FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab for metastatic colorectal cancer (FIRE-3): a post-hoc analysis of tumour dynamics in the final RAS wild-type subgroup of this randomised open-label phase 3 trial

The Lancet Oncology

Volumn 17, Issue 10, 2016, Pages 1426-1434

  Stintzing, Sebastian ^a,b   Modest, Dominik P ^a,b   Rossius, Lisa ^a   Lerch, Markus M ^c   von Weikersthal, Ludwig Fischer ^d   Decker, Thomas ^e   Kiani, Alexander ^f   Vehling Kaiser, Ursula ^g   Al Batran, Salah Eddin ^h   Heintges, Tobias ⁱ   Lerchenmüller, Christian ^j   Kahl, Christoph ^k   Seipelt, Gernot ^l   Kullmann, Frank ^m   Stauch, Martina ⁿ   Scheithauer, Werner ^o   Held, Swantje ^p   Giessen Jung, Clemens ^a   Moehler, Markus ^q   Jagenburg, Andreas ^r   Kirchner, Thomas ^a,b   Jung, Andreas ^a,b   Heinemann, Volker ^a,b   more..

^a UNIVERSITY OF MUNICH   (Germany)

^b GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

^c UNIVERSITY MEDICINE GREIFSWALD   (Germany)

^d Gesundheitszentrum St Marien GmbH   (Germany)

^e Studienzentrum Onkologie Ravensburg   (Germany)

^f INSTITUTE OF PATHOLOGY   (Germany)

^g Praxis Hämatologie Onkologie Palliativmedizin Tagesklinik   (Germany)

^h KRANKENHAUS NORDWEST   (Germany)

ⁱ Lukaskrankenhaus GmbH   (Germany)

^j Gemeinschaftspraxis für Hämatologie und Onkologie   (Germany)

^k Stadtisches Klinikum Magdeburg   (Germany)

^l Onkologische Schwerpunktpraxis   (Germany)

^m Klinikum Weiden   (Germany)

ⁿ Praxis für Hämatologie und Internistische Onkologie   (Germany)

^o MEDICAL UNIVERSITY OF VIENNA   (Austria)

^p CLINASSESS GMBH   (Germany)

^q JOHANNES GUTENBERG UNIVERSITY   (Germany)

^r Dr Knoell Consult GmbH   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; CETUXIMAB; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; ANTINEOPLASTIC AGENT; CAMPTOTHECIN;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; DRUG EFFICACY; GENE MUTATION; GENE SEQUENCE; HUMAN; INTENTION TO TREAT ANALYSIS; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MEDIAN SURVIVAL TIME; METASTATIC COLORECTAL CANCER; MULTIPLE CYCLE TREATMENT; ONCOGENE K RAS; ONCOGENE N RAS; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT RESPONSE; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; COLORECTAL NEOPLASMS; FEMALE; MALE; METASTASIS; MIDDLE AGED; MORTALITY; ONCOGENE RAS; PATHOLOGY; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; X-RAY COMPUTED TOMOGRAPHY;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BEVACIZUMAB; CAMPTOTHECIN; CETUXIMAB; COLORECTAL NEOPLASMS; FEMALE; FLUOROURACIL; GENES, RAS; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; NEOPLASM METASTASIS; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; TOMOGRAPHY, X-RAY COMPUTED;

EID: 84992317442     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(16)30269-8     Document Type: Article

References (21)

