Changing the paradigm in conducting randomized clinical studies in advanced pancreatic cancer: An opportunity for better clinical development

Journal of Clinical Oncology

Volumn 27, Issue 33, 2009, Pages 5487-5491

  Tabernero, Josep ^a   Macarulla, Teresa ^a  

^a HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

AFLIBERCEPT; AXITINIB; BEVACIZUMAB; BIOLOGICAL MARKER; CAPECITABINE; CETUXIMAB; CISPLATIN; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; EXATECAN; FLUOROPYRIMIDINE DERIVATIVE; GEMCITABINE; IRINOTECAN; K RAS PROTEIN; MARIMASTAT; OXALIPLATIN; PEMETREXED; PLACEBO; PLATINUM DERIVATIVE; TIPIFARNIB; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE; FLUOROURACIL;

ADVANCED CANCER; ANTIANGIOGENIC ACTIVITY; CLINICAL STUDY; CLINICAL TRIAL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; EDITORIAL; GENE MUTATION; HUMAN; METASTASIS; MOLECULAR BIOLOGY; NONHUMAN; ONCOGENE K RAS; OVERALL SURVIVAL; PANCREAS CANCER; PRIORITY JOURNAL; PROGNOSIS; PROGRESSION FREE SURVIVAL; RASH; CANCER INVASION; CANCER STAGING; DOSE RESPONSE; DRUG ADMINISTRATION; FEMALE; FOLLOW UP; FORECASTING; MALE; MAXIMUM TOLERATED DOSE; MORTALITY; NOTE; PANCREAS TUMOR; PATHOLOGY; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SURVIVAL; TIME;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; FOLLOW-UP STUDIES; FORECASTING; HUMANS; MALE; MAXIMUM TOLERATED DOSE; NEOPLASM INVASIVENESS; NEOPLASM STAGING; PANCREATIC NEOPLASMS; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SURVIVAL ANALYSIS; TIME FACTORS;

EID: 73949155519     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2009.23.3098     Document Type: Editorial

References (45)

