Patient-reported outcomes (PROs) in locally advanced cervical cancer (LACC): Insights from the OUTBACK trial.

5503 Background: OUTBACK (ACTRN12610000732088), an open-label, international, randomized phase 3 trial of 919 participants (pts) with LACC, showed that adding adjuvant chemotherapy (ACT) after chemoradiotherapy (CRT) increased adverse events without improving overall survival compared to CRT alone. PRO objectives of OUTBACK were to determine the: 1) prevalence of patient-reported moderate-severe symptom issues at years 1-3 post-randomisation 2) duration of common issues; 3) long-term psycho-sexual health. Methods: Pts completed the EORTC core questionnaire QLQ-C30; cervical cancer module QLQ-CX24 (questions 50-54 only for sexually active pts); EORTC Item Library questions on abdominal, urinary, bowel and chemotherapy side-effects; & FACT-GOG-NTX4 neurotoxicity over 36 months. A moderate-severe long-term symptom issue was defined as a score in the worst 2 response categories (EORTC items), a total score ≤8/16 on FACT-GOG-NTX4 at years 1, 2 or 3 for Objectives 1-2, or equivalent subscale score for Objective 3. The availability of PROs for analysis was not related to 11 pre-specified demographic/clinical variables so no imputation for missing data was performed. Results: PRO completion rates were 94% at baseline, 64% at year 1 & 37% by year 3. Table 1 shows the 10 top-ranked issues at year 1 & their persistence or resolution by years 2-3. These may be underestimates, due to lower PRO completion rates at years 2-3. Issues and frequencies were similar across treatment arms by year 1. Moderate-severe peripheral neuropathy affected 24% post CRT+ACT & 18% post CRT (year 1); 19% post CRT+ACT & 12% post CRT (year 3). At baseline, 77% reported no sexual activity in the past 4 weeks. Overall, 92% of pts reported low sexual activity at years 1, 2 or 3; 68% reported low enjoyment, 40% moderate-severe vaginal tightness, 37% vaginal dryness during sex and 32% were moderately-severely worried sex would be painful. Conclusions: Long-term symptom issues & sexual health concerns are common & persistent following CRT +/-ACT for LACC and need dedicated survivorship care. Clinical trial information: 12610000732088 . Frequency and duration of top-ranked moderate-severe symptoms. Item CRT + ACTn (%) CRT alonen (%) All participants n (%) Issue rated moderate-severe at Year 1 Issue rated moderate-severe at Year 1 Issue rated moderate-severe at Year 1 Issue from Year 1 resolved by Year 2 or 3 Issue from Year 1 persistent at Year 2 or 3 Worried future health 76 (50) 59 (38) 135 (44) 14 (10) 49 (36) Hot flushes/ sweats 68 (39) 64 (35) 132 (37) 24 (18) 49 (37) Frequent urination 67 (38) 59 (32) 126 (35) 24 (19) 45 (36) Sexual activity (not) enjoyable 59 (63) 66 (65) 125 (64) 11 (9) 43 (34) Trouble sleeping 62 (35) 55 (30) 117 (32) 19 (16) 37 (32) Tired 53 (30) 51 (28) 104 (29) 22 (21) 33 (32) Changed bowel habit 56 (32) 46 (25) 102 (28) 22 (22) 41 (40) Financial difficulties 51 (27) 50 (28) 101 (28) 17 (17) 32 (32) Pain 54 (29) 42 (24) 96 (27) 21 (22) 23 (24) Dissatisfied with body 48 (26) 47 (27) 95 (26) 21 (22) 27 (28)