1. 1 Heinemann, V, von Weikersthal, LF, Decker, T, et al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol 15 (2014), 1065–1075.
2. 2 Therasse, P, Arbuck, SG, Eisenhauer, EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92 (2000), 205–216.
3. 3 Sclafani, F, Cunningham, D, Cetuximab or bevacizumab in metastatic colorectal cancer?. Lancet Oncol 15 (2015), 1040–1041.
4. 4 Venook, AP, Tabernero, J, Progression-free survival: helpful biomarker or clinically meaningless end point?. J Clin Oncol 33 (2015), 4–6.
5. 5 Piessevaux, H, Buyse, M, Schlichting, M, et al. Use of early tumor shrinkage to predict long-term outcome in metastatic colorectal cancer treated with cetuximab. J Clin Oncol 31 (2013), 3764–3775.
6. 6 Modest, DP, Laubender, RP, Stintzing, S, et al. Early tumor shrinkage in patients with metastatic colorectal cancer receiving first-line treatment with cetuximab combined with either CAPIRI or CAPOX: an analysis of the German AIO KRK 0104 trial. Acta Oncol 52 (2013), 956–962.
7. 7 Claret, L, Girard, P, Hoff, PM, et al. Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics. J Clin Oncol 27 (2009), 4103–4108.
8. 8 Claret, L, Gupta, M, Han, K, et al. Evaluation of tumor-size response metrics to predict overall survival in Western and Chinese patients with first-line metastatic colorectal cancer. J Clin Oncol 31 (2013), 2110–2114.
9. 9 Sharma, MR, Gray, E, Goldberg, RM, Sargent, DJ, Karrison, TG, Resampling the N9741 trial to compare tumor dynamic versus conventional end points in randomized phase II trials. J Clin Oncol 33 (2015), 36–41.
10. 10 Mansmann, UR, Sartorius, U, Laubender, RP, Giessen, CA, Esser, R, Heinemann, V, Deepness of response: a quantitative analysis of its impact on post-progression survival time after first-line treatment in patients with mCRC. Proc Am Soc Clin Oncol, 31(suppl 4), 2013 abstr 427.
11. 11 Eisenhauer, EA, Therasse, P, Bogaerts, J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45 (2009), 228–247.
12. 12 Jang, HJ, Kim, BC, Kim, HS, et al. Comparison of RECIST 1.0 and RECIST 1.1 on computed tomography in patients with metastatic colorectal cancer. Oncology 86 (2014), 117–121.
13. 13 Schwartzberg, LS, Rivera, F, Karthaus, M, et al. PEAK: a randomized, multicenter phase II study of panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated, unresectable, wild-type KRAS exon 2 metastatic colorectal cancer. J Clin Oncol 32 (2014), 2240–2247.
14. 14 Lenz, H, Niedzwiecki, D, Innocenti, F, et al. CALGB/SWOG 80405: phase III trial of FOLFIRI or mFOLFOX6 with bevacizumab or cetuximab for patients with expanded RAS analyses in untreated metastatic adenocarcinoma of the colon or rectum. Ann Oncol, 25(suppl 4), 2014 abstr 501O.
15. 15 Khattak, MA, Martin, H, Davidson, A, Phillips, M, Role of first-line anti-epidermal growth factor receptor therapy compared with anti-vascular endothelial growth factor therapy in advanced colorectal cancer: a meta-analysis of randomized clinical trials. Clin Colorectal Cancer 14 (2015), 81–90.
16. 16 Venook, AP, Niedzwiecki, D, Lenz, H, et al. CALGB/SWOG 80405: phase III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab (CET) for patients (pts) with KRAS wild-type (wt) untreated metastatic adenocarcinoma of the colon or rectum (MCRC). Proc Am Soc Clin Oncol, 32(suppl 5s), 2014 abstr LBA3.
17. 17 Heinemann, V, Stintzing, S, Modest, DP, Giessen-Jung, C, Michl, M, Mansmann, UR, Early tumour shrinkage (ETS) and depth of response (DpR) in the treatment of patients with metastatic colorectal cancer (mCRC). Eur J Cancer 51 (2015), 1927–1936.
18. 18 Rivera, F, Karthaus, M, Hecht, JR, et al. First-line treatment with modified FOLFOX6 (mFOLFOX6) + panitumumab (pmab) or bevacizumab (bev) in wild-type (WT)RAS metastatic colorectal carcinoma (mCRC): tumor response outcomes beyond RECIST. Proc Am Soc Clin Oncol, 33(suppl 3), 2015 abstr 660.
19. 19 Douillard, JY, Siena, S, Peeters, M, Koukakis, R, Terwey, JH, Tabernero, J, Impact of early tumour shrinkage and resection on outcomes in patients with wild-type RAS metastatic colorectal cancer. Eur J Cancer 51 (2015), 1231–1242.
20. 20 Cremolini, C, Loupakis, F, Antoniotti, C, et al. Early tumor shrinkage and depth of response predict long-term outcome in metastatic colorectal cancer patients treated with first-line chemotherapy plus bevacizumab: results from phase III TRIBE trial by the Gruppo Oncologico del Nord Ovest. Ann Oncol 26 (2015), 1188–1194.
21. 21 Giessen, C, Laubender, RP, Fischer von Weikersthal, L, et al. Early tumor shrinkage in metastatic colorectal cancer: retrospective analysis from an irinotecan-based randomized first-line trial. Cancer Sci 104 (2013), 718–724.