Superiority of Adjuvant Hyperfractionated Radiotherapy Over Chemotherapy Following Radical Cystectomy.
Bladder cancer (LABC) after radical cystectomy (RC) is common, even with chemotherapy, and is associated with high morbidity and mortality. Therefore, this work aimed to investigate the effect and efficacy of adjuvant sandwich chemotherapy plus radiotherapy versus adjuvant chemotherapy alone for LABC after RC.
This phase III trial was conducted in 125 patients with bladder cancer who underwent RC and were randomized to one of the following two adjuvant treatments. The chemotherapy plus RT arm received 2 cycles of gemcitabine and cisplatin before and after RT, with a 1-week break between chemotherapy and RT. The second arm, receiving chemotherapy alone, had 4 cycles of gemcitabine and cisplatin.
LRF was significantly reduced in the combined group (P < 0.001); however, DM was comparable between groups (p = 0.3). Furthermore, 64.9% of patients in the combined group were still alive, compared with only 5.9% in the chemotherapy group. Moreover, the mean time to local failure was not significantly different between the two groups (24.0 ± 0.1 vs. 26.5 ± 9.8, p = 0.08, respectively, for the combined group compared with the chemotherapy arm), but the mean time to DM was significantly prolonged in the combined group compared with the chemotherapy group (51.2 ± 14.9 vs. 29.7 ± 12.1, p < 0.001, respectively).
Adjuvant chemotherapy plus RT was associated with significant improvements in LRFS and improvements in OS compared with chemotherapy alone in LABC.
This phase III trial was conducted in 125 patients with bladder cancer who underwent RC and were randomized to one of the following two adjuvant treatments. The chemotherapy plus RT arm received 2 cycles of gemcitabine and cisplatin before and after RT, with a 1-week break between chemotherapy and RT. The second arm, receiving chemotherapy alone, had 4 cycles of gemcitabine and cisplatin.
LRF was significantly reduced in the combined group (P < 0.001); however, DM was comparable between groups (p = 0.3). Furthermore, 64.9% of patients in the combined group were still alive, compared with only 5.9% in the chemotherapy group. Moreover, the mean time to local failure was not significantly different between the two groups (24.0 ± 0.1 vs. 26.5 ± 9.8, p = 0.08, respectively, for the combined group compared with the chemotherapy arm), but the mean time to DM was significantly prolonged in the combined group compared with the chemotherapy group (51.2 ± 14.9 vs. 29.7 ± 12.1, p < 0.001, respectively).
Adjuvant chemotherapy plus RT was associated with significant improvements in LRFS and improvements in OS compared with chemotherapy alone in LABC.