Division of Surgical Oncology and Endocrine Surgery, Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Department of Cutaneous Oncology, Moffitt Cancer Center, Tampa, FL.
J Am Coll Surg. 2019 Apr;228(4):644-649. doi: 10.1016/j.jamcollsurg.2018.12.027. Epub 2019 Jan 25.
Talimogene laherparepvec (TVEC) is an FDA-approved oncolytic herpes virus used to treat unresectable stage IIIB to IV metastatic melanoma via intralesional injection. This study aims to characterize the efficacy TVEC in patients with unresectable stage IIIB to IV melanoma.
We performed a multi-institutional, IRB-approved review of all patients who received TVEC at 3 centers from October 2015 to October 2018. Clinicopathologic characteristics, TVEC treatment data, and outcomes were assessed.
One hundred and twenty-one patients received TVEC, of which 80 patients had available treatment response data with at least 3-month follow-up. Anatomic sites treated were 19 (24%) head and neck, 9 (11%) upper extremity, 12 (15%) torso, and 40 (50%) lower extremity. Thirty-four (42.5%) patients did not receive therapy before TVEC. Side effects were mild and self-limited, most commonly flu-like symptoms seen in 22 (28%) patients. Median follow-up was 9 months (range 3 to 28 months), with complete local response in 31 (39%) and partial response in 14 (18%) patients. Of complete responders, 29 (37%) had no evidence of disease at last follow-up and received a median of 6 (range 2 to 12) cycles of therapy.
Talimogene laherparepvec is a well-tolerated, durable treatment option for patients with unresectable locoregional melanoma, particularly in stage IIIB/C disease. Additionally, we found that TVEC can be administered safely across anatomic sites that are otherwise not amenable to other local therapies.
Talimogene laherparepvec（TVEC）是一种获得 FDA 批准的溶瘤单纯疱疹病毒，用于通过瘤内注射治疗不可切除的 IIIB 期至 IV 期转移性黑色素瘤。本研究旨在评估 TVEC 在不可切除的 IIIB 期至 IV 期黑色素瘤患者中的疗效。
我们对 2015 年 10 月至 2018 年 10 月在 3 个中心接受 TVEC 治疗的所有患者进行了一项多机构、IRB 批准的回顾性研究。评估了临床病理特征、TVEC 治疗数据和结局。
共有 121 例患者接受了 TVEC 治疗，其中 80 例患者有至少 3 个月随访的可评估治疗反应数据。治疗的解剖部位为 19 例（24%）头颈部、9 例（11%）上肢、12 例（15%）躯干和 40 例（50%）下肢。34 例（42.5%）患者在接受 TVEC 治疗前未接受过治疗。副作用轻微且自限，最常见的是 22 例（28%）患者出现流感样症状。中位随访时间为 9 个月（范围 3 至 28 个月），完全局部缓解 31 例（39%），部分缓解 14 例（18%）。完全缓解者中，29 例（37%）末次随访时无疾病证据，接受 TVEC 治疗的中位数为 6 个周期（范围 2 至 12 个）。
Talimogene laherparepvec 是一种耐受性良好、疗效持久的治疗选择，尤其适用于不可切除的局部区域性黑色素瘤患者，尤其是 IIIB/C 期疾病患者。此外，我们发现 TVEC 可以安全地应用于其他局部治疗方法不可用的解剖部位。
