PMID- 34181096 OWN - NLM STAT- MEDLINE DCOM- 20220420 LR - 20220909 IS - 1432-1335 (Electronic) IS - 0171-5216 (Linking) VI - 148 IP - 5 DP - 2022 May TI - Efficacy and safety of anti-PD-1 inhibitor combined with nab-paclitaxel in Chinese patients with refractory melanoma. PG - 1159-1169 LID - 10.1007/s00432-021-03700-9 [doi] AB - PURPOSE: This retrospective study aimed to evaluate the combined effect of anti-PD-1 inhibitor and nanoparticle albumin-bound (nab)-paclitaxel for refractory melanoma among Chinese patients. METHODS: Data from January 2018 to March 2021 were retrospectively collected and analyzed. Sixty-four patients were eligible for analysis from a single Chinese cancer center. RESULTS: The median follow-up was 16.0 months at data cutoff. The objective response rate (ORR) was 29.7%, and the disease control rate (DCR) was 67.2% in all patients. Treatment-naive patients had significantly higher ORR than pretreated patients (42.9% vs 13.8%, p = 0.011). Cutaneous melanoma patients with NRAS gene mutation benefited more than non-mutated patients (DCR of 100% vs. 54.5%) (p = 0.030). The median progression-free survival (mPFS) of all patients was 5.2 months and the duration of response was 10.8 months. Median duration of disease control was 7.7 months. Prior treatment-naive patients had significantly longer PFS than those who accepted prior treatments (7.2 vs. 5.1 months, p = 0.024). Patients with abnormally high LDH level had shorter mPFS (3.6 months vs. 6.6 months, p = 0.020). Median overall survival was not reached in this study. Most patients experienced adverse events (AEs), but only 17.2% of patients experienced grade 3 severe AEs. The most common AEs were alopecia (89.1%), neutropenia (18.8%), pruritus (15.6%), and arthralgia (14.1%). Some patients had immune related AEs (irAEs). No grade 4 or 5 AEs were observed. Patients with >/= 3 AEs or with irAEs had longer mPFS (p < 0.05). CONCLUSION: Nab-paclitaxel combined with PD-1 antibody is a well-tolerated and effective regimen for Chinese patients with refractory melanoma. CI - (c) 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. FAU - Li, Jing-Jing AU - Li JJ AUID- ORCID: 0000-0002-4410-2629 AD - Biotherapy Center, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, China. FAU - Wang, Jiu-Hong AU - Wang JH AD - Biotherapy Center, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, China. FAU - Dingv, Ya AU - Dingv Y AD - Biotherapy Center, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, China. FAU - Li, Dan-Dan AU - Li DD AD - Biotherapy Center, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, China. FAU - Wen, Xi-Zhi AU - Wen XZ AD - Biotherapy Center, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, China. FAU - Zhao, Jing-Jing AU - Zhao JJ AD - Biotherapy Center, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, China. FAU - Jiang, Hang AU - Jiang H AD - Biotherapy Center, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, China. FAU - Liu, Xing AU - Liu X AD - Biotherapy Center, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, China. FAU - Huang, Fu-Xue AU - Huang FX AD - Biotherapy Center, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, China. FAU - Zhang, Xiao-Shi AU - Zhang XS AUID- ORCID: 0000-0003-3011-1134 AD - Biotherapy Center, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, China. zhangxsh@sysucc.org.cn. LA - eng GR - 81802725/National Natural Science Foundation of China/ GR - PT04180201/Foundation of Sun Yat-sen University Cancer Center for Distinguished Young Scholar/ PT - Journal Article DEP - 20210628 PL - Germany TA - J Cancer Res Clin Oncol JT - Journal of cancer research and clinical oncology JID - 7902060 RN - 0 (130-nm albumin-bound paclitaxel) RN - 0 (Albumins) RN - 0 (Immune Checkpoint Inhibitors) RN - P88XT4IS4D (Paclitaxel) SB - IM MH - Albumins/adverse effects MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - China MH - Humans MH - Immune Checkpoint Inhibitors MH - *Melanoma/drug therapy/genetics MH - Paclitaxel/adverse effects MH - Retrospective Studies MH - *Skin Neoplasms/etiology OTO - NOTNLM OT - Anti-PD-1 OT - Immune checkpoint inhibitors OT - Melanoma OT - Mucosal malignant melanoma OT - Nab-paclitaxel EDAT- 2021/06/29 06:00 MHDA- 2022/04/21 06:00 CRDT- 2021/06/28 12:28 PHST- 2021/05/12 00:00 [received] PHST- 2021/06/14 00:00 [accepted] PHST- 2021/06/29 06:00 [pubmed] PHST- 2022/04/21 06:00 [medline] PHST- 2021/06/28 12:28 [entrez] AID - 10.1007/s00432-021-03700-9 [pii] AID - 10.1007/s00432-021-03700-9 [doi] PST - ppublish SO - J Cancer Res Clin Oncol. 2022 May;148(5):1159-1169. doi: 10.1007/s00432-021-03700-9. Epub 2021 Jun 28.