Characterization of Adverse Reactions in Patients with Advanced Endometrial Cancer (aEC) Receiving Lenvatinib + Pembrolizumab (Study 309/KEYNOTE-775): Nurse Roles in Patient Education and Adverse-Reaction Management

December 2021 Vol 12, No 12
Giorgia Villa
Gynecologic Oncology Program, European Institute of Oncology IRCCS, Milan, Italy
Nicoletta Colombo
Gynecologic Oncology Program, University of Milan-Bicocca, European Institute of Oncology IRCCS, Milan, Italy
Melissa Zale
Merck & Co., Inc., Kenilworth, NJ, USA
Min Ren
Eisai Inc., Woodcliff Lake, NJ
Lea Dutta
Eisai Inc., Woodcliff Lake, NJ, USA
Vicky Makker
Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical Center, New York, NY, USA
Vania Hom
Clinical Trials Nursing, GYN Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA

Background: In study 309/KEYNOTE-775, lenvatinib + pembrolizumab showed significant and clinically meaningful improvements in overall survival, progression-free survival, and objective response rate versus treatment of physician’s choice (TPC) in patients with aEC following prior platinum-based therapy. Safety considerations are important because they can impact quality of life (QOL) and limit the ability to take life-prolonging medication. In this analysis, we characterize common adverse reactions (ARs) in patients with aEC in study 309/KEYNOTE-775 and review their respective management strategies.

Objectives: This analysis will characterize the common ARs (ie, time to first onset; ARs that led to study drug discontinuation, dose reduction, or dose interruption) occurring in patients with aEC who received lenvatinib + pembrolizumab; it will also outline the management strategies for common ARs. As nurses are often the first point of patient contact, they play a pivotal role in monitoring patients, proactively managing ARs, and educating patients regarding ARs. The role of nurses within a multidisciplinary team will be emphasized with regard to patient education, as well as the prevention, assessment, and monitoring/management of ARs. Nurses’ role in individualized care will be highlighted.

Methods: In study 309/KEYNOTE-775, patients were randomly assigned (1:1) to receive lenvatinib 20 mg QD PO + pembrolizumab 200 mg IV Q3W (n = 411) or TPC (n = 416; doxorubicin 60 mg/m2 IV Q3W or paclitaxel 80 mg/m2 IV QW, 3 weeks on/1 week off). Herein, characterization of key ARs (ie, hypertension, musculoskeletal pain, fatigue, nausea, diarrhea, decreased appetite, stomatitis, vomiting, hypothyroidism, palmar-plantar erythrodysesthesia [PPES], and decreased weight) is based on incidence and known association with lenvatinib + pembrolizumab, and interventions for ARs in aEC patients. Key ARs are grouped by preferred terms per FDA definitions for ARs in patients with endometrial carcinoma from the US prescribing information.

Results: Median times (weeks) to first onset of key ARs (any grade) were hypertension (2.1), fatigue (2.3), musculoskeletal pain (3.2), nausea (4.7), decreased appetite (4.9), stomatitis (4.9), vomiting (7.6), diarrhea (7.9), hypothyroidism (8.9), PPES (9.6), and decreased weight (10.7). Among the ARs described in this analysis, those that led to withdrawal of lenvatinib included decreased appetite (2%), fatigue (2%), hypertension (2%), diarrhea (1%), musculoskeletal pain (1%), vomiting (1%), and decreased weight (1%); decreased appetite (1%) and diarrhea (1%) led to withdrawal of pembrolizumab. Hypertension was the AR that most frequently led to lenvatinib dose reduction (18%); diarrhea and hypertension were the most frequent cause of dose interruption with lenvatinib (11% each). Diarrhea most frequently led to pembrolizumab interruption (8%). Additional efficacy and safety data, as well as AR management strategies from a nursing perspective, will be reported.

Conclusions: In general, ARs due to lenvatinib + pembrolizumab were consistent with the known safety profile of this combination and often occurred within 3 months of treatment initiation. As will be presented, nurses play a critical role in patient education regarding AR management and in regular follow-up and proactive management of patients during treatment in an effort to minimize the occurrence and/or severity of ARs. Such management may potentially reduce treatment interruption(s) and/or lenvatinib dose reduction, and optimize patient outcomes and QOL.

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Last modified: August 10, 2023

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