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

Martin, Andrew; Gibbs, Emma; Sjoquist, Katrin Marie; Pavlakis, Nick; Simes, John; Price, Tim; Shannon, Jenny; Gill, Sanjeev; Jain, Vikram; Liu, Geoffrey; Kannourakis, George; Kim, Yeul Hong; Kim, Jin Won; Goldstein, David

doi:10.1007/s10120-017-0754-1

Cited by 21 publications

(29 citation statements)

References 17 publications

(20 reference statements)

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“…Nevertheless, to the extent that data collected via these instruments can be associated with clinical outcomes, the EORTC modules can enhance use of QoL data to improve the development of treatments and patient care. A recent third-line study (INTEGRATE 1), enrolling patients with gastric and GEJ cancer, used the QLQ-C30 and the QLQ-STO22 [25]. Similar to our findings, fatigue, pain and appetite loss were common symptoms reported by this patient population, although body image was also considerably impaired and would not be captured with only the QLQ-C30.…”

Section: Discussionsupporting

confidence: 79%

Association of quality of life with disease characteristics and treatment outcomes in patients with advanced gastric cancer: Exploratory analysis of RAINBOW and REGARD phase III trials

Chau

Fuchs

Ohtsu

et al. 2019

European Journal of Cancer

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Background: Inadequate understanding of interpretation of quality of life (QoL) instruments leads to unsatisfactory data reporting and clinical decision-making, including in gastric cancer care. Materials and methods: Pooled QoL data from two phase III studies of ramucirumab with or without paclitaxel in previously treated patients with gastric or gastroesophageal junction cancer were used to explore associations with clinical attributes, including tumour response, disease measurability and performance status (PS). The European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ)-C30 was used in both studies. Changes in QLQ-C30 scores from baseline to week 6 as a predictor of clinical outcomes and impacts of changes in clinical status on QoL were estimated by multivariate logistic regression and analyses of variance, respectively.

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Section: Discussionsupporting

confidence: 79%

Association of quality of life with disease characteristics and treatment outcomes in patients with advanced gastric cancer: Exploratory analysis of RAINBOW and REGARD phase III trials

Chau

Fuchs

Ohtsu

et al. 2019

European Journal of Cancer

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“…Using this approach, the TAGS data are robust enough to allow analysis for 3 treatment cycles (≈ 12 weeks) for placebo and 6 cycles (≈ 24 weeks) for trifluridine/tipiracil. Similarly, in INTEGRATE, the 10% cut-off point corresponded to week 8 for placebo and week 16 for regorafenib [22]. In both INTEGRATE and the current TAGS, baseline QLQ symptom scores were highest for anxiety, fatigue, body image, and appetite loss [22].…”

Section: Discussionmentioning

confidence: 98%

“…A QoL sub-study of the phase 2 INTEGRATE study used the QLQ-C30, QLQ-STO22 and EuroQol-5D (EQ-5D) questionnaires as well as the patient disease and treatment (PTDATA) form to measure QoL in patients (n = 142) with advanced gastric cancer receiving second-or third-line regorafenib or placebo [22]. To interpret results in a clinically meaningful way, both INTEGRATE and the current TAGS analyzed only results for which at least 10% of the original patient population completed QoL questionnaires.…”

Section: Discussionmentioning

confidence: 99%

“…Similarly, in INTEGRATE, the 10% cut-off point corresponded to week 8 for placebo and week 16 for regorafenib [22]. In both INTEGRATE and the current TAGS, baseline QLQ symptom scores were highest for anxiety, fatigue, body image, and appetite loss [22]. At week 4 in INTE-GRATE, the mean diarrhea score was significantly higher for regorafenib than placebo; however, there were no other between-group differences in QoL scores at week 4 or 8 [22].…”

Section: Discussionmentioning

confidence: 99%

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Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS

et al. 2020

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Background In TAGS, an international, double-blind, phase 3 trial, trifluridine/tipiracil significantly improved overall survival and progression-free survival compared with placebo in heavily pretreated metastatic gastric cancer patients. This paper reports pre-specified quality of life (QoL) outcomes for TAGS. Methods Patients were randomized 2:1 to trifluridine/tipiracil (35 mg/m 2 twice daily on days 1-5 and 8-12 of each 28-day cycle) plus best supportive care (BSC) or placebo plus BSC. QoL was evaluated at baseline and at each treatment cycle, using the EORTC QLQ-C30 and EORTC QLQ-STO22 questionnaires; results were considered valid for analysis only if ≥ 10% of patients completed the questionnaires. Key QoL outcomes were mean changes from baseline and time to deterioration in QoL. A post hoc analysis assessed the association between QoL and time to deterioration of Eastern Cooperative Oncology Group performance score (ECOG PS) to ≥ 2. Results Of 507 randomized patients, 496 had baseline QoL data available. The analysis cutoff was 6 cycles for trifluridine/ tipiracil and 3 cycles for placebo. In both treatment groups, there were no clinically significant deteriorations in the mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores. In a sensitivity analysis including death and disease progression as events, there was a trend towards trifluridine/tipiracil reducing the risk of deterioration of QoL scores compared with placebo. Deterioration in the GHS score was associated with deterioration in ECOG PS. Conclusion QoL was maintained in TAGS, and there was a trend towards trifluridine/tipiracil reducing the risk of QoL deterioration compared with placebo. Trial registration ClinicalTrials.gov number: NCT02500043

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“…Cox proportional hazards regression was used to assess the association between EST and OST, accounting for other covariates that had clinical relevance and were found to be associated with OS in a previous analysis of the INTEGRATE trial (EORTC QLQC30 physical function score, neutrophil to lymphocyte ratio ≥3, treatment group ECOG performance status, primary site of disease, and number of metastatic sites) . The effect of adjustment for each covariate was evaluated individually, and a multivariate model was constructed using a backward elimination approach.…”

Section: Subjects Materials and Methodsmentioning

confidence: 99%

Accuracy and Prognostic Significance of Oncologists’ Estimates and Scenarios for Survival Time in Advanced Gastric Cancer

et al. 2019

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Background Worst‐case, typical, and best‐case scenarios for survival, based on simple multiples of an individual's expected survival time (EST), estimated by their oncologist, are a useful way of formulating and explaining prognosis. We aimed to determine the accuracy and prognostic significance of oncologists’ estimates of EST, and the accuracy of the resulting scenarios for survival time, in advanced gastric cancer. Materials and Methods Sixty‐six oncologists estimated the EST at baseline for each of the 152 participants they enrolled in the INTEGRATE trial. We hypothesized that oncologists’ estimates of EST would be unbiased (∼50% would be longer or shorter than the observed survival time [OST]); imprecise (<33% within 0.67–1.33 times the OST); independently predictive of overall survival (OS); and accurate at deriving scenarios for survival time with approximately 10% of patients dying within a quarter of their EST (worst‐case scenario), 50% living within half to double their EST (typical scenario), and 10% living three or more times their EST (best‐case scenario). Results Oncologists’ estimates of EST were unbiased (45% were shorter than the OST, 55% were longer); imprecise (29% were within 0.67–1.33 times observed); moderately discriminative (Harrell's C‐statistic 0.62, p = .001); and an independently significant predictor of OS (hazard ratio, 0.89; 95% confidence interval, 0.83–0.95; p = .001) in a Cox model including performance status, number of metastatic sites, neutrophil‐to‐lymphocyte ratio ≥3, treatment group, age, and health‐related quality of life (EORTC‐QLQC30 physical function score). Scenarios for survival time derived from oncologists’ estimates were remarkably accurate: 9% of patients died within a quarter of their EST, 57% lived within half to double their EST, and 12% lived three times their EST or longer. Conclusion Oncologists’ estimates of EST were unbiased, imprecise, moderately discriminative, and independently significant predictors of OS. Simple multiples of the EST accurately estimated worst‐case, typical, and best‐case scenarios for survival time in advanced gastric cancer. Implications for Practice Results of this study demonstrate that oncologists’ estimates of expected survival time for their patients with advanced gastric cancer were unbiased, imprecise, moderately discriminative, and independently significant predictors of overall survival. Simple multiples of the expected survival time accurately estimated worst‐case, typical, and best‐case scenarios for survival time in advanced gastric cancer.

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

Abstract: Regorafenib improved DFS without an excessively negative effect on QoL. Progressing development to the phase III setting is warranted.

Cited by 21 publications

References 17 publications

Association of quality of life with disease characteristics and treatment outcomes in patients with advanced gastric cancer: Exploratory analysis of RAINBOW and REGARD phase III trials

Association of quality of life with disease characteristics and treatment outcomes in patients with advanced gastric cancer: Exploratory analysis of RAINBOW and REGARD phase III trials

Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS

Accuracy and Prognostic Significance of Oncologists’ Estimates and Scenarios for Survival Time in Advanced Gastric Cancer

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