Abstract
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-naïve 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-naïve 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.
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The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.
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Abbreviations
- AEs:
-
Adverse events
- ALT:
-
Alanine aminotransferase
- AST:
-
Aspartate aminotransferase
- BRAF:
-
V-Raf murine sarcoma viral oncogene homolog B
- CI:
-
Confidence interval
- CR:
-
Complete response
- DCR:
-
Disease control rate
- DDC:
-
Duration of disease control
- ECOG:
-
Eastern cooperative oncology group
- ICIs:
-
Immune checkpoint inhibitors
- LDH:
-
Lactate dehydrogenase
- MDM2:
-
Murine double minute 2
- NRAS:
-
Neuroblastoma rat sarcoma viral oncogene homolog
- ORR:
-
Objective response rate
- OS:
-
Overall survival
- PD-1:
-
Programmed cell death protein 1
- PD-L1:
-
Programmed death-ligand 1
- PFS:
-
Progression-free survival
- RECIST:
-
Response evaluation criteria
- PR:
-
Partial response
- SD:
-
Stable disease
- TMB:
-
Tumor mutation burden
- ULN:
-
Upper limits of normal
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Funding
This study was funded by the Foundation of Sun Yat-sen University Cancer Center for Distinguished Young Scholar (grant number: PT04180201), National Natural Science Foundation of China (grant number: 81802725) and Foundation of Chinese Society of Clinical Oncology (grant number: Y-SY201901-0247).
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X-sZ: study design and concepts. J-jL, J-hW, YD, D-dL, X-zW, J-jZ, HJ, XL, F-xH: data acquisition. J-jL, J-hW, YD: quality control of data, algorithms, data analysis, and interpretation. J-jL, J-hW: statistical analysis, manuscript preparation, and manuscript editing. J-jL, J-hW and YD contribute equally to this article. All authors read and approved the final manuscript.
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Li, Jj., Wang, Jh., Dingv, Y. et al. Efficacy and safety of anti-PD-1 inhibitor combined with nab-paclitaxel in Chinese patients with refractory melanoma. J Cancer Res Clin Oncol 148, 1159–1169 (2022). https://doi.org/10.1007/s00432-021-03700-9
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DOI: https://doi.org/10.1007/s00432-021-03700-9