Radiotherapy activities and technological equipment in Veneto, Italy: a report from the Rete Radioterapica Veneta.

BACKGROUND: Despite the pivotal role of radiotherapy in oncology, the provision of radiation treatments remains inadequate in many areas of the world. The present report is an assessment conducted among Radiation Oncology centers of Veneto region with the aim to collect information concerning radiotherapy assets and technological equipment availability. METHODS: Data concerning Veneto Radiation Oncology departments about radiotherapy activities, number of treatments, techniques used and radiotherapy machines available were collected. The reference time period was 2018. Reimbursement system databases and business intelligence systems were used. Extra-regional attraction and migration were evaluated. When available, data were compared to previous years. RESULTS: Veneto in 2018 was endowed with 1 megavolt unit for about 153,000 inhabitants. The number of megavolt machines per million inhabitants resulted to be 6.72. In 51% of radiotherapy treatments, intensity-modulated techniques were performed. Six percent of treatments were administered to extra-regional patients. CONCLUSION: Radiotherapy assets and equipment in Veneto seem to be appropriate to standard requests in terms of availability and technology.

Estimated direct costs of non-small cell lung cancer by stage at diagnosis and disease management phase: A whole-disease model.

BACKGROUND: Non-small cell lung cancer (NSCLC) is the first cause of cancer-related death among men and the second among women worldwide. It also poses an economic threat to the sustainability of healthcare services. This study estimated the direct costs of care for patients with NSCLC by stage at diagnosis, and management phase of pathway recommended in local and international guidelines. METHODS: Based on the most up-to-date guidelines, we developed a very detailed "whole-disease" model listing the probabilities of all potentially necessary diagnostic and therapeutic actions involved in the management of each stage of NSCLC. We assigned a cost to each procedure, and obtained an estimate of the total and average per-patient costs of each stage of the disease and phase of its management. RESULTS: The mean expected cost of a patient with NSCLC is 21,328 € (95% C.I. -20 897-22 322). This cost is 16 291 € in stage I, 19530 € in stage II, 21938 € in stage III, 22175 € in stage IV, and 28 711 € for a Pancoast tumor. In the early stages of the disease, the main cost is incurred by surgery, whereas in the more advanced stages radiotherapy, medical therapy, treatment for progressions, and supportive care become variously more important. CONCLUSIONS: An estimation of the direct costs of care for NSCLC is fundamental in order to predict the burden of new oncological therapies and treatments on healthcare services, and thus orient the decisions of policy-makers regarding the allocation of resources. KEY POINTS: SIGNIFICANT FINDINGS OF THE STUDY: The high costs of surgery make the early stages of the disease no less expensive than the advanced stages. WHAT THIS STUDY ADDS: An estimation of the direct costs of care is fundamental in order to orient the decisions of policy-makers regarding the allocation of resources.

Radiotherapy during COVID-19 pandemic. How to create a No fly zone: a Northern Italy experience.

BACKGROUND: SARS-CoV-2 pandemic represents a troubling health emergency but also a main challenge for the clinical governance of the system. Discontinuation of radiation treatments is not desirable and potentially life-threatening. On the other hand, accesses to hospital expose cancer patients to an increased risk of COVID-19 infection. We report our extended protocol, draft to manage clinical activities in our radiotherapy department, by minimizing contagion risks. METHODS: We used telephonic screening to assess the need for patient admission. A telephonic triage was performed to identify the presence of COVID-19 infection risk factors or symptoms. New treatments were stratified according to priority codes. A reserved entrance to radiotherapy department was assured for patients and staff. Surgical disposable mask was required for patients and caregivers. The activities were distributed during the whole workday, avoiding overlap to reduce aggregation. RESULTS: From 1st February 2020 to 31 March 2020, we reported an increase in the number of first medical examinations and treatments, compared to the same period of the previous year. Outpatients first medical examinations have been spread over the 12 working hours. No COVID-19 cases were detected. CONCLUSION: During COVID-19 pandemic, we introduced procedures that allowed us to ensure the continuity in oncological cares, with limited risks of infection for patients and staff.

Pituitary Non-Functioning Adenoma Disclosed at 18F-Choline PET/CT to Investigate a Prostate Cancer Relapse.

