Publications by authors named "V Galimberti"

273 Publications

A Randomized Trial of Robotic Mastectomy versus Open Surgery in Women With Breast Cancer or BRCA Mutation.

Ann Surg 2021 Jun 9. Epub 2021 Jun 9.

Division of Breast Surgery, European Institute of Oncology IRCCS, Milan, Italy.

Objective: To compare robotic mastectomy with open classical technique outcomes in breast cancer patients.

Summary Background Data: As the use of robotic nipple sparing mastectomy continues to rise, improved understanding of the surgical, oncologic and quality of life outcomes is imperative for appropriate patient selection as well as to better understand indications, limits, advantages and dangers.

Methods: In a phase III, open label, single center, randomized controlled trial involving 80 women with breast cancer (69) or with BRCA mutation (11), we compared the outcome of robotic and open nipple sparing mastectomy. Primary outcomes were surgical complications and quality of life using specific validated questionnaires. Secondary objective included oncologic outcomes.

Results: Robotic procedure was 1 hour and 18 minutes longer than open (P < 0.001). No differences in the number or type of complications (P = 0.11) were observed. Breast-Q scores in satisfaction with breasts, psychosocial, physical and sexual well-being were significantly higher after robotic mastectomy vs open procedure. Respect to baseline, physical and sexual well-being domains remained stable after robotic mastectomy while they significantly decreased after open procedure (P<= 0.02). The overall Body Image Scale questionnaire score was 20.7 +/- 13.8 vs. 9.9 +/- 5.1 in the robotic vs open groups respectively, P < 0.0001. At median follow-up 28.6 months (range 3.7-43.3), no local events were observed.

Conclusions: Complications were similar among groups upholding the robotic technique to be safe. Quality of life was maintained after robotic mastectomy while significantly decrease after open surgery. Early follow up confirm no premature local failure. ClinicalTrials.gov NCT03440398.
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http://dx.doi.org/10.1097/SLA.0000000000004969DOI Listing
June 2021

Comparing TomoHelical and TomoDirect in postmastectomy hypofractionated radiotherapy after immediate breast reconstruction.

Phys Med 2021 Sep 23;90:66-72. Epub 2021 Sep 23.

Division of Radiation Oncology, IEO, European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Hemato-oncology, University of Milan, Milan, Italy.

Background: Postmastectomy radiotherapy (PMRT) with TomoHelical™ (TH) or TomoDirect™ (TD) allows a uniform target coverage. In this study, we compare treatment plans using TD and TH in the setting of hypofractionated PMRT and immediate breast reconstruction.

Material And Methods: The TD-treatment plans of breast cancer patients treated between May 2016 and August 2019 were retrospectively selected. All the TD plans were re-planned on TH with the same prescription dose (40.05 Gy/15 fractions) and according to our dose/volume constraints. Data about the 2 treatment plans were compared with a focus on PTV coverage and all the organs at risk (OARs) constraints.

Results: Fifty patients for a total number of 100 treatment plans (50 with TD and 50 re-planned with TH) were analyzed. All the median value in the TD PTV CHEST WALL plans fulfilled the predefined planning objectives, even though TH emerged as best for target coverage with statistically significant difference for V90%. TD provided the lowest V95% for the PTV SVC, but the median value was near to the recommended value of 90% (89.8 % vs 98.6% for TD and TH, respectively). Overall, TD reached the best OARs sparing. The main statistically significant differences with TH were for contralateral breast, ipsilateral and contralateral lung. All the other dose values for TH were higher than TD, but they fulfilled the recommended/acceptable predefined planning objectives.

Conclusions: In the setting of PMRT, TD compared to TH reached an acceptable target volume coverage, with an optimal sparing of OARs.
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http://dx.doi.org/10.1016/j.ejmp.2021.09.007DOI Listing
September 2021

Early Breast Cancers During Pregnancy Treated With Breast-Conserving Surgery in the First Trimester of Gestation: A Feasibility Study.

Front Oncol 2021 24;11:723693. Epub 2021 Aug 24.

Division of Breast Surgery, IEO, European Institute of Oncology IRCCS, Milan, Italy.

