International Journal of Radiation Oncology*Biology*Physics
Clinical InvestigationIntraoperative Radiotherapy in Early-Stage Breast Cancer: Results of the Montpellier Phase II Trial
Introduction
Several randomized trials have established the equivalence of breast-conserving therapy (BCT) to mastectomy in terms of overall survival 1, 2, 3. BCT, i.e., breast-conserving surgery followed by a course of postoperative radiotherapy (RT), is now considered the current standard of care for patients with early-stage breast cancer (4). Routine whole-breast RT (WBRT) comprises 50 Gy in daily fractions for 5 weeks (4). The additional application of an external boost of 10 to 16 Gy to the tumor bed leads to excellent local tumor control, with local recurrence rates around 6% after a median of 10 years follow-up (5). However, considering the low and focal local recurrence rates, the concept of accelerated partial breast irradiation (PBI) therapy has gained widespread interest employing various methods. Intraoperative RT (IORT) is one method that may offer the advantage of an excellent delineation of the tumor bed under visual control, very good dose homogeneity, and high sparing of normal tissue 6, 7.
Given as a boost after breast-conserving surgery, IORT is now considered the reliable alternative to a conventional postoperative fractionated boost radiation (8). We recently showed that this technique is efficiently able to prevent local recurrence and allows excellent cosmetic results, with a median follow-up of 9 years (9). In 2004, we started a strict program to investigate the feasibility of IORT as the sole treatment in very-low-risk patients, namely those older than 65 years, suffering from T1N0M0 (10) invasive ductal carcinoma. We report here the results of this monocentric phase II trial (RADELEC) with a median follow-up of 30 months.
Section snippets
Patient selection criteria
Between November 2004 and November 2007, 96 women were included in this phase II trial evaluating IORT delivered to the tumor bed as the exclusive adjuvant RT. Inclusion criteria were T1N0M0 invasive unifocal ductal carcinoma (10) and an age of ≥65 years. All patients underwent staging tests including chest x-ray, bone scan, and liver ultrasonography to rule out metastatic disease at diagnosis. Local evaluation consisted of mammography and breast ultrasonography (magnetic resonance imaging was
Patient, tumor, and treatment details
Ninety-four patients agreed to participate in this trial and signed the informed consent before surgery. Of these, 42 patients were actually included according to the study criteria. The main reasons for nondelivery of IORT were (i) pT/pN restaging during the IORT pathology assessment (n = 29 patients), (ii) operative room availability (n = 6 patients), (iii) machine disorder (n = 3 patients), (iv) anesthesia complications (n = 2 patients), and informed consent withdrawal (n = 1 patient). In
Discussion
The updated publication of the collaborative meta-analyses based on individual patient data confirmed the positive impact of adjuvant WBRT in terms of locoregional recurrence with a long-term follow-up (4). These results confirm that the greater the reduction in local events obtained during the first 5 years, the greater the specific survival will be over the next decade. In addition, WBRT routinely associated with a 16-Gy boost is able to produce similar proportional reductions in local
Conclusions
In conclusion, and from the results of this phase II study, we are continuing with a prospective database, evaluating the carcinogenic and long-term side effects of a single 21-Gy IORT fraction on patients older than 65 years, presenting with a HR-positive tumor (<2 cm) with a negative sentinel node. We suggest that this selected population, at very-low risk of local recurrence, is an excellent group in which to administer a one-shot procedure, avoiding a 5- to 6-week postoperative treatment.
Acknowledgments
The authors thank Frances Godson for excellent editorial assistance.
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2023, Cancer/RadiotherapieThe Role of Intraoperative Radiation in Early-stage Breast Cancer
2021, Clinical Breast CancerCitation Excerpt :On the UNC phase II trial, cosmetic outcomes were similarly favorable, with a rating of “good or excellent” by physicians and patients in approximately 80%.50 The phase II trial from France additionally found measures of QOL to be maximal and measures of cosmesis to be good to excellent at 6 months from IORT.34 In the CT-guided high dose rate brachytherapy IORT phase II trial through the University of Virginia, only 3.4% of patients experienced a grade 3 toxicity, and 95% experienced excellent or good cosmetic outcomes at 12 months, including little or no pigmentation change in 94%, little to no size change in 88%, and minimal shape change in 87%.40
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2020, Radiotherapy and OncologyDesign, construction and performance evaluation of the target tissue thickness measurement system in intraoperative radiotherapy for breast cancer
2017, Nuclear Instruments and Methods in Physics Research, Section A: Accelerators, Spectrometers, Detectors and Associated EquipmentCitation Excerpt :There is significant interest in improving techniques for partial breast irradiation (PBI) and recognizing patient subgroups that may take advantage of this approach. Proponents of PBI remark on the conformance of several benefits of this treatment over conventional whole breast EBRT including both sparing of normal tissues and having a shorter RT course that could enhance patient comfort and compliance [8–14]. One kind of PBI is called intraoperative radiotherapy (IORT), which is typically delivered in a single fraction at the time of partial mastectomy (PM).
Claire Lemanski and David Azria contributed equally to this work and should be considered as joint first authors.
Conflict of interest: none.