Meta-analyses of chemotherapy for locally advanced and metastatic pancreatic cancer

Journal of Clinical Oncology

Volumn 25, Issue 18, 2007, Pages 2607-2615

  Sultana, Asma ^a   Smith, Catrin Tudur ^a   Cunningham, David ^a   Starling, Naureen ^a   Neoptolemos, John P ^a   Ghaneh, Paula ^a  

^a UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; FLUOROURACIL; GEMCITABINE; IRINOTECAN; OXALIPLATIN;

CANCER CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; META ANALYSIS; METASTASIS; MONOTHERAPY; PANCREAS CANCER; PRIORITY JOURNAL; PUBLICATION; RANDOMIZED CONTROLLED TRIAL; REVIEW; SYSTEMATIC REVIEW;

ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DEOXYCYTIDINE; FLUOROURACIL; HUMANS; NEOPLASM METASTASIS; OUTCOME ASSESSMENT (HEALTH CARE); PANCREATIC NEOPLASMS; RANDOMIZED CONTROLLED TRIALS;

EID: 34247188535     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2006.09.2551     Document Type: Review

References (84)

1. Jemal A, Siegel R, Ward E, et al: Cancer Statistics. CA Cancer J Clin 56:106-130, 2006
2. Hawes R, Xiong Q, Waxman I, al e: A multi-speciality approach to approach to the diagnosis and management of pancreatic cancer. Am J Gastroenterol 95:17-31, 2000
3. Burris H, Moore M, Andersen J, et al: Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomised trial. J Clin Oncol 15:2403-2413, 1997
4. Berlin J, Catalano P, Thomas J, et al: Phase III study of gemcitabine in combination with fluorouracil versus gemcitabine alone in patients with advanced pancreatic carcinoma. J Clin Oncol 20:3270-3275, 2002
5. Bramhall S, Rosemurgy A, Brown P, et al: Marimastat as first-line therapy for patients with unresectable pancreatic cancer: A randomized trial. J Clin Oncol 19:3447-3455, 2001
6. Bramhall S, Rosemurgy A, 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
7. Sacks H, Berrier J, Reitman D, et al: Meta-analysis of randomised controlled trials. N Engl J Med 316:450-455, 1987
8. Fung M, Takayama S, Ishiguro H, et al: Chemotherapy for advanced or metastatic pancreatic cancer: Analysis of 43 randomised trials in 3 decades (1974-2002). Gan To Kagaku Ryoho 30:1101-1111, 2003
9. Yip D, Karapetis C, Strickland A et al: Chemotherapy and radiotherapy for inoperable pancreatic cancer. Cochrane Database Syst Rev 3:CD002093, 2006.
10. Banu E, Oudard S, Banu A, et al: Cumulative meta-analysis of randomized trials comparing gemcitabine-based chemotherapy versus gemcitabine alone in patients with advanced or metastatic pancreatic cancer. J Clin Oncol 23:308s, 2005 (suppl; abstr 4101)
11. Liang H: Comparing gemcitabine-based combination chemotherapy with gemcitabine alone in inoperable pancreatic cancer: A meta-analysis. J Clin Oncol 23:335s, 2005 (suppl; abstr 4110)
12. Milella M, Carlini P, Gelibter A, et al: Gemcitabine-based polychemotherapy for advanced pancreatic cancer (APC): Is it ready for prime time? A pooled analysis of 3,682 patients (pts) enrolled in 12 phase III trials. J Clin Oncol 24:207s, 2006 (suppl 18S; abstr 4118)
13. Bria E, Carlini P, Gelibter A, et al: Current status of targeted agents in advanced pancreatic cancer (APC): A pooled analysis of 2,361 patients (pts) enrolled in six phase III trials. J Clin Oncol 24:209s, 2006 (suppl 18S; abstr 4126)
14. Xie D, Liang H, Wang Y, et al: Meta-analysis of inoperable pancreatic cancer: Gemcitabine combined with cisplatin versus gemcitabine alone. Chin J Dig Dis 7:49-54, 2006
