Communicating the safety profile of an oncology drug

At the centre of any communication on the adverse event (AE) profile of a new drug lies a fundamental principle: no medication is ever completely safe. Every drug, from over-the-counter paracetamol to cutting-edge biologics, is associated with a specific set of AEs listed on the package insert. Having said that, anticancer drugs exist in a unique therapeutic space of balancing the crucial potential benefit of (extended) survival with potential risks of toxicity. Decades of experience shows that patients and, perhaps a bit more readily, clinicians routinely accept risks of significant toxicity (nausea, diarrhoea, fatigue, neuropathy, immunosuppression, organ damage) in exchange for survival gains. An AE profile that would be unacceptable for a chronic disease treatment is often labelled as ‘favourable’ in oncology.

Tolerability versus safety

Oncology communications carefully distinguish between two terms:

• safety (AEs that may cause serious harm, irreversible damage, or are life-threatening)

and

• tolerability (essentially, a judgement on whether patients can continue therapy despite side effects).

These terms are neither mutually exclusive nor interchangeable: a drug may demonstrate good tolerability yet still present significant safety concerns, and vice versa. The treating physician will carefully evaluate these risks to determine the drug’s appropriateness for each patient. Furthermore, the impact of AE profiles associated with anticancer agents can vary based on the therapeutic window. In early-stage cancer, in the context of cure as the therapeutic goal, concerns around tolerability will have a lower weight against the risk of life-threatening events. The balance is reversed in the metastatic setting.

New drugs with new or unusual AE profiles

With a steady flow of new drug classes and innovative modes of action in the oncology landscape, physicians and patients have to keep up with new, unusual or unexpected AEs. In previous century, when oncologists mostly used variations of cytotoxic chemotherapy, the toxicities could be challenging, but were familiar: gastrointestinal toxicities (nausea, vomiting, diarrhoea), myelosuppression, alopecia, peripheral neuropathy. Development of targeted agents and immune therapies offered hope for prolonged survival but brought new safety concerns. In particular, immune checkpoint inhibitors have introduced an entirely new category of immune-related AEs. These can affect virtually any organ system, often require immunosuppression to manage (the opposite of typical cancer treatment supportive care), and can occur months after treatment initiation or even after discontinuation. This therapeutic evolution has demanded new language, new monitoring strategies, and new communication approaches.

Communicating safety profiles to different stakeholders

Healthcare professionals are the primary target audience in medical communications, and their needs for specific information should be considered when communicating about safety. Here, the best practice is to prioritise actionability. Physicians need to know whether the AEs are serious or life threatening, whether they are manageable, and when the treatment should be modified. If your clinical study publication mentions a high incidence of diarrhoea, a good idea is to explain the grading, typical onset, duration and any recommended management approaches that are different from international guidelines. With any non-standard AEs, your standard safety table will not be enough – consider including patient monitoring schedules and management algorithms in the supplementary materials.

What about communicating AE profiles to patients? We’ve seen a welcome increase in plain language summaries (PLS) and plain language summary publications (PLSPs) that make Phase 3 trial results accessible to patients and the public. Despite the intrinsic value of PLSPs, most of them follow the contents and flow of the related medical publication and don’t cover what patients actually need to know about the efficacy and safety of drugs. Next time you’re developing a PLSP, consider rewriting the AE section with a focus on what the patients need to know:

• What to expect: Not just percentages, but what common AEs actually feel like and when they typically occur
• When to worry: Clear signals that warrant contacting the healthcare team versus expected, manageable effects
• How to communicate with their healthcare teams: Empowering patients to report symptoms accurately and advocate for supportive care

Informed patients feel more empowered and engaged in shared treatment decision making and are better equipped to persist with effective therapy.

In summary, clear, concise, and audience-appropriate communication around AE profiles is essential to responsible medical communications. Our goal should be not to minimise the risks or to maximise alarms, but to ensure that stakeholders have the background knowledge to make informed choices. If done well, these communications support individual treatment decisions and effective toxicity management, ultimately leading to better patient care.