Results of multicenter phase II WSG Neo-Predict trial: Predictive markers for evaluation of response to neoadjuvant paclitaxel+trastuzumab+lapatinib in HER2-positive early breast cancer
In: Journal of Clinical Oncology, Jg. 35 (2017-05-20), S. 582-582
Online
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Zugriff:
582 Background: Trastuzumab (T) and Lapatinib (L) containing neoadjuvant chemotherapy (NACT) increases pathological complete response (pCR) (vs. T or nihil) in HER2+ early breast cancer (EBC). Early clinical response markers (e.g. Ki67) in a 3-week biopsy or in residual tumor correlate with therapy efficacy and risk of relapse. This WSG Neo-Predict trial aimed to define early predictive markers for therapy response in a dual blockade (T+L) NACT setting. Methods: Patients with cT1c-cT4c HER2+ EBC were treated by paclitaxel (P) (80 mg/m2weekly) with L (750 mg p.o. daily) + T (2 mg/kg) weekly for 12 weeks. Adjuvant treatment with 4 cycles of Epirubicin/Cyclophosphamide (omission allowed in patients with pCR) and T for an additional 40 weeks was recommended. Primary objectives were pCR (ypT0/is/ypN0) and identification of a dynamic predictive test for pCR using a re-biopsy after three weeks of NACT (early response defined as central Ki67 decrease >30% (vs. baseline) and/or low cellularity ( grade 3 AEs (including diarrhea, septic shock, leukopenia, and pneumonia). Conclusions: We observed a clinically meaningful pCR with moderate toxicity with only 12 weeks of paclitaxel weekly with dual HER2 blockade (T+L). Effect of additional chemotherapy in patients with pCR after 12 weeks of monochemotherapy remains questionable due to a strong prognostic effect of pCR in HER2+ EBC. In view of 0% pCR (by hypothesis-generating explorative analysis), a different treatment approach should be investigated in patients without “early response” by further prospective trials. Clinical trial information: 2012-003679-21.
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Results of multicenter phase II WSG Neo-Predict trial: Predictive markers for evaluation of response to neoadjuvant paclitaxel+trastuzumab+lapatinib in HER2-positive early breast cancer
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Autor/in / Beteiligte Person: | Skrobol, Markus ; Krabisch, Petra ; Kates, Ronald E. ; Nitz, Ulrike ; Hackenberg, Reinhard ; Harbeck, Nadia ; Schumacher, Johannes ; Christgen, Matthias ; Eichler, Christian ; Möbus, Volker ; Kreipe, Hans ; Gluz, Oleg ; Warm, Mathias |
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Zeitschrift: | Journal of Clinical Oncology, Jg. 35 (2017-05-20), S. 582-582 |
Veröffentlichung: | American Society of Clinical Oncology (ASCO), 2017 |
Medientyp: | unknown |
ISSN: | 1527-7755 (print) ; 0732-183X (print) |
DOI: | 10.1200/jco.2017.35.15_suppl.582 |
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