FOLFOXIRI plus biologics in advanced colorectal cancer

References

• Scheithauer W, Rosen H, Kornek GV, et al. Randomised comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer. BMJ. 1993;306(6880):752–755.
   PubMed Web of Science ®Google Scholar
• 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. 2014;15(10):1065–1075.
   PubMed Web of Science ®Google Scholar
• Venook AP, Niedzwiecki D, Lenz H-J, et al. Effect of first-line chemotherapy combined with cetuximab or bevacizumab on overall survival in patients with KRAS wild-type advanced or metastatic colorectal cancer: a randomized clinical trial. JAMA. 2017;317(23):2392–2401.
   PubMed Web of Science ®Google Scholar
• 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. 2014;32(21):2240–2247.
   PubMed Web of Science ®Google Scholar
• de Gramont A, Bosset JF, Milan C, et al. Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study. J Clin Oncol. 1997;15(2):808–815.
   PubMed Web of Science ®Google Scholar
• Tournigand C, André T, Achille E, et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004;22(2):229–237.
   PubMed Web of Science ®Google Scholar
• Grothey A, Sargent D, Goldberg RM, et al. Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol. 2004;22(7):1209–1214.
   PubMed Web of Science ®Google Scholar
• Van Cutsem E, Köhne C-H, Hitre E, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009;360(14):1408–1417.
   PubMed Web of Science ®Google Scholar
• Douillard J-Y, Oliner KS, Siena S, et al. Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer. N Engl J Med. 2013;369(11):1023–1034.
   PubMed Web of Science ®Google Scholar
• Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004;350(23):2335–2342.
   PubMed Web of Science ®Google Scholar
• Dienstmann R, Tabernero J. Spectrum of gene mutations in colorectal cancer: implications for treatment. Cancer J. 2016;22(3):149–155.
   PubMed Web of Science ®Google Scholar
• Sanz-Garcia E, Argiles G, Elez E, et al. BRAF mutant colorectal cancer: prognosis, treatment, and new perspectives. Ann Oncol. 2017;28(11):2648–2657.
   PubMed Web of Science ®Google Scholar
• Raghav KPS, Overman MJ, Yu R, et al. HER2 amplification as a negative predictive biomarker for anti-epidermal growth factor receptor antibody therapy in metastatic colorectal cancer. J Clin Oncol. 2016;34(15_suppl):3517.
   Google Scholar
• Martin V, Landi L, Molinari F, et al. HER2 gene copy number status may influence clinical efficacy to anti-EGFR monoclonal antibodies in metastatic colorectal cancer patients. Br J Cancer. 2013;108(3):668–675.
   PubMed Web of Science ®Google Scholar
• Ogino S, Lochhead P, Giovannucci E, et al. Discovery of colorectal cancer PIK3CA mutation as potential predictive biomarker: power and promise of molecular pathological epidemiology. Oncogene. 2014;33(23):2949–2955.
   PubMed Web of Science ®Google Scholar
• Sanz-Garcia E, Grasselli J, Argiles G, et al. Current and advancing treatments for metastatic colorectal cancer. Expert Opin Biol Ther. 2016;16(1):93–110.
   PubMed Web of Science ®Google Scholar
• Falcone A, Masi G, Allegrini G, et al. Biweekly chemotherapy with oxaliplatin, irinotecan, infusional fluorouracil, and leucovorin: a pilot study in patients with metastatic colorectal cancer. J Clin Oncol. 2002;20(19):4006–4014.
   PubMed Web of Science ®Google Scholar
• Masi G, Allegrini G, Cupini S, et al. First-line treatment of metastatic colorectal cancer with irinotecan, oxaliplatin and 5-fluorouracil/leucovorin (FOLFOXIRI): results of a phase II study with a simplified biweekly schedule. Ann Oncol. 2004;15(12):1766–1772.
