{"title":"辅助抗pd -1单药治疗与观察III期足底肢黑色素瘤：一项日本患者的多中心回顾性研究","authors":"Shigeru Koizumi, Naoya Yamazaki, Yuki Ichigozaki, Hiroshi Kitagawa, Yukiko Kiniwa, Sayuri Sato, Toshihiro Takai, Reiichi Doi, Takamichi Ito, Masahito Yasuda, Yutaka Kuwatsuka, Takeo Maekawa, Jun Asai, Takuya Miyagawa, Shigeto Matsushita, Takeru Funakoshi, Yosuke Yamamoto, Takashi Inozume, Akiko Kishi, Tatsuya Takenouchi, Hiraku Kokubu, Shusaku Ito, Yoshiyasu Umeda, Yuki Yamamoto, Shoichiro Ishizuki, Shiro Iino, Hiroshi Uchi, Tomoe Nakagawa, Kazuhiro Inafuku, Takahiro Haga, Takahide Kaneko, Masahiro Nakagawa, Hideki Kamiya, Masaru Arima, Toshihiko Hoashi, Azusa Hiura, Nobuo Kanazawa, Keiko Manabe, Masashi Ishikawa, Kenji Asagoe, Utsugi Iwasawa, Takafumi Kadono, Naohito Hatta, Shoichiro Minami, Eiji Nakano, Dai Ogata, Satoshi Fukushima, Hisashi Uhara, Kenta Nakama, Yasuhiro Nakamura","doi":"10.1200/GO-24-00644","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Adjuvant anti-PD-1 (adj PD-1) antibodies are extensively used to improve survival in patients with resected melanoma. Clinical trials on adj PD-1 antibodies have revealed significant improvements in recurrence-free survival (RFS); however, few of these trials have included patients with acral melanoma (AM).</p><p><strong>Methods: </strong>Clinical data were retrospectively collected from Japanese patients who underwent resection of stage III sole AM between 2014 and 2021. Survival outcomes, including RFS, distant metastasis-free survival (DMFS), and overall survival (OS), were compared between patients without adjuvant therapy (OBS group) and those receiving adj PD-1 group.</p><p><strong>Results: </strong>This study included 139 patients (OBS: 79; adj PD-1: 60), with a median follow-up of 2.6 years. The baseline characteristics were comparable, except for age and nodal metastasis. No significant differences in survival were observed between the OBS and adj PD-1 groups (3-year RFS: 36.7% <i>v</i> 27.5%, <i>P</i> = .13; 3-year DMFS: 51.0% <i>v</i> 45.3%, <i>P</i> = .51; 3-year OS: 65.3% <i>v</i> 67.4%, <i>P</i> = .45). Multivariate analysis showed no survival benefit of adj PD-1 (RFS: hazard ratio [HR], 1.25, <i>P</i> = .29; DMFS: HR, 1.03, <i>P</i> = .89; and OS: HR, 0.69, <i>P</i> = .23). Each survival outcome after propensity score matching confirmed no significant difference between the matched OBS group (n = 52) and adj PD-1 group (n = 52; 3-year RFS: 34.3% <i>v</i> 25.9%, <i>P</i> = .22; 3-year DMFS: 45.6% <i>v</i> 46.5%, <i>P</i> = .85; 3-year OS: 60.7% <i>v</i> 68.9%, <i>P</i> = .29).</p><p><strong>Conclusion: </strong>Adj PD-1 did not improve the prognosis in sole AM. However, further studies are essential to evaluate the efficacy of the adj anti-PD-1 antibody in AM.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"11 ","pages":"e2400644"},"PeriodicalIF":3.2000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12004986/pdf/","citationCount":"0","resultStr":"{\"title\":\"Adjuvant Anti-PD-1 Monotherapy Versus Observation for Stage III Acral Melanoma of the Sole: A Multicenter Retrospective Study in Japanese Patients.\",\"authors\":\"Shigeru Koizumi, Naoya Yamazaki, Yuki Ichigozaki, Hiroshi Kitagawa, Yukiko Kiniwa, Sayuri Sato, Toshihiro Takai, Reiichi Doi, Takamichi Ito, Masahito Yasuda, Yutaka Kuwatsuka, Takeo Maekawa, Jun Asai, Takuya Miyagawa, Shigeto Matsushita, Takeru Funakoshi, Yosuke Yamamoto, Takashi Inozume, Akiko Kishi, Tatsuya Takenouchi, Hiraku Kokubu, Shusaku Ito, Yoshiyasu Umeda, Yuki Yamamoto, Shoichiro Ishizuki, Shiro Iino, Hiroshi Uchi, Tomoe Nakagawa, Kazuhiro Inafuku, Takahiro Haga, Takahide Kaneko, Masahiro Nakagawa, Hideki Kamiya, Masaru Arima, Toshihiko Hoashi, Azusa Hiura, Nobuo Kanazawa, Keiko Manabe, Masashi Ishikawa, Kenji Asagoe, Utsugi Iwasawa, Takafumi Kadono, Naohito Hatta, Shoichiro Minami, Eiji Nakano, Dai Ogata, Satoshi Fukushima, Hisashi Uhara, Kenta Nakama, Yasuhiro Nakamura\",\"doi\":\"10.1200/GO-24-00644\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Adjuvant anti-PD-1 (adj PD-1) antibodies are extensively used to improve survival in patients with resected melanoma. Clinical trials on adj PD-1 antibodies have revealed significant improvements in recurrence-free survival (RFS); however, few of these trials have included patients with acral melanoma (AM).</p><p><strong>Methods: </strong>Clinical data were retrospectively collected from Japanese patients who underwent resection of stage III sole AM between 2014 and 2021. Survival outcomes, including RFS, distant metastasis-free survival (DMFS), and overall survival (OS), were compared between patients without adjuvant therapy (OBS group) and those receiving adj PD-1 group.