Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): A randomised, multicentre, open-label, non-inferiority phase 3 study

The Lancet Oncology

Volumn 15, Issue 6, 2014, Pages 569-579

  Price, Timothy J ^a   Peeters, Marc ^b   Kim, Tae Won ^c   Li, Jin ^d   Cascinu, Stefano ^e   Ruff, Paul ^f   Suresh, Atilli Satya ^g   Thomas, Anne ^h   Tjulandin, Sergei ⁱ   Zhang, Kathy ^j   Murugappan, Swaminathan ^j   Sidhu, Roger ^j  

^a UNIVERSITY OF ADELAIDE   (Australia)

^b ANTWERP UNIVERSITY HOSPITAL   (Belgium)

^c University of Ulsan   (South Korea)

^d FUDAN UNIVERSITY SHANGHAI CANCER CENTER   (China)

^e UNIVERSITÀ POLITECNICA DELLE MARCHE   (Italy)

^f UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^g APOLLO HOSPITAL   (India)

^h LEICESTER ROYAL INFIRMARY   (United Kingdom)

ⁱ INSTITUTE OF BIOMEDICAL CHEMISTRY   (Russian Federation)

^j AMGEN INC   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CETUXIMAB; PANITUMUMAB;

ABDOMINAL PAIN; ACNE; ADULT; AFRICA; AGED; ANEMIA; ARTICLE; ASIA; ASTHENIA; AUSTRALIA; BACKACHE; CANCER CHEMOTHERAPY; CANCER SURVIVAL; COLORECTAL CANCER; COMPARATIVE EFFECTIVENESS; CONSTIPATION; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DERMATITIS; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRY SKIN; DYSPEPSIA; DYSPNEA; EUROPE; EXON; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HYPOCALCEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; INFUSION RELATED REACTION; INSOMNIA; LUNG INFECTION; MAJOR CLINICAL STUDY; MALE; METASTASIS; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAIL DISEASE; NAUSEA; NORTH AMERICA; ONCOGENE K RAS; OPEN STUDY; OVERALL SURVIVAL; PARONYCHIA; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RISK BENEFIT ANALYSIS; SKIN FISSURE; SKIN TOXICITY; SOUTH AMERICA; STOMATITIS; SURVIVAL TIME; UPPER RESPIRATORY TRACT INFECTION; VOMITING;

AGED; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; COLORECTAL NEOPLASMS; EXONS; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; PROPORTIONAL HAZARDS MODELS; PROTO-ONCOGENE PROTEINS; RAS PROTEINS; TREATMENT OUTCOME;

EID: 84899981129     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)70118-4     Document Type: Article

References (36)

