title: Long-Term Outcomes Among Patients Who Achieve Complete or Near-Complete Responses After the Induction Phase of Bladder-Preserving Combined-Modality Therapy for Muscle-Invasive Bladder Cancer: A Pooled Analysis of NRG Oncology/RTOG 9906 and 0233.
abstract: OBJECTIVE
  To investigate the differences in outcomes among patients with muscle-invasive bladder cancer on NRG Oncology Radiation Therapy Oncology Group protocols 9906 and 0233 who achieved complete response and near-complete response after induction chemoradiation and then completed bladder-preserving therapy with chemoradiation therapy (chemo-RT) to full dose (60-64 Gy).
  
  
  METHODS
  A pooled analysis was performed on 119 eligible patients with muscle-invasive bladder cancer enrolled on NRG Oncology Radiation Therapy Oncology Group trials 9906 and 0233, who were classified as having a complete (T0) or near-complete (Ta or Tis) response after induction chemo-RT and completed consolidation with a total RT dose of at least 60 Gy. Bladder recurrence, salvage cystectomy rates, and disease-specific survival were estimated by the cumulative incidence method and bladder-intact and overall survivals by the Kaplan-Meier method.
  
  
  RESULTS
  Among the 119 eligible patients, 101 (85%) achieved T0, and 18 (15%) achieved Ta or Tis after induction chemo-RT and proceeded to consolidation. After a median follow-up of 5.9 years, 36 of 101 T0 patients (36%) versus 5 of 18 Ta or Tis patients (28%) experienced bladder recurrence (P=.52). Thirteen patients among complete responders eventually required late salvage cystectomy for tumor recurrence, compared with 1 patient among near-complete responders (P=.63). Disease-specific, bladder-intact, and overall survivals were not significantly different between T0 and Ta/Tis cases.
  
  
  CONCLUSIONS
  The bladder recurrence and salvage cystectomy rates of the complete and the near-complete responders were similar. Therefore it is reasonable to recommend that patients with Ta or Tis after induction chemo-RT continue with bladder-sparing therapy with consolidation chemo-RT to full dose (60-64 Gy).
authors.affiliation: Oregon Health & Science University, Portland, Oregon. Electronic address: mitin@ohsu.edu.
authors.forename: Timur
authors.initials: T
authors.lastname: Mitin
authors.affiliation: NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
authors.forename: Asha
authors.initials: A
authors.lastname: George
authors.affiliation: Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Anthony L
authors.initials: AL
authors.lastname: Zietman
authors.affiliation: Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Niall M
authors.initials: NM
authors.lastname: Heney
authors.affiliation: Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Donald S
authors.initials: DS
authors.lastname: Kaufman
authors.affiliation: Fox Chase Cancer Center, Philadelphia, Pennsylvania.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Uzzo
authors.affiliation: University of Virginia, Charlottesville, Virginia.
authors.forename: Robert
authors.initials: R
authors.lastname: Dreicer
authors.affiliation: University of Vermont College of Medicine, Burlington, Vermont.
authors.forename: H James
authors.initials: HJ
authors.lastname: Wallace
authors.affiliation: McGill University Health Centre, Montreal, Québec, Canada.
authors.forename: Luis
authors.initials: L
authors.lastname: Souhami
authors.affiliation: University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: M Chris
authors.initials: MC
authors.lastname: Dobelbower
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Howard M
authors.initials: HM
authors.lastname: Sandler
authors.affiliation: Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: William U
authors.initials: WU
authors.lastname: Shipley
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002295:Carcinoma, Transitional Cell / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy / Q000379:methods; D060830:Consolidation Chemotherapy / Q000379:methods*; D015653:Cystectomy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000601:surgery; D059351:Organ Sparing Treatments / Q000379:methods*; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D012074:Remission Induction; D016879:Salvage Therapy / Q000379:methods; D001749:Urinary Bladder Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D017239:Paclitaxel; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine