Breast Cancer Surgery During the COVID-19 Pandemic: An Observational Clinical Study of the Breast Surgery Clinic at Ospedale Policlinico San Martino – Genoa, Italy

Patients and Methods

The study protocol was submitted to the Regional Ethics Committee; no specific consent was required since all clinical information was already mentioned in the standard Privacy Module that each patient signed at hospitalization.

Patient screening flowchart. From March 9^th to April 9th 2020, case-tailored flowcharts were developed to screen our patients for COVID-19 symptoms (fever, cough and respiratory symptoms) covering three distinct settings: Home, hospitalization, and post-discharge triage (Figures 1 and 2) (5-8). In-hospital and post-discharge triages were developed according to the recommendations of national legislation ISS COVID-19 n. 1/2020 (9-11) and WHO recommendations of February 27^th 2020 (12), and properly adapted to our local requirements.

Telephone triage. This was performed 7 days before the hospitalization by a dedicated Breast Care Nurse who was properly trained by our Infectious Disease Team as regards suspicious COVID-19 symptoms; the patient was kindly asked to contact the Breast Unit if symptoms of infection developed thereafter. The pool of questions is shown in Table I, and COVID-19 symptoms were classified according to major and minor criteria shown in Table II. When the patient tested positive for one major or at least two minor criteria, the Public Health Office was alerted for home monitoring and the surgical program was temporarily suspended; a new telephone triage was performed 2 weeks later. Patients who tested negative had a confirmatory telephone triage repeated on the day before hospitalization.

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Figure 2.

Flowchart of triage-based selection of patients.

In-hospital triage. As soon as the patient got to the Breast Unit, she followed a three-steps procedure before any interface with HCWs, that is: i) she used an automatic hand sanitizer dispenser; ii) she took a disposable face mask from an automatic dispenser, and iii) she wore disposable latex-free gloves (12-15). The nurse dedicated to the in-hospital triage was properly equipped with Personal Protective Equipment (PPE), that is: gloves, face mask, goggles, and gown (12-15). A COVID-19 questionnaire developed by the Hospital Department of Public Health Epidemiology was given to the patient, including health clinical data such as body temperature and any COVID-19 symptoms occurring during the past 2 weeks. The patient's body temperature was then detected by means of a tele-thermometer and only negative patients were permitted access to our Breast Unit; of note, the patient was introduced into the Breast Unit alone, with no family members; elderly patients and those with motor impairments were assisted by a dedicated HCW properly equipped with PPE until completion of all logistic procedures.

Hence, the patient submitted the certifications of these two triages (telephone and in-hospital triage) in the anteroom of the Breast Unit, and a second body temperature detection was acquired, always maintaining the correct interpersonal distance. After admission, the patient was immediately subjected to nasopharyngeal (NP) swab and humoral tests for IgM and IgG COVID-19 antibodies and, while waiting for the definitive results, she was isolated in a single room. Surgery was definitively scheduled as soon as the NP swab tested negative, while the COVID-19 serology test was performed only for investigational purpose and did not affect the surgical program. Whenever sentinel lymph-node biopsy (SLNB) was scheduled, the patient underwent lymphoscintigraphy at the Nuclear Medicine Department; surgery was re-scheduled if any logistic delay that precluded a timely lymphoscintigraphy occurred.

After completion of the operation, the surgeon contacted the patient's family members as indicated by the patient in order to clarify the immediate surgical outcome since no visitor was permitted into the ward. The patients were discharged as soon as they were clinically stable in order to minimize the risk of re-admission.

Post-discharge triage. A dedicated well-trained Breast Care nurse made a video-call to the patient at home on the first and third day after discharge in order to verify her clinical status (body temperature, pain level by means of Visual Analogue Scale, drainage volume and macroscopic appearance, etc.) while waiting for the first visit on the seventh post-operative day at the Outpatient Clinic, post-discharge visits being reduced to the minimum required (16). Whenever a patient developed COVID-19 related symptoms, Public Health Officers and Family Doctors were informed in order to monitor her clinical course.

Patient selection. The re-allocation to our Breast Unit of all patients with breast cancer coming from our Region required urgent and well-defined criteria to prioritize surgical timing without impairing the prognostic outcome or increasing the risk of infection among patients and HCWs. According to the American College of Surgeons guidelines, patients were divided into two groups: The treated group of patients, that is patients with an actual risk of impaired survival when surgery is delayed for more than 3 months; and secondly, the deferred group, that is patients for whom the surgical procedure might be delayed until resolution or mitigation of the COVID-19 pandemic (17).

Treated group:

• Patients who had completed neoadjuvant chemotherapy, regardless of T or N stages;

• Patients with clinical (c) T_1-2N0, estrogen receptor-/progesterone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer less than 50 years of age;

• Patients with cT₁N0 triple-negative or HER2-positive disease;

• Patients with highly suspicious (B4) tru-cut biopsy;

• Patients with local recurrence;

• Those who underwent re-excision surgery;

• Patients with cTisN0 breast cancer, especially with nodule/mass lesion, histological grade 3, or with extensive area of microcalcifications.

Deferred group:

• Patients who underwent excision of benign lesions (e.g. fibroadenoma or other benign nodules);

• Those with duct excision (i.e. suspected intraductal papilloma);

• Patients with likely-benign (B3) tru-cut biopsy;

• Patients who underwent prophylactic mastectomy for BRCA1/2 DNA repair associated gene-positive disease;

• Patients with cT_1-2N0 estrogen receptor-/progesterone receptor-positive, and HER2-negative breast cancer over 50 years of age undergoing neoadjuvant hormonal treatment;

• Those with complete response after neoadjuvant chemotherapy;

• Patients with cN positive regardless of cT stage re-directed to neoadjuvant chemotherapy.

Whenever possible, breast-conserving surgery was the preferred surgical option. Definitive mastectomy, either nipple-sparing mastectomy or simple mastectomy, with reconstruction performed when indicated to couple an oncological safe procedure with the best cosmetic outcome. All these clinical aspects were discussed weekly by means of video-conferencing within the Multidisciplinary Breast Cancer meetings, including patients coming from other Regional Breast Units.