Individual patient data analysis of progression-free survival versus overall survival as a first-line end point for metastatic colorectal cancer in modern randomized trials: Findings from the analysis and research in cancers of the digestive system database

Journal of Clinical Oncology

Volumn 33, Issue 1, 2015, Pages 22-28

  Shi, Qian ^a   De Gramont, Aimery ^b   Grothey, Axel ^a   Zalcberg, John ^d   Chibaudel, Benoist ^b   Schmoll, Hans Joachim ^g   Seymour, Matthew T ^k   Adams, Richard ^y   Saltz, Leonard ^m   Goldberg, Richard M ^l,n   Punt, Cornelis J A ^o   Douillard, Jean Yves ^e   Hoff, Paulo M ^p   Hecht, Joel Randolph ^q   Hurwitz, Herbert ^r   Díaz Rubio, Eduardo ^s   Porschen, Rainer ^h   Tebbutt, Niall C ^f   Fuchs, Charles ^t   Souglakos, John ^u   Falcone, Alfredo ^v   Tournigand, Christophe ^c   Kabbinavar, Fairooz F ^q   Heinemann, Volker ⁱ   Van Cutsem, Eric ^w   Bokemeyer, Carsten ^j   Buyse, Marc ^x   Sargent, Daniel J ^a   more..

^a MAYO CLINIC   (United States)

^b HÔPITAL SAINT ANTOINE   (France)

^c UNIVERSITÉ PARIS EST CRÉTEIL   (France)

^d Institute of Cancer Research in Western ^*  (France)

^e MONASH UNIVERSITY   (Australia)

^f AUSTIN HEALTH   (Australia)

^g MARTIN LUTHER UNIVERSITY HALLE WITTENBERG   (Germany)

^h KLINIKUM BREMEN OST   (Germany)

ⁱ UNIVERSITY OF MUNICH   (Germany)

^j UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^k IMPERIAL CANCER RESEARCH FUND   (United Kingdom)

^l CARDIFF UNIVERSITY   (United Kingdom)

^m MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

ⁿ OHIO STATE UNIVERSITY   (United States)

^o ACADEMIC MEDICAL CENTER   (Netherlands)

^p HOSPITAL SÍRIO LIBANÊS   (Brazil)

^q UNIVERSITY OF CALIFORNIA   (United States)

^r DUKE UNIVERSITY   (United States)

^s HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^t DANA FARBER CANCER INSTITUTE   (United States)

^u UNIVERSITY OF CRETE   (Greece)

^v UNIVERSITY OF PISA   (Italy)

^w UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^x INTERNATIONAL DRUG DEVELOPMENT INSTITUTE   (Belgium)

^y NONE

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOGENESIS INHIBITOR; BIOLOGICAL PRODUCT; CETUXIMAB; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; IRINOTECAN; OXALIPLATIN; ANTINEOPLASTIC AGENT; EPIDERMAL GROWTH FACTOR RECEPTOR; PROTEIN KINASE INHIBITOR;

ADULT; AGED; ANTIANGIOGENIC THERAPY; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CONTROLLED STUDY; CORRELATION ANALYSIS; FEMALE; HAZARD RATIO; HUMAN; MAJOR CLINICAL STUDY; MALE; METASTATIC COLORECTAL CANCER; MIDDLE AGED; OVERALL SURVIVAL; PATIENT CODING; PROGRESSION FREE SURVIVAL; PROPORTIONAL HAZARDS MODEL; RANDOMIZED CONTROLLED TRIAL; REGRESSION ANALYSIS; SURVIVAL; TREATMENT DURATION; TREATMENT OUTCOME; ANTAGONISTS AND INHIBITORS; COLORECTAL NEOPLASMS; DIGESTIVE SYSTEM; DISEASE FREE SURVIVAL; DRUG EFFECTS; FACTUAL DATABASE; MEDICAL RESEARCH; METASTASIS; NEOPLASMS; OUTCOME ASSESSMENT; PATHOLOGY; PROCEDURES; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICS AND NUMERICAL DATA; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ANGIOGENESIS INHIBITORS; ANTINEOPLASTIC AGENTS; BIOMEDICAL RESEARCH; COLORECTAL NEOPLASMS; DATABASES, FACTUAL; DIGESTIVE SYSTEM; DISEASE-FREE SURVIVAL; HUMANS; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASMS; OUTCOME ASSESSMENT (HEALTH CARE); PROGNOSIS; PROTEIN KINASE INHIBITORS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTOR, EPIDERMAL GROWTH FACTOR; YOUNG ADULT;

