PSYChosomatic Medicine in ONcologIc and Cardiac Disease (PSYCHONIC) Study-A Retrospective and Prospective Observational Research Protocol.

Psychosocial factors play an important role in non-communicable diseases (NCDs). This observational study is primarily aimed at assessing the relationship of psychological characteristics of patients with the outcomes of different NCDs, and to assess short-term psychotherapy (STP) efficacy in the real world. Methods: One hundred and forty patients with recent acute myocardial infarction, Takotsubo syndrome, or non-metastatic breast cancer and a control group of 140 age and sex-matched healthy subjects, will be enrolled. All subjects will be administered psychometric tests, quality of life tests, a specific body perception questionnaire, a dream questionnaire, and a projective test, the Six Drawing test at baseline and follow-up. All subjects with medical conditions will be asked to freely choose between an ontopsychological STP along with standard medical therapy and, whenever indicated, rehabilitation therapy or medical therapy plus rehabilitation alone. The study endpoints will be to evaluate: the relationship of the psychological characteristics of enrolled subjects with the outcomes of different NCDs, predictors of the choice of psychotherapy, and the efficacy of ontopsychological intervention on psychological and medical outcomes. Conclusion: This study will generate data on distinctive psychological characteristics of patients suffering from different CDs and their relationship with medical outcomes, as well as explore the efficacy of ontopsychological STP in these patients in the real world. (Number of registration: NCT03437642).

IOERT versus external beam electrons for boost radiotherapy in stage I/II breast cancer: 10-year results of a phase III randomized study.

BACKGROUND: Intraoperative radiotherapy with electrons (IOERT) boost could be not inferior to external beam radiotherapy (EBRT) boost in terms of local control and tissue tolerance. The aim of the study is to present the long-term follow-up results on local control, esthetic evaluation, and toxicity of a prospective study on early-stage breast cancer patients treated with breast-conserving surgery with an IOERT boost of 10 Gy (experimental group) versus 5 × 2 Gy EBRT boost (standard arm). Both arms received whole-breast irradiation (WBI) with 50 Gy (2 Gy single dose). METHODS: A single-institution phase III randomized study to compare IOERT versus EBRT boost in early-stage breast cancer was conducted as a non-inferiority trial. Primary endpoints were the evaluation of in-breast true recurrences (IBTR) and out-field local recurrences (LR) as well as toxicity and cosmetic results. Secondary endpoints were overall survival (OS), disease-free survival (DFS), and patient's grade of satisfaction with cosmetic outcomes. RESULTS: Between 1999 and 2004, 245 patients were randomized: 133 for IOERT and 112 for EBRT. The median follow-up was 12 years (range 10-16 years). The cumulative risk of IBTR at 5-10 years was 0.8% and 4.3% after IOERT, compared to 4.2% and 5.3% after EBRT boost (p = 0.709). The cumulative risk of out-field LR at 5-10 years was 4.7% and 7.9% for IOERT versus 5.2% and 10.3% for EBRT (p = 0.762). All of the IOERT arm recurrences were observed at > 100 months' follow-up, whereas the mean time to recurrence in the EBRT group was earlier (55.2 months) (p < 0.05). No late complications associated with IOERT were observed. The overall cosmetic results were scored as good or excellent in physician and patient evaluations for both IOERT and EBRT. There were significantly better scores for IOERT at all time points in physician and patient evaluations with the greatest difference at the end of EBRT (p = 0.006 objective and p = 0.0004 subjective) and most narrow difference at 12 months after the end of EBRT (p = 0.08 objective and p = 0.04 subjective analysis). CONCLUSION: A 10-Gy IOERT boost during breast-conserving surgery provides high local control rates without significant morbidity. Although not significantly superior to external beam boosts, the median time to local recurrences after IOERT is prolonged by more than 4 years.

Short course radiotherapy and delayed surgery for locally advanced rectal cancer in frail patients: is it a valid option?

OBJECTIVE: The endpoint of the present study was to evaluate the outcomes of short-course radiotherapy (SCRT) and SCRT with delayed surgery (SCRT-DS) on a selected subgroup of frail patients with locally advanced middle/low rectal adenocarcinoma. METHODS: From January 2008 to December 2018, a total of 128 frail patients with locally advanced middle-low rectal adenocarcinoma underwent SCRT and subsequent restaging for eventual delayed surgery. Rates of complete pathological response, down-staging, disease free survival (DFS) and overall survival (OS) were analyzed. RESULTS: 128 patients completed 5 × 5 Gy pelvic radiotherapy. 69 of these were unfit for surgery; 59 underwent surgery 8 weeks (average time: 61 days) after radiotherapy. Downstaging of T occurred in 64% and down-staging of N in 50%. The median overall survival (OS) of SCRT alone was 19.5 months. The 1-year, 2-year, 3-year and 5-year OS was 48%, 22%, 14% and 0% respectively. In the surgical group, the median disease-free survival (DFS) and median OS were, respectively, 67 months (95% CI 49.8-83.1 months) and 72.1 months (95% CI 57.5-86.7 months). The 1, 2, 3, 5-year OS was 88%, 75%, 51%, 46%, respectively. Post-operative morbidity was 22%, mortality was 3.4%. CONCLUSIONS: Frail patients with advanced rectal cancer are often "unfit" for long-term neoadjuvant chemoradiation. A SCRT may be considered a valid option for this group of patients. Once radiotherapy is completed, patients can be re-evaluated for surgery. If feasible, SCRT and delayed surgery is the best option for frail patients.

Perfusion Computed Tomography (PCT) adopting different perfusion metrics: recurrence of brain metastasis or radiation necrosis?

OBJECTIVE: Different perfusion metrics were investigated to determine the accuracy of Perfusion CT (PCT) in differentiating recurrence of brain metastases from radiation necrosis in patients who previously underwent stereotactic radiation therapy (SRT). PATIENTS AND METHODS: Twenty patients previously treated with SRT underwent PCT examination of the brain. Normalized Cerebral Blood Volume (nCBV) values within the region of interest (ROI) were calculated. Fractional volumes at nCBV values between 1.0 and 2.25, defined as V(1.0)-V(2.25), were derived as alternative metrics and compared to the conventional method based on the mean CBV value within the lesion (nCBV(mean)). The Mann-Whitney test was used to compare the two patient's groups with recurrence and radiation necrosis with respect to the different nCBV metrics. Predictive powers and optimal thresholds for both the nCBV(mean) and the V(1.0)-V(2.25) were evaluated using the Receiver Operating Characteristic Curves. The gold standard was represented either by the histopathological examination or the Magnetic Resonance (MR) imaging follow-up longer than six months. RESULTS AND CONCLUSION: The differences between the patient's group with recurrence and that with radiation necrosis resulted statistically significant for all the metrics, showing the lowest p-value for V(1.75) and V(2). The metrics based on the fractional volumes were found to show higher predictive powers, with the highest value of 0.96 for V(2.0). Quantitative analysis of the CBV map deriving different metrics may potentially improve the diagnostic accuracy of PCT in differentiating brain metastasis recurrence from radiation necrosis.

Treatment of recurrent malignant gliomas with fotemustine monotherapy: impact of dose and correlation with MGMT promoter methylation.

BACKGROUND: In recurrent malignant gliomas (MGs), a high rate of haematological toxicity is observed with the use of fotemustine at the conventional schedule (100 mg/m(2) weekly for 3 consecutive weeks followed by triweekly administration after a 5-week rest period). Also, the impact of O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status on fotemustine activity has never been explored in the clinical setting. METHODS: 40 patients with recurrent pretreated MG were identified as being treated with fotemustine at doses ranging from 65 mg/m(2) to 100 mg/m(2). Patients were classified into 3 groups according to the dose of fotemustine received, from the lowest dosage received in group A, to the highest in group C. Analysis of MGMT promoter methylation in tumor tissue was successfully performed in 19 patients. RESULTS: Overall, 20% of patients responded to treatment, for a disease control rate (DCR, responses plus stabilizations) of 47.5%. Groups A and B experienced a response rate of 40% and 26.5% respectively, while the corresponding value for group C was 10%. Out of 19 patients, MGMT promoter was found methylated in 12 cases among which a DCR of 66.5% was observed. All 7 patients with unmethylated MGMT promoter were progressive to fotemustine. CONCLUSION: Low-dose fotemustine at 65-75 mg/m(2) (induction phase) followed by 75-85 mg/m(2) (maintenance phase) has an activity comparable to that of the conventional schedule. By determination of the MGMT promoter methylation status patients might be identified who are more likely to benefit from fotemustine chemotherapy.

Hypofractionated Conformal Radiotherapy (HCRT) for primary and metastatic lung cancers with small dimension : efficacy and toxicity.

PURPOSE: : To report on the clinical outcome of hypofractionated conformal radiotherapy (HCRT) for medically inoperable stage I non-small cell lung carcinoma (NSCLC) or limited pulmonary metastases or = 4 months were considered suitable for analysis. Local response was evaluated with CT imaging 4 months after the end of HCRT and every 3 months thereafter. Local relapse-free survival (LRFS) and overall survival (OS) were calculated with the Kaplan-Meier method. RESULTS: : Local response to the treatment was complete response, partial response, no change, and progressive disease as seen in 29%, 43%, 14%, and 7% of tumors, respectively. LRFS at 1 year and 3 years was 76% and 63%, respectively. Lung toxicities > or = grade 2 were observed in 4/40 patients, but no grade 4. Pericardial effusion occurred in one patient. In stage I NSCLC patients (n = 15) with a median follow-up of 25 months, the 1-year LRFS and OS rates were 88% and 81%, respectively, and the 3-year rates 72% and 61%, respectively. CONCLUSION: : HCRT is an effective and low-toxic treatment for medically inoperable early-stage lung cancers and pulmonary metastases for all clinicians lacking the aid of a dedicated stereotactic system.