Treatment > Doxorubicin · Temozolomide Clinical Trials

Meeting Abstract

Pegylated liposomal doxorubicin plus temozolamide in the salvage treatment of brain metastases: A feasibility study

S. Del Prete, M. Caraglia, R. Addeo, R. Costanzo, V. Faiola, G. Facchini

Medical Oncology Department 'S.Giovanni di Dio' Hospital, Frattaminore, LA, Italy; 'S.Giovanni di Dio' Hospital, Frattaminore, Italy

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 brain tumours.
The two drugs have been already used in combination in a phase I cinical study in the treatment of advanced solid tumours.
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 9 consecutive patients (5 F and 4 M, mean age: 62.4 + 15.8; median age: 68) affected by brain metastases from different solid tumours (3 breast adenocarcinoma, 4 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.
Eight out of 10 pts. have received previous whole brain irradiation plus TMZ.
Twenty-one cycles were performed.
Three grade II and 8 grade I neutropenia (CTC), 1 grade I hand and foot syndrome, 8 grade I thrombocytopenia and 9 grade I alopecia were recorded.
Nausea and vomiting or liver or renal toxicity was never observed in our series beeing the schedule well tolerated in all patients.
Two PRs and 1 SD was recorded