دورية أكاديمية
Neoadjuvant talimogene laherparepvec plus surgery versus surgery alone for resectable stage IIIB-IVM1a melanoma: a randomized, open-label, phase 2 trial.
| العنوان: | Neoadjuvant talimogene laherparepvec plus surgery versus surgery alone for resectable stage IIIB-IVM1a melanoma: a randomized, open-label, phase 2 trial. |
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| المؤلفون: | Dummer, R, Gyorki, D E, Hyngstrom, J, Berger, A C, Conry, R, Demidov, L, Sharma, A, Treichel, S A, Radcliffe, H, Gorski, K S, Anderson, A, Chan, E, Faries, M, Ross, M I |
| المصدر: | Articles, Abstracts, and Reports |
| بيانات النشر: | Providence St. Joseph Health Digital Commons |
| سنة النشر: | 2021 |
| المجموعة: | Providence St. Joseph Health Digital Commons |
| مصطلحات موضوعية: | california, jwci, Adult, Aged, Biological Products, Combined Modality Therapy, Disease-Free Survival, Female, Herpesvirus 1, Human, Humans, Immunotherapy, Male, Melanoma, Middle Aged, Neoadjuvant Therapy, Neoplasm Recurrence, Local, Neoplasm Staging, Oncolytic Virotherapy, Oncolytic Viruses, Oncology, Surgery |
| الوصف: | Talimogene laherparepvec (T-VEC) is a herpes simplex virus type 1-based intralesional oncolytic immunotherapy approved for the treatment of unresectable melanoma. The present, ongoing study aimed to estimate the treatment effect of neoadjuvant T-VEC on recurrence-free survival (RFS) of patients with advanced resectable melanoma. An open-label, phase 2 trial (NCT02211131) was conducted in 150 patients with resectable stage IIIB-IVM1a melanoma who were randomized to receive T-VEC followed by surgery (arm 1, n = 76) or surgery alone (arm 2, n = 74). The primary endpoint was a 2-year RFS in the intention-to-treat population. Secondary and exploratory endpoints included overall survival (OS), pathological complete response (pCR), safety and biomarker analyses. The 2-year RFS was 29.5% in arm 1 and 16.5% in arm 2 (overall hazard ratio (HR) = 0.75, 80% confidence interval (CI) = 0.58-0.96). The 2-year OS was 88.9% for arm 1 and 77.4% for arm 2 (overall HR = 0.49, 80% CI = 0.30-0.79). The RFS and OS differences between arms persisted at 3 years. In arm 1, 17.1% achieved a pCR. Increased CD8+ density correlated with clinical outcomes in an exploratory analysis. Arm 1 adverse events were consistent with previous reports for T-VEC. The present study met its primary endpoint and estimated a 25% reduction in the risk of disease recurrence for neoadjuvant T-VEC plus surgery versus upfront surgery for patients with resectable stage IIIB-IVM1a melanoma. |
| نوع الوثيقة: | text |
| اللغة: | unknown |
| العلاقة: | https://digitalcommons.psjhealth.org/publications/5351Test; https://pubmed.ncbi.nlm.nih.gov/34608333Test |
| الإتاحة: | https://digitalcommons.psjhealth.org/publications/5351Test https://pubmed.ncbi.nlm.nih.gov/34608333Test |
| رقم الانضمام: | edsbas.BC8D204D |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |