Tyck till om SwePub Sök här!
WFRF:(Foukakis Theodoros)
Search: WFRF:(Foukakis Theodoros) > Örebro University > Pekar Gyula > Neoadjuvant Trastuz...
- 1 of 1
- Previous record
- Next record
- To hitlist
Neoadjuvant Trastuzumab, Pertuzumab, and Docetaxel vs Trastuzumab Emtansine in Patients With ERBB2-Positive Breast Cancer A Phase 2 Randomized Clinical Trial
-
- Hatschek, Thomas (author)
- Breast Cancer Center, Karolinska University Hospital, Stockholm, Sweden; Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden,Karolinska Univ Hosp, Breast Canc Ctr, Stockholm, Sweden.;Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden.
-
- Foukakis, Theodoros (author)
- Karolinska Institutet,Karolinska Univ Hosp, Breast Canc Ctr, Stockholm, Sweden.;Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden.
-
- Bjöhle, Judith (author)
- Breast Cancer Center, Karolinska University Hospital, Stockholm, Sweden,Karolinska Univ Hosp, Breast Canc Ctr, Stockholm, Sweden.
- show more...
- show less...
- Breast Cancer Center, Karolinska University Hospital, Stockholm, Sweden; Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden Karolinska Univ Hosp, Breast Canc Ctr, Stockholm, Sweden;Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden. (creator_code:org_t)
- American Medical Association, 2021
- 2021
- English.
- In: JAMA Oncology. - : American Medical Association. - 2374-2437 .- 2374-2445. ; 7:9, s. 1360-1367
- Journal article (peer-reviewed)
Abstract
Subject headings
Close
- IMPORTANCE: Trastuzumab emtansine (T-DM1) is presently approved for treatment of advanced breast cancer and after incomplete response to neoadjuvant therapy, but the potential of T-DM1 as monotherapy is so far unknown.OBJECTIVE: To assess pathologic complete response (pCR) to standard neoadjuvant therapy of combination docetaxel, trastuzumab, and pertuzumab (DTP) vs T-DM1 monotherapy in patients with ERBB2 (formerly HER2)-positive breast cancer.DESIGN, SETTING, AND PARTICIPANTS: This randomized phase 2 trial, conducted at 9 sites in Sweden, enrolled 202 patients between December 1, 2014, and October 31, 2018. Participants were 18 years or older, with ERBB2-positive tumors larger than 20 mm and/or verified lymph node metastases. Analysis was performed on an intention-to-treat basis.INTERVENTIONS: Patients were randomized to receive 6 cycles of DTP (standard group) or T-DM1 (investigational group). Crossover was recommended at lack of response or occurrence of intolerable toxic effects. Assessment with fluorine 18-labeled fluorodeoxyglucose (F-18-FDG) positron emission tomography combined with computed tomography (PET-CT) was performed at baseline and after 2 and 6 treatment cycles.MAIN OUTCOME AND MEASURES: Pathologic complete response, defined as ypT0 or Tis ypN0. Secondary end points were clinical and radiologic objective response; event-free survival, invasive disease-free survival, distant disease-free survival, and overall survival; safety; health-related quality of life (HRQoL); functional and biological tumor characteristics; and frequency of breast-conserving surgery.RESULTS: Overall, 202 patients were randomized; 197 (99 women in the standard group [median age, 51 years (range, 26-73 years)] and 98 women in the investigational group [median age, 53 years (range, 28-74 years)]) were evaluable for the primary end point. Pathologic complete response was achieved in 45 patients in the standard group (45.5%; 95% CI 35.4%-55.8%) and 43 patients in the investigational group (43.9%; 95% CI 33.9%-54.3%). The difference was not statistically significant (P = .82). In a subgroup analysis, the pCR rate was higher in hormone receptor-negative tumors than in hormone receptor-positive tumors in both treatment groups (45 of 72 [62.5%] vs 45 of 125 [36.0%]). Three patients in the T-DM1 group experienced progression during therapy. In an exploratory analysis, tumor-infiltrating lymphocytes at 10% or more (median) estimated pCR significantly (odds ratio, 2.76; 95% CI, 1.42-5.36; P = .003). Response evaluation with F-18-FDG PET-CT revealed a relative decrease of maximum standardized uptake value by more than 31.3% (median) was associated with pCR (odds ratio, 6.67, 95% CI, 2.38-20.00; P < .001).CONCLUSIONS AND RELEVANCE: In this study, treatment with standard neoadjuvant combination DTP was equal to T-DM1.
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
- ref (subject category)
- art (subject category)
Find in a library
- JAMA Oncology (Search for host publication in LIBRIS)
To the university's database
- 1 of 1
- Previous record
- Next record
- To hitlist
Find more in SwePub
- By the author/editor
- Hatschek, Thomas
- Foukakis, Theodo ...
- Bjöhle, Judith
- Lekberg, Tobias
- Fredholm, Hanna
- Elinder, Ellinor
- show more...
- Bosch, Ana
- Pekar, Gyula
- Lindman, Henrik
- Schiza, Aglaia
- Einbeigi, Zakari ...
- Adra, Jamila
- Andersson, Anne, ...
- Carlsson, Lena
- Dreifaldt, Ann C ...
- Isaksson-Friman, ...
- Agartz, Susanne
- Azavedo, Edward
- Grybäck, Per
- Hellström, Mats
- Johansson, Hemmi ...
- Maes, Claudia
- Zerdes, Ioannis
- Hartman, Johan
- Brandberg, Yvonn ...
- Bergh, Jonas
- show less...
- About the subject
-
- MEDICAL AND HEALTH SCIENCES
- MEDICAL AND HEAL ...
- and Clinical Medicin ...
- and Cancer and Oncol ...
- Articles in the publication
- JAMA Oncology
- By the university
- Örebro University
- Umeå University
- Karolinska Institutet
- Uppsala University
Search outside SwePub
- Extend your search to:
- Google Book Search
- Google Scholar
Kungliga biblioteket hanterar dina personuppgifter i enlighet med EU:s dataskyddsförordning (2018), GDPR. Läs mer om hur det funkar här.
Så här hanterar KB dina uppgifter vid användning av denna tjänst.
- Copyright © LIBRIS - National Library Systems
- LIBRIS.kb.se