We report the incidental finding of a pituitary macroadenoma on an F-choline PET/CT in a patient with recurrent prostate cancer. The pituitary gland was clearly enlarged and intensely FDG avid (SUVmax, 6.6). The diagnosis was confirmed by a subsequent contrast-enhanced MR evaluation, and the macroadenoma was classified as nonfunctioning on the basis of normality of the specific serum hormonal profile. A follow-up F-choline PET/CT scan performed after 6 months revealed stable dimension, and uptake of the pituitary macroadenoma patient deceased 1 month later. At autopsy, intracytoplasmic vesicles containing growth and prolactin hormones were observed at immunohistochemistry.

Breakthrough pain management in patients undergoing radiotherapy: a national survey on behalf of the Palliative and Supportive Care Study Group.

AIMS: To assess the contribution of radiation oncologists in Italy in current management of breakthrough pain (BtP). METHODS: In 2012, the Palliative and Supportive Care Study Group of the Italian Association of Radiation Oncology (AIRO) proposed a survey. All Italian radiation oncologists were individually invited to complete an online questionnaire regarding their management of BtP in patients undergoing radiotherapy treatment. RESULTS: A total of 303 Italian radiation oncologists (of 330 who had access to the Web site) completed the questionnaire over an 8-month period. Some important differences were shown in pain intensity assessment by validated measurement scales, as well as in setting and prescribing analgesic therapy to prevent procedural pain. These differences were also reviewed and discussed related to international guidelines and data available from the literature. CONCLUSIONS: Compared to other medical professionals, the involvement of radiation oncologists in cancer pain management remains marginal, at least in Italy. More than 70% of radiation oncologists directly optimized the analgesic therapy during the treatment course and more than 50% implemented specific treatment for BtP. However, the ability of the radiation oncologist to manage BtP could be improved. In order to increase the consciousness of systematic symptom measurement and to spread the knowledge of the best type of analgesic drugs to be used, training events promoted by national associations, such as AIRO, and a collaborative multidisciplinary approach of the management of cancer pain will be promoted.

The first survey on defensive medicine in radiation oncology.

PURPOSE: Defensive Medicine occurs when doctors order tests, procedures, visits or avoid high-risk patients and procedures, primarily to reduce their exposure to malpractice liability. Some medical specialities are at "high-risk" for legal argument, but no data is actually available for radiation oncology. We present here the first survey of radiation oncologists' views regarding malpractice liability and defensive medicine practice. MATERIALS AND METHODS: A three-page questionnaire was sent to 611 active radiation oncologists, members of the Italian Association of Radiation Oncology (AIRO), with questions pertaining to the incidence, nature and causes in their practice of defensive medicine. RESULTS: A total of 361 questionnaires were completed (59 % feedback). Physicians practise defensive medicine by ordering further imaging studies (39 %) or laboratory tests (35 %), referring patients to consultants (43 %) or prescribing additional medication (35 %). Approximately, 70 % declared that the climate of opinion that exists towards doctors is one of the major issues for practising defensive medicine. CONCLUSION: Although radiation oncology is generally considered a "medium/low risk" speciality for defensive medicine, the present survey reflects a widespread use of this behaviour in daily practice. Investigating which radiation oncologist categories are more prone to defensive medical behaviour can be advantageous for implementing programmes aimed at improving awareness of this phenomenon and to increase good clinical practice.

Predictive factors for oropharyngeal mycosis during radiochemotherapy for head and neck carcinoma and consequences on treatment duration. Results of mycosis in radiotherapy (MIR): a prospective longitudinal study.

