Gemcitabine and oxaliplatin combination as first-line treatment for advanced pancreatic cancer: A multicenter phase II study

Cancer Chemotherapy and Pharmacology

Volumn 64, Issue 2, 2009, Pages 317-325

  Lee, Kyung Hee ^a   Kim, Min Kyoung ^a   Kim, Yeol Hong ^b   Ryoo, Baek Yeol ^c   Lim, Ho Yeong ^d   Song, Hong Suk ^e   Kim, Hoon Kyo ^f   Lee, Myung Ah ^g   Im, Seock Ah ^h   Chang, Heung Moon ⁱ   Cho, Jae Yong ^j   Zang, Dae Young ^k   Kim, Bong Seog ^l   Kim, Jun Suk ^m  

^a Yeungnam University College of Medicine   (South Korea)

^b College of Medicine   (South Korea)

^c Korea Cancer Center Hospital   (South Korea)

^d Samsung Medical Center   (South Korea)

^e Keimyung University   (South Korea)

^f The Catholic University of Korea   (South Korea)

^g The Catholic University of Korea   (South Korea)

^h Seoul National University Hospital   (South Korea)

ⁱ Asan Medical Center   (South Korea)

^j Yonsei University College of Medicine   (South Korea)

^k Hallym University Dongtan Sacred Heart Hospital   (South Korea)

^l Seoul Veterans Hospital   (South Korea)

^m Korea University College of Medicine   (South Korea)

more..

Author keywords

Advanced pancreatic cancer; Combination chemotherapy; Gemcitabine; GEMOX; Oxaliplatin

Indexed keywords

GEMCITABINE; OXALIPLATIN;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG ABSORPTION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG HALF LIFE; DRUG RESPONSE; DRUG SAFETY; EDEMA; FATIGUE; FEMALE; HUMAN; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA AND VOMITING; NEUROPATHY; NEUTROPENIA; PANCREAS ADENOCARCINOMA; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; SENSORY NEUROPATHY; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT REFUSAL; UNSPECIFIED SIDE EFFECT; VOMITING;

ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DEOXYCYTIDINE; FEMALE; FOLLOW-UP STUDIES; HUMANS; LIVER NEOPLASMS; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; ORGANOPLATINUM COMPOUNDS; PANCREATIC NEOPLASMS; PROGNOSIS; QUALITY OF LIFE; SURVIVAL RATE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 67349175594     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-008-0873-9     Document Type: Article

References (44)

