Table 3.
Morbidity outcomes in the included studies
| Comparison | SLND + ALND versus SLND alone | ALND versus aRT | |||
|---|---|---|---|---|---|
| Study | ATTRM-048-13-2000 | IBCSG-23-01 | ACOSOG Z0011 | AMAROS | OTOASOR |
| Short-term adverse events | Not reported |
Post-operative infection: ALND: 1/464 SLND: 0/467 |
Wound infection: ALND: 31/373 SLND: 11/371; Axillary seromas: ALND: 53/373 SLND: 21/371; Axillary paresthesias: ALND: 174/373 SLND: 43/371; Objective lymphodema b: ALND: 23/255 SLND: 17/272 |
Not reported | Not reported |
| Long-term complications | Not reported |
Sensory neuropathy
a: Any: ALND: 82/447 SLND: 55/453 Grade 3–4: ALND: 1/447 SLND: 0/453 Lymphoedema a: Any: ALND: 59/447 SLND: 15/453 Grade 3–4: ALND: 3/447 SLND: 0/453 Motor neuropathy a: Any: ALND: 37/447 SLND: 13/453 Grade 3–4: ALND: 3/447 SLND: 1/453 |
Brachial plexus injury: 6 months: ALND: 5/406; SLND: 3/415; 12 months: ALND: 1/406; SLND: 0/415; Axillary paresthesias: 6 months: ALND: 146/335; SLND: 35/288; 12 months: ALND: 113/287; SLND: 24/268; Objective lymphoedema b: 6 months: ALND: 29/270; SLND: 21/271; 12 months: ALND: 26/242; SLND: 14/226; Subjective lymphodema c: 6 months: ALND: 27/327; SLND: 19/339; 12 months: ALND: 37/288; SLND: 12/268; >12 months: ALND: 52/272; SLND: 14/253 |
Sign of lymphoedema
d: Baseline: ALND: 3/655; aRT: 0/586, p = 0.25; 12 months: ALND: 114/410; aRT: 62/410, p < 0.0001; 3 years: ALND: 84/373; aRT: 47/341, p = 0.003; 5 years: ALND: 76/328; aRT: 31/286, p < 0.0001; Arm circumference increase ≥ 10 % e: Baseline: ALND: 33/655; aRT: 24/586, p = 0.5; 12 months: ALND: 32/410; aRT: 24/410, p = 0.332; 3 years: ALND: 38/373; aRT: 22/341, p = 0.08; 5 years: ALND: 43/328; aRT: 16/286, p = 0.0009; Shoulder mobility f: No differences found in the range of motion in the four excursions at 1 (p = 0.29) or 5 years (p = 0.47). |
Not reported |
| Quality of life | Not reported | Not reported | Not reported | No differences foundg | Not reported |
ALND axillary lymph node dissection, SLND sentinel lymph node dissection, aRT axillary radiotherapy
aThe treating physician assessed and reported long-term surgical events (sensory neuropathy, lymphoedema, and motor neuropathy) at every follow-up visit (every 4 months from the date of randomisation for the first year, and every 6 months for years 2–5) on the basis of the National Cancer Institute Common Toxicity Criteria version 2. No more information reported
bLympheoedema (objective): 2 cm or greater post-operative increase in the ipsilateral arm circumference (assessed by phycisian)
cLympheoedema (subjective): according to patient self-report or physician diagnosis
dAny clinical sign of lymphoedema
eArm circumference was measure 15 cm above the medial epicondyle (upper arms) and 15 cm below the medial epicondyle (lower arms). An increase in arm circumference of at least 10 % in the lower arm or the upper arm, or both, compared with the contralateral arm at the same timepoint was judged to be clinically significant lymphoedema
fThe range of motion in both arms was measured in four excursions: abduction, adduction, anteversion, and retroversion and compared between arms. The four relative excursions were combined in a multivariate composite endpoint at 1 and 5 years
gAssessed using the EORTC quality-of-life questionnaire (EORTC-QLQ-C30; version 3) and breast cancer module (QLQ-BR23) using the pain, body image, and arm symptoms scales. The arm symptoms scale was composed of three items: pain in arm or shoulder, swollen arm or hand, and difficulties moving arm. Questionnaires were completed at baseline and at years 1, 2, 3, 5, and 10. All outcome data at 10 years subject to a future report