Patient-reported outcomes (PROs) in locally advanced cervical cancer (LACC): Insights from the OUTBACK trial.
Bibliographic record
Abstract
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)
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.010 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".