Abstract 3736
Background
For decades, conventionally fractionated whole breast irradiation (CF-WBI) was used after breast conserving surgery (BCS). Pivotal phase 3 trials on hypofractionated-WBI (HF-WBI) showed its non-inferiority as compared to CF-WBI. However, younger patients (<60 years) are not currently worldwide treated with HF-WBI. The aim of this multi-center comparative study is to confirm the safety of HF-WBI in a real-life series of younger patients.
Methods
Between 2010 and 2016, a total of 786 patients aged less than 60 years old with early stage breast cancer were treated with postoperative WBI after BCS in three breast cancer centers: 340 underwent HF-WBI while 446 were treated with CF-WBI. Acute toxicity was evaluated at the end of WBI. Late toxicity was evaluated at 6, 12, 24, and 36 months.
Results
At univariate logistic analysis, hypofractionation showed a significant protective effect in terms of acute edema (p = 0.0001), acute wet desquamation (p = 0.009), chronic edema (p = 0.0001), chronic erythema/pigmentation (p = 0.0001), and breast fibrosis (p = 0.0002). At multivariate logistic analysis, hypofractionation was independent significant factor for acute edema (OR 0.09, 95% CI 0.02 to 0.48; p = 0.005), acute wet desquamation (OR 0.07, 95% CI 0.009 to 0.59; p = 0.014), and chronic edema (OR 0.18, 95% CI 0.04 to 0.75; p = 0.018). Significant association between individual characteristics and toxicity (grade 2 or more) are summarized in Table.Table:
215P
Toxicity | N | Protective factor | p-value | OR (95%CI) | Risk factor | p-value | OR (95%CI) |
---|---|---|---|---|---|---|---|
Acute edema | 43 | Hypofractionation Dmax/Prescribed dose° <107% | 0.0001 0.001 | 0.09 (0.03-0.30) 0.16 (0.06-0.46) | Chemotherapy | 0.002 | 2.63 (1.42-4.90) |
Chronic edema | 50 | Hypofractionation Dmax/Prescribed dose° <107% | 0.0001 0.003 | 0.20 (0.09-0.44) 0.31 (0.14-0.66) | EIC presence Boost dose >10 Gy Breast size >492 cc | 0.0001 0.032 0.003 | 3.0 (1.66-5.46) 9.02 (1.21-67.45) 2.67 (1.41-5.05) |
Acute erythema/ pigmentation | 163 | HER2 positive status Trastuzumab | 0.002 0.022 | 0.30 (0.14-0.63) 0.39 (0.18-0.87) | Smoking habits Boost dose >10 Gy Breast size >492 cc | 0.001 0.038 0.002 | 2.14 (1.37-3.32) 2.60 (1.06-6.41) 1.78 (1.24-2.54) |
Chronic erythema/ pigmentation | 110 | Hypofractionation Dmax/Prescribed dose° <107% | 0.0001 0.001 | 0.40 (0.25-0.63) 0.45 (0.28-0.73) | EIC presence Positive FSM Boost dose >10 Gy Breast size >492 cc | 0.0001 0.002 0.007 0.034 | 2.39 (1.54-3.71) 3.47 (1.56-7.71) 15.43 (2.08-114.3) 1.58 (1.04-2.41) |
Acute wet desquamation | 20 | Hypofractionation Dmax/Prescribed dose° <107% | 0.009 0.047 | 0.14 (0.03-0.61) 0.29 (0.08-0.99) | - | - | - |
Breast fibrosis | 117 | Hypofractionation Tumor grade Ki67 index Dmax/Prescribed dose° <107% | 0.0002 0.022 0.023 0.017 | 0.44 (0.29-0.68) 0.53 (0.31-0.92) 0.60 (0.38-0.93) 0.58 (0.37-0.91) | EIC presence Boost dose >10 Gy Breast size >492 cc | 0.0001 0.022 0.0001 | 3.03 (1.99-4.62) 6.76 (2.04-22.45) 2.84 (1.83-4.41) |
Conclusions
HF-WBI showed significantly improved toxicity outcomes in terms of both acute skin edema and wet desquamation, and chronic skin edema. HF-WBI after BCS should replace CF-WBI independently of age.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1398 - Phase 1 study of liposomal formulation of eribulin (E7389-LF) in patients (pts) with advanced solid tumors: primary results of dose-escalation part
Presenter: Noboru Yamamoto
Session: Poster Display session 2
Resources:
Abstract
5818 - Polo-like Kinase 1 inhibitor onvansertib synergizes with paclitaxel in breast cancer carrying p53 mutation
Presenter: Antonio Giordano
Session: Poster Display session 2
Resources:
Abstract
5927 - Phase 1b study of heat shock protein 90 inhibitor, onalespib in combination with paclitaxel in patients with advanced, triple negative breast cancer (NCT02474173).
Presenter: Robert Wesolowski
Session: Poster Display session 2
Resources:
Abstract
1695 - Impact of pertuzumab and T-DM1 on prognosis of HER2-positive metastatic breast cancer (MBC) and factors affecting their efficacy: results from the AGMT_MBC-Registry
Presenter: Simon Peter Gampenrieder
Session: Poster Display session 2
Resources:
Abstract
1742 - Clinical profile and outcome of HER2 positive breast cancer patients with brain metastases treated with HER2 targeted therapy: Real world experience.
Presenter: Prabhat Bhargava
Session: Poster Display session 2
Resources:
Abstract
1846 - Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer: results of single arm phase IV COMACHI study
Presenter: Norikazu Masuda
Session: Poster Display session 2
Resources:
Abstract
5385 - Anti HER-2 Therapies and Left Ventricular Dysfunction The Renaissance Study
Presenter: ANDRES DANIELE
Session: Poster Display session 2
Resources:
Abstract
3320 - Safety and efficacy of T-DM1 in 128 patients with advanced HER2+ breast cancer: The Royal Marsden experience.
Presenter: Nicolò Battisti
Session: Poster Display session 2
Resources:
Abstract
4540 - Use of trastuzumab emtansine (T-DM1; K) after pertuzumab + trastuzumab (PH) in patients with HER2-positive metastatic breast cancer (mBC): challenges in assessing effectiveness of treatment sequencing in the real world (RW)
Presenter: Thibaut Sanglier
Session: Poster Display session 2
Resources:
Abstract
2376 - Patient Reported Outcomes (PRO) in patients (pts) with HER2- advanced breast cancer (ABC) and a germline BRCA1/2 mutation (gBRCAm) receiving talazoparib (TALA) vs physician’s choice chemotherapy (PCT) in the EMBRACA trial: A focus on subgroups with/ without visceral disease
Presenter: Johannes Ettl
Session: Poster Display session 2
Resources:
Abstract