inhibitors With Patient-Reported Outcomes Assessed in Randomized Clinical Trials

et al. 2022

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“…As observed in several other immune checkpoint inhibition trials, the rates of serious side effects were lowest among patients treated with pembrolizumab alone. Surprisingly, the patients' reported quality of life data using 2 different assessments (EORTC QLQ-C30 and EORTC QLQ-STO22 scales) did not show any improvement of quality of life in the cohort of patients with pembrolizumab alone against chemotherapy [17].…”

Section: First Linementioning

confidence: 82%

“…Hence, the toxicity profile of therapies has to be considered and discussed with the patient when deciding which therapy is the best, particularly for the patients with biomarker positivity. It was, however, surprising to see that the documented better toxicity profile of pembrolizumab was not translated into an improved quality of life in patients with pembrolizumab monotherapy when compared to chemotherapy [17]. Further subgroup analysis and long-term results of this data are however lacking.…”

Section: Discussionmentioning

confidence: 99%

New Treatment Options for Advanced Gastroesophageal Tumours: Mature for the Current Practice?

Puhr

Preusser

Prager

2020

Cancers

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Several clinical trials attempted to identify novel treatment options for advanced gastroesophageal tumours in first, second and further lines. Although results of targeted therapy regimens were mainly disappointing, novel immunotherapy agents showed promising activity, which led to their approval in second and third lines in many countries. This review focuses on the results of recent clinical trials investigating novel agents including targeted therapies, immunotherapy components and chemotherapies and discuss their current impact as well as current approval status on the treatment armamentarium of advanced gastroesophageal tumours.

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“…Data suggest that the toxicity profile of ICIs in gastric cancer is similar to that observed in other malignancies, and combining anti-PD-1 agents with chemotherapy is feasible [ 200 ]. QoL analysis for first-line therapy in KEYNOTE-062 showed similar outcomes for pembrolizumab compared with chemotherapy, but the toxicity profile of single-agent pembrolizumab is generally milder [ 208 ].…”

Section: Resultsmentioning

confidence: 99%

Beyond the Guidelines: The Grey Zones of the Management of Gastric Cancer. Consensus Statements from the Gastric Cancer Italian Network (GAIN)

Fornaro

Spallanzani

Vita

et al. 2021

Cancers

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Background: Management of gastric and gastroesophageal junction (GEJ) adenocarcinoma remains challenging, because of the heterogeneity in tumor biology within the upper gastrointestinal tract. Daily clinical practice is full of grey areas regarding the complexity of diagnostic, staging, and therapeutic procedures. The aim of this paper is to provide a guide for clinicians facing challenging situations in routine practice, taking a multidisciplinary consensus approach based on available literature. Methods: The GAIN (GAstric cancer Italian Network) group was established with the aims of reviewing literature evidence, discussing key issues in prevention, diagnosis, and management of gastric and GEJ adenocarcinoma, and offering a summary of statements. A Delphi consensus method was used to obtain opinions from the expert panel of specialists. Results: Forty-nine clinical questions were identified in six areas of interest: role of multidisciplinary team; risk factors; diagnosis; management of early gastric cancer and multimodal approach to localized gastric cancer; treatment of elderly patients with locally advanced resectable disease; and treatment of locally advanced and metastatic cancer. Conclusions: The statements presented may guide clinicians in practical management of this disease.

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Health-related quality of life (HRQoL) impact of pembrolizumab (P) versus chemotherapy (C) as first-line (1L) treatment in PD-L1–positive advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma

Cited by 6 publications

References 0 publications

Association of Anticancer Immune Checkpoint Inhibitors With Patient-Reported Outcomes Assessed in Randomized Clinical Trials

Association of Anticancer Immune Checkpoint Inhibitors With Patient-Reported Outcomes Assessed in Randomized Clinical Trials

New Treatment Options for Advanced Gastroesophageal Tumours: Mature for the Current Practice?

Beyond the Guidelines: The Grey Zones of the Management of Gastric Cancer. Consensus Statements from the Gastric Cancer Italian Network (GAIN)

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