PMID- 24985882 OWN - NLM STAT- MEDLINE DCOM- 20150514 LR - 20211021 IS - 1559-131X (Electronic) IS - 1357-0560 (Linking) VI - 31 IP - 8 DP - 2014 Aug TI - How to determine post-FCR therapy for cytogenetic risk-tailored elderly patients with chronic lymphocytic leukemia, maintenance rituximab or observation. PG - 104 LID - 10.1007/s12032-014-0104-7 [doi] AB - 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. FAU - Huang, Bin-Tao AU - Huang BT AD - Department of Hematology, The Affiliated Hospital of Inner Mongolia Medical University, 1 TongDao Avenue North, Hohhot, 010059, People's Republic of China, huangbintao1979@sina.com. FAU - Zeng, Qing-Chun AU - Zeng QC FAU - Zhao, Wei-Hong AU - Zhao WH FAU - Li, Bing-Sheng AU - Li BS FAU - Chen, Rui-lin AU - Chen RL LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20140702 PL - United States TA - Med Oncol JT - Medical oncology (Northwood, London, England) JID - 9435512 RN - 0 (Antibodies, Monoclonal, Murine-Derived) RN - 4F4X42SYQ6 (Rituximab) RN - 8N3DW7272P (Cyclophosphamide) RN - FA2DM6879K (Vidarabine) RN - P2K93U8740 (fludarabine) SB - IM MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal, Murine-Derived/administration & dosage/*adverse effects/*therapeutic use MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Cyclophosphamide/administration & dosage MH - Disease-Free Survival MH - Female MH - Follow-Up Studies MH - Humans MH - Leukemia, Lymphocytic, Chronic, B-Cell/*drug therapy/*genetics/mortality MH - Male MH - Prospective Studies MH - Risk Factors MH - Rituximab MH - Treatment Outcome MH - Vidarabine/administration & dosage/analogs & derivatives EDAT- 2014/07/06 06:00 MHDA- 2015/05/15 06:00 CRDT- 2014/07/03 06:00 PHST- 2014/05/22 00:00 [received] PHST- 2014/06/23 00:00 [accepted] PHST- 2014/07/03 06:00 [entrez] PHST- 2014/07/06 06:00 [pubmed] PHST- 2015/05/15 06:00 [medline] AID - 10.1007/s12032-014-0104-7 [doi] PST - ppublish SO - Med Oncol. 2014 Aug;31(8):104. doi: 10.1007/s12032-014-0104-7. Epub 2014 Jul 2.