ArticleGynecologic oncology2014
Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper.
Article in Gynecologic oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Olaparib maintenance versus placebo or standard of care in ovarian cancer: a biomarker-driven systematic review and meta-analysis of randomized trials.International journal of clinical oncology · 2026Pooled it
- Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer.The Cochrane database of systematic reviews · 2022Pooled it
- The survival outcome and complication of secondary cytoreductive surgery plus chemotherapy in recurrent ovarian cancer: a systematic review and meta-analysis.Journal of ovarian research · 2021Pooled it
- A phase II trial of cytoreductive surgery combined with niraparib maintenance in platinum-sensitive, secondary recurrent ovarian cancer: SGOG SOC-3 study.Journal of gynecologic oncology · 2020Trial
- Trial
- Timing and duration of bevacizumab treatment and survival in patients with recurrent ovarian, fallopian tube, and peritoneal cancer: a multi-institution study.European journal of gynaecological oncology · 2023Article
- A prospective cross-sectional survey comparing patient and provider expectations regarding ovarian cancer prognosis.Gynecologic oncology reports · 2022Article
- The Application of Preference Elicitation Methods in Clinical Trial Design to Quantify Trade-Offs: A Scoping Review.The patient · 2022Article
- A Systematic Review of Patient Preferences, Expectations, and Values for the Management and Treatment of Hypertension.Patient preference and adherence · 2022Review
- Preferences of adults with cancer for systemic cancer treatment: do preferences differ based on age?Future oncology (London, England) · 2022Article
- Outcome quality standards in advanced ovarian cancer surgery.World journal of surgical oncology · 2020Review
- Cost-effectiveness analysis comparing "PARP inhibitors-for-all" to the biomarker-directed use of PARP inhibitor maintenance therapy for newly diagnosed advanced stage ovarian cancer.Gynecologic oncology · 2020Article
- Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Article
- Rucaparib for patients with platinum-sensitive, recurrent ovarian carcinoma (ARIEL3): post-progression outcomes and updated safety results from a randomised, placebo-controlled, phase 3 trial.The Lancet. Oncology · 2020Article
- Use of a multi-drug regimen gemcitabine, 5-fluorouracil, irinotecan, cisplatin, bevacizumab, docetaxel, and cyclophosphamide (GFIP/BDC) for heavily pretreated relapsed epithelial ovarian, fallopian tube and primary peritoneal cancer.Journal of ovarian research · 2019Article
- Comparison of first-line chemotherapy regimens for ovarian carcinosarcoma: a single institution case series and review of the literature.BMC cancer · 2018Article
- Progression-free survival as a surrogate endpoint for overall survival in modern ovarian cancer trials: a meta-analysis.Therapeutic advances in medical oncology · 2018Article
- Quality of life is significantly associated with survival in women with advanced epithelial ovarian cancer: An ancillary data analysis of the NRG Oncology/Gynecologic Oncology Group (GOG-0218) study.Gynecologic oncology · 2017Article
- Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: recurrent disease.Annals of oncology : official journal of the European Society for Medical Oncology · 2017Article
- Ovarian cancer.Nature reviews. Disease primers · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
objectiveTo explore the value of multiple clinical endpoints in the unique setting of ovarian cancer.
methodsA clinical trial workgroup was established by the Society of Gynecologic Oncology to develop a consensus statement via multiple conference calls, meetings and white paper drafts.
resultsClinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics. Selection of the optimal clinical trial endpoint is particularly provocative in ovarian cancer where long overall survival (OS) is observed. The lack of new regulatory approvals and the lack of harmony between regulatory bodies globally for ovarian cancer therapeutics are of concern. The advantages and disadvantages of the numerous endpoints available are herein discussed within the unique context of ovarian cancer where both crossover and post-progression therapies potentially uncouple surrogacy between progression-free survival (PFS) and OS, the two most widely supported and utilized endpoints. The roles of patient reported outcomes (PRO) and health related quality of life (HRQoL) are discussed, but even these widely supported parameters are affected by the unique characteristics of ovarian cancer where a significant percentage of patients may be asymptomatic. Original data regarding the endpoint preferences of ovarian cancer advocates is presented.
conclusionsEndpoint selection in ovarian cancer clinical trials should reflect the impact on disease burden and unique characteristics of the treatment cohort while reflecting true patient benefit. Both OS and PFS have led to regulatory approvals and are clinically important. OS remains the most objective and accepted endpoint because it is least vulnerable to bias; however, the feasibility of OS in ovarian cancer is compromised by the requirement for large trial size, prolonged time-line for final analysis, and potential for unintended loss of treatment effect from active post-progression therapies. A large magnitude of effect in PFS improvement should establish benefit, and further communication with regulatory authorities to clarify acceptable endpoints should be undertaken.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.