Artikel
Concomitant and adjuvant radiochemotherapy (RCT) with temozolomide (TMZ) followed by oral chemotherapy with temozolomide (TMZ) after resection of newly diagnosed high grade glioma: a phase II study
Adjuvante Radiochemotherapie mit Temozolomid (TMZ) und nachfolgende orale Chemotherapie mit TMZ nach Resektion neu diagnostizierter maligner Gliome: eine Phase II Studie
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Autoren
Veröffentlicht: | 4. Mai 2005 |
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Gliederung
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Objective
Evaluation of safety and efficacy of combined RCT with TMZ and adjuvant oral chemotherapy with TMZ in patients with histologically confirmed high grade glioma.
Methods
Combined RT/TMZ therapy (75mg/m2/d) was initiated four weeks after surgical resection in patients with supratentorial high grade glioma grade III and IV. Five weeks after RT/TMZ adjuvant oral chemotherapy with TMZ was initiated. Inclusion criteria were age ≥18 and ≤75 years, a Karnofsky score ≥70, platelets ≥100 K/μl and WBC ≥3,0 K/μl. TMZ was given 200 mg/m2 over five days every five weeks. Recurrent tumors were resected if possible. Clinical evaluation and blood count (WBC and platelets) were performed every four weeks, MRI follow-up five weeks after RT/TMZ and every three months.
Results
53 patients (age 40 to 73 median 57,5) were enrolled in this ongoing study in the period from November 2001 until August 2004. Histological diagnosis at first surgery was a grade III tumor in 17 and a grade IV tumor in 36 patients. The observation period is 4 to 33 months (median 18,5 months) at this time. 30 patients have so far undergone surgery for recurrent tumor. 22 out of 53 patients are still alive after 4 to 33 months (median 15,5 months). The Karnofsky score had improved in 38 patients after 12 months of therapy remained stable in 11 patients and worsened in four patients. The most common side effects were nausea and vomiting, which were controllable by anti-emetics.
Conclusions
Combined RT/TMZ therapy and oral chemotherapy with TMZ in patients with high grade glioma after tumor resection may extend time of survival compared to conventional therapy, while Karnofsky-score improves or remains stable.