Breast cancer is the most common malignancy occurring during gestation. In early-stage breast cancer during pregnancy (PrBC), breast-conserving surgery (BCS) with delayed RT is a rational alternative to mastectomy, for long considered the standard-of-care. Regrettably, no specific guidelines on the surgical management of these patients are available. In this study, we investigated the feasibility and safety of BCS during the first trimester of pregnancy in women with early-stage PrBC. All patients with a diagnosis of PrBC during the first trimester of pregnancy jointly managed in two PrBC-specialized Centers were included in this study. All patients underwent BCS followed by adjuvant radiotherapy to the ipsilateral breast after delivery. Histopathological features and biomarkers were first profiled on pre-surgical biopsies. The primary outcome was the isolated local recurrence (ILR). Among 168 PrBC patients, 67 (39.9%) were diagnosed during the first trimester of gestation. Of these, 30 patients (age range, 23-43 years; median=36 years; gestational age, 2-12 weeks; median=7 weeks; median follow-up time=6.5 years) met the inclusion criteria. The patients that were subjected to radical surgery (n=14) served as controls. None of the patients experienced perioperative surgical complications. No ILR were observed within three months (n=30), 1 year (n=27), and 5 years (n=18) after surgery. Among the study group, 4 (12.3%) patients experienced ILR or new carcinomas after 6-13 years, the same number (n=4) had metastatic dissemination after 3-7 years. These patients are still alive and disease-free after 14-17 years of follow-up. The rate of recurrences and metastasis in the controls were not significantly different. The findings provide evidence that BCS in the first trimester PrBC is feasible and reasonably safe for both the mother and the baby.
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http://dx.doi.org/10.3389/fonc.2021.723693DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8421851PMC
August 2021

Ten-year outcome results of cT4 breast cancer after neoadjuvant treatment.

J Surg Oncol 2021 Sep 1. Epub 2021 Sep 1.

Division of Breast Surgery, European Institute of Oncology, IRCCS, Milan, Italy.

Background And Objectives: cT4 breast cancer (BC) is classified as noninflammatory breast cancer (non-IBC) or inflammatory breast cancer (IBC). The outcome often is considered worse. The purpose of this study was to determine recurrence and outcomes in overall survival (OS), invasive disease-free survival (IDFS), distant disease-free survival (DDFS) according to pathological complete response (pCR), and inflammatory status.

Methods: From 2000 to 2015 we selected 634 nonmetastatic cT4 BC patients treated with neoadjuvant therapy followed by surgery at the European Institute of Oncology. OS, IDFS, and DDFS were estimated with the Kaplan-Meier method.

Results: The median follow-up was 9.0 years. Twenty patients underwent only sentinel node biopsy (SNB), 13 SNB + AD, and 601 only AD. Considering the 614 patients with AD, only 2.5% of non-IBC patients reported pCR compared to 15% of IBC cases. Only two axillary recurrences were reported. Ten-year results were 52.3% (95% confidence interval [CI]: 47.8-56.5) for OS, 37.0% (95% CI: 32.6-41.3) for IDFS, and 49.8% (95% CI: 45.0-54.4) for DDFS. OS, IDFS, and DDFS were better in all BC with pCR (irrespective of inflammatory status).

Conclusion: Our long-term results demonstrated that pCR significantly improves survival, reducing locoregional and distant recurrence risk in cT4 tumors with respect to patients with no pCR and according to inflammatory status of cT4 BC.
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http://dx.doi.org/10.1002/jso.26662DOI Listing
September 2021

Predictors of positive axillary non-sentinel lymph nodes in breast cancer patients with positive sentinel lymph node biopsy after neoadjuvant systemic therapy.

Radiother Oncol 2021 Aug 27;163:128-135. Epub 2021 Aug 27.

Division of Radiotherapy, IEO, European Institute of Oncology, IRCCS, Milan, Italy; Department of Oncology and Hemato-oncology, University of Milan, Italy.

Aim: To assess the rate of positive non-sentinel lymph nodes (non-SLNs) after neoadjuvant systemic therapy (NAST) in breast cancer (BC) following positive sentinel lymph node biopsy (SLNB).

Materials And Methods: From institutional database, 265 consecutive patients receiving NAST for cT1-3, any N, M0 BC between 2001 and 2018 were identified. Patients presented clinically negative axilla before surgery and were candidate for SLNB. Following metastatic SLNB, completion axillary lymph node dissection (AxLND) was performed. Non-SLNs rate was investigated using multivariate (MV) logistic regression models. The distribution of non-SLNs across the axilla was observed.

Results: Positive non-SLNs were found in 62.3% of cases and showed no correlation with SLN metastasis size. At MV, statistically significant variables associated with non-SLNs were older age (p = 0.025), clinically positive lymph nodes (p = 0.002), SLN extracapsular extension (ECE, p = 0.001), and higher ratio of positive SLNs/total SLNs (p = 0.016). ECE and higher nodal ratio were independent predictors of III axillary level positivity. By categorizing patients in intermediate- and high-risk groups using the study variables, positive non-SLNs were found in the range of 23-56% across the three axillary levels, rates which did not support radiotherapy volume de-escalation. The III axillary level lower involvement (6.3%) was better identified with the RAPCHEM trial criteria based on the ypN status after AxLND.

Conclusions: Involved non-SLNs rate following positive SLNB after NAST is nearly double the rate observed after primary surgery, supporting some intervention on the axilla. If AxLND is limited to I and II level, the involvement of the III level up to 31% of the cases seems to require some additional treatment, while the omission in selected cases needs further investigation.
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http://dx.doi.org/10.1016/j.radonc.2021.08.013DOI Listing
August 2021
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