Increased Risk of High-Grade Hemorrhage in Cancer Patients Treated with Gemcitabine: A Meta-Analysis of 20 Randomized Controlled Trials

PLoS ONE

Volumn 8, Issue 9, 2013, Pages

  Hu, Yi ^a   Wang, Jingliang ^a   Tao, Haitao ^a   Wu, Baishou ^a   Sun, Jin ^a   Cheng, Yao ^a   Dong, Weiwei ^a   Li, Ruixin ^a  

^a CHINESE PLA GENERAL HOSPITAL   (China)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CISPLATIN; GEMCITABINE; IRINOTECAN; PACLITAXEL; PEMETREXED; SORAFENIB;

ADULT; AGED; ARTICLE; BLADDER CANCER; BLEEDING; CANCER PATIENT; CENTRAL NERVOUS SYSTEM DISEASE; ECCHYMOSIS; EPISTAXIS; GASTROINTESTINAL HEMORRHAGE; GINGIVA BLEEDING; HEMATEMESIS; HEMATOTHORAX; HEMATURIA; HEMOPTYSIS; HUMAN; INCIDENCE; INJECTION SITE BLEEDING; INTRAOCULAR HEMORRHAGE; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MELENA; MENORRHAGIA; META ANALYSIS; METRORRHAGIA; MULTIPLE CYCLE TREATMENT; NEOPLASM; OVERALL SURVIVAL; PANCREAS CANCER; PETECHIA; PROGRESSION FREE SURVIVAL; PURPURA; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECTUM HEMORRHAGE; RETROPERITONEAL HEMORRHAGE; RISK FACTOR; SOLID TUMOR; SYSTEMATIC REVIEW; VAGINA BLEEDING;

DEOXYCYTIDINE; HEMORRHAGE; HUMANS; INCIDENCE; NEOPLASMS; PUBLICATION BIAS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK FACTORS; TREATMENT OUTCOME;

EID: 84884520629     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0074872     Document Type: Article

References (47)

