Comparative effectiveness of sphincter-sparing surgery (SSS) versus abdomino-perineal resection (APR) in rectal cancer: Patient-reported outcomes (PROs) from NSABP R-04.

Abstract

3545 Background: R-04 is a trial of pre-surgical RT and either capecitabine or 5-FU with or without oxaliplatin in patients (Pts) with resectable rectal cancer. PROs were measured before treatment, post-RT, and 1 yr post-op. We compare PROs at 1 yr by type of surgery with hypothesis that APR Pts would have worse quality of life (QOL). Methods: Pts completed the FACT-C and EORTC-CR38 at all times. Baseline and 1 yr were compared within groups (SSS and APR) with paired t-test, and between groups at 1 yr, with adjustment for covariates of age, gender, clinical stage, baseline score, and surgery intent in a general linear model. These secondary/exploratory hypotheses were significant if p < 0.05. Results: 1,608Pts were randomized and 1405 completed baseline QOL form after consent, prior to treatment. 1,003 completed QOL form 1 yr post-op: 6 were ineligible, 10 did not have surgery, leaving 987 Pts. 615 had SSS and 372 had APR. 66.6% were male, 61.5% stage II, and almost all had post-surgical adjuvant chemotherapy. SSS Pts were significantly younger (60.3% vs. 53.5% < 59 yr, p=0.04). FACT-C total and subscale scores were not significantly different by surgery type at 1 yr, with only minimal decline from baseline in both groups. For SSS Pts, EORTC-CR38 scores significantly worsened for body image, sexual function, sexual enjoyment (all p <0.0001), while future perspective improved (p<0.0001) at 1 yr from baseline. All symptom subscales except weight loss and micturition showed worsened symptoms (GI tract, chemo side effects, defecation problems, sexual problems) all p < 0.0001 at 1 yr from baseline. Compared to APR Pts, SSS had less severe functional problems and symptoms, especially in sexual enjoyment, weight loss, GI symptoms, and body image, all significant. Conclusions: Contrary to prediction, there were no significant differences in FACT-C scores for SSS vs. APR. Symptoms and functional problems were detected by the EORTC-CR38, reflecting expected differences. The largest differences between the surgical treatments were for GI symptoms and body image. Information from these PROs may be useful in counseling Pts anticipating surgery for rectal cancer.