PMID- 33507342
OWN - NLM
STAT- MEDLINE
DCOM- 20210726
LR  - 20240426
IS  - 1432-0851 (Electronic)
IS  - 0340-7004 (Print)
IS  - 0340-7004 (Linking)
VI  - 70
IP  - 8
DP  - 2021 Aug
TI  - T-VEC for stage IIIB-IVM1a melanoma achieves high rates of complete and durable 
      responses and is associated with tumor load: a clinical prediction model.
PG  - 2291-2300
LID - 10.1007/s00262-020-02839-7 [doi]
AB  - BACKGROUND: Talimogene laherparepvec (T-VEC) is a genetically modified herpes 
      simplex type 1 virus and known as an effective oncolytic immunotherapy for 
      injectable cutaneous, subcutaneous and nodal melanoma lesions in stage IIIB-IVM1a 
      patients. This study set out to identify prognostic factors for achieving a 
      complete response that can be used to optimize patient selection for T-VEC 
      monotherapy. METHODS: Patients with stage IIIB-IVM1a melanoma, treated with T-VEC 
      at the Netherlands Cancer Institute between 2016-12 and 2020-01 with a follow-up 
      time > 6 months, were included. Data were collected on baseline characteristics, 
      responses and adverse events (AEs). Uni- and multivariable analyses were 
      conducted, and a prediction model was developed to identify prognostic factors 
      associated with CR. RESULTS: A total of 93 patients were included with a median 
      age of 69 years, median follow-up time was 16.6 months. As best response, 58 
      patients (62%) had a CR, and the overall response rate was 79%. The durable 
      response rate (objective response lasting > 6 months) was 51%. Grade 1-2 AEs 
      occurred in almost every patient. Tumor size, type of metastases, prior treatment 
      with systemic therapy and stage (8Th AJCC) were independent prognostic factors 
      for achieving CR. The prediction model includes the predictors tumor size, type 
      of metastases and number of lesions. CONCLUSIONS: This study shows that 
      intralesional T-VEC monotherapy is able to achieve high complete and durable 
      responses. The prediction model shows that use of T-VEC in patients with less 
      tumor burden is associated with better outcomes, suggesting use earlier in the 
      course of the disease.
CI  - (c) 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part 
      of Springer Nature.
FAU - Stahlie, Emma H A
AU  - Stahlie EHA
AUID- ORCID: 0000-0002-8691-289X
AD  - Departments of Surgical Oncology, Netherlands Cancer Institute-Antoni Van 
      Leeuwenhoek, Plesmanlaan 121, Room U2.38, 1066 CX, Amsterdam, The Netherlands.
FAU - Franke, Viola
AU  - Franke V
AUID- ORCID: 0000-0002-0703-5092
AD  - Departments of Surgical Oncology, Netherlands Cancer Institute-Antoni Van 
      Leeuwenhoek, Plesmanlaan 121, Room U2.38, 1066 CX, Amsterdam, The Netherlands.
FAU - Zuur, Charlotte L
AU  - Zuur CL
AUID- ORCID: 0000-0002-1777-012X
AD  - Head and Neck Surgery and Oncology, Netherlands Cancer Institute-Antoni Van 
      Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
FAU - Klop, Willem M C
AU  - Klop WMC
AUID- ORCID: 0000-0002-6333-971X
AD  - Head and Neck Surgery and Oncology, Netherlands Cancer Institute-Antoni Van 
      Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
FAU - van der Hiel, Bernies
AU  - van der Hiel B
AUID- ORCID: 0000-0001-8158-405X
AD  - Nuclear Medicine, Netherlands Cancer Institute-Antoni Van Leeuwenhoek, 
      Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
FAU - Van de Wiel, Bart A
AU  - Van de Wiel BA
AUID- ORCID: 0000-0001-7716-3308
AD  - Pathology, Netherlands Cancer Institute-Antoni Van Leeuwenhoek, Plesmanlaan 121, 
      1066 CX, Amsterdam, The Netherlands.
FAU - Wouters, Michel W J M
AU  - Wouters MWJM
AUID- ORCID: 0000-0001-6173-0662
AD  - Departments of Surgical Oncology, Netherlands Cancer Institute-Antoni Van 
      Leeuwenhoek, Plesmanlaan 121, Room U2.38, 1066 CX, Amsterdam, The Netherlands.
