ImportancePeritoneal metastasis in patients with locally advanced colon cancer (T4 stage) is estimated to recur at a rate of approximately 25% at 3 years from surgical resection and is associated with poor prognosis. There is controversy regarding the clinical benefit of prophylactic hyperthermic intraperitoneal chemotherapy (HIPEC) in these patients.ObjectiveTo assess the efficacy and safety of intraoperative HIPEC in patients with locally advanced colon cancer.Design, Setting, and ParticipantsThis open-label, phase 3 randomized clinical trial was conducted in 17 Spanish centers from November 15, 2015, to March 9, 2021. Enrolled patients were aged 18 to 75 years with locally advanced primary colon cancer diagnosed preoperatively (cT4N02M0).InterventionsPatients were randomly assigned 1:1 to receive cytoreduction plus HIPEC with mitomycin C (30 mg/m2 over 60 minutes; investigational group) or cytoreduction alone (comparator group), both followed by systemic adjuvant chemotherapy. Randomization of the intention-to-treat population was done via a web-based system, with stratification by treatment center and sex.Main Outcomes and MeasuresThe primary outcome was 3-year locoregional control (LC) rate, defined as the proportion of patients without peritoneal disease recurrence analyzed by intention to treat. Secondary end points were disease-free survival, overall survival, morbidity, and rate of toxic effects.ResultsA total of 184 patients were recruited and randomized (investigational group, n = 89; comparator group, n = 95). The mean (SD) age was 61.5 (9.2) years, and 111 (60.3%) were male. Median duration of follow-up was 36 months (IQR, 27-36 months). Demographic and clinical characteristics were similar between groups. The 3-year LC rate was higher in the investigational group (97.6%) than in the comparator group (87.6%) (log-rank P = .03; hazard ratio [HR], 0.21; 95% CI, 0.05-0.95). No differences were observed in disease-free survival (investigational, 81.2%; comparator, 78.0%; log-rank P = .22; HR, 0.71; 95% CI, 0.41-1.22) or overall survival (investigational, 91.7%; comparator, 92.9%; log-rank P = .68; HR, 0.79; 95% CI, 0.26-2.37). The definitive subgroup with pT4 disease showed a pronounced benefit in 3-year LC rate after investigational treatment (investigational: 98.3%; comparator: 82.1%; log-rank P = .003; HR, 0.09; 95% CI, 0.01-0.70). No differences in morbidity or toxic effects between groups were observed.Conclusions and RelevanceIn this randomized clinical trial, the addition of HIPEC to complete surgical resection for locally advanced colon cancer improved the 3-year LC rate compared with surgery alone. This approach should be considered for patients with locally advanced colorectal cancer.Trial RegistrationClinicalTrials.gov Identifier: NCT02614534

Background: Subcutaneous trastuzumab (T-SC) administration does not allow the historical target concentration of 20 µg/mL for efficacy to be reached, from the start of treatment in patients with a body mass index (BMI) >30 kg/m2. Objectives: To analyze the influence of the strategy of dosification (fixed vs adjusted patient’s body weight dose) on the initial minimum plasma concentration ( Cmin) of trastuzumab in obese patients. Methods: This was an observational, prospective study, which included patients with HER2-positive nonmetastatic breast cancer treated with trastuzumab. The determination of the Cmin of trastuzumab was performed on day +21 of the first cycle using the ELISA technique. Patients were stratified according to the strategy of dosification and BMI. Results: A total of 50 patients were included; 16 patients received the drug intravenously and 34 in a fixed dosage subcutaneous (T-SC) regimen. The proportion of patients who achieved an adequate plasma concentration since the beginning of treatment was significantly higher when the drug was administered intravenously (93.8% vs 67.6%, P = 0.042). These differences are especially greater in T-SC patients with BMI >30 kg/m2, with only 20% of patients exceeding the pharmacokinetic target. Conclusion and Relevance: Our study suggests that trastuzumab SC fixed dose of 600 mg is not equivalent to IV administration, especially in obese patients. An adequate trastuzumab exposure in this population needs patient weight–adjusted IV dosage in the first administration. The clinical relevance of these findings remains to be elucidated, and further research, including larger controlled trials, is warranted.

IntroductionThe advent of Luer-type needleless venous access catheters has been accompanied by a growing number of catheter-related bloodstream infections. Our main objective was to compare rates of colonisation and phlebitis between our standard of care and the new passive disinfection system, using a Luer SwabCap bearing a sponge impregnated with 70% isopropyl alcohol.MethodsWe performed a prospective experimental study involving patients attending our day hospital oncology unit, with central venous (CV) or peripheral venous (PV) access lines with needleless connectors for antineoplastic treatment delivery. We assessed the colonisation rate by culture of the inside of the hubs (qualitative culture) and also assessed the possible appearance of phlebitis and the extra cost of introducing the new system in our oncology day hospital; nurse satisfaction was evaluated by a questionnaire. The effectiveness of the isopropyl alcohol disinfection cap was evaluated by analysing rates of catheter colonisation and phlebitis between two groups: group 1 comprised of patients receiving the standard disinfection method and group 2 comprised of patients receiving SwabCaps on any venous access connectors. Samples were taken from the catheter lumen through a sterile swab seeded in Luria Bertani-rich broth and cultivated for at least 48 h at 37°C. We also assessed the extra cost of introducing the new system in our oncology day hospital, and nurse satisfaction was evaluated by a questionnaire.Results29 patients were included (13 in group 1 and 16 in group 2). In group 1, 56% of the samples were taken from CV access connectors versus 40% in group 2. Bacterial growth was detected in 43.7% of group 1 samples versus 0% in group 2 (p=0.006). No differences in the degree of contamination were found between CV and PV access connectors. No cases of phlebitis were observed. Nurse satisfaction with the new system was 9.2 out of a maximum score of 10. The incremental cost of incorporating the new system in our oncology unit was estimated at €1.87 836.ConclusionPassive disinfection systems help reduce colonisation of venous access catheters without requiring large economic investment or special training of health personnel.

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Introduction The addition of imatinib to the therapeutic arsenal for chronic myeloid leukaemia (CML) has changed the natural course of the disease, in such a way that it is now considered a chronic pathology. However, to achieve therapeutic success, it is necessary to reach adequate plasma concentrations to ensure efficacy and safety. In this study, we aimed to evaluate the plasma concentration of imatinib, analysing its influence on effectiveness and safety in patients with CML. Methods We performed a descriptive, multicentre study in which imatinib plasma levels from patients diagnosed with CML between 2019–2020 were analysed. An optimal therapeutic range of 750–1500 ng/mL was established for the stratification of patients, according to their minimum plasma concentrations measured at steady state (Cssmin). Results A total of 28 patients were included, of whom only 39.3% (n = 11) showed Cssmin within the therapeutic range. 100% of patients with Cssmin >750 ng/mL achieved an optimal molecular response, while only 50% of patients with Cssmin <750 ng/mL achieved an optimal molecular response ( p = 0.0004). The toxicity rate was 36.4% for patients with Cssmin >1500 ng/mL and 5.9% for those with Cssmin <1500 ng/mL ( p = 0.039). Conclusions This study aimed to describe the correlation between the toxicity and effectiveness of imatinib according to its Cssmin in routine clinical practice conditions. Based on our findings, it would be certainly justified to monitor patient plasma concentrations of imatinib on a daily routine basis in our hospitals.