Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer

British Journal of Cancer

Volumn 115, Issue 7, 2016, Pages 789-796

  Dalgleish, Angus G ^a   Stebbing, Justin ^b   JA Adamson, Douglas ^c   Arif, Seema Safia ^d   Bidoli, Paolo ^e   Chang, David ^f   Cheeseman, Sue ^g   Diaz Beveridge, Robert ^h   Fernandez Martos, Carlos ⁱ   Glynne Jones, Rob ^j   Granetto, Cristina ^k   Massuti, Bartomeu ^l   McAdam, Karen ^m   McDermott, Raymond ⁿ   Munoz Martin, Andres J ^o   Papamichael, Demetris ^p   Pazo Cid, Roberto ^q   Vieitez, Jose M ^r   Zaniboni, Alberto ^s   Carroll, Kevin J ^t   Wagle, Shama ^t   Gaya, Andrew ^u   Mudan, Satvinder S ^a   more..

^a ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^b HAMMERSMITH HOSPITAL   (United Kingdom)

^c NINEWELLS HOSPITAL   (United Kingdom)

^d VELINDRE CANCER CENTRE   (United Kingdom)

^e SAN GERARDO HOSPITAL   (Italy)

^f ROYAL BLACKBURN HOSPITAL   (United Kingdom)

^g BRADFORD TEACHING HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^h HOSPITAL UNIVERSITARIO LA FE   (Spain)

ⁱ INSTITUTO VALENCIANO DE ONCOLOGÍA   (Spain)

^j MOUNT VERNON CANCER CENTRE   (United Kingdom)

^k S CROCE E CARLE HOSPITAL   (Italy)

^l HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE   (Spain)

^m PETERBOROUGH CITY HOSPITAL   (United Kingdom)

ⁿ ST VINCENT S UNIVERSITY HOSPITAL   (Ireland)

^o HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^p Bank of Cyprus Group Oncology Centre   (Cyprus)

^q HOSPITAL UNIVERSITARIO MIGUEL SERVET   (Spain)

^r HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS   (Spain)

^s Fondazione Poliambulanza   (Italy)

^t TRANSCRIP PARTNERS LLP   (United Kingdom)

^u GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

more..

Author keywords

advanced pancreatic ductal adenocarcinoma; gemcitabine; IMM 101; immunomodulator; immunotherapy; Mycobacterium obuense; pancreatic cancer; phase II

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTINEOPLASTIC AGENT; BILIRUBIN; C REACTIVE PROTEIN; CA 19-9 ANTIGEN; CARCINOEMBRYONIC ANTIGEN; GEMCITABINE; IMM 101; IMMUNOMODULATING AGENT; LACTATE DEHYDROGENASE; POTASSIUM; UNCLASSIFIED DRUG; ANTINEOPLASTIC ANTIMETABOLITE; CANCER VACCINE; DEOXYCYTIDINE; IMM-101; TUMOR MARKER;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGE; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; ASTHENIA; BILIARY SEPSIS; BILIARY TRACT INFECTION; BILIRUBIN BLOOD LEVEL; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER IMMUNOTHERAPY; CANCER PATIENT; CANCER PROGNOSIS; CANCER SURVIVAL; CHOLESTASIS; CONTROLLED STUDY; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EXPLORATORY RESEARCH; FATIGUE; FEMALE; FEVER; FOLLOW UP; HUMAN; HYPOKALEMIA; INCIDENCE; INJECTION SITE REACTION; INTENTION TO TREAT ANALYSIS; LEUKOCYTE COUNT; LEUKOPENIA; MALE; MEDIAN SURVIVAL TIME; METASTASIS; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NEUTROPHIL COUNT; NEUTROPHIL LYMPHOCYTE RATIO; OPEN STUDY; OVERALL SURVIVAL; PANCREAS CANCER; PHASE 2 CLINICAL TRIAL; POTASSIUM BLOOD LEVEL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SEPSIS; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; URINARY TRACT INFECTION; VOMITING; ACTIVE IMMUNOTHERAPY; ANALOGS AND DERIVATIVES; BLOOD; CARCINOMA, PANCREATIC DUCTAL; CLINICAL TRIAL; COMPARATIVE STUDY; DISEASE FREE SURVIVAL; EUROPE; KAPLAN MEIER METHOD; MIDDLE AGED; MULTIMODALITY CANCER THERAPY; PANCREATIC NEOPLASMS; PATHOLOGY; SECONDARY; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANTIMETABOLITES, ANTINEOPLASTIC; BIOMARKERS, TUMOR; CANCER VACCINES; CARCINOMA, PANCREATIC DUCTAL; COMBINED MODALITY THERAPY; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; EUROPE; FEMALE; HUMANS; IMMUNOTHERAPY, ACTIVE; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PANCREATIC NEOPLASMS; TREATMENT OUTCOME;

