The role of integrated psychological support in breast cancer patients: a randomized monocentric prospective study evaluating the Fil-Rouge Integrated Psycho-Oncological Support (FRIPOS) program.

PURPOSE: This study examined the effects of Fil-Rouge Integrated Psycho-Oncological Support (FRIPOS) in a group of women with breast cancer compared with a group receiving treatment as usual (TAU). METHODS: The research design was a randomized, monocentric, prospective study with three time points of data collection: after the preoperative phase (T0), in the initial phase of treatments (T1), and 3 months after the start of treatments (T2). The FRIPOS group (N = 103) and the TAU group (N = 79) completed a sociodemographic questionnaire, the Symptom Checklist-90-R (SCL-90-R) at T0; the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and EORTC QLQ-BR23 at T1; and SCL-90-R, EORTC QLQ-C30, and EORTC QLQ-BR23 at T2. RESULTS: A series of independent and paired t tests showed that patients in the FRIPOS group performed better on all scales related to symptomatic manifestations and on some quality of life scales (fatigue, dyspnea, and sleep disturbances) at T2. In addition, a series of ten multiple regressions were performed to predict each SCL subscale at T2 from the SCL score at T0 and the EORTC QLQ-C30 scores at T2. In nine of ten regression models (all except somatization), both FRIPOS group membership and QoL subscale contributed significantly to prediction. CONCLUSIONS: This study suggests that patients in the FRIPOS group have more benefits in emotional, psychological, and collateral symptoms than patients in the TAU group and that these improvements are due to integrated psycho-oncology care.

Almost one year of COVID-19 pandemic: how radiotherapy centers have counteracted its impact on cancer treatment in Lombardy, Italy. CODRAL/AIRO-L study.

Lombardy has represented the Italian and European epicenter of the coronavirus disease 2019 (COVID-19) pandemic. Although most clinical efforts within hospitals were diverted towards the care of virally infected patients, therapies for patients with cancer, including radiotherapy (RT), have continued. During both the first and second pandemic waves, several national and regional organizations provided Italian and Lombardian RT departments with detailed guidelines aimed at ensuring safe treatments during the pandemic. The spread of infection among patients and personnel was limited by adopting strict measures, including triage procedures, interpersonal distance, and adequate implementation of personal protective equipment (PPE). Screening procedures addressed to both the healthcare workforce and patients, such as periodic nasopharyngeal swabs, have allowed the early identification of asymptomatic or pauci-symptomatic COVID-19 cases, thus reducing the spread of the infection. Prevention of infection was deemed of paramount importance to protect both patients and personnel and to ensure the availability of a minimum number of staff members to maintain clinical activity. The choice of treating COVID-19-positive patients has represented a matter of debate, and the risk of oncologic progression has been weighted against the risk of infection of personnel and other patients. Such risk was minimized by creating dedicated paths, reserving time slots, applying intensified cleaning procedures, and supplying personnel and staff with appropriate PPE. Remote working of research staff, medical physicists, and, in some cases, radiation oncologists has prevented overcrowding of shared spaces, reducing infection spread.

B3 Lesions at Vacuum-Assisted Breast Biopsy under Ultrasound or Mammography Guidance: A Single-Center Experience on 3634 Consecutive Biopsies.

