27 | Real-world data for malignant melanoma stage II adjuvant therapy

Silvana Cozzolino¹, Antonino Colloca¹, Miriam Forte¹, Francesco Caraglia¹, Alfonso Esposito¹, Maria Cristina Giugliano¹, Eleonora Cioli¹, Marcella Scala², Maria Chiara Sergi³, Teresa Del Giudice⁴, Francesca Sparano⁵, Immacolata Paciolla⁶, Mariangela Pasqualoni⁷, Luigi Formisano², Stefania Napolitano¹, Antonio Maria Grimaldi¹, Paolo Antonio Ascierto⁵, Fortunato Ciardiello¹, Teresa Troiani¹, Vincenzo De Falco¹ | ¹Medical Oncology, Department of Precision Medicine, University of Campania "Luigi Vanvitelli", Naples; ²Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy; ³Division of Medical Oncology, "Mons. A.R. Dimiccoli" Hospital, Barletta; ⁴Nuclear Medicine Unit, "Mater Domini" University Hospital, Catanzaro; ⁵Melanoma, Cancer Immunotherapy and Development Therapeutics Unit, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples; ⁶Medical Oncology Unit, AORN "San Pio", Benevento, Italy; ⁷Medical Oncology Unit, ASL Taranto, Italy.

Background: Malignant melanoma (MM) is an aggressive cancer with high metastatic potential from early stages. Stage IIB/C MM shows overall survival lower than stage IIIA, with high recurrence risk. Recently, 1-year pembrolizumab or nivolumab was approved as adjuvant therapy for stage II.

Methods: We retrospectively analyzed stage IIB/C MM patients treated with adjuvant immunotherapy in 7 “Gruppo Oncologico Italia Meridionale (GOIM)” centers. Median follow-up: 10 months.

Results: Since the approval in Italy in July 2023 of stage II adjuvant immunotherapy, 51 stage II MM patients were treated in GOIM centers. Patients characteristics were: median age of 56 years, 29 males (56.8%) and 22 females (43.1%), 30 stage IIB MM patients (58.8%) and 21 stage IIC (41.2%), 27 out of 49 cases (52.9%) were MM of the trunk, 6 were localized in the head and neck district (11.8%), 5 upper limbs MM (9.8%) and 13 lower limbs MM (25.5%). Recurrence of disease has been observed only in 2 out of 51 patients (3.9%), both stage IIB presenting melanoma ulceration, one BRAF V600 mutated and one BRAF wild type. Recurrence was only loco-regional and after lymphadenectomy patients continued the adjuvant treatment. Adverse events (AEs) have been experienced by 23 out of 51 patients (45.1%), even though 87.1% of the AEs were G1-G2. The most frequent G1-G2 toxicities were thyroid dysfunction (13.7%), gastrointestinal disorders (11.7%), itchiness (7.8%) and skin reactions (7.8%). In addition, 3 patients (5.9%) experienced G3 toxicity, pancreatitis and thyroid dysfunction, and 1 patient (1.9%) G4 hepatits. Out of all treated patients, 5 (9.8%) definitively suspended the treatment because of related AEs (Figure 1-2).

Conclusions: Preliminary real-world data show 3.9% recurrence in stage IIB/IIC patients receiving adjuvant immunotherapy, with manageable toxicity. Ongoing molecular analyses on tumor samples aim to correlate patients’ molecular features with adjuvant therapy outcomes.

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