Document Detail


A randomized trial of cisplatin, vinblastine, and bleomycin versus vinblastine, cisplatin, and etoposide in the treatment of advanced germ cell tumors of the testis: a Southwest Oncology Group study.
MedLine Citation:
PMID:  1702148     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This is a Southwest Oncology Group (SWOG) prospective randomized trial of cisplatin, vinblastine, and bleomycin (PVB) versus vinblastine, cisplatin, and etoposide (VP-16) (VPV) in the treatment of advanced germ cell tumors of the testis. The study objective was to determine what effect the replacement of bleomycin with VP-16 has on complete response (CR), survival, and drug toxicity. One hundred sixty-nine patients were registered and randomized. Of these patients, 160 were assessable for response. All had histologically confirmed disseminated germ cell neoplasms of testicular origin. Forty-six had minimal metastatic disease, and 114 had maximal disease. Seventy-seven were randomized to PVB and 83 to VPV chemotherapy. There was no significant difference in pretreatment characteristics between the two arms with regard to tumor burden, histologic type, and overall performance status. Patients received four courses of induction chemotherapy, either PVB (cisplatin 120 mg/m2 day 3, vinblastine 12 mg/m2 day 1, bleomycin 15 U/m2 twice per week) or VPV (vinblastine 8 mg/m2 day 1, cisplatin 120 mg/m2 day 3, VP-16 50 mg/m2 days 2 to 5). Chemotherapy was given every 3 weeks. Cytoreductive surgery was done postinduction if a chemotherapy CR was not achieved. There was no difference in the percentage of patients achieving a disease-free status between PVB (77%) and VPV (73%). The mean leukocyte nadir was similar for both treatments, but the mean platelet nadir was significantly lower (P = .003) in the VPV arm. All bleomycin-related toxicities (pulmonary, mucositis, skin) were avoided in the VPV arm. We conclude that bleomycin can be replaced in first-line therapy for advanced germ cell tumors without sacrificing efficacy and with the advantage of avoiding unnecessary drug toxicity.
Authors:
A J Wozniak; M K Samson; N T Shah; E D Crawford; C D Ford; S J Altman; R L Stephens; R B Natale; B A Bouroncle; B A Blumenstein
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  9     ISSN:  0732-183X     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  1991 Jan 
Date Detail:
Created Date:  1991-02-07     Completed Date:  1991-02-07     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  70-6     Citation Subset:  IM    
Affiliation:
Wayne State University Medical Center, Detroit, MI.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Antineoplastic Combined Chemotherapy Protocols / adverse effects,  therapeutic use*
Bleomycin / administration & dosage
Cisplatin / administration & dosage
Etoposide / administration & dosage
Hematologic Diseases / chemically induced
Humans
Male
Middle Aged
Neoplasms, Germ Cell and Embryonal / drug therapy*,  mortality,  secondary
Prospective Studies
Recurrence
Remission Induction
Survival Rate
Testicular Neoplasms / drug therapy*,  mortality
Vinblastine / administration & dosage
Grant Support
ID/Acronym/Agency:
CA-04920/CA/NCI NIH HHS; CA-14028/CA/NCI NIH HHS; CA-37429/CA/NCI NIH HHS
Chemical
Reg. No./Substance:
0/PVB protocol; 0/VEP combination; 11056-06-7/Bleomycin; 15663-27-1/Cisplatin; 33419-42-0/Etoposide; 865-21-4/Vinblastine
Comments/Corrections
Comment In:
J Clin Oncol. 1991 Jun;9(6):1092-4   [PMID:  1709684 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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