Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial

Fong, 1999, Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: analysis of 1001 consecutive cases, Ann Surg, 230, 309, 10.1097/00000658-199909000-00004 Nordlinger, 1996, Surgical resection of colorectal carcinoma metastases to the liver. A prognostic scoring system to improve case selection, based on 1568 patients, Cancer, 77, 1254, 10.1002/(SICI)1097-0142(19960401)77:7<1254::AID-CNCR5>3.0.CO;2-I Giacchetti, 1999, Long-term survival of patients with unresectable colorectal cancer liver metastases following infusional chemotherapy with 5-fluorouracil, leucovorin, oxaliplatin and surgery, Ann Oncol, 10, 663, 10.1023/A:1008347829017 Andre, 2004, Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer, N Engl J Med, 350, 2343, 10.1056/NEJMoa032709 Lorenz, 1998, Randomized trial of surgery versus surgery followed by adjuvant hepatic arterial infusion with 5-fluorouracil and folinic acid for liver metastases of colorectal cancer. German Cooperative on Liver Metastases (Arbeitsgruppe Lebermetastasen), Ann Surg, 228, 756, 10.1097/00000658-199812000-00006 Kemeny, 1999, Hepatic arterial infusion of chemotherapy after resection of hepatic metastases from colorectal cancer, N Engl J Med, 341, 2039, 10.1056/NEJM199912303412702 Kemeny, 2002, Combined-modality treatment for resectable metastatic colorectal carcinoma to the liver: surgical resection of hepatic metastases in combination with continuous infusion of chemotherapy—an intergroup study, J Clin Oncol, 20, 1499 Mitry, 2006, Adjuvant chemotherapy after potentially curative resection of metastases from colorectal cancer. A meta-analysis of two randomized trials. ASCO Annual Meeting Proceedings, J Clin Oncol, 24, 152s, 10.1200/jco.2006.24.18_suppl.3524 Portier, 2006, Multicenter randomized trial of adjuvant fluorouracil and folinic acid compared with surgery alone after resection of colorectal liver metastases: FFCD ACHBTH AURC 9002 trial, J Clin Oncol, 24, 4976, 10.1200/JCO.2006.06.8353 Freedman, 1976, On the use of Pocock and Simon's method for balancing treatment numbers over prognostic factors in the controlled clinical trial, Biometrics, 32, 691, 10.2307/2529759 de Gramont, 2000, Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer, J Clin Oncol, 18, 2938, 10.1200/JCO.2000.18.16.2938 Cunningham, 2006, Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer, N Engl J Med, 355, 11, 10.1056/NEJMoa055531 Therasse, 2000, New guidelines to evaluate the response to treatment in solid tumors, J Natl Cancer Inst, 92, 205, 10.1093/jnci/92.3.205 Hwang, 1990, Group sequential designs using a family of type I error probability spending functions, Stat Med, 9, 1439, 10.1002/sim.4780091207 Kaplan, 1958, Nonparametric estimation from incomplete observations, J Am Stat Assoc, 53, 457, 10.1080/01621459.1958.10501452 Kalbfleisch, 1980, 163 Adam, 2003, Liver resection for colorectal metastases: the third hepatectomy, Ann Surg, 238, 871, 10.1097/01.sla.0000098112.04758.4e Kokudo, 2007, Control arm for surgery alone is needed but difficult to obtain in randomized trials for adjuvant chemotherapy after liver resection for colorectal metastases, J Clin Oncol, 25, 1299, 10.1200/JCO.2006.09.9069 Charnsangavej, 2006, Selection of patients for resection of hepatic colorectal metastases: expert consensus statement, Ann Surg Oncol, 13, 1261, 10.1245/s10434-006-9023-y Adam, 2004, Tumor progression while on chemotherapy: a contraindication to liver resection for multiple colorectal metastases?, Ann Surg, 240, 1052, 10.1097/01.sla.0000145964.08365.01 Rubbia-Brandt, 2004, Severe hepatic sinusoidal obstruction associated with oxaliplatin-based chemotherapy in patients with metastatic colorectal cancer, Ann Oncol, 15, 460, 10.1093/annonc/mdh095 Bilchik, 2005, Neoadjuvant chemotherapy for metastatic colon cancer: a cautionary note, J Clin Oncol, 23, 9073, 10.1200/JCO.2005.03.2334 Vauthey, 2006, Chemotherapy regimen predicts steatohepatitis and an increase in 90-day mortality after surgery for hepatic colorectal metastases, J Clin Oncol, 24, 2065, 10.1200/JCO.2005.05.3074 Karoui, 2006, Influence of preoperative chemotherapy on the risk of major hepatectomy for colorectal liver metastases, Ann Surg, 243, 1, 10.1097/01.sla.0000193603.26265.c3 Janunger, 2002, Chemotherapy in gastric cancer: a review and updated meta-analysis, Eur J Surg, 168, 597, 10.1080/11024150201680005 Hurwitz, 2004, Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer, N Engl J Med, 350, 2335, 10.1056/NEJMoa032691 Cunningham, 2004, Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer, N Engl J Med, 351, 337, 10.1056/NEJMoa033025 Hoff, 2007, Targeted therapy trials: approval strategies, target validation, or helping patients?, J Clin Oncol, 1, 1639, 10.1200/JCO.2006.09.8384