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

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• 作者：Prof Vratislav Strnad ; MD^a ; ^{vratislav.strnad@uk-erlangen.de" class="auth_mail" title="E-mail the corresponding author} ; Oliver J Ott ; MD^a ; Prof Guido Hildebrandt ; MD^c ; ^d ; Daniela Kauer-Dorner ; MD^e ; Hellen Knauerhase ; MD^d ; Tibor Major ; PhD^b ; Jaroslaw Lyczek ; MD^f ; ^g ; Jose Luis Guinot ; MD^h ; Prof Jü ; rgen Dunst ; MDⁱ ; Cristina Gutierrez Miguelez ; MD^k ; Prof Pavel Slampa ; MD^l ; Michael Allgä ; uer ; MDⁿ ; Kristina Lö ; ssl ; MD^m ; Bü ; lent Polat ; MD^q ; Prof Gyö ; rgy Ková ; cs ; MD^o ; Prof Arnt-Ren&eacute ; Fischedick ; MD^p ; Prof Thomas G Wendt ; MD^r ; Prof Rainer Fietkau ; MD^a ; ^d ; Marion Hindemith ; MD^c ; Alexandra Resch ; MD^e ; Anna Kulik ; MD^f ; Prof Leo Arribas ; MD^h ; Prof Peter Niehoff ; MDⁱ ; ^j ; Prof Fernando Guedea ; MD^k ; Annika Schlamann ; MD^c ; Prof Richard Pö ; tter ; MD^e ; Christine Gall ; DSc^s ; Martina Malzer ; MDO^s ; Prof Wolfgang Uter ; MD^s ; Prof Csaba Polgá ; r ; MD^b ; on behalf of the Groupe Europ&eacute ; en de Curieth&eacute ; rapie of European Society for Radiotherapy ; Oncology (GEC-ESTRO)
• 刊名：The Lancet
• 出版年：2016
• 出版时间：16-22 January 2016
• 年：2016
• 卷：387
• 期：10015
• 页码：229-238
• 全文大小：497 K

文摘

In a phase 3, randomised, non-inferiority trial, accelerated partial breast irradiation (APBI) for patients 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.

d="absSec_2">Methods

d="spara140">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 surgery 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 d="interrefs10" class="interref" data-locatorType="url" data-locatorKey="http://ClinicalTrials.gov">ClinicalTrials.gov, number d="interrefs20" class="interref" data-locatorType="ctgov" data-locatorKey="NCT00402519">NCT00402519.

d="absSec_3">Findings

d="spara150">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, nine patients treated with APBI and five 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 (difference 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).

d="absSec_4">Interpretation

d="spara160">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.

d="absSec_5">Funding

d="spara170">German Cancer Aid.