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Phase II study of Gemcitabine for treatment of patients with advanced stage marginal zone B-cell lymphoma: Consortium for Improving Survival of Lymphoma (CISL) trial

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Summary

Background: Therapeutic approaches to marginal zone B-cell 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 one-third 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 multi-center, 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], 0.0–41%), 9 SD (75%), and 1 PD (8%). There were 8/69 cycles (12%) of grade 3/4 neutropenia. Non-hematologic 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 treatment-related death occurred in this study. The median TTP was 10.2 months (95% CI, 5.3–15.1). 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.

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Acknowledgement

This Paper was supported by the Dong-A University Research Fund.

Gemcitabine (Gemzar®) was kindly provided by Lilly Company.

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Authors and Affiliations

  1. Department of Internal Medicine, Dong-A University College of Medicine, Busan, South Korea

    Sung Yong Oh & Sung Hyun Kim

  2. Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

    Won Seog Kim & Seok Jin Kim

  3. Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

    Dae Ho Lee & Cheolwon Suh

  4. Division of Hematology–Oncology, Department of Internal Medicine, Korea Cancer Center Hospital, Seoul, South Korea

    Baek Yeol Ryoo & Hye Jin Kang

  5. Department of Internal Medicine, College of Medicine, Pusan National University, Busan, South Korea

    Young Jin Choi & Joo Seop Chung

  6. Department of Internal Medicine, Hallym University College of Medicine, Seoul, Korea

    Hyo Jung Kim

  7. Department of Hematology–Oncology, Asan Medical Center, University of Ulsan College of Medicine, 86 Asan Byungwon Gil, Songpa-gu, Seoul, 138-736, Korea

    Cheolwon Suh

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  1. Sung Yong Oh
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Oh, S.Y., Kim, W.S., Lee, D.H. et al. Phase II study of Gemcitabine for treatment of patients with advanced stage marginal zone B-cell lymphoma: Consortium for Improving Survival of Lymphoma (CISL) trial. Invest New Drugs 28, 171–177 (2010). https://doi.org/10.1007/s10637-009-9260-6

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