428P - 'Low-dose metronomic temozolomide' in recurrent TMZ-refractory glioblastoma patients: a retrospective analysis of national data in Korea

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Central Nervous System Malignancies
Presenter Yunjung Choi
Citation Annals of Oncology (2014) 25 (suppl_4): iv137-iv145. 10.1093/annonc/mdu330
Authors Y. Choi1, M.S. Yun1, S.H. Lim1, S. Bae1, Y. Na2, Y.H. Kim3, K.S. Kang1, S. Lee4
  • 1Pharmaceutical Benefits Guideline Division, Health Insurance Review & Assessment Service, 137-927 - Seoul/KR
  • 2Drug Management Dept., Health Insurance Review & Assessment Service, 137-927 - Seoul/KR
  • 3Internal Medicine, Korea University Medical Center, KR-136-705 - Seoul/KR
  • 4Department Of Internal Medicine, Seoul National University Hospital, Seoul/KR

Abstract

Aim

The aim of this retrospective study is to evaluate the efficacy and safety of metronomic temozolomide (TMZ) treatment in 125 Korean patients with recurrent TMZ-refractory glioblastoma from national data in Korea.

Methods

In Korea, KFDA (Korean Ministry of Food and Drug Administration) off-label use of anticancer drug has to approve its use in advance from HIRA (Health Insurance Review & Assessment Service in Republic of Korea), and report a one-year outcome data to HIRA. The KFDA approved dosage of temozolomide is TMZ 150 to 200 mg/m2 × 5 days in a 28-day cycle, while ‘low dose metronomic temozolomide’ is KFDA unapproved dosage, continuous dose-intense TMZ 50 mg/m2/day. We reviewed a total 125 patients' national clinical data retrospectively, which is reported to the efficacy and toxicity of ‘low-dose metronomic temozolomide’ in recurrent TMZ-refractory glioblastoma, as KFDA unapproved use in Korea.

Results

A total 125 patients (male 58.4%, female 41.6%, mean 50 ± 12 yrs, range 13-75yrs) in 13 hospitals received ‘low-dose metronomic temozolomide’ during Mar. 2009 to Sep. 2013 in Korea. The 6-month PFS rate was 19.2% (95% CI: 12.2 ∼ 26.1). Complete response (CR) rate was 6.5%, and the average period of this state was 32.9+ months. Partial response (PR) rate was 4.3%, A progression free survival (PFS) time was 2.1 months. Median overall survival time was 7.5 months. Only 1 patient has a grade 3+ thrombocytopenia. Total 100 patients stopped the medication. Among them, the 95 patients were due to disease progression and the 5 patients were due to toxicities

Conclusions

The results of this study show ‘Low-dose metronomic temozolomide’ also might be option for recurrent TMZ-refractory glioblastoma. And it can be necessary for some recurrent Korean GBM patients to receive KFDA unapproved low dosage.

Disclosure

All authors have declared no conflicts of interest.