OS07.9 Standard of care temozolomide chemotherapy ± tumor treating fields (TTFields) in newly diagnosed glioblastoma. Final results of the phase III EF-14 clinical trial
| Autor: | Roger Stupp, Z. Ram |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Chemotherapy Standard of care Temozolomide business.industry medicine.medical_treatment Newly diagnosed medicine.disease Mitotic Anaphase Chemotherapy regimen Clinical trial 03 medical and health sciences ORAL PRESENTATIONS 0302 clinical medicine 030220 oncology & carcinogenesis Internal medicine Medicine Neurology (clinical) business 030217 neurology & neurosurgery Glioblastoma medicine.drug |
| Popis: | BACKGROUND: Tumor Treating Fields (TTFields) is an established, frequency-tuned, anti-mitotic, physical treatment modality that acts in metaphase, anaphase and telophase. TTFields are delivered to the brain by a patient operated, portable medical device (Optune™, Novocure Ltd.). This multicenter, prospective, randomized phase 3 trial (EF-14) tested the efficacy and safety of combining TTFields with maintenance temozolomide (TMZ) compared to TMZ alone in patients with newly diagnosed GBM (Stupp et al. JAMA 2015). Here we report the outcomes of all 695 patients enrolled with a mature minimum follow-up of 18 month (median follow-up 36 months, range 19–80 months). METHODS: Within 7 weeks after the end of TMZ/RT and stratification for extent of resection and MGMT status patients were randomized (at a 1:2 ratio) to either standard adjuvant TMZ alone (150–200 mg/m2/d x 5d) or TMZ and continuous administration of TTFields. Eligible patients had a newly diagnosed GBM, non-progressive after concomitant chemoradiotherapy, a performance status of ≥70%, and adequate hematological, liver and renal function. The primary endpoint of the study is progression free survival (PFS) as determined by blinded central radiology review; overall survival (OS) is a powered secondary endpoint. Results: A total of 695 patients were randomized from 7/2009 - 11/2014. Patient characteristics are balanced, median age was 56 years (range 19–83), 87 % had undergone prior tumor resection and 13 % a biopsy only. The median number of adjuvant TMZ cycles were 6 and 5 cycles, for the TTFields and the TMZ alone control arm, respectively. Progression-free survival was 4 months (mo) and 6.7 months, with a hazard ratio of 0.63 (95% CI 0.52 - 0.76, p= 0.00005); this ultimately translated into a benefit in overall survival (calculated from the date of randomization) of 20.8 mo compared to 16.0 mo (HR 0.65 (CI 0.54 - 0.79; p=0.0006), and at 2 years of 43% compared to 30% for the experimental and standard arm, respectively. Updated results with additional data on molecular markers, quality of life and correlative analyses will be presented. Conclusions: Tumor treating fileds (TTFields) combined with standard maintenance (adjuvant) TMZ chemotherapy significantly improves both progression-free and overall survival in newly diagnosed GBM. Toxicity was generally mild and easily manageable. Adjuvant/maintenance TMZ chemotherapy n combination with TTFields has been established as the new standard of care for patients with a newly diagnosed GBM who completed initial chemoradiotherapy. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|