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Pegylated liposomal doxorubicin plus temozolamide in the salvage treatment of brain metastases: The update.

Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)


Posted on: 06/08/2004

Pegylated liposomal doxorubicin plus temozolamide in the salvage treatment of brain metastases: The update.

Meeting: 2004 ASCO Annual Meeting
Category: Central Nervous System Tumors
SubCategory: CNS Tumors

Abstract No: 1576
Author(s): M. Caraglia, R. Addeo, R. Costanzo, L. Montella, V. Faiola, E. Capasso, S. Del Prete; S. Giovanni di Dio Hospital, Frattamaggiore, Italy

Abstract: Background:
It has been recently demonstrated that pegylated liposomal doxorubicin (Caelyx, PLD) can cross the brain-blood barrier with a consequent accumulation in primitive and secondary brain tumours. Moreover, temozolamide (TMZ) is a new imidazo-tetrazine that accumulates in brain tissue and is used alone or in combination with radiotherapy in the treatment of primary and secondary brain tumours. The two drugs have been already used in combination in a phase I cinical study in the treatment of advanced solid tumours.
Methods: We have evaluated the feasibility of the concomitant administration of TMZ and PLD in the treatment of brain mestastases and a preliminary evaluation of the activity was also performed. We have treated 12 consecutive patients (7 F and 5 M, mean age: 62.83 + 13.9 yrs; median age: 65.5 yrs) affected by brain metastases from different solid tumours (4 breast adenocarcinoma, 6 non small lung cancer, 1 melanoma, 1 ovarian cancer) with TMZ 1000 mg/m2 fractionated in 5 days and PLD 40 mg/m2 day 1 every 28 days. Nine out of 12 pts. have received previous whole brain irradiation plus TMZ.

Results: Thirty-four cycles were performed. Three grade II ad 8 grade I neutropenia (CTC), 2 grade II hand and foot syndrome, 8 grade I thrombocytopenia and 9 grade I alopecia were recorded. Nausea and vomiting or liver or renal toxicity were never observed in our series being the schedule well tolerated in all patients. Two CR and two PRs was recorded in the four patients with breast tumours, while a clinical benefit was achieved in other 4 patients (1 with melanoma and 3 with lung cancer). In the long-surviving pt. (overall survival, OS: 27+ months), who achieved CR, also a remission of a neoplastic pleural effusion was observed. Other 2 still alive pts. (breast and NSCLC, respectively), who achieved a PR and a SD, had an OS of 14 and 9 months, respectively.

Conclusions: the schedule was a well tolerated treatment (also in elder pts.) and has suggested an encouraging activity in brain metastases from breast.

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