{"doi":"10.1200/jco.2022.40.16_suppl.9502","title":"Neoadjuvant PD-1 blockade in patients with resectable desmoplastic melanoma (SWOG 1512).","abstract":"9502 Background: Desmoplastic melanoma (DM) is a rare cancer defined by a dense fibrous collagen matrix. It is associated with high UV exposure leading to a high mutational load. When locally advanced, the standard of care is wide excision and radiation therapy due to its propensity for local relapses. Metastatic DM has a high response rate (RR) to PD-1 blockade therapy (Eroglu et al. Nature 2018). We hypothesized that neoadjuvant treatment with anti-PD-1 monotherapy may induce pathologically confirmed regressions in a high percentage of cases, potentially allowing for less extensive local treatment. Methods: Patients > 18 years old with histologically confirmed resectable (primary, recurrent, or regional lymph node metastasis) DM with clinical evidence of residual disease received pembrolizumab 200 mg q3 weeks (wk) 3 followed by excision. No adjuvant therapy was administered. Primary endpoint: pathological complete response (pCR), with the assumption that pCR of 25% would be considered a positive result worthy of future study. To test this hypothesis, a single arm trial with 25 eligible patients would have a 3.4% probability of a positive result with a true pCR of 5%, and a power of 90% of a positive result if the true pCR is 25%. Secondary endpoints: clinical RR by imaging and clinical exam, median overall survival (OS), and evaluation of safety/tolerability of neoadjuvant pembrolizumab. Adverse events were assessed q3 wk. Disease assessments occurred at baseline and q9 wk. NCT02775851. Results: We enrolled-29 eligible patients with resectable DM. One patient refused treatment and was omitted from further analysis. Median age was 75, 79% were male, primary sites of disease were 72% H&N, 10% torso, 14% extremities, 3% unknown. No patients received prior systemic therapy. Mean time from C1D1 treatment to surgery was 84.2 (range: 52-135) days, mean number of cycles received 3.3 (range: 2-4). 26/27 (93%) of patients underwent wide excision of the resectable disease, of which 14 (54%) underwent sentinel lymph node biopsy. One patient underwent resection of a nodal recurrence thus did not require wide excision. pCR was noted in 15/27 (56%) of patients (95% CI: 35%-75%). One patient without a pCR had a major pathologic response with 0.2 mm residual melanoma. In addition, one patient with a clinical CR did not undergo resection by choice. None became inoperable. Clinical RR was 52% (95% CI: 32%-71%). Median OS has not been reached, with two nontreatment related deaths (acute hypoxic respiratory failure; unknown). No > grade 2 related adverse events were observed. Conclusions: Neoadjuvant pembrolizumab in resectable DM results in a high pCR rate with excellent tolerance, which supports consideration of PD-1 blockade therapy prior to surgery. Funding: U10CA180888 and U10CA180819; and in part by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Clinical trial information: NCT02775851.","journal":"Journal of Clinical Oncology","year":2022,"id":296691,"datarank":0.4636563680037475,"base_score":3.091042453358316,"endowment":3.091042453358316,"self_citation_contribution":0.4636563680037475,"citation_network_contribution":0.0,"self_endowment_contribution":0.4636563680037475,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":21,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9624,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":39515,"name":"James Moon","orcid":"0000-0001-8071-1491","position":1,"is_corresponding":false},{"id":268509,"name":"Zeynep Eroglu","orcid":"0000-0002-2307-7030","position":2,"is_corresponding":false},{"id":259518,"name":"Siwen Hu‐Lieskovan","orcid":"0000-0001-5836-4710","position":3,"is_corresponding":false},{"id":417798,"name":"William E. Carson","orcid":"0000-0001-7024-7533","position":4,"is_corresponding":false},{"id":698867,"name":"David A. Wada","orcid":null,"position":5,"is_corresponding":false},{"id":983590,"name":"Jose A. Plaza","orcid":"0000-0003-1123-5078","position":6,"is_corresponding":false},{"id":748460,"name":"Gino K. In","orcid":"0000-0002-7060-5123","position":7,"is_corresponding":false},{"id":803887,"name":"Alexandra P. Ikeguchi","orcid":"0000-0002-4448-9755","position":8,"is_corresponding":false},{"id":920775,"name":"John Hyngstrom","orcid":"0000-0002-4833-3838","position":9,"is_corresponding":false},{"id":557881,"name":"Andrew S. Brohl","orcid":"0000-0002-0071-0534","position":10,"is_corresponding":false},{"id":58580,"name":"Bartosz Chmielowski","orcid":"0000-0002-2374-3320","position":11,"is_corresponding":false},{"id":325115,"name":"Nikhil I. Khushalani","orcid":"0000-0002-3636-4143","position":12,"is_corresponding":false},{"id":983591,"name":"Joseph Markowitz","orcid":"0000-0003-2490-5464","position":13,"is_corresponding":false},{"id":776915,"name":"Marcus M. Monroe","orcid":"0000-0001-8899-2304","position":14,"is_corresponding":false},{"id":68945,"name":"Kenneth F. Grossmann","orcid":"0000-0002-8523-7407","position":15,"is_corresponding":false},{"id":403074,"name":"Vernon K. Sondak","orcid":"0000-0003-1090-484X","position":16,"is_corresponding":false},{"id":262226,"name":"Elad Sharon","orcid":"0000-0002-0044-9719","position":17,"is_corresponding":false},{"id":318790,"name":"Michael C. 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