The rate of upgrade to cancer for breast lesions with uncertain malignant potential (B3 lesions) diagnosed at needle biopsy is highly influenced by several factors, but large series are seldom available. We retrospectively assessed the upgrade rates of a consecutive series of B3 lesions diagnosed at ultrasound- or mammography-guided vacuum-assisted biopsy (VAB) at an EUSOMA-certified Breast Unit over a 7-year timeframe. The upgrade rate was defined as the number of ductal carcinoma in situ (DCIS) or invasive cancer at pathology after excision or during follow-up divided by the total number of B3 lesions. All lesions were reviewed by one of four pathologists with a second opinion for discordant assessments of borderline cases. Excision or surveillance were defined by the multidisciplinary tumor board, with 6- and 12-month follow-up. Out of 3634 VABs (63% ultrasound-guided), 604 (17%) yielded a B3 lesion. After excision, 17/604 B3 lesions were finally upgraded to malignancy (2.8%, 95% confidence interval [CI] 1.8-4.5%), 10/17 (59%) being upgraded to DCIS and 7/17 (41%) to invasive carcinoma. No cases were upgraded during follow-up. B3a lesions showed a significantly lower upgrade rate (0.4%, 95% CI 0.1-2.1%) than B3b lesions (4.7%, 95% CI 2.9-7.5%, p = 0.001), that had a 22.0 adjusted odds ratio for upgrade (95% CI 2.1-232.3). No significant difference was found in upgrade rates according to imaging guidance or needle caliper. Surveillance-oriented management can be considered for B3a lesions, while surgical excision should be pursued for B3b lesions.

Back to (new) normality-A CODRAL/AIRO-L survey on cancer radiotherapy in Lombardy during Italian COVID-19 phase 2.

BACKGROUND: Italy experienced one of the world's severest COVID-19 outbreak, with Lombardy being the most afflicted region. However, the imposed safety measures allowed to flatten the epidemic curve and hence to ease the restrictions and inaugurate, on the 4th of May 2020, the Italian phase (P) 2 of the pandemic. The present survey study, endorsed by CODRAL and AIRO-L, aimed to assess how radiotherapy (RT) departments in Lombardy have dealt with the recovery. MATERIALS AND METHODS: A questionnaire dealing with the management of pandemic was developed online and sent to all CODRAL Directors on the 10th of June 2020. Answers were collected in full anonymity one week after. RESULTS: All the 33 contacted RT facilities (100%) responded to the survey. Despite the scale of the pandemic, during P1 14 (42.4%) centres managed to safely continue the activity (≤ 10% reduction). During P2, 10 (30.3%) centres fully recovered and 14 (42.4%) reported an increase. Nonetheless, 6 (18.2%) declared no changes and, interestingly, 3 (9.1%) reduced activities. Overall, 21 centres (63.6%) reported suspected or positive cases within healthcare workforce since the beginning of the pandemic. Staff units were quarantined in 19 (57.6%) and 6 (18.2%) centres throughout P1 and P2, respectively. In the two phases, about two thirds centres registered positive or suspected cases amongst patients. CONCLUSION: The study revealed a particular attention to anti-contagion measures and a return to normal or even higher clinical workload in most RT centres in Lombardy, necessary to carry out current and previously deferred treatments.

Association between acute histopathological changes of rectal walls and late radiation proctitis following radiotherapy for prostate cancer.

PURPOSE: The impact of acute histopathological changes (HC) of the rectum on development of late clinical proctitis (LCP) after external radiotherapy (RT) for prostate cancer is poorly explored and was the primary end point of this prospective study. METHODS: In 70 patients, 15 HC of early rectal biopsies after RT were identified, whereby RT was conventional 2D RT in 41 cases and conformational 3D RT in 29. Associations of HC in anterior and posterior rectal walls (ARW, PRW) with LCP, acute endoscopic (AEP) and acute clinical proctitis (ACP) were statistically evaluated considering as explicative variables the patient general characteristics and the HC. RESULTS: The mean patients' follow-up was 123.5 months (24-209). The median prostatic dose was 72 Gy (2 Gy/fraction). For the 41 and 29 patients the ARW and PRW doses were 64 and 49 Gy vs. 63 and 50 Gy, respectively. The incidence of LCP ≥ grade 2 at 10 years was 12.9%. The univariate (p = 0.02) and Kaplan-Meyer methods (p = 0.007) showed that the gland (or crypts) loss in the ARW was significantly associated with LCP. AEP and ACP occurred in 14.3 and 55.7% of cases. At multivariate level AEP significantly correlated with hemorrhoids (p = 0.014) and neutrophilia in ARW (p = 0.042). CONCLUSIONS: Early after RT, substantial gland loss in ARW is predictive of LCP. To reduce this complication with conventional fractionation, we suggest keeping the mean dose to ARW ≤48-52 Gy.

