Phase II study of Gemcitabine for treatment of pat

Authors: Sung Yong Oh Won Seog Kim Dae Ho Lee Seok Jin Kim Sung Hyun Kim Baek Yeol Ryoo Hye Jin Kang Young Jin Choi Joo Seop Chung Hyo Jung Kim Cheolwon Suh

Publish Date: 2009/05/07

Volume: 28, Issue: 2, Pages: 171-177

PDF Link

Abstract

Background Therapeutic approaches to marginal zone Bcell lymphoma MZL continue to evolve Localized MZL responds favorably to local treatments including surgery and/or local radiation therapy However MZL manifests as a disseminated disease in onethird of the cases at diagnosis Moreover relapses involving distant sites after local therapy have been reported previously Therefore the search for effective forms of systemic therapy is a critical issue We conducted this multicenter phase II trial to assess the efficacy and safety of gemcitabine single chemotherapy for patients with stage III/IV MZL Methods Patients received gemcitabine 1250 mg/m2 on days 1 and 8 of each cycle The treatment was repeated every 3 weeks and continued for 6 cycles until disease progression withdrawal due to toxicity or withdrawal of consent Results Between Sep 2006 and Sep 2008 a total of 16 patients were enrolled with informed consent into this trial from 6 institutes in Korea Among these patients 4 patients dropped out without evaluation The median age of the 12 9 males 3 females evaluated patients was 62 range 25–73 years Seven patients 58 evidenced involvement of extranodal sites All patients received previous treatment for MZL The patients received a total of 69 cycles of gemcitabine chemotherapy range 3–6 median 6 cycles/person There were 2 PR 17 95 Confidence Interval CI 00–41 9 SD 75 and 1 PD 8 There were 8/69 cycles 12 of grade 3/4 neutropenia Nonhematologic toxicities were mild and tolerable There were 5 cycles 8 of delayed chemotherapy median 1 week owing to neutropenia Dose reduction was required in 12 cycles However no treatmentrelated death occurred in this study The median TTP was 102 months 95 CI 53–151 As the response rate in stage I did not justify progressing to stage II ≥8/15 this study had to be discontinued in accordance with the established protocols Conclusion Gemcitabine as a single agent in this dosage and at this schedule evidenced minimal clinical activity in cases of advanced MZL

Keywords: