Gene Therapy Shows Early Efficacy Against Recurrent Brain Cancer


“More than a quarter of patients with recurrent high-grade glioma, a form of brain cancer, treated with the retroviral vector Toca 511 and the prodrug of the chemotherapy 5-fluorouracil, Toca FC, were alive more than three years after treatment, according to data from a subset of patients in a phase I clinical trial presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held Oct. 26-30.”

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Four Cycles of FEC Chemotherapy Are as Good as Six Cycles in Node-Negative Breast Cancer

The gist: A recent clinical trial showed that people with node-negative breast cancer did just as well on a shorter, four-week chemotherapy treatment as people who took a longer, six-week one. The shorter treatment consisted of four cycles of doxorubicin and cyclophosphamide. The longer one involved six cycles of 5-fluorouracil, epirubicin and cyclophosphamide. Patients in both groups had similar survival rates, and people in the longer treatment group had worse side effects.

“Patients with node-negative breast cancer who received six cycles of 5-fluorouracil, epirubicin and cyclophosphamide experienced similar DFS and OS as patients who received four cycles of doxorubicin and cyclophosphamide, according to results of a phase 3 study presented at the San Antonio Breast Cancer Symposium.

“ ‘[In the MA-5 trial, the NCIC Clinical Trials Group] administered a dose-intensified epirubicin program, and the RFS and OS results were encouraging,’ Charles Edward Geyer, Jr., MD, FACP, associate director for clinical research at Virginia Commonwealth University Massey Cancer Center, said during his presentation. ‘Additionally, the French Adjuvant Study Group around that time had also evaluated their standard adjuvant regimen of FEC-50 and had shown that six cycles of therapy were more effective than three. So, at that time, we had two separate trials looking at different epirubicin schedules, both of which had seemed to be positive. It seemed reasonable at that time to compare [doxorubicin and cyclophosphamide] with one of those regimens. Since we were going to conclude the study in node-negative patients and include post-menopausal women, we chose the FEC-100 [chemotherapy regimen] because of its improved toxicity profile…’

“ ‘[Six cycles of] FEC-100 did not improve the primary endpoint of DFS or our secondary endpoint of OS relative to [four cycles of] AC,’ Geyer said. ‘Toxicities were increased with the FEC-100, which wasn’t unexpected because it did administer additional cycles of therapy compared with AC. Overall, the results do not support the use of six cycles of anthracycline-based regimens in node-negative breast cancer.’ “

Higher Bar Set for Trials in Advanced Colorectal Cancer

Editor’s note: This article describes the results of a clinical trial—a research study with volunteer patients. The goal of the trial was to compare four different treatments for metastatic colorectal cancer (mCRC). All patients took a combination of chemotherapy drugs; either FOLFIRI [which combines folinic acid, fluorouracil and irinotecan] or FOLFOX [folinic acid, 5-fluorouracil and oxaliplatin]. Patients also took a targeted drug alongside the chemo; either bevacizumab (aka Avastin) or cetuximab (Erbitux). All four treatment combinations resulted in similar survival times—a median of 29 months. Compared to other clinical trials, this is a relatively long survival time. Based on these results, oncologists will now have more options for treating their patients according to patients’ preferences and side effects.

“Patients with KRAS wild-type metastatic colorectal cancer (mCRC) receiving first-line treatment with a chemotherapy backbone plus bevacizumab or cetuximab survived for a median of 29 months, the longest median survival time reported in a major trial of these severely ill patients.

“Importantly, survival times were the same, whether patients received the anti–vascular endothelial growth factor bevacizumab (Avastin, Genentech) or the anti–epidermal growth factor receptor (EGFR) cetuximab (Erbitux, Bristol-Myers Squibb), or whether they received FOLFOX or FOLFIRI, results from the long-awaited Phase III CALGB/SWOG 80405 trial showed.

“ ‘What this tells us is that either FOLFIRI [folinic acid, fluorouracil and irinotecan] or FOLFOX [folinic acid, 5-fluorouracil and oxaliplatin] with either bevacizumab or cetuximab are perfectly reasonable options,’ said Alan P. Venook, MD, the Madden Family Distinguished Professor of Medical Oncology and Translational Research at the University of California, San Francisco.”