BACKGROUND AND PURPOSE: Oropharyngeal mycosis (OPM) is a complication of radiotherapy (RT) treatments for head and neck (H&N) cancer, worsening mucositis and dysphagia, causing treatment interruptions and increasing overall treatment time. Prophylaxis with antifungals is expensive. Better patient selection through the analysis of prognostic factors should improve treatment efficacy and reduce costs. MATERIALS AND METHODS: A multicentre, prospective, controlled longitudinal study, with ethics committee approval, examined H&N cancer patients who were candidates for curative treatments with radio-chemotherapy. Patients were divided in groups according to OPM appearance: before the starting of RT (cases), during RT (new cases) and never (no cases). RESULTS: Of 410 evaluable patients, 20 were existing cases, 201 new cases and 189 did not report OPM. In our study OPM appears in 42.4% of people >70years and in 58.2% of younger individuals (p=0.0042), and in 68.6% of women versus 50.8% of men (p=0.0069). Mucositis and dysphagia were higher and salivation reduced among people with OPM (p<0.0000). Patients with OPM had longer hospitalization (p=0.0002) and longer (>12days) treatment interruptions (p=0.0288). CONCLUSIONS: Patients with OPM had higher toxicity and a greater number of long treatment interruptions. Analyses of prognostic factors can help clinicians understand OPM distribution and select patients with the highest probability of OPM for antifungal prophylaxis.

Diarrhoea in irradiated patients: a prospective multicentre observational study.

AIMS: To determine the incidence of cancer treatment-induced diarrhoea in patients submitted to irradiation. METHODS: Forty-five Italian radiation oncology departments took part in this prospective observational study and a total of 1020 patients were enrolled. The accrual lasted three consecutive weeks; evaluation was based on diary cards filled in daily by patients during radiotherapy and one week after cessation. Diary cards recorded both the onset and intensity of diarrhoea. RESULTS: A total of 1004 patients were eligible for this analysis. 147/1004 (14.6%) patients had diarrhoea. The median minimum number of daily events was 1 (range 1-7) with a median maximum events of 3 (range 1-23). 82/147 patients (56.2%) had a drug prescription for diarrhoea. In the evaluation of the onset of diarrhoea, in multivariate analysis, we found the following factors to be statistically significant predictors of an increased likelihood of diarrhoea: primitive tumour site, therapeutic purpose and field size. CONCLUSIONS: Patients with abdominal-pelvic cancer, treated with curative purpose and using large field sizes are at high risk of cancer treatment-induced diarrhoea. Diarrhoea was also observed in patients treated at other sites. In this population group there is the need for more stringent monitoring during the delivery of radiation therapy.

18F-FDG-PET/CT in patients with breast cancer and rising Ca 15-3 with negative conventional imaging: a multicentre study.

OBJECTIVES: Breast cancer is the second cause of death in women in Europe and North America. The mortality of this disease can be reduced with effective therapy and regular follow up to detect early recurrence. Tumor markers are sensitive in detecting recurrent or residual disease but imaging is required to customize the therapeutic option. Rising tumor markers and negative conventional imaging (US, X-mammography, CT and MR) poses a management problem. Our aim is to assess the role of 18F-FDG-PET/CT in the management of post-therapy patients with rising markers but negative conventional imaging. MATERIALS AND METHODS: In the period from January 2008 to September 2009, 89 female patients with breast cancer who developed post-therapy rising markers (serum Ca 15-3 levels=64.8±16.3 U/mL) but negative clinical examination and conventional imaging were investigated with 18F-FDG-PET/CT. RESULTS: Tumor deposits were detected in 40/89 patients in chest wall, internal mammary nodes, lungs, liver and skeleton. The mean SUVmax value calculated in these lesions was 6.6±1.7 (range 3.1-12.8). In 23/40 patients solitary small lesion were amenable to radical therapy. In 7 out of these 23 patients a complete disease remission lasting more than 1 year was observed. CONCLUSIONS: 18F-FDG-PET/CT may have a potential role in asymptomatic patients with rising markers and negative conventional imaging. Our findings agree with other studies in promoting regular investigations such as tumor markers and 18F-FDG-PET/CT rather than awaiting the developments of physical symptoms as suggested by current guidelines since the timely detection of early recurrence may have a major impact on therapy and survival.

A prospective observational trial on emesis in radiotherapy: analysis of 1020 patients recruited in 45 Italian radiation oncology centres.

