title: Comparison of treatment tolerance and outcomes in patients with cervical cancer treated with concurrent chemoradiotherapy in a prospective randomized trial or with standard treatment.
abstract: OBJECTIVE
  To compare the treatment and outcomes of cervical cancer patients treated with concurrent chemoradiotherapy (CT-RT) in a multi-institutional trial or as standard care.
  
  
  METHODS
  We reviewed the records of 302 patients treated with CT-RT for locoregionally confined, intact cervical cancer between 1990 and 2005. Of the 302 patients, 76 were treated using cisplatin and 5-fluorouracil (C/F) on Radiation Therapy Oncology Group protocol 90-01 (CT-RT(90-01)); 226 underwent CT-RT as standard care with either C/F [CT-RT(SC(C/F)); n = 115] or weekly cisplatin [CT-RT(SC(WC)); n = 111).
  
  
  RESULTS
  The CT-RT(90-01) patients more often had tumors >or=6 cm and were less often diabetic than were the CT-RT(SC) patients. The CT-RT(SC(WC)) patients were more likely than the CT-RT(SC(C/F)) patients to be >or=60 years old or to have Stage III-IV disease. During treatment, CT-RT(SC(C/F)) patients experienced more Grade 2-3 neutropenia and were, therefore, less likely to receive 200 mg/m(2) cisplatin than were either CT-RT(SC(WC)) or CT-RT(90-01) patients (52% vs. 77% vs. 85%, respectively; p <0.001). At 5 years, the disease-specific survival rates were greater for patients treated with C/F [CT-RT(SC(C/F)), 75%; CT-RT(90-01), 79%] than for those treated with CT-RT(SC(WC)) (58%; p = 0.02). On multivariate analysis, C/F chemotherapy, cisplatin dose >or=200 mg/m(2), Stage I-II disease, and negative pelvic lymph nodes were independent predictors of improved disease-specific survival.
  
  
  CONCLUSIONS
  Even within a large comprehensive cancer center, the high rates of chemotherapy completion achieved on a multi-institutional trial can be difficult to reproduce in standard practice. Although C/F toxicity was greater in the standard care patients, their outcomes were similar to those of patients treated with C/F on Radiation Therapy Oncology Group protocol 90-01.
authors.affiliation: Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77030, USA.
authors.forename: Mylin A
authors.initials: MA
authors.lastname: Torres
authors.forename: Anuja
authors.initials: A
authors.lastname: Jhingran
authors.forename: Howard D
authors.initials: HD
authors.lastname: Thames
authors.forename: Charles F
authors.initials: CF
authors.lastname: Levenback
authors.forename: Diane C
authors.initials: DC
authors.lastname: Bodurka
authors.forename: Lois M
authors.initials: LM
authors.lastname: Ramondetta
authors.forename: Patricia J
authors.initials: PJ
authors.lastname: Eifel
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D018196:Carcinoma, Adenosquamous / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000379:methods; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007970:Leukopenia / Q000209:etiology; D008875:Middle Aged; D015999:Multivariate Analysis; D009503:Neutropenia / Q000209:etiology; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*
chemical_list: D002945:Cisplatin; D005472:Fluorouracil