15. Parmar M, Torri V, Stewart L: Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Stat Med 17:2815-2834, 1998
16. Jadad A, Moore R, Carrol D, et al: Assessing the quality of reports of randomised clinical trials: Is blinding necessary? Control Clin Trials 17:1-12, 1996
17. Detsky A, Naylor C, O'Rourke K, et al: Incorporating variations in the quality of individual randomized trials into meta-analysis. J Clin Epidemiol 45:255-265, 1992
18. Sterne J, Egger M, Sutton A: Meta-analysis software, in Egger M, Smith G, Altman D (eds): Systematic Reviews in Health Care: Meta-Analysis in Context (ed 2). London, United Kingdom, BMJ Publishing Group, 2001, pp 336-346
19. Altman D, De Stavola B, Love S, et al: Review of survival analysis published in cancer journals. Br J Cancer 72:511-518, 1995
20. Williamson P, Smith C, Hutton J, et al: Aggregate data meta-analysis with time-to-event outcome. Stat Med 21:3337-3351, 2002
21. Huguier M, Barrier A, Valinas R, et al: Randomised trial of 5-fluorouracil, leucovorin and cisplatin in advanced pancreatic cancer. Hepatogastroenterology 48:875-878, 2001
22. Takada T, Nimura Y, Katoh H, et al: Prospective randomised trial of 5-fluorouracil, doxorubicin, and mitomycin C for non-resectable pancreatic and biliary carcinoma: Multicentre randomised trial. Hepatogastroenterology 45:2020-2026, 1998
23. Palmer K, Kerr M, Knowles G, et al: Chemotherapy prolongs survival in inoperable pancreatic carcinoma. Br J Surg 81:882-885, 1994
24. Mallinson C, Rake M, Cocking J, et al: Chemotherapy in pancreatic cancer: Results of a controlled, prospective, randomised, multicentre trial. Br Med J 281:1589-1591, 1980
25. Cullinan S, Moertel C, Fleming T, et al: A comparison of three chemotherapeutic regimens in the treatment of advanced pancreatic and gastric carcinoma. JAMA 253:2061-2067, 1985
26. Cullinan S, Moertel C, Wieand H, et al: A phase III trial on therapy of advanced pancreatic carcinoma. Cancer 65:2207-2212, 1990
27. Kovach J, Moertel C, Schutt A, et al: A controlled study of combined 1,3 bis-(2-chloroethyl)-1-nitrosourea and 5-fluorouracil therapy for advanced gastric and pancreatic cancer. Cancer 33:563-567, 1974
28. Di Costanzo F, Carlini P, Doni L, et al: Gemcitabine with or without continuous infusion 5-FU in advanced pancreatic cancer: A randomised phase II trial of the Italian Oncology Group for Clinical Research (GOIRC). Br J Cancer 93:185-189, 2005
29. Deeks J, Higgins J, Altman D: Analysing and presenting results. Cochrane Reviewers Handbook 4.2.2. http://www.cochrane.dk/cochrane/handbook/ hbook.htm
30. Light R, Pillemer D: Summing Up: The Science of Reviewing Research. Cambridge, MA, Harvard University Press, 1984
31. Tempera 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 21:3383-3384, 2003
32. Schein P, Lavin P, Moertel C, et al: Randomised phase II clinical trial of Adriamycin, methotrexate, and actinomycin-D in advanced measurable pancreatic carcinoma: A Gastrointestinal Tumor Study Group Report. Cancer 42:19-22, 1978
33. Asbury R, Cnaan A, Johnson L, et al: An Eastern Cooperative Oncology Group phase II study of single agent DHAD, VP-16, aclacinomycin, or spirogermanium in metastatic pancreatic cancer. Am J Clin Oncol 17:166-169, 1994
34. Gastrointestinal Tumor Study Group: Treatment of locally unresectable carcinoma of the pancreas: Comparison of combined-modality therapy (chemotherapy plus radiotherapy) to chemotherapy alone. J Natl Cancer Inst 80:751-755, 1988