1. Pawarode A, Voravud N, Sriuranpong V, Kullavanijaya P, Patt YZ, (1998) Natural history of untreated primary hepatocellular carcinoma: a retrospective study of 157 patients. Am J Clin Oncol 21: 386-391.
2. Carron PL, Cousin L, Caps T, Belle E, Pernet D, et al. (2001) Gemcitabine-associated diffuse alveolar hemorrhage. Intensive Care Med 27: 1554.
3. Nichols L, Saunders R, Knollmann FD, (2012) Causes of death of patients with lung cancer. Arch Pathol Lab Med 136: 1552-1557.
4. Chait MM, Turnbull AD, Winawer SJ, (1979) Risk factors and mortality in patients with cancer and hemorrhage from stress ulcer. Am J Gastroenterol 72: 227-233.
5. Elting LS, Rubenstein EB, Martin CG, Kurtin D, Rodriguez S, et al. (2001) Incidence, cost, and outcomes of bleeding and chemotherapy dose modification among solid tumor patients with chemotherapy-induced thrombocytopenia. J Clin Oncol 19: 1137-1146.
6. Levine MN, Raskob G, Landefeld S, Kearon C, (2001) Hemorrhagic complications of anticoagulant treatment. Chest 119: 108S-121S.
7. Hapani S, Sher A, Chu D, Wu S, (2010) Increased risk of serious hemorrhage with bevacizumab in cancer patients: a meta-analysis. Oncology 79: 27-38.
8. Je Y, Schutz FA, Choueiri TK, (2009) Risk of bleeding with vascular endothelial growth factor receptor tyrosine-kinase inhibitors sunitinib and sorafenib: a systematic review and meta-analysis of clinical trials. Lancet Oncol 10: 967-974.
9. Hang XF, Xu WS, Wang JX, Wang L, Xin HG, et al. (2011) Risk of high-grade bleeding in patients with cancer treated with bevacizumab: a meta-analysis of randomized controlled trials. Eur J Clin Pharmacol 67: 613-623.
10. Burris HA III, Moore MJ, Andersen J, Green MR, Rothenberg ML, et al. (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.
11. Frasci G, Comella P, D'Aiuto G, Thomas R, Capasso I, et al. (2000) Weekly docetaxel plus gemcitabine or vinorelbine in refractory advanced breast cancer patients: a parallel dose-finding study. Southern Italy Cooperative Oncology Group (SICOG). Ann Oncol 11: 367-371.
12. Culine S, Lortholary A, Voigt JJ, Bugat R, Theodore C, et al. (2003) Cisplatin in combination with either gemcitabine or irinotecan in carcinomas of unknown primary site: results of a randomized phase II study-trial for the French Study Group on Carcinomas of Unknown Primary (GEFCAPI 01). J Clin Oncol 21: 3479-3482.
13. Oettle H, Post S, Neuhaus P, Gellert K, Langrehr J, et al. (2007) Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. JAMA 297: 267-277.
14. De Santis M, Bellmunt J, Mead G, Kerst JM, Leahy M, et al. (2009) Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer "unfit" for cisplatin-based chemotherapy: phase II-results of EORTC study 30986. J Clin Oncol 27: 5634-5639.
15. Addeo R, Caraglia M, Bellini S, Abbruzzese A, Vincenzi B, et al. (2010) Randomized phase III trial on gemcitabine versus mytomicin in recurrent superficial bladder cancer: evaluation of efficacy and tolerance. J Clin Oncol 28: 543-548.
16. Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, et al. (2010) Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 362: 1273-1281.
17. Paz-Ares LG, Biesma B, Heigener D, von Pawel J, Eisen T, et al. (2012) Phase III, randomized, double-blind, placebo-controlled trial of gemcitabine/cisplatin alone or with sorafenib for the first-line treatment of advanced, nonsquamous non-small-cell lung cancer. J Clin Oncol 30: 3084-3092.
18. Eli Lilly and Company: Gemzar (gemcitabine) product insert. Available: http://pi.lilly.com/us/gemzar.pdf. Accessed 2013 Jan 1.
19. Crino L, Scagliotti GV, Ricci S, De Marinis F, Rinaldi M, et al. (1999) Gemcitabine and cisplatin versus mitomycin, ifosfamide, and cisplatin in advanced non-small-cell lung cancer: A randomized phase III study of the Italian Lung Cancer Project. J Clin Oncol 17: 3522-3530.
20. Sandler AB, Nemunaitis J, Denham C, von Pawel J, Cormier Y, et al. (2000) Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 18: 122-130.
21. von der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, et al. (2000) Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 18: 3068-3077.
22. Gridelli C, Gallo C, Shepherd FA, Illiano A, Piantedosi F, et al. (2003) Gemcitabine plus vinorelbine compared with cisplatin plus vinorelbine or cisplatin plus gemcitabine for advanced non-small-cell lung cancer: a phase III trial of the Italian GEMVIN Investigators and the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 21: 3025-3034.
23. Georgoulias V, Ardavanis A, Tsiafaki X, Agelidou A, Mixalopoulou P, et al. (2005) Vinorelbine plus cisplatin versus docetaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III randomized trial. J Clin Oncol 23: 2937-2945.
24. Zielinski C, Beslija S, Mrsic-Krmpotic Z, Welnicka-Jaskiewicz M, Wiltschke C, et al. (2005) Gemcitabine, epirubicin, and paclitaxel versus fluorouracil, epirubicin, and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: a Central European Cooperative Oncology Group International, multicenter, prospective, randomized phase III trial. J Clin Oncol 23: 1401-1408.
25. Gridelli C, Maione P, Illiano A, Piantedosi FV, Favaretto A, et al. (2007) Cisplatin plus gemcitabine or vinorelbine for elderly patients with advanced non small-cell lung cancer: the MILES-2P studies. J Clin Oncol 25: 4663-4669.
26. Moher D LA, Tetzlaff J, Altman DG, (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 6: e1000097.
27. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, et al. (1998) Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 352: 609-613.
28. NCI, Cancer Therapy Evaluation Program. CTC v 2.0 and common terminology criteria for adverse events criteria V3.0 (CTCAE). Available: http://ctepcancergov/protocolDevelopment/electronic_applications/ctchtm. Accessed 2013 Jan 27.
29. Zintzaras E, Ioannidis JP, (2005) Heterogeneity testing in meta-analysis of genome searches. Genet Epidemiol 28: 123-137.
30. Yusuf S, Peto R, Lewis J, Collins R, Sleight P, (1985) Beta blockade during and after myocardial infarction: an overview of the randomized trials. Prog Cardiovasc Dis 27: 335-371.
31. Begg CB, Mazumdar M, (1994) Operating characteristics of a rank correlation test for publication bias. Biometrics 50: 1088-1101.
32. Cardenal F, Lopez-Cabrerizo MP, Anton A, Alberola V, Massuti B, et al. (1999) Randomized phase III study of gemcitabine-cisplatin versus etoposide-cisplatin in the treatment of locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 17: 12-18.
33. Sculier JP, Lafitte JJ, Lecomte J, Berghmans T, Thiriaux J, et al. (2002) A three-arm phase III randomised trial comparing combinations of platinum derivatives, ifosfamide and/or gemcitabine in stage IV non-small-cell lung cancer. Ann Oncol 13: 874-882.
34. Comella P, Frasci G, Carnicelli P, Massidda B, Buzzi F, et al. (2004) Gemcitabine with either paclitaxel or vinorelbine vs paclitaxel or gemcitabine alone for elderly or unfit advanced non-small-cell lung cancer patients. Br J Cancer 91: 489-497.
35. Thomas P, Robinet G, Gouva S, Fournel P, Lena H, et al. (2006) Randomized multicentric phase II study of carboplatin/gemcitabine and cisplatin/vinorelbine in advanced non-small cell lung cancer GFPC 99-01 study (Groupe francais de pneumo-cancerologie). Lung Cancer 51: 105-114.
36. Ohe Y, Ohashi Y, Kubota K, Tamura T, Nakagawa K, et al. (2007) Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: Four-Arm Cooperative Study in Japan. Ann Oncol 18: 317-323.
37. Gronberg BH, Bremnes RM, Flotten O, Amundsen T, Brunsvig PF, et al. (2009) Phase III study by the Norwegian lung cancer study group: pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first-line chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol 27: 3217-3224.
38. Treat JA, Gonin R, Socinski MA, Edelman MJ, Catalano RB, et al. (2010) A randomized, phase III multicenter trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic non-small-cell lung cancer. Ann Oncol 21: 540-547.
39. Gridelli C, Morgillo F, Favaretto A, de Marinis F, Chella A, et al. (2011) Sorafenib in combination with erlotinib or with gemcitabine in elderly patients with advanced non-small-cell lung cancer: a randomized phase II study. Ann Oncol 22: 1528-1534.
40. Spigel DR, Hainsworth JD, Shipley DL, Ervin TJ, Kohler PC, et al. (2012) A randomized phase II trial of pemetrexed/gemcitabine/bevacizumab or pemetrexed/carboplatin/bevacizumab in the first-line treatment of elderly patients with advanced non-small cell lung cancer. J Thorac Oncol 7: 196-202.
41. Feher O, Vodvarka P, Jassem J, Morack G, Advani SH, et al. (2005) First-line gemcitabine versus epirubicin in postmenopausal women aged 60 or older with metastatic breast cancer: a multicenter, randomized, phase III study. Ann Oncol 16: 899-908.
42. Brufsky A, Hoelzer K, Beck T, Whorf R, Keaton M, et al. (2011) A randomized phase II study of paclitaxel and bevacizumab with and without gemcitabine as first-line treatment for metastatic breast cancer. Clin Breast Cancer 11: 211-220.
43. Ueno H, Kosuge T, Matsuyama Y, Yamamoto J, Nakao A, et al. (2009) A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer. Br J Cancer 101: 908-915.
44. El-Khoueiry AB, Ramanathan RK, Yang DY, Zhang W, Shibata S, et al. (2012) A randomized phase II of gemcitabine and sorafenib versus sorafenib alone in patients with metastatic pancreatic cancer. Invest New Drugs 30: 1175-1183.
45. Hainsworth JD, Spigel DR, Clark BL, Shipley D, Thompson DS, et al. (2010) Paclitaxel/carboplatin/etoposide versus gemcitabine/irinotecan in the first-line treatment of patients with carcinoma of unknown primary site: a randomized, phase III Sarah Cannon Oncology Research Consortium Trial. Cancer J 16: 70-75.
46. Gorter JW, (1999) Major bleeding during anticoagulation after cerebral ischemia: patterns and risk factors. Stroke Prevention In Reversible Ischemia Trial (SPIRIT). European Atrial Fibrillation Trial (EAFT) study groups. Neurology 53: 1319-1327.
47. Avvisati G, Tirindelli MC, Annibali O, (2003) Thrombocytopenia and hemorrhagic risk in cancer patients. Crit Rev Oncol Hematol 48: S13-16.