San Francisco, CA USA (UroToday.com) Adjuvant radiation therapy (RT) is used to reduce local failures after radical cystectomy for locally advanced bladder cancer. The group reports on a three-arm randomized clinical trial comparing the efficacy of adjuvant RT, adjuvant chemo-RT, or adjuvant chemotherapy alone after radical cystectomy. The primary end-points were disease free survival (DFS). The secondary-end points were Overall Survival, loco-regional free survival (LRFS), distant metastasis free survival (DMFS), and toxicity of treatment.
Patients ≤ 70 yrs with ECOG ≤ 2 with locally advanced bladder cancer with at least one high risk feature who underwent radical cystectomy with negative margins at the Egyptian National Cancer Institute were enrolled. High-risk features include stage ≥ pT3b, grade 3, or positive nodes. Patients were randomized to radiation therapy (45 Gy in 1.5 Gy fractions), chemo-RT with 2 cycles of gemcitabine/cisplatin before and after RT, or 4 cycles of gemcitabine/cisplatin alone. Patients were followed regularly with CT scans every 6 months in the first 2 years and then annually.
198 patients were enrolled—78 received RT, 75 chemo-RT, and 45 chemo alone. Median age was 54 (27-70). 53% had urothelial carcinoma, 41% had SCC and 6% other. Median follow-up was 19 months (1-127 months). Chemo-RT patients were younger than RT and chemo arm patients. Otherwise clinical variables were similar across all arms.
There was no significant difference in DFS, DMFS, or OS. There was a trend toward improved DFS favoring the RT-containing arms with 3 year rates being 63% in RT alone, 68% chemo-RT and 56% chemo arm (p = 0.25). LRFS was significantly improved for the RT arms vs chemo alone arm with 3 year rates of 87% RT alone, 96% chemo+RT, and 69% chemo alone (p<0.01) regardless of histology.
Treatment was well tolerated. Grade ≥ 3 GI toxicity occurred in 8% in RT alone, 7% in chemo-RT, and 2% in chemo alone arms.
In conclusion, the study reports no difference in DFS, DMFS, or OS comparing the use of adjuvant RT, chemo+RT, and chemo alone. Loco-regional control favored the use of RT.
Reported By:
Mohammed Haseebuddin, MD, at the 2016 Genitourinary Cancers Symposium - January 7 - 9, 2016 – San Francisco, CA
Fox Chase Cancer Center, Philadelphia, PA