A Systematic Review of Health-Related Quality of Life Reporting in Ovarian Cancer Phase III Clinical Trials: Room to Improve

Wilson, Michelle; Friedlander, Michael; Joly, Florence; Oza, Amit M.

doi:10.1634/theoncologist.2017-0297

Cited by 30 publications

(44 citation statements)

References 77 publications

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“…Given the potential chronicity of EOC, patients may experience a multitude of relapses and treatment-related adverse events (AE) that can impact quality of life (QOL). Efforts are on-going to integrate this endpoint into clinical trials and design studies in recurrent disease where the patient reported outcomes (PRO) are major endpoints 133 . At the time of recurrence, the goal of treatment is to control the disease and maintain QOL.…”

Section: Quality Of Life -Symptom Managementmentioning

confidence: 99%

Epithelial ovarian cancer

et al. 2019

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Epithelial ovarian cancer (EOC) generally presents at an advanced stage and is the most common cause of gynecologic cancer death. Treatment requires expert multidisciplinary care. Population based screening has been ineffective to date but new approaches for early diagnosis and prevention that leverage molecular genomics are in development. Initial therapy includes surgery and adjuvant therapy. EOC is composed of distinct histologic subtypes with unique genomic characteristics, which are improving the precision and effectiveness of therapy, allowing discovery of predictors of response such as BRCA1/2 mutations, homologous recombination (HR) deficiency for DNA damage response pathway inhibitors, or resistance (CCNE1). Rapidly evolving techniques to measure genomic changes in tumour and blood allow assessment of sensitivity and emergence of resistance to therapy, and may be accurate indicators of residual disease. Recurrence unfortunately remains usually incurable, and patient symptom control and quality of life are key considerations at that time. Treatments for recurrence have to be designed from a patient's perspective, and incorporate meaningful measures of benefit. Urgent progress is needed to develop evidence and consensus-based treatment guidelines for each subgroup, and requires close international cooperation in conducting clinical trials through academic research groups such as the Gynecologic Cancer Intergroup.

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Section: Quality Of Life -Symptom Managementmentioning

confidence: 99%

Epithelial ovarian cancer

et al. 2019

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“…41 Although PRO data after disease progression is reached can be useful to assess the impact of treatments over time, a recent review of ovarian cancer clinical trials showed that none of the 35 phase 3 studies reviewed reported PRO findings after disease progression. 42 Missing values, attributable to death, dropouts, and patients being too ill to provide data, may be addressed by performing sensitivity analyses. Nevertheless, missing values caused by administrative errors, which generally arise when the PRO assessments are for exploratory endpoints (which may lack priority during study planning and conduct), may be difficult to address in analysis.…”

Section: Missing Datamentioning

confidence: 99%

A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016)

et al. 2019

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To compare US Food and Drug Administration (FDA) and European Medicines Agency (EMA) labeling for evidence based on patient-reported outcomes (PROs) of new oncology treatments approved by both agencies. Methods: Oncology drugs and indications approved between 2012 and 2016 by both the FDA and the EMA were identified. PRO-related language and analysis reported in US product labels and drug approval packages and EMA summaries of product characteristics were compared for each indication. Results: In total, 49 oncology drugs were approved for a total of 64 indications. Of the 64 indications, 45 (70.3%) included PRO data in either regulatory submission. No FDA PRO labeling was identified. PRO language was included in the summary of product characteristics for 21 (46.7%) of 45 indications. European Organisation for Research and Treatment of Cancer and Functional Assessment of Cancer Therapy measures were used frequently in submissions. FDA's comments suggest that aspects of study design (eg, open labels) or the validity of PRO measures was the primary reason for the lack of labeling based on PRO endpoints. Both agencies identified missing PRO data as problematic for interpretation. Conclusions: During this time period, the FDA and the EMA used different evidentiary standards to assess PRO data from oncology studies, with the EMA more likely to accept data from open-label studies and broad concepts such as health-related quality of life. An understanding of the key differences between the agencies may guide sponsor PRO strategy when pursuing labeling. Patient-focused proximal concepts are more likely than distal concepts to receive positive reviews.

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“…The integration of patient-reported outcomes into clinical trials may provide greater insight into regimen tolerability, patients' symptom burden, and the implications of AEs beyond the CTCAE grading by clinicians. 16 A recent report by Henon et al 13 showed that patients' most feared AEs, which they deemed intolerable even when they were low grade (grade 1 or 2), were gastrointestinal and neurological toxicities as well as personality changes; these AEs were different from physicians' most feared toxicities and the definition of DLT. To this end, the NCI has developed a patient-reported outcomes version of CTCAE for use in clinical trials and is actively addressing the operational concerns to allow its full integration into clinical trials in collaboration with the US Food and Drug Administration and the Office for Human Research Protection.…”

Section: Discussionmentioning

confidence: 99%

“…The majority of gynecologic cancers were ovarian/fallopian tube/peritoneal cancers (n = 527 [77%]), which were followed by cervical cancer (n = 76 [11%]) and uterine cancer (n = 72 [11%]). The median number of lines of treatment before study enrollment for all patients was 4 (range, [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20].…”

Section: Patient Characteristicsmentioning

confidence: 99%

Evaluation of toxicities related to novel therapy in clinical trials for women with gynecologic cancer

Lee

Wang

Kohn

et al. 2020

Cancer

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BACKGROUND: Women with gynecologic cancer may be at increased risk for adverse events (AEs) due to peritoneal disease burden and prior treatment (surgery, chemotherapy, and pelvic radiotherapy). This study compared the toxicity profiles of patients with and without gynecologic cancer enrolled in phase 1 trials. METHODS: This was a retrospective analysis of the National Cancer Institute phase 1 database for all trials enrolling 1 or more patients with gynecologic cancer over 2 decades . Clinical parameters collected included demographics, cancer history, trial information, AEs, and responses. AEs (according to the Common Terminology Criteria for Adverse Events) were documented for each patient during treatment, and they were counted once and analyzed on the basis of the highest grade and drug attribution. Multiple regression models were used to compare AEs at the baseline and during treatment. RESULTS: A total of 4269 patients enrolled in 150 trials were divided into 3 groups: 1) women with gynecologic cancer (n = 685), 2) women with nongynecologic cancer (n = 1698), and 3) men with cancer (n = 1886). The median age was 58 years. The mean number of total AEs reported during treatment was highest for women with gynecologic cancer (17.1 vs 14.7 vs 13.5; P < .001), even though they were similar at the baseline (7.0 vs 7.4 vs 7.0; P = .09). The mean number of drug-related AEs was also highest for women with gynecologic cancer (8.3 vs 6.9 vs 6.2; P < .001). Grade 3 to 5 AEs were similar (2.3 vs 2.3 vs 2.1); however, grade 2 AEs were more frequent in women with gynecologic cancer (4.6 vs 3.9 vs 3.5). Treatment discontinuations due to AEs were similar (9% vs 9% vs 10%). CONCLUSIONS: Women with gynecologic cancer experienced more frequent low-grade AEs during treatment, and this warrants attention to support their symptom burden. Study dose management should be considered for recurrent grade 2 AEs, particularly during continuous therapy.

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A Systematic Review of Health-Related Quality of Life Reporting in Ovarian Cancer Phase III Clinical Trials: Room to Improve

Cited by 30 publications

References 77 publications

Epithelial ovarian cancer

Epithelial ovarian cancer

A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016)

Evaluation of toxicities related to novel therapy in clinical trials for women with gynecologic cancer

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