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A phase II study of talimogene laherparepvec for patients with inoperable locoregional recurrence of breast cancer
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A phase II study of talimogene laherparepvec for patients with inoperable locoregional recurrence of breast cancer
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Journal Article
A phase II study of talimogene laherparepvec for patients with inoperable locoregional recurrence of breast cancer
2021
Overview
Talimogene laherparepvec (T-VEC) is an immunotherapy that generates local tumor lysis and systemic antitumor immune response. We studied the efficacy of intratumoral administration of T-VEC as monotherapy for inoperable locoregional recurrence of breast cancer. T-VEC was injected intratumorally at 10
6
PFU/mL on day 1 (cycle 1), 10
8
PFU/mL on day 22 (cycle 2), and 10
8
PFU/mL every 2 weeks thereafter (cycles ≥ 3). Nine patients were enrolled, 6 with only locoregional disease and 3 with both locoregional and distant disease. No patient completed the planned 10 cycles or achieved complete or partial response. The median number of cycles administered was 4 (range, 3–8). Seven patients withdrew prematurely because of uncontrolled disease progression, 1 withdrew after cycle 3 because of fatigue, and 1 withdrew after cycle 4 for reasons unrelated to study treatment. Median progression-free survival and overall survival were 77 days (95% CI, 63–NA) and 361 days (95% CI, 240–NA). Two patients received 8 cycles with clinically stable disease as the best response. The most common grade 2 or higher adverse event was injection site reaction (n = 7, 78%). Future studies could examine whether combining intratumoral T-VEC with concurrent systemic therapy produces better outcomes.
Publisher
Nature Publishing Group UK,Nature Publishing Group,Nature Portfolio
Subject
/ 692/308
/ 692/4028
/ Adult
/ Aged
/ Biological Products - administration & dosage
/ Biological Products - adverse effects
/ Biological Products - therapeutic use
/ Breast Neoplasms - diagnosis
/ Breast Neoplasms - mortality
/ Female
/ Humanities and Social Sciences
/ Humans
/ Lysis
/ Oncolytic Virotherapy - adverse effects
/ Oncolytic Virotherapy - methods
/ Patients
/ Science
/ Survival
/ T-Lymphocyte Subsets - immunology
/ T-Lymphocyte Subsets - metabolism
/ T-Lymphocyte Subsets - pathology
/ Tumors
