Artikel
Prospective, multicenter, non-interventional cohort study of concomitant and adjuvant temozolomide radiochemotherapy in glioblastoma patients with no or minimal residual enhancing tumor load after surgery
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Veröffentlicht: | 28. April 2011 |
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Gliederung
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Objective: Survival of glioblastoma patients has been linked to the completeness of surgical resection. Available data, however, were generated with radiotherapy as adjuvant therapy. Little data is available to confirm that cytoreductive therapy remains beneficial in patients treated according the present standard of care that is radiotherapy with concomitant and adjuvant temozolomide.
Methods: We report on a prospective, multicenter cohort study. Entry criteria were histological diagnosis of glioblastoma, small enhancing residual tumor loads (RECIST ≤1.5 cm) on early post-operative MRI and intended radiochemotherapy with temozolomide. The primary study aim was progression-free survival based on MRI and secondary study aims were overall survival and toxicity. In addition, the prognostic role of O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation was investigated in relation to resection status.
Results: A total of 180 patients were initially enrolled. Fourteen patients had to be excluded by patient request or failure to initiate radiochemotherapy and 23 patients had non-evaluable early, post-operative MRI. Thus, 143 patients qualified for the intent to treat cohort, of which 107 patients had residual tumor volumes ≤1.5cm (per protocol patients). Median duration of follow-up was 24.0 months. Median survival for patients without residual enhancing tumor was not reached, whereas median survival was 16.9 months for 107 patients with residual tumor diameters ≤1.5cm (95% CI: 13.3 - 20.5, p = 0.039), and 13.9 months (10.3 - 17.5, overall p < 0.001) for 36 patients with residual tumor diameters >1.5 cm. In multivariate analysis, patient age at diagnosis and degree of resection were independently associated with survival. Patients with MGMT promoter methylated tumors and complete resection demonstrated the best prognosis.
Conclusions: Completeness of resection acts synergistically with concomitant and adjuvant radiochemotherapy, especially in patients with MGMT promoter methylation.