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Phase 2 study of temozolomide and Caelyx in
patients with recurrent glioblastoma multiforme
Susan L. Chua, Mark A. Rosenthal, Shirley S. Wong, David M. Ashley,
Anne-marie Woods, Anthony Dowling, and Lawrence M. Cher
Centre for Developmental Cancer Therapeutics, Parkville,
Victoria, affiliates: Department of Clinical Haematology and Medical Oncology,
Royal Melbourne Hospital, Parkville, Victoria 3050 (S.L.C., M.A.R., S.S.W.,
A.W.); Department of Medical Oncology, Royal Children’s Hospital, Parkville,
Victoria 3050 (D.M.A.); Department of Medical Oncology, St. Vincent’s
Hospital, Fitzroy, Victoria 3065 (A.D.); and Department of Medical Oncology,
Austin and Repatriation Medical Centre, Heidelberg, Victoria 3184 (L.M.C.);
Australia.
Temozolomide has established activity in the treatment of recurrent
glioblastoma multiforme (GBM).
Caelyx (liposomal doxorubicin) has established activity in a broad range of
tumors but has not been extensively evaluated in the treatment of GBM.
Phase 1 data suggest that temozolomide and Caelyx can be combined safely at full
dose.
In this phase 2 study, combination temozolomide (200 mg/m2 orally,
days 1-5) and Caelyx (40 mg/m2 i.v., day 1) was given every 4 weeks
to a cohort of 22 patients with recurrent GBM, who received a total of 109
cycles (median 3.5 cycles).
The median age of the patients was 55 years (range, 31-80 years), and 17 were
male.
All patients had received radiotherapy, but only 2 had received prior
chemotherapy.
One patient (5%) had a complete response, 3 patients (14%) had a partial
response, and 11 patients (50%) had stable disease.
The median time to progression for the cohort was 3.2 months (range, 1-13
months).
Median overall survival was 8.2 months (range, 1-16+ months).
Seven patients (32%) were progression free at 6 months.
Hematological toxicity included grade 3/4 neutropenia in 4 patients (18%) and
grade 3/4 thrombocytopenia in 4 patients (18%).
Grade 3 non-hematologic toxicity included rash in 3 patients (14%), nausea and
vomiting in 1 patient (4%), hypersensitivity reaction to Caelyx in 3 patients
(14%), and palmar-plantar toxicity in 1 patient (4%).
We conclude that the combination of temozolomide and Caelyx is well tolerated,
results in a modest objective response rate, but has encouraging disease
stabilization in the treatment of recurrent GBM.
© 2003 Duke University Press
Source: http://juno.ingentaselect.com/cgi-bin/linker?ini=dup_no&reqidx=/cw/dup/15228517/v6n1/s7/p38
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