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Effect of Adjuvant ...
Effect of Adjuvant Trastuzumab for a Duration of 9 Weeks vs 1 Year With Concomitant Chemotherapy for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer The SOLD Randomized Clinical Trial
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- Joensuu, Heikki (author)
- Helsinki Univ Hosp, Dept Oncol, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland;Univ Helsinki, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland
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- Fraser, Judith (author)
- Beatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland
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- Wildiers, Hans (author)
- Univ Hosp Leuven, Leuven, Belgium
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- Huovinen, Riikka (author)
- Turku Univ, Dept Oncol, Cent Hosp, Turku, Finland
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- Auvinen, Paivi (author)
- Kuopio Univ Hosp, Dept Oncol, Kuopio, Finland
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- Utriainen, Meri (author)
- Helsinki Univ Hosp, Dept Oncol, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland;Univ Helsinki, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland
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- Nyandoto, Paul (author)
- Paijat Hame Cent Hosp, Lahti, Finland
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- Villman, Kenneth K. (author)
- Orebro Univ Hosp, Orebro, Sweden
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- Halonen, Paivi (author)
- Helsinki Univ Hosp, Dept Oncol, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland;Univ Helsinki, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland
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- Granstam-Bjorneklett, Helena (author)
- Vasteras Hosp, Vasteras, Sweden
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- Lundgren, Lotta (author)
- Skane Univ Hosp, Lund, Sweden
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- Sailas, Liisa (author)
- Vaasa Cent Hosp, Vaasa, Finland;North Carelia Cent Hosp, Joensuu, Finland
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- Turpeenniemi-Hujanen, Taina (author)
- Oulu Univ Hosp, Dept Radiotherapy & Oncol, Oulu, Finland
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- Tanner, Minna (author)
- Tampere Univ Hosp, Dept Oncol, Tampere, Finland
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- Yachnin, Jeffrey (author)
- Karolinska Institutet
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- Ritchie, Diana (author)
- Beatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland
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- Johansson, Oskar (author)
- Landspitali Univ Hosp, Reykjavik, Iceland
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- Huttunen, Teppo (author)
- 4Pharma, Turku, Finland
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- Neven, Patrick (author)
- Univ Hosp Leuven, Leuven, Belgium
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- Canney, Peter (author)
- Beatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland
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- Harvey, Vernon J. (author)
- Auckland City Hosp, Auckland, New Zealand
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- Kellokumpu-Lehtinen, Pirkko-Liisa (author)
- Tampere Univ Hosp, Dept Oncol, Tampere, Finland
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- Lindman, Henrik (author)
- Uppsala universitet,Experimentell och klinisk onkologi
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(creator_code:org_t)
- AMER MEDICAL ASSOC, 2018
- 2018
- English.
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In: JAMA Oncology. - : AMER MEDICAL ASSOC. - 2374-2437 .- 2374-2445. ; 4:9, s. 1199-1206
- Related links:
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https://jamanetwork....
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https://urn.kb.se/re...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
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- Importance: Trastuzumab plus chemotherapy is the standard adjuvant treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. While the standard duration of trastuzumab treatment is 12 months, the benefits and harms of trastuzumab continued beyond the chemotherapy are unclear.Objective: To evaluate the efficacy and safety of adjuvant trastuzumab continued beyond chemotherapy in women treated with up-front chemotherapy containing a taxane and trastuzumab.Design, Setting, and Participants: Open-label, randomized (1:1) clinical trial including women with HER2-positive breast cancer. Chemotherapy was identical in the 2 groups, consisting of 3 cycles of 3-weekly docetaxel (either 80 or 100 mg/m2) plus trastuzumab for 9 weeks, followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide. Thereafter, no trastuzumab was administered in the 9-week group, whereas controls received trastuzumab to complete 1 year of administration. Disease-free survival (DFS) was compared between the groups using a Cox model and the noninferiority approach. The estimated sample size was 2168 patients (1-sided testing, with a relative noninferiority margin of 1.3). From January 3, 2008, to December 16, 2014, 2176 patients were accrued from 7 countries.Intervention: Docetaxel plus trastuzumab for 9 weeks, followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide in both groups. Controls continued trastuzumab to 1 year.Main Outcomes and Measures: The primary objective was DFS; secondary objectives included distant disease–free survival, overall survival, cardiac DFS, and safety.Results: In the 2174 women analyzed, median age was 56 (interquartile range [IQR], 48-64) years. The median follow-up was 5.2 (IQR, 3.8-6.7) years. Noninferiority of the 9-week treatment could not be demonstrated for DFS (hazard ratio, 1.39; 2-sided 90% CI, 1.12-1.72). Distant disease–free survival and overall survival did not differ substantially between the groups. Thirty-six (3%) and 21 (2%) patients in the 1-year and the 9-week groups, respectively, had cardiac failure; the left ventricle ejection fraction was better maintained in the 9-week group. An interaction was detected between the docetaxel dose and DFS; patients in the 9-week group treated with 80 mg/m2 had inferior and those treated with 100 mg/m2 had similar DFS as patients in the 1-year group.Conclusions and Relevance: Nine weeks of trastuzumab was not noninferior to 1 year of trastuzumab when given with similar chemotherapy. Cardiac safety was better in the 9-week group. The docetaxel dosing with trastuzumab requires further study.Trial Registration: ClinicalTrials.gov Identifier: NCT00593697
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)
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- By the author/editor
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Joensuu, Heikki
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Fraser, Judith
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Wildiers, Hans
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Huovinen, Riikka
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Auvinen, Paivi
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Utriainen, Meri
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Nyandoto, Paul
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Villman, Kenneth ...
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Halonen, Paivi
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Granstam-Bjornek ...
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Lundgren, Lotta
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Sailas, Liisa
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Turpeenniemi-Huj ...
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Tanner, Minna
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Yachnin, Jeffrey
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Ritchie, Diana
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Johansson, Oskar
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Huttunen, Teppo
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Neven, Patrick
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Canney, Peter
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Harvey, Vernon J ...
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Kellokumpu-Lehti ...
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Lindman, Henrik
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- 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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JAMA Oncology
- By the university
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Uppsala University
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Karolinska Institutet