Bevacizumab plus gemcitabine and oxaliplatin as first-line therapy for metastatic or locally advanced pancreatic cancer: A phase II trial

Cancer Chemotherapy and Pharmacology

Volumn 68, Issue 6, 2011, Pages 1431-1438

  Fogelman, David ^a   Jafari, Mehrdad ^b   Varadhachary, Gauri R ^a   Xiong, Henry ^c   Bullock, Susie ^a   Ozer, Harold ^d   Lin, E ^a   Morris, Jeffrey ^a   Cunningham, Patti ^d   Bennett, Bronwyn ^d   Abbruzzese, James L ^a   Wolff, Robert A ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b Skagit Cancer Care Center   (United States)

^c Center for Cancer and Blood Disorders   (United States)

^d UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER   (United States)

Author keywords

Adenocarcinoma; Antibodies; Chemotherapy; Clinical trial; Monoclonal; Pancreatic cancer; Pharmacotherapy

Indexed keywords

ANTICOAGULANT AGENT; BEVACIZUMAB; CA 19-9 ANTIGEN; DOCETAXEL; FLUOROURACIL; GEMCITABINE; IRINOTECAN; OXALIPLATIN;

ABDOMINAL PAIN; ADJUVANT THERAPY; ADULT; ADVANCED CANCER; AGE; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER MORTALITY; CANCER RADIOTHERAPY; CANCER RELAPSE; CANCER STAGING; CANCER SURGERY; CEREBROVASCULAR ACCIDENT; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; COLD INTOLERANCE; COLD TOLERANCE; COMPUTER ASSISTED TOMOGRAPHY; CONSTIPATION; CREATININE URINE LEVEL; DIGESTIVE SYSTEM PERFORATION; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG RESPONSE; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; ECOG PERFORMANCE STATUS; FATIGUE; FEMALE; GENDER; HEALTH STATUS; HOSPITALIZATION; HUMAN; HYPERTENSION; LYMPH NODE; MALE; METASTASIS POTENTIAL; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PANCREAS CANCER; PHASE 2 CLINICAL TRIAL; POSTOPERATIVE CARE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN URINE LEVEL; PROTEINURIA; RADIOFREQUENCY ABLATION; RATING SCALE; SALVAGE THERAPY; SIDE EFFECT; STOMACH OBSTRUCTION; SURVIVAL RATE; SURVIVAL TIME; SYSTOLIC HYPERTENSION; TRANSIENT ISCHEMIC ATTACK; URINE PROTEIN CREATININE RATIO;

ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DEOXYCYTIDINE; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM STAGING; ORGANOPLATINUM COMPOUNDS; PANCREATIC NEOPLASMS;

EID: 82455171860     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-011-1601-4     Document Type: Article

References (25)

