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Phase II Trial of Continuous Dose-Intense Temozolomide in Recurrent Malignant Glioma: RESCUE Study.


Posted on: 03/29/2010

 

J Clin Oncol. 2010 Mar 22. [Epub ahead of print]

Phase II Trial of Continuous Dose-Intense Temozolomide in Recurrent Malignant Glioma: RESCUE Study.

Perry JR, Bélanger K, Mason WP, Fulton D, Kavan P, Easaw J, Shields C, Kirby S, Macdonald DR, Eisenstat DD, Thiessen B,Forsyth P, Pouliot JF.

 

Odette Cancer Centre and Sunnybrook Health Sciences Centre; Princess Margaret Hospital, Toronto; London Regional Cancer Program, London Health Sciences Centre, London, Ontario; Hôpital Notre-Dame; Royal Victoria Hospital, Montreal; Hôpital de l'Enfant-Jésus, Quebec City; Schering-Plough Canada, Kirkland, Quebec; Cross Cancer Institute, Edmonton; Tom Baker Cancer Center, Calgary, Alberta; Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia; Cancer Care Manitoba, Winnipeg, Manitoba; and British Columbia Cancer Agency-Vancouver Cancer Centre, Vancouver, British Columbia, Canada.

PURPOSE: Concomitant temozolomide (TMZ)/radiotherapy followed by adjuvant TMZ has increased survival in patients with glioblastoma multiforme (GBM). However, few options are effective for patients who experience treatment failure. We conducted a multicenter, phase II study to assess the efficacy and safety of continuous dose-intense TMZ for recurrent GBM.

 

PATIENTS AND METHODS: Patients with malignant glioma at progression after standard TMZ 150 to 200 mg/m(2) x 5 days in a 28-day cycle for three or more cycles were stratified by tumor type (anaplastic glioma group A, GBM, group B). Ninety-one patients with GBM were prospectively divided into three groups (early [B1], extended [B2], and rechallenge [B3]) according to the timing of progression during adjuvant therapy. All patients received continuous dose-intense TMZ 50 mg/m(2)x for up to 1 year or until progression occurred. Response was assessed by using RECIST (Response Evaluation Criteria in Solid Tumors).

 

RESULTS: A total of 116 of 120 patients were evaluable for efficacy. For patients with GBM, 6-month progression-free survival (PFS) was 23.9% (B1, 27.3%; B2, 7.4%; B3, 35.7%). One-year survival from time of study entry was 27.3%, 14.8%, and 28.6% for the B1, B2 and B3 groups, respectively. For patients with anaplastic glioma, 6-month PFS was 35.7%; 1-year survival was 60.7%. The most common grades 3 and 4 nonhematologic toxicities were nausea/vomiting (6.7%) and fatigue (5.8%). Grades 3 and 4 hematologic toxicities were uncommon.

 

CONCLUSION: Rechallenge with continuous dose-intense TMZ 50 mg/m(2)/d is a valuable therapeutic option for patients with recurrent GBM. Patients who experience progression during the first six cycles of conventional adjuvant TMZ therapy or after a treatment-free interval get the most benefit from therapy.

 

PMID: 20308655 [PubMed - as supplied by publisher]


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