iSABR Trial Now Open
from UCLA October, 2017 Patient Newsletter
A new randomized, phase 1/2 study of stereotactic ablative body radiotherapy with or without durvalumab is now open to enrollment at UCLA Main Campus. Stereotactic ablative body radiotherapy is a highly focused radiation treatment that uses intense doses of radiation concentrated on a tumor, while limiting the dose to surrounding organs. Durvalumab, on the other hand, is an immunotherapy drug that blocks the interaction of the PD-1 cellular receptor with its ligand in order to improve the immune system’s ability to fight cancer.
This study is for patients with newly-diagnosed, early stage (I or II) NSCLC who are ineligible for or who have refused surgery. The trial is currently enrolling 15 subjects with early-stage, inoperable NSCLC for its first phase to evaluate the safety and tolerability of radiotherapy + durvalumab. This first phase will be followed by a 90-subject, randomized second phase to test the eficacy of durvalumab + radiotherapy versus radiotherapy alone.
For more information, please contact Dr. Percy Lee, Dr. Jonathan Goldman, or CRC Care Felix.
Annals of Oncology Publication
The Program’s Dr. Edward Garon is among the authors on a paper recently published in Annals of Oncolo- gy. The publication, by lead author Dr. Dirk Arnold of the Instituto CUF de Oncologia in Portugal, analyzes a large amount of patient safety data from six independent, randomized, placebo-controlled studies of the antiangiogenic agent ramucirumab in various tumor types. Ramucirumab is an an -VEGFR2 an body, a kind of drug that works by limiting the growth of new blood vessels that tumors use to support themselves. Ramucirumab has been approved for the treatment of gastric/gastroesophageal junction, non- small cell lung, and metastatic colorectal cancers. Using data from six prior studies in various tumor types, the authors were able to evaluate safety data from a population of 4,996 patients, of whom 2,748 received ramucirumab and 2,248 received placebo. Based on their analyses, Arnold et al. found ramucirumab’s risk profile to be generally similar to that of other an angiogenic agents, but with some key difierences. Like those other agents, ramucirumab was associated with increased risk of developing hypertension, proteinuria, low-grade bleeding, GI perforation, infusion-related reactions, and wound healing complications when compared to placebo. However, ramucirumab was unlike other antiangiogenic agents in that the authors did not find increased risk of arterial thromboembolic events (ATEs), venous thromboembolic events (VTEs), high-grade bleeding, or high-grade GI bleeding in patients receiving ramucirumab rather than placebo across the trials included in the meta-analysis. These findings are significant to ramucirumab’s use as an anti-cancer therapy. While the drug is similar to other an angiogenic agents in some respects, it does have a distinct risk profile with regard to several important side-effects.