1. Jemal A, Siegel R, Ward E, et al: Cancer statistics, 2008. CA Cancer J Clin 58:71-96, 2008
2. Burris HA III, Moore MJ, Andersen J, et al: 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, 1997
3. Louvet C, Labianca R, Hammel P, et al: 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, 2005
4. Abou-Alfa GK, Letourneau R, Harker G, et al: Randomized phase III study of exatecan and gemcitabine compared with gemcitabine alone in untreated advanced pancreatic cancer. J Clin Oncol 24:4441-4447, 2006
5. Oettle H, Richards D, Ramanathan RK, et al: A phase III trial of pemetrexed plus gemcitabine versus gemcitabine in patients with unresectable or metastatic pancreatic cancer. Ann Oncol 16:1639-1645, 2005
6. Van Cutsem E, van de Velde H, Karasek P, et al: Phase III trial of gemcitabine plus tipifarnib compared with gemcitabine plus placebo in advanced pancreatic cancer. J Clin Oncol 22:1430-1438, 2004
7. Bramhall SR, Schulz J, Nemunaitis J, et al: A double-blind placebo-controlled, randomised 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, 2002
8. Cunningham D, Chau I, Stocken C, et al: Phase III randomised comparision of gemcitabine (GEM) versus gemcitabine plus capecitabine (GEM-CAP) in patients with advanced pancreatic cancer. Eur J Cancer 3:4, 2005(suppl 3, abstr PS11)
9. Cunningham D, Chau I, Stocken C, et al: Phase III randomised comparision of gemcitabine (GEM) versus gemcitabine plus capecitabine (GEM-CAP) in patients with advanced pancreatic cancer. J Clin Oncol 27:5513-5518, 2009
10. Herrmann R, Bodoky G, Ruhstaller T, et al: Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: A randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol 25:2212-2217, 2007
11. Scheithauer W, Schull B, Ulrich-Pur H, et al: Biweekly high-dose gemcitabine alone or in combination with capecitabine in patients with metastatic pancreatic adenocarcinoma: A randomized phase II trial. Ann Oncol 14:97-104, 2003
12. Jaffel E, Hnuban R, Canto M, et al: Focus on pancreas cancer. Cancer Cell 2:25-28, 2002
13. Almoguera C, Shibata D, Forrester K, et al: Most human carcinomas of the exocrine pancreas contain mutant K-ras genes. Cell 53:549-554, 1988
14. Harsha HC, Jimeno A, Molina H, et al: Activated epidermal growth factor receptor as a novel target in pancreatic cancer therapy. J Proteome Res 7:4651-4658, 2008
15. Moore MJ, Goldstein D, Hamm J, et al: 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, 2007
16. Moore MJ, da Cunha Santos G, Kamel-Reid S, et al: The relationship of k-ras mutations and EGFR gene copy number to outcome in the patients treated with erlotinib on National Cancer Institute of Canada Clinical Trials Group trial study PA. 3. J Clin Oncol 25:200, 2007 (suppl 18; abstr 4521)
17. Philip P, Benedetti J, Fenoglio-Preiser C, et al: Phase III study of gemcitabine plus cetuximab versus gemcitabine in patients with locally advanced or metastatic pancreatic adenocarcinoma: SWOG S0205 study. J Clin Oncol 25:199, 2007 (suppl 18; abstr 4509)
18. Kindler H, Niedzwiecki D, Hollis D, et al: A double-blind, placebo-controlled, randomized phase III trial of gemcitabine plus bevacizumab versus gemcitabine plus placebo in patients with advanced pancreatic cancer: A preliminary analysis of CALGB 80303. J Clin Oncol 25:199, 2007 (suppl 18; abstr 4508)
19. Van Cutsem E, Vervenne W, Bennouna J, et al: Phase III trial of bevacizumab in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. J Clin Oncol 27:2231-2237, 2009
20. Kabbinabar F, Schulz J, McCleod M, et al: Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: Results of a randomised phase II trial. J Clin Oncol 23:3697-3705, 2005
21. Hurwitz H, Fehrenbacher L, Novotny W, et al: Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350:2335-2342, 2004
22. Saltz LB, Clarke S, Diaz-Rubio E, et al: Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: A randomized phase III study. J Clin Oncol 26:2013-2019, 2008
23. Miller K, Wang M, Gralow J, et al: Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 357:2666-2676, 2007
24. Sandler A, Gray R, Perry MC, et al: Paclitaxel-carboplatin alone or with bevacizumab for non-small cell lung cancer. N Engl J Med 355:2542-2550, 2006
25. Tabernero J: The role of VEGF and EGFR inhibition: Implications for combining anti-VEGF and anti-EGFR Agents. Mol Cancer Res 5:203-220, 2007
26. Kindler HL, Ioka T, Richel DJ, et al: A double-blinded, placebo-controlled, randomized, phase III study of axitinib (AG-013736) plus gemcitabine (G) vs. G plus placebo (P) in advanced pancreatic cancer (PC) patients (pts). Eur J Cancer 7:361, 2009 (suppl 2; abstr A6502)
27. Baker CH, Solorzano CC, Fidler IJ, et al: Blockade of vascular endotherlial growth factor receptor and epithelial growth factor receptor signaling for therapy of metastatic human pancreatic cancer. Cancer Res 62:1996-2003, 2002
28. sanofi-aventis: Phase 3 trial of aflibercept in metastatic pancreatic cancer discontinued. http://en.sanofi-aventis.com/binaries/20090911-aflibercept- en-tcm28-26185.pdf
29. Kindler HL, Gangadhar T, Karrison T, et al: Final analysis of a randomized phase II study of bevacizumab and gemcitabine plus cetuximab or erlotinib in patients with advanced pancreatic cancer. J Clin Oncol 26: 213s , 2008 (suppl; abstr 4502)
30. Baselga J, Tabernero J: Combined antiangiogenesis and antiepidermal growth factor receptor targeting in the treatment of cancer: Hold back, we are not there yet. J Clin Oncol 25:4516-4518, 2007
31. Bukowski RM, Kabbinavar FF, Figlin RA, et al: Randomized phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastatic renal cancer. J Clin Oncol 25:4536-4541, 2007
32. Hecht JR, Mitchell E, Chidiac T, et al: A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol 27:672-680, 2009
33. Tol J, Koopman M, Cats A, et al : Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. N Engl J Med 360: 563-572, 2009
34. Saltz LB, Lenz HJ, Kindler HL, et al: Randomized phase II trial of cetuximab, bevacizumab, and irinotecan compared with cetuximab and bevacizumab alone in irinotecan-refractory colorectal cancer: The BOND-2 study. J Clin Oncol 25:4557-4561, 2007
35. Starling N, Watkins D, Cunningham D, et al: Dose finding and early efficacy study of gemcitabine plus capecitabine in combination with bevacizumab plus erlotinib in advanced pancreatic cancer. J Clin Oncol 27:5499-5505, 2009
36. Heinemann V, Boeck S, Hinke A, et al: Meta-analysis of randomized trials: Evaluation of benefit from gemcitabine-based combination chemotherapy applied in advanced pancreatic cancer. BMC Cancer 8:82, 2008
37. Sultana A, Smith CT, Cunningham D, et al: Meta-analysis of chemotherapy for locally advanced and metastatic pancreatic cancer. J Clin Oncol 25:2607-2615, 2007
38. Kulke M, Tempero M, Niedzwiecki D, et al: A randomized phase II study of gemcitabine administered at a fixed dose rate or in combination with cisplatin, docetaxel, or irinotecan in patients with metastatic pancreatic cancer (CALGB 89904). J Clin Oncol 27:5506-5512, 2009
39. Tempero M, Plunkett W, Ruiz Van Haperen V, et al: Randomized phase II comparison of dose-intense gemcitabine: Thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma. J Clin Oncol 21:3402-3408, 2003
40. Poplin E, Feng Y, Berlin J, et al: Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: A trial of the Eastern Cooperative Oncology Group. J Clin Oncol 27:3778-3785, 2009
41. Heinemann V, Quietzsch D, Gieseler F, et al: Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J Clin Oncol 24:3946-3952, 2006
42. Heinemann V, Labianca R, Hinke A, et al: Increased survival using platinum analog combined with gemcitabine as compared to single-agent gemcitabine in advanced pancreatic cancer: Pooled analysis of two randomized trials, the GERCOR/GISCAD intergroup study and a German multicenter study. Ann Oncol 18:1652-1659, 2007
43. Rocha Lima CM, Green MR, Rotche R, et al: 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 22:3776-3783, 2004
44. Ychou M, Desseigne F, Guimbaud R, et al: Randomized phase II trial comparing folfirinox (5FU/leucovorin, irinoteca, and oxaliplatin) vs gemcitabine as first-line treatment for metastatic pancreatic adenocarcinoma: First results of the ACCORD 11 trial. J Clin Oncol 25: 201, 2007 (suppl 18, abstr 4516)
45. Philip PA, Mooney M, Jaffe D, et al: Consensus report of the National Cancer Institute Clinical Trials Planning Meeting on pancreas cancer treatment J Clin Oncol 27:5660-5669, 2009