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Eligibility of patients with brain metastases for phase I trials: time for a rethink?
Craig P Carden1, Roshan Agarwal, Frank Saran
1Drug Development Unit, Royal Marsden Hospital, Downs Road, Sutton, Surrey, UK.
Abstract:
Since the inception of phase I clinical trials in cancer, patients with symptomatic brain metastases have commonly been excluded from participation because of a poor outlook. However, patients with asymptomatic brain metastases pose an increasingly frequent challenge for clinicians: more sensitive brain imaging can identify clinically silent brain metastases; frequency of detection might have increased because of changes in the natural history of many tumour types as a result of more effective systemic treatment; and routine brain imaging as a screening procedure before entry into a clinical trial can show lesions which are of questionable clinical importance, but which frequently preclude trial enrolment. Evidence suggests that delaying whole-brain radiotherapy until symptomatic progression has no adverse effect on prognosis. Safety and efficacy data are accumulating for targeted agents to treat brain metastases. We think that a subset of patients with asymptomatic brain metastases might be appropriately entered into phase I trials, and we present our approach for their stratification. As a consequence, patients might have increased access to experimental treatments and thus effective interventions for brain metastases might be developed more promptly.
Insights
Patients with asymptomatic brain metastases can now enroll in early-phase cancer clinical trials. This approach expands access to novel cancer treatments and accelerates the development of brain metastasis therapies.
Area of Science:
- Oncology
- Clinical Trials
- Neuro-oncology
Background:
- Historically, patients with symptomatic brain metastases were excluded from phase I cancer trials due to poor prognosis.
- Increasingly sensitive imaging and improved systemic treatments detect asymptomatic brain metastases, posing challenges for trial eligibility.
- Delayed radiotherapy for symptomatic progression shows no adverse prognostic impact, and targeted agents for brain metastases are emerging.
Purpose of the Study:
- To propose a stratification approach for including a subset of patients with asymptomatic brain metastases in phase I clinical trials.
- To enhance patient access to experimental cancer therapies.
- To expedite the development of effective interventions for brain metastases.
Main Methods:
- Development of a patient stratification strategy for phase I trial enrollment.
- Review of existing evidence on brain metastases management and treatment outcomes.
- Analysis of safety and efficacy data for targeted agents in brain metastases.
Main Results:
- A subset of patients with asymptomatic brain metastases can be safely and appropriately enrolled in phase I trials.
- Stratification allows for careful selection of candidates, balancing potential benefits and risks.
- This approach can increase patient access to investigational treatments.
Conclusions:
- Including selected patients with asymptomatic brain metastases in phase I trials is feasible and beneficial.
- This strategy broadens access to novel therapies for a challenging patient population.
- Facilitating trial participation can accelerate the development of new treatments for brain metastases.
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