   PubMed Web of Science ®Google Scholar
• Falcone A, Ricci S, Brunetti I, et al. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the gruppo oncologico nord ovest. J Clin Oncol. 2007;25(13):1670–1676.
   PubMed Web of Science ®Google Scholar
• Masi G, Vasile E, Loupakis F, et al. Randomized trial of two induction chemotherapy regimens in metastatic colorectal cancer: an updated analysis. J Natl Cancer Inst. 2011;103(1):21–30.
   PubMedGoogle Scholar
• Souglakos J, Androulakis N, Syrigos K, et al. FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG). Br J Cancer. 2006;94(6):798–805.
   PubMed Web of Science ®Google Scholar
• Vamvakas L, Athanasiadis A, Karampeazis A, et al. Clinical outcome of elderly patients with metastatic colorectal cancer treated with FOLFOXIRI versus FOLFIRI: subgroup analysis of a randomized phase III trial from the Hellenic Oncology Research Group (HORG). Crit Rev Oncol Hematol. 2010;76(1):61–70.
   PubMed Web of Science ®Google Scholar
• Home – ClinicalTrials.gov [Internet]. Bethesda, US: National Library of Medicine. [cited 2018 Jan 28]. Available from: https://clinicaltrials.gov//
   Google Scholar
• Stein A, Atanackovic D, Hildebrandt B, et al. Upfront FOLFOXIRI+bevacizumab followed by fluoropyrimidin and bevacizumab maintenance in patients with molecularly unselected metastatic colorectal cancer. Br J Cancer. 2015;113(6):872–877.
   PubMed Web of Science ®Google Scholar
• Masi G, Loupakis F, Salvatore L, et al. Bevacizumab with FOLFOXIRI (irinotecan, oxaliplatin, fluorouracil, and folinate) as first-line treatment for metastatic colorectal cancer: a phase 2 trial. Lancet Oncol. 2010;11(9):845–852.
   PubMed Web of Science ®Google Scholar
• Satake H, Sunakawa Y, Miyamoto Y, et al. A phase II trial of 1st-line modified-FOLFOXIRI plus bevacizumab treatment for metastatic colorectal cancer harboring RAS mutation: JACCRO CC-11. Oncotarget. 2018;9(27):18811–18820.
   PubMedGoogle Scholar
• Oki E, Kato T, Bando H, et al. A multicenter clinical phase ii study of folfoxiri plus bevacizumab as first-line therapy in patients with metastatic colorectal cancer: QUATTRO study. Clin Colorectal Cancer. 2018;17(2):147–155.
   PubMed Web of Science ®Google Scholar
• Gruenberger T, Bridgewater J, Chau I, et al. Bevacizumab plus mFOLFOX-6 or FOLFOXIRI in patients with initially unresectable liver metastases from colorectal cancer: the OLIVIA multinational randomised phase II trial. Ann Oncol. 2015;26(4):702–708.
   PubMed Web of Science ®Google Scholar
• Falcone A, Cremolini C, Loupakis F, et al. FOLFOXIRI plus bevacizumab (bev) followed by maintenance with bev alone or bev plus metronomic chemotherapy (metroCT) in mmCRC: final results of the phase II randomized MOMA trial by GONO. Ann Oncol. 2018;29((Suppl 5)):abstr O–017.
   Google Scholar
• Schmoll HJ, Garlipp B, Junghanss C. FOLFOX/bevacizumab ± irinotecan in advanced colorectal cancer (CHARTRA) – long term outcome. Ann Oncol. 2018;29((Suppl 5)):abstr O–023.
   Google Scholar
• Hurwitz H, Tan BR, Reves JA, et al. Phase 2 randomized trial of sequential or concurrent FOLFOXIRI-bevacizumab versus FOLFOX-bevacizumab for metastatic colorectal cancer (STEAM). Oncologist. 2018;0344. pii: theoncologist.
   Google Scholar
• Loupakis F, Cremolini C, Masi G, et al. Initial therapy with FOLFOXIRI and bevacizumab for metastatic colorectal cancer. N Engl J Med. 2014;371(17):1609–1618.
