Association between progression-free survival and health-related quality of life in oncology: a systematic review protocol

Kovic, Bruno; Guyatt, Gordon; Brundage, Michael; Thabane, Lehana; Bhatnagar, Neera; Xie, Feng

doi:10.1136/bmjopen-2016-012909

Cited by 12 publications

(23 citation statements)

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“…Our study protocol detailing design and analysis was previously published 10 and registered on the International Prospective Register of Ongoing Systematic Reviews (CRD42016047162). 11,12 We conducted a review of human cancer RCTs published from January 1, 2000, to May 4, 2016, using standard methodology described by the Cochrane Collaboration.…”

Section: Methodsmentioning

confidence: 99%

“…We used comprehensive search strategies developed with help from an experienced research librarian (eAppendix in the Supplement). 10 We used the OVID platform to search in MEDLINE, Embase, and the Wiley Cochrane databases, and used MeSH terms and free text to capture RCTs published in Abridged Index Medicus. 16 Our search strategies were built by combining terms from disease key areas (cancer categories), HRQoL, cancer therapies, and an RCT filter.…”

Section: Literature Searchmentioning

confidence: 99%

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Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology

et al. 2018

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IMPORTANCE Progression-free survival (PFS) has become a commonly used outcome to assess the efficacy of new cancer drugs. However, it is not clear if delay in progression leads to improved quality of life with or without overall survival benefit. OBJECTIVE To evaluate the association between PFS and health-related quality of life (HRQoL) in oncology through a systematic review and quantitative analysis of published randomized clinical trials. Eligible trials addressed oral, intravenous, intraperitoneal, or intrapleural chemotherapy or biological treatments, and reported PFS or health-related quality of life. DATA SOURCES For this systematic review and quantitative analysis of randomized clinical trials of patients with cancer, we searched Medline, Embase, and the Cochrane Central Register of Controlled Trials from January 1, 2000, through May 4, 2016. STUDY SELECTION Paired reviewers independently screened citations, extracted data, and assessed risk of bias of included studies. DATA EXTRACTION AND SYNTHESIS We examined the association of difference in median PFS duration (in months) between treatment groups with difference in global, physical, and emotional HRQoL scores between groups (standardized to a range of 0-100, with higher scores representing better HRQoL) using weighted simple regressions. MAIN OUTCOME AND MEASURE The association between PFS duration and HRQoL. RESULTS Of 35 960 records screened, 52 articles reporting on 38 randomized clinical trials involving 13 979 patients across 12 cancer types using 6 different HRQoL instruments were included. The mean (SD) difference in median PFS between the intervention and the control arms was 1.91 (3.35) months. The mean (SD) differences in change of HRQoL adjusted to per-month values were −0.39 (3.59) for the global domain, 0.26 (5.56) for the physical domain, and 1.08 (3.49) for the emotional domain. The slope of the association between the difference in median PFS and the difference in change for global HRQoL (n = 30 trials) was 0.12 (95% CI, −0.27 to 0.52); for physical HRQoL (n = 20 trials) it was −0.20 (95% CI, −0.62 to 0.23); and for emotional HRQoL (n = 13 trials) it was 0.78 (95% CI, −0.05 to 1.60). CONCLUSIONS AND RELEVANCE We failed to find a significant association between PFS and HRQoL in cancer clinical trials. These findings raise questions regarding the assumption that interventions prolonging PFS also improve HRQoL in patients with cancer. Therefore, to ensure that patients are truly obtaining important benefit from cancer therapies, clinical trial investigators should measure HRQoL directly and accurately, ensuring adequate duration and follow-up.

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Section: Methodsmentioning

confidence: 99%

Section: Literature Searchmentioning

confidence: 99%

Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology

et al. 2018

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“…Most of the trials analyzed did not collect data on HRQoL after progression. 6,10 Patients and physicians testify to the psychological and physical distress associated with disease progression, caused not only by complications from the progressing cancer or adverse effects of subsequent new treatments, but also by fear of losing control over cancer and fear of death. 11 Robust scientific data on the association of disease progression with patient-reported outcomes (PROs) on HRQoL are still scarce.…”

