Meeting
2023 ASCO Annual Meeting
Efficacy of adjuvant therapy in patients (pts) with AJCC v8 stage IIIA cutaneous melanoma.
Authors
Piyush Grover
Melanoma Institute Australia, Sydney, Australia
Piyush Grover , Isabel Li , Anke Kuijpers , Firas Y. Kreidieh , Andrew Williamson , Teresa Maria Santos Amaral , Florentia Dimitriou , Joanna Placzke , Kelly Olino , Maria Grazia Vitale , Philippe Saiag , Ralf Gutzmer , Clara Allayous , Roger Olofsson Bagge , Nethanel Asher , Tarek Meniawy , Aleigha Lawless , Lydia Warburton , Alexander M. Menzies , Georgina V. Long
Organizations
Melanoma Institute Australia, Sydney, Australia, The Netherlands Cancer Institute, Amsterdam University Medical Centers, Amsterdam, Netherlands, The University of Texas MD Anderson Cancer Center, Houston, TX, The Christie NHS Foundation Trust, Manchester, United Kingdom, Center for Dermatooncology, Department of Dermatology, Eberhard Karls University of Tuebingen, Tuebingen, Germany, Department of Dermatology, University Hospital of Zurich, Zürich, Switzerland, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, Yale School of Medicine, New Haven, CT, Melanoma, Cancer Immunotherapy and Development Therapeutics Unit, Istituto Nazionale Tumori-IRCCS Fondazione "G. Pascale", Naples, Italy, Dermatology Department, Ambroise Paré Hospital, APHP, Versailles University – Paris-Saclay, Boulogne-Billancourt, France, Department of Dermatology, Mühlenkreiskliniken, Ruhr University Bochum Campus Minden, Bochum, Germany, APHP Hôpital Saint-Louis, Dermatology Department, DMU ICARE, Paris, France, Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, Ella Lemelbaum Institute for Immuno Oncology and Melanoma, Sheba Medical Center, Ramat-Gan, Israel, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia, Massachusetts General Hospital, Boston, MA, Fiona Stanley Hospital, Edith Cowan University, Perth, Australia, Melanoma Institute Australia, Faculty of Medicine and Health, The University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, NSW, Australia, The University of Sydney, Sydney, NSW, Australia
Research Funding
No funding received
None.
Background: Pts with resected AJCC v8 stage IIIA melanoma have been under-represented in clinical trials of adjuvant drug therapy. The benefit of adjuvant targeted and immunotherapy in this population is unclear. Methods: In this multicenter, retrospective study, pts with stage IIIA melanoma (AJCC v8) who received adjuvant pembrolizumab or nivolumab (PD1), BRAF/MEK-targeted therapy dabrafenib + trametinib (TT), or no adjuvant treatment (OBS) were included. Recurrence free survival (RFS), distant metastasis free survival (DMFS), and toxicity rates were examined. Results: 613 pts from 34 centers across Australia, Europe and USA were included. The median follow-up was 2.6 yrs (IQR, 1.6-3.4 yrs). Pt characteristics and follow-up were similar across the cohorts (Table). Completion rates of 12-month PD1 and TT therapy were 57.0% and 69.2% respectively. 1-yr RFS was 93.3% (95% CI, 90.3-96.4) in PD1, 100% in TT and 91.3% (95% CI, 88.1-94.7) in OBS cohorts. 2-yr RFS was 79.3% (95% CI, 74.1-84.8) for PD1, 100% for TT and 84.3% (95% CI, 79.9-89.0) in OBS cohorts. 2-yr DMFS was 88.4% (95% CI, 84.3-92.8) in PD1, 100% in TT and 91.1% (95% CI, 87.7-94.7) in OBS cohorts. Risk of recurrence was associated with higher breslow thickness (HR 1.73, 95% CI 1.36-2.20), higher mitotic rate (HR 1.07, 95% CI 1.02-1.12) and neck as the site of nodal metastases (HR 2.71, 95% CI 1.45-5.06) in the overall cohort (p<0.05). Neck nodal metastases were associated with higher risk of recurrence in OBS cohort (HR 3.82, 95% CI 1.91-7.66; p<0.05) but not in the PD1 cohort. Rates of ≥ Grade 3 toxicities were 10.9% with PD1 and 20.0% with TT; discontinuation due to toxicity occurred in 25.0% and 30.0%, respectively. No new safety signals were observed. Rates of unresolved toxicity at last follow-up were 26.9% in PD1 and 7.7% in TT cohorts. Conclusions: In this large international study, adjuvant PD1 or TT did not significantly improve RFS or DMFS compared to OBS in pts with resected stage IIIA melanoma. Prognosis in stage IIIA melanoma is favourable and outcomes after adjuvant therapy in this population needs further study in prospective randomised trials.
| PD1, n=256 | TT, n=65 | OBS, n=292 | |
|---|---|---|---|
| Male, n (%) | 150 (58.6) | 31 (47.7) | 151 (51.7) |
| Age, median (years) (IQR) | 54 (42-64) | 49 (37-58) | 58 (46-68) |
| ECOG PS 0-1, n (%) | 246 (96.1) | 65 (100) | 283 (97.0) |
| Breslow thickness, median (mm) (IQR) | 1.3 (1.1-1.7) | 1.3 (1.1-1.5) | 1.3 (1.1-1.6) |
| Mitotic rate, median (per mm2) (IQR) | 3.0 (1.0-5.0) | 2.0 (1.8-4.0) | 2.0 (1.0-4.0) |
| Presence of ulceration, n (%) | 22 (8.6) | 2 (3.1) | 8 (2.7) |
| Lymph node involvement, N1a, n (%) | 206 (80.5) | 55 (84.6) | 253 (86.6) |
| Maximum diameter of the largest node, median (mm) (IQR) | 1.2 (0.5-2.0) | 1.0 (0.3-2.0) | 0.5 (0.1-1.1) |
| Complete lymph node dissection, n (%) | 55 (21.5) | 4 (6.2) | 24 (8.2) |
| BRAFV600 mutation, n (%) | 91 (35.5) | 65 (100) | 90 (30.8) |
| Follow-up, median (years) (IQR) | 2.7 (1.7-3.4) | 2.4 (1.5-3.1) | 2.6 (1.5-3.4) |
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Abstract Details
Session Type
Poster Discussion Session
Session Title
Melanoma/Skin Cancers
Track
Melanoma/Skin Cancers
Sub Track
Local-Regional Disease
Citation
J Clin Oncol 41, 2023 (suppl 16; abstr 9518)
DOI
10.1200/JCO.2023.41.16_suppl.9518
Abstract #
9518
Poster Bd #
281
Abstract Disclosures
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