GEC-ESTRO multicenter phase 3-trial: Accelerated partial breast irradiation with interstitial multicatheter brachytherapy versus external beam whole breast irradiation: Early toxicity and patient compliance

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• 作者：Oliver J. Ott^a ; ^{oliver.ott@uk-erlangen.de" class="auth_mail" title="E-mail the corresponding author} ; Vratislav Strnad^a ; Guido Hildebrandt^b ; ^c ; Daniela Kauer-Dorner^d ; Hellen Knauerhase^c ; Tibor Major^e ; Jaroslaw Łyczek^f ; ^g ; José ; Luis Guinot^h ; Jü ; rgen Dunstⁱ ; Cristina Gutierrez Miguelez^j ; Pavel Slampa^k ; Michael Allgä ; uer^m ; Kristina Lö ; ssl^l ; Bü ; lent Polat^p ; Gyö ; rgy Ková ; csⁿ ; Arnt-René ; Fischedick^o ; Thomas G. Wendt^q ; Rainer Fietkau^a ; ^d ; Rolf-Dieter Kortmann^b ; Alexandra Resch^e ; Anna Kulik^f ; Leo Arribas^h ; Peter Niehoffⁱ ; ^r ; Ferran Guedea^j ; Annika Schlamann^b ; Richard Pö ; tter^e ; Christine Gall^s ; Martina Malzer^s ; Wolfgang Uter^s ; Csaba Polgá ; r^e ; on behalf of the Groupe Europé ; en de Curiethé ; rapie of European Society for Radiotherapy ; Oncology (GEC-ESTRO)
• 关键词：Breast cancer ; Accelerated partial breast irradiation ; Multicatheter brachytherapy ; Randomized trial ; Early toxicity ; GEC-ESTRO APBI trial
• 刊名：Radiotherapy and Oncology
• 出版年：2016
• 出版时间：July 2016
• 年：2016
• 卷：120
• 期：1
• 页码：119-123
• 全文大小：526 K

文摘

To compare early side effects and patient compliance of accelerated partial breast irradiation (APBI) with multicatheter brachytherapy to external beam whole breast irradiation (WBI) in a low-risk group of patients with breast cancer.

Material and methods

Between April 2004 and July 2009, 1328 patients with UICC stage 0–IIA breast cancer were randomized to receive WBI with 50 Gy and a boost of 10 Gy or APBI with either 32.0 Gy/8 fractions, or 30.1 Gy/7 fractions (HDR-brachytherapy), or 50 Gy/0.60–0.80 Gy per pulse (PDR-brachytherapy). This report focuses on early side-effects and patient compliance observed in 1186 analyzable patients. ClinicalTrials.gov identifier: NCT00402519.

Results

Patient compliance was excellent in both arms. Both WBI and APBI were well tolerated with moderate early side-effects. No grade 4 toxicity had been observed. Grade 3 side effects were exclusively seen for early skin toxicity (radiation dermatitis) with 7% vs. 0.2% (p < 0.0001), and breast infection with 0% vs. 0.2% (p = n.s.) for patients treated with WBI and APBI. The incidence of grades 1–2 early side effects for WBI and APBI was 86% vs. 21% (p < 0.0001) for skin toxicity, 2% vs. 20% (p < 0.0001) for mild hematoma, and 2% vs. 5% (p = 0.01) for mild breast infection rates, respectively. No differences had been found regarding grades 1–2 early breast pain (26% vs. 29%, p = 0.23).

Conclusions

APBI with interstitial multicatheter brachytherapy was tolerated very well and dramatically reduced early skin toxicity in comparison to standard WBI.