EID: 84986598342     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2016.271     Document Type: Article

References (24)

1. Bazzi S, Modjtahedi H, Mudan S, Akle C, Bahr GM. (2015). Analysis of the immunomodulatory properties of two heat-killed mycobacterial preparations in a human whole blood model. Immunobiology 220: 1293-1304
2. Bilici A. (2014). Prognostic factors related with survival in patients with pancreatic adenocarcinoma. World J Gastroenterol 20(31): 10802-10812
3. Braiteh F, Patel M, Parisi M, Quanhong N, Park S, Faria C. (2016). Comparative effectiveness and resource utilization of nab-paclitaxel plus gemcitabine (nab-P+G) versus FOLFIRINOX (FFX) in first-line treatment of advanced pancreatic adenocarcinoma (PDAC) in a U.S. community oncology setting. J Clin Oncol 2016(4): abstract 433
4. Burris 3rd HA, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. (1997). Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 15(6): 2403-2413
5. Carrato A, Falcone A, Ducreux M, Valle JW, Parnaby A, Djazouli K, Alnwick-Allu K, Hutchings A, Palaska C, Parthenaki I. (2015). A systematic review of the burden of pancreatic cancer in Europe: real world impact on survival, quality of life and costs. J Gastrointest Cancer 46: 201-211
6. Colucci G, Labianca R, Di Costanzo F, Gebbia V, Carteni G, Massidda B, Dapretto E, Manzione L, Piazza E, Sannicolo M, Ciaparrone M, Cavanna L, Giuliani F, Maiello E, Testa A, Pederzoli P, Falconi M, Gallo C, Di Maio M, Perrone F, Gruppo Oncologico Italia M. Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato D, Gruppo Oncologico Italiano di Ricerca C. (2010). Randomized phase III trial of gemcitabine plus cisplatin compared with single-Agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: the GIP-1 study. J Clin Oncol 28(10): 1645-1651
7. Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, De La Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M. Groupe Tumeurs Digestives of U, Intergroup P. (2011). FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 364(19): 1817-1825
8. Fowler D, Copier J, Wilson N, Dalgleish AG, Bodman-Smith MD. (2011). Mycobacteria activate gamma delta T-cell anti-Tumour responses via cytokines from type 1 myeloid dendritic cells: a mechanism of action for cancer immunotherapy. Cancer Immunol Immunother 61(4): 535-547
9. Gunturu KS, Rossi GR, Saif MW. (2013). Immunotherapy updates in pancreatic cancer: are we there yet?. Therap Adv Med Oncol 5(1): 81-89
10. Haas M, Heinemann V, Kullmann F, Laubender RP, Klose C, Bruns CJ, Holdenrieder S, Modest DP, Schulz C, Boeck S. (2013). Prognostic value of CA 19-9, CEA, CRP, LDH and bilirubin levels in locally advanced and metastatic pancreatic cancer: results from a multicenter, pooled analysis of patients receiving palliative chemotherapy. J Cancer Res Clin Oncol 139(4): 681-689
11. Hidalgo M, Cascinu S, Kleeff J, Labianca R, Lohr JM, Neoptolemos J, Real FX, Van Laethem JL, Heinemann V. (2015). Addressing the challenges of pancreatic cancer: future directions for improving outcomes. Pancreatology 15(1): 8-18
