PMID- 27599039
OWN - NLM
STAT- MEDLINE
DCOM- 20170623
LR  - 20240326
IS  - 1532-1827 (Electronic)
IS  - 0007-0920 (Print)
IS  - 0007-0920 (Linking)
VI  - 115
IP  - 7
DP  - 2016 Sep 27
TI  - Randomised, open-label, phase II study of gemcitabine with and without IMM-101 
      for advanced pancreatic cancer.
PG  - 789-96
LID - 10.1038/bjc.2016.271 [doi]
AB  - BACKGROUND: Immune Modulation and Gemcitabine Evaluation-1, a randomised, 
      open-label, phase II, first-line, proof of concept study (NCT01303172), explored 
      safety and tolerability of IMM-101 (heat-killed Mycobacterium obuense; NCTC 
      13365) with gemcitabine (GEM) in advanced pancreatic ductal adenocarcinoma. 
      METHODS: Patients were randomised (2 : 1) to IMM-101 (10 mg ml(-l) 
      intradermally)+GEM (1000 mg m(-2) intravenously; n=75), or GEM alone (n=35). 
      Safety was assessed on frequency and incidence of adverse events (AEs). Overall 
      survival (OS), progression-free survival (PFS) and overall response rate (ORR) 
      were collected. RESULTS: IMM-101 was well tolerated with a similar rate of AE and 
      serious adverse event reporting in both groups after allowance for exposure. 
      Median OS in the intent-to-treat population was 6.7 months for IMM-101+GEM v 5.6 
      months for GEM; while not significant, the hazard ratio (HR) numerically favoured 
      IMM-101+GEM (HR, 0.68 (95% CI, 0.44-1.04, P=0.074). In a pre-defined metastatic 
      subgroup (84%), OS was significantly improved from 4.4 to 7.0 months in favour of 
      IMM-101+GEM (HR, 0.54, 95% CI 0.33-0.87, P=0.01). CONCLUSIONS: IMM-101 with GEM 
      was as safe and well tolerated as GEM alone, and there was a suggestion of a 
      beneficial effect on survival in patients with metastatic disease. This warrants 
      further evaluation in an adequately powered confirmatory study.
FAU - Dalgleish, Angus G
AU  - Dalgleish AG
AD  - Cancer Vaccine Institute, St George's University of London, London, UK.
FAU - Stebbing, Justin
AU  - Stebbing J
AD  - Department of Oncology, Imperial College, Hammersmith Hospital, London, UK.
FAU - Adamson, Douglas Ja
AU  - Adamson DJ
AD  - Department of Oncology, Ninewells Hospital, Dundee, UK.
FAU - Arif, Seema Safia
AU  - Arif SS
AD  - Velindre Cancer Centre, Cardiff, UK.
FAU - Bidoli, Paolo
AU  - Bidoli P
AD  - Department of Oncology, Azienda Ospedaliera San Gerardo, Monza, Italy.
FAU - Chang, David
AU  - Chang D
AD  - Department of General Surgery, Royal Blackburn Hospital, Blackburn, UK.
FAU - Cheeseman, Sue
AU  - Cheeseman S
AD  - Department of Oncology, Bradford Teaching Hospitals NHS Foundation Trust, 
      Bradford, UK.
FAU - Diaz-Beveridge, Robert
AU  - Diaz-Beveridge R
AD  - Medico Adjunto de Oncologia Medica, Hospital La Fe de Valencia, Valencia, Spain.
FAU - Fernandez-Martos, Carlos
AU  - Fernandez-Martos C
AD  - Instituto Valenciano de Oncologia, Valencia, Spain.
FAU - Glynne-Jones, Rob
AU  - Glynne-Jones R
AD  - Mount Vernon Cancer Centre, Northwood, UK.
FAU - Granetto, Cristina
AU  - Granetto C
AD  - Medical Oncology, Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy.
FAU - Massuti, Bartomeu
AU  - Massuti B
AD  - Ensayos Clinicos Oncologia, Hospital General Universitario de Alicante, Alicante, 
      Spain.
FAU - McAdam, Karen
AU  - McAdam K
AD  - Oncology Department, Peterborough and Stamford Hospitals NHS Trust, Peterborough, 
      UK.
