Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer
Resumen: 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.
Idioma: Inglés
DOI: 10.1038/bjc.2016.271
Año: 2016
Publicado en: BRITISH JOURNAL OF CANCER 115, 7 (2016), 789-796
ISSN: 0007-0920

Factor impacto JCR: 6.176 (2016)
Categ. JCR: ONCOLOGY rank: 32 / 217 = 0.147 (2016) - Q1 - T1
Factor impacto SCIMAGO: 3.03 - Oncology (Q1) - Cancer Research (Q1)

Tipo y forma: Article (Published version)

Creative Commons You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.

Exportado de SIDERAL (2020-02-21-13:28:55)

Este artículo se encuentra en las siguientes colecciones:

 Record created 2016-11-25, last modified 2020-02-21

Versión publicada:
Rate this document:

Rate this document:
(Not yet reviewed)