Table 5.
Longitudinal analysis of moderate or marked patient-assessed late normal tissue effects from baseline to 5 years for patients with at least one completed questionnaire (n=1774)
Number of patients reporting moderate or marked event at baseline/total* | Number of moderate or marked events/total number of assessments over 3–60 months follow-up | Odds ratio for schedule (95% CI) | p value for comparison with 40 Gy | p value for comparison between 27 Gy and 26 Gy | Odds ratio for years of follow-up (95% CI); p value | ||
---|---|---|---|---|---|---|---|
Protocol-specific items | |||||||
Breast appearance changed | .. | .. | .. | .. | .. | 1·03 (1·01–1·05); 0·0010 | |
40 Gy | 170/573 (29·7%) | 778/2480 (31·4%) | 1 (ref) | .. | .. | .. | |
27 Gy | 177/583 (30·4%) | 929/2550 (36·4%) | 1·22 (1·02–1·46) | 0·033 | .. | .. | |
26 Gy | 155/581 (26·7%) | 770/2563 (30·0%) | 0·91 (0·75–1·10) | 0·33 | 0·0018 | .. | |
Breast smaller | .. | .. | .. | .. | .. | 1·11 (1·09–1·13); <0·0001 | |
40 Gy | 96/560 (17·1%) | 585/2445 (23·9%) | 1 (ref) | .. | .. | .. | |
27 Gy | 106/576 (18·4%) | 606/2520 (24·0%) | 1·05 (0·85–1·29) | 0·67 | .. | .. | |
26 Gy | 90/574 (15·7%) | 515/2542 (20·3%) | 0·81 (0·65–1·00) | 0·053 | 0·017 | .. | |
Breast harder or firmer | .. | .. | .. | .. | 0·95 (0·93–0·97); <0·0001 | ||
40 Gy | 94/558 (16·8%) | 499/2446 (20·4%) | 1 (ref) | .. | .. | .. | |
27 Gy | 105/572 (18·4%) | 690/2512 (27·5%) | 1·42 (1·17–1·72) | 0·0003 | .. | .. | |
26 Gy | 95/566 (16·8%) | 626/2534 (24·7%) | 1·22 (1·00–1·48) | 0·048 | 0·1007 | .. | |
Skin appearance changed | .. | .. | .. | .. | .. | 0·96 (0·93–0·99); 0·0080 | |
40 Gy | 78/577 (13·5%) | 345/2505 (13·8%) | 1 (ref) | .. | .. | .. | |
27 Gy | 61/586 (10·4%) | 392/2571 (15·2%) | 1·03 (0·83–1·28) | 0·77 | .. | .. | |
26 Gy | 67/580 (11·5%) | 338/2576 (13·1%) | 0·90 (0·72–1·13) | 0·37 | 0·23 | .. | |
European Organisation for Research and Treatment of Cancer QLQ-BR23 items | |||||||
Breast pain | .. | .. | .. | .. | .. | 0·96 (0·94–0·99); 0·011 | |
40 Gy | 53/583 (9·1%) | 338/2538 (13·3%) | 1 (ref) | .. | .. | .. | |
27 Gy | 42/590 (7·1%) | 428/2601 (16·5%) | 1·23 (0·98–1·54) | 0·068 | .. | .. | |
26 Gy | 53/588 (9·0%) | 417/2597 (16·1%) | 1·23 (0·98–1·53) | 0·074 | 0·96 | .. | |
Breast swollen | .. | .. | .. | .. | .. | 0·84 (0·80–0·89); <0·0001 | |
40 Gy | 56/583 (9·6%) | 122/2538 (4·8%) | 1 (ref) | .. | .. | .. | |
27 Gy | 43/589 (7·3%) | 236/2597 (9·1%) | 1·46 (1·10–1·94) | 0·0080 | .. | .. | |
26 Gy | 47/589 (8·0%) | 192/2599 (7·4%) | 1·27 (0·95–1·69) | 0·11 | 0·22 | .. | |
Breast oversensitive | .. | .. | .. | .. | .. | 0·96 (0·93–0·99); 0·0097 | |
40 Gy | 57/579 (9·8%) | 283/2528 (11·2%) | 1 (ref) | .. | .. | .. | |
27 Gy | 42/584 (7·2%) | 334/2596 (12·9%) | 1·10 (0·87–1·40) | 0·43 | .. | .. | |
26 Gy | 62/586 (10·6%) | 319/2587 (12·3%) | 1·11 (0·88–1·41) | 0·37 | 0·91 | .. | |
Skin problems in breast | .. | .. | .. | .. | .. | 0·96 (0·92–1·01); 0·11 | |
40 Gy | 26/582 (4·5%) | 156/2539 (6·1%) | 1 (ref) | .. | .. | .. | |
27 Gy | 24/290 (4·1%) | 209/2596 (8·0%) | 1·25 (0·95–1·65) | 0·11 | .. | .. | |
26 Gy | 18/590 (3·0%) | 164/2592 (6·3%) | 0·98 (0·73–1·31) | 0·90 | 0·084 | .. | |
Arm or shoulder pain | .. | .. | .. | .. | .. | 1·00 (0·97–1·03); >0·99 | |
40 Gy | 66/582 (11·3%) | 401/2537 (15·8%) | 1 (ref) | .. | .. | .. | |
27 Gy | 78/591 (13·2%) | 441/2601 (17·0%) | 1·12 (0·91–1·37) | 0·29 | .. | .. | |
26 Gy | 81/589 (13·7%) | 455/2599 (17·5%) | 1·14 (0·93–1·40) | 0·2006 | 0·83 | .. | |
Arm or hand swollen | .. | .. | .. | .. | .. | 1·06 (1·00–1·11); 0·031 | |
40 Gy | 24/582 (4·1%) | 101/2536 (4·0%) | 1 (ref) | .. | .. | .. | |
27 Gy | 17/588 (2·9%) | 103/2600 (4·0%) | 0·95 (0·66–1·36) | 0·77 | .. | .. | |
26 Gy | 22/590 (3·7%) | 124/2592 (4·8%) | 1·14 (0·80–1·62) | 0·46 | 0·31 | .. | |
Difficulty raising arm | .. | .. | .. | .. | .. | 1·04 (0·99–1·08); 0·089 | |
40 Gy | 27/582 (4·6%) | 171/2533 (6·7%) | 1 (ref) | .. | .. | .. | |
27 Gy | 36/589 (6·1%) | 209/2599 (8·0%) | 1·24 (0·94–1·63) | 0·12 | .. | .. | |
26 Gy | 37/587 (6·3%) | 188/2596 (7·2%) | 1·12 (0·85–1·48) | 0·42 | 0·46 | .. |
Results for years of follow-up show trend in normal tissue effects over follow-up across all fractionation schedules. p values are calculated by Wald test; odds ratios are estimated from the generalised estimating equations model including all questionnaires (baseline to 5 years) and show relative odds of moderate or marked adverse events (vs none or mild) for each pairwise comparison of fractionation schedules across all questionnaires.
Total is those who completed the corresponding question.