Electrons for intraoperative radiotherapy in selected breast-cancer patients: late results of the Montpellier phase II trial
Radiation Oncology
Electrons for intraoperative radiotherapy in selected breast-cancer patients: late results of the Montpellier phase II trial
Claire Lemanski 0 3
David Azria 0 3
Sophie Gourgou-Bourgade 2
Norbert Ailleres 0 3
Aurelie Pastant 0 3
Philippe Rouanet 1
Pascal Fenoglietto 0 3
Jean-Bernard Dubois 0 3
Marian Gutowski 1
0 Department of Radiation Oncology and Medical Physics, I.C.M. - Institut regional du Cancer Montpellier, INSERM U896 , Montpellier cedex 5 F-34298 , France
1 Department of Oncology and Reconstructive Surgery, I. C.M. - Institut regional du Cancer Montpellier , Montpellier , France
2 Unit of Biostatistics, I.C.M. - Institut regional du Cancer Montpellier , Montpellier , France
3 Department of Radiation Oncology and Medical Physics, I.C.M. - Institut regional du Cancer Montpellier, INSERM U896 , Montpellier cedex 5 F-34298 , France
Background: The Montpellier cancer institute phase II trial started in 2004 and evaluated the feasibility of intraoperative radiotherapy (IORT) technique given as a sole radiation treatment for patients with an excellent prognostic and very low recurrence risk. Methods: Forty-two patients were included between 2004 and 2007. Inclusion criteria were patients 65 years old, T0-T1, N0, ductal invasive unifocal carcinoma, free-margin > 2 mm. IORT was delivered using dedicated linear accelerator. One fraction of 21 Gy was prescribed and specified at the 90% isodose using electrons. In vivo dosimetry was performed for all patients. Primary end-point was the quality index. Secondary endpoints were quality of life, local recurrences, cosmetic results, specific and overall survival. Results: At inclusion, median age was 72 years (range, 66-80). Median tumor diameter was 10 mm. All patients received the total prescribed dose. No acute grade 3 toxicities were observed. Late cosmetic results were good at 5 years despite the poor agreement of accuracy assessment between patients and physicians. Four patients (9.5%) experienced a local failure and underwent salvage mastectomy. The 5 year-disease free survival is 92.7% (range 79.197.6). All patients are still alive with a median follow-up of 72 months (range 66-74). Conclusion: Our results confirm with a long-term follow-up that exclusive partial breast IORT is feasible for early-breast cancer in selected patients. IORT provides good late cosmetics results and should be considered as a safe and very comfortable one-step treatment procedure. Nevertheless, patient assessments are essential for long-term quality results.
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Background
Breast-conserving surgery followed by a whole-breast
postoperative RT (WBRT) is widely considered to be the
current standard of care for patients with early breast
cancer. This treatment leads to an excellent local tumor
control with local recurrence rates around 6% after 10
years, particularly in the very-low risk subgroup [1]. This
classical 57 weeks WBRT is simple and safe in the large
majority of patients but may bring some local early and
late side effects. In addition, it is frequently inconvenient
for women, namely in the elderly, who sometimes prefer
to omit it assuming the risk of local recurrence. During
the last decades, through numerous observational series
and large clinical trials, more than 80% of the local
relapses occurred in the same quadrant in this clinical
situation [2].
On this basis, reducing both the treatment volume
and duration was considered to be an innovative
approach and was developed under the name of
accelerated partial breast irradiation (APBI). Intraoperative
radiotherapy (IORT) is one of them that offers the
advantages of an excellent delineation of the tumor bed
under visual control, a very good dose homogeneity, and
a high normal tissue sparing [3,4].
Alongside our IORT experience delivered as a boost
[5], we started in 2004 the RADELEC phase II trial
evaluating IORT as a sole treatment in very low-risk
patients. We report here the long-term results of safety,
cosmesis, and carcinologic events.
Patients and methods
This study was conducted in accordance with the
declaration of Helsinki and the local institutional review board.
All patients provided written informed consent.
Inclusion criteria
Between November 2004 and November 2007, 96
women accepted to participate in the RADELEC phase
II trial evaluating IORT delivered to the tumor bed as
exclusive radiotherapy. Inclusion criteria were T1N0M0
[6] unifocal ductal invasive carcinoma (biopsy-proven)
with positive (> 10%) estrogen receptors, non-metastatic
disease, and age 65 years old. No extensive intraductal
(EIC) or lymph vessel invasion had to be identified on
primary biopsy.
Local evaluation (mammography and breast
ultrasound) evaluated precisely the diameter of the tumor
(MRI was optional). Lobular tumors were excluded due
to the risk of multifocality. Neoadjuvant treatments were
not allowed before surgery.
IORT procedure and postoperative therapies
The detailed procedure was described in a p (...truncated)