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-René ; 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 Europé ; en de Curiethé ; 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.

Methods

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 ClinicalTrials.gov, number NCT00402519.

Findings

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).

Interpretation

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.

Funding

German Cancer Aid.