Publications by authors named "C Sangalli"

91 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

The prolonged clinical benefit with metronomic chemotherapy (VEX regimen) in metastatic breast cancer patients.

Anticancer Drugs 2021 Aug 16. Epub 2021 Aug 16.

Division of Medical Senology, Istituto Europeo di Oncologia, IRCCS Department of Statistics and Quantitative Methods, University of Milan-Bicocca Data Management Division of pharmacy, Istituto Europeo di Oncologia, IRCCS Milan Research Unit Phase I Trials, ASST Monza, Monza Division of Senology Division of Pathology, Istituto Europeo di Oncologia, IRCCS Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.

Objective: Metronomic chemotherapy is a treatment option for metastatic breast cancer (MBC) patients who require prolonged disease control without cumulative toxicity. Data available on the efficacy and tolerability of prolonged usage of metronomic therapy are limited.

Methods: We analyzed patients with MBC, enrolled in a clinical trial, who obtained a prolonged clinical benefit for a duration of at least 12 months with vinorelbine 30 or 40 mg orally three times a week, cyclophosphamide 50 mg daily and capecitabine 500 mg three times a day (VEX regimen). The patients were treated at the European Institute of Oncology, Milan.

Results: We identified 67 MBC patients. The median age before starting the VEX regimen was 53 years. There were 59 patients (88%) who had hormone-receptors positive and HER2 negative BC. We had 37 patients who received VEX as the first-line treatment for MBC, while 30 patients were pretreated. The objective response rate was 49% (95% CI, 37-62). The median duration of VEX treatment after the first year was 14 months (min-max range 0.3-81.3 months). The progression-free survival at 3 years was 25.4% (95% CI, 15.7-36.2) and at 4 years was 18.5% (95% CI, 10.1-28.8 time 0 corresponds to 1 year after starting VEX). A total of 25 patients required a dose reduction, 7% of patients experienced G3 hand and foot syndrome.

Conclusions: Metronomic VEX regimen can induce prolonged clinical benefit in MBC. On the basis of this long-term safety evaluation, there is no evidence of specific cumulative or delayed toxicities with metronomic chemotherapy.
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http://dx.doi.org/10.1097/CAD.0000000000001209DOI Listing
August 2021

Primary Health Care Intervention Reduces Added Sugars Consumption During Childhood.

J Nutr Educ Behav 2021 Aug 14. Epub 2021 Aug 14.

Graduate Program in Pediatrics, Child and Adolescent Health Care, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil; Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil. Electronic address:

Objective: To investigate the effectiveness of a training program for health workers regarding infant feeding practices to reduce sugar consumption in children.

Design: A cluster randomized trial was conducted at 20 health centers in southern Brazil randomly assigned to an intervention (n = 9) or control (n = 11) group.

Participants: The 715 pregnant women enrolled were assessed when their children were aged 6 months, 3 years, and 6 years.

Intervention: A training session for primary care workers based on the Brazilian National Guidelines for Children.

Main Outcome Measure: Mothers were asked when sugar was first offered to children. Added sugars intake was obtained from dietary recalls.

Analysis: The effectiveness of the intervention was modeled using generalized estimation equations and Poisson regression with robust variance.

Results: Children attending intervention health centers had a 27% reduced risk of sugar introduction before 4 months of age (relative risk, 0.73; 95% confidence interval [CI], 0.61-0.87) as well as lower added sugars consumption (difference, -6.36 g/d; 95% CI, -11.49 to -1.23) and total daily energy intake (difference, -116.90 kcal/d; 95% CI, -222.41 to -11.40) at 3 years of age.

Conclusions And Implications: Health care worker training in infant feeding guidelines may be an effective intervention to delay the introduction of added sugars and lower the subsequent intake of added sugars in infants and toddlers.
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http://dx.doi.org/10.1016/j.jneb.2021.07.007DOI Listing
August 2021
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