TG4010 immunotherapy and first-line chemotherapy for advanced non-small-cell lung cancer (TIME): Results from the phase 2b part of a randomised, double-blind, placebo-controlled, phase 2b/3 trial

The Lancet Oncology

Volumn 17, Issue 2, 2016, Pages 212-223

  Quoix, Elisabeth ^a   Lena, Hervé ^b   Losonczy, Gyorgy ^c   Forget, Frédéric ^d   Chouaid, Christos ^e   Papai, Zsolt ^f   Gervais, Radj ^g   Ottensmeier, Christian ^h   Szczesna, Aleksandra ⁱ   Kazarnowicz, Andrzej ^f   Beck, Joseph T ^j   Westeel, Virginie ^k   Felip, Enriqueta ^l   Debieuvre, Didier ^m   Madroszyk, Anne ⁿ   Adam, Julien ^o   Lacoste, Gisèle ^p   Tavernaro, Annette ^p   Bastien, Bérangère ^p   Halluard, Céline ^p   Palanché, Tania ^p   Limacher, Jean Marc ^p,q   more..

^a HÔPITAL CIVIL   (France)

^b RENNES UNIVERSITY HOSPITAL   (France)

^c SEMMELWEIS UNIVERSITY   (Hungary)

^d Centre Hospitalier de l'Ardenne   (Belgium)

^e CENTRE HOSPITALIER INTERCOMMUNAL DE CRÉTEIL   (France)

^f Szent Gyorgy Korhaz ^*  (Poland)

^g CENTRE FRANÇOIS BACLESSE   (France)

^h UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST   (United Kingdom)

ⁱ Division III   (Poland)

^j Highlands Oncology Group   (United States)

^k UNIVERSITY HOSPITAL OF BESANÇON   (France)

^l HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^m Hôpitaux Universitaires de Strasbourg   (France)

ⁿ INSTITUT PAOLI CALMETTES   (France)

^o INSTITUT GUSTAVE ROUSSY   (France)

^p TRANSGENE S A   (France)

^q Pasteur Hospital   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; CARBOPLATIN; CISPLATIN; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; GAMMA GLUTAMYLTRANSFERASE; GEMCITABINE; MUCIN 1; PACLITAXEL; PEMETREXED; TG 4010; ANTINEOPLASTIC AGENT; CANCER VACCINE; CD56 ANTIGEN; CD69 ANTIGEN; DEOXYCYTIDINE; FC RECEPTOR; LECTIN; LEUKOCYTE ANTIGEN; MEMBRANE PROTEIN; MUC1 PROTEIN, HUMAN; T LYMPHOCYTE ANTIGEN; TUMOR MARKER;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; ALOPECIA; ANEMIA; ARTICLE; BACKACHE; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER IMMUNOTHERAPY; CANCER PAIN; CANCER STAGING; CONTROLLED STUDY; DECREASED APPETITE; DEHYDRATION; DIARRHEA; DRUG SAFETY; DYSPNEA; ERYSIPELAS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GENE MUTATION; HEADACHE; HEMOPTYSIS; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; HYPERTENSION; HYPOKALEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; INJECTION SITE REACTION; INTENTION TO TREAT ANALYSIS; KIDNEY FAILURE; LEUKOPENIA; LUNG EMBOLISM; LUNG INFECTION; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL PAIN; NAUSEA; NEUTROPENIA; NON SMALL CELL LUNG CANCER; OVERALL SURVIVAL; PERIPHERAL ISCHEMIA; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PREDICTIVE VALUE; PRIMARY HEALTH CARE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; SIDE EFFECT; STOMATITIS; SUPERIOR CAVA VEIN SYNDROME; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; WEIGHT REDUCTION; ADVERSE EFFECTS; AGED; ANALOGS AND DERIVATIVES; BLOOD; CARCINOMA, NON-SMALL-CELL LUNG; CHEMISTRY; CLINICAL TRIAL; DISEASE FREE SURVIVAL; DOUBLE BLIND PROCEDURE; IMMUNOTHERAPY; LUNG NEOPLASMS; LYMPHOCYTE; LYMPHOCYTE ACTIVATION; MIDDLE AGED;

AGED; ANEMIA; ANTIGENS, CD; ANTIGENS, CD56; ANTIGENS, DIFFERENTIATION, T-LYMPHOCYTE; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BEVACIZUMAB; BIOMARKERS, TUMOR; CANCER VACCINES; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; ERLOTINIB HYDROCHLORIDE; FATIGUE; FEMALE; HUMANS; IMMUNOTHERAPY; LECTINS, C-TYPE; LUNG NEOPLASMS; LYMPHOCYTE ACTIVATION; LYMPHOCYTES; MALE; MEMBRANE GLYCOPROTEINS; MIDDLE AGED; MUCIN-1; NEUTROPENIA; PACLITAXEL; PEMETREXED; PREDICTIVE VALUE OF TESTS; RECEPTORS, IGG;

EID: 84959273798     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(15)00483-0     Document Type: Article

References (15)

1. Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A Global cancer statistics, 2012. CA Cancer J Clin 2015, 65:87-108.
2. D'Addario G, Fruh M, Reck M, Baumann P, Klepetko W, Felip E Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010, 21:v116-v119.
3. Azzoli CG, Temin S, Aliff T, et al. 2011 focused update of 2009 American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non-small-cell lung cancer. J Clin Oncol 2011, 29:3825-3831.
4. Rosenberg SA Decade in review-cancer immunotherapy: entering the mainstream of cancer treatment. Nat Rev Clin Oncol 2014, 11:630-632.
5. Limacher JM, Quoix E TG4010: a therapeutic vaccine against MUC1 expressing tumors. Oncoimmunology 2012, 1:791-792.
6. Quoix E, Ramlau R, Westeel V, et al. Therapeutic vaccination with TG4010 and first-line chemotherapy in advanced non-small-cell lung cancer: a controlled phase 2B trial. Lancet Oncol 2011, 12:1125-1133.
7. Ramlau R, Quoix E, Rolski J, et al. A phase II study of TG4010 (MVA-MUC1-IL2) in association with chemotherapy in patients with stage III/IV non-small cell lung cancer. J Thorac Oncol 2008, 3:735-744.
8. Vivier E, Tomasello E, Baratin M, Walzer T, Ugolini S Functions of natural killer cells. Nat Immunol 2008, 9:503-510.
9. Oudard S, Rixe O, Beuselinck B, et al. A phase II study of the cancer vaccine TG4010 alone and in combination with cytokines in patients with metastatic renal clear-cell carcinoma: clinical and immunological findings. Cancer Immunol Immunother 2011, 60:261-271.
10. Dreicer R, Stadler WM, Ahmann FR, et al. MVA-MUC1-IL2 vaccine immunotherapy (TG4010) improves PSA doubling time in patients with prostate cancer with biochemical failure. Invest New Drugs 2009, 27:379-386.
11. Chen TT Statistical issues and challenges in immuno-oncology. J Immunother Cancer 2013, 1:18.
12. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010, 363:711-723.
13. Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010, 363:411-422.
14. Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med 2015, 373:123-135.
15. Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 2015, 372:2018-2028.