Equipment, staffing, and provision of radiotherapy in Lombardy, Italy: Results of three surveys performed between 2012 and 2016.

INTRODUCTION:: Several efforts are being implemented at the European level to measure provision of up-to-date radiation treatments across the continent. METHODS:: A snapshot survey involving all radiation oncology centers within Lombardy, Italy, was performed in 2012 and repeated in 2014 and 2016, in cooperation with regional governmental officers. Centers were asked to provide detailed information concerning all individual patients being treated on the index day, and to report data on available local resources. RESULTS:: We observed an increase in the number of centers and of megavoltage units (MVU) (from 76 to 87, i.e., 8.7 MVU per million inhabitants in 2016). Mean number of MVU per center was 2.5. Average age of MVU increased from 5.3 to 7.5 years and patients on the waiting list also increased. Conformal 3D radiotherapy (RT) treatments decreased from 56% to 42% and were progressively replaced by intensity-modulated RT treatments (from 39% to 49%). Waiting times were overall satisfactory. Radiation oncologists treated on average 152 and radiation therapists 100 RT courses per year. Average reimbursement per course was €4,879 (range €2,476-€8,014). CONCLUSIONS:: The methodology of snapshot survey proved feasible and provided valuable information about radiation oncology provision and accessibility in Lombardy.

Urinary bladder preservation for muscle-invasive bladder cancer: a survey among radiation oncologists of Lombardy, Italy.

AIMS AND BACKGROUND: Bladder preservation is a treatment option in muscle-invasive bladder carcinoma. The most investigated approach is a trimodality schedule including maximum transurethral resection of bladder tumor (TURBT) followed by chemoradiotherapy. Our aim was to evaluate the use of bladder preservation by radiation oncologists of the Lombardy region in Italy. METHODS AND STUDY DESIGN: A survey with 13 items regarding data of 2012 was sent to all 32 radiotherapy centers within the collaboration between the Lombardy Oncological Network and the Lombardy Section of the Italian Society of Oncological Radiotherapy. RESULTS: Thirteen centers (41%) answered the survey; the presented data come from 11 active centers. In these centers, 11,748 patients were treated with external-beam radiotherapy in 2012, 100 of whom having bladder cancer (0.9%). 74/100 patients received radiotherapy as palliative treatment for T, N or M lesions. A further 9 and 5 patients received radiotherapy for oligometastatic disease (ablative doses to small volumes) and postoperatively, respectively. Bladder preservation was performed in 12 cases and included trimodality and other strategies (mainly TURBT followed by radiotherapy). A multidisciplinary urology tumor board met regularly in 5 of 11 centers. All responders declared their interest in the Lombardy multicenter collaboration on bladder preservation. CONCLUSIONS: Our survey showed that bladder preservation is rarely used in Lombardy despite the availability of the latest radiotherapy technologies and the presence of an urology tumor board in half of the centers. The initiative of multicenter and multidisciplinary collaboration was undertaken to prepare the platform for bladder preservation as a treatment option in selected patients.

Neurosurgical management and postoperative whole-brain radiotherapy for colorectal cancer patients with symptomatic brain metastases.

