Articles related to CLINICAL TRIALS

During its April 28 meeting, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11-1 on whether access to the combination should be limited to patients whose tumors carry BRCA mutations. The majority of members shared the FDA reviewers’ concerns regarding clinical trial results and uncertainty about whether people without the BRCA mutation would benefit from the regimen. The FDA argued that the results of the phase 3 PROpel clinical trial could not be applied to patients who had not had their BRCA or HRR mutation status determined. As a result, the FDA contended that the PROpel intention-to-treat (ITT) group was heterogeneous, complicating the interpretation and application of the trial’s results to unselected patients.

From November 15, 2015, to March 9, 2021, scientists conducted an open-label, phase 3 randomized clinical trial at 17 Spanish centers to assess the efficacy and safety of intraoperative HIPEC in patients with locally advanced colon cancer. The primary outcome was the 3-year locoregional control (LC) rate, which was defined as the proportion of patients who did not have peritoneal disease recurrence after adjusting for intention to treat. Patients included ranged in age from 18 to 75 years old and had been diagnosed with locally advanced primary colon cancer prior to surgery. They discovered that combining HIPEC with complete surgical resection for locally advanced colon cancer enhanced the 3-year LC rate compared to surgery alone, and they recommend that this strategy be evaluated for patients with locally advanced colorectal cancer.

A total of 246 patients were randomly allocated to one of two groups: adult patients who had received no more than two previous chemotherapy regimens for the treatment of advanced colorectal cancer (combination group) or FTD-TPI alone (FTD-TPI group). The median overall survival in the combo group was 10.8 months and 7.5 months in the FTD-TPI group. The median progression-free survival in the combo group was 5.6 months and 2.4 months in the FTD-TPI group.

In a randomized, double-blind, repeated crossover trial that involved almost 1,500 individuals with stage II hypertension, researchers found significant variation in individual responses to different antihypertensive treatments, particularly for lisinopril versus hydrochlorothiazide, lisinopril versus amlodipine, candesartan versus hydrochlorothiazide, and candesartan versus amlodipine. The study highlights the need for personalized antihypertensive therapy as there is substantial heterogeneity in blood pressure response to drug therapy for hypertension. The researchers recommend further studies to identify the mechanisms behind these individual differences to enable personalized antihypertensive therapy in routine clinical practice. This study’s findings underscore the importance of considering individualized treatment approaches for hypertension management to achieve optimal outcomes.

New findings from an open-label clinical trial show that by 12 weeks into the maintenance phase, daily off time had decreased by an average of about three hours. Daily “good on” time consistently increased by an average of three hours per day when symptoms are under control without bothersome dyskinesia. By week 12, 62.1% had less free time—at least two hours less per day. The amount of levodopa taken on average every day during the research significantly decreased, which was consistent with improved symptom control. At week 12, just over two-thirds (65%) of patients said they had “much improved” or “very much improved” since beginning SPN-830. Patients reported that their overall health had improved by about 90%.

Previously untreated patients in this phase III research receiving enzalutamide with or without abiraterone acetate and prednisone (AAP) were being treated for metastatic castration-resistant prostate cancer (mCRPC). Median overall survival (OS), the main outcome, did not differ statistically between the two groups. Enzalutamide plus AAP, however, resulted in a longer radiographic progression-free survival (rPFS) than enzalutamide alone. Abiraterone clearance was two to three times higher when administered with enzalutamide than when given alone, according to pharmacokinetic studies. In the combo arm, there were more high-grade adverse events, such as atrial fibrillation, transaminitis, hypertension, and fatigue. Patients with mCRPC did not have their OS lengthened by the addition of AAP to enzalutamide, and the authors theorize that this may have been due to the combination arm’s higher abiraterone clearance.