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

被引：543

作者：

Strnad, Vratislav ^{[1
]}

Ott, Oliver J. ^{[1
]}

Hildebrandt, Guido ^{[3
,4
]}

Kauer-Dorner, Daniela ^{[5
]}

Knauerhase, Hellen ^{[4
]}

Major, Tibor ^{[2
]}

Lyczek, Jaroslaw ^{[6
,7
]}

Guinot, Jose Luis ^{[8
]}

Dunst, Juergen ^{[9
]}

Gutierrez Miguelez, Cristina ^{[11
]}

Slampa, Pavel ^{[12
]}

Allgaeuer, Michael ^{[14
]}

Loessl, Kristina ^{[13
]}

Polat, Buelent ^{[17
]}

Kovacs, Gyoergy ^{[15
]}

Fischedick, Arnt-Rene ^{[16
]}

Wendt, Thomas G. ^{[18
]}

Fietkau, Rainer ^{[1
,4
]}

Hindemith, Marion ^{[3
]}

Resch, Alexandra ^{[5
]}

Kulik, Anna ^{[6
]}

Arribas, Leo ^{[8
]}

Niehoff, Peter ^{[9
,10
]}

Guedea, Fernando ^{[11
]}

Schlamann, Annika ^{[3
]}

Poetter, Richard ^{[5
]}

Gall, Christine ^{[19
]}

Malzer, Martina ^{[19
]}

Uter, Wolfgang ^{[19
]}

Polgar, Csaba ^{[2
]}

机构：

[1] Univ Hosp Erlangen, Dept Radiat Oncol, D-91054 Erlangen, Germany

[2] Natl Inst Oncol, Ctr Radiotherapy, Budapest, Hungary

[3] Univ Hosp Leipzig, Dept Radiat Oncol, Leipzig, Germany

[4] Univ Hosp Rostock, Dept Radiat Oncol, Rostock, Germany

[5] Univ Hosp AKH Wien, Dept Radiat Oncol, Vienna, Austria

[6] Inst Marii Sklodowskej, Ctr Onkol, Brachytherapy Dept, Warsaw, Poland

[7] Podkarpacki Hosp, Canc Ctr Brzozow, Brzozow, Poland

[8] Valencian Inst Oncol, Dept Radiat Oncol, Valencia, Spain

[9] Univ Hosp Kiel, Dept Radiat Oncol, Kiel, Germany

[10] Univ Witten Herdecke, Dept Radiotherapy, Municipal Hosp Cologne, Witten, Germany

[11] Catalan Inst Oncol, Dept Radiat Oncol, Barcelona, Spain

[12] Masaryk Mem Canc Inst, Dept Radiat Oncol, Brno, Czech Republic

[13] Univ Hosp Bern, Inselspital, Dept Radiat Oncol, CH-3010 Bern, Switzerland

[14] Hosp Barmherzige Bruder Regensburg, Dept Radiat Oncol, Regensburg, Germany

[15] Med Univ Lubeck, Interdisciplinary Brachytherapy Unit, D-23538 Lubeck, Germany

[16] Clemens Hosp, Dept Radiat Oncol, Munster, Germany

[17] Univ Hosp Wurzburg, Dept Radiat Oncol, Wurzburg, Germany

[18] Univ Hosp Jena, Dept Radiat Oncol, Jena, Germany

[19] Univ Erlangen Nurnberg, Dept Med Informat Biometry & Epidemiol, D-91054 Erlangen, Germany

来源：

LANCET | 2016年 / 387卷 / 10015期

关键词：

LUMPECTOMY PLUS TAMOXIFEN; RADIATION-THERAPY; INTRAOPERATIVE RADIOTHERAPY; FOLLOW-UP; CANCER; WOMEN; MANAGEMENT; TOXICITY; SURVIVAL; HEART;

D O I：

10.1016/S0140-6736(15)00471-7

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background 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.

引用

页码：229 / 238

页数：10

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