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Poster display session

2944 - Second interim analysis of HerSCin, a German non-interventional study of subcutaneous trastuzumab for HER2-positive early breast cancer in routine clinical practice

Date

11 Sep 2017

Session

Poster display session

Presenters

Kerstin Lüdtke-Heckenkamp

Citation

Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362

Authors

K. Lüdtke-Heckenkamp1, S. Kümmel2, A. Ruf-Dördelmann3, A. Distelrath4, J. Wacker5, S. Schmatloch6, S. Busch-Liles7, M. Schmidt8

Author affiliations

  • 1 Department Of Oncology And Hematology, Niels Stensen Kliniken, Franziskus Hospital Harderberg, 49124 - Georgsmarienhütte/DE
  • 2 Cancer Center Essen, Klinikum Essen Mitte, Essen/DE
  • 3 Department Of Gynecology And Obstetrics, Municipal Clinic Karlsruhe, Karlsruhe/DE
  • 4 Oncologic Centre, Clinic Fulda gAG, Fulda/DE
  • 5 Gynaekologische Onkologie, Frauenklinik Bruchsal, Bruchsal/DE
  • 6 Senology, Elisabeth Hospital, Kassel/DE
  • 7 Medical Affairs, Roche Pharma AG, Grenzach-Wyhlen/DE
  • 8 Department Of Obstetrics And Gynecology, University Hospital Mainz, Mainz/DE
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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)
a

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.

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S. Busch-Liles: Employment: Roche Pharma AG.

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M. Schmidt: Membership on advisory board or board of directors: Novartis, Pfizer, Pierre-Fabre, Roche. Corporate-sponsored research: Pierre-Fabre.

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All 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.

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