1. HA Burris 3rd MJ Moore J Andersen 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 (Pubitemid 27251144)
2. E Van Cutsem R Aerts K Haustermans 2004 Systemic treatment of pancreatic cancer Eur J Gastroenterol Hepatol 16 265 274 (Pubitemid 38368369)
3. S Rao D Cunningham 2002 Advanced pancreatic cancer-5 years on Ann Oncol 13 1165 1168
4. E O'Reilly G Abou-Alfa 2007 Cytotoxic therapy for advanced pancreatic adenocarcinoma Semin Oncol 34 347 353 (Pubitemid 47176624)
5. SY Yoon KH Park SC Oh 2002 Phase II trial of gemcitabine, UFT-E, leucovorin combination chemotherapy in advanced pancreatic adenocarcinoma Cancer Res Treat 34 111 116
6. GJ Peters AM Bergman VW Ruiz van Haperen 1995 Interaction between cisplatin and gemcitabine in vitro and in vivo Semin Oncol 22 suppl 11 72 79
7. E Cvitkovic 1998 Ongoing and unsaid on oxaliplatin: the hope Br J Cancer 77 suppl 4 8 11
8. Heinemann V, Quietzsch D, Gieseler F et al. (2001) Gemcitabine plus cisplatin versus gemcitabine in advanced pancreatic cancer: preliminary results of a randomized phase III trial. Proc Am Soc Clin Oncol 20 (abstract 625)
9. C Louvet R Labianca P Hammel 2005 Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial J Clin Oncol 23 3509 3516 (Pubitemid 46243495)
10. Woynarowski JM, Chapman W et al (1996) Mechanism of action of oxaliplatin, specificity of adduct formation. San Antonio, Texas
11. Woynarowski JM, Chapman W, Napier C et al (1997) Mechanisms of action of oxaliplatin:oxaliplatin-induced lesions in cellular DNA. San Antonio, Texas
12. V Boudný O Vrána F Gaucheron 1992 Biophysical analysis of DNA modified by 1, 2-diaminocyclohexane platinum(II) complexes Nucleic Acids Res 20 267 272
13. EL Mamenta EE Poma WK Kaufmann 1994 Enhanced replicative bypass of platinum-DNA adducts in cisplatin-resistant human ovarian carcinoma cell lines Cancer Res 54 3500 3505 (Pubitemid 24225973)
14. S Aebi B Kurdi-Haidar R Gordon 1996 Loss of DNA mismatch repair in acquired resistance to cisplatin Cancer Res 56 3087 3090 (Pubitemid 26199755)
15. D Fink H Zheng S Nebel 1997 In vitro and in vivo resistance to cisplatin in cells that have lost DNA mismatch repair Cancer Res 57 1841 1845 (Pubitemid 27209707)
16. E Raymond SG Chaney A Taamma E Cvitkovic 1998 Oxaliplatin: a review of preclinical and clinical studies Ann Oncol 9 1053 1071 (Pubitemid 28518143)
17. M Kornmann H Fakler U Butzer HG Beger KH Link 2000 Oxaliplatin exerts potent in vitro cytotoxicity in colorectal and pancreatic cancer cell lines and liver metastases Anticancer Res 20 3259 3264
18. ML Rothenberg MJ Moore MC Cripps 1996 A phase II trial of gemcitabine in patients with 5 FU-refractory pancreas cancer Ann Oncol 7 347 353 (Pubitemid 26246785)
19. NK Aaronson S Ahmedzai B Bergman 1993 The European Organization for Research and Treatment of Cancer QLQ-C 30: a quality-of-life instrument for use in international clinical trials in oncology J Natl Cancer Inst 85 365 376 (Pubitemid 23073154)
20. B Glimelius K Hoffman PO Sjödén 1996 Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer Ann Oncol 7 593 600 (Pubitemid 26285639)
21. D Fitzsimmons CD Johnson S George 1999 Development of disease specific quality of life (QoL) questionnaire module to supplement the EORTC core cancer QoL questionnaire, the QLQ-C30 in patients with pancreatic cancer Eur J Cancer 35 939 941 (Pubitemid 29277128)
22. TR Fleming 1982 One-sample multiple testing procedures for phase II clinical trials Biometrics 38 143 151
23. KU Lee ID Kim JC Kim JP Kim 1989 Prognostic factors and adequate surgical management of pancreatic cancer-clinical analysis of 12 years from 1976-1987 Korean J Gastroenterol 21 404 413
24. SJ Lee YC Lee SY Song 1994 Clinical study on pancreatic cancer and its prognostic factors Korean J Gastroenterol 26 1010 1020
25. YJ Min KR Joo NH Park 2002 Gemcitabine therapy in patients with advanced pancreatic cancer Korean J Int Med 17 259 262
26. SW Jung JY Park YS Kim 2005 Survival analysis according to treatment modality in pancreatic cancer patients Korean J Gastroenterol 46 120 128 (in Korean)
