The data clearly confirm that capecitabine is an adequate substitute for 5-fluorouracil in preoperative chemoradiation of rectal cancer with a favorable safety profile.
194 Background: Salvage radiotherapy (RT) is often utilized in case of biochemical progression after radical prostatectomy (RP). Here we report the outcomes of the European SAKK 09/10 randomized phase 3 trial with the aim to compare effectiveness and tolerability of conventional vs. dose-intensified salvage RT. Methods: SAKK 09/10 is an open-label, multicenter, randomized phase 3 trial performed in 24 centers in Switzerland, Germany and Belgium. Men with biochemical progression (two consecutive rises with the final PSA > 0.1 ng/mL or three consecutive rises) after RP with a PSA nadir of ≤ 0.4 ng/mL, with a PSA ≤ 2 ng/mL at randomization and without clinical evidence of macroscopic disease were recruited. Patients were randomly assigned to either conventional dose RT (64 Gy in 32 fractions) or dose-intensified RT (70 Gy in 35 fractions) directed to the prostate bed. Three-dimensional conformal RTor intensity-modulated RT/rotational techniques were used. The primary endpoint was freedom from biochemical progression (PSA ≥ 0.4 ng/mL and rising). Secondary endpoints included clinical progression-free survival, time to hormonal treatment, overall survival, acute and late toxicity (according to the NCI CTCAE v4.0) and quality of life (according to the EORTC QLQ-C30 and PR25). The trial was registered under NCT01272050 in clinicaltrials.gov. Results: Between 02/2011 and 04/2014, 350 patients were randomly assigned to 64 Gy (n = 175) or 70 Gy (n = 175), of whom 344 aged between 48 to 75 years were assessable for the intention-to-treat population. The median PSA at randomization was 0.3 ng/mL (range, 0.03-1.61 ng/mL). At the time of data cutoff (July 3, 2020), the median follow-up was 6.2 years (IQR 5.5-7.2) and a total of 138 biochemical progression events occurred. The estimated freedom from biochemical progression rate at 6 years was 62.3% (95% CI 54.2-69.4%) and 61.3% (95% CI 53.4-68.3%) for the 64 Gy and the 70 Gy arm, respectively, and the hazard ratio adjusted by stratification factors was 1.14 (95% CI 0.82-1.60; log-rank p = 0.44). No significant difference was found for clinical progression-free survival, time to hormonal treatment and overall survival between the two arms, respectively. Late grade 2 and 3 genitourinary toxicity was observed in 35 (21.2%) and 13 (7.9%) patients treated with 64 Gy, and in 46 (26.3%) and 7 (4%) patients with 70 Gy (p = 0.81). Lategrade 2 and 3 gastrointestinal toxicity was observed in 12 (7.3%) and 7 (4.2%) patients with 64 Gy, and in 35 (20%) and 4 (2.3%) patients with 70 Gy(p = 0.009). Quality of life data will be presented. Conclusions: Dose-intensified salvage RT to the prostate bed was not superior to conventional dose RT. However, dose-intensified salvage RT was associated with higher frequencies of late grade ≥ 2 gastrointestinal toxicity. Clinical trial information: NCT01272050.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.