Tolerability of Concurrent Chemoradiotherapy with Gemcitabine (GemX), with and without prior Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer

Purpose

The aim of this study is to assess the tolerability of concurrent chemoradiotherapy with gemcitabine (GemX) in muscle invasive bladder cancer (MIBC) following neoadjuvant chemotherapy (neoGemX) using patient and provider reported outcomes.

Materials and Methods

Seventy eight patients were treated with GemX. Thirty-eight received prior neoadjuvant chemotherapy (NAC). Patients were prospectively assessed during treatment and at 6 weeks and 12 months post treatment completion. Radiotherapy was given to a total dose of 52.5 Gy in 20 fractions with weekly concurrent gemcitabine chemotherapy 100mg/m2. Toxicity was assessed by care provider and using a patient reported outcome questionnaire collecting Lent Soma (LS) scores and statistically compared at baseline and 12 months and between the neoGemX and GemX groups.

Results

Median duration of follow up was 15.9 months. Radiotherapy completion rate was 95% and 96% of patients completed at least 3 cycles of gemcitabine. Bowel toxicity ≥ grade 3 was reported in 7/38 (18%) of patients in the neoGemX group and 5/25 (20%) in the GemX group. Three GemX and 2 neoGemX patients had grade ≥3 urinary toxicity.

Forty nine patients completed questionnaires and were included in the analysis. LS scores showed an expected peak by week 4 of treatment. There was no statistically significant difference between mean scores at baseline and 12 months post treatment completion, or between the neoGemx and Gemx groups.

Conclusion

This study demonstrates that GemX, alone or following NAC, has manageable toxicity and acceptable treatment completion rates. Allowing for small patient numbers and the non randomised nature of this study, these results do not suggest any additional toxicity from the use of NAC prior to GemX.