title: Decitabine plus thalidomide yields more sustained survival rates than decitabine monotherapy for risk-tailored elderly patients with myelodysplastic syndrome.
abstract: OBJECTIVE
  The open-label, prospective, observational study aimed to evaluate whether decitabine (DAC) plus thalidomide versus DAC monotherapy improved progression-free (PFS), overall survival (OS) and acute myeloid leukemia-free survival (AML-FS) for risk-tailored elderly patients with myelodysplastic syndromes (MDS).
  
  
  METHODS
  Enrolled 107 patients (age: 65-82 years) received DAC (52/107) or DAC plus thalidomide (55/107) therapy for MDS.
  
  
  RESULTS
  35/52 patients (67.3%) with DAC therapy reached overall response (OR), compared with 36/55 patients (65.5%) in DAC+thalidomide regimen (P>0.05). DAC+thalidomide administered did not gain more profits of PFS and OS than DAC monotherapy. Risk-tailored analysis showed that DAC+thalidomide therapy did not enhance PFS (48.9% versus 42.8%, P>0.05) and OS (78.6% versus 71.2%, P>0.05) when compared with simple DAC regimen. Nevertheless, DAC+thalidomide markedly improved OS over DAC monotherapy (50.6% versus 40.2%, P<0.05) in high risk profile. Meanwhile, low risk group was superior to high risk group in AML-FS (57.2% versus 21.3%, P<0.01), but DAC+thalidomide still did not prolong 2-year AML-FS when compared with DAC (32.4% versus 27.8%, P<0.05). Moreover, thalidomide had a favorable toxicity profile as a single agent. In comparison with DAC monotherapy, the DAC+thalidomide regimen was relatively well tolerated. There was no severe non-hematological toxicity appearing in elderly patients with MDS.
  
  
  CONCLUSIONS
  The study demonstrated that DAC+thalidomide improved 2-year OS for high risk patients. Thalidomide's proven activity and low toxicity profile made it an alternative treatment option for risk-tailored elderly patients with MDS.
authors.affiliation: Department of Gastroenterology, The Affiliated Hospital of Inner Mongolia Medical University, 010059 Hohhot, PR China.
authors.forename: Wei-Hong
authors.initials: WH
authors.lastname: Zhao
authors.affiliation: Department of Medicine, Nanfang Hospital, Southern Medical University, 1838 North Guangzhou Avenue, Guangzhou, Guangdong 510515, PR China.
authors.forename: Qing-Chun
authors.initials: QC
authors.lastname: Zeng
authors.affiliation: Department of Hematology, The Affiliated Hospital of Inner Mongolia Medical University, 1 TongDao Avenue North, Hohhot 010059, PR China. Electronic address: huangbintao1979@sina.com.
authors.forename: Bin-Tao
authors.initials: BT
authors.lastname: Huang
authors.affiliation: Huizhou Medicine Institute, 516003 Huizhou, PR China.
authors.forename: Bing-Sheng
authors.initials: BS
authors.lastname: Li
authors.affiliation: Department of Medicine, The Second Affiliated Hospital of Guangzhou Medical University, 510260 Guangzhou, PR China.
authors.forename: Rui-Lin
authors.initials: RL
authors.lastname: Chen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001374:Azacitidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077209:Decitabine; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage
chemical_list: D013792:Thalidomide; D000077209:Decitabine; D001374:Azacitidine
keywords: Decitabine; Elderly patients; Myelodysplastic syndrome; Thalidomide