1. Siegel R, Naishadham D, Jemal A Cancer statistics, 2013. CA Cancer J Clin 2013, 63:11-30.
2. Douillard JY, Siena S, Cassidy J, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. J Clin Oncol 2010, 28:4697-4705.
3. Stintzing S, Fischer von Weikersthal L, Decker T, et al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer-subgroup analysis of patients with KRAS: mutated tumours in the randomised German AIO study KRK-0306. Ann Oncol 2012, 23:1693-1699.
4. Jonker DJ, O'Callaghan CJ, Karapetis CS, et al. Cetuximab for the treatment of colorectal cancer. N Engl J Med 2007, 357:2040-2048.
5. Karapetis CS, Khambata-Ford S, Jonker DJ, et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008, 359:1757-1765.
6. Van Cutsem E, Peeters M, Siena S, et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 2007, 25:1658-1664.
7. Van Cutsem E, Siena S, Humblet Y, et al. An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy. Ann Oncol 2008, 19:92-98.
8. 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.
9. Schmoll HJ, Van Cutsem E, Stein A, et al. ESMO Consensus Guidelines for management of patients with colon and rectal cancer. a personalized approach to clinical decision making. Ann Oncol 2012, 23:2479-2516.
10. NCCN clinical practice guidelines in oncology: colon cancer v.3.2014 National Comprehensive Cancer Network, (accessed Feb 11, 2014). http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf.
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 2009, 45:228-247.
12. Common terminology criteria for adverse events v3.0 (CTCAE) National Cancer Institute Cancer Therapy Evaluation Program, (accessed Nov 13, 2013). http://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf.
13. Hung HM, Wang SJ, Tsong Y, Lawrence J, O'Neil RT Some fundamental issues with non-inferiority testing in active controlled trials. Stat Med 2003, 22:213-225.
14. Rothmann M, Li N, Chen G, Chi GY, Temple R, Tsou HH Design and analysis of non-inferiority mortality trials in oncology. Stat Med 2003, 22:239-264.
15. Hassalblad V, Kong DF Statistical methods for comparison to placebo in active-control trials. Drug Inf J 2001, 35:435-449.
16. US Food and Drug Administration. Guidance for industry non-inferiority clinical trials. Wilmington, DE: Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, US Dept of Health and Human Services, 2010.
17. Shao J, Chang M, Chow SC Statistical inference for cancer trials with treatment switching. Stat Med 2005, 24:1783-1790.
18. Hasselblad V, Kong DF Statistical methods for comparison to placebo in active-control trials. Drug Inf J 2001, 35:435-449.
19. Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG, Group C Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA 2012, 308:2594-2604.
20. Peeters M, Price TJ, Cervantes A, et al. Final results from a randomized phase 3 study of FOLFIRI {+/-} panitumumab for second-line treatment of metastatic colorectal cancer. Ann Oncol 2014, 25:107-116.
21. Siu LL, Shapiro JD, Jonker DJ, et al. Phase III randomized, placebo-controlled study of cetuximab plus brivanib alaninate versus cetuximab plus placebo in patients with metastatic, chemotherapy-refractory, wild-type K-RAS colorectal carcinoma: the NCIC Clinical Trials Group and AGITG CO.20 Trial. J Clin Oncol 2013, 31:2477-2484.
22. 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.
23. Maughan TS, Adams RA, Smith CG, et al. Addition of cetuximab to oxaliplatin-based first-line combination chemotherapy for treatment of advanced colorectal cancer: results of the randomised phase 3 MRC COIN trial. Lancet 2011, 377:2103-2114.
24. Van Cutsem E, Köhne CH, Hitre E, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009, 360:1408-1417.
25. Hecht JR, Patnaik A, Berlin J, et al. Panitumumab monotherapy in patients with previously treated metastatic colorectal cancer. Cancer 2007, 110:980-988.
26. Thaler J, Karthaus M, Mineur L, et al. Skin toxicity and quality of life in patients with metastatic colorectal cancer during first-line panitumumab plus FOLFIRI treatment in a single-arm phase II study. BMC Cancer 2012, 12:438.
27. Sobrero AF, Maurel J, Fehrenbacher L, et al. EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. J Clin Oncol 2008, 26:2311-2319.
28. Weiner LM Fully human therapeutic monoclonal antibodies. J Immunother 2006, 29:1-9.
29. Chen P, Wang L, Li H, Liu B, Zou Z Incidence and risk of hypomagnesemia in advanced cancer patients treated with cetuximab: A meta-analysis. Oncol Lett 2013, 5:1915-1920.
30. Kim GP, Grothey A Targeting colorectal cancer with human anti-EGFR monoclonocal antibodies: focus on panitumumab. Biologics 2008, 2:223-228.
31. Custodio A, Feliu J Prognostic and predictive biomarkers for epidermal growth factor receptor-targeted therapy in colorectal cancer: beyond KRAS mutations. Crit Rev Oncol Hematol 2013, 85:45-81.
32. Douillard JY, Oliner KS, Siena S, et al. Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer. N Engl J Med 2013, 369:1023-1034.
33. Peeters M, Oliner KS, Parker A, et al. Massively parallel tumor multigene sequencing to evaluate response to panitumumab in a randomized phase III study of metastatic colorectal cancer. Clin Cancer Res 2013, 19:1902-1912.
34. Stintzing S, Jung A, Rossius L, et al. Analysis of KRAS/NRAS and BRAF mutations in FIRE-3: A randomized phase III study of FOLFIRI plus cetuximab or bevacizumab as first-line treatment for wild-type (WT) KRAS (exon 2) metastatic colorectal cancer (mCRC) patients. Eur J Cancer 2013, 49. abstract 17.
35. Langer C, Kopit J, Awad M, et al. Analysis of K-RAS mutations in patients with metastatic colorectal cancer receiving cetuximab in combination with irinotecan: results from the EPIC trial. Ann Oncol 2008, 19(suppl 8):viii133. abstract 385.
36. 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, 27:663-671.