EID: 84920602447     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2014.56.5887     Document Type: Article

References (43)

1. Broglio KR, Berry DA: Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst 101:1642-1649, 2009
2. Biomarkers Definitions Working Group: Bio-markers and surrogate endpoints: Preferred definitions and conceptual framework. Clin Pharmacol Ther 69:89-95, 2001
3. Buyse M, Thirion P, Carlson R.W., et al.: Relation between tumour response to first-line chemotherapy and survival in advanced colorectal cancer: A meta-analysis-Meta-Analysis Group in Cancer. Lancet 356:373-378, 2000
4. Molenberghs G, Burzykowski T, Alonso A., et al.: A perspective on surrogate endpoints in controlled clinical trials. Stat Methods Med Res 13:177-206, 2004
5. Tang PA, Bentzen SM, Chen E.X., et al.: Surrogate end points for median overall survival in meta-static colorectal cancer: Literature-based analysis from 39 randomized controlled trials of first-line chemotherapy. J Clin Oncol 25:4562-4568, 2007
6. Buyse M, Burzykowski T, Carroll K., et al.: Progression-free survival is a surrogate for survival in advanced colorectal cancer. J Clin Oncol 25:5218-5224, 2007
7. Díaz-Rubio E., Tabernero J, Gómez-España A, et al.: Phase III study of capecitabine plus oxaliplatin compared with continuous-infusion fluorouracil plus oxaliplatin as first-line therapy in metastatic colorec-tal cancer: Final report of the Spanish Cooperative Group for the Treatment of Digestive Tumors Trial. J Clin Oncol 25:4224-4230, 2007
8. Tebbutt NC, Wilson K, Gebski V.J., et al.: Cape-citabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: Results of the Australasian Gastrointestinal Trials Group Randomized Phase III MAX Study. J Clin Oncol 28:3191-3198, 2010
9. Porschen R, Arkenau HT, Kubicka S, et al.: Phase III study of capecitabine plus oxaliplatin compared with fluorouracil and leucovorin plus oxalipla-tin in metastatic colorectal cancer: A final report of the AIO Colorectal Study Group. J Clin Oncol 25: 4217-4223, 2007
10. Hurwitz H, Fehrenbacher L, Novotny W., et al.: Bevacizumab plus irinotecan, fluorouracil, and leuco-vorin for metastatic colorectal cancer. N Engl J Med 350:2335-2342, 2004
11. Kabbinavar FF, Schulz J, McCleod M., et al.: Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: Results of a randomized phase II trial. J Clin Oncol 23:3697-3705, 2005
12. 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 25:4779-4786, 2007
13. 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 22:229-237, 2004
14. 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 28:4697-4705, 2010
15. Hecht JR, Mitchell E, Chidiac T., et al.: A randomized phase IIIB trial of chemotherapy, bev-acizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol 27:672-680, 2009
16. Koopman M, Antonini NF, Douma J, et al.: Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): A phase III randomised controlled trial. Lancet 370:135-142, 2007
17. Tol J, Koopman M, Cats A., et al.: Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. N Engl J Med 360:563-572, 2009
18. Maughan TS, Adams RA, Smith C.G., 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 377:2103-2114, 2011
19. Moosmann N, von Weikersthal LF, Vehling-Kaiser U, et al.: Cetuximab plus capecitabine and irinotecan compared with cetuximab plus capecit-abine and oxaliplatin as first-line treatment for patients with metastatic colorectal cancer: AIO KRK-0104-A randomized trial of the German AIO CRC study group. J Clin Oncol 29:1050-1058, 2011
20. Seymour MT, Maughan TS, Ledermann J.A., et al.: Different strategies of sequential and combination chemotherapy for patients with poor prognosis advanced colorectal cancer (MRC FOCUS): A randomised controlled trial. Lancet 370:143-152, 2007
21. Seymour MT, Thompson LC, Wasan H.S., et al.: Chemotherapy options in elderly and frail patients with metastatic colorectal cancer (MRC FOCUS2): An open-label, randomised factorial trial. Lancet 377:1749-1759, 2011