BACKGROUND: New systemic treatments for advanced colorectal cancer have conferred a survival advantage, allowing patients to reach a median survival of almost 2 years. Due to this remarkable life extension, the incidence of brain metastases, though still low, is progressively increasing over time. There is little reported data on the optimal strategy to manage brain lesions from colorectal cancer. METHODS: To explore the role of an aggressive approach to colorectal cancer brain metastases, we retrospectively collected and analyzed data from 30 patients who underwent neurosurgical resection + whole-brain radiotherapy between March 1998 and December 2006. Univariate (logrank) and multivariate (Cox's model) analyses were used to identify prognostic factors. RESULTS: Median age at the time of surgery was 66 years, median ECOG PS was 1, most patients (87%) had concomitant lung and/or liver metastases. Median number of previous chemotherapies was two, with half of the patients being exposed both to oxaliplatin and irinotecan. A median of 27 Gy of radiotherapy were administered to 16 patients after resection. At the time of the analysis, 29 out of 30 patients had died, with a median survival time after brain metastasectomy of 167 days (8-682). Only one patient died within a month from surgery. Median survival was significantly longer in patients who received postsurgical radiotherapy (7.6 vs. 4.7 months, P = 0.014). CONCLUSIONS: Neurosurgical management of symptomatic brain metastases from colorectal cancer is feasible, relatively safe, and offers a chance of prolonged survival. Patients who received radiotherapy after resection experienced a better outcome.

Radiotherapy resources for the care of head and neck patients in Italy. A survey by the head and neck group of the Italian Association for Radiation Oncology (AIRO).

AIMS AND BACKGROUND: In 2006 a survey was performed to define the resources available in Italy for the provision of radiotherapy services to head and neck cancer patients. This was the first initiative of the newly founded Head and Neck Group of the Italian Association for Radiation Oncology. METHODS: A questionnaire was sent to all 138 radiotherapy centers active in the country. Items investigated included total numbers of head and neck cancer patients treated per year, waiting time before the start of treatment, general technical issues, and integration with surgery and chemotherapy. RESULTS: Sixty-nine questionnaires were returned (50% response rate). The total number of patients treated was 4,670, averaging 68 cases per center. The larynx was the primary site most frequently involved. Average waiting time was 30 days and 47 days for nonresected and postoperative cases, respectively. The combination of chemotherapy and radiotherapy was delivered to nonresected and resected patients in 96% and 54% of centers, respectively. Survey response rates, waiting time, and the use of organ preservation protocols were the issues showing more variations across the country. CONCLUSIONS: This survey provides important data on radiotherapy resources available for head and neck cancer patients in Italy. The evidence of significant differences across the country concerning several relevant issues and the potential for cooperative clinical efforts in this relatively rare group of diseases urge the Group to plan further initiatives.

Prognostic value of pathologic complete response after neoadjuvant therapy in locally advanced rectal cancer: long-term analysis of 566 ypCR patients.

PURPOSE: In the literature, a favorable prognosis was observed for complete pathologic response after preoperative therapy (ypCR) in patients with locally advanced rectal cancer. The aim of this study is to verify whether ypCR predicts a favorable outcome in a large series of patients. METHODS AND MATERIALS: The Gastro-Intestinal Working Group of the Italian Association of Radiation Oncology collected clinical data for 566 patients with ypCR (ypT0N0) after neoadjuvant therapy. Eligibility criteria included locally advanced rectal cancer with no evidence of metastases at the time of diagnosis, evidence of ypCR after preoperative radiotherapy +/- chemotherapy (CT). RESULTS: Median radiation dose was 50 Gy. A total of 527 patients (93%) received one of 12 different neoadjuvant CT schedules. Sphincter preservation, anteroposterior resection, and endoscopic surgery were performed in 73%, 22%, and 5% of patients, respectively. Adjuvant CT was administered to 22% of patients. Median follow-up was 46.4 months. Locoregional recurrence occurred in 7 patients (1.6%). Distant metastases occurred in 49 patients (8.9%). Overall, 5-year rates of disease-free survival, overall survival, and cancer-specific survival were 85%, 90%, and 94%, respectively. In multivariate analysis, only age and clinical stage statistically correlated with survival outcome. Adjuvant CT was still of borderline significance (worse for adjuvant CT). No relation was found between survival and neoadjuvant CT schedules. CONCLUSION: A ypCR after neoadjuvant therapy identified a favorable group of patients, even in this large series of 566 patients collected in 61 centers. Locoregional recurrence occurred only in 1.6% patients.