Arandomized phase II clinical study of combining panitumumab and bevacizumab, plus irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) compared with FOLFIRI alone as second-line treatment for patients with metastatic colorectal cancer and KRAS mutation

OncoTargets and Therapy

Volumn 8, Issue , 2015, Pages 1061-1068

  Liu, Yuguo ^a   Luan, Lijuan ^a   Wang, Xingli ^a  

^a SHANDONG CANCER HOSPITAL AND INSTITUTE   (China)

Author keywords

Bevacizumab; FOLFIRI; Metastatic colorectal cancer; Panitumumab; Second line chemotherapy

Indexed keywords

BEVACIZUMAB; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; PANITUMUMAB;

ADULT; AGED; ARTICLE; BLEEDING; COLORECTAL CANCER; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; GENE MUTATION; HUMAN; HYPERTENSION; HYPOKALEMIA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; METASTASIS; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; ONCOGENE K RAS; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; SKIN TOXICITY; VERY ELDERLY;

EID: 84929394431     PISSN: 11786930     EISSN: 11786930     Source Type: Journal    
DOI: 10.2147/OTT.S81442     Document Type: Article

References (29)

1. Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010;60:277–300.
2. Ciombor KK, Berlin J. Targeting metastatic colorectal cancer – present and emerging treatment options. Pharmgenomics Pers Med. 2014; 7:137–144.
3. Cunningham D, Pyrhonen S, James RD, et al. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet. 1998;352:1413–1418.
4. Rougier P, Van Cutsem E, Bajetta E, et al. Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet. 1998;352: 1407–1412.
5. Fuchs CS, Marshall J, Mitchell E, et al. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: results from the BICC-C Study. J Clin Oncol. 2007;25:4779–4786.
6. Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. New Engl J Med. 2004;350:2335–2342.
7. Peeters M, Price TJ, Cervantes A, et al. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol. 2010;28:4706–4713.
8. Van Cutsem E, Kohne CH, Lang I, et al. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol. 2011;29:2011–2019.
9. Macarulla T, Sauri T, Tabernero J. Evaluation of aflibercept in the treatment of metastatic colorectal cancer. Expert Opin Biol Ther. 2014; 14:1493–1505.
10. Sastre J, Argiles G, Benavides M, et al. Clinical management of regorafenib in the treatment of patients with advanced colorectal cancer. Clin Transl Oncol. 2014.
11. Timar J. The clinical relevance of KRAS gene mutation in non-small-cell lung cancer. Curr Opin Oncol. 2014;26:138–144.
12. Bos JL. Ras oncogenes in human cancer: a review. Cancer Res. 1989; 49:4682–4689.
13. Andreyev HJ, Norman AR, Cunningham D, et al. Kirsten ras mutations in patients with colorectal cancer: the ‘RASCAL II’ study. Br J Cancer. 2001;85:692–696.
14. Esteller M, Gonzalez S, Risques RA, et al. K-ras and p16 aberrations confer poor prognosis in human colorectal cancer. J Clin Oncol. 2001; 19:299–304.
15. Imamura Y, Lochhead P, Yamauchi M, et al. Analyses of clinicopathological, molecular, and prognostic associations of KRAS codon 61 and codon 146 mutations in colorectal cancer: cohort study and literature review. Mol Cancer. 2014;13:135.
16. Cohn AL, Shumaker GC, Khandelwal P, et al. An open-label, single-arm, phase 2 trial of panitumumab plus FOLFIRI as second-line therapy in patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2011;10:171–177.
17. Mitchell EP, Piperdi B, Lacouture ME, et al. The efficacy and safety of panitumumab administered concomitantly with FOLFIRI or Irinotecan in second-line therapy for metastatic colorectal cancer: the secondary analysis from STEPP (Skin Toxicity Evaluation Protocol With Panitumumab) by KRAS status. Clin Colorectal Cancer. 2011;10:333–339.
18. Hocking CM, Price TJ. Panitumumab in the management of patients with KRAS wild-type metastatic colorectal cancer. Therap Adv Gastroenterol. 2014;7:20–37.
19. Kohne CH, Hofheinz R, Mineur L, et al. First-line panitumumab plus irinotecan/5-fluorouracil/leucovorin treatment in patients with metastatic colorectal cancer. J Cancer Res Clin Oncol. 2012;138:65–72.
20. Berlin J, Posey J, Tchekmedyian S, et al. Panitumumab with irinotecan/leucovorin/5-fluorouracil for first-line treatment of metastatic colorectal cancer. Clin Colorectal Cancer. 2007;6:427–432.
21. Rak J, Yu JL, Kerbel RS, Coomber BL. What do oncogenic mutations have to do with angiogenesis/vascular dependence of tumors? Cancer Res. 2002;62:1931–1934.
22. Mizukami Y, Kohgo Y, Chung DC. Hypoxia inducible factor-1 independent pathways in tumor angiogenesis. Clin Cancer Res. 2007;13:5670–5674.
23. Heinemann V, Hoff PM. Bevacizumab plus irinotecan-based regimens in the treatment of metastatic colorectal cancer. Oncology. 2010;79: 118–128.
24. Hurwitz HI, Yi J, Ince W, Novotny WF, Rosen O. The clinical benefit of bevacizumab in metastatic colorectal cancer is independent of K-ras mutation status: analysis of a phase III study of bevacizumab with chemotherapy in previously untreated metastatic colorectal cancer. Oncologist. 2009;14:22–28.
25. Xie S, Han G, Fan Z, He L, Xu W, Qin Z. Safety and efficacy of second-line treatment with folinic acid, 5-fluorouracil and irinotecan (FOLFIRI) in combination of panitumumab and bevacizumab for patients with metastatic colorectal cancer. Med Oncol. 2014;31:35.
26. Liang HL, Hu AP, Li SL, Liu JY. Combining bevacizumab and panitumumab with irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as second-line treatment in patients with metastatic colorectal cancer. Med Oncol. 2014;31:976.
27. Amado RG, Wolf M, Peeters M, et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008;26:1626–1634.
28. Fuchs CS, Moore MR, Harker G, Villa L, Rinaldi D, Hecht JR. Phase III comparison of two irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer. J Clin Oncol. 2003;21:807–814.
29. Muro K, Boku N, Shimada Y, et al. Irinotecan plus S-1 (IRIS) versus fluorouracil and folinic acid plus irinotecan (FOLFIRI) as second-line chemotherapy for metastatic colorectal cancer: a randomised phase 2/3 non-inferiority study (FIRIS study). Lancet Oncol. 2010;11:853–860.