PMID- 29176501
DCOM- 20180817
LR  - 20181019
IS  - 1473-5636 (Electronic)
IS  - 0960-8931 (Linking)
VI  - 28
IP  - 1
DP  - 2018 Feb
TI  - Phase IIIb safety results from an expanded-access protocol of talimogene
      laherparepvec for patients with unresected, stage IIIB-IVM1c melanoma.
PG  - 44-51
LID - 10.1097/CMR.0000000000000399 [doi]
AB  - Talimogene laherparepvec is a genetically modified herpes simplex virus-1-based
      oncolytic immunotherapy for the local treatment of unresectable cutaneous,
      subcutaneous, and nodal tumors in patients with melanoma recurrence following
      surgery. We aim to describe the safety of talimogene laherparepvec. Intralesional
      talimogene laherparepvec was administered at less than or equal to 4 mlx10 PFU/ml
      at protocol day 1, then less than or equal to 4 mlx10 PFU/ml 21 days later, and
      then every 14 days. Treatment continued until complete response, absence of
      injectable tumors, progressive disease, intolerance, or US Food and Drug
      Administration approval. Adverse events were graded during and 30 days after the 
      end of treatment. Lesions suspected to have herpetic origin were tested for
      talimogene laherparepvec DNA by quantitative PCR (qPCR). Between September 2014
      and October 2015, 41 patients were enrolled with stage IIIB (22%), IIIC (37%),
      IVM1a (34%), IVM1b (5%), and IVM1c (2%) melanoma. The median age was 72 (range:
      32-96) years and 54% of the patients were men. Patients had an ECOG performance
      status of 0 (68%) or 1 (32%). The median treatment duration was 13.1 (3.0-41.1)
      weeks. Treatment-related adverse events of greater than or equal to grade 3 were 
      reported in three (7.3%) patients and included vomiting, upper abdominal pain,
      chills, hyperhidrosis, nausea, pyrexia, and wound infection. Suspected herpetic
      lesions were swabbed in five (12%) patients. One of the five tested positive for 
      talimogene laherparepvec DNA by qPCR, but this lesion had been injected
      previously with talimogene laherparepvec. During the study, five patients
      completed treatment because of complete response per investigators. In the
      clinical practice setting, talimogene laherparepvec has a safety profile
      comparable to that observed in previous clinical trials. Talimogene laherparepvec
      (IMLYGIC) is now approved in the US, European Union, and Australia.
FAU - Chesney, Jason
AU  - Chesney J
AD  - Department of Medicine, University of Louisville, Louisville, Kentucky.
FAU - Awasthi, Sanjay
AU  - Awasthi S
AD  - Department of Medical Oncology, City of Hope, Duarte.
FAU - Curti, Brendan
AU  - Curti B
AD  - Earle A Chiles Research Institute, Providence Cancer Center, Portland, Oregon.
FAU - Hutchins, Laura
AU  - Hutchins L
AD  - Department of Internal Medicine, Division of Hematology Oncology, University of
      Arkansas for Medical Sciences, Little Rock, Arkansas.
FAU - Linette, Gerald
AU  - Linette G
AD  - Division of Oncology, Washington University School of Medicine, St. Louis,
FAU - Triozzi, Pierre
AU  - Triozzi P
AD  - Section of Hematology and Oncology, Wake Forest School of Medicine,
FAU - Tan, Marcus C B
AU  - Tan MCB
AD  - Division of Surgical Oncology, University of South Alabama, Mobile, Alabama.
FAU - Brown, Russell E
AU  - Brown RE
AD  - Department of Surgery, Ochsner Medical Center, New Orleans, Louisiana.
FAU - Nemunaitis, John
AU  - Nemunaitis J
AD  - Department of Medical Hematology and Oncology, Mary Crowley Cancer Research
      Center, Dallas, Texas.
FAU - Whitman, Eric
AU  - Whitman E
AD  - Department of Endocrine and Oncologic Surgery, Atlantic Melanoma Center, Atlantic
      Health System Cancer Care, Morristown, New Jersey.
FAU - Windham, Christopher
AU  - Windham C
AD  - Department of Oncology, Cone Health, Greensboro, North Carolina.
FAU - Lutzky, Jose
AU  - Lutzky J
AD  - Division of Hematology and Oncology, Mount Sinai Medical Center, Miami Beach,
FAU - Downey, Gerald F
AU  - Downey GF
AD  - Center for Design and Analysis, Amgen Limited, Cambridge, UK.
FAU - Batty, Nicolas
AU  - Batty N
AD  - Department of Clinical Research, Amgen Inc., Thousand Oaks, California.
FAU - Amatruda, Thomas
AU  - Amatruda T
AD  - Department of Hematology and Oncology, Minnesota Oncology, Fridley, Minnesota.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Melanoma Res
JT  - Melanoma research
JID - 9109623
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Injections, Intralesional
MH  - Male
MH  - Melanoma/pathology/*therapy
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - *Oncolytic Virotherapy
MH  - Safety
MH  - Survival Rate
MH  - Treatment Outcome
EDAT- 2017/11/28 06:00
MHDA- 2018/08/18 06:00
CRDT- 2017/11/28 06:00
PHST- 2017/11/28 06:00 [pubmed]
PHST- 2018/08/18 06:00 [medline]
PHST- 2017/11/28 06:00 [entrez]
AID - 10.1097/CMR.0000000000000399 [doi]
PST - ppublish
SO  - Melanoma Res. 2018 Feb;28(1):44-51. doi: 10.1097/CMR.0000000000000399.