Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: A randomized multicenter phase III study (NEOPAC study)

BMC Cancer

Volumn 11, Issue , 2011, Pages

  Heinrich, Stefan ^a   Pestalozzi, Bernhard ^b   Lesurtel, Mickael ^b   Berrevoet, Frederik ^c   Laurent, Stéphanie ^c   Delpero, Jean Robert ^d   Raoul, Jean Luc ^d   Bachellier, Phillippe ^e   Dufour, Patrick ^e   Moehler, Markus ^a   Weber, Achim ^b   Lang, Hauke ^a   Rogiers, Xavier ^c   Clavien, Pierre Alain ^b  

^a UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^b UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^c GHENT UNIVERSITY HOSPITAL   (Belgium)

^d Institut Pauli Calmettes   (France)

^e HÔPITAL DE HAUTEPIERRE   (France)

Author keywords

[No Author keywords available]

Indexed keywords

GEMCITABINE; OXALIPLATIN; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE; PLATINUM COMPLEX;

ABDOMINAL RADIOGRAPHY; ADULT; ARTICLE; CANCER ADJUVANT THERAPY; CANCER STAGING; CLINICAL PROTOCOL; COMPUTER ASSISTED TOMOGRAPHY; DRUG EFFICACY; FEMALE; HISTOPATHOLOGY; HUMAN; LAPAROSCOPY; MALE; MULTICENTER STUDY (TOPIC); MULTIPLE CYCLE TREATMENT; PANCREAS ADENOCARCINOMA; PANCREAS CANCER; PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; SWITZERLAND; THORAX RADIOGRAPHY; ADENOCARCINOMA; ADJUVANT CHEMOTHERAPY; ADJUVANT THERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; MULTICENTER STUDY; PANCREAS TUMOR; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; TRANSLATIONAL RESEARCH;

ADENOCARCINOMA; ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; DEOXYCYTIDINE; FEMALE; HUMANS; MALE; NEOADJUVANT THERAPY; ORGANOPLATINUM COMPOUNDS; PANCREATIC NEOPLASMS; PROSPECTIVE STUDIES; TOMOGRAPHY, X-RAY COMPUTED; TRANSLATIONAL MEDICAL RESEARCH;

EID: 81155158875     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-11-346     Document Type: Article

References (21)

