Patient-reported acute and chronic toxicities from adjuvant therapies post resection of melanoma.

Abstract

e21568 Background: One year ofadjuvant anti-programmed cell death protein-1 (anti-PD1) or dabrafenib-trametinib are standards of care for patients (pts) with resected stage III-IV melanoma. There is limited data regarding the incidence, spectrum and resolution or persistence of toxicities from the pt’s perspective. We describe this in a real-world population up to 2 years post initiation of adjuvant therapy. Methods: A prospective, longitudinal study of pts with resected stage IIB-IV melanoma receiving adjuvant anti-PD1 or dabrafenib-trametinib at an Australian comprehensive cancer center. Fourteen items from the Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) reflecting potential toxicities were collected pre-treatment and at 1, 3, 6, 12, and 24 months post treatment initiation using Research Electronic Data Capture (REDCap). PRO-CTCAE responses were converted to CTCAE-equivalent grades using a published algorithm. Chronic toxicities were defined as those persisting >3 months after treatment cessation. Results: From September 2021-December 2024 , 70 pts were eligible and 52 (74%) consented: 17 (33%) female, median age 64 years (IQR 60-71), 46 (89%) had resected stage III, 32 (62%) adjuvant anti-PD1. 41 pts had completed treatment and 11 were still receiving treatment at data cut off (17 December 2024). The table shows the most common toxicities by PRO-CTCAE composite grade up to 2 years post initiation of adjuvant therapy. Most toxicities reported at 12 months persisted at 24 months (71/103 reported toxicities, 71%). Fatigue was the most commonly reported toxicity at 12 and 24 months. Of the 18 pts with data at both 12 and 24 months, 15 pts had fatigue at 12 months, persisting at 24 months in 14 pts (93%). In terms of chronic toxicities, 19 pts completed at least one survey >3 months post treatment cessation and 18 (95%) reported ongoing toxicities. 16 (84%) had chronic fatigue, including 9 (82%) on adjuvant anti-PD1 and 7 (88%) on adjuvant targeted therapy. Conclusions: Both acute and chronic toxicities from adjuvant therapy are common. This data can inform shared decision-making regarding risks, benefits and expectations from adjuvant therapy and identify priorities for supportive care interventions. PRO-CTCAE term (n, %) Pre-treatment (n=51) 12 months (n=31) 24 months (n=18) No. of pts who completed item Any grade G1 > G2 No. of pts who completed item Any grade G1 > G2 No. of pts who completed item Any grade G1 > G2 Fatigue 50 30 (60%) 23 (46%) 7 (14%) 31 24 (77%) 10 (32%) 14 (45%) 18 14 (78%) 5 (28%) 9 (50%) Skin dryness 51 13 (26%) 10 (20%) 3 (6%) 31 20 (65%) 14 (45%) 6 (20%) 18 12 (67%) 7 (39%) 5 (28%) Itching 51 12 (24%) 10 (20%) 2 (4%) 31 18 (58%) 14 (45%) 4 (13%) 18 10 (56%) 5 (28%) 5 (28%) Muscle pain 50 17 (34%) 11 (22%) 6 (12%) 30 17 (57%) 10 (33%) 7 (24%) 18 10 (56%) 4 (22%) 6 (34%) Joint pain 51 21 (41%) 13 (25%) 8 (16%) 31 17 (55%) 9 (29%) 8 (26%) 18 8 (44%) 2 (11%) 6 (33%)