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Poster Discussion session - Breast cancer, metastatic

2770 - PERNETTA – A non comparative randomized open label phase II trial of pertuzumab (P) + trastuzumab (T) with or without chemotherapy both followed by T-DM1 in case of progression, in patients with HER2-positive metastatic breast cancer (MBC): (SAKK 22/10 / UNICANCER UC-0140/1207)

Date

21 Oct 2018

Session

Poster Discussion session - Breast cancer, metastatic

Presenters

Jens Huober

Citation

Annals of Oncology (2018) 29 (suppl_8): viii90-viii121. 10.1093/annonc/mdy272

Authors

J. Huober1, P. Weder2, C. Veyret3, B. Thürlimann2, A. Xyrafas4, L. Vanlemmens5, S. Guiu6, E. Brain7, J. Grenier8, F. Dalenc9, C. Levy10, A.M. Savoye11, A. Müller12, V. Membrez-Antonioli13, M.A. Gerard14, J. Lemonnier15, H. Hawle16, E. Boven17, H. Bonnefoi18

Author affiliations

  • 1 Breast Center, University hospital Ulm, 89075 - Ulm/DE
  • 2 Breast Center, Cantonal hospital St. Gallen, 9007 - St. Gallen/CH
  • 3 Medical Oncology, Centre Henri Becquerel, 76038 - Rouen/FR
  • 4 Statistics, SAKK - Swiss Group for Clinical Cancer Research, 3008 - Bern/CH
  • 5 Medical Oncology, Centre Oscar Lambret, 59020 - Lille/FR
  • 6 Medical Oncology, Reginal cancer institute, 34298 - Montpellier/FR
  • 7 Department Of Medical Oncology, Institut Curie, 75005 - Paris & Saint-Cloud/FR
  • 8 Medical Oncology, Institut Ste Catherine, 84082 - Avignon/FR
  • 9 Medical Oncology, Centre Claudius-Regaud, 31052 - Toulouse/FR
  • 10 Medical Oncology, Centre Francois Baclesse, 14076 - Caen/FR
  • 11 Medical Oncology, Institut Jean Godinot, 51056 - Reims/FR
  • 12 Department Of Medical Oncology, Kantonsspital Winterthur, Winterthur/CH
  • 13 Medical Oncology, Hospital of Valais, 1951 - Sion/CH
  • 14 Clinical research Center, SAKK - Swiss Group for Clinical Cancer Research, 3008 - Bern/CH
  • 15 R&d, Unicancer, 75654 - Paris/FR
  • 16 Clinical research, SAKK - Swiss Group for Clinical Cancer Research, 3008 - Bern/CH
  • 17 Medical Oncology, Vrije University Medical Centre (VUMC), 1081 HV - Amsterdam/NL
  • 18 Medical Oncology, Institute Bergonié, 33076 - Bordeaux/FR
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Resources

Abstract 2770

Background

Dual blockade with P plus T is highly active as 1st-line treatment in patients (pts) with HER2+ MBC. In 2nd line therapy T-DM1 is considered standard of care. We hypothesize that a strategy with dual blockade with T+P without chemotherapy followed by T-DM1 at progression could be less toxic with similar efficacy in terms of overall survival (OS).

Methods

Pts with centrally confirmed HER2+ MBC were randomized 1:1 to receive either P+T alone (arm A) or P+T combined with weekly paclitaxel or vinorelbine (arm B), followed by maintenance treatment with T+P until progression. After progression, T-DM1 was given as second line therapy in both arms. The primary endpoint was OS at 24 months (mo), described by the proportion of successes, along with the exact Clopper-Pearson confidence interval (CI). Secondary endpoints included progression free survival (PFS) and time to failure of strategy (TFS: PD after having received both 1st and 2nd-line treatment or death to any reason).

Results

Between 05/13 and 01/16, 210 pts were enrolled. Median age was 58 years, 63% of pts had lung or liver metastases, 36% of tumors were hormone receptor negative, paclitaxel / vinorelbine was given in 46/59 pts. In both arms, 2-year OS was the same. 61/44 of pts of arm A/B proceeded to 2nd line treatment with T-DM1. There were more hematologic, gastrointestinal, neurological toxicities and more alopecia in arm B. Efficacy results.Table: 288PD

Kaplan-Meier estimatorsP+TP+T with chemo
[%/median (95% CI)][%/median (95% CI)]
2-year OS (%)*76.2 (68.4-82.9)*76.2 (68.4-82.9)*
3-year OS (%)73.0 (62.8-80.8)73.1 (62.3-81.2)
1st line PFS (median - mo)#8.4 (7.7-12.0)23.3 (17.6-32.6)
2nd line PFS (T-DM1, median - mo)7.0 (4.3-11.3)5.3 (4.0-10.3)
TFS (median - mo)33.6 (23.2-not reached)48.6 (39.5-not reached)
*

Binomial with 90% CI reported;

#

1st CNS metastasis was ignored for this endpoint.

Conclusions

P+T alone as first line treatment followed by T-DM1 is a reasonable therapeutic strategy in HER2+MBC. Despite shorter PFS and TFS survival at 2 and 3 years was not affected and side effects were less frequently seen in the chemotherapy free arm. T-DM1 as second line therapy is active and safe after dual blockade with T+P.

Clinical trial identification

EudraCT: 2012-002556-17.

Legal entity responsible for the study

Sakk-Swiss Group for Clinical Cancer Research.

Funding

Roche.

Editorial Acknowledgement

Disclosure

J. Huober: Travel grants, advisory board: Novartis, Roche, Pfizer, Celgene. P. Weder: Consultant, advisory board: MSD, Roche. B. Thürlimann: Stock ownership (Roche) and advisory board (Roche). E. Brain: Honoraria or consultation fees (Roche). All other authors have declared no conflicts of interest.

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