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. 2020 Apr 28;395(10237):1613–1626. doi: 10.1016/S0140-6736(20)30932-6

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.