35. Cheverton P, Friess H, Andras C, et al: Phase III results of exatecan (DX-8951f) versus gemcitabine in chemotherapy-naive patients with advanced pancreatic cancer. J Clin Oncol 22:314s, 2004 (suppl 14S; abstr 4005)
36. Lersch C, Van Cutsem E, Amado R, et al: Randomized phase II study of SCH 66336 and gemcitabine in the treatment of metastatic adenocarcinoma of the pancreas. Proc Am Soc Clin Oncol 20:153a, 2001 (abstr 608)
37. Moore M, Hamm J, Dancey P, et al: 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, 2003
38. Smith D, Gallagher N: A phase II/III study comparing intravenous ZD9331 with gemcitabine in patients with pancreatic cancer. Eur J Cancer 39: 1377-1383, 2003
39. Gansauge F, Ramadani M, Pressmar J, et al: NSC-631570 (Ukrain) in the palliative treatment of pancreatic cancer. Langenbecks Arch Surg 386:570-574, 2002
40. Richards D, Waterhouse D, Wagener D, et al: Randomised double-blind, placebo-controlled phase 2 study of the histone deacetylase inhibitor CI-994 plus gemcitabine (CI-994 plus G) versus placebo plus gemcitabine (P plus G) in the treatment of patients with advanced pancreatic cancer. Proc Am Soc Clin Oncol 21:162a, 2002 (abstr 644)
41. 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
42. Mackenzie M, Moore M, Saltman D, et al: A phase II study of triapine in combination with gemcitabine in advanced pancreatic carcinoma: A Princess Margaret Hospital Phase II Consortium Trial. J Clin Oncol 23:331s, 2005 (suppl; abstr 4093)
43. Richards D, Oettle H, Vervenne W, et al: Randomised double-blind phase II trial comparing gemcitabine (GEM) plus LY293111 vs. GEM plus placebo in advanced adenocarcinoma of the pancreas. J Clin Oncol 23:330s, 2005 (suppl; abstr 4092)
44. Shapiro J, Marshall J, Karasek P, et al: G17DT + gemcitabine versus placebo + gemcitabine in untreated subjects with locally advanced, recurrent, or metastatic adenocarcinoma of the pancreas: Results of a randomized, double-blind, multinational, multicenter study. J Clin Oncol 23:310s, 2005 (suppl; abstr LBA4012)
45. Cantore M, Fiorentini G, Luppi G, et al: Gemcitabine versus FLEC regimen given intra-arterially to patients with unresectable pancreatic cancer: A prospective, randomized phase III trial of the Italian Society for Integrated Locoregional Therapy in Oncology. J Chemother 16:589-594, 2004
46. Feng N, Jin H, Wang M, et al: Antitumour activity of Virulizin, a novel biological response modifier (BRM) in a panel of human pancreatic cancer and melanoma xenografts. Cancer Chemother Pharmacol 51:247-255, 2003
47. Aigner K, Gailhoter S, Kopp S: Regional versus systemic chemotherapy for advanced pancreatic cancer: A randomised study. Hepatogastroenterology 45:1125-1129, 1998
48. Frey C, Twomey P, Keehn R, et al: Randomised study of 5-FU and CCNU in pancreatic cancer: Report of the Veterans Administration Surgical Adjuvant Cancer Chemotherapy Study Group. Cancer 47:27-31, 1981
49. Andren-Sandberg A, Holmberg J, Ihse I: Treatment of unresectable pancreatic carcinoma with 5-fluorouracil, vincristine, and CCNU. Scand J Gastroenterol 18:609-612, 1983
50. Glimelius B, Hoffman K, Sjoden P, et al: Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol 7:593-600, 1996
51. Ducreux M, Rougier P, Pignon J-P, et al: A randomised trial comparing 5-FU with 5-FU plus cisplatin in advanced pancreatic carcinoma. Ann Oncol 13:1185-1191, 2002
