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The European Medicines Agency strongly recommends administration of trabectedin through a central venous catheter (CVC) to minimize the risk of extravasation. However, CVCs place patients at risk of catheter-related complications and have a significant budgetary impact for oncology departments. The most frequently used CVCs are subcutaneously implanted PORT-chamber catheters (PORTs); peripherally inserted central venous catheters (PICCs) are relatively new. We reviewed data of trabectedin-treated patients to evaluate the relative cost-effectiveness of the use of PORTs and PICCs in six Italian centres. Data on 102 trabectedin-treated patients (20 with sarcoma, 80 with ovarian cancer and two with cervical cancer) were evaluated. Forty-five patients received trabectedin by a PICC, inserted by trained nurses using an ultrasound-guided technique at the bedside, whereas 57 patients received trabectedin infusion by a PORT, requiring a day surgery procedure in the hospital by a surgeon. Device dislocation and infections were reported in four patients, equally distributed between PORT or PICC users. Thrombosis occurred in a single patient with a PORT. Complications requiring devices removal were not reported during any of the 509 cycles of therapy (median 5; range 1-20). PICC misplacement or early malfunctions were not reported during trabectedin infusion. The cost-efficiency ratio favours PORT over PICC only when the device is used for more than 1 year. Our data suggest that trabectedin infusion by PICC is safe and well accepted, with a preferable cost-efficiency ratio compared with PORT in patients requiring short-term use of the device (≤1 year).

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IMPORTANCESeveral studies have evaluated cardioprotective strategies to prevent myocardial dysfunction in patients who are receiving cardiotoxic therapies. However, the optimal approach still represents a controversial issue.OBJECTIVE To determine whether pharmacological cardioprevention could reduce subclinical heart damage in patients with breast cancer who are being treated with anthracycline-based chemotherapy. DESIGN, SETTING, AND PARTICIPANTSThe SAFE trial was a 4-arm, randomized, phase 3, double-blind, placebo-controlled, national multicentric study conducted at 8 oncology departments in Italy. It was a prespecified interim analysis on the first 174 patients who had completed cardiac assessment at 12 months. The study recruitment was conducted between July 2015 and June 2020. The interim analysis was performed in 2020. Patients were eligible for trial inclusion if they had indication to receive primary or postoperative systemic therapy using an anthracycline-based regimen. Patients with a prior diagnosis of cardiovascular disease were excluded.INTERVENTIONS Cardioprotective therapy (bisoprolol, ramipril, or both drugs compared with placebo) was administered for 1 year from the initiation of chemotherapy or until the end of trastuzumab therapy in case of ERBB2-positive patients. Doses for all groups were systematically up-titrated up to the daily target dose of bisoprolol (5 mg, once daily), ramipril (5 mg, once daily), and placebo, if tolerated. MAIN OUTCOMES AND MEASURESThe primary end point was defined as detection of any subclinical impairment (worsening Ն10%) in myocardial function and deformation measured with standard and 3-dimensional (3D) echocardiography, left ventricular ejection fraction (LVEF), and global longitudinal strain (GLS). RESULTSThe analysis was performed on 174 women (median age, 48 years; range, 24-75 years) who had completed a cardiological assessment at 12 months and reached the end of treatment. At 12 months, 3D-LVEF worsened by 4.4% in placebo arm and 3.0%, 1.9%, 1.3% in the ramipril, bisoprolol, ramipril plus bisoprolol arms, respectively (P = .01). Global longitudinal strain worsened by 6.0% in placebo arm and 1.5% and 0.6% in the ramipril and bisoprolol arms, respectively, whereas it was unchanged (0.1% improvement) in the ramipril plus bisoprolol arm (P < .001). The number of patients showing a reduction of 10% or greater in 3D-LVEF was 8 (19%) in the placebo arm, 5 (11.5%) in the ramipril arm, 5 (11.4%) in the bisoprolol, arm and 3 (6.8%) in the ramipril plus bisoprolol arm; 15 patients (35.7%) who received placebo showed a 10% or greater worsening of GLS compared with 7 (15.9; ramipril), 6 (13.6%; bisoprolol), and 6 (13.6%; ramipril plus bisoprolol) (P = .03). CONCLUSIONS AND RELEVANCEThe interim analysis of this randomized clinical trials suggested that cardioprotective pharmacological strategies in patients who were affected by breast cancer and were receiving an anthracycline-based chemotherapy are well tolerated and seem to protect against cancer therapy-related LVEF d...

Objective Fear of recurrence is a crucial issue in cancer care. On the one hand, the increase of cancer‐survival rates and complexity of care is exposing patients to this type of fear. On the other hand, it is a distressing and recurrent psychosocial risk that affects quality of life and adherence to follow‐up. Patients should have access to targeted psychological interventions aimed at reducing or preventing fear of recurrence. This mixed‐methods pilot study reports the preliminary results of a novel mindfulness‐ and metacognition‐based intervention specifically targeting fear of recurrence. Methods The study was composed of an individual (n = 76) and a group (n = 38) intervention, both lasting 8 weeks, that were evaluated through a preassessment and postassessment and a 1‐month follow‐up. We enrolled women recovering from breast cancer (n = 114) in follow‐up care, with significant psychosocial distress. Patients with more severe psychopathology were assigned to the individual treatment, whereas the less severe ones were assigned to the group treatment. We explored the distress and the fear of recurrence through standardized measures and in‐depth qualitative interviews. Results Results showed that depressive, anxious, and post‐traumatic symptoms were reduced significantly in the entire sample. Patients reported a significant reduction of fear of recurrence, which was described in terms of loss of control, increase of uncertainty, and decrease of metacognitive and interpersonal skills. Conclusions Although further studies are needed, these findings provide preliminary proof‐of‐concept results for the potential of integrated mindfulness‐ and metacognition‐based interventions to reduce fear of recurrence in cancer patients.

Over the years, thanks to the addition of new generation systemic agents, as well as the use of more advanced and precise radiotherapy techniques, it was able to obtain a high curability rate for breast cancer. Anthracyclines play a key role in the treatment of breast disease, with a well-known benefit on disease-free survival of patients with positive nodal status. Trastuzumab have shown a significant outcome advantage after 1-year administration in case of HER2-positive disease. Unfortunately, significant increase in cardiotoxicity has been observed after anthracyclines and trastuzumab therapies. Even though the cardiology and oncology community strongly recommend a cardiotoxicity prevention strategy for this subset of patients, there is still no consensus on the optimal patient's approach. We aimed to review the published and ongoing researches on cardioprevention strategies and to present the SAFE trial (CT registry ID: NCT2236806; EudraCT number: 2015-000914-23). It is a randomized phase 3, four-arm, single-blind, placebo-controlled study that aims to evaluate the effect of bisoprolol, ramipril or both drugs, compared to placebo, on subclinical heart damage evaluated by speckle tracking cardiac ultrasound in non-metastatic breast cancer patients.

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