Pietro Caldarella

Full-Dose Intraoperative Radiotherapy With Electrons During Breast-Conserving Surgery: Experience With 590 Cases

Background:Previous studies show that local recurrences after breast-conserving treatment occur in the site of the primary tumor. The need for postoperative radiotherapy on the whole breast is challenged in favor of radiotherapy limited to the area of the breast at high risk of recurrence. The new mobile linear accelerators easily moved close to the operating table to allow the full-dose irradiation during surgery. Patients and Methods:From July 1999 to December 2003, 590 patients affected by unifocal breast carcinoma up to a diameter of 2.5 cm received wide resection of the breast followed by intraoperative radiotherapy with electrons (ELIOT). Most patients received 21 Gy intraoperatively, biologically equivalent to 58 to 60 Gy in standard fractionation. Patients were evaluated 1, 3, 6, and 12 months after surgery, and thereafter every 6 months, to look for early, intermediate, late complications, and other events. Results:After a follow-up from 4 to 57 months (mean, 24 months; median, 20 months), 19 patients (3.2%) developed breast fibrosis, mild in 18, severe in 1, which resolved within 24 months. Three patients (0.5%) developed local recurrences, 3 patients ipsilateral carcinomas in other quadrants and other 5 patients contralateral breast carcinoma. One patient (0.2%) died of distant metastases. Conclusions:ELIOT is a safe method for treating conservatively operated breasts, avoids the long period of postoperative radiotherapy, and reduces drastically the cost of radiotherapy. ELIOT reduces radiation to normal tissues and organs. Results on short-term and middle-term toxicity up to 5 years of follow-up are good. Data on local control are encouraging.

Axillary metastases in breast cancer patients with negative sentinel nodes: a follow-up of 3548 cases.

UNLABELLED PREMISES: Sentinel node biopsy (SNB) in patients with breast carcinoma accurately predicts the axillary node status. However, in some 4-7% of patients with negative sentinel nodes, the remaining axillary nodes harbour cancer cells. OBJECTIVE Our purpose was the long-term observation of a large number of patients who did not receive axillary dissection after a negative sentinel node biopsy, in order to evaluate the incidence of overt axillary metastases. METHODS Patients (3548) treated from 1996 to 2004, with negative sentinel nodes not submitted to axillary dissection, were followed up to 11 years with a median follow-up of 48 months. RESULTS Three hundred and sixteen unfavourable events occurred among the 3548 patients, 196 of which (5.5%) related to primary breast carcinoma. Thirty one cases of overt axillary metastases were found (0.9%): they received total axillary dissection and 27 of them are at present alive and well. The 5-year overall survival rate of the whole series was 98%. CONCLUSIONS Patients with negative sentinel node biopsy not submitted to axillary dissection show, at follow-up, a rate of overt axillary metastases lower than expected.

The surgical margin status after breast-conserving surgery: discussion of an open issue

Hypothesis The best therapeutic approach to the involved or proximal surgical margins has not been defined yet; surgical margins status can influence the local relapse of disease in breast carcinoma, but the impact on overall survival has not been clearly demonstrated. Purpose of this work is to find in the available literature further evidence to guide the therapeutic behaviour in patients with close margins by invasive carcinoma. Design Review of the currently available literature on the evaluation of surgical margins in breast conserving surgery; influence of margin involvement by invasive component or intraductal component. Patients or other participants Literature research by PubMed on the topics of breast carcinoma, conservative surgery and margin definition and status; therapeutic approach to involved margins. Main outcome measure We reviewed the available literature focusing our attention to the definition of clear surgical margins and to the value of the close proximity of margins in relation to the local control of disease and the best therapeutic management of different situations. Results Further evidence is needed on large numbers of patients to understand how to evaluate surgical margins in invasive breast carcinoma. Conclusions There is no consensus on the definition of “clear surgical margins”, and the ideal approach to the close proximity of margins has not been defined. It is not sure whether a new surgical procedure is really needed in every case of close proximity of tumor cells to the margins. Radiation therapy could be a good option in the management of these cases, but further evidence is needed to establish the real impact of clear surgical margins on local control of disease and, furthermore, on survival.

