TY - JOUR
T1 - Adjuvant Anti-PD-1 Antibody Therapy for Advanced Melanoma
T2 - A Multicentre Study of 78 Japanese Cases
AU - Muto, Yusuke
AU - Kambayashi, Yumi
AU - Kato, Hiroshi
AU - Fukushima, Satoshi
AU - Ito, Takamichi
AU - Maekawa, Takeo
AU - Fujisawa, Yasuhiro
AU - Yoshino, Koji
AU - Hiroshi, Uchi
AU - Matsushita, Shigeto
AU - Yamamoto, Yuki
AU - Amagai, Ryo
AU - Ohuchi, Kentaro
AU - Hashimoto, Akira
AU - Fujimura, Taku
N1 - Funding Information:
Disclosures: K, HU, YF, SF, SM, and TF have received honoraria from MSD and Ono Pharma. TM and KY have received honoraria from Ono Pharma. YF, SF, and TF have received research funding from Ono Pharma.
Publisher Copyright:
© 2022, Medical Journals/Acta D-V. All rights reserved.
PY - 2022
Y1 - 2022
N2 - Anti-PD-1 antibodies (Abs) are among the optimal adjuvant therapies for melanoma at high risk of recurrence, especially BRAF wild-type melanoma, but the anti-tumour effects of anti-PD-1 Abs in the adjuvant setting for acral melanoma have not been evaluated previously. The aim of this study was to analyse the efficacy and safety profiles of anti-PD-1 Ab monotherapy in the adjuvant setting in an Asian population including a high ratio of acral melanoma. The efficacy and safety profiles of anti-PD-1 Ab monotherapy in the adjuvant setting were retrospectively analysed in 78 Japanese patients with advanced melanoma, including 31 cases (40%) of acral melanoma. Overall relapse-free survival was 60.3% (47 of 78 cases, 95% confidence interval (CI) 49.2–70.4%), and 39.7% of patients (31 of 78 patients, 95% CI 29.6–50.8%) relapsed during the adjuvant PD-1 Ab treatment. Six cases (7.9%) discontinued the protocol due to serious adverse events. One case (1.3%) discontinued the protocol due to trauma. The relapse-free survival of acral melanoma was 25.8%, whereas that of high cumulative sun damage was 60.0%, and that of low cumulative sun damage was 57.1%. The acral type had a significantly lower 12-month relapse-free survival than other cutaneous types (p = 0.029). The acral type appeared to be an independent prognostic factor on multivariate analysis (p = 0.015). Adverse events due to anti-PD-1 antibody were observed in 37.1% overall. The results of this study suggest that anti-PD-1 Ab therapy in the adjuvant setting is less effective for acral melanoma than for other cutaneous types.
AB - Anti-PD-1 antibodies (Abs) are among the optimal adjuvant therapies for melanoma at high risk of recurrence, especially BRAF wild-type melanoma, but the anti-tumour effects of anti-PD-1 Abs in the adjuvant setting for acral melanoma have not been evaluated previously. The aim of this study was to analyse the efficacy and safety profiles of anti-PD-1 Ab monotherapy in the adjuvant setting in an Asian population including a high ratio of acral melanoma. The efficacy and safety profiles of anti-PD-1 Ab monotherapy in the adjuvant setting were retrospectively analysed in 78 Japanese patients with advanced melanoma, including 31 cases (40%) of acral melanoma. Overall relapse-free survival was 60.3% (47 of 78 cases, 95% confidence interval (CI) 49.2–70.4%), and 39.7% of patients (31 of 78 patients, 95% CI 29.6–50.8%) relapsed during the adjuvant PD-1 Ab treatment. Six cases (7.9%) discontinued the protocol due to serious adverse events. One case (1.3%) discontinued the protocol due to trauma. The relapse-free survival of acral melanoma was 25.8%, whereas that of high cumulative sun damage was 60.0%, and that of low cumulative sun damage was 57.1%. The acral type had a significantly lower 12-month relapse-free survival than other cutaneous types (p = 0.029). The acral type appeared to be an independent prognostic factor on multivariate analysis (p = 0.015). Adverse events due to anti-PD-1 antibody were observed in 37.1% overall. The results of this study suggest that anti-PD-1 Ab therapy in the adjuvant setting is less effective for acral melanoma than for other cutaneous types.
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U2 - 10.2340/actadv.v102.678
DO - 10.2340/actadv.v102.678
M3 - Article
C2 - 35670329
AN - SCOPUS:85136340018
SN - 0001-5555
VL - 102
JO - Acta Dermato-Venereologica
JF - Acta Dermato-Venereologica
M1 - adv00756
ER -