title: Late pelvic toxicity after bladder-sparing therapy in patients with invasive bladder cancer: RTOG 89-03, 95-06, 97-06, 99-06.
abstract: OBJECTIVE
  In selected patients with muscle-invasive bladder cancer, combined-modality therapy (transurethral resection bladder tumor [TURBT], radiation therapy, chemotherapy) with salvage cystectomy, if necessary, can achieve survival rates similar to radical cystectomy. We investigated late pelvic toxicity after chemoradiotherapy for patients treated on prospective protocols.
  
  
  METHODS
  Between 1990 and 2002, 285 eligible patients enrolled on four prospective protocols (Radiation Therapy Oncology Group [RTOG] 8903, 9506, 9706, 9906) and 157 underwent combined-modality therapy, surviving >or= 2 years from start of treatment with their bladder intact. Rates of late genitourinary (GU) and GI toxicity were assessed using the RTOG Late Radiation Morbidity Schema, with worst toxicity grade (scale 0 to 5) occurring >or= 180 days after start of consolidation therapy reported for each patient. Persistence of toxicity was defined as grade 3+ toxicity not decreasing by at least one grade. Logistic and Cox regression analyses were performed to evaluate relationship between clinical characteristics, frequency, and time to late grade 3+ pelvic toxicity. Covariates included age, sex, stage, presence of carcinoma in situ, completeness of TURBT, and protocol.
  
  
  RESULTS
  Median follow-up was 5.4 years (range, 2.0 to 13.2 years). Seven percent of patients experienced late grade 3+ pelvic toxicity: 5.7% GU and 1.9% GI. In only one of nine patients did a grade 3+ GU toxicity persist. Notably there were no late grade 4 toxicities and no treatment-related deaths. None of the clinical variables studied predicted for late grade 3+ pelvic toxicity.
  
  
  CONCLUSIONS
  Rates of significant late pelvic toxicity for patients completing combined-modality therapy for invasive bladder cancer and retaining their native bladder are low.
authors.affiliation: Department of Radiation Oncology, Massachusetts General Hospital, 100 Blossom St, Cox 3, Boston, MA 02114, USA. jefstathiou@partners.org
authors.forename: Jason A
authors.initials: JA
authors.lastname: Efstathiou
authors.forename: Kyounghwa
authors.initials: K
authors.lastname: Bae
authors.forename: William U
authors.initials: WU
authors.lastname: Shipley
authors.forename: Donald S
authors.initials: DS
authors.lastname: Kaufman
authors.forename: Michael P
authors.initials: MP
authors.lastname: Hagan
authors.forename: Niall M
authors.initials: NM
authors.lastname: Heney
authors.forename: Howard M
authors.initials: HM
authors.lastname: Sandler
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D015653:Cystectomy; D005260:Female; D005767:Gastrointestinal Diseases / Q000209:etiology*; D006801:Humans; D016015:Logistic Models; D008297:Male; D052801:Male Urogenital Diseases / Q000209:etiology*; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D016017:Odds Ratio; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011832:Radiation Injuries / Q000209:etiology*; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D018570:Risk Assessment; D016879:Salvage Therapy; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D001749:Urinary Bladder Neoplasms / Q000473:pathology / Q000628:therapy*; D013520:Urologic Surgical Procedures