22. Falcone A, Ricci S, Brunetti I., et al.: Phase III trial of infusional fluorouracil, leucovorin, oxalipla-tin, 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 25:1670-1676, 2007
23. 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 94:798-805, 2006
24. Hoff PM, Hochhaus A, Pestalozzi B.C., et al.: Cediranib plus FOLFOX/CAPOX versus placebo plus FOLFOX/CAPOX in patients with previously untreated metastatic colorectal cancer: A randomized, double-blind, phase III study (HORIZON II). J Clin Oncol 30:3596-3603, 2012
25. Schmoll HJ, Cunningham D, Sobrero A., et al.: Cediranib with mFOLFOX6 versus bevacizumab with mFOLFOX6 as first-line treatment for patients with advanced colorectal cancer: A double-blind, randomized phase III study (HORIZON III). J Clin Oncol 30:3588-3595, 2012
26. Díaz-Rubio E., Gómez-España A, Massutí B, et al.: First-line XELOX plus bevacizumab followed by XELOX plus bevacizumab or single-agent bevaci-zumab as maintenance therapy in patients with metastatic colorectal cancer: The phase III MACRO TTD study. Oncologist 17:15-25, 2012
27. Goldberg RM, Sargent DJ, Morton R.F., et al.: A randomized controlled trial of fluorouracil plus leuco-vorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colo-rectal cancer. J Clin Oncol 22:23-30, 2004
28. Saltz LB, Clarke S, Díaz-Rubio E, et al.: Bevaci-zumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: A randomized phase III study. J Clin Oncol 26:2013-2019, 2008
29. Tournigand C, Cervantes A, Figer A., et al.: OPTIMOX1: A randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-go fashion in advanced colorectal cancer-A GERCOR study. J Clin Oncol 24:394-400, 2006
30. Chibaudel B, Maindrault-Goebel F, Lledo G., et al.: Can chemotherapy be discontinued in unresect-able metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol 27:5727-5733, 2009
31. Lièvre A, Bachet JB, Le Corre D, et al.: KRAS mutation status is predictive of response to cetux-imab therapy in colorectal cancer. Cancer Res 66: 3992-3995, 2006
32. Di Fiore F, Blanchard F, Charbonnier F., et al.: Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by Cetuximab plus chemotherapy. Br J Cancer 96:1166-1169, 2007
33. De Roock W, Piessevaux H, De Schutter J, et al.: KRAS wild-type state predicts survival and is associated to early radiological response in meta-static colorectal cancer treated with cetuximab. Ann Oncol 19:508-515, 2008
34. Cox DR. Regression models and life tables. J R Stat Soc B 34:187-220, 1972
35. Burzykowski T, Molenberghs G, Buyse M., et al.: Validation of surrogate end points in multiple randomized clinical trials with failure time end points. J R Stat Soc C 50:405-422, 2001
36. Burzykowski T, Molenberghs G, Buyse M (eds): Evaluation of Surrogate Endpoints. Heidelberg, Germany, Springer Verlag, 2005
37. Van Cutsem E, Köhne CH, Hitre E., et al.: Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 360:1408-1417, 2009
38. Van Cutsem E, Köhne CH, Láng I, et al.: Cetuximab plus irinotecan, fluorouracil, and leuco-vorin as first-line treatment for metastatic colorectal cancer: Updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol 29:2011-2019, 2011
39. Bokemeyer C, Bondarenko I, Hartmann J.T., et al.: Efficacy according to biomarker status of cetux-imab plus FOLFOX-4 as first-line treatment for met-astatic colorectal cancer: The OPUS study. Ann Oncol 22:1535-1546, 2011
40. Ocana A, Amir E, Vera-Badillo F, et al.: Phase III trials of targeted anticancer therapies: Redesigning the concept. Clin Cancer Res 19:4931-4940, 2013
41. Booth CM, Eisenhauer EA: Progression-free survival: Meaningful or simply measurable? J Clin Oncol 30:1030-1033, 2012
42. Saltz LB, Cox JV, Blanke C, et al.: Irinotecan plus fluorouracil and leucovorin for metastatic colo-rectal cancer: Irinotecan Study Group. N Engl J Med 343:905-914, 2000
43. de Gramont A, Figer A, Seymour M., et al.: Leucovorin and fluorouracil with or without oxalipla-tin as first-line treatment in advanced colorectal cancer. J Clin Oncol 18:2938-2947, 2000