Table 4.
Study | Year | Design | Assessment times | Study groups | Measurement instrument | Results | ||
---|---|---|---|---|---|---|---|---|
SLNB | S+Ac | ALND | ||||||
Peintinger et al.41 | 2003 | Prospective |
T0: pre-surgery T1: post-surgery T2: 9–12 months |
25 | 31 | EORTC-QLQ-C30(functional scales and global QoL) | At T1 SLNB patients reported higher global QoL than at T0. At T2, both groups reported higher global QoL than at T0. No other time differences were found. No differences between groups were found. | |
Purushotham et al.42 | 2005 | RCT |
T0: post-surgery T1: 3 months T2: 6 months T3: 12 months |
134a | 143 | SF-36 (physical summary score, physical functioning, vitality) | At T0, SLNB patients reported higher on physical summary score, physical functioning and vitality than ALND patients. No differences between groups were found at later follow-up times. | |
Fleissig et al.39 | 2006 | RCT |
T0: pre-surgery T1: 1 months T2: 3 months T3: 6 months T4: 12 months T5: 18 months |
424b | 405 | FACT-B+4 total score, TOI | SLNB patients reported better QoL at all postoperative measurement times and faster recovery to baseline levels than ALND patients. Decline in TOI was >5 points in the ALND group at T1, T2 and T4. No clinically relevant change in TOI was found in the SLNB group. | |
Del Bianco et al.43 | 2007 | Clinical trial |
T0: pre-surgery T1: 6 months T2: 12 months T3: 24 months |
159a | 151 | SF-36 (physical and mental summary scores), PGWB (total index and anxiety) | No differences between study groups were found in the physical and mental summary scores. At T1, SLNB patients reported a higher mean PGBW score. At later measurement times, no significant differences between groups were found. At T1, T2 and T3 both groups reported a decline in physical summary score compared to T0. | |
Kootstra et al. | 2008 | Prospective |
T0: pre-surgery T1: 6 weeks T2: 6 months T3: 12 months T4: 24 months |
54 | 56 | 65 | EORTC-QLQ-C30 (functional scales and global QoL) | Significant time effects were found in physical, role and emotional functioning. No significant effects of treatment groups were found on any of the scales. At T4, all patients reported higher emotional functioning than at T0. At T4, ALND patients (+/– SLNB) reported lower physical and role functioning than at T0. |
a SLNB group included women treated with SLNB+ALND; b SLNB group included women treated with SLNB+ALND and women treated with SLNB+ axillary radiotherapy. c SLNB followed by ALND; RCT, randomised clinical trial; FACT-B+4, functional assessment cancer therapy breast version 4; TOI, trial outcome index; PGWB, phychological general well-being.