Cardio-protection and monitoring for early phase clinical trials: Recommendations from the therapeutic advances in childhood leukemia and lymphoma (TACL) consortium.
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BACKGROUND: Many effective anti-cancer modalities potentially induce cardiotoxicity. Pediatric patients with relapsed/refractory hematologic malignancies are often excluded from anthracycline-containing regimens based on historical data showing population-level risk of heart failure after cumulative doses of anthracyclines without considering individual patient risk variability, modernized cumulative anthracycline equivalence ratios, novel anthracycline formulations, and use of supportive cardio-protectant medications. Additionally, standard guidelines are lacking for patients with a history of prior cardiotoxicity or previous anthracycline exposure. METHODS: The Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) consortium convened a task force to review the relevant literature and create evidence-based cardiac eligibility recommendations for patients who enroll on TACL relapse clinical trials. RESULTS: Recommendations for assessment of cardiotoxicity risk, cardiac monitoring, supportive care, management of cardiac dysfunction during therapy, and considerations for clinical trial design were created. Key guidance includes: 1) excluding potential subjects from therapies with cardiotoxic risk should be based on individual risk factors and real-time cardiac function assessments rather than past cardiotoxic exposures; 2) comprehensive subject-based cardiac monitoring before, during and after therapy is essential; 3) the liberal use of cardioprotective measures is encouraged; 4) uniform and evidence-based approaches for management of cardiac dysfunction during protocol therapy are crucial; 5) correlative cardiac aims should accompany protocols with potentially cardiotoxic therapies. CONCLUSIONS: Adoption of these updated recommendations should allow more accurate and inclusive study eligibility criteria for TACL's clinical trials and inform future trial development while ultimately improving both quality and interpretability of study data, patient safety, treatment, and outcomes.