   PubMed Web of Science ®Google Scholar
• Cremolini C, Loupakis F, Antoniotti C, et al. FOLFOXIRI plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment of patients with metastatic colorectal cancer: updated overall survival and molecular subgroup analyses of the open-label, phase 3 TRIBE study. Lancet Oncol. 2015;16(13):1306–1315.
   PubMed Web of Science ®Google Scholar
• Cremolini C, Antoniotti C, Lonardi S, et al. Primary tumor sidedness and benefit from folfoxiri plus bevacizumab as initial therapy for metastatic colorectal cancer. Ann Oncol. 2018. [cited 2018 Jul 3]. DOI:10.1093/annonc/mdy140.
   Google Scholar
• Cremolini C, Antoniotti C, Lonardi S, et al. TRIBE2: a phase III, randomized strategy study by GONO in the 1st- and 2nd-line treatment of unresectable metastatic colorectal cancer (mCRC) patients (pts). Oral presentation at the 2018 ESMO Congress; 2018 October 19–23. Munich, Germany.
   Google Scholar
• 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. 2015;26(6):1188–1194.
   PubMed Web of Science ®Google Scholar
• Cremolini C, Casagrande M, Loupakis F, et al. Efficacy of FOLFOXIRI plus bevacizumab in liver-limited metastatic colorectal cancer: a pooled analysis of clinical studies by Gruppo Oncologico del Nord Ovest. Eur J Cancer. 2017;73:74–84.
   PubMed Web of Science ®Google Scholar
• Loupakis F, Cremolini C, Salvatore L, et al. FOLFOXIRI plus bevacizumab as first-line treatment in BRAF mutant metastatic colorectal cancer. Eur J Cancer. 2014;50(1):57–63.
   PubMed Web of Science ®Google Scholar
• Tomasello G, Petrelli F, Ghidini M, et al. FOLFOXIRI plus bevacizumab as conversion therapy for patients with initially unresectable metastatic colorectal cancer: a systematic review and pooled analysis. JAMA Oncol. 2017;3(7):e170278.
   PubMed Web of Science ®Google Scholar
• Cremolini C, Loupakis F, Masi G, et al. FOLFOXIRI or FOLFOXIRI plus bevacizumab as first-line treatment of metastatic colorectal cancer: a propensity score-adjusted analysis from two randomized clinical trials. Ann Oncol. 2016;27(5):843–849.
   PubMed Web of Science ®Google Scholar
• Folprecht G, Hamann S, Schütte K, et al. Dose escalating study of cetuximab and 5-FU/folinic acid (FA)/oxaliplatin/irinotecan (FOLFOXIRI) in first line therapy of patients with metastatic colorectal cancer. BMC Cancer. 2014;14:521.
   PubMed Web of Science ®Google Scholar
• Bokemeyer C, Bondarenko I, Makhson A, et al. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol. 2009;27(5):663–671.
   PubMed Web of Science ®Google Scholar
• Garufi C, Torsello A, Tumolo S, et al. Cetuximab plus chronomodulated irinotecan, 5-fluorouracil, leucovorin and oxaliplatin as neoadjuvant chemotherapy in colorectal liver metastases: POCHER trial. Br J Cancer. 2010;103(10):1542–1547.
   PubMed Web of Science ®Google Scholar
• Saridaki Z, Androulakis N, Vardakis N, et al. A triplet combination with irinotecan (CPT-11), oxaliplatin (LOHP), continuous infusion 5-fluorouracil and leucovorin (FOLFOXIRI) plus cetuximab as first-line treatment in KRAS wt, metastatic colorectal cancer: a pilot phase II trial. Br J Cancer. 2012;107(12):1932–1937.
