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Effect of Adjuvant ...
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Joensuu, HeikkiHelsinki Univ Hosp, Dept Oncol, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland;Univ Helsinki, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland
(författare)
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
- Artikel/kapitelEngelska2018
Förlag, utgivningsår, omfång ...
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AMER MEDICAL ASSOC,2018
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printrdacarrier
Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:uu-366270
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-366270URI
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https://doi.org/10.1001/jamaoncol.2018.1380DOI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:139172274URI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
Anmärkningar
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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
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Fraser, JudithBeatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland
(författare)
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Wildiers, HansUniv Hosp Leuven, Leuven, Belgium
(författare)
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Huovinen, RiikkaTurku Univ, Dept Oncol, Cent Hosp, Turku, Finland
(författare)
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Auvinen, PaiviKuopio Univ Hosp, Dept Oncol, Kuopio, Finland
(författare)
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Utriainen, MeriHelsinki Univ Hosp, Dept Oncol, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland;Univ Helsinki, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland
(författare)
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Nyandoto, PaulPaijat Hame Cent Hosp, Lahti, Finland
(författare)
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Villman, Kenneth K.Orebro Univ Hosp, Orebro, Sweden
(författare)
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Halonen, PaiviHelsinki Univ Hosp, Dept Oncol, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland;Univ Helsinki, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland
(författare)
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Granstam-Bjorneklett, HelenaVasteras Hosp, Vasteras, Sweden
(författare)
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Lundgren, LottaSkane Univ Hosp, Lund, Sweden
(författare)
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Sailas, LiisaVaasa Cent Hosp, Vaasa, Finland;North Carelia Cent Hosp, Joensuu, Finland
(författare)
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Turpeenniemi-Hujanen, TainaOulu Univ Hosp, Dept Radiotherapy & Oncol, Oulu, Finland
(författare)
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Tanner, MinnaTampere Univ Hosp, Dept Oncol, Tampere, Finland
(författare)
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Yachnin, JeffreyKarolinska Institutet
(författare)
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Ritchie, DianaBeatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland
(författare)
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Johansson, OskarLandspitali Univ Hosp, Reykjavik, Iceland
(författare)
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Huttunen, Teppo4Pharma, Turku, Finland
(författare)
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Neven, PatrickUniv Hosp Leuven, Leuven, Belgium
(författare)
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Canney, PeterBeatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland
(författare)
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Harvey, Vernon J.Auckland City Hosp, Auckland, New Zealand
(författare)
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Kellokumpu-Lehtinen, Pirkko-LiisaTampere Univ Hosp, Dept Oncol, Tampere, Finland
(författare)
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Lindman, HenrikUppsala universitet,Experimentell och klinisk onkologi(Swepub:uu)henrlind
(författare)
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Helsinki Univ Hosp, Dept Oncol, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland;Univ Helsinki, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, FinlandBeatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:JAMA Oncology: AMER MEDICAL ASSOC4:9, s. 1199-12062374-24372374-2445
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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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