12. Le DT, Wang-Gillam A, Picozzi V, Greten TF, Crocenzi T, Springett G, Morse M, Zeh H, Cohen D, Fine RL, Onners B, Uram JN, Laheru DA, Lutz ER, Solt S, Murphy AL, Skoble J, Lemmens E, Grous J, Dubensky Jr. T, Brockstedt DG, Jaffee EM. (2015). Safety and survival with GVAX pancreas prime and Listeria Monocytogenes-expressing mesothelin (CRS-207) boost vaccines for metastatic pancreatic cancer. J Clin Oncol 33(12): 1325-1333
13. Network. NCC Pancreatic adenocarcinoma (Version 2.2015
14. NICE. (2001). Guidance on the use of gemcitabine for the treatment of pancreatic cancer
15. NICE. (2015). Paclitaxel as albumin-bound nanoparticles in combination with gemcitabine for previously untreated metastatic pancreatic cancer
16. Nywening T, Wang-Gillam A, Sanford D, Belt B, Panni R, Cusworth B. (2016). Targeting tumour-Associated macrophages with CCR2 inhibition in combination with FOLFIRINOX in patients with borderline resectable and locally advanced pancreatic cancer: a single-centre, open-label, dosefinding, non-randomised, phase 1b trial. Lancet Oncol 17(5): 651-662
17. Pico De Coana Y, Choudhury A, Kiessling R. (2015). Checkpoint blockade for cancer therapy: revitalizing a suppressed immune system. Trends Mol Med 21(8): 482-491
18. Poplin E, Feng Y, Berlin J, Rothenberg ML, Hochster H, Mitchell E, Alberts S, O'Dwyer P, Haller D, Catalano P, Cella D, Benson 3rd AB. (2009). Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol 27(23): 3778-3785
19. Seufferlein T, Bachet JB, Van Cutsem E, Rougier P. Group EGW. (2012). Pancreatic adenocarcinoma: ESMO-ESDO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 23(Suppl 7): vii33-vii40
20. Stebbing J, Dalgleish A, Gifford-Moore A, Martin A, Gleeson C, Wilson G, Brunet LR, Grange J, Mudan S. (2012). An intra-patient placebo-controlled phase I trial to evaluate the safety and tolerability of intradermal IMM-101. in melanoma. Ann Oncol 23(5): 1314-1319
21. Tempero MA, Arnoletti JP, Behrman SW, Ben-Josef E, Benson 3rd AB, Casper ES, Cohen SJ, Czito B, Ellenhorn JD, Hawkins WG, Herman J, Hoffman JP, Ko A, Komanduri S, Koong A, Ma WW, Malafa MP, Merchant NB, Mulvihill SJ, Muscarella 2nd P, Nakakura EK, Obando J, PitmanMB, Sasson AR, Tally A, Thayer SP, Whiting S, Wolff RA, Wolpin BM, Freedman-Cass DA, Shead DA. National Comprehensive Cancer N. (2012). Pancreatic Adenocarcinoma, version 2.2012: featured updates to the NCCN Guidelines. J Natl Comprehens Cancer Netw 10(6): 703-713
22. Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. (2013). Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med 369(18): 1691-1703
23. Wang-Gillam A, Li C, Bodoky G, Dean A, Shan Y, Jameson G, Macarulla T, Lee K, Cunningham D, Blanc J, Hubner R, Chiu C, Schwartsmann G, Siveke J, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen L. (2016). Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet Oncol 387(10018): 545-547
24. Wormann SM, Diakopoulos KN, Lesina M, Algul H. (2014). The immune network in pancreatic cancer development and progression. Oncogene 33: 2956-2967