A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer

British Journal of Cancer

Volumn 101, Issue 10, 2009, Pages 1658-1663

  Yoo, C ^a   Hwang, J Y ^a   Kim, J E ^a   Kim, T W ^a   Lee, J S ^a   Park, D H ^a   Lee, S S ^a   Seo, D W ^a   Lee, S K ^a   Kim, M H ^a   Han, D J ^a   Kim, S C ^a   Lee, J L ^a  

^a University of Ulsan College of Medicine   (South Korea)

Author keywords

Gemcitabine; Irinotecan; Oxaliplatin; Pancreatic cancer; Second line chemotherapy

Indexed keywords

CAPECITABINE; FLUOROURACIL; FOLINIC ACID; GEMCITABINE; IRINOTECAN; OXALIPLATIN;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE CONTROL; DRUG TOLERABILITY; FEBRILE NEUTROPENIA; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROTOXICITY; NEUTROPENIA; OVERALL SURVIVAL; PANCREAS CANCER; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SURVIVAL RATE; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DRUG RESISTANCE, NEOPLASM; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; PANCREATIC NEOPLASMS; PROGNOSIS; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 70449525483     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6605374     Document Type: Article

References (27)

1. Bilimoria K, Bentrem D, Ko C, Ritchey J, Stewart A, Winchester D, Talamonti M (2007) Validation of the 6th edition AJCC Pancreatic Cancer Staging System: report from the National Cancer Database. Cancer 110: 738-744
2. Boeck S, Heinemann V (2008) Second-line therapy in gemcitabine-pretreated patients with advanced pancreatic cancer. J Clin Oncol 26: 1178-1179
3. Brell J, Matin K, Evans T, Volkin R, Kiefer G, Schlesselman J, Dranko S, Rath L, Schmotzer A, Lenzner D, Ramanathan R (2009) Phase II study of docetaxel and gefitinib as second-line therapy in gemcitabine pretreated patients with advanced pancreatic cancer. Oncology 76: 270-274
4. Burris HR, Moore M, Andersen J, Green M, Rothenberg M, Modiano M, Cripps M, Portenoy R, Storniolo A, Tarassoff P, Nelson R, Dorr F, Stephens C, Von HD (1997) Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 15: 2403-2413
5. Cunningham D, Chau I, Stocken DD (2005) Phase III randomized comparison of gemcitabine (GEM) versus gemcitabine plus capecitabine (GEM-CAP) in patients with advanced pancreatic cancer. Eur J Cancer 3: 3 (abstr
6. Demols A, Peeters M, Polus M, Marechal R, Gay F, Monsaert E, Hendlisz A, Van LJ (2006) Gemcitabine and oxaliplatin (GEMOX) in gemcitabine refractory advanced pancreatic adenocarcinoma: a phase II study. Br J Cancer 94: 481-485
7. Gebbia V, Maiello E, Giuliani F, Borsellino N, Caruso M, Di MG, Ferrau F, Bordonaro R, Verderame F, Tralongo P, Di CL, Agueli R, Russo P, Colucci G (2007) Second-line chemotherapy in advanced pancreatic carcinoma: a multicenter survey of the Gruppo Oncologico Italia Meridionale on the activity and safety of the FOLFOX4 regimen in clinical practice. Ann Oncol 18(Suppl 6): vi124-vi127
8. Glimelius B, Hoffman K, Sjoden PO, Jacobsson G, Sellstrom H, Enander LK, Linne T, Svensson C (1996) Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol 7: 593-600
9. Herrmann C, Abel U, Stremmel W, Jaeger D, Herrmann T (2008) Short time to progression under first-line chemotherapy is a negative prognostic factor for time to progression and residual survival under second-line chemotherapy in advanced pancreatic cancer. Oncology 73: 335-339
10. Kang S, Saif M (2008) Optimal second line treatment options for gemcitabine refractory advanced pancreatic cancer patients. Can we establish standard of care with available data? JOP 9: 83-90
11. Kozuch P, Grossbard ML, Barzdins A, Araneo M, Robin A, Frager D, Homel P, Marino J, DeGregorio P, Bruckner HW (2001) Irinotecan Combined with Gemcitabine, 5-Fluorouracil, Leucovorin, and Cisplatin (G-FLIP) is an effective and noncrossresistant treatment for chemotherapy refractory metastatic pancreatic cancer. Oncologist 6: 488-495
