000057719 001__ 57719
000057719 005__ 20200221144253.0
000057719 0247_ $$2doi$$a10.1038/bjc.2016.271
000057719 0248_ $$2sideral$$a96633
000057719 037__ $$aART-2016-96633
000057719 041__ $$aeng
000057719 100__ $$aDalgleish, A.G.
000057719 245__ $$aRandomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer
000057719 260__ $$c2016
000057719 5060_ $$aAccess copy available to the general public$$fUnrestricted
000057719 5203_ $$aBackground: 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.
000057719 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/
000057719 590__ $$a6.176$$b2016
000057719 591__ $$aONCOLOGY$$b32 / 217 = 0.147$$c2016$$dQ1$$eT1
000057719 592__ $$a3.03$$b2016
000057719 593__ $$aOncology$$c2016$$dQ1
000057719 593__ $$aCancer Research$$c2016$$dQ1
000057719 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000057719 700__ $$aStebbing, J.
000057719 700__ $$aJA Adamson, D.
000057719 700__ $$aArif, S.S.
000057719 700__ $$aBidoli, P.
000057719 700__ $$aChang, D.
000057719 700__ $$aCheeseman, S.
000057719 700__ $$aDiaz-Beveridge, R.
000057719 700__ $$aFernandez-Martos, C.
000057719 700__ $$aGlynne-Jones, R.
000057719 700__ $$aGranetto, C.
000057719 700__ $$aMassuti, B.
000057719 700__ $$aMcAdam, K.
000057719 700__ $$aMcDermott, R.
000057719 700__ $$aMunoz Martin, A.J.
000057719 700__ $$aPapamichael, D.
000057719 700__ $$0(orcid)0000-0002-8026-7391$$aPazo-Cid, R.
000057719 700__ $$aVieitez, J.M.
000057719 700__ $$aZaniboni, A.
000057719 700__ $$aCarroll, K.J.
000057719 700__ $$aWagle, S.
000057719 700__ $$aGaya, A.
000057719 700__ $$aMudan, S.S.
000057719 773__ $$g115, 7 (2016), 789-796$$pBr. J. Cancer$$tBRITISH JOURNAL OF CANCER$$x0007-0920
000057719 8564_ $$s434588$$uhttps://zaguan.unizar.es/record/57719/files/texto_completo.pdf$$yVersión publicada
000057719 8564_ $$s110547$$uhttps://zaguan.unizar.es/record/57719/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000057719 909CO $$ooai:zaguan.unizar.es:57719$$particulos$$pdriver
000057719 951__ $$a2020-02-21-13:28:55
000057719 980__ $$aARTICLE