52. Maisey N, Chau I, Cunningham D, et al: Multicenter randomized phase III trial comparing protracted infusion 5-fluorouracil with PVI 5-FU plus mitomycin in inoperable pancreatic cancer. J Clin Oncol 20:3130-3136, 2002
53. Reiss H, Helm A, Niedergethmann M, et al: A randomized, prospective, multicenter, phase III trial of gemcitabine, 5-fluorouracil, folinic acid versus gemcitabine alone in patients with advanced pancreatic cancer. J Clin Oncol 23:310s, 2005 (suppl; abstr LBA4009)
54. Hermann R, Bodoky G, Ruhstaller T, et al: Gemcitabine plus capecitabine versus gemcitabine alone in locally advanced or metastatic pancreatic cancer: A randomised phase III study of the Swiss Group for Clinical Cancer Research (SAKK) and the Central European Cooperative Oncology Group (CECOG). J Clin Oncol 23: 310s, 2005 (suppl; abstr LBA4010)
55. Stathopoulos G, Aravantinos G, Syrigos K, et al: A randomized phase III study of irinotecan/gemcitabine combination versus gemcitabine in patients with advanced/metastatic pancreatic cancer. J Clin Oncol 23:334s, 2005 (suppl; abstr 4106)
56. Reni M, Cordio S, Milandri C, et al: Gemcitabine versus cisplatin, epirubicin, fluorouracil, and gemcitabine in advanced pancreatic cancer: A randomised controlled multicentre phase III trial. Lancet Oncol 6:369-376, 2005
57. 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
58. Cunningham D, Chau I, Stocken D, et al: Phase III randomised comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. Eur J Cancer 3:4, 2005 (suppl)
59. Viret F, Ychou D, Lepille L, et al: Gemcitabine in combination with cisplatin versus gemcitabine alone in the treatment of locally advanced or metastatic pancreatic cancer: Final results of a multicenter randomized phase II study. J Clin Oncol 22:342s, 2004 (suppl 14s; abstr 4118)
60. Rocha Lima C, Green M, 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 18:3776-3783, 2004
61. O'Reilly E, Abou-Alfa G, Letourneau R, et al: A randomized phase III trial of DX-8951f (exatecan mesylate) and gemcitabine versus gemcitabine alone in advanced pancreatic cancer. J Clin Oncol 22:315s, 2004 (suppl; abstr 4006)
62. Oettle H, Richards D, Ramanathan R, 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
63. Li C-P, Chao Y: A prospective randomized trial of gemcitabine alone or gemcitabine + cisplatin in the treatment of metastatic pancreatic cancer. J Clin Oncol 22:349s, 2004 (suppl; abstr 4144)
64. Colucci G, Giuliani F, Gebbia V, et al: Gemcitabine alone or with cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic carcinoma: A prospective, randomised phase III study of the Gruppo Oncologico dell'Italia Meridionale. Cancer 94:902-910, 2002
65. 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
66. Ohkawa S: Randomized controlled trial of gemcitabine in combination with UFT versus gemcitabine alone in patients with advanced pancreatic cancer. J Clin Oncol 22:346s, 2004 (suppl 14S; abstr 4131)
67. Heinemann V, Quietzsch D, Gieseler F, et al: A phase III trial comparing gemcitabine plus cisplatin versus gemcitabine alone in advanced pancreatic carcinoma. Proc Am Soc Clin Oncol 22:250, 2003 (abstr 1003)
68. Wang X, Ni Q, Jin M, et al: Gemcitabine or gemcitabine plus cisplatin in 42 patients with locally advanced or metastatic pancreatic cancer. Zhonghua Zhong Liu Za Zhi 24:404-407, 2002