27. JK Park YB Yoon YT Kim 2007 Survival and prognostic factors of unresectable pancreatic cancer Korean J Med 72 151 161
28. H Oettle D Arnold C Hempel H Riess 2000 The role of gemcitabine alone and in combination in the treatment of pancreatic cancer Anticancer Drugs 11 771 786
29. DR Xie HL Liang Y Wang SS Guo Q Yang 2006 Meta-analysis on inoperable pancreatic cancer: a comparison between gemcitabine-based combination therapy and gemcitabine alone World J Gastroenterol 12 6973 6981 (Pubitemid 44834888)
30. C Louvet T André G Lledo 2002 Gemcitabine combined with oxaliplatin in advanced pancreatic adenocarcinoma: final results of a GERCOR multicenter phase II study J Clin Oncol 20 1512 1518 (Pubitemid 34260530)
31. E Poplin DE Levy J Berlin 2006 Phase III trial of gemcitabine (30 minute infusion) vs gemcitabine (fixed dose-rate infusion [FDR]) vs gemcitabine + oxaliplatin (GEMOX) in patients with advanced pancreatic cancer Proc Am Clin Oncol 26 180s (abstract 4004)
32. SR Alberts PM Townley RM Goldberg 2003 Gemcitabine and oxaliplatin for metastatic pancreatic adenocarcinoma: a North Central Cancer Treatment Group phase II study Ann Oncol 14 580 585 (Pubitemid 41295087)
33. D Mavroudis C Kourousis S Kakolyris 2000 Phase I study of the gemcitabine/oxaliplatin combination in patients with advanced solid tumors: a preliminary report Semin Oncol 27 Suppl 2 25 30 (Pubitemid 30108681)
34. S Shibata W Chow P Frankel 2001 A phase I trial of oxaliplatin (OX) in combination with gemcitabine (G): a California Consortium trial Proc Am Soc Clin Oncol 20 96a (abstract 381)
35. S Faivre E Raymond F Lokiec 2001 Final results of the phase I-II and pharmacokinetic study GEM/OX combining gemcitabine (Gem) with oxaliplatin (Ox) in patients (pts) with advanced non-small-cell lung (NSCLC) and ovarian carcinoma (OC) Proc Am Soc Clin Oncol 20 89b (abstract 2105)
36. M Airoldi L Cattel R Passera 2006 Gemcitabine and oxaliplatin in patients with pancreatic adenocarcinoma: clinical and pharmacokinetic data Pancreas 32 44 50 (Pubitemid 41803646)
37. R Grunewald JL Abbruzzese P Tarassoff W Plunkett 1991 Saturation of 2?, 2?-difluorodeoxycytidine 5'-triphosphate accumulation by mononuclear cells during a phase I trial of gemcitabine Cancer Chemother Pharmacol 27 258 262
38. V Gandhi W Plunkett M Du M Ayres EH Estey 2002 Prolonged infusion of gemcitabine: clinical and pharmacodynamic studies during a phase I trial in relapsed acute myelogenous leukemia J Clin Oncol 20 665 673 (Pubitemid 34111372)
39. M Tempero W Plunkett V Ruiz van Haperen 1999 Randomized phase II trial of dose intense gemcitabine by standard infusion vs. fixed dose rate in metastatic pancreatic adenocarcinoma Proc Am Soc Clin Oncol 18 273a (abstract 1048)
40. B Escudier T Eisen WM Stadler 2007 Sorafenib in advanced clear-cell renal cell carcinoma N Engl J Med 356 125 134 (Pubitemid 46089673)
41. Gradishar W, Drasnojon D, Cheporov S et al. (2007) Randomized comparison of weekly or every 3-week nab-paclitaxel compared to q3w docetaxel as first line therapy in patients with metastatic breast cancer. J Clin Oncol 25(18S) (abstract 1032)
42. SR Bramhall J Schulz J Nemunaitis 2002 A double-blind placebo-controlled, randomized study comparing gemcitabine and marimastat with gemcitabine and placebo as first line therapy in patients with advanced pancreatic cancer Br J Cancer 87 161 167
43. MJ Moore J Hamm J Dancey 2003 Comparison of gemcitabine versus the matrix metalloproteinase inhibitor BAY 12-9566 in patients with advanced or metastatic adenocarcinoma of the pancreas: a phase III trial of the National Cancer Institute of Canada clinical trials group J Clin Oncol 21 3296 3302 (Pubitemid 46606263)
44. T Conroy B Paillot E François 2005 Irinotecan plus oxaliplatin and leucovorin-modulated fluorouracil in advanced pancreatic cancer-A Groupe Tumeurs Digestives of the Federation Nationale des Centres de Lutte Contre Le Cancer Study J Clin Oncol 23 1228 1236 (Pubitemid 46202280)