title: Combination transurethral resection, systemic chemotherapy, and pelvic radiotherapy for invasive (T2-T4) bladder cancer unsuitable for cystectomy: a phase I/II Southwestern Oncology Group study.
abstract: OBJECTIVE
  Primarily to evaluate the toxicity and, secondarily, the tumor response and patient survival associated with a three-phase combined modality treatment plan for patients with invasive transitional cell carcinoma (TCC) of the bladder (T2-T4,NX-N2, MO) who are medically unsuitable for or who refuse cystectomy.
  
  
  METHODS
  Eligible patients initially underwent extensive transurethral resection (TUR) of the primary tumor with the attempt to resect disease totally. Subsequently, they received systemic combination chemotherapy consisting of two cycles of methotrexate, cisplatin, and vinblastine (MCV), followed by cystoscopic re-evaluation of the bladder tumor. Patients then received 6480 cGy radiotherapy to the bladder with concurrent systemic cisplatin. Toxicity, primary tumor response, and overall survival were evaluated.
  
  
  RESULTS
  Of 34 eligible patients, 27 patients completed the treatment series. Twenty-two received 80% to 100% of the prescribed doses of MCV and only 2 patients experienced grade 4 hematologic toxicities. The most common toxicities were gastrointestinal (23), hematologic (21), and renal (8). The complete response (CR) rate after all treatment phases was 56% (19 of 34), 10 patients achieving a complete tumor resection of visible tumor at the initial TUR of the bladder (TURB); 3, a CR after MCV; and 6, after radiotherapy and concomitant cisplatin. The median overall survival was 21 months with 6 of 34 (18%) alive at 57 months (range, 36 to 75). Complete resection of tumor by TURB was associated with prolonged overall survival. The bladder was the initial site of recurrence in 85% of patients who had achieved a CR status.
  
  
  CONCLUSIONS
  This older age patient group tolerated this combined modality therapy with acceptable toxicities, but the overall survival rate was not improved compared with those reported with radiotherapy alone.
authors.affiliation: H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.
authors.forename: A B
authors.initials: AB
authors.lastname: Einstein
authors.forename: M
authors.initials: M
authors.lastname: Wolf
authors.forename: K R
authors.initials: KR
authors.lastname: Halliday
authors.forename: G J
authors.initials: GJ
authors.lastname: Miller
authors.forename: M
authors.initials: M
authors.lastname: Hafermann
authors.forename: B A
authors.initials: BA
authors.lastname: Lowe
authors.forename: F J
authors.initials: FJ
authors.lastname: Meyers
authors.forename: J T
authors.initials: JT
authors.lastname: Leimert
authors.forename: E D
authors.initials: ED
authors.lastname: Crawford
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002295:Carcinoma, Transitional Cell / Q000401:mortality / Q000473:pathology / Q000556:secondary / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000627:therapeutic use; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D018714:Radiotherapy, Adjuvant; D012074:Remission Induction; D013514:Surgical Procedures, Operative / Q000379:methods; D015996:Survival Rate; D014521:Urethra; D001749:Urinary Bladder Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D014747:Vinblastine / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D014747:Vinblastine; D002945:Cisplatin; D008727:Methotrexate