Koizumi Shigeru, Yamazaki Naoya, Ichigozaki Yuki, Kitagawa Hiroshi, Kiniwa Yukiko, Sato Sayuri, Takai Toshihiro, Doi Reiichi, Ito Takamichi, Yasuda Masahito, Kuwatsuka Yutaka, Maekawa Takeo, Asai Jun, Miyagawa Takuya, Matsushita Shigeto, Funakoshi Takeru, Yamamoto Yosuke, Inozume Takashi, Kishi Akiko, Takenouchi Tatsuya, Kokubu Hiraku, Ito Shusaku, Umeda Yoshiyasu, Yamamoto Yuki, Ishizuki Shoichiro, Iino Shiro, Uchi Hiroshi, Nakagawa Tomoe, Inafuku Kazuhiro, Haga Takahiro, Kaneko Takahide, Nakagawa Masahiro, Kamiya Hideki, Arima Masaru, Hoashi Toshihiko, Hiura Azusa, Kanazawa Nobuo, Manabe Keiko, Ishikawa Masashi, Asagoe Kenji, Iwasawa Utsugi, Kadono Takafumi, Hatta Naohito, Minami Shoichiro, Nakano Eiji, Ogata Dai, Fukushima Satoshi, Uhara Hisashi, Nakama Kenta, Nakamura Yasuhiro
Department of Skin Oncology/Dermatology, Saitama Medical University International Medical Center, Saitama, Japan.
Department of Dermatology, Chiba University, Chiba, Japan.
JCO Glob Oncol. 2025 Apr;11:e2400644. doi: 10.1200/GO-24-00644. Epub 2025 Apr 4.
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).
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.
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% 27.5%, = .13; 3-year DMFS: 51.0% 45.3%, = .51; 3-year OS: 65.3% 67.4%, = .45). Multivariate analysis showed no survival benefit of adj PD-1 (RFS: hazard ratio [HR], 1.25, = .29; DMFS: HR, 1.03, = .89; and OS: HR, 0.69, = .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% 25.9%, = .22; 3-year DMFS: 45.6% 46.5%, = .85; 3-year OS: 60.7% 68.9%, = .29).
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.
辅助性抗程序性死亡蛋白1（adj PD-1）抗体被广泛用于提高黑色素瘤切除术后患者的生存率。关于adj PD-1抗体的临床试验显示无复发生存期（RFS）有显著改善；然而，这些试验中很少纳入肢端黑色素瘤（AM）患者。
回顾性收集2014年至2021年间在日本接受III期足底AM切除术患者的临床资料。比较未接受辅助治疗的患者（观察组）和接受adj PD-1治疗的患者的生存结局，包括RFS、无远处转移生存期（DMFS）和总生存期（OS）。
本研究纳入139例患者（观察组：79例；adj PD-1组：60例），中位随访时间为2.6年。除年龄和淋巴结转移外，基线特征具有可比性。观察组和adj PD-1组之间未观察到生存差异有统计学意义（3年RFS：36.7%对27.5%，P = 0.13；3年DMFS：51.0%对45.3%，P = 0.51；3年OS：65.3%对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，0.69，P = 0.23）。倾向评分匹配后的各生存结局证实匹配后的观察组（n = 52）和adj PD-1组（n = 52；3年RFS：34.3%对25.9%，P = 0.22；3年DMFS：45.6%对46.5%，P = 0.85；3年OS：60.7%对68.9%，P = 0.29）之间无显著差异。
adj PD-1并未改善足底AM的预后。然而，进一步研究对于评估adj抗PD-1抗体在AM中的疗效至关重要。
