Management of Metastatic Disease in Campania (MAMETIC): An Observational Multicenter Retrospective and Prospective Trial on Palliative Radiotherapy in an Italian Region. Study Protocol.

Background: In the Italian Campania Region, 30.517 new cases of solid cancer have been diagnosed, in 2019. Of those, patients with metastatic disease are up to 20%. This class of patients is extremely diversified and copious, and the offer of radiotherapy may vary in different geographical areas within the same region. The aim of this observational multicenter retrospective and prospective trial is to evaluate the occurrence of metastatic metastatic cancer patients candidates for palliative radiotherapy in several areas of a great Italian region, the management of the disease through RT approaches, and its impact on cancer-related pain and overall HRQoL. Methods: This is a multicenter, retrospective and prospective observational investigation. The retrospective part of the study concerns all patients enrolled with a diagnosis of metastatic disease and treated in RT centers within the Campania Region between January 2019 and July 2020. The prospective phase is going to involve all the metastatic patients with an indication of palliative RT. Considering regional epidemiological data, we expect an enrollment of 12.500-21.000 patients in 5 years. Conclusion: The MAMETIC Trial in an observational study designed for investigating on the use of radiotherapy in patients with advanced disease within a regional area, and for evaluating the local response to the patient's request. It can be a unique opportunity, not only to highlight possible geographic differences but also to regularly collect and share data to standardize the therapeutic offer within the regional area. ClinicalTrials.gov ID NCT04595032, retrospectively registered.

Validation of DWI in assessment of radiotreated bone metastases in elderly patients.

Bone metastases are commonly observed in oncologic patients with advanced disease. These metastases are considered the main cause of neoplastic pain, with more than half of oncologic patients experiencing neoplastic pain during the course of the disease due to bone involvement. Lung, breast, and prostate cancers are the primary causes of bone metastases. Magnetic resonance imaging (MRI), especially diffusion weighted imaging (DWI) sequences, is the focus of our research, as it has been proven to be an optimal predictive index to assess the radiation treatment in many patients. We included patients treated with standard fractioning of radiation therapy. First, we examined the irradiated lesions with the MRI-DWI technique, before treatment and 30 and 60 days after its completion. Then we combined the MRI results and clinical parameters in a table with a predictive score for the quality of life in patients with bone metastases. This was a significant predictor of the efficacy of radiation treatment, from both clinical and psychological points of view, as it can allow an early assessment of the response to RT and therefore better scheduling of the next therapeutic steps to be performed. The table of the score we proposed helped guide patient monitoring, enabling us to undertake, where possible, follow-up with therapeutic strategies tailored to each patient's needs.

Short-course radiotherapy in elderly women with breast cancer: Comparison by age, comorbidity index and toxicity.

BACKGROUND: Breast cancer is the most common malignancy amongst elderly women. It represents the main cause of mortality for those women and it is steadily increasing. The primary therapeutic approach remains surgery, as in other age groups. The role of radiotherapy following surgery is still debated. The use of hypofractionated schedules is challenging the standard fractionation and has now been considered an advantageous option within this subgroup of patients. Results from randomized controlled trials have not been shown to be inferior to standard fractionation in terms of local recurrence, disease-free survival and overall survival. Acute and late side effects were not increased by hypofractionated regimens. PATIENTS AND METHODS: 60 elderly women treated by hypofractionated radiotherapy after breast conserving surgery were stratified by age. Comorbidities associated compliance and toxicity correlation to age were the first endpoints of the study. Comorbidity associated compliance was calculated by Cumulative Illness Rating Scale Geriatric. RESULTS: At a median follow-up of 15 months overall survival was 100%, without severe late toxicity. No statistical significant differences were found between Cumulative Illness Rating Scale-Geriatric, systemic therapy and toxicity. CONCLUSION: In our experience hypofractioned regimens seem to be safe and reliable in the elderly setting, although longer follow up is needed.