FAU - Schrage, Yvonne M
AU  - Schrage YM
AUID- ORCID: 0000-0001-7065-514X
AD  - Departments of Surgical Oncology, Netherlands Cancer Institute-Antoni Van 
      Leeuwenhoek, Plesmanlaan 121, Room U2.38, 1066 CX, Amsterdam, The Netherlands.
FAU - van Houdt, Winan J
AU  - van Houdt WJ
AUID- ORCID: 0000-0002-2303-3468
AD  - Departments of Surgical Oncology, Netherlands Cancer Institute-Antoni Van 
      Leeuwenhoek, Plesmanlaan 121, Room U2.38, 1066 CX, Amsterdam, The Netherlands.
FAU - van Akkooi, Alexander C J
AU  - van Akkooi ACJ
AUID- ORCID: 0000-0002-3262-6935
AD  - Departments of Surgical Oncology, Netherlands Cancer Institute-Antoni Van 
      Leeuwenhoek, Plesmanlaan 121, Room U2.38, 1066 CX, Amsterdam, The Netherlands. 
      a.v.akkooi@nki.nl.
LA  - eng
PT  - Journal Article
DEP - 20210128
PL  - Germany
TA  - Cancer Immunol Immunother
JT  - Cancer immunology, immunotherapy : CII
JID - 8605732
RN  - 0 (Biological Products)
RN  - 0 (talimogene laherparepvec)
SB  - IM
MH  - Aged
MH  - Biological Products/*immunology
MH  - Female
MH  - Herpesvirus 1, Human/*immunology
MH  - Humans
MH  - Immunotherapy/methods
MH  - Injections, Intralesional/methods
MH  - Male
MH  - Melanoma/*immunology/pathology/*therapy
MH  - Oncolytic Virotherapy/methods
MH  - Oncolytic Viruses/immunology
MH  - Prognosis
MH  - Skin Neoplasms/*immunology/pathology/*therapy
MH  - Tumor Burden/*immunology
MH  - Melanoma, Cutaneous Malignant
PMC - PMC10991270
OTO - NOTNLM
OT  - Complete response
OT  - Durable response
OT  - Prediction model
OT  - Stage IIIB-IVM1a melanoma
OT  - Talimogene laherparepvec
OT  - Tumor load
COIS- Winan van Houdt declares advisory board/consultancy agreement and research grant 
      received from Amgen. Michel Wouters declares a research grant received from 
      Novartis. Alexander van Akkooi declares advisory board/consultancy agreements for 
      Bristol-Myers Squibb, Novartis, MSD - Merck, Merck - Pfizer, 4SC and Amgen and a 
      research grant received from Bristol-Myers Squibb, Novartis and Amgen. All other 
      others have no relevant financial or non-financial interests to disclose.
EDAT- 2021/01/29 06:00
MHDA- 2021/07/27 06:00
PMCR- 2021/01/28
CRDT- 2021/01/28 12:14
PHST- 2020/10/27 00:00 [received]
PHST- 2020/12/20 00:00 [accepted]
PHST- 2021/01/29 06:00 [pubmed]
PHST- 2021/07/27 06:00 [medline]
PHST- 2021/01/28 12:14 [entrez]
PHST- 2021/01/28 00:00 [pmc-release]
AID - 10.1007/s00262-020-02839-7 [pii]
AID - 2839 [pii]
AID - 10.1007/s00262-020-02839-7 [doi]
PST - ppublish
SO  - Cancer Immunol Immunother. 2021 Aug;70(8):2291-2300. doi: 
      10.1007/s00262-020-02839-7. Epub 2021 Jan 28.