title: Quality of life and treatment related toxicity in 335 patients with locally advanced cervical carcinoma treated by two chemoradiation regimens.
abstract: OBJECTIVE
  Concomitant chemoradiotherapy (CT/RT) is the gold standard for advanced cervical carcinoma, but with frequent debates over treatment schedules and toxicity. This study compared 2 concomitant CT/RT regimens in terms of quality of life (QoL) and acute toxicity.
  
  
  METHODS
  Between March 2003 and March 2005, 335 patients with stage IIB-IIIB cervical carcinoma were evaluated in a randomized single-center phase III trial at the Oncology Institute Cluj-Napoca. Patients received concurrent CT/RT with cisplatin 20 mg/m(2), days 1-5, every 21 days (arm A, n=171) or 40 mg/m(2)/weekly (arm B, n=164). QoL was estimated using the EORTC QLQ-30, v.3.0 questionnaire and acute toxicity using the common toxicity criteria (CTC) v.2.0.
  
  
  RESULTS
  Significant improvement of global health status (p <0.01) and a decrease in pain (p <0.01) was observed in arm A. In arm B fatigue increased (p=0.01) and role functioning diminished (p=0.05). In both arms depression, nausea, vomiting and diarrhea increased (p <0.05). Gastrointestinal toxicity was similar in both arms (76% vs. 77.5%). Hemoglobin drop was higher in arm B: 75% vs. 63% (p=0.02), while no differences were seen in leukocyte and platelet toxicity.
  
  
  CONCLUSIONS
  Concomitant CT/RT with cisplatin 20 mg/m(2) x 5 days every 21 days has better impact on patients' QoL and lower toxicity compared with the weekly chemotherapy regimen.
authors.affiliation: Department of Radiotherapy, Oncology Institute Ion Chiricuta, Cluj-Napoca, Romania. nagyviorica@yahoo.com
authors.forename: V
authors.initials: V
authors.lastname: Nagy
authors.forename: N
authors.initials: N
authors.lastname: Todor
authors.forename: O
authors.initials: O
authors.lastname: Coza
authors.forename: C
authors.initials: C
authors.lastname: Ordeanu
authors.forename: N
authors.initials: N
authors.lastname: Ghilezan
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002277:Carcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use; D003131:Combined Modality Therapy / Q000009:adverse effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D011838:Radiation-Sensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*
chemical_list: D000970:Antineoplastic Agents; D011838:Radiation-Sensitizing Agents; D002945:Cisplatin