Radiation plus PCV chemotherapy may become standard of care for anaplastic oligodendrogliomas
The addition of six cycles of procarbazine, lomustine and vincristine chemotherapy to radiotherapy improved OS and PFS among patients with anaplastic oligodendroglioma, according to long-term results of a randomized phase 3 study.
Martin J. van den Bent
Martin J. van den Bent, MD, of Erasmus Medical College in Rotterdam, the Netherlands, and colleagues randomly assigned 368 adult patients who were newly diagnosed with anaplastic oligodendroglial tumors to either 59.4 Gy of radiotherapy alone (n=183) or radiotherapy followed by six cycles of adjuvant procarbazine, lomustine and vincristine (PCV) chemotherapy (n=185).
The researchers analyzed the correlation between 1p/19q status and survival. They retrospectively defined the methylation status of methyl-guanine methyl transferase gene promoter and the mutational status of isocitrate dehydrogenase.
OS and PFS based on an intent-to-treat analysis served as the primary endpoints.
Patients underwent a neurologic exam — which included measurement of ECOG performance status, mini-mental status examination, a quality-of-life questionnaire, and MRI or CT scans — at baseline and every 3 months until progression. Once disease progressed, the researchers followed up on patients every 3 months to measure survival.
By February 2012, 298 patients (81%) had been diagnosed with disease progression and 281 patients (76.4%) had died.
At a median follow-up of 140 months, patients assigned to the radiotherapy/PCV combination demonstrated significantly longer OS (42.3 months vs. 30.6 months; HR=0.75; 95% CI, 0.60-0.95) and median PFS (24.3 months vs. 13.2 months; HR=0.66; 95% CI, 0.52-0.83).
The 80 patients with 1p/19q codeletions also experienced longer OS, with a trend toward more benefit from adjuvant PCV.
Patients assigned to the radiotherapy/PCV combination arm reported more frequent nausea/vomiting, loss of appetite and drowsiness during and shortly after PCV chemotherapy, the researchers said. However, the investigators identified no long-term effects of PCV chemotherapy on quality of life.
“The present long-term survival analysis … is the first trial of grade 3 glioma to show a clinically relevant and significant increase in OS in the intent-to-treat population with the addition of adjuvant chemotherapy to radiotherapy,” van den Bent and colleagues wrote.
van den Bent MJ. J Clin Oncol. 2012;doi:10.1200/JCO.2012.43.2229.