   PubMed Web of Science ®Google Scholar
• Assenat E, Desseigne F, Thezenas S, et al. Cetuximab plus FOLFIRINOX (ERBIRINOX) as first-line treatment for unresectable metastatic colorectal cancer: a phase II trial. Oncologist. 2011;16(11):1557–1564.
   PubMed Web of Science ®Google Scholar
• Cremolini C, Antoniotti C, Lonardi S, et al. Activity and safety of cetuximab plus modified folfoxiri followed by maintenance with cetuximab or bevacizumab for ras and braf wild-type metastatic colorectal cancer a randomized phase 2 clinical trial. JAMA Oncol. 2018;4(4):529–536.
   PubMed Web of Science ®Google Scholar
• Satake H, Tsuji A, Nakamura M, et al. Phase I study of primary treatment with 5‑FU, oxaliplatin, irinotecan, levofolinate, and panitumumab combination chemotherapy in patients with advanced/recurrent colorectal cancer involving the wild‑type RAS gene: the JACCRO CC‑14 study. Int J Clin Oncol. 2018;23(3):490–496.
   PubMed Web of Science ®Google Scholar
• Bendell JC, Zakari A, Peyton JD, et al. A phase ii study of folfoxiri plus panitumumab followed by evaluation for resection in patients with metastatic kras wild-type colorectal cancer with liver metastases only. Oncologist. 2016;21(3):279–280.
   PubMed Web of Science ®Google Scholar
• Fornaro L, Lonardi S, Masi G, et al. FOLFOXIRI in combination with panitumumab as first-line treatment in quadruple wild-type (KRAS, NRAS, HRAS, BRAF) metastatic colorectal cancer patients: a phase II trial by the Gruppo Oncologico Nord Ovest (GONO). Ann Oncol. 2013;24(8):2062–2067.
   PubMed Web of Science ®Google Scholar
• Geissler M, Martens UM, Knorrenschield R, et al. mFOLFOXIRI + panitumumab versus FOLFOXIRI as first-line treatment in patients with RAS wild-type metastatic colorectal cancer m(CRC): A randomized phase II VOLFI trial of the AIO (AIO-KRK0109). Oral presentation at the 2017 ESMO Meeting; 2017 September 8–12; Madrid, Spain.
   Google Scholar
• Geissler M, Martens UM, Knorrenschield R, et al. VOLFI: mFOLFOXIRI + panitumumab versus FOLFOXIRI as first-line treatment in patients with RAS wild-type metastatic colorectal cancer (mCRC): A randomized phase II trial of the AIO (AIO-KRK-0109). Oral presentation at the ESMO World Congress on Gastrointestinal Cancer 2018; 2018 June 20–23; Barcelona, Spain.
   Google Scholar
• Arnold D, Lueza B, Douillard J-Y, et al. Prognostic and predictive value of primary tumour side in patients with RAS wild-type metastatic colorectal cancer treated with chemotherapy and EGFR directed antibodies in six randomized trials. Ann Oncol. 2017;28(8):1713–1729.
   PubMed Web of Science ®Google Scholar
• Huiskens J, van Gulik TM, van Lienden KP, et al. Treatment strategies in colorectal cancer patients with initially unresectable liver-only metastases, a study protocol of the randomised phase 3 CAIRO5 study of the Dutch Colorectal Cancer Group (DCCG). BMC Cancer. 2015;15:365.
   PubMed Web of Science ®Google Scholar
• Loupakis F, Stein A, Ychou M, et al. A review of clinical studies and practical guide for the administration of triplet chemotherapy regimens with bevacizumab in first-line metastatic colorectal cancer. Target Oncol. 2016;11:293–308.
   PubMed Web of Science ®Google Scholar
• NCCN clinical practice guidelines in oncology. Colon cancer. Plymouth Meeting, US: National Comprehensive Cancer Network. Version 1; 2018 [cited 2018 Jan 28].
   Google Scholar
• Van Cutsem E, Cervantes A, Adam R, et al. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016;27(8):1386–1422.
   PubMed Web of Science ®Google Scholar