Anti-PD-1 antibody monotherapy versus anti-PD-1 plus anti-CTLA-4 combination therapy as first-line immunotherapy in unresectable or metastatic mucosal melanoma: a retrospective, multicenter study of 329 Japanese cases (JMAC study)
| العنوان: | Anti-PD-1 antibody monotherapy versus anti-PD-1 plus anti-CTLA-4 combination therapy as first-line immunotherapy in unresectable or metastatic mucosal melanoma: a retrospective, multicenter study of 329 Japanese cases (JMAC study) |
|---|---|
| المؤلفون: | Shintaro Saito, Y. Umeda, Yukiko Kiniwa, Yukiko Teramoto, Takashi Inozume, N. Yamazaki, Dai Ogata, Satoshi Fukushima, Noriki Fujimoto, Osamu Yamasaki, Tatsuya Takenouchi, Yasuo Nakai, A. Takahashi, Ryo Tanaka, Yasuhiro Nakamura, S. Yoshikawa, Takehiro Onuma, M. Otsuka, Kotaro Nagase, Yutaka Kuwatsuka, S. Matsushita, Natsuki Baba, Taisuke Matsuya, Motoo Nomura, Kenjiro Namikawa, Taiki Isei, Takahide Kaneko, Masazumi Onishi, Hiroshi Kato, Takeo Maekawa, Atsushi Otsuka |
| المصدر: | ESMO Open |
| بيانات النشر: | Elsevier BV, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | anti-PD-1 antibody, Cancer Research, medicine.medical_specialty, Skin Neoplasms, anti-CTLA-4 antibody, Combination therapy, chemical and pharmacologic phenomena, Ipilimumab, Pembrolizumab, Gastroenterology, Japan, Internal medicine, medicine, Humans, CTLA-4 Antigen, mucosal melanoma, ipilimumab, Adverse effect, Melanoma, Aged, Retrospective Studies, Original Research, nivolumab, business.industry, Hazard ratio, Mucosal melanoma, medicine.disease, Confidence interval, Oncology, Immunotherapy, pembrolizumab, Nivolumab, business, medicine.drug |
| الوصف: | Background Anti-programmed cell death protein 1 (PD-1) antibody monotherapy (PD1) has led to favorable responses in advanced non-acral cutaneous melanoma among Caucasian populations; however, recent studies suggest that this therapy has limited efficacy in mucosal melanoma (MCM). Thus, advanced MCM patients are candidates for PD1 plus anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) combination therapy (PD1 + CTLA4). Data on the efficacy of immunotherapy in MCM, however, are limited. We aimed to compare the efficacies of PD1 and PD1 + CTLA4 in Japanese advanced MCM patients. Patients and methods We retrospectively assessed advanced MCM patients treated with PD1 or PD1 + CTLA4 at 24 Japanese institutions. Patient baseline characteristics, clinical responses (RECIST), progression-free survival (PFS), and overall survival (OS) were estimated using Kaplan–Meier analysis, and toxicity was assessed to estimate the efficacy and safety of PD1 and PD1 + CTLA4. Results Altogether, 329 patients with advanced MCM were included in this study. PD1 and PD1 + CTLA4 were used in 263 and 66 patients, respectively. Baseline characteristics were similar between both treatment groups, except for age (median age 71 versus 65 years; P < 0.001). No significant differences were observed between the PD1 and PD1 + CTLA4 groups with respect to objective response rate (26% versus 29%; P = 0.26) or PFS and OS (median PFS 5.9 months versus 6.8 months; P = 0.55, median OS 20.4 months versus 20.1 months; P = 0.55). Cox multivariate survival analysis revealed that PD1 + CTLA4 did not prolong PFS and OS (PFS: hazard ratio 0.83, 95% confidence interval 0.58-1.19, P = 0.30; OS: HR 0.89, 95% confidence interval 0.57-1.38, P = 0.59). The rate of ≥grade 3 immune-related adverse events was higher in the PD1 + CTLA4 group than in the PD1 group (53% versus 17%; P < 0.001). Conclusions First-line PD1 + CTLA4 demonstrated comparable clinical efficacy to PD1 in Japanese MCM patients, but with a higher rate of immune-related adverse events. Highlights • Anti-PD-1 plus anti-CTLA-4 antibody therapy (PD1 + CTLA4) is an option for patients with advanced mucosal melanoma (MCM). • Data on the efficacy of PD1 + CTLA4 compared with PD-1 monotherapy (PD1) for MCM, however, are limited. • We retrospectively analyzed data from 329 Japanese patients with advanced MCM treated with PD1 or PD1 + CTLA4. • No significant differences in objective response rate, progression-free survival, or overall survival were observed. • Immune-related adverse events resulting in treatment cessation were higher in the PD1 + CTLA4 group. |
| تدمد: | 2059-7029 |
| DOI: | 10.1016/j.esmoop.2021.100325 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d33186286659bc630c7c55b23e7c7348 https://doi.org/10.1016/j.esmoop.2021.100325 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....d33186286659bc630c7c55b23e7c7348 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20597029 |
|---|---|
| DOI: | 10.1016/j.esmoop.2021.100325 |