Late side-eff ects and cosmetic results of accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: 5-year results of a randomised, controlled, phase 3 trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00209805%3A_____%2F17%3A00077908" target="_blank" >RIV/00209805:_____/17:00077908 - isvavai.cz</a>

Výsledek na webu

<a href="https://www.ncbi.nlm.nih.gov/pubmed/?term=28094198" target="_blank" >https://www.ncbi.nlm.nih.gov/pubmed/?term=28094198</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S1470-2045(17)30011-6" target="_blank" >10.1016/S1470-2045(17)30011-6</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Late side-eff ects and cosmetic results of accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: 5-year results of a randomised, controlled, phase 3 trial

Popis výsledku v původním jazyce

Background We previously confi rmed the non-inferiority of accelerated partial breast irradiation (APBI) with interstitial brachytherapy in terms of local control and overall survival compared with whole-breast irradiation for patients with early-stage breast cancer who underwent breast-conserving surgery in a phase 3 randomised trial. Here, we present the 5-year late side-eff ects and cosmetic results of the trial. Methods We did this randomised, controlled, phase 3 trial at 16 centres in seven European countries. Women aged 40 years or older with stage 0-IIA breast cancer who underwent breast-conserving surgery with microscopically clear resection margins of at least 2 mm were randomly assigned 1:1, via an online interface, to receive either whole-breast irradiation of 50 Gy with a tumour-bed boost of 10 Gy or APBI with interstitial brachytherapy. Randomisation was stratifi ed by study centre, menopausal status, and tumour type (invasive carcinoma vs ductal carcinoma in situ), with a block size of ten, according to an automated dynamic algorithm. Patients and investigators were not masked to treatment allocation. The primary endpoint of our initial analysis was ipsilateral local recurrence; here, we report the secondary endpoints of late side-eff ects and cosmesis. We analysed physician-scored late toxicities and patient-scored and physician-scored cosmetic results from the date of breast-conserving surgery to the date of onset of event. Analysis was done according to treatment received (as-treated population). This trial is registered with ClinicalTrials.gov, number NCT00402519. Findings Between April 20, 2004, and July 30, 2009, we randomly assigned 1328 women to receive either whole-breast irradiation (n=673) or APBI with interstitial brachytherapy (n=655); 1184 patients comprised the as-treated population (551 in the whole-breast irradiation group and 633 in the APBI group). At a median follow-up of 6.6 years (IQR 5.8-7.6), no patients had any grade 4 toxities, and three (&lt;1%) of 484 patients in the APBI group and seven (2%) of 393 in the wholebreast irradiation group had grade 3 late skin toxicity (p=0.16). No patients in the APBI group and two (&lt;1%) in the wholebreast irradiation group developed grade 3 late subcutaneous tissue toxicity (p=0.10). The cumulative incidence of any late side-eff ect of grade 2 or worse at 5 years was 27.0% (95% CI 23.0-30.9) in the whole-breast irradiation group versus 23.3% (19.9-26.8) in the APBI group (p=0.12). The cumulative incidence of grade 2-3 late skin toxicity at 5 years was 10.7% (95% CI 8.0-13.4) in the whole-breast irradiation group versus 6.9% (4.8-9.0) in the APBI group (diff erence -3.8%, 95% CI -7.2 to 0.4; p=0.020). The cumulative risk of grade 2-3 late subcutaneous tissue side-eff ects at 5 years was 9.7% (95% CI 7.1-12.3) in the whole-breast irradiation group versus 12.0% (9.4-14.7) in the APBI group (diff erence 2.4%; 95% CI -1.4 to 6.1; p=0.28). The cumulative incidence of grade 2-3 breast pain was 11.9% (95% CI 9.0-14.7) after whole-breast irradiation versus 8.4% (6.1-10.6) after APBI (diff erence -3.5%; 95% CI -7.1 to 0.1; p=0.074). At 5 years&apos; follow-up, according to the patients&apos; view, 413 (91%) of 454 patients had excellent to good cosmetic results in the wholebreast irradiation group versus 498 (92%) of 541 patients in the APBI group (p=0.62); when judged by the physicians, 408 (90%) of 454 patients and 503 (93%) of 542 patients, respectively, had excellent to good cosmetic results (p=0.12). No treatment-related deaths occurred, but six (15%) of 41 patients (three in each group) died from breast cancer, and 35 (85%) deaths (21 in the whole-breast irradiation group and 14 in the APBI group) were unrelated. Interpretation 5-year toxicity profi les and cosmetic results were similar in patients treated with breast-conserving surgery followed by either APBI with interstitial brachytherapy or conventional whole-breast irradiation, with signifi cantly fewer grade 2-3 late skin side-eff ects after APBI with interstitial brachytherapy. These fi ndings provide further clinical evidence for the routine use of interstitial multicatheter brachytherapy-based APBI in the treatment of patients with low-risk breast cancer who opt for breast conservation.

