解剖位置预测反应率：超过1100个TVEC周期的真实世界结果描述：对前瞻性维护数据库的回顾性回顾。

IF 6.4 1区医学 Q1 SURGERY

Annals of surgery Pub Date : 2025-09-10 DOI:10.1097/sla.0000000000006931

Kristen E Dougherty,Gray B Peery,Chris B Agala,Veronica P Pham,Morgan E Gwynn,Michael O Meyers,Karyn B Stitzenberg,Jonathan D Sorah,Patricia K Long,C Paige Jones,Frances A Collichio,David W Ollila

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引用次数: 0

摘要

目的：我们假设转移性黑色素瘤的解剖位置与TVEC治疗反应的程度有关。摘要：tvec是fda批准的首个可注射溶瘤病毒，用于治疗不可切除的IIIB-IV期转移性黑色素瘤患者。先前公布的实际结果显示，TVEC的完全缓解率（CR）为39%。方法分析2015年12月- 2023年12月TVEC治疗患者的前瞻性单中心黑色素瘤数据库。根据治疗的解剖部位对患者进行分组。使用频率、平均值、中位数、比较和比例检验（使用卡方检验、Fisher精确检验和Wilcoxon秩和检验）总结患者特征。我们使用未经调整的广义估计方程模型和重复测量来估计局部治疗反应和解剖部位的相对风险比。结果纳入173例患者：中位年龄75岁；以男性112例（64.7%）和白人170例（98.3%）为主。我们分析了190个TVEC治疗方案，共1133个周期，中位6个周期/例（1-18）。中位随访41个月（11-107）。在治疗的解剖部位中，头颈部73例（38.4%），下肢73例（38.4%），躯干25例（13.2%），上肢19例（10%）。79例（41.6%）出现CR， 41例（21.6%）出现部分缓解（PR）， 37例（19.5%）出现混合缓解/疾病稳定，33例（17.4%）出现疾病进展。在CR组中，头颈部40例（50.6%），下肢24例（30.4%），躯干11例（13.9%），上肢4例（5.1%）。结论：这是基于解剖位置评估TVEC治疗转移性黑色素瘤患者实际结果的最大前瞻性队列研究。TVEC是一种耐受性良好、持久的治疗晚期黑色素瘤的方法。我们的研究结果表明，头颈部转移具有最高的CR率，应考虑将其作为选择患者的一线治疗。

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Anatomic Location Predicts Response Rates: Real World Outcomes with Over 1,100 Cycles of Talimogene Laherparepvec (TVEC) Description: A Retrospective Review of a Prospectively Maintained Database.

OBJECTIVE We hypothesized that anatomic location of metastatic melanoma is associated with the degree of therapeutic response to TVEC. SUMMARY TVEC is the first FDA-approved injectable oncolytic virus to treat unresectable stage IIIB-IV metastatic melanoma patients. Previously published real-world outcomes demonstrated a 39% complete response (CR) rate to TVEC. METHODS A prospective single-center melanoma database of patients treated with TVEC from December 2015-December 2023 was analyzed. Patients were categorized into groups based on treated anatomic sites. Patient characteristics were summarized using frequencies, means, medians, comparisons, and tests of proportions using chi-square, Fisher's exact, and Wilcoxon rank sum tests. We used unadjusted generalized estimating equation models with repeated measures to estimate relative risk ratios for local treatment response and anatomic sites. RESULTS 173 patients were included: median age 75 years; majority male (n=112, 64.7%) and white (n=170, 98.3%). We analyzed 190 therapeutic plans of TVEC with a total of 1,133 cycles, median 6 cycles/patient (1-18). Median follow-up was 41 months (11-107). Of the anatomic sites treated, 73 were head/neck (38.4%), 73 lower extremity (38.4%), 25 torso (13.2%), and 19 upper extremity (10%). CR was seen in 79 (41.6%), partial response (PR) in 41 (21.6%), mixed response/stable disease in 37 (19.5%), and disease progression in 33 (17.4%). In the CR group, 40 (50.6%) responses were head/neck, 24 (30.4%) lower extremity, 11 (13.9%) torso, and 4 (5.1%) upper extremity. CONCLUSIONS This is the largest prospective cohort evaluating real-world outcomes of metastatic melanoma patients treated with TVEC based on anatomic location. TVEC is a well-tolerated, durable treatment for advanced staged melanoma. Our findings demonstrate head/neck metastases have the greatest CR rate and should be considered as a possible first-line therapy in select patients.

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来源期刊

Annals of surgery 医学-外科

CiteScore

14.40

自引率

4.40%

发文量

687

审稿时长

4 months

期刊介绍： The Annals of Surgery is a renowned surgery journal, recognized globally for its extensive scholarly references. It serves as a valuable resource for the international medical community by disseminating knowledge regarding important developments in surgical science and practice. Surgeons regularly turn to the Annals of Surgery to stay updated on innovative practices and techniques. The journal also offers special editorial features such as "Advances in Surgical Technique," offering timely coverage of ongoing clinical issues. Additionally, the journal publishes monthly review articles that address the latest concerns in surgical practice.