Table 1.
Characteristics and Treatment of CALOR Patients According to Randomised Treatment Assignment
| Characteristics | Chemotherapy (N=85) |
No Chemotherapy (N=77) |
|---|---|---|
| Primary surgery – N (%) | ||
| Mastectomy | 33 (39) | 31 (40) |
| Breast conserving surgery | 52 (61) | 46 (60) |
| Prior chemotherapy1 – N (%) | ||
| Yes | 49 (58) | 52 (68) |
| No | 36 (42) | 25 (32) |
| Time from primary to surgery for ILRR | ||
| Median (range) in years | 5·0 (0·3-31·6) | 6·2 (0·4-22·0) |
| Interquartile range (Q1, Q3) | (2·9, 9·5) | (2·9, 11·3) |
| N (%) ≥ 2 years | 72 (85) | 65 (84) |
| Menopausal status at ILRR – N (%) | ||
| Premenopausal | 20 (24) | 14 (18) |
| Postmenopausal | 65 (76) | 63 (82) |
| Median age at ILRR – years (range) | 56 (38-81) | 56 (31-82) |
| Location of ILRR – N (%) | ||
| Breast | 47 (55) | 42 (55) |
| Mastectomy scar/chest wall | 28 (33) | 25 (32) |
| Regional lymph nodes | 10 (12) | 10 (13) |
| ER status of the ILRR – N (%) | ||
| Negative | 29 (34) | 29 (38) |
| Positive | 56 (66) | 48 (62) |
| PgR status of the ILRR – N (%) | ||
| Negative | 39 (46) | 40 (52) |
| Positive | 44 (52) | 35 (45) |
| Unknown | 2 (2) | 2 (3) |
| ER status of the primary tumour – N (%) | ||
| Negative | 27 (32) | 20 (26) |
| Positive | 49 (58) | 47 (61) |
| Missing | 9 (11) | 10 (13) |
| Treatment for ILRR | ||
| Radiation therapy administered – N (%) | ||
| Yes | 31 (36) | 29 (38) |
| HER2-directed therapies – N (%) | ||
| Yes | 6 (7) | 4 (5) |
| Patients with ER+ or PgR+ ILRR tumours | N=58 | N=52 |
| Any Endocrine Therapy – N (%)2 | 53 (91) | 50 (96) |
| LHRH agonist or oophorectomy | 4 (7) | 10 (19) |
| Fulvestrant | 0 | 1 (2) |
| Tamoxifen | 15 (26) | 15 (29) |
| Aromatase inhibitors | 47 (81) | 41 (79) |
| None | 5 (9) 3 | 2 (4) 4 |
| Chemotherapy Randomised Group | N = 85 | |
| No chemotherapy received – N (%) | 5 (6) | |
| Monochemotherapy – N (%) | 25 (29) | |
| Docetaxel or Paclitaxel | 16 (19) | |
| Capecitabine | 9 (11) | |
| Polychemotherapy – N (%) | 55 (65) | |
| Cyclophosphomide, methotrexate, 5- fluorouracil (CMF) |
2 (2) | |
| Gemcitabine + navelbine | 1 (1) | |
| Anthracycline-based | 38 (45) | |
| Taxane-based | 13 (15) | |
| Anthracycline+taxane-based | 1 (1) |
1
See Section 2, Table S1 in the appendix for information about the types of adjuvant chemotherapy given for the trial ILRR and as prior chemotherapy.
2
Patient may have received more than one endocrine therapy.
3
5 patients did not receive endocrine therapy due to: withdrawal from the study (2); relapse prior to starting endocrine therapy (1); medical decision as ER = 5% (1); PgR+/ER− disease (1).
4
2 patients did not receive endocrine therapy due to: death prior to starting endocrine therapy (1); PgR+/ER− disease (1).
Abbreviations: ILRR, isolated locoregional recurrence; ER, oestrogen receptor; PgR, progesterone receptor