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Health-related qual...
Health-related quality of life in the Swedish PREDIX HER2 trial, evaluating docetaxel, trastuzumab, pertuzumab versus trastuzumab emtansine as neoadjuvant treatment of HER2-positive breast cancer.
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Brandberg, Yvonne (författare)
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- Andersson, Anne, 1966- (författare)
- Umeå universitet,Onkologi
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Bjohle, Judith (författare)
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Bosch, Ana (författare)
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Carlsson, Lena (författare)
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- Dreifaldt, Ann Charlotte, 1964- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper
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Einbeigi, Zakaria (författare)
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Fredholm, Hanna (författare)
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Isaksson-Friman, Erika (författare)
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Foukakis, Theodoros (författare)
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Elinder, Ellinor (författare)
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Hellstrom, Mats (författare)
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Johansson, Hemming (författare)
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Lekberg, Tobias (författare)
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Lindman, Henrik (författare)
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Bergh, Jonas C. S. (författare)
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Hatschek, Thomas (författare)
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(creator_code:org_t)
- American Society of Clinical Oncology, 2019
- 2019
- Engelska.
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Ingår i: Journal of Clinical Oncology. - : American Society of Clinical Oncology. - 0732-183X .- 1527-7755. ; 37:15, s. 583-583
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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http://kipublication...
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Abstract
Ämnesord
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- Background: Neoadjuvant therapy combining docetaxel, trastuzumab and pertuzumab (DTP) was compared to trastuzumab emtansine (T-DM1) in the randomized phase 2 PREDIX HER2 trial. Patients, ≥18 years with HER2 positive breast cancer, ≥20mm or with verified lymph node metastases, were randomized to six courses of DTP (Standard arm) or T-DM1 (Experimental arm). Primary endpoint was pathological objective response to primary medical therapy at post-treatment surgery. Health related quality of life (HRQoL) was a secondary outcome, and is of specific interest as there was no difference between the randomization groups regarding the main endpoint (results presented in a separate abstract sent to ASCO 2019, Bergh et al.). Methods: Of 202 randomized patients, 190 are available for evaluation at this point. HRQoL was measured, using EORTC QLQ-C30 + EORTC QLQ-BR23, at baseline before randomization and after six courses. Results: No differences between the randomization arms were found at baseline. Results after six courses, based on 163 patients (86%) and adjusted to baseline values, revealed statistical significant differences (p≤0.01), favoring the experimental T-DM1 arm on 7 out of 15 of the EORTC QLQ-C30 variables (Physical functioning, Role functioning, Social functioning, Global quality of Life, Fatigue, Dyspnea, and Diarrhea). For the breast cancer specific questionnaire (EORTC-BR23), the experimental arm scored statistically significantly better on 5 out of 7 subscales (Body image, Sexual functioning, Sexual enjoyment, Systemic therapy side effects and Upset by hair loss). All of the statistical significant differences were of moderate or large clinical significance (≥10 scale scores). No differences between the randomization arms were found for the remaining HRQoL variables. Conclusions: The experimental arm reported better HRQoL than the control arm after six courses. Trastuzumab emtansine may be a useful treatment alternative due to better HRQoL and lower toxicity. Clinical trial information: NCT02568839.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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Brandberg, Yvonn ...
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Andersson, Anne, ...
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Bjohle, Judith
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Bosch, Ana
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Carlsson, Lena
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Dreifaldt, Ann C ...
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visa fler...
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Einbeigi, Zakari ...
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Fredholm, Hanna
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Isaksson-Friman, ...
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Foukakis, Theodo ...
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Elinder, Ellinor
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Hellstrom, Mats
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Johansson, Hemmi ...
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Lekberg, Tobias
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Lindman, Henrik
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Bergh, Jonas C. ...
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Hatschek, Thomas
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visa färre...
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Umeå universitet
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Örebro universitet
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Karolinska Institutet