69. Poplin E, Levy D, Berlin J, et al: Phase III trial of gemcitabine (30-minute infusion) versus gemcitabine (fixed-dose rate infusion) versus gemcitabine + oxaliplatin in patients with advanced pancreatic cancer (E6201). J Clin Oncol 24:180s, 2006 (suppl 18S; abstr LBA4004)
70. Heinemann V, Hoehler T, Seipelt G, et al: Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (GemOx): A randomised phase II trial in advanced pancreatic cancer. J Clin Oncol 23:315s, 2005 (suppl; abstr 4030)
71. Lionetto R, Pugliese V, Bruzzi P, et al: No standard treatment is available for advanced pancreatic cancer. Eur J Cancer 31A:882-887, 1995
72. Permert J, Hafstrom L, Nygren P, et al: A systematic overview of chemotherapy effects in pancreatic cancer. Acta Oncol 40:361-370, 2001
73. Michiels S, Piedbois P, Burdett S, et al: Meta-analysis when only the median survival times are known: A comparison with individual patient data results. Int J Technol Assess Health Care 21:119-125, 2005
74. Andersen J, Friis-Moller A, Hancke S, et al: A controlled trial of combination chemotherapy with 5-FU and BCNU in pancreatic cancer. Scand J Gastroenterol 16:973-975, 1981
75. Tsavaris N, Tentas K, Tzivras M, et al: Combined epirubicin, 5-FU, and folinic acid vs no treatment for patients with advanced pancreatic cancer: A prospective comparative study. J Chemother 10:331-337, 1998
76. Awrich A, Fletcher W, Klotz J, et al: 5-FU versus combination therapy with tubercidin, streptozotocin, and 5-FU in the treatment of pancreatic carcinomas: COG protocol 7230. J Surg Oncol 12:267-273, 1979
77. Takada T, Kato H, Matsushiro T, et al: Comparison of 5-fluorouracil, doxorubicin and mitomycin C with 5-fluorouracil alone in the treatment of pancreatic-biliary carcinomas. Oncology 51:396-400, 1994
78. Ducreux M, Mitry E, Ould-Kaci M, et al: Randomized phase II study evaluating oxaliplatin alone, oxaliplatin combined with infusional 5-FU, and infusional 5-FU alone in advanced pancreatic carcinoma patients. Ann Oncol 15:467-473, 2004
79. Levi F, Tubiana-Mathieu N, Focan C, et al: Chronomodulated vs constant rate infusional 5-fluorouracil with or without cisplatin in patients with advanced or metastatic pancreatic cancer: A multicenter randomized trial of the Chronotherapy Group of the European Organisation for Research and Treatment of Cancer (EORTC 05962). J Clin Oncol 22:342s, 2004 (suppl 14S; abstr 4117)
80. Cunningham D, Chau I, Stocken D, et al: Phase III randomised comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. Eur J Cancer 3:4, 2005 (abstr PS11)
81. Heinemann V, Labianca R, Hinke A, et al: Superiority of gemcitabine plus platinum analog compared to gemcitabine alone in advanced pancreatic cancer: Pooled analysis of two randomised trials, the GERCOR/GISCAD Intergroup Study and a German Multicenter Study. 2006 Gastrointestinal Cancers Symposium, San Francisco, CA, January 26-28, 2006 (abstr 96)
82. Moore M, Goldstein D, Hamm J, et al: Erlotinib plus gemcitabine compared to 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 23:1s, 2005 (suppl; abstr 1)
83. Genentech: Phase III study of avastin in advanced pancreatic cancer does not meet primary endpoint. http://www.gene.com/gene/news/press-releases/ display.do?method=detail&id=9867&categoryid=4
84. Southwest Oncology Group: S0205-phase III (closed). http://www.swog.org/ Visitors/ViewProtocol Details.asp?ProtocolID=1933