Efficacy and safety of anti-PD-1 inhibitor combined with nab-paclitaxel in Chinese patients with refractory melanoma

J Cancer Res Clin Oncol. 2022 May;148(5):1159-1169. doi: 10.1007/s00432-021-03700-9. Epub 2021 Jun 28.

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.

Keywords: Anti-PD-1; Immune checkpoint inhibitors; Melanoma; Mucosal malignant melanoma; Nab-paclitaxel.

MeSH terms

  • Albumins / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • China
  • Humans
  • Immune Checkpoint Inhibitors
  • Melanoma* / drug therapy
  • Melanoma* / genetics
  • Paclitaxel / adverse effects
  • Retrospective Studies
  • Skin Neoplasms* / etiology

Substances

  • 130-nm albumin-bound paclitaxel
  • Albumins
  • Immune Checkpoint Inhibitors
  • Paclitaxel