title: Comparing intra-arterial chemotherapy combined with intravesical chemotherapy versus intravesical chemotherapy alone: a randomised prospective pilot study for T1G3 bladder transitional cell carcinoma after bladder-preserving surgery.
abstract: OBJECTIVE
  To compare the efficacy of intra-arterial chemotherapy combined with intravesical chemotherapy versus intravesical chemotherapy alone for T1G3 bladder transitional cell carcinoma (BTCC) followed by bladder-preserving surgery.
  
  
  METHODS
  Sixty patients with T1G3 BTCC were randomly divided into two groups. After bladder-preserving surgery, 29 patients (age 30-80 years, 24 male and 5 female) received intra-arterial chemotherapy in combination with intravesical chemotherapy (group A), whereas 31 patients (age 29-83 years, 26 male and 5 female) were treated with intravesical chemotherapy alone (group B). Twenty-nine patients were treated with intra-arterial epirubicin (50 mg/m(2)) + cisplatin (60 mg/m(2)) chemotherapy 2-3 weeks after bladder-preserving surgery once every 4-6 weeks. All of the patients received the same intravesical chemotherapy: An immediate prophylactic was administered in the first 6 h. After that, therapy was administered one time per week for 8 weeks and then one time per month for 8 months. The instillation drug was epirubicin (50 mg/m(2)) and lasted for 30-40 min each time. The end points were tumour recurrence (stage Ta, T1), tumour progression (to T2 or greater), and disease-specific survival. During median follow-up of 22 months, the overall survival rate, tumour-specific death rate, recurrence rate, progression rate, time to first recurrence, and adverse reactions were compared between groups.
  
  
  RESULTS
  The recurrence rates were 10.3 % (3 of 29) in group A and 45.2 % (14 of 31) in group B, and the progression rates were 0 % (0 of 29) in group A and 22.6 % (7 of 31) in group B. There was a significant difference between the two groups regarding recurrence (p = 0.004) and progression rates (p = 0.011). Median times to first recurrence in the two groups were 15 and 6.5 months, respectively. The overall survival rates were 96.6 and 87.1 %, and the tumour-specific death rates were 0 % (0 of 29) and 13.5 % (4 of 31) in groups A and B, respectively. During the intra-arterial chemotherapy cycle, although more than 50 % patients experienced some toxicities, most were minor and reversible [grade 1-2 (46.7 %) vs. grade 1-2 (6.9 %)].
  
  
  CONCLUSIONS
  These findings suggest that combining intra-arterial chemotherapy with intravesical chemotherapy could delay tumour recurrence and progression compared with intravesical chemotherapy alone and this type treatment is relatively safe.
authors.affiliation: Department of Urology, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China.
authors.forename: Junxing
authors.initials: J
authors.lastname: Chen
authors.affiliation: Department of Urology, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China.
authors.forename: Zhijun
authors.initials: Z
authors.lastname: Yao
authors.affiliation: Department of Urology, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China.
authors.forename: Shaopeng
authors.initials: S
authors.lastname: Qiu
authors.affiliation: Department of Urology, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China.
authors.forename: Lingwu
authors.initials: L
authors.lastname: Chen
authors.affiliation: Department of Interventional Oncology, First Affiliated Hospital of Sun Yat-Sen University, 58 Zhongshan 2nd Road, Guangzhou, 510080, Guangdong, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Department of Interventional Oncology, First Affiliated Hospital of Sun Yat-Sen University, 58 Zhongshan 2nd Road, Guangzhou, 510080, Guangdong, China.
authors.forename: Jianyong
authors.initials: J
authors.lastname: Yang
authors.affiliation: Department of Interventional Oncology, First Affiliated Hospital of Sun Yat-Sen University, 58 Zhongshan 2nd Road, Guangzhou, 510080, Guangdong, China. jpli3s@126.com.
authors.forename: Jiaping
authors.initials: J
authors.lastname: Li
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant / Q000379:methods; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use; D018450:Disease Progression; D004359:Drug Therapy, Combination / Q000379:methods; D015251:Epirubicin / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007261:Infusions, Intra-Arterial / Q000379:methods; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D059351:Organ Sparing Treatments; D010865:Pilot Projects; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000601:surgery*; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000601:surgery
chemical_list: D000903:Antibiotics, Antineoplastic; D000970:Antineoplastic Agents; D015251:Epirubicin; D002945:Cisplatin