Section: Introductionmentioning

confidence: 99%

Association of Disease Progression With Health-Related Quality of Life Among Adults With Breast, Lung, Pancreatic, and Colorectal Cancer

et al. 2020

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IMPORTANCE Mortality, morbidity, and health-related quality of life (HRQoL) are patient-relevant end points generally considered in the early benefit assessments of new cancer treatments. Progression-related end points, such as time to progression or progression-free survival, are not included, although patients and physicians testify to the detrimental association of disease progression with HRQoL. OBJECTIVE To examine the association of disease progression and HRQoL in 4 prevalent solidcancer entities in routine clinical practice. DESIGN, SETTING, AND PARTICIPANTS This cohort study evaluated data from 4 prospective, nonintervention, multicenter registries collected between 2011 and 2018 in 203 centers in Germany. Patients' HRQoL was assessed regularly for up to 5 years. The change in HRQoL scores after disease progression was examined with linear mixed models, adjusting for demographic and clinical covariates. Patients with metastatic breast, pancreatic, lung, and colorectal cancer were recruited at the start of systemic first-line treatment. Data analysis was performed from February 2019 to April 2019. EXPOSURES All patients received systemic, palliative first-line treatment according to their physician's choice. MAIN OUTCOMES AND MEASURES The primary outcome was deterioration of HRQoL associated with disease progression, as measured by 4 validated questionnaires: Functional Assessment of Cancer Therapy-General version 4, European Organization for Research and Treatment of Cancer QLQ-C30 version 3.0, European Organization for Research and Treatment of Cancer QLQ-C15-PAL version 1, and Hospital Anxiety and Depression Scale. RESULTS More than 8000 questionnaires from 2314 patients with 2562 documented disease progressions were analyzed. In total, 464 patients had breast cancer (464 [100.0%] female; median [range] age, 61.6 [26.4-90.1] years), 807 patients had pancreatic cancer (352 [43.6%] female; median [range] age, 70.0 [39.0-93.0] years), 341 patients had lung cancer (118 [34.6%] female; median [range] age, 65.9 [28.4-88.2] years), and 702 patients had colorectal cancer (248 [35.3%] female; median [range] age, 66.9 [26.9-92.1] years). The first disease progression was associated with a statistically significant worsening of 37 of 45 HRQoL scales; for 17 of these scales, the worsening was clinically meaningful.

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“…Theoretically, 3-year OS in the IIb retention group will resemble that in the dissection group. A summary of 38 RCTs [7,23] reports no significant association between PFS duration and HRQoL. In addition, as PFS is not as reliable as OS and can also increase difficulties in follow-up, we did not use PFS as the primary outcome.…”

Section: Secondary Outcomesmentioning

confidence: 99%

“…At present, we aim to extend survival and at the same time improve health-related quality of life (HRQoL) [6,7]. After neck dissection, shoulder weaknesses such as dyskinesia, trapezius atrophy, loss of shoulder abduction, and shoulder and neck pain will occur; collectively, these are called 'shoulder syndrome' [8][9][10].…”

Section: Introductionmentioning

confidence: 99%

The necessity of IIb dissection in T1–T2N0M0 oral squamous cell carcinoma: protocol for a randomized controlled trial

Wang

Song

et al. 2019

Trials

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Background: There is a growing debate on the relationship between health-related quality of life (HRQoL) and patient survival which has been going on for the last few decades. The greatest wish of clinicians is to extend the latter while improving the former. Following neck dissection of early-stage oral carcinoma, "shoulder syndrome" appears due to traction of the accessory nerve during removal of level IIb, which greatly affects patient quality of life. Since occult metastasis in level IIb of early-stage oral carcinoma is extremely low, some surgeons suggest that level IIb can be exempt from dissection to improve the HRQoL. However, other surgeons take the opposite view, and thus there is no consensus on the necessity of IIb dissection in T1-2N0M0 oral squamous cell carcinoma (OSCC). Methods: We designed a parallel-group, randomized, non-inferiority trial that is supported by

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Association between progression-free survival and health-related quality of life in oncology: a systematic review protocol

Cited by 12 publications

References 10 publications

Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology

Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology

Association of Disease Progression With Health-Related Quality of Life Among Adults With Breast, Lung, Pancreatic, and Colorectal Cancer

The necessity of IIb dissection in T1–T2N0M0 oral squamous cell carcinoma: protocol for a randomized controlled trial

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