1. Tran KT, Smeenk HG, van Eijck CH, Kazemier G, Hop WC, Greve JW, Terpstra OT, Zijlstra JA, Klinkert P, Jeekel H. Pylorus preserving pancreaticoduodenectomy versus standard Whipple procedure: a prospective, randomized, multicenter analysis of 170 patients with pancreatic and periampullary tumors. Ann Surg 2004, 240(5):738-745. 10.1097/01.sla.0000143248.71964.29, 1356476, 15492552.
2. Klinkenbijl JH, Jeekel J, Sahmoud T, van Pel R, Couvreur ML, Veenhof CH, Arnaud JP, Gonzalez DG, de Wit LT, Hennipman A, et al. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group. Ann Surg 1999, 230(6):776-782. 10.1097/00000658-199912000-00006, 1420941, 10615932.
3. GITSG Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg 1985, 120(8):899-903. GITSG.
4. Ueno H, Kosuge T, Matsuyama Y, Yamamoto J, Nakao A, Egawa S, Doi R, Monden M, Hatori T, Tanaka M, et al. A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer. Br J Cancer 2009, 101(6):908-915. 10.1038/sj.bjc.6605256, 2743365, 19690548.
5. Oettle H, Post S, Neuhaus P, Gellert K, Langrehr J, Ridwelski K, Schramm H, Fahlke J, Zuelke C, Burkart C, et al. Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. Jama 2007, 297(3):267-277. 10.1001/jama.297.3.267, 17227978.
6. Neoptolemos JP, Stocken DD, Friess H, Bassi C, Dunn JA, Hickey H, Beger H, Fernandez-Cruz L, Dervenis C, Lacaine F, et al. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med 2004, 350(12):1200-1210. 10.1056/NEJMoa032295, 15028824.
7. Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, et al. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. Jama 2010, 304(10):1073-1081. 10.1001/jama.2010.1275, 20823433.
8. Corsini MM, Miller RC, Haddock MG, Donohue JH, Farnell MB, Nagorney DM, Jatoi A, McWilliams RR, Kim GP, Bhatia S, et al. Adjuvant radiotherapy and chemotherapy for pancreatic carcinoma: the Mayo Clinic experience (1975-2005). J Clin Oncol 2008, 26(21):3511-3516. 10.1200/JCO.2007.15.8782, 18640932.
9. Herman JM, Swartz MJ, Hsu CC, Winter J, Pawlik TM, Sugar E, Robinson R, Laheru DA, Jaffee E, Hruban RH, et al. Analysis of fluorouracil-based adjuvant chemotherapy and radiation after pancreaticoduodenectomy for ductal adenocarcinoma of the pancreas: results of a large, prospectively collected database at the Johns Hopkins Hospital. J Clin Oncol 2008, 26(21):3503-3510. 10.1200/JCO.2007.15.8469, 18640931.
10. Russ AJ, Weber SM, Rettammel RJ, Mahvi DM, Rikkers LF, Cho CS. Impact of selection bias on the utilization of adjuvant therapy for pancreas adenocarcinoma. Ann Surg Oncol 2010, 17(2):371-376. 10.1245/s10434-009-0759-z, 19851808.
11. Heinrich S, Schafer M, Weber A, Hany TF, Bhure U, Pestalozzi BC, Clavien PA. Neoadjuvant chemotherapy generates a significant tumor response in resectable pancreatic cancer without increasing morbidity: results of a prospective phase II trial. Ann Surg 2008, 248(6):1014-1022. 10.1097/SLA.0b013e318190a6da, 19092346.
12. Heinrich S, Schäfer M, Weber A, Hany TF, Bauerfeind P, Pestalozzi BC, Clavien PA. Neoadjuvant chemotherapy with gemcitabine/cisplatin for resectable pancreatic cancer generates a significant tumor response - Results of a prospective phase II trial. Ann Surg accepted for publication
13. Heinrich S, Pestalozzi B, Schafer M, Weber A, Bauerfeind P, Knuth A, Clavien P. Prospective Phase II trial on Neoadjuvant Chemotherapy with Gemcitabine and Cisplatin for Resectable Adenocarcinoma of the Pancreatic Head. J Clin Oncol 2008, 26(15):2526-2531. 10.1200/JCO.2007.15.5556, 18487569.
14. Li D, Xie K, Wolff R, Abbruzzese JL. Pancreatic cancer. Lancet 2004, 363(9414):1049-1057. 10.1016/S0140-6736(04)15841-8, 3062508, 15051286.
15. Sahora K, Kuehrer I, Eisenhut A, Akan B, Koellblinger C, Goetzinger P, Teleky B, Jakesz R, Peck-Radosavljevic M, Ba'ssalamah A, et al. NeoGemOx: Gemcitabine and oxaliplatin as neoadjuvant treatment for locally advanced, nonmetastasized pancreatic cancer. Surgery 2011, 149(3):311-320. 10.1016/j.surg.2010.07.048, 20817204.
16. Dindo D, Demartines N, Clavien P. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004, 240(2):205-213. 10.1097/01.sla.0000133083.54934.ae, 1360123, 15273542.
17. Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery 2005, 138(1):8-13. 10.1016/j.surg.2005.05.001, 16003309.
18. Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, et al. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med 2006, 355(1):11-20. 10.1056/NEJMoa055531, 16822992.
19. Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, et al. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med 2004, 351(17):1731-1740. 10.1056/NEJMoa040694, 15496622.
20. Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011, 364(19):1817-1825. 10.1056/NEJMoa1011923, 21561347.
21. Heinemann V, Boeck S, Hinke A, Labianca R, Louvet C. Meta-analysis of randomized trials: evaluation of benefit from gemcitabine-based combination chemotherapy applied in advanced pancreatic cancer. BMC Cancer 2008, 8:82. 10.1186/1471-2407-8-82, 2292732, 18373843.