Background: The standard treatment for high-grade astrocytoma (grades 3 and 4) is surgery followed by radiotherapy (post-op RT). Adjuvant chemotherapy increases disease-free survival (DFS) and overall survival (OS). There are several drugs used for this purpose, each of which have shown benefits and shortcomings. The superiority of combination therapies such as PVC (procarbazine, CCNU and vincristine) over single agents such as BCNU (carmustine) and CCNU (lumostin) has not been definitively established. Single agent CCNU could be a very convenient treatment, as it only involves oral prescription every six weeks. Thus, in this study, we compare CCNU alone with PCV to establish any potential superiority with regard to DFS and OS.
Methods: From 2003-2006, patients with high-grade astrocytoma who had undergone surgery and radiotherapy in the Cancer Institute of Imam Khomeini Hospital, Tehran, Iran, were randomized to CCNU alone or PCV. Chemotherapy was repeated every six weeks for six cycles. Six weeks after the end of sixth cycle, a CT scan was performed. New neurologic signs and symptoms or increases in the previous signs and symptoms and/or new masses in imaging and/or growth of the residual tumor (> 25%) and/or enhancement of any inactive mass from the previous imaging was considered a recurrence. DFS was considered to be the duration from the end of RT to the date of recurrence or last follow-up. OS was taken as the duration from the end of RT to date of death or last follow-up.
Results: After informed consent, of the 70 patients included in this study, 38 were treated with PCV and 32 were treated with CCNU. The mean age was 44 years, ranging from 16 to 78 years, and 51 of the patients were male. Nineteen patients had grade 3 anaplastic astrocytoma and 51 patients had grade 4 glioblastoma multiforme. There were no significant differences with regard to patient age, gender and pathology between the CCNU and PCV groups. DFS and OS were 26 and 27 months, respectively, in the CCNU group and 29 and 34 months, respectively, in the PCV group. By log-rank test, the difference between CCNU and PCV was not statistically significant with regard to the length of DFS and OS.
Conclusion: Although no significant differences were found, a trend toward better survival could be seen in patients treated with PCV. Further studies with more patients and longer follow-up are needed to definitively resolve this issue.