Crossref journal-article
Wiley
Cancer (311)
Abstract

AbstractBACKGROUND.Several attempts have been made at improving the efficacy of gemcitabine in advanced pancreatic cancer by combining it with other chemotherapeutic or molecularly targeted agents. However, randomized trials have produced conflicting results.METHODS.All prospective, randomized, phase 3 trials that compared single‐agent gemcitabine with gemcitabine‐based combinations were considered eligible for the current analysis. A literature‐based meta‐analysis was performed, event‐based relative risk ratios with 95% confidence intervals were derived through both a fixed‐effect model approach and a random‐effect model approach, and overall survival (OS) was explored as the primary endpoint. To estimate the magnitude of the eventual benefit, absolute differences and the number of patients needed to treat (NNT) for 1 patient to benefit were calculated. A sensitivity analysis for OS was performed according to the type of agent used in combination with gemcitabine.RESULTS.Twenty trials that involved 6296 patients were identified. No significant differences in the primary endpoint were observed in the overall population or in the sensitivity analysis. Conversely, a significant advantage was evident with regard to both progression‐free survival (PFS) and the overall response rate (ORR) in the overall population, with an absolute benefit of 2.6% (NTT = 39 patients) and 3.0% (NNT = 33 patients). Platinum combinations led to the greatest absolute benefits for PFS and ORR compared with single‐agent gemcitabine (10% and 6.5%, respectively), but this did not result in an OS benefit. Improvement in PFS, but not in the ORR, was correlated with an improvement in OS.CONCLUSIONS.Single‐agent gemcitabine remains the standard of care for patients with advanced pancreatic cancer. However, platinum/gemcitabine combinations appeared to improve PFS and the ORR and, thus, may be considered in selected patients. Cancer 2007. © 2007 American Cancer Society.

Bibliography

Bria, E., Milella, M., Gelibter, A., Cuppone, F., Pino, M. S., Ruggeri, E. M., Carlini, P., Nisticò, C., Terzoli, E., Cognetti, F., & Giannarelli, D. (2007). Gemcitabine‐based combinations for inoperable pancreatic cancer: Have we made real progress? Cancer, 110(3), 525–533. Portico.

