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How to determine post-FCR therapy for cytogenetic risk-tailored elderly patients with chronic lymphocytic leukemia, maintenance rituximab or observation

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Abstract

The open-label, prospective, observational study aimed to evaluate whether the addition of maintenance rituximab (MR) improved progression-free survival (PFS) and overall survival (OS), after fludarabine, cyclophosphamide, and rituximab (FCR) for cytogenetic risk-tailored elderly patients with chronic lymphocytic leukemia (CLL). Enrolled 201 patients (ages 65–84 years) who received FCR and gained an overall response. One hundred and four of 201 patients were in the observation (OBS) arm while 97/201 patients continued to receive MR therapy. After FCR, no more benefits were provided by MR versus OBS in cytogenetic better intermediate-risk cohort. PFS at 10 years reached 68.6 versus 58.1 % (P > 0.05). Ten-year OS was 81.8 versus 74.6 % (P > 0.05). However, the improvement of PFS and OS were as dramatic as the improvements of being MR treating versus OBS mainly in the poor-risk cohort. PFS at 10 years reached 57.1 versus 22.7 % (P < 0.01), and 10-year OS was 71.2 versus 41.7 % (P < 0.01). Compared with OBS, no severe hematologic adverse events (AEs) (Grades 3–4) appeared in patients with MR; only some mild non-hematologic AEs incurred (nausea–vomiting 0.96 %, allergy 1.9 % and infection 1.9 %) during the maintenance treatment. The study showed that MR improved 10-year RFS and OS for cytogenetic poor-risk patients with CLL.

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Acknowledgments

We would like to thank all the patients and clinicians from the participating sites. This work was supported by Grants from the Natural Science Foundation of Inner Mongolia (2013MS1157) and Inner Mongolia Autonomous Region Health and Family Planning Health Research Projects (201302059). All authors discussed the results and commented on the manuscript.

Conflict of interest

I would like to declare on behalf of my co-authors that this work is original research that has not been published previously and is not under consideration for publication elsewhere, either in part of in whole. All the authors listed have approved the manuscript that is enclosed.

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Authors and Affiliations

  1. Department of Hematology, The Affiliated Hospital of Inner Mongolia Medical University, 1 TongDao Avenue North, Hohhot, 010059, People’s Republic of China

    Bin-Tao Huang

  2. Department of Medicine, Nanfang Hospital, Southern Medical University, 1838 North Guangzhou Ave, Guangzhou, 510515, Guangdong, China

    Qing-Chun Zeng

  3. Department of Gastroenterology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010059, People’s Republic of China

    Wei-Hong Zhao

  4. Huizhou Medicine Institute, Huizhou, 516003, People’s Republic of China

    Bing-Sheng Li

  5. Department of Medicine, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510260, China

    Rui-lin Chen

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  1. Bin-Tao Huang
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  2. Qing-Chun Zeng
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  3. Wei-Hong Zhao
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  4. Bing-Sheng Li
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  5. Rui-lin Chen
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Corresponding author

Correspondence to Bin-Tao Huang.

Additional information

Bin-Tao Huang and Qing-Chun Zeng have equally contributed to this work.

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Huang, BT., Zeng, QC., Zhao, WH. et al. How to determine post-FCR therapy for cytogenetic risk-tailored elderly patients with chronic lymphocytic leukemia, maintenance rituximab or observation. Med Oncol 31, 104 (2014). https://doi.org/10.1007/s12032-014-0104-7

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  • DOI: https://doi.org/10.1007/s12032-014-0104-7

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