ArticleClinical cancer research : an official journal of the American Association for Cancer Research2013
Modeling the relationship between progression-free survival and overall survival: the phase II/III trial.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 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
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.
- Estimation of time to progression and post progression survival using joint modeling of summary level OS and PFS data with an ordinary differential equation model.Journal of pharmacokinetics and pharmacodynamics · 2022Pooled it
- Correlations of survival with progression-free survival, response rate, and disease control rate in advanced biliary tract cancer: a meta-analysis of randomised trials of first-line chemotherapy.British journal of cancer · 2016Pooled it
- In search of effective therapies: the current landscape of phase II trials in patients with advanced soft tissue sarcoma.Journal of cancer research and clinical oncology · 2023Trial
- Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment ofJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Trial
- Randomized phase II/III confirmatory treatment selection design with a change of survival end points: Statistical design of Radiation Therapy Oncology Group 1216.Head & neck · 2019Trial
- A multistate platform model for time-to-event endpoints in oncology clinical trials.CPT: pharmacometrics & systems pharmacology · 2024Article
- Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review.Journal of clinical medicine · 2022Review
- Surrogate endpoints in advanced sarcoma trials: a meta-analysis.Oncotarget · 2018Article
- Bias, Operational Bias, and Generalizability in Phase II/III Trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018Article
- Summary and Recommendations from the National Cancer Institute's Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer.Bladder cancer (Amsterdam, Netherlands) · 2016Article
- Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper.Gynecologic oncology · 2014Article
- The imaging viewpoint: how imaging affects determination of progression-free survival.Clinical cancer research : an official journal of the American Association for Cancer Research · 2013Article
- Overview: progression-free survival as an endpoint in clinical trials with solid tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2013Review
- A Multi-state Model for Designing Clinical Trials for Testing Overall Survival Allowing for Crossover after Progression.Statistics in biopharmaceutical researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 1 country.
Funding
Abstract
The standard phase II trial design has changed dramatically over the past decade. Randomized phase II studies have essentially become the standard phase II design in oncology for a variety of reasons. The use of these designs is motivated by concerns about the use of historical data to determine if a new agent or regimen shows promise of activity. However, randomized phase II designs come with the cost of increased study duration and patient resources. Progression-free survival (PFS) is an important endpoint used in many phase II designs. In many clinical settings, changes in PFS with the introduction of a new treatment may represent true benefit in terms of the gold standard outcome, overall survival (OS). The phase II/III design has been proposed as an approach to shorten the time of discovery of an active regimen. In this article, design considerations for a phase II/III trial are discussed and presented in terms of a model defining the relationship between OS and PFS. The design is also evaluated using 15 phase III trials completed in the Southwest Oncology Group (SWOG) between 1990 and 2005. The model provides a framework to evaluate the validity and properties of using a phase II/III design. In the evaluation of SWOG trials, three of four positive studies would have also proceeded to the final analysis and 10 of 11 negative studies would have stopped at the phase II analysis if a phase II/III design had been used. Through careful consideration and thorough evaluation of design properties, substantial gains could occur using this approach.
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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.