Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 1503
© 2005 American Society of Clinical Oncology

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Abstract

First analysis of EORTC trial 26951, a randomized phase III study of adjuvant PCV chemotherapy in patients with highly anaplastic oligodendroglioma

Daniel den Hoed Oncology Ctr, Rotterdam, The Netherlands; Federation de Neurologie Mazarin, Groupe Hospitalier Pitié Salpetriere, Paris, France; Azienda Ospedale-Universita of Padova, Padova, Italy; Medisch Centrum Haaglanden, The Hague, The Netherlands; Canisius Wilhemina Ziekenhuis, Nijmegen, The Netherlands; Ctr Antoine Lacassagne, Nice, France; Kaiser Frans Joseph Spital, Vienna, Austria; EORTC Datacenter, Brussels, Belgium

1503

Background. Anaplastic oligodendroglioma are sensitive to chemotherapy. EORTC 26951 was initiated to investigate whether the addition of 6 cycles PCV chemotherapy after radiotherapy (RT) improves overall survival (OS) and progression free survival (PFS). Methods. Eligibility criteria: histologically confirmed newly diagnosed anaplastic oligodendroglioma (AOD) or anaplastic oligoastrocytoma (AOA) with 25% oligodendral elements; age between 18–70 years; ECOG Performance Status (PS) 0–2; written informed consent. After stratification for age, institution, extent of resection, ECOG PS, and prior surgery for a low grade oligodendroglioma patients were randomized to either 33 x 1.8 Gy radiotherapy (control arm) or to the same radiotherapy followed by 6 cycles of standard PCV chemotherapy (PCV arm). Primary endpoint was overall survival, with PFS as a secondary endpoint. Results. 368 patients were randomised, 185 to the PCV arm and 183 patients to the control arm. Median follow-up is 4.1 years, 204 patients (55.4%) have died. Treatment groups were well balanced with respect to known prognostic factors. The median number of administered PCV cycles was 3; 35% of patients completed at least 5 cycles. At recurrence, PCV chemotherapy was given to 64% of patients in the control arm vs to 11% in the PCV arm. In addition, 51% of the patients in the PCV arm and 48% of patients in the control arm received other chemotherapy (mostly temozolomide) at recurrence. PFS was significantly increased after adjuvant PCV chemotherapy (table; hazard ratio (HR) 0.69; 95% confidence interval (CI) [0.53;0.88], p = 0.0035). However, no difference in OS was observed (HR 0.88; 95% CI [0.67;1.16]. Conclusion. Adjuvant PCV chemotherapy prolongs PFS from 13 months to 24 months in AOD/AOA, without a statistically significant improvement of OS. Analysis of 1p/19q status is in progress.

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Abstract presentation from the 2005 ASCO Annual Meeting