PURPOSE: A prospective observational multicentre trial was carried out to assess the incidence, pattern, and prognostic factors of radiation-induced emesis (RIE), and to evaluate the use of antiemetic drugs in patients treated with radiotherapy or concomitant radio-chemotherapy. The application in clinical practice of the Multinational Association of Supportive Care in Cancer guidelines was also studied. MATERIALS AND METHODS: Forty-five Italian radiation oncology centres took part in this trial. The accrual lasted for 3 consecutive weeks and only patients starting radiotherapy or concomitant radio-chemotherapy in this period were enrolled. Evaluation was based on diary card filled in daily by patients during treatment and one week after stopping it. Diary card recorded the intensity of nausea/vomiting and prophylactic/symptomatic antiemetic drug prescriptions. RESULTS: A total of 1020 patients entered into the trial, and 1004 were evaluable. Vomiting and nausea occurred in 11.0% and 27.1% of patients, respectively, and 27.9% patients had both vomiting and nausea. In multifactorial analysis, the only statistically significant patient-related risk factors were concomitant chemotherapy and previous experience of vomiting induced by chemotherapy. Moreover, two radiotherapy-related factors were significant risk factors for RIE, the irradiated site (upper abdomen) and field size (>400 cm(2)). An antiemetic drug was given only to a minority (17%) of patients receiving RT, and the prescriptions were prophylactic in 12.4% and symptomatic in 4.6%. Different compounds and a wide range of doses and schedules were used. CONCLUSIONS: These data were similar to those registered in our previous observational trial, and the radiation oncologists' attitude in underestimating RIE and under prescribing antiemetics was confirmed.

Long-term prognostic value of 18F-FDG PET in patients with locally advanced rectal cancer previously treated with neoadjuvant radiochemotherapy.

OBJECTIVE: The purpose of this study was to assess the prognostic value of (18)F-FDG PET performed at restaging in patients with locally advanced rectal cancer who previously underwent neoadjuvant radiochemotherapy. SUBJECTS AND METHODS: Eighty-eight patients with histologically proven rectal cancer classified at clinical TNM stages II and III were enrolled. Six weeks after radiochemotherapy completion, all patients were restaged by sonography, CT, MRI, endoscopy, and (18)F-FDG PET. Surgery was performed in all patients within 8-9 weeks from completion of radiochemotherapy. Median follow-up after surgery was 38 months (range, 6-66 months). RESULTS: The 5-year overall survival and disease-free survival were 83% and 73%, respectively. Cox multivariate analysis showed that only two parameters at restaging were independent prognostic predictors of both overall survival and disease-free survival: pathologic stage and, especially, after radiochemotherapy (18)F-FDG PET findings. The 5-year overall survival was 91% in patients with a negative PET after radiochemotherapy versus 72% in those with a positive PET (p = 0.024) after radiochemotherapy, whereas disease-free survival was 81% and 62% (p = 0.003) for those with the negative and positive PET findings, respectively. Statistical data were further enhanced when combining the pathologic stage with the (18)F-FDG PET results: 95% 5-year overall survival in the PET-negative pathologic stages 0 and I patients versus 70% in PET-positive pathologic stages II-IV patients (p = 0.001), whereas disease-free survival was 93% and 65% (p = 0.0003) for the negative and positive PETs, respectively. CONCLUSION: In patients with locally advanced rectal cancer previously treated with neoadjuvant radiochemotherapy, the combined evaluation of pathologic stage and after-radiochemotherapy (18)F-FDG PET at restaging identified a subgroup of patients characterized by good response to radiochemotherapy and a more favorable prognosis. In these patients, a conservative surgical approach might be considered.

Italian survey in postoperative radiation therapy for prostate carcinoma by the AIRO National Working Group on Prostate Radiotherapy: definitive results.

AIMS AND BACKGROUND: The National Working Group on Prostate Radiotherapy of AIRO (Associazione Italiana Radioterapia Oncologica, Italian Association of Radiotherapeutic Oncology) was established in March 2001. A retrospective multi-center survey was performed to analyze the patterns of care for prostate cancer patients treated with postoperative radiotherapy following radical prostatectomy in Italy with regard to the year 2000. MATERIALS AND METHODS: A structured questionnaire was mailed to 47 Italian radiotherapy centers to assess patient accrual in the postoperative setting in the interval comprised between period January-December 2000. Numbers of patients treated for different stages, specific prognostic factors indicating the need for adjuvant radiotherapy, fractionation schedules and prescription doses were acquired as well as other clinically important factors such as radiotherapy timing and the use of hormone therapy. More technical features of the treatment, such as patient positioning, mode of simulation, typical field setup and dose prescription criteria were also included in the questionnaire. RESULTS: The questionnaire was returned by 24 radiotherapy Institutions (51%) with a total number of 470 patients treated postoperatively in the year 2000. An average of about 20 patients were enrolled by each radiotherapy center. The age range was 45-81 years. Radiotherapy was delivered within 6 months of radical prostatectomy in 297 patients (65.4%) (mean, 3.4 months). In 157 (34.6%), the treatment was delivered as a salvage approach for biochemical or micro-macroscopic recurrence. Most of patients had locally advanced stage disease (pT3-pT4) (76%). Unfavorable prognostic factors, such as positive margins, capsular invasion, Gleason pattern score > 7 were present in about 50% of patients. CONCLUSIONS: The study confirmed that important risk factors for recurrences are present in a significant percentage of patients treated by radical prostatectomy. The number of patients that would benefit from adjuvant radiotherapy is therefore potentially very large. Future prospective studies should be conducted to assess and to clarify the respective roles of adjuvant and salvage radiotherapy in prostate cancer patients.

Information priorities of Italian early-stage prostate cancer patients and of their health-care professionals.

The study was designed to compare the information priorities of Italian early-stage prostate cancer patients to those of their health-care professionals. Doctors (urologists and oncologists), nurses, radiation therapy technologist (RTs), and patients treated with radiotherapy in Northern Italy were surveyed. Respondents rated the importance of addressing each of 78 questions as: essential, important, or superfluous. We compared priorities between pairs of groups by correlating the percentage of each group that rated each question (a) essential and (b) superfluous. We assessed within-group agreement by identifying questions that >50% of one response. Fifty-nine doctors, 53 nurses, and 45 RTs (overall 70% response rate) and 50 patients (91% response rate) participated. All correlations between professional groups were high (all >0.74). All professional group-patient correlations were significant but much lower than those among the professionals. More importantly, there was considerable variation within each group: within each group, almost all questions were rated essential by some members but less than seven of the 78 questions were rated so by half (or more) of its members. In addition, almost all questions were also rated superfluous by some members of each profession. We concluded that the professional groups appear to agree with one another on questions essential and those superfluous to address more than they agree with a group of their patients. More importantly, there is considerable disagreement within each group. The results imply that the professionals cannot assume that their own information priorities are the same as those of their patients.

Restaging after neoadjuvant chemoradiotherapy for rectal adenocarcinoma: role of F18-FDG PET.

Multimodality treatment of loco-regional advanced rectal cancer has demonstrated to improve local control and overall survival. Proctoscopy, digital rectal examination (DRE), computer tomography (CT), endorectal ultrasound (ERUS), and magnetic resonance imaging (MRI) cannot correctly detect downstaging in rectal tumors after chemo radiation therapy (CRT). New imaging techniques, like 18F-FDG PET, may play some role in predicting the pathologic response to CRT before surgical resection. Aim of the present study was to further investigate the accuracy and predictive value of 18F-FDG PET in a large series of patients with rectal cancer treated with preoperative intensified CRT. Between January 2000 and December 2003, 81 patients with histologically proven adenocarcinoma in clinical stage II-III disease, according to criteria of TNM classification, were included in this study. All patients were submitted to diagnostic staging workup with DRE, proctoscopy with biopsy, ERUS, CT scan of the abdomen and pelvis or pelvic MRI plus liver ultrasonography, coloscopy or barium colonic enema. One month later the end of CRT all patients were submitted to diagnostic restaging work-up (DRW) and 18F-FDG PET. Surgery was performed 8-9 weeks after the end of CRT and pathologic stage was defined. Moreover a pathologic assessment of tumor regression was made with tumor regression grade score (TRG). PET correctly identified 22/28 (79% specificity) patients with complete pathologic response (pCR). However, sensitivity was 45% (24/53) while PPV, and NPV were equal to 77 and 43%, respectively. Total PET accuracy rate was 56%. PET sensitivity increased from 45 to 56% if the end-point was pCR, or TRG score, respectively. The best correlation was found between PET findings and pathologic stage (P <0.01) or TRG score (P <0.01). The accurate identification of rectal cancer patients with major pathological response after preoperative CRT further supports the necessity of designing prospective studies with new and more accurate was imaging technologies with the main object of offering conservative treatment in responder patients.