5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00209805%3A_____%2F16%3AN0000091" target="_blank" >RIV/00209805:_____/16:N0000091 - isvavai.cz</a>

Alternative codes found

RIV/00216224:14110/16:00092643

Result on the web

<a href="http://dx.doi.org/10.1016/S0140-6736(15)00471-7" target="_blank" >http://dx.doi.org/10.1016/S0140-6736(15)00471-7</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S0140-6736(15)00471-7" target="_blank" >10.1016/S0140-6736(15)00471-7</a>

Result language

angličtina

Original language name

5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial

Original language description

In a phase 3, randomised, non-inferiority trial, accelerated partial breast irradiation (APBI) for patiens with stage 0, I, and IIA breast cancer who underwent breast-conserving treatment was compared with whole-breast irradiation. Here, we present 5-year follow-up results. We did a phase 3, randomised, non-inferiority trial at 16 hospitals and medical centres in seven European countries. 1184 patients with low-risk invasive and ductal carcinoma in situ treated with breast-conserving Sumery were centrally randomised to either whole-breast irradiation or APBI using multicatheter brachytherapy. The primary endpoint was local recurrence. Analysis was done according to treatment received. This trial is registered with ClinicalTrials.gov, number NCT00402519. Between April 20, 2004, and July 30, 2009, 551 patients had whole-breast irradiation with tumour-bed boost and 633 patients received APBI using interstitial multicatheter brachytherapy. At 5-year follow-up, 9 patiens treated with APBI and 5 patients receiving whole-breast irradiation had a local recurrence; the cumulative incidence of local recurrence was 1•44% (95% CI 0•51–2•38) with APBI and 0•92% (0•12–1•73) with whole-breast irradiation (diff erence 0•52%, 95% CI –0•72 to 1•75; p=0•42). No grade 4 late side-effects were reported. The 5-year risk of grade 2–3 late side-effects to the skin was 3•2% with APBI versus 5•7% with whole-breast irradiation (p=0•08), and 5-year risk of grade 2–3 subcutaneous tissue late side-effects was 7•6% versus 6•3% (p=0•53). The risk of severe (grade 3) fibrosis at 5 years was 0•2% with whole-breast irradiation and 0% with APBI (p=0•46). The difference between treatments was below the relevance margin of 3 percentage points. Therefore, adjuvant APBI using multicatheter brachytherapy after breast-conserving surgery in patients with early breast cancer is not inferior to adjuvant whole-breast irradiation with respect to 5-year local control, disease-free survival, and overall survival.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FD - Oncology and haematology

OECD FORD branch

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Project

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Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2016

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Lancet

ISSN

0140-6736

e-ISSN

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Volume of the periodical

387

Issue of the periodical within the volume

10015

Country of publishing house

US - UNITED STATES

Number of pages

9

Pages from-to

229-238

UT code for WoS article

000368130700030

EID of the result in the Scopus database

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