A Randomized Trial of Radical Radiotherapy for the Management of pT1G3 NXM0 Transitional Cell Carcinoma of the Bladder

Abstract

To our knowledge this is the largest randomized trial performed in patients with pT1G3 disease for which 210 patients were recruited during 11 years. There is no evidence that radiotherapy is better than more conservative treatment. The prognosis of this group of patients appears to be poor irrespective of treatment and new treatment strategies need to be investigated.

Alternative therapies in patients with non-muscle invasive bladder cancer

“…However, a multi-intuitional RCT in the UK revealed no advantage of adding radiotherapy in terms of progression-free survival over conservative treatments defined as observation for single tumors and intravesical therapy (BCG or MMC) for multiple tumors or CIS. [74] Meanwhile, a non-randomized trial has shown comparable outcomes for RC as 89%, 19%, and 80% complete response, 5-year progression and bladder preservation rates, respectively. [75] The ongoing RTOG-0926 trial (NCT00981656) comparing 61.2 Gy radiation plus cisplatin or 5-FU/MMC in patients with recurrent disease after BCG treatment in a randomized-controlled study will provide conclusive evidence to this debate.…”

“…[71] Despite lack of any clinical data , a phase 1 study has revealed an increased rate of tumor infiltrating lymphocytes (60% vs. 16%) after intradermal vaccine injections combined with BCG treatment. [72] Meanwhile, ALT-801 is a fusion molecule between IL-2 and t-cell receptor that enhances immune response by displaying target peptide/HLA complexes. [73] The ongoing phase Ib/II study (NCT01625260) basically evaluates systemic administration of ALT-801 with GEM.…”

Treatment Options for High-Risk T1 Bladder Cancer

“…These figures are in the same range as primary cystectomy series in T1 bladder cancer ( well be an alternative to intravesical treatment or early cystectomy for this group of patients. Recently, a multicenter phase III randomized trial was published comparing radical RT (60 Gy to the bladder) versus conservative treatment in T1 G3 bladder cancer (Figure 2) [20]. None of the patients received concurrent RCT.…”

Consensus statement on best practice management regarding the use of intravesical immunotherapy with BCG for bladder cancer

“…Early studies showed reasonable response rates (48-69%), 93,94 and one randomized trial in patients with highgrade T1 tumours comparing conservative treatment with radiation alone showed no difference between treatments in terms of recurrence. 95 There is increasing data on combined radiochemo therapy for highrisk NMIBC following maximum trans urethral resection of the bladder tumour (TURBT). One study compared radiotherapy or radiochemo therapy in 141 patients and reported a complete response rate of 88%; at 5 years and 10 years, overall progression rates were 19% and 30% (13% and 29% for highgrade T1 tumours) and overall diseasespecific survival was 82% and 73% (89% and 79% for complete responders, 80% and 71% for highgrade T1 tumours), respectively.…”