Abstract 2944
Background
Compared with IV trastuzumab, subcutaneous trastuzumab (HSC) showed non-inferior outcomes in the HannaH trial and was preferred by patients (pts) and healthcare professionals in the PrefHer study. The ongoing HerSCin study (NCT01959386) is evaluating HSC in routine clinical practice in Germany.
Methods
Pts with HER2-positive early breast cancer treated with (neo)adjuvant HSC (investigator’s chosen regimen) in routine oncology practice between Nov 2013 and Nov 2016 were eligible. Pts could be enrolled retrospectively up to 9 wks after starting HSC. Baseline characteristics, treatment, adverse events (AEs), clinical outcomes and quality of life (EORTC QLQ-C30/QLQ-BR23) data are collected prospectively. Primary efficacy endpoints are pCR rate (neoadjuvant setting) and 2-year disease-free survival (adjuvant setting).
Results
At the data cut-off for the second planned interim analysis (Nov 2016), 420 of 1003 pts enrolled to date from 103 German centres had completed therapy and were eligible for analysis. The median duration of follow-up was 12.2 (range 3.3–25.8) mo. Baseline characteristics are below. The mean duration of HSC was 8.8 mo (neoadjuvant: 9.2; adjuvant: 8.7). All-grade and grade ≥3 AEs were reported in 63% and 15% of pts, respectively. The most common all-grade AEs were fatigue (10%), diarrhoea (9%) and arthralgia (7%). AEs led to treatment interruption/withdrawal in 48 pts (11%). Only 1 of the 4 fatal AEs was considered treatment related (cardiac/respiratory failure). The pCR rate (including carcinoma in situ) in the neoadjuvant subgroup was 60.3% (95% CI 48.5–71.2). Efficacy results in the adjuvant subgroup are not mature.Table:
178P
| Parameter, No. of pts (%) | All pts (n = 420) | Neoadjuvant subgroup (n = 78) | Adjuvant subgroup (n = 342) | |
|---|---|---|---|---|
| Median age, years (range) | 56 (20–90) | 52 (20–77) | 57 (27–90) | |
| ECOG performance status | 0 | 258 (61) | 44 (56) | 214 (63) |
| 1 | 116 (28) | 26 (33) | 90 (26) | |
| 2 | 10 (2) | 1 (1) | 9 (3) | |
| Missing | 36 (9) | 7 (9) | 29 (8) | |
| Cardiac conditions at baseline | Arterial hypertension | 134 (32) | 24 (31) | 110 (32) |
| Coronary heart disease | 14 (3) | 3 (4) | 11 (3) | |
| HER2 status by IHC | 0/1+ | 3 (1) | 0 | 3 (1) |
| 2+ | 104 (25) | 13 (17) | 91 (27) | |
| 3+ | 310 (74) | 65 (83) | 245 (72) | |
| Missing | 3 (1) | 0 | 3 (1) | |
| Histological grade | 1 | 7 (2) | 0 | 7 (2) |
| 2 | 184 (44) | 30 (38) | 154 (45) | |
| 3 | 222 (53) | 46 (59) | 176 (51) | |
| Missing/unknown | 7 (2) | 2 (3) | 5 (1) | |
| Subtypea | Ductal | 343 (82) | 65 (83) | 278 (81) |
| Lobular | 24 (6) | 3 (4) | 21 (6) | |
| Other | 54 (13) | 10 (13) | 44 (13) | |
| Positive nodal status | 161 (38) | 25 (32) | 136 (40) | |
| Hormone receptor status | ER positive | 280 (67) | 42 (54) | 238 (70) |
| PgR positive | 234 (56) | 39 (50) | 195 (57) | |
| ER and PgR negative | 127 (30) | 31 (40) | 96 (28) | |
One patient (adjuvant setting) recorded as both ductal and lobular. ER=oestrogen receptor; IHC=immunohistochemistry; PgR=progesterone receptor.
Conclusions
The 60.3% pCR rate is consistent with prospective trials of IV trastuzumab and HSC. Tolerability is as expected based on results from randomised trials. HSC is an active, feasible and tolerable treatment for use in routine oncology practice as well as the clinical trial setting.
Clinical trial identification
NCT01959386
Legal entity responsible for the study
Roche Pharma AG
Funding
Roche Pharma AG
Disclosure
S. Kümmel: Membership on advisory board or board of directors: Roche Pharma AG.
\r\nS. Busch-Liles: Employment: Roche Pharma AG.
\r\nM. Schmidt: Membership on advisory board or board of directors: Novartis, Pfizer, Pierre-Fabre, Roche. Corporate-sponsored research: Pierre-Fabre.
\r\nAll other authors have declared no conflicts of interest.
Disclosure
S. Kümmel: Membership on advisory board or board of directors: Roche Pharma AG.
S. Busch-Liles: Employment: Roche Pharma AG.
M. Schmidt: Membership on advisory board or board of directors: Novartis, Pfizer, Pierre-Fabre, Roche. Corporate-sponsored research: Pierre-Fabre.
All other authors have declared no conflicts of interest.