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

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00216224:14110/16:00092643

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FD - Onkologie a hematologie

OECD FORD obor

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Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2016

Kód důvěrnosti údajů

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

Název periodika

Lancet

ISSN

0140-6736

e-ISSN

—

Svazek periodika

387

Číslo periodika v rámci svazku

10015

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

229-238

Kód UT WoS článku

000368130700030

EID výsledku v databázi Scopus

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