With pembrolizumab plus chemoradiotherapy now approved by the FDA for patients with advanced cervical cancer, one expert explained the importance of “making sure that patients know what to look for and what to report.”
The FDA recently approved the combination of pembrolizumab (Keytruda) and chemoradiotherapy for the treatment of patients with stages III to IVA cervical cancer marked the first approval of an anti-PD-1 therapy in combination with chemoradiotherapy for this patient population, as well as the third FDA approval for the treatment of cervical cancer with pembrolizumab.
The approval was based on findings from the KEYNOTE-A18 trial, which enrolled 1,060 patients with cervical cancer who had not been previously treated with surgery, radiation, or systemic therapy, including 596 patients with stage III to IVA disease and 462 patients with stage IB2 to IIB, node-positive disease, according to the FDA.
Common adverse reactions experienced by at least 10% of patients participating in KEYNOTE-A18 who were treated with pembrolizumab and chemoradiotherapy included nausea, diarrhea, vomiting, urinary tract infection, fatigue, hypothyroidism, constipation, decreased appetite, weight loss, abdominal pain, pyrexia, hyperthyroidism, dysuria, rash, and pelvic pain, according to the FDA.
According to Linda R. Duska, MD, MPH, a gynecologic oncologist at University of Virginia Health and the United States principal investigator on KEYNOTE-A18, nurses can play a key role in helping patients treated with pembrolizumab manage their adverse reactions by making sure patients are educated about their treatment.
“This is a unique class of drugs; it's not like chemotherapy at all, [and] the side effect profiles are completely different,” Duska said. “And making sure that patients know what to look for and what to report [is important] because pembrolizumab is a relatively benign drug; people tolerate it very well — but every now and then, you'll get a really bad myocarditis, or a heart inflammation, or really bad pneumonitis, or lung inflammation, or a really bad colitis. Those sorts of things, when they get really bad, people can die from [them].
“And so, making sure that people understand what the side effects of these drugs are that we see most often, what to look out for, when to call us, is really important. So, I think patient education is critical, and [so is] having the patient play a part in this, because it's not just [about] the providers managing side effects, but also educating patients as to when to call.”
There are, as Duska noted, “really good guidelines” for how providers should grade and treat immune-mediated responses to treatment, but there is a part for the patient to play, too.
“The most important part is educating patients, making sure that if a patient goes to the emergency room, the patient knows to tell the emergency provider, 'I'm on this medication, and my nurse told me to look out for this, and I'm telling you that I'm having an immune-related effect,' because not all physicians know what this is, or not all providers know what this,” Duska said. “So, I would say education of the patient is the most important piece of this, and then recognizing when you need to treat these side effects with steroids, when you need to hold the drug. All of those things are really important for all providers.”
FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer. FDA. January 12, 2024. Accessed January 12, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemoradiotherapy-figo-2014-stage-iii-iva-cervical-cancer