KEY TAKEAWAYS
- The METEOR, CABOSUN, CELESTIAL, and COSMIC-311 phase 2 & 3 trial aimed to investigate the efficacy of cabozantinib management for patients with advanced RCC.
- Researchers noticed a significant enhancement in treatment tolerability and patient adherence with cabozantinib
Cabozantinib is an oral tyrosine kinase inhibitor (TKI) approved in the US for patients ≥18 years old with advanced renal cell carcinoma (RCC) or with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib, and patients ≥12 years old with advanced differentiated thyroid cancer (DTC) who progressed following VEGFR-targeted therapy and are radioiodine refractory (RAIR) or ineligible. Approvals were based on 4 randomized controlled trials (RCTs) that demonstrated significant improvements in overall survival (OS), progression-free survival (PFS), and/or objective response rate (ORR) with cabozantinib versus standard of care or placebo; safety was predictable and manageable with dose modification (see cabozantinib product label).
Steven Lee-Ramos and the team aimed to improve tolerability, cabozantinib adverse events (AEs) require proactive management. Reviewing the cabozantinib product label and other relevant literature will provide AE management strategies for the oncology nurse.
They performed an inclusive analysis of 4 pivotal RCTs, including METEOR (NCT01865747) and CABOSUN (NCT01835158) for RCC, CELESTIAL (NCT01908426) for HCC, and COSMIC-311 (NCT03690388) for RAIR-DTC. The most common AEs observed in patients receiving cabozantinib encompassed diarrhea (51%-74%), fatigue (42%-56%), palmar-plantar erythrodysesthesia (PPE; 42%-46%), and hypertension (30%-39%). Strategies for managing these AEs involved prophylaxis, supportive care, and dose modification. Dose holds were required by 70%-84% and reductions for 46%-62% of patients, while only 5%-21% discontinued cabozantinib due to AEs, endorsing proactive management.
Oncology nurses played a crucial role throughout the AE management process, aiding in identifying potential treatment challenges, educating patients about AEs and management strategies, and facilitating routine communication about AEs and potential dose modifications. Frequent office visits and laboratory tests were highlighted for AE monitoring, and prophylaxis/supportive care encompassed dietary changes for diarrhea, exercise and nutrition for fatigue, skincare for PPE, and oral medications for symptom relief.
Dose modifications were considered to individualize therapy and improve tolerability, emphasizing the importance of maintaining treatment. Cabozantinib discontinuation was recommended if AEs persisted despite dose adjustments or for specific AEs as outlined in the product label.
The study concluded that comprehensive and individualized AE management strategies, overseen by nurses, play a vital role in enhancing treatment tolerability and promoting patient adherence to cabozantinib therapy for advanced RCC, HCC, and RAIR-DTC.
The trial was sponsored by Exelixis and the National Cancer Institute (NCI).
Source: https://ons.confex.com/ons/2024/meetingapp.cgi/Paper/15349
Clinical Trials: https://clinicaltrials.gov/study/NCT01865747
https://clinicaltrials.gov/study/NCT01835158
https://clinicaltrials.gov/study/NCT01908426
https://clinicaltrials.gov/study/NCT03690388
Ramos S L, Seery V, Andresen D, et al. (2024). “Management of adverse events associated with cabozantinib for the treatment of advanced renal cell carcinoma, hepatocellular carcinoma, or radioiodine-refractory differentiated thyroid cancer.” Presented at ONS 2024 (Abstract I32).
