In the Literature

Transparent and comprehensive reporting of AEs in published results of oncology-related clinical trials is crucial for the treatment of patients with cancer. In efforts to improve reporting of clinical trials results, the Consolidated Standards of Reporting Trials (CONSORT) extension group developed 10 recommendations in 2003 for reporting AEs. A new study of 175 publications assessed the degree to which the publication of phase 3 trials in oncology adhered with CONSORT recommendations (Sivendran S, et al. J Clin Oncol. 2014;32:83-89).

The anti-CD20 antibody rituximab (Rituxan), combined with chemotherapy agents, had been shown to prolong overall survival (OS) in physically fit patients with previously untreated chronic lymphocytic leukemia (CLL), but not in those with comorbidities.

In a new study, researchers analyzed data from 2 trials to determine if early tumor shrinkage was associated with long-term outcomes in patients with colorectal cancer receiving first-line treatment with cetuximab (Piessevaux H, et al. J Clin Oncol. 2013;31:3764-3775).

The prognosis for patients with pancreatic cancer is poor, even for patients with surgically resectable tumors. Gemcitabine (Gemzar) is the standard chemotherapy for advanced pancreatic cancer.

In a new exploratory analysis, researchers evaluated the relationship between PSA doubling time and BMFS, time to first bone metastasis, and OS in recipients of denosumab and placebo (Smith MR, et al. J Clin Oncol. 2013;31:3800-3806).

A new study compared the ability of 3 modalities—the new Breast Cancer Index (BCI) molecular test, the 21-gene recurrence score known as Oncotype DX, and the immunohistochemical (IHC4) prognostic model—to predict early and late disease recurrence in patients with ER-positive, node-negative breast cancer (Sgroi DC, et al. Lancet Oncol. 2013;14:1067-1076).

Lambrolizumab (previously known as MK-3475) is a humanized monoclonal immunoglobulin G4 antibody that blocks the programmed death 1 (PD-1) receptor and reactivates an immune response to the cancer cells.

The cost of cancer care continues to rise, and especially the cost of cancer drugs. Since their introduction in the 1990s, clinical pathways have demonstrated an improvement in the quality of care, while lowering costs in numerous clinical settings.

Treatment for chronic lymphocytic leukemia (CLL) has resulted in few cases of durable remissions. Bruton’s tyrosine kinase (BTK), an essential component of B-cell receptor signaling, mediates interactions with the tumor microenvironment and promotes the survival and proliferation of CLL cells.

>The American Society of Clinical Oncology (ASCO) revised its policy on financial conflicts of interest (FCOIs) in 2005, establishing for the first time certain types of financial relationships for clinical trial principal investigators.