Document Detail


Phase 2 trial of combined cisplatin, etoposide, gemcitabine, and methylprednisolone (PEGS) in peripheral T-cell non-Hodgkin lymphoma: Southwest Oncology Group Study S0350.
MedLine Citation:
PMID:  22833464     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Patients with peripheral T-cell lymphomas (PTCLs) have inferior progression-free survival (PFS) and overall survival (OS) compared with patients who have aggressive B-cell non-Hodgkin lymphoma. Because PTCLs over express multidrug resistance gene 1/P-glycoprotein (MDR-1/P-gp), we devised platinum, etoposide, gemcitabine, and methylprednisolone (PEGS) with agents that are not substrates of the efflux pump. Gemcitabine was included because of its excellent single-agent activity in PTCL.
METHODS: Patients who had PTCL with stage II bulky disease, stage III or IV disease with extra-nodal, nodal, and transformed cutaneous presentations were eligible. Patients received intravenous cisplatin 25 mg/m(2) on days 1 through 4, etoposide 40 mg/m(2) on days 1 through 4, gemcitabine 1000 mg/m(2) on day 1, and methylprednisolone 250 mg on days 1 through 4 of a 21-day cycle for 6 cycles.
RESULTS: In total, 34 patients were enrolled, 33 were eligible, and 79% were newly diagnosed. Histologic types were PTCL not otherwise specified (n = 15), anaplastic lymphoma kinase (ALK)-negative anaplastic large cell lymphoma (n = 4), angioimmunoblastic T-cell lymphoma (n = 6), or other T-cell non-Hodgkin lymphomas (n = 8). Adverse events included 1 grade 5 infection with grade 3 or 4 neutropenia and 9 grade 4 hematologic toxicities. The overall response rate was 39% (47% in PTCL not otherwise specified, 33% in angioimmunoblastic T-cell lymphoma, 25% in ALK-negative and 38% in other T-cell non-Hodgkin lymphomas). The PFS rate at 2 years was 12% (95% confidence interval, 0.1%-31%), and the median PFS was 7 months. The OS rate at 2 years was 30% (95% confidence interval, 8%-54%), and the median OS was 17 months. Immunohistochemical analysis of P-gp expression revealed strong positivity in a subset of lymphoma cells (n = 6) and tumor endothelium (n = 25).
CONCLUSIONS: Overall, PEGS was well tolerated, but OS was not considered promising given the design-specified targets. These results may serve as a benchmark for future comparisons for non-CHOP regimens.
Authors:
Daruka Mahadevan; Joseph M Unger; Catherine M Spier; Daniel O Persky; Fay Young; Michael LeBlanc; Richard I Fisher; Thomas P Miller
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2012-07-25
Journal Detail:
Title:  Cancer     Volume:  119     ISSN:  1097-0142     ISO Abbreviation:  Cancer     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-07     Completed Date:  2013-02-20     Revised Date:  2014-01-26    
Medline Journal Info:
Nlm Unique ID:  0374236     Medline TA:  Cancer     Country:  United States    
Other Details:
Languages:  eng     Pagination:  371-9     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 American Cancer Society.
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols / adverse effects,  therapeutic use*
Cisplatin / administration & dosage
Deoxycytidine / administration & dosage,  analogs & derivatives
Disease-Free Survival
Etoposide / administration & dosage
Female
Humans
Kaplan-Meier Estimate
Lymphoma, T-Cell, Peripheral / drug therapy*,  metabolism,  mortality,  pathology
Male
Methylprednisolone / administration & dosage
Middle Aged
Neoplasm Staging
P-Glycoprotein / metabolism
Treatment Outcome
Young Adult
Grant Support
ID/Acronym/Agency:
CA11083/CA/NCI NIH HHS; CA128567/CA/NCI NIH HHS; CA13612/CA/NCI NIH HHS; CA142559/CA/NCI NIH HHS; CA20319/CA/NCI NIH HHS; CA32102/CA/NCI NIH HHS; CA35119/CA/NCI NIH HHS; CA37981/CA/NCI NIH HHS; CA38926/CA/NCI NIH HHS; CA45807/CA/NCI NIH HHS; CA46136/CA/NCI NIH HHS; CA46282/CA/NCI NIH HHS; CA46441/CA/NCI NIH HHS; CA63848/CA/NCI NIH HHS; U10 CA032102/CA/NCI NIH HHS
Chemical
Reg. No./Substance:
0/P-Glycoprotein; 0W860991D6/Deoxycytidine; 6PLQ3CP4P3/Etoposide; B76N6SBZ8R/gemcitabine; Q20Q21Q62J/Cisplatin; X4W7ZR7023/Methylprednisolone
Comments/Corrections

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