1. A Jemal R Siegel E Ward Y Hao J Xu MJ Thun 2009 Cancer statistics, 2009 CA Cancer J Clin 59 225 249 19474385 10.3322/caac.20006
2. C Louvet R LaBianca P Hammel, et al. 2005 Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic patients with pancreatic cancer: results of a GERCOR and GISCAD phase III trial J Clin Oncol 23 3509 3516 15908661 10.1200/JCO.2005.06.023 1:CAS:528: DC%2BD2MXlsVyhsrg%3D
3. HA Burris MJ Moore J Andersen, et al. 1997 Improvements in survival and clinical benefit with gemcitabine for advanced pancreatic cancer: a randomized trial J Clin Oncol 15 2403 2413 9196156 1:CAS:528:DyaK2sXlsFKksLY%3D (Pubitemid 27251144)
4. V Heinemann D Quietzsch F Gieseler, et al. 2006 Randomized Phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer J Clin Oncol 24 3946 3952 16921047 10.1200/JCO.2005.05.1490 1:CAS:528:DC%2BD28Xps1Sit78%3D (Pubitemid 46630743)
5. CM Rocha Lima MR Green R Rotche, et al. 2004 Irinotecan plus gemcitabine results in no survival advantage compared with gemcitabine monotherapy in patients with locally advanced or metastatic pancreatic cancer despite increased tumor response rate J Clin Oncol 18 3776 3783 10.1200/JCO.2004.12.082 (Pubitemid 41095218)
6. H Oettle D Richards RK Ramanathan, et al. 2005 A Phase III trial of pemetrexed plus gemcitabine versus gemcitabine in patients with unrespectable or metastatic pancreatic cancer Ann Oncol 16 1639 1645 16087696 10.1093/annonc/mdi309 1:STN:280:DC%2BD2MvpvFKhsg%3D%3D (Pubitemid 41510138)
7. JD Berlin P Catalano JP Thomas JW Kugler DG Haller AB Benson 2002 Phase III study of gemcitabine in combination with fluorouracil versus gemcitabine alone in patients with advanced pancreatic carcinoma: eastern cooperative oncology group trial E2297 J Clin Oncol 20 3270 3275 12149301 10.1200/JCO.2002.11.149 1:CAS:528:DC%2BD38XmsF2rs74%3D (Pubitemid 34831525)
8. D Cunningham I Chau D Stocken, et al. 2009 Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer J Clin Oncol 27 5513 5518 19858379 10.1200/JCO.2009.24.2446 1:CAS:528:DC%2BC3cXhtVWitrc%3D
9. MJ Moore D Goldstein J Hamm, et al. 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 17452677 10.1200/JCO.2006.07.9525 1:CAS:528:DC%2BD2sXmvVWmsr0%3D (Pubitemid 46972777)
10. S Faivre D Chan R Salinas B Woynarowska JM Woynarowski 2003 DNA strand breaks and apoptosis induced by oxaliplatin in cancer cells Biochem Pharmacol 66 225 237 12826265 10.1016/S0006-2952(03)00260-0 1:CAS:528:DC%2BD3sXkvVKit7o%3D (Pubitemid 36776396)
11. E Poplin Y Feng J Berlin, et al. 2009 Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30 min infusion) in patients with pancreatic carcinoma E7201: a trial of the eastern cooperative oncology group J Clin Oncol 27 3778 3785 19581537 10.1200/JCO.2008.20.9007 1:CAS:528:DC%2BD1MXhtFaitr3L
12. HL Kindler G Friberg DA Singh, et al. 2005 Phase II trial of bevacizumab plus gemcitabine in patients with advanced pancreatic cancer J Clin Oncol 23 8033 8040 16258101 10.1200/JCO.2005.01.9661 1:CAS:528:DC%2BD2MXht1CqsL%2FE (Pubitemid 46657405)
13. P Therasse SG Arbuck EA Eisenhauer, et al. 2000 New guidelines to evaluate the response to treatment in solid tumors J Nat Cancer Inst 92 205 216 10655437 10.1093/jnci/92.3.205 1:STN:280:DC%2BD3c7it1Gitg%3D%3D (Pubitemid 30099779)
14. EL Kaplan P Meier 1958 Non parametric estimation from incomplete observations J Am Stat Assoc 53 457 481 10.2307/2281868
15. DR Cox 1972 Regression models and life tables J R Stat Soc A 29 187 220
16. Available at: http://ctep.info.nih.gov/protocolDevelopment/electronic- applications/ctc.htm
17. Kindler HL, Niedzwiecki D, Hollis D et al (2007) A double-blind, placebo controlled, randomized phase III trial of gemcitabine (G) plus bevacizumab (B) versus gemcitabine plus placebo (P) in patients (pts) with advanced pancreatic cancer (PC): a preliminary analysis of cancer and leukemia group B (CALGB) 80303. J Clin Oncol 25:18s (suppl; abstr 4508)
18. E Van Cutsem WL Vervenne J Bennouna, et al. 2009 Phase III trial of bevacizumab in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer J Clin Oncol 27 2231 2237 19307500 10.1200/JCO.2008.20.0238
19. Conroy T, Desseigne F, Ychou M et al (2010) Randomized phase III trial comparing FOLFIRINOX (F: 5FU/leucovorin [LV], irinotecan [I], and oxaliplatin [O]) versus gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): Preplanned interim analysis results of the PRODIGE 4/ACCORD 11 trial. J Clin Oncol 28:15s (suppl, Abstr 4010)
20. RL Fine DR Fogelman SM Schreibman M Desai W Sherman J Strauss S Guba R Andrade J Chabot 2008 The gemcitabine, docetaxel, and capecitabine (GTX) regimen for metastatic pancreatic cancer: a retrospective analysis Cancer Chemother Pharmacol 61 1 165 167
21. V Heinemann S Boeck A Hinke R Labianca C Louvet 2008 Meta-analysis of randomized trials: evaluation of benefit from gemcitabine-based combination chemotherapy applied in advanced pancreatic cancer BMC Cancer 8 82 18373843 10.1186/1471-2407-8-82 (Pubitemid 351552578)
22. AH Ko E Dito B Schillinger, et al. 2008 A phase II study evaluating bevacizumab in combination with fixed-dose gemcitabine and low-dose cisplatin for metastatic pancreatic cancer: is an anti-VEGF strategy still applicable? Invest New Drugs 26 5 463 471 18379729 10.1007/s10637-008-9127-2 1:CAS:528:DC%2BD1cXhtVSku7fI
23. AH Ko J Hwang AP Venook JL Abbruzzese EK Bergsland MA Tempero 2005 Serum CA 19-9 response as a surrogate for clinical outcome in patients receiving fixed-dose rate gemcitabine for advanced pancreatic cancer Br J Cancer 93 195 199 15999098 10.1038/sj.bjc.6602687 1:CAS:528:DC%2BD2MXmt1yhurs%3D (Pubitemid 41133205)
24. Friberg G, Kasza K, Vokes E, Kindler H (2005) Early Hypertension as a potential pharmacodynamic (PD) marker for survival in pancreatic cancer (PC) patients (pts) treated with bevacizumab (B) and gemcitabine (G). J Clin Oncol 23(16S):3020
25. P Bono H Elfving T Utriainen, et al. 2009 Letter to the editor Annal Oncol 20 393 394 10.1093/annonc/mdn729 1:STN:280:DC%2BD1M7jsFOrsA%3D%3D