Název v anglickém jazyce

Late side-eff ects and cosmetic results of accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: 5-year results of a randomised, controlled, phase 3 trial

Popis výsledku anglicky

Background We previously confi rmed the non-inferiority of accelerated partial breast irradiation (APBI) with interstitial brachytherapy in terms of local control and overall survival compared with whole-breast irradiation for patients with early-stage breast cancer who underwent breast-conserving surgery in a phase 3 randomised trial. Here, we present the 5-year late side-eff ects and cosmetic results of the trial. Methods We did this randomised, controlled, phase 3 trial at 16 centres in seven European countries. Women aged 40 years or older with stage 0-IIA breast cancer who underwent breast-conserving surgery with microscopically clear resection margins of at least 2 mm were randomly assigned 1:1, via an online interface, to receive either whole-breast irradiation of 50 Gy with a tumour-bed boost of 10 Gy or APBI with interstitial brachytherapy. Randomisation was stratifi ed by study centre, menopausal status, and tumour type (invasive carcinoma vs ductal carcinoma in situ), with a block size of ten, according to an automated dynamic algorithm. Patients and investigators were not masked to treatment allocation. The primary endpoint of our initial analysis was ipsilateral local recurrence; here, we report the secondary endpoints of late side-eff ects and cosmesis. We analysed physician-scored late toxicities and patient-scored and physician-scored cosmetic results from the date of breast-conserving surgery to the date of onset of event. Analysis was done according to treatment received (as-treated population). This trial is registered with ClinicalTrials.gov, number NCT00402519. Findings Between April 20, 2004, and July 30, 2009, we randomly assigned 1328 women to receive either whole-breast irradiation (n=673) or APBI with interstitial brachytherapy (n=655); 1184 patients comprised the as-treated population (551 in the whole-breast irradiation group and 633 in the APBI group). At a median follow-up of 6.6 years (IQR 5.8-7.6), no patients had any grade 4 toxities, and three (&lt;1%) of 484 patients in the APBI group and seven (2%) of 393 in the wholebreast irradiation group had grade 3 late skin toxicity (p=0.16). No patients in the APBI group and two (&lt;1%) in the wholebreast irradiation group developed grade 3 late subcutaneous tissue toxicity (p=0.10). The cumulative incidence of any late side-eff ect of grade 2 or worse at 5 years was 27.0% (95% CI 23.0-30.9) in the whole-breast irradiation group versus 23.3% (19.9-26.8) in the APBI group (p=0.12). The cumulative incidence of grade 2-3 late skin toxicity at 5 years was 10.7% (95% CI 8.0-13.4) in the whole-breast irradiation group versus 6.9% (4.8-9.0) in the APBI group (diff erence -3.8%, 95% CI -7.2 to 0.4; p=0.020). The cumulative risk of grade 2-3 late subcutaneous tissue side-eff ects at 5 years was 9.7% (95% CI 7.1-12.3) in the whole-breast irradiation group versus 12.0% (9.4-14.7) in the APBI group (diff erence 2.4%; 95% CI -1.4 to 6.1; p=0.28). The cumulative incidence of grade 2-3 breast pain was 11.9% (95% CI 9.0-14.7) after whole-breast irradiation versus 8.4% (6.1-10.6) after APBI (diff erence -3.5%; 95% CI -7.1 to 0.1; p=0.074). At 5 years&apos; follow-up, according to the patients&apos; view, 413 (91%) of 454 patients had excellent to good cosmetic results in the wholebreast irradiation group versus 498 (92%) of 541 patients in the APBI group (p=0.62); when judged by the physicians, 408 (90%) of 454 patients and 503 (93%) of 542 patients, respectively, had excellent to good cosmetic results (p=0.12). No treatment-related deaths occurred, but six (15%) of 41 patients (three in each group) died from breast cancer, and 35 (85%) deaths (21 in the whole-breast irradiation group and 14 in the APBI group) were unrelated. Interpretation 5-year toxicity profi les and cosmetic results were similar in patients treated with breast-conserving surgery followed by either APBI with interstitial brachytherapy or conventional whole-breast irradiation, with signifi cantly fewer grade 2-3 late skin side-eff ects after APBI with interstitial brachytherapy. These fi ndings provide further clinical evidence for the routine use of interstitial multicatheter brachytherapy-based APBI in the treatment of patients with low-risk breast cancer who opt for breast conservation.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30204 - Oncology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2017

Kód důvěrnosti údajů

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

Název periodika

Lancet Oncology

ISSN

1470-2045

e-ISSN

—

Svazek periodika

18

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

259-268

Kód UT WoS článku

000396343000052

EID výsledku v databázi Scopus

2-s2.0-85009384686