Authors 11
  1. Emilio Bria (first)
  2. Michele Milella (additional)
  3. Alain Gelibter (additional)
  4. Federica Cuppone (additional)
  5. Maria Simona Pino (additional)
  6. Enzo Maria Ruggeri (additional)
  7. Paolo Carlini (additional)
  8. Cecilia Nisticò (additional)
  9. Edmondo Terzoli (additional)
  10. Francesco Cognetti (additional)
  11. Diana Giannarelli (additional)
References 38 Referenced 72
  1. 10.3322/canjclin.56.2.106
  2. 10.1200/JCO.1997.15.6.2403
  3. 10.1200/JCO.2005.06.023
  4. 10.1016/S1359-6349(05)82014-2
  5. 10.1200/JCO.2004.10.112
  6. 10.1200/JCO.2003.02.098
  7. 10.1038/sj.bjc.6600446
  8. 10.1200/JCO.2001.19.15.3447
  9. {'issue': '1', 'key': 'e_1_2_6_10_2', 'first-page': '16S', 'article-title': 'G17DT+gemcitabine [Gem] versus placebo+Gem in untreated subjects with locally advanced, recurrent, or metastatic adenocarcinoma of the pancreas: results of a randomized, double‐blind, multinational, multicenter study', 'volume': '23', 'author': 'Shapiro J', 'year': '2005', 'journal-title': 'J Clin Oncol.'} / J Clin Oncol. / G17DT+gemcitabine [Gem] versus placebo+Gem in untreated subjects with locally advanced, recurrent, or metastatic adenocarcinoma of the pancreas: results of a randomized, double‐blind, multinational, multicenter study by Shapiro J (2005)
  10. 10.1002/1097-0142(19810101)47:1<207::AID-CNCR2820470134>3.0.CO;2-6
  11. 10.1634/theoncologist.7-3-181
  12. 10.1002/cncr.21886
  13. {'key': 'e_1_2_6_14_2', 'volume-title': 'Survival Analysis: A Practical Approach', 'author': 'Parmar MKB', 'year': '1995'} / Survival Analysis: A Practical Approach by Parmar MKB (1995)
  14. 10.1136/bmj.317.7168.1309
  15. 10.1002/cncr.10323
  16. 10.1200/JCO.2005.05.1490
  17. 10.1016/S1470-2045(05)70175-3
  18. {'key': 'e_1_2_6_19_2', 'first-page': '14S', 'article-title': 'A prospective randomized trial of gemcitabine alone or gemcitabine + cisplatin in the treatment of metastatic pancreatic cancer', 'volume': '22', 'author': 'Li CP', 'year': '2004', 'journal-title': 'J Clin Oncol.'} / J Clin Oncol. / A prospective randomized trial of gemcitabine alone or gemcitabine + cisplatin in the treatment of metastatic pancreatic cancer by Li CP (2004)
  19. {'key': 'e_1_2_6_20_2', 'first-page': '21', 'article-title': 'Gemcitabine (G) or gemcitabine plus cisplatin (GC) as first‐line treatment in Chinese patients (pts) with locally advanced (LAPC) and metastatic pancreatic cancer (MPC): a multicenter, randomized, study', 'author': 'Wang XY', 'year': '2002', 'journal-title': 'Proc Am Soc Clin Oncol.'} / Proc Am Soc Clin Oncol. / Gemcitabine (G) or gemcitabine plus cisplatin (GC) as first‐line treatment in Chinese patients (pts) with locally advanced (LAPC) and metastatic pancreatic cancer (MPC): a multicenter, randomized, study by Wang XY (2002)
  20. 10.1200/JCO.2002.11.149
  21. {'key': 'e_1_2_6_22_2', 'first-page': '310s', 'article-title': 'Gemcitabine (G) plus Capecitabine (C) versus G alone in locally advanced or metastatic pancreatic cancer. A randomized phase III study of the Swiss Group for Clinical Cancer Research (SAKK) and the Central European Cooperative OncologyGroup (CECOG)', 'volume': '23', 'author': 'Hermann R', 'year': '2005', 'journal-title': 'Proc Am Soc Clin Oncol.'} / Proc Am Soc Clin Oncol. / Gemcitabine (G) plus Capecitabine (C) versus G alone in locally advanced or metastatic pancreatic cancer. A randomized phase III study of the Swiss Group for Clinical Cancer Research (SAKK) and the Central European Cooperative OncologyGroup (CECOG) by Hermann R (2005)
  22. 10.1200/jco.2004.22.90140.4131 / J Clin Oncol. / Randomized controlled trial of gemcitabine in combination with UFT versus gemcitabine alone in patients with advanced pancreatic cancer by Ohkawa S (2004)
  23. {'issue': '16', 'key': 'e_1_2_6_24_2', 'first-page': '1092', 'article-title': 'A randomised, prospective, multicenter, phase III trial of gemcitabine, 5‐fluorouracil (5‐FU), folinic acid vs gemcitabine alone in patients with advanced pancreatic cancer', 'volume': '23', 'author': 'Riess H', 'year': '2005', 'journal-title': 'J Clin Oncol.'} / J Clin Oncol. / A randomised, prospective, multicenter, phase III trial of gemcitabine, 5‐fluorouracil (5‐FU), folinic acid vs gemcitabine alone in patients with advanced pancreatic cancer by Riess H (2005)
  24. 10.1093/annonc/mdi309
  25. 10.1038/sj.bjc.6603301
  26. 10.1200/JCO.2006.07.0201
  27. 10.1200/JCO.2004.12.082
  28. 10.1200/JCO.2006.07.9525
  29. 10.1002/14651858.CD002093.pub2
  30. {'issue': '9', 'key': 'e_1_2_6_31_2', 'first-page': 'ix308', 'article-title': 'Meta‐analysis of randomized trials: evaluation of benefit from combination chemotherapy applied in advanced pancreatic cancer', 'volume': '17', 'author': 'Heinemann V', 'year': '2006', 'journal-title': 'Ann Oncol.'} / Ann Oncol. / Meta‐analysis of randomized trials: evaluation of benefit from combination chemotherapy applied in advanced pancreatic cancer by Heinemann V (2006)
  31. 10.1093/jnci/djk022
  32. 10.3748/wjg.v12.i43.6973
  33. 10.1200/jco.2006.24.18_suppl.4126 / J Clin Oncol. / Current status of targeted agents in advanced pancreatic cancer (APC): a pooled analysis of 2,361 patients (pts) enrolled in six phase III trials by Bria E (2006)
  34. 10.1634/theoncologist.10-8-565
  35. 10.1038/sj.bjc.6602687
  36. 10.1002/cncr.21286
  37. 10.1200/JCO.2005.03.8315
  38. {'key': 'e_1_2_6_39_2', 'first-page': '180S', 'article-title': 'Phase III trial of gemcitabine (30‐minute infusion) versus gemcitabine (fixed‐dose‐rate infusion [FDR]) versus gemcitabine + oxaliplatin (GEMOX) in patients with advanced pancreatic cancer (E6201)', 'volume': '24', 'author': 'Poplin E', 'year': '2006', 'journal-title': 'Proc Am Soc Clin Oncol.'} / Proc Am Soc Clin Oncol. / Phase III trial of gemcitabine (30‐minute infusion) versus gemcitabine (fixed‐dose‐rate infusion [FDR]) versus gemcitabine + oxaliplatin (GEMOX) in patients with advanced pancreatic cancer (E6201) by Poplin E (2006)
Dates
Type When
Created 18 years, 2 months ago (June 18, 2007, 11:50 a.m.)
Deposited 1 year, 9 months ago (Nov. 20, 2023, 3:05 p.m.)
Indexed 5 months, 1 week ago (March 22, 2025, 5:03 a.m.)
Issued 18 years, 2 months ago (June 18, 2007)
Published 18 years, 2 months ago (June 18, 2007)
Published Online 18 years, 2 months ago (June 18, 2007)
Published Print 18 years ago (Aug. 1, 2007)
Funders 0

None

@article{Bria_2007, title={Gemcitabine‐based combinations for inoperable pancreatic cancer: Have we made real progress?: A meta‐analysis of 20 phase 3 trials}, volume={110}, ISSN={1097-0142}, url={http://dx.doi.org/10.1002/cncr.22809}, DOI={10.1002/cncr.22809}, number={3}, journal={Cancer}, publisher={Wiley}, author={Bria, Emilio and Milella, Michele and Gelibter, Alain and Cuppone, Federica and Pino, Maria Simona and Ruggeri, Enzo Maria and Carlini, Paolo and Nisticò, Cecilia and Terzoli, Edmondo and Cognetti, Francesco and Giannarelli, Diana}, year={2007}, month=jun, pages={525–533} }