12. Kulke M, Blaszkowsky L, Ryan D, Clark J, Meyerhardt J, Zhu A, Enzinger P, Kwak E, Muzikansky A, Lawrence C, Fuchs C (2007) Capecitabine plus erlotinib in gemcitabine-refractory advanced pancreatic cancer. J Clin Oncol 25: 4787-4792
13. Moore M, Goldstein D, Hamm J, Figer A, Hecht J, Gallinger S, Au H, Murawa P, Walde D, Wolff R, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W (2007) Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 25: 1960-1966
14. Nakachi K, Furuse J, Ishii H, Suzuki E, Yoshino M (2007) Prognostic factors in patients with gemcitabine-refractory pancreatic cancer. Jpn J Clin Oncol 37: 114-120
15. Novarino A, Satolli M, Chiappino I, Giacobino A, Bellone G, Rahimi F, Milanesi E, Bertetto O, Ciuffreda L (2009) Oxaliplatin, 5-fluorouracil, and leucovorin as second-line treatment for advanced pancreatic cancer. Am J Clin Oncol 32: 44-48
16. Oettle H, Post S, Neuhaus P, Gellert K, Langrehr J, Ridwelski K, Schramm H, Fahlke J, Zuelke C, Burkart C, Gutberlet K, Kettner E, Schmalenberg H, Weigang-Koehler K, Bechstein W-O, Niedergethmann M, Schmidt-Wolf I, Roll L, Doerken B, Riess H (2007) Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. JAMA 297: 267-277
17. Oettle H, Pelzer U, Stieler J, Hilbig A, Roll L, Schwaner I, Adler M, Detken S, Riess H (2005) Oxaliplatin/folinic acid/5-fluorouracil [24h] (OFF) plus best supportive care versus best supportive care alone (BSC) in second-line therapy of gemcitabine-refractory advanced pancreatic cancer (CONKO 003). J Clin Oncol 23: 315s (abstr 4031
18. Palmer KR, Kerr M, Knowles G, Cull A, Carter DC, Leonard RC (1994) Chemotherapy prolongs survival in inoperable pancreatic carcinoma. Br J Surg 81: 882-885
19. Pelzer U, Kubica K, Stieler J, Schwaner I, Heil G, Görner M, Mölle M, Hilbig A, Dörken B, Riess H, Oettle H (2008) A randomized trial in patients with gemcitabine refractory pancreatic cancer. Final results of the CONKO 003 study. J Clin Oncol 26: 215s (abstr 4508
20. Sener SF, Fremgen A, Menck HR, Winchester DP (1999) Pancreatic cancer: a report of treatment and survival trends for 100,313 patients diagnosed from 1985-1995, using the National Cancer Database. J Am Coll Surg 189: 1-7
21. Simon R, Wittes RE, Ellenberg SS (1985) Randomized phase II clinical trials. Cancer Treat Rep 69: 1375-1381
22. Taieb J, Lecomte T, Aparicio T, Asnacios A, Mansourbakht T, Artru P, Fallik D, Spano J, Landi B, Lledo G, Desrame J (2007) FOLFIRI.3, a new regimen combining 5-fluorouracil, folinic acid and irinotecan, for advanced pancreatic cancer: results of an Association des Gastro-Enterologues Oncologues (Gastroenterologist Oncologist Association) multicenter phase II study. Ann Oncol 18: 498-503
23. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92: 205-216
24. Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A (2004) FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 22: 229-237
25. Tsavaris N, Kosmas C, Skopelitis H, Gouveris P, Kopterides P, Loukeris D, Sigala F, Zorbala-Sypsa A, Felekouras E, Papalambros E (2005) Second-line treatment with oxaliplatin, leucovorin and 5-fluorouracil in gemcitabine-pretreated advanced pancreatic cancer: a phase II study. Invest New Drugs 23: 369-375
26. Xiong H, Varadhachary G, Blais J, Hess K, Abbruzzese J, Wolff R (2008) Phase 2 trial of oxaliplatin plus capecitabine (XELOX) as second-line therapy for patients with advanced pancreatic cancer. Cancer 113: 2046-2052
27. Yeo C, Yeo T, Hruban R, Kern S, Iacobuzio-Donohue C, Maitra A, Goggins M, Canto M, Hessersmith W, Abrams R, Laheru D, Hidalgo M, Jaffe E (2005) Cancer of the pancreas Volume1, 7 edition Lippincott Williams & Wilkins: Philadelphia, PA