Non-muscle-invasive high-grade (T1G3) bladder cancers have high potential for progression. The objective of this study is to clarify the clinicopathological factors affecting the outcome of T1G3 bladder cancer.

We retrospectively reviewed 60 cases of T1G3 bladder cancer between 1994 and 2006. The correlations of both intravesical recurrence and progression with prognostic factors, such as T stage, history of bladder cancer, multiplicity, concomitant carcinoma in situ, tumor size, intravesical instillation of bacillus Calmette–Guérin and intravesical chemotherapy, were evaluated by multivariate analysis with the Cox proportional hazards model.

Median follow-up period was 52 months (4–105 months). Thirty-seven cases of intravesical recurrence (61.7%) were observed during follow-up. Two- and 5-year recurrence-free survival rates were 44.1% and 36.1%, respectively. Tumor multiplicity and instillation of bacillus Calmette–Guérin were significantly correlated with intravesical recurrence on multivariate analysis. Ten cases of progression (16.7%) were observed during the follow-up period. Two- and 5-year progression-free survival rates were 87.7% and 83.4%, respectively. Only tumor multiplicity was significantly correlated with progression on multivariate analysis.

T1G3 cancers with multiple lesions showed high risks of intravesical recurrence and progression. Although bacillus Calmette–Guérin instillation reduced the risk of intravesical recurrence, no effect was observed on disease progression.

A Phase I/II study of S-1 combined radiation therapy was conducted in patients with Stage II (T2N0) glottic cancer. The purpose of the Phase I study was to identify the maximum tolerated dose, the recommended dose and the dose limiting toxicity. The objectives in the phase II study were to estimate the local control and the overall survival, and the incidence of adverse events.

In Phase I, S-1 was administered orally in a split-course fashion as two doses of 40 mg/m², for a total daily dose of 80 mg/m². The course involved a 2-week rest after a 2-week administration (Level 1) and a 1-week rest after a 3-week administration (Level 2). Radiation therapy was administered in 2-Gy daily (total 60-Gy) standard fractionation.

Seven patients were enrolled in the Phase I, and 19 in the Phase II study. Mucositis was the most common toxicity encountered. All 26 patients completed radiation therapy without delay. The overall response rate was 100% (26/26) with all patients showing a complete response. One patient developed a local recurrence 28 months after the treatment. The 3-year local control and overall survival rates were 94.7 and 85.4%, respectively (limited to 22 patients from Level 2).

The use of S-1 at 80 mg/m² per day in a split-course with 1-week rest during the course of radiation therapy was safe and effective for Stage II glottic cancer. The treatment strategy employing orally available S-1 proved to be beneficial over the conventional injection of antitumor agents for maintaining the patients' quality of life.