Beyond maximum grade: tolerability of immunotherapies, cellular therapies, and targeted agents in haematological malignancies.

Bröckelmann, Paul J; Cliff, Edward R Scheffer; Iacoboni, Gloria; Simon, Florian; Horowitz, Mary M; Keating, Armand; Mateos, Maria-Victoria; Mohty, Mohamad et al. · Lancet Haematol · 2025

review · Level V

Where this comes from

Abstract

The increasing use of immunotherapeutic approaches, cellular therapies, and targeted agents is rapidly and profoundly changing the treatment paradigms of haematological malignancies. These novel therapies are increasingly incorporated into earlier lines of treatment. Some are administered for a fixed duration, often with curative intent, whereas others are administered chronically for disease control. The associated acute, mid-term, and long-term toxic effects can differ markedly from conventional cytotoxic chemotherapy and radiotherapy. Accumulating clinical experience and data enable identification of class-specific effects and development of consensus-based guidelines for toxicity management. In this third paper in the Series on adverse event reporting, we build on our emerging understanding of toxicity profiles of novel treatments to propose an actionable framework for improved assessment, reporting, and critical appraisal of treatment tolerability. We discuss recent insights regarding second cancers and the relevance of infectious complications, explore tolerability aspects of time-limited treatments, and suggest approaches to address gaps in tolerability assessment.

Medical subject headings