Patients with cancer may receive neoadjuvant and adjuvant systemic therapy either before or after undergoing treatment aimed at curing the disease locally. These therapies are designed to reduce the likelihood of cancer recurrence, improve the chances of a complete cure, or enable less invasive surgical interventions. When a therapy or a class of therapy is known to be beneficial in the advanced or metastatic setting, in order to prove it is beneficial to give the same drug to everyone in the (neo)adjuvant setting, as compared to only those who will recur, it is vital that patients in the control group have an optimal access to best care upon relapse.
This visual indicates that, in trials, patients in the control arm may receive suboptimal care upon relapse. This raises questions about the applicability of the reported survival benefits to current practice, since those patients would likely have received optimal care in actual practice.
Why are some patients receiving substandard care after the trial protocol? This often occurs because many registration trials enroll participants globally, including in countries with limited or no access to the best available treatments for patients who ultimately experience cancer relapse.
To go deeper in undertanding the relevance of post-protocol care in trials, you should read the following articles :
Haslam, Prasad. When is crossover desirable in cancer drug trials and when is it problematic? Ann Oncol. 2018 May; 29(5): 1079–1081.
Olivier, Haslam, Prasad: Post‑progression treatment in cancer randomized trials: a cross‑sectional study of trials leading to FDA approval and published trials between 2018 and 2020. BMC Cancer (2023) 23:448
This Shiny App was created by Timothée Olivier