Introduction :Neoadjuvant chemoradiotherapy (neoCRT) followed by surgery is the standard of care for locally advanced rectal cancer (LARC), and sphincter preservation is a desirable endpoint, but quality of life (QOL) is often impaired after treatment. Objective To evaluate QOL in five different moments of treatment in a randomized trial comparing two different neoadjuvant regimens. Methods Stage II and III rectal cancer patients were randomized to receive neoCRT with either capecitabine (Group

more »

... 1) or 5-Fu and leucovorin (Group 2) concomitant to long course radiotherapy. EORTCs QLQ C30 and CR38 were applied before treatment (T0), after neoCRT (T1), after rectal resection (T2), early after adjuvant chemotherapy (T3), and one year after end of treatment or stoma closure (T4). Wexner scale was used for continence evaluation at T4. A C30 summary score (Geisinger et cols) was calculated to compare QOL results.Results 32 patients were assigned to Group 1and 31 to Group 2. QOL was improved comparing T0 to T1 (mean 80.5 vs 88.0, p<0.001), and decreased comparing T1 to T2 (mean 88.0 vs 80.4, p<0.001). No difference in QOL summary was detected comparing T2 to T3 (79.8 vs 82.4, p=0.194) or T3 to T4 (83.0 vs 83.0, p=0.993). No difference in QOL was detected comparing the two treatment groups as clinical response was comparable. Mean Wexner scale score was 9.2, and a score ≥10 correlated with symptoms of diarrhea and defecation problems at T4. Conclusion : QOL improved after neoCRT but worsened following rectal resection, with no significant recovery during follow-up. Capecitabine and 5-Fu/Lv were equivalent in neoadjuvant regimen. Incontinence was high after sphincter preservation. C30 summary score was useful to detect differences in overall Quality of Life in addition to C30 multiple item questionnaire.