Articles related to CLINICAL TRIALS

Study: This meta-analysis includes 232 randomized, double-blind, placebo-controlled trials of drug monotherapy for major depressive disorder submitted to the FDA between 1979 and 2016, and comprises nearly 75,000 adult and child participants. Conclusion: Patients with depression are likely to improve substantially from acute treatment of their depression with drug or placebo. Although the mean effect of antidepressants is only a small improvement over placebo, the effect of active drug seems to increase the probability that any patient will benefit substantially from treatment by about 15%.

This is an 8-year follow-up to the author’s initial report of a randomized phase II study in patients with newly diagnosed primary CNS lymphoma treated with high-dose methotrexate-based induction chemotherapy followed by whole-brain radiotherapy (WBRT) or high-dose chemotherapy (thiotepa-busulfan-cyclophosphamide) with autologous stem-cell transplantation (ASCT). They conclude that 40 Gy WBRT should be avoided in first-line treatment in this population because of its neurotoxicity and suboptimal efficacy in reducing relapses, while ASCT appears to be highly efficient in preventing relapses.

Memorial Sloan Kettering oncologist Raajit Rampal presents a case report, discusses the rationale for the few treatment options available, and summarizes the 5-year follow-up data for the RESPONSE and RESPONSE 2 trials.

This phase III trial evaluated the PARP inhibitor fuzuloparib versus placebo as a maintenance treatment after second- or later-line platinum-based chemotherapy in patients with high-grade, platinum-sensitive, recurrent ovarian cancer. Two-hundred-fifty-two (252) patients were randomly assigned to the fuzuloparib (n = 167) or placebo (n = 85). Twice daily oral fuzuloparib as maintenance therapy was superior to placebo in PFS improvement. Further, benefit was observed both in patients with germline BRCA 1/2 mutations and in those without mutations.

The poor showing for immunotherapy in PDAC is likely a result of the cancer’s complex immunosuppressive tumor microenvironment, acting to insulate the tumor against an effective cytotoxic immune response. This review summarizes the mechanisms of immunosuppression within the PDAC tumor microenvironment and provides an up-to-date review of completed and ongoing clinical trials using various immunotherapy strategies.

The 18-month OS rates in this trial were: 66.7% for neoadjuvant mFOLFIRINOX 47.3% for neoadjuvant mFOLFIRINOX and hypofractionated radiotherapy 87.5% for mFOLFIRINOX followed by pancreatectomy 78.9% for mFOLFIRINOX plus radiotherapy followed by pancreatectomy The authors state these results “suggest that mFOLFIRINOX represents a reference neoadjuvant treatment regimen for borderline resectable pancreatic cancer; however, the role of radiotherapy in this setting remains undefined.”