</p><p><strong>Results: </strong>This study included 139 patients (OBS: 79; adj PD-1: 60), with a median follow-up of 2.6 years. The baseline characteristics were comparable, except for age and nodal metastasis. No significant differences in survival were observed between the OBS and adj PD-1 groups (3-year RFS: 36.7% <i>v</i> 27.5%, <i>P</i> = .13; 3-year DMFS: 51.0% <i>v</i> 45.3%, <i>P</i> = .51; 3-year OS: 65.3% <i>v</i> 67.4%, <i>P</i> = .45). Multivariate analysis showed no survival benefit of adj PD-1 (RFS: hazard ratio [HR], 1.25, <i>P</i> = .29; DMFS: HR, 1.03, <i>P</i> = .89; and OS: HR, 0.69, <i>P</i> = .23). Each survival outcome after propensity score matching confirmed no significant difference between the matched OBS group (n = 52) and adj PD-1 group (n = 52; 3-year RFS: 34.3% <i>v</i> 25.9%, <i>P</i> = .22; 3-year DMFS: 45.6% <i>v</i> 46.5%, <i>P</i> = .85; 3-year OS: 60.7% <i>v</i> 68.9%, <i>P</i> = .29).</p><p><strong>Conclusion: </strong>Adj PD-1 did not improve the prognosis in sole AM. However, further studies are essential to evaluate the efficacy of the adj anti-PD-1 antibody in AM.</p>\",\"PeriodicalId\":14806,\"journal\":{\"name\":\"JCO Global Oncology\",\"volume\":\"11 \",\"pages\":\"e2400644\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2025-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12004986/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JCO Global Oncology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1200/GO-24-00644\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/4/4 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JCO Global Oncology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1200/GO-24-00644","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/4/4 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的：辅助抗PD-1 （adj PD-1）抗体被广泛用于提高黑色素瘤切除术患者的生存率。临床试验显示，adj PD-1抗体显著改善无复发生存期（RFS）；然而，这些试验中很少包括肢端黑色素瘤（AM）患者。方法：回顾性收集2014年至2021年期间接受III期鞋底AM切除术的日本患者的临床资料。生存结果，包括RFS，远端无转移生存（DMFS）和总生存（OS），比较无辅助治疗组（OBS组）和接受形容词PD-1组的患者。结果：本研究纳入139例患者(OBS: 79；PD-1: 60)，中位随访时间为2.6年。除了年龄和淋巴结转移外，基线特征具有可比性。OBS组和adj PD-1组的生存率无显著差异(3年RFS: 36.7% vs 27.5%, P = 0.13；3年DMFS: 51.0% vs 45.3%, P = 0.51；3年OS: 65.3% vs 67.4%, P = 0.45)。多因素分析显示，adj - PD-1无生存获益(RFS：风险比[HR]， 1.25, P = 0.29；Dmfs: hr, 1.03, p = 0.89；OS: HR为0.69,P = 0.23)。倾向评分匹配后的各生存结局均证实匹配的OBS组（n = 52）与adj PD-1组(n = 52；3年RFS: 34.3% vs 25.9%, P = 0.22；3年DMFS: 45.6% vs 46.5%, P = 0.85；3年OS: 60.7% vs 68.9%, P = 0.29)。结论：Adj - PD-1对单纯AM的预后无改善作用。然而，还需要进一步的研究来评估抗pd -1抗体在AM中的作用。
Adjuvant Anti-PD-1 Monotherapy Versus Observation for Stage III Acral Melanoma of the Sole: A Multicenter Retrospective Study in Japanese Patients.
Purpose: Adjuvant anti-PD-1 (adj PD-1) antibodies are extensively used to improve survival in patients with resected melanoma. Clinical trials on adj PD-1 antibodies have revealed significant improvements in recurrence-free survival (RFS); however, few of these trials have included patients with acral melanoma (AM).
Methods: Clinical data were retrospectively collected from Japanese patients who underwent resection of stage III sole AM between 2014 and 2021. Survival outcomes, including RFS, distant metastasis-free survival (DMFS), and overall survival (OS), were compared between patients without adjuvant therapy (OBS group) and those receiving adj PD-1 group.
Results: This study included 139 patients (OBS: 79; adj PD-1: 60), with a median follow-up of 2.6 years. The baseline characteristics were comparable, except for age and nodal metastasis. No significant differences in survival were observed between the OBS and adj PD-1 groups (3-year RFS: 36.7% v 27.5%, P = .13; 3-year DMFS: 51.0% v 45.3%, P = .51; 3-year OS: 65.3% v 67.4%, P = .45). Multivariate analysis showed no survival benefit of adj PD-1 (RFS: hazard ratio [HR], 1.25, P = .29; DMFS: HR, 1.03, P = .89; and OS: HR, 0.69, P = .23). Each survival outcome after propensity score matching confirmed no significant difference between the matched OBS group (n = 52) and adj PD-1 group (n = 52; 3-year RFS: 34.3% v 25.9%, P = .22; 3-year DMFS: 45.6% v 46.5%, P = .85; 3-year OS: 60.7% v 68.9%, P = .29).
Conclusion: Adj PD-1 did not improve the prognosis in sole AM. However, further studies are essential to evaluate the efficacy of the adj anti-PD-1 antibody in AM.
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