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PREDIX HER2 trial :
PREDIX HER2 trial : Event-free survival and pathologic complete response in clinical subgroups and stromal TILs levels
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- Hatschek, T. (author)
- Karolinska Universitetssjukhuset, Solna, Sweden
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- Andersson, A. (author)
- Norrlands University Hospital, Umeå, Sweden
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- Bjöhle, J. (author)
- Karolinska Universitetssjukhuset, Solna, Sweden
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- Bosch, A. (author)
- Lund University, Lund, Sweden
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- Carlsson, L. (author)
- Länssjukhuset Sundsvall, Sundsvall, Sweden
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- Dreifaldt, Ann Charlotte, 1964- (author)
- Örebro universitet,Institutionen för medicinska vetenskaper,Örebro University Hospital,Örebro, Sweden
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- Einbeigi, Z. (author)
- Sahlgrenska University Hospital, Göteborg, Sweden
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- Elinder, E. (author)
- Södersjukhuset, Stockholm, Sweden
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- Fredholm, H. (author)
- Karolinska Universitetssjukhuset, Solna, Sweden
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- Isaksson-Friman, E. (author)
- St Görans Hospital, Stockholm, Sweden
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- Hellström, M. (author)
- Karolinska Universitetssjukhuset, Solna, Sweden
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- Johansson, H. (author)
- Karolinska Universitetssjukhuset, Solna, Sweden
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- Lekberg, T. (author)
- Karolinska Universitetssjukhuset, Solna, Sweden
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- Lindman, H. (author)
- University Hospital Uppsala Akademiska Sjukhuset, Uppsala, Sweden
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- Zerdes, I. (author)
- Karolinska Universitetssjukhuset, Solna, Sweden
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- Foukakis, T. (author)
- Radiumhemmet, Solna, Sweden
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- Hartman, J. (author)
- Södersjukhuset, Stockholm, Sweden
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- Brandberg, Y. (author)
- Karolinska Institutet, Stockholm, Sweden
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- Bergh, J. (author)
- Karolinska Institutet - Bioclinicum, Solna, Sweden
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(creator_code:org_t)
- Elsevier, 2020
- 2020
- English.
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In: Annals of Oncology. - : Elsevier. - 0923-7534 .- 1569-8041. ; 31:Suppl. 2, s. S49-S49
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Abstract
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- Background: Neoadjuvant treatment with Trastuzumab-emtansine was associated with similar rates of pathological complete remission (pCR) as standard therapy withd ocetaxel, trastuzumab and pertuzumab in the PREDIX HER2 trial. Here, results of event-free survival (EFS), and pCR rates in key clinical-pathological subgroups and biomarkers including the abundance of stromal tumor infiltrating lymphocytes (TILs) are presented.Methods: PREDIX HER2 is a randomized, multicenter, open-label, phase 2 study involving 9 Swedish sites. Patients with HER2 positive breast cancer, verified by ISH, T>20 mm and/or verified lymph node metastases were randomized to six three-weekly courses of either docetaxel, trastuzumab SC and pertuzumab (group A), or trastuzumab emtansine (T-DM1, group B). Switch of treatment to the opposite arm was allowed in case of lack of response or severe toxicity. Radiological evaluation included 18F-FDG PET/CT. Patients in both groups received adjuvant chemotherapy with epirubicin and cyclophosphamide. TILs were evaluated using standard methodology, median 10%.Results: In total 197 pts. were evaluable, 99 in group A, and 98 in group B. pCR (ypT0/is ypN0) was achieved in 90 pts, 45.7%, with no significant difference between the two treatment groups. pCR rates were lower in the group of patients with hormone receptor (HR)epositive compared with HR-negative tumors but similar in both treatment groups. pCR rates did not differ between the two treatments in subgroups defined by age, menopausal status, tumor grade, T size, node status, HR-status, HER2 status and Ki67. Progressive disease was observed in 3 pts. (3%) during treatment with T-DM1, none in group A. After a median follow-up of 2.4 years 13 EFS events occurred, with no significant differences between the treatment groups. The presence of 10% TILs predicted pCR significantly (p¼0.009), similar in both treatment groups. We also found that a decrease of SUVmax by more than 80% was highly predictive of pCR. HRQoL was significantly better in pts. receiving T-DM1.Conclusions: Our data suggest that neoadjuvant T-DM1 may be as effective as standard neoadjuvant treatment in all clinical subgroups evaluated. Both TILs and PET/CT showed potential to predict pCR.Clinical trial identification: NCT02568839.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Publication and Content Type
- vet (subject category)
- art (subject category)
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To the university's database
- By the author/editor
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Hatschek, T.
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Andersson, A.
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Bjöhle, J.
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Bosch, A.
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Carlsson, L.
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Dreifaldt, Ann C ...
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show more...
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Einbeigi, Z.
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Elinder, E.
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Fredholm, H.
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Isaksson-Friman, ...
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Hellström, M.
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Johansson, H.
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Lekberg, T.
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Lindman, H.
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Zerdes, I.
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Foukakis, T.
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Hartman, J.
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Brandberg, Y.
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Bergh, J.
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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Annals of Oncolo ...
- By the university
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Örebro University
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Karolinska Institutet