title: Role of recombinant human erythropoietin in patients of advanced cervical cancer treated "by chemoradiotherapy".
abstract: BACKGROUND
  Cervical cancer, in women, is the second most common cancer world wide, next to breast cancer. During the treatment of carcinoma cervix, anemia is selectively frequent and its origin is complex combining hemorrhage, iron deprivation, inflammatory reactions and infection. The objective of this study is to evaluate the role of epoetin in correction of anemia and on treatment outcomes in patients with advanced cervical cancer receiving concurrent chemoradiotherapy.
  
  
  RESULTS
  A total of 120 patients were enrolled in the study of which 60 patients were randomized to receive epoetin beta in the treatment arm and 60 patients were in control arm where epoetin beta was not given. Total two and three patients absconded during treatment from treatment and control arm respectively; therefore total evaluable patients were 115. Mean Hb at baseline in the control arm was 10.70 g/dl +/- 0.62 g/dl and 10.45 g/dl +/- 0.43 g/dl in the treatment arm (p > 0.05). At the end of treatment period mean Hb increased by 1.55 g/dl in patients receiving epoetin beta (p < 0.01), but decreased by 1.50 g/dl in the control arm (p < 0.01). There was significant reduction in blood transfusion in patients receiving epoetin beta (p < 0.01). At the end of treatment there was significant improvement in energy level, activity level and overall quality of life in the treatment arm (p < 0.01). There was no significant difference in overall survival (p > 0.05), or disease free survival (p > 0.05) between the two study arms. Adverse events were well matched between the two study arms. No Thromboembolic events associated with epoetin beta was observed in our study.
  
  
  METHODS
  Total 120, stage IIB to IIIB cervical cancer patients, aged 18-70 years with 9.50-12.50 gm/dl baseline Hb value who were to receive radiotherapy together with cisplatin were randomized to receive either epoetin beta 10,000 IU thrice weekly and oral iron starting 10-15 days before their 5-week course of whole pelvic irradiation and weekly cisplatin (treatment arm) or standard supportive care (control arm), where epoetin beta was not given. Blood transfusion was given in patients of both the arms if hemoglobin was < or =10 gm/dl.
  
  
  CONCLUSIONS
  Treatment with epoetin beta safely and effectively corrects anemia in patients with advanced cervical cancer receiving chemoradiotherapy and is not associated with adverse effects on response rate, overall survival, disease free survival and chemoradiotherapy related acute and late toxicities.
authors.affiliation: Department of Radiotherapy, C.S.M. Medical University, Central Drug Research Institute, Lucknow, India. guptaseema41@yahoomal.com
authors.forename: Seema
authors.initials: S
authors.lastname: Gupta
authors.forename: P K
authors.initials: PK
authors.lastname: Singh
authors.forename: S S
authors.initials: SS
authors.lastname: Bisth
authors.forename: M L
authors.initials: ML
authors.lastname: Bhatt
authors.forename: M
authors.initials: M
authors.lastname: Pant
authors.forename: R
authors.initials: R
authors.lastname: Gupta
authors.forename: Sharad
authors.initials: S
authors.lastname: Singh
authors.forename: M P S
authors.initials: MP
authors.lastname: Negi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001803:Blood Transfusion; D003131:Combined Modality Therapy; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D011994:Recombinant Proteins; D016019:Survival Analysis; D017741:Survivors; D013997:Time Factors; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin