Crossover trials balance patient care and evidence generation Patient-centered trials in aggressive cancers should not limit future access In aggressive cancers, crossover is often ethically necessary and clinically appropriate. But it can complicate interpretation of clinical trial results. Aggressive cancers are characterized by rapid tumor growth , faster spread to other parts of the body, limited treatment options , poorer prognosis and lower survival rates .
Crossover allows patients in a clinical trial control group to switch to the experimental treatment when it has a proven benefit in later lines of therapy and their condition worsens. Access to the most effective treatment is a fundamental right. This is particularly important in aggressive cancers, where patients may not have another opportunity to receive the best available care.
Examples include certain lung and pancreatic cancers, as well as aggressive subtypes of breast cancer such as triple-negative breast cancer, which affects approximately 1 in 7 women diagnosed with breast cancer. 1 Clinical trials have two jobs 1) Generate data to inform evidence-based decisions on new therapies In aggressive cancers, allowing control arm patients to crossover to a treatment with established benefit is often the right and ethical choice. It means: Better access: not denying effective treatment as the disease worsens Better evidence: mimicking real-world clinical care, enhancing the relevance of trial results Better participation: supporting enrolment in clinical trials Although overall survival (OS) remains the gold standard endpoint, crossover can make survival differences between trial arms appear smaller, making the true patient benefit harder to interpret. Progression-free survival (PFS) offers an important complementary, patient-centric measure by capturing how long patients live, or before their cancer worsens.
For patients, delaying progression can mean: Funding for the creation of this consensus statement was provided by Gilead Sciences Inc., which reviewed the content for factual accuracy, but which had no editorial control over the final wording. Document code: GFM-UNB-2591. > Same as treatment that the participant would receive outside the trial > Other next line of treatment 2Gilead Confidential & Internal Information Only. Do Not Copy or Distribute.
Gilead Confidential & Internal Information Only. ABBREVIATIONS: HTA – Health Technology Assessment; mTNBC - metastatic Triple-negative Breast Cancer; OS – Overall Survival; PFS – Progression-Free Survival; PFS2 - PFS after next line of treatment; QoL – Quality of Life. This document reflects the outcome of a series of expert roundtables and offline consultations conducted with the Crossover Consensus Group, convened and sponsored by Gilead Sciences.
The Crossover Consensus Group included the following clinical and patient experts: Prof. Grazia Arpino (Federico II University Hospital of Naples, Italy); Dr Eitan Amir (University of Toronto, Canada); Dr Stephen Chia (University of British Columbia, Canada); MJ DeCoteau (Rethink Breast Cancer, Canada); Dr Ana Garrido-Castro (Dana-Farber Cancer Institute, United States); Dr Diana Lüftner (Charité Hospital Berlin, Germany); Dr Barbara Pistilli (Institut Gustave Roussy, France); Prof. Fabio Puglisi (Oncology Reference Center, IRCCS Aviano, Italy); Eva Schumacher-Wulf (†) (Mamma Mia!, Germany); Prof Dr.
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