FAU - McDermott, Raymond
AU  - McDermott R
AD  - Medical Oncology, St Vincent's University Hospital and The Adelaide and Meath 
      Hospital, Dublin, Republic of Ireland.
FAU - Martin, Andres J Munoz
AU  - Martin AJ
AD  - Gastrointestinal Cancer Unit, Hospital General Universitario Gregorio Maranon, 
      Madrid, Spain.
FAU - Papamichael, Demetris
AU  - Papamichael D
AD  - Department of Medical Oncology, Bank of Cyprus Oncology Centre, Nicosia, Cyprus.
FAU - Pazo-Cid, Roberto
AU  - Pazo-Cid R
AD  - Servicio de Oncologia Medica, Hospital Miguel Servet, Zaragoza, Spain.
FAU - Vieitez, Jose M
AU  - Vieitez JM
AD  - Area and Neuroendocrine Tumors Gastrointestinal Medical Oncology, Hospital 
      Central de Asturias, Asturias, Spain.
FAU - Zaniboni, Alberto
AU  - Zaniboni A
AD  - Oncology Department, Fondazione Poliambulanza, Brescia, Italy.
FAU - Carroll, Kevin J
AU  - Carroll KJ
AD  - TranScrip Partners LLP, Reading, UK.
FAU - Wagle, Shama
AU  - Wagle S
AD  - TranScrip Partners LLP, Reading, UK.
FAU - Gaya, Andrew
AU  - Gaya A
AD  - Clinical Oncology, Guy's & St Thomas' Hospitals NHS Trust, London, UK.
FAU - Mudan, Satvinder S
AU  - Mudan SS
AD  - St George's University of London, Imperial College, London and The Royal Marsden 
      Hospital, London, UK.
LA  - eng
SI  - EudraCT/2010-022757-42
GR  - NIHR-RP-011-053/DH_/Department of Health/United Kingdom
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160906
PL  - England
TA  - Br J Cancer
JT  - British journal of cancer
JID - 0370635
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 0 (Biomarkers, Tumor)
RN  - 0 (Cancer Vaccines)
RN  - 0W860991D6 (Deoxycytidine)
RN  - IZT740JY57 (IMM-101)
RN  - 0 (Gemcitabine)
SB  - IM
EIN - Br J Cancer. 2016 Oct 25;115(9):e16. PMID: 27727233
MH  - Aged
MH  - Aged, 80 and over
MH  - Antimetabolites, Antineoplastic/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Biomarkers, Tumor
MH  - Cancer Vaccines/administration & dosage/adverse effects/*therapeutic use
MH  - Carcinoma, Pancreatic Ductal/blood/*drug therapy/secondary
MH  - Combined Modality Therapy
MH  - Deoxycytidine/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Disease-Free Survival
MH  - Europe
MH  - Female
MH  - Humans
MH  - *Immunotherapy, Active
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Pancreatic Neoplasms/blood/*drug therapy/pathology
MH  - Treatment Outcome
MH  - Gemcitabine
PMC - PMC5046215
COIS- Angus G Dalgleish and Andrew Gaya have received travel grants and conference 
      funding from Immodulon Therapeutics. Satvinder Mudan is an unsalaried director 
      and shareholder of Immodulon Therapeutics, Ltd. Robert Glynne-Jones received 
      honoraria and research funding from Merck KgaA, Roche and Sanofi-Aventis. Shama 
      Wagle and Kevin Carroll, of TranScrip, LLP, provided medical writing and 
      statistical support to Immodulon Therapeutics. The remaining authors declare no 
      conflict of interest.
EDAT- 2016/09/07 06:00
MHDA- 2017/06/24 06:00
PMCR- 2016/09/27
CRDT- 2016/09/07 06:00
PHST- 2016/03/31 00:00 [received]
PHST- 2016/06/22 00:00 [revised]
PHST- 2016/07/22 00:00 [accepted]
PHST- 2016/09/07 06:00 [entrez]
PHST- 2016/09/07 06:00 [pubmed]
PHST- 2017/06/24 06:00 [medline]
PHST- 2016/09/27 00:00 [pmc-release]
AID - bjc2016271 [pii]
AID - 10.1038/bjc.2016.271 [doi]
PST - ppublish
SO  - Br J Cancer. 2016 Sep 27;115(7):789-96. doi: 10.1038/bjc.2016.271. Epub 2016 Sep 
      6.