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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

The result's identifiers

  • Result code in 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>

  • Result on the web

    <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>

Alternative languages

  • Result language

    angličtina

  • Original language name

    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

  • Original language description

    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.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30204 - Oncology

Result continuities

  • Project

  • Continuities

    I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Others

  • Publication year

    2017

  • Confidentiality

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

Data specific for result type

  • Name of the periodical

    Lancet Oncology

  • ISSN

    1470-2045

  • e-ISSN

  • Volume of the periodical

    18

  • Issue of the periodical within the volume

    2

  • Country of publishing house

    US - UNITED STATES

  • Number of pages

    10

  • Pages from-to

    259-268

  • UT code for WoS article

    000396343000052

  • EID of the result in the Scopus database

    2-s2.0-85009384686