Title |
A phase II trial of oral gimatecan for recurrent glioblastoma
|
---|---|
Published in |
Journal of Neuro-Oncology, December 2012
|
DOI | 10.1007/s11060-012-1023-0 |
Pubmed ID | |
Authors |
Jethro Hu, Patrick Y. Wen, Lauren E. Abrey, Camilo E. Fadul, Jan Drappatz, Nadia Salem, Jeffrey G. Supko, Fred Hochberg |
Abstract |
Gimatecan is a lipophilic oral camptothecin analogue with preclinical activity in glioma models. We conducted a multicenter phase II trial to evaluate the efficacy of gimatecan in adults with recurrent glioblastoma. Eligibility criteria included ≤1 prior treatment for recurrent disease, age ≥18, Eastern Cooperative Oncology Group performance status 0-1, and normal organ function. Patients taking enzyme-inducing anti-seizure medications were excluded. Gimatecan 1.22 mg/m(2) was given orally once daily for 5 consecutive days during each 28-day cycle. The primary endpoint was progression-free survival at 6 months. A Simon 2-stage optimal design was used in which 19 patients were evaluated in the 1st stage, with an additional 36 patients accrued if >4 patients in stage 1 achieved PFS at 6 months. 29 patients were enrolled in the study, with median age of 58 years (range, 25-77 years); 58.6 % female. All patients received prior surgery, radiation therapy, and at least one chemotherapy regimen. The daily dose was reduced to 1.0 mg/m(2) after four of the first 10 patients experienced grade 4 hematologic toxicity. Treatment-related grade 3/4 toxicities included thrombocytopenia (17.2 %), leukopenia (17.2 %) and neutropenia (10.3 %). None of the 19 patients treated at 1.0 mg/m(2)/day experienced grade 4 hematologic toxicity. One patient had a partial radiographic response by modified Macdonald criteria. Only 3 patients (12 %) were progression-free at 6 months. Median time to progression was 12.0 weeks (7.0, 17.0).Treatment with gimatecan 1.0 mg/m(2)/day for 5 days, repeated every 28-days showed minimal efficacy. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Netherlands | 1 | 2% |
Brazil | 1 | 2% |
United Kingdom | 1 | 2% |
China | 1 | 2% |
Poland | 1 | 2% |
Unknown | 54 | 92% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 11 | 19% |
Student > Ph. D. Student | 8 | 14% |
Student > Master | 8 | 14% |
Student > Doctoral Student | 6 | 10% |
Student > Bachelor | 5 | 8% |
Other | 6 | 10% |
Unknown | 15 | 25% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 22 | 37% |
Neuroscience | 7 | 12% |
Biochemistry, Genetics and Molecular Biology | 4 | 7% |
Nursing and Health Professions | 3 | 5% |
Agricultural and Biological Sciences | 2 | 3% |
Other | 3 | 5% |
Unknown | 18 | 31% |