The indocyanine green method is equivalent to the 99mTc-labeled radiotracer method for identifying the sentinel node in breast cancer: A concordance and validation study

AIMS The aim of this study was to assess concordance between the indocyanine green (ICG) method and (99m)Tc-radiotracer method to identify the sentinel node (SN) in breast cancer. Evidence supports the feasibility and efficacy of the ICG to identify the SN, however this method has not been prospectively compared with the gold-standard radiotracer method in terms of SN detection rate. METHODS Between June 2011 and January 2013, 134 women with clinically node-negative early breast cancer received subdermal/peritumoral injection of (99m)Tc-labeled tracer for lymphoscintigraphy, followed by intraoperative injection of ICG for fluorescence detection of SNs using an exciting light source combined with a camera. In all patients, SNs were first identified by the fluorescence method (ICG-positive) and removed. A gamma ray-detecting probe was then used to determine whether ICG-positive SNs were hot ((99m)Tc-positive) and to identify and remove any (99m)Tc-positive (ICG-negative) SNs remaining in the axilla. The study was powered to perform an equivalence analysis. RESULTS The 134 patients provided 246 SNs, detected by one or both methods. 1, 2 and 3 SNs, respectively, were detected, removed and examined in 70 (52.2%), 39 (29.1%) and 17 (12.7%) patients; 4-10 SNs were detected and examined in the remaining 8 patients. The two methods were concordant for 230/246 (93.5%) SNs and discordant for 16 (6.5%) SNs. The ICG method detected 99.6% of all SNs. CONCLUSIONS Fluorescent lymphangiography with ICG allows easy identification of axillary SNs, at a frequency not inferior to that of radiotracer, and can be used alone to reliably identify SNs.

Sentinel node biopsy after neoadjuvant treatment in breast cancer: Five-year follow-up of patients with clinically node-negative or node-positive disease before treatment.

PURPOSE It is controversial whether sentinel node biopsy (SNB) without axillary dissection (AD) should be performed in cN1/2 breast cancer patients who become cN0 after neoadjuvant treatment, since the false negative rate (FNR) may be unacceptably high. We assessed outcomes to address this issue. METHODS We retrospectively assessed 396 cT1-4, cN0/1/2 patients, who became or remained cN0 after neoadjuvant treatment and underwent SNB with at least one sentinel node (SN) found, and AD not performed if the SN was negative. RESULTS After a median follow-up of 61 months (interquartile range 38-82), five-year overall survival was 90.7% (95% CI, 87.7-93.7) in the whole cohort, 93.3% (95% CI, 90.0-96.6) in those initially cN0, and 86.3% (95% CI, 80.6-92.1) in those initially cN1/2 (P = 0.12). Axillary failure occurred in only 1 (0.7%) initially cN1/2 patient who became cN0. In initially cN0 patients, and also initially cN1/2 patients who responded well to neoadjuvant treatment (ypT0/ypTx), SN-negativity was a significant predictor of good outcome, consistent with the known prognostic significance of axillary status, and suggesting that SN status accurately reflected axillary status. By contrast, in initially cN1/2 patients found to be ypT1/2/3, SN status (and whether or not AD was performed) had no influence on survival. CONCLUSIONS These findings suggest that SNB is acceptable in cN1/2 patients who become cN0 after neoadjuvant therapy.

Immediate breast reconstruction after mastectomy

AIMS There is a general agreement for immediate breast reconstruction in case of in situ tumors, while the reconstruction is often still delayed in cases of invasive cancers or not performed in the elderly cohort. Aim of this review is to investigate the safety of immediate postmastectomy reconstruction for invasive cancers and in the elderly population. METHODS AND RESULTS We reviewed our series and the recent literature on this topic. While there is a general consensus that advanced age is not a contraindication to immediate reconstruction and breast reconstruction can be successfully performed on well-selected elderly patients, many oncologists in Europe do not prefer immediate reconstruction for invasive carcinoma, advocating the risk of delay of the medical adjuvant treatment in case of complications due to the reconstructive procedure. Our experience and a lot of studies suggest that immediate breast reconstruction is a safe and reliable treatment option in case of invasive cancers. However, if postmastectomy irradiation is necessary on the basis of the final pathological finding, this is associated with a high rate of surgical complications and implant loss among patients who underwent immediate reconstruction with prostheses. Moreover, current evidence suggests that postmastectomy radiation therapy also adversely affects autologous tissue reconstruction. CONCLUSIONS Immediate breast reconstruction after mastectomy is an integral part of the complete management of breast cancer. Determining the risk of postmastectomy irradiation prior to definitive resection and reconstructive operations may reduce complications and improve aesthetic outcomes by guiding surgical decision making.

The sentinel lymph node biopsy under local anesthesia in breast carcinoma: experience of the European Institute of Oncology and impact on quality of life.

AbstractBackground: Sentinel lymph node biopsy performed under local anesthesia currently represents one of the main fields of investigation in breast cancer surgery because of its positive impact on the management and organisation of treatment. We previously published our preliminary experience with 115 patients; here we present an update of our experience with particular attention devoted to quality of life.Patients and methods: From September 2000 to April 2003 we treated 244 patients with this technique. We developed a ‘questionnaire of impact on quality of life – LA’ to be administered to these patients, to assess their reactions to the procedure: we administered the questionnaire to 243 patients. Our aim was to verify whether the advantages in terms of treatment planning are accompanied by an improvement in quality of life and a good degree of acceptance by the patients.Results: The questionnaire was administered to the patients during follow-up and we obtained positive results; the impact of the procedure under local anesthesia was positive for 81% of patients, while the remaining 19% reported that it had ‘no impact at all’. We can conclude that axillary sentinel node biopsy, when performed under local anesthesia, meets with a very high degree of acceptance by the patients and exerts an optimal impact on quality of life.

The Changing Face of Mastectomy (from Mutilation to Aid to BreastReconstruction)

Breast cancer is the most common cancer in women. Primary treatment is surgery, with mastectomy as the main treatment for most of the twentieth century. However, over that time, the extent of the procedure varied, and less extensive mastectomies are employed today compared to those used in the past, as excessively mutilating procedures did not improve survival. Today, many women receive breast-conserving surgery, usually with radiotherapy to the residual breast, instead of mastectomy, as it has been shown to be as effective as mastectomy in early disease. The relatively new skin-sparing mastectomy, often with immediate breast reconstruction, improves aesthetic outcomes and is oncologically safe. Nipple-sparing mastectomy is newer and used increasingly, with better acceptance by patients, and again appears to be oncologically safe. Breast reconstruction is an important adjunct to mastectomy, as it has a positive psychological impact on the patient, contributing to improved quality of life.

Long-term side effects and cosmetic outcome in a pool of breast cancer patients treated with intraoperative radiotherapy with electrons as sole treatment

AIMS To evaluate late toxicity and cosmetic outcome after intraoperative radiotherapy using electrons (ELIOT) as sole treatment modality in early breast cancer patients. METHODS A total of 119 patients selected randomly among 1200 cases was analyzed. Late toxicities were documented using the LENT-SOMA scoring system, cosmesis was evaluated with the Harvard scale, and a numeric rating scale was used to assess symptoms. RESULTS After a median follow-up of 71 months, grade II fibrosis was observed in 38 patients (31.9%) and grade III fibrosis in 7 patients (5.9%). Postoperative complications (12.6%) did not correlate with late toxicity. Physicians and patients scored cosmesis as excellent or good in 84% and 77.3% of the cases, respectively. Patient satisfaction was higher than 90%. CONCLUSIONS In the study, ELIOT gives low and acceptable long-term toxicity. A longer follow-up and a larger number of patients are needed to confirm these promising results.

Synchronous bilateral breast cancer in men: a case report and review of the literature.

Breast carcinoma is a rare disease in men, and bilateral cases are extremely uncommon. The rarity of male breast carcinoma and the small number of large studies on this topic have made it necessary to extrapolate treatment standards and outcomes from those established for women. Between 1997 and 2007, 75 men with breast cancer were referred to our institute, and the bilateral case we present here was the only one we have observed since 1994. The goal of our work was to contribute to the available literature with this extremely unusual presentation of the disease.