Vinorelbine-related cardiac events: A meta-analysis of randomized clinical trials

Fundamental and Clinical Pharmacology

Volumn 18, Issue 1, 2004, Pages 97-105

  Lapeyre Mestre, Maryse ^a   Gregoire, Nicolas ^a,b   Bugat, Roland ^b   Montastruc, Jean Louis ^a  

^a UNIVERSITÉ DE TOULOUSE   (France)

^b INSTITUT CLAUDIUS REGAUD   (France)

Author keywords

Cardiac events; Drug safety; Meta analysis; Pharmacoepidemiology; Vinorelbine

Indexed keywords

ANTHRACYCLINE DERIVATIVE; CARBOPLATIN; CISPLATIN; CYCLOPHOSPHAMIDE; DOXORUBICIN; EPIRUBICIN; FLUOROURACIL; FOLINIC ACID; GEMCITABINE; IFOSFAMIDE; MELPHALAN; MITOMYCIN; NAVELBINE; PACLITAXEL; VINDESINE;

ACUTE HEART INFARCTION; ACUTE KIDNEY FAILURE; ARTICLE; BREAST CANCER; CARDIOTOXICITY; CARDIOVASCULAR RISK; CLINICAL TRIAL; COCHRANE LIBRARY; COLIC; CONFIDENCE INTERVAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; COR PULMONALE; DATA BASE; DRUG EFFECT; DRUG FATALITY; DRUG OVERDOSE; DRUG SAFETY; EMBASE; FEBRILE NEUTROPENIA; HEART ARRHYTHMIA; HEART ATRIUM FIBRILLATION; HEART ATRIUM FLUTTER; HEART DEATH; HEART DISEASE; HEART FAILURE; HEART MUSCLE ISCHEMIA; HEART VENTRICLE TACHYCARDIA; HUMAN; LUNG NON SMALL CELL CANCER; MEDLINE; META ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SEPSIS; STATISTICAL ANALYSIS; STROKE; THORAX PAIN;

ADULT; AGED; AGED, 80 AND OVER; ANTI-BACTERIAL AGENTS; ANTINEOPLASTIC AGENTS, PHYTOGENIC; DRUG THERAPY, COMBINATION; FEMALE; HEART DISEASES; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; RANDOMIZED CONTROLLED TRIALS; VINBLASTINE;

EID: 1042276539     PISSN: 07673981     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.0767-3981.2003.00215.x     Document Type: Article

References (47)

1. Bergeron A., Raffy O., Vannetzel J.M. Myocardial ischemia and infarction associated with vinorelbine. J. Clin. Oncol. (1995) 13 531-532.
2. Dubos C., Prevost J.N., Brun J., Rousselot P. Myocardial infarction and vinorelbine. Report of a case. Rev. Mal. Respir. (1991) 8 299-300.
3. Ruffenach M., Missler J., Meier M., Salen J.M. Coronary disease and vinorelbine. Rev. Pneumol. Clin. (1994) 50 94.
4. Todesco F., Orfeuvre H., Mousseau B.C., Mallaret M., Massot C. Effets indésirables cardiovasculaires après perfusion de navelbine (vinorelbine). 14èmes Journées de Pharmacovigilance. 2nd European Pharmacovigilance Symposium, Paris, November 26-27, 1992, 2ème symposium européen de Pharmacovigilance (abstract).
5. Vincent L., Lamrini R., Pommier P. et al. Cardiac arrest and vinorelbine? A propos of a case and review of the literature. Rev. Pneumol. Clin. (1997) 53 360-361.
6. Zabernigg A., Gattringer C. Myocardial infarction associated with vinorelbine (Navelbine). Eur. J. Cancer (1996) 32A 1618-1619.
7. Raymond E., Goldwasser E., Espie M. et al. The cardiotoxicity of vinorelbine. Cancer Res. Ther. Control (1994) 4 87-88.
8. Vaylet F., Plotton C., Algayres J.P., Verkindre C., L'Her P. Acute pulmonary edema induced by vinorelbine. Presse Med. (1996) 25 1259.
9. Dickersin K., Scherer R., Lefebvre C. Identifying relevant studies for systematic reviews. Br. Med. J. (1994) 309 1286-1291.
10. Poynard T. Evaluation of the methodological quality of randomized therapeutic trials. Presse Med. (1988) 17 315-318.
11. Lièvre M., Cucherat M., Leizorovicz A. Pooling, meta-analysis, and the evaluation of drug safety. Curr. Control. Trials Cardiovasc. Med. (2002) 3 6.
12. Boissel J.P., Blanchard J., Panak E., Peyrieux J.C., Sacks H. Considerations for the meta-analysis of randomized clinical trials. Summary of a panel discussion. Control. Clin. Trials (1989) 10 254-281.
13. Cucherat M., Boissel J.P., Leizorovitz A., Haugh M.C. EasyMA®: a program for the meta-analysis of clinical trials. Comput. Methods Programs Biomed. (1997) 53: 187-190.
14. Le Chevalier T., Brisgand D., Douillard J.Y. et al. Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: results of a European multicenter trial including 612 patients. J. Clin. Oncol. (1994) 12 360-367.
15. Le Chevalier T., Brisgand D., Pujol J.L. et al. Results of a randomized study comparing combination of navelbine-cisplatin to combination of vindesine-cisplatin and to navelbine alone in 612 patients with inoperable non-small cell lung cancer. Bull. Cancer (1996) 83 385-394.
16. Le Chevalier T., Pujol J.L., Douillard J.Y. et al. A three-arm trial of vinorelbine (Navelbine) plus cisplatin, vindesine plus cisplatin, and single-agent vinorelbine in the treatment of non-small cell lung cancer: an expanded analysis. Semin. Oncol. (1994) 21 28-33.
17. Soria J.C., Brisgand D., Le Chevalier T. Do all patients with advanced non-small cell lung cancer benefit from cisplatin-based combination therapy? Ann. Oncol. (2001) 12 1667-1670.
18. Le Chevalier T., Brisgand D., Soria J.C. et al. Long term analysis of survival in the European randomized trial comparing vinorelbine/cisplatin to vindesine/cisplatin and vinorelbine alone in advanced non-small cell lung cancer. Oncologist (2001) 6 S8-11.
19. Jones S., Winer E., Vogel C. et al. Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. J. Clin. Oncol. (1995) 13 2567-2574.
20. Comella P., Frasci G., De Cataldis G. et al. Cisplatin/carboplatin + etoposide + vinorelbine in advanced non-small-cell lung cancer: a multicentre randomised trial. Gruppo Oncologico Campano. Br. J. Cancer (1996) 74 1805-1811.
21. Crawford J., O'Rourke M., Schiller J.H. et al. Randomized trial of vinorelbine compared with fluorouracil plus leucovorin in patients with stage IV non-small-cell lung cancer. J. Clin. Oncol. (1996) 14 2774-2784.
22. Furuse K., Fukuoka M., Kuba M. et al. Randomized study of vinorelbine (VRB) versus vindesine (VDS) in previously untreated stage IIIB or IV non-small-cell lung cancer (NSCLC). The Japan Vinorelbine Lung Cancer Cooperative Study Group. Ann. Oncol. (1996) 7 815-820.
23. Perol M., Guerin J.C., Thomas P. et al. Multicenter randomized trial comparing cisplatin-mitomycin-vinorelbine versus cisplatin-mitomycin-vindesine in advanced non-small cell lung cancer. 'Groupe Francais de Pneumo- Cancerologie'. Lung Cancer (1996) 14 119-134.
24. Colucci G., Gebbia V., Galetta D. et al. Cisplatin and vinorelbine followed by ifosfamide plus epirubicin vs the opposite sequence in advanced unresectable stage III and metastatic stage IV non-small-cell lung cancer: a prospective randomized study of the Southern Italy Oncology Group (GOIM). Br. J. Cancer (1997) 76 1509-1517.
25. Baldini E., Tibaldi C., Ardizzoni A. et al. Cisplatin-vindesine- mitomycin (MVP) vs cisplatin-ifosfamide-vinorelbine (PIN) vs carboplatin-vinorelbine (CaN) in patients with advanced non-small-cell lung cancer (NSCLC): a FONICAP randomized phase II study. Italian Lung Cancer Task Force (FONICAP). Br. J. Cancer (1998) 77 2367-2370.
26. Martoni A., Guaraldi M., Piana E. et al. Multicenter randomized clinical trial on high-dose epirubicin plus cis-platinum versus vinorelbine plus cis-platinum in advanced non small cell lung cancer. Lung Cancer (1998) 22 31-38.
27. Martoni A., Guaraldi M., Piana E. Anthracyclines in non-small cell lung cancer: do they have a therapeutic role? Ann. Oncol. (1999) 10 S19-23.
28. Wozniak A.J. Cisplatin alone vs cisplatin plus vinorelbine in stage IV NSCLC. Oncology (1997) 11 S28-S30.
29. Wozniak A.J., Crowley J.J., Balcerzak S.P. et al. Randomized trial comparing cisplatin with cisplatin plus vinorelbine in the treatment of advanced non-small-cell lung cancer: a Southwest Oncology Group study. J. Clin. Oncol. (1998) 16 2459-2465.
30. Blajman C., Balbiani L., Block J. et al. A prospective, randomized phase in trial comparing combination chemotherapy with cyclophosphamide, doxorubicin, and 5-fluorouracil with vinorelbine plus doxorubicin in the treatment of advanced breast carcinoma. Cancer (1999) 85 1091-1097.
31. Comella P. Interim analysis of a phase III trial. Triple versus double agent chemotherapy for advanced non-small cell lung cancer. Southern Italy Cooperative Oncology Group. Oncology (2000) 14 S35-40.
32. Comella P., Frasci G., Panza N. et al. Randomised trial comparing cisplatin, gemcitabine, and vinorelbine with either cisplatin and gemcitabine or cisplatin and vinorelbine in advanced non-small-cell lung cancer: interim analysis of a phase III trial of the Southern Italy Cooperative Oncology Group. J. Clin. Oncol. (2000) 18 1451-1457.
33. Norris B., Pritchard K.I., James K. et al. Phase III comparative study of vinorelbine combined with doxorubicin versus doxorubicin alone in disseminated metastatic/recurrent breast cancer: National Cancer institute of Canada Clinical trials Group study MA8. J. Clin. Oncol. (2000) 18 2385-2394.
34. Namer M., Soler-Michel P., Turpin F. et al. Results of a phase III prospective, randomised trial, comparing mitoxantrone and vinorelbine (MV) in combination with standard FAC/FEC in front-line therapy of metastatic breast cancer. Eur. J. Cancer (2001) 37 1132-1140.
35. Kelly K., Crowley J., Bunn P.A. et al. Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small cell lung cancer: a Southwest Oncology Group trial. J. Clin. Oncol. (2001) 19 3210-3218.
36. Ramsey S.D., Moinpour C.M., Lovato L.C. et al. Economic analysis of vinorelbine plus cisplatin versus paclitaxel plus carboplatin for advanced non-small cell lung cancer. J. Nat. Cancer Inst. (2002) 94 291-297.
37. Moinpour C.M., Lyons B., Grevstad P.K. et al. Quality of life in advanced non small cell lung cancer: results of a Southwest Oncology Group randomized trial. Qual. Life Res. (2002) 11 115-126.
38. Gridelli C., Cigolari S., Gallo C. et al. Activity and toxicity of gemcitabine and gemcitabine + vinorelbine in advanced non-small cell lung cancer elderly patients: phase II data from the Multicenter Italian Lung Cancer in the Elderly Study (MILES) randomized trial. Lung Cancer (2001) 31 277-284.
39. Greco F.A., Gray J.R., Thompson D.S. et al. Prospective randomized study of four novel chemotherapy regimens in patients with advanced non-small cell lung carcinoma: a Minnie Pearl cancer research network trial. Cancer (2002) 95 1279-1285.
40. Vokes E.E., Herndon J.E., Crawford J. et al. Randomized phase n study of cisplatin with gemcitabine or paclitaxel or vinorelbien as induction chemotherapy followed by concomittant chemoradiotherapy for stage IIIB non-small cell lung cancer: cancer and leukemia group B study 9431. J. Clin. Oncol. (2002) 20 4191-4198.
41. Gebbia V., Galetta D., Riccardi D. et al. Vinorelbine plus cisplatin versus cisplatin plus vindesine and mitomycin C in stage IIIB-IV non small cell lung carcinoma: a prospective randomized study. Lung Cancer (2002) 37 179-187.
42. Aymard J.P., Ferry R., Netter P., Balaud A., Streiff F. Toxicité cardique des alcaloides de la pervenche. Thérapie (1985) 40 361.
43. Lampidis T.J., Kolonias D., Savaraj N., Rubin R.W. Cardiostimulatory and antiarrhythmic activity of tubulin-binding agents. Proc. Natl. Acad. Sci. U. S. A. (1992) 89 1256-1260 (abstract).
44. Nesme P., Trillet-Lenoir V., Brune J. Infarctus du myocarde induit par la vinorelbine? Cahiers d'Oncologie (1993) 2 237-238.
45. Henry D., Hill S. Meta-analysis: its role in assessing drug safety. Pharmacoepidemiol. Drug Saf. (1999) 8 167-168.
46. Begg C., Cho M., Eastwood S. et al. Improving the quality of reporting of randomized clinical trials. J. A. M. A. (1996) 276 637-639.
47. Aronson J.K., Deery S., Loke Y.K. Adverse drug reactions: keeping up to date. Fundan. Clin. Pharamcol. (2002) 16 49-56.