Articles related to CLINICAL TRIALS

Data from a large phase III trial (Myeloma XI) were examined to determine the relationship between MRD status, PFS, and OS in post-ASCT patients randomly assigned to lenalidomide maintenance or no maintenance at 3 months after ASCT. At ASCT + 3 and ASCT + 9, MRD-negative status was associated with improved PFS and OS. Sustained MRD negativity from ASCT + 3 to ASCT + 9 or the conversion to MRD negativity by ASCT + 9 was associated with the longest PFS/OS.

An analysis by an Australian physician is making waves by suggesting that an infamous study of vitamin C treatments for sepsis may be fraudulent. The study author alleges that the pre- and post-comparison groups involved in the 94-patient study were too similar to be realistic and that the data were fabricated.

In an editorial accompanying the final results of the TOURMALINE-MM1 study, Drs. D’Souza and Lonial question whether overall survival (OS) is “still the gold standard for demonstrating the value of a novel agent in phase III trials early in the disease course given the current treatment landscape.”

According to the results of a study published in Annals of Hematology, two novel analytical approaches for detecting malignant plasma cell clones appear to accurately indicate the course of multiple myeloma (MM) and may be valuable for monitoring patients with serologically nontrackable disease.

The BILCAP study established capecitabine as the adjuvant standard of care for patients after curatively resected biliary tract cancer (BTC). This publication presents the long-term data of that study. In the intention-to-treat analysis, the median OS was 49.6 months in the capecitabine group compared with 36.1 months in the observation group.

Short-term radiotherapy with preoperative chemotherapy followed by surgery (total neoadjuvant therapy, TNT) was compared to standard long-term chemoradiotherapy in patients with locally advanced rectal cancer. At a median follow-up of 35.0 months, 3-year DFS was 64.5% and 62.3% in the TNT and CRT groups, respectively. There was no significant difference in metastasis-free survival or locoregional recurrence, but the TNT group had better 3-year overall survival than the CRT group (86.5% v 75.1%; P = .033). Treatment effects on DFS and overall survival were similar regardless of prognostic factors. The prevalence of acute grade III-V toxicities during preoperative treatment was 26.5% in the TNT group versus 12.6% in the CRT group (P < .001).