NRAS突变的晚期黑色素瘤患者一线化疗疗效分析

Efficacy of chemotherapy as the first-line therapy in patients with advanced melanoma harboring NRAS mutation

目的 探讨一线化疗在NRAS突变晚期黑色素瘤患者中的疗效与安全性。方法 回顾性分析2008年12月至2019年6月就诊于北京大学肿瘤医院的NRAS突变晚期黑色素瘤患者,一线接受单纯化疗,按不同治疗方案分为A组(替莫唑胺/达卡巴嗪+顺铂)和B组(紫杉醇/白蛋白紫杉醇+卡铂),分析其近期疗效及远期生存。结果 全组共纳入148例患者,其中A组108例(73.0%),B组40例(27.0%)。全组一线化疗的客观有效率(ORR)为7.4%;B组患者的ORR为12.5%,高于A组的5.6%,但差异无统计学意义(P=0.281)。全组患者的中位PFS为4.0个月(95%CI:3.0~5.0个月);A、B两组的中位PFS分别为3.8个月(95%CI:2.5~5.1个月)和4.0个月(95%CI:2.6~5.4个月),差异无统计学意义(P=0.757);LDH正常组患者的中位PFS优于LDH升高组,差异有统计学意义(P=0.003)。全组患者的中位OS为12.8个月(95%CI:10.2~15.4个月);A、B两组的中位OS分别为14.3个月(95%CI:11.1~17.6个月)和10.9个月(95%CI:8.0~13.8个月),差异无统计学意义(P=0.677)。ECOG评分0级、LDH正常组患者的中位OS均优于ECOG评分≥1级、LDH升高组患者(P<0.05)。结论 化疗在NRAS突变的晚期黑色素瘤患者中仍有一定疗效,一线含紫杉醇/白蛋白紫杉醇的化疗疗效可能优于含替莫唑胺/达卡巴嗪化疗组。

Objective To evaluate the efficacy and safety of chemotherapy as the first-line therapy in patients with advanced melanoma harboring NRAS mutation. Methods Patients with advanced melanoma harboring NRAS mutation diagnosed in Peking University Cancer Hospital from December 2008 to June 2019 were collected in this study. Total patients were treated with chemotherapy alone and divided into two groups: group A( temozolomide/dacarbazine + cisplatin) and group B( paclitaxel/albumin paclitaxel + carboplatin). The efficacy and survival were observed. Results A total of 148 patients were enrolled,including 108patients( 73. 0%) in group A and 40 patients( 27. 0%) in group B. The objective response rate( ORR) of first-line chemotherapy in the whole group was 7. 4%,and the ORR of group B was higher than group A( 12. 5% vs. 5. 6%) without statistical difference( P =0. 281). The median PFS of 148 patients was 4. 0 months( 95% CI: 3. 0-5. 0 months). The median PFS was 3. 8 months( 95% CI:2. 5-5. 1 months) in group A and 4. 0 months( 95% CI: 2. 6-5. 4 months) in group B,but there was no significant difference between the two groups( P = 0. 757). The median PFS of patients with normal LDH was longer than patients with elevated LDH,and the difference was statistically significant( P = 0. 003). The median OS of 148 patients was 12. 8 months( 95% CI: 10. 2-15. 4 months).The median OS of group A and group B was 14. 3 months( 95% CI: 11. 1-17. 6 months) and 10. 9 months( 95% CI: 8. 0-13. 8months),respectively. There was no significant difference between the two groups( P = 0. 677). ECOG 0 and normal LDH were related to better median OS( P< 0. 05). Conclusion Chemotherapy is still effective in patients with advanced melanoma harboring NRAS mutation. The efficacy of first-line chemotherapy containing paclitaxel/albumin paclitaxel may be better than that of chemotherapy containing temozolomide/dacarbazine.