Abstract 3270
Background
In China, treatment options for late-stage melanoma, particularly for second-line (2L) therapy, are limited. This retrospective, observational study used electronic medical records (EMRs) of patients (pts) with melanoma treated at Beijing Cancer Hospital (BCH) to describe the treatment pattern and real-world clinical outcomes in locally advanced, metastatic melanoma in China.
Methods
All adult pts with unresectable stage III or IV melanoma who initiated treatment between Jan 1, 2014, and Dec 31, 2015, were eligible. Pts were treated and followed up with regular imaging (every 3 mo). Trained researchers performed additional medical chart reviews to supplement data captured in the EMR database. Complete or partial responses, per RECIST v1.1 were adjudicated case by case. Survival analysis involved the Kaplan-Meier method, pts were censored at last known date alive before Dec 31, 2017.
Results
Of 248 pts included in the study, 40.7% and 30.6% had acral and mucosal histology, respectively; almost all (∼95%) had stage IV melanoma; 221 received first-line (1L) therapy and 116 received 2L therapy (89 received both at BCH within the treatment period). The most common 1L regimens were dacarbazine + cisplatin + recombinant human endostatin (RHE) (36.7%) and paclitaxel + carboplatin + bevacizumab (22.2%). The most common 2L regimens were paclitaxel albumin + carboplatin + bevacizumab (22.4%), paclitaxel + carboplatin + RHE (15.5%) and paclitaxel albumin + cisplatin + RHE (12.1%). Clinical outcomes in pts with advanced melanoma are summarized in the table and are generally unfavorable: ORR <10%; median PFS <4 months; median OS < 1 year. Median DOR was 9.1 mo for 1L and 7.5 mo for 2L therapy.Table: 1283P
| 1L Therapy (N = 221) | 2L Therapy (N = 116) | |
|---|---|---|
| Response | ||
| CR, n | 2 | 0 |
| PR, n | 12 | 4 |
| ORR, % (95% CI) | 6.3% (3.5-10.4) | 3.4% (0.9-8.6) |
| Median DOR (range), months | 9.1 (1.7-28.4+) | 7.5 (4.6-24.2+) |
| Median PFS (95% CI), months | 3.5 (2.9-4.2) | 2.3 (2.0-3.0) |
| 12-month PFS rate | 10.6% | 5.2% |
| Deaths, n (%) | 171 (77.4) | 101 (87.1) |
| Median OS (95% CI), months | 10.5 (9.2-12.1) | 7.5 (6.5-8.7) |
| 12-month OS rate | 43.5% | 30.5% |
CI, confidence interval; CR, complete response; DOR, duration of response; 1L, first-line therapy; 2L, second-line therapy; ORR, objective response rate; OS, overall survival; PR, partial response; PFS, progression-free survival.
Conclusions
The poor outcomes observed in this study suggest a high degree of unmet medical need for advanced melanoma in China in both the 1L and 2L settings.
Clinical trial identification
Legal entity responsible for the study
Merck & Co., Inc.
Funding
Merck & Co., Inc.
Editorial Acknowledgement
Medical writing and/or editorial assistance was provided by Doyel Mitra, PhD, of the ApotheCom pembrolizumab team, Yardley, PA, USA. This assistance was funded by Merck & Co., Inc., Kenilworth, NJ, USA.
Disclosure
C. Cui, X. Yan, L. Si, Z. Chi, X. Sheng, X. Wang, L. Mao, B. Tang, L. Zhou, X. Bai, S. Li: Research funding: Merck & Co., Inc. S. Liu, J. Li, J. Ge, H. Wu: Employee, Stockholder: MSD China. A. Deitz: Employee, Stockholder: Merck & Co., Inc. B. Lian: Research funding: Merck. B. Li: Employee: MSD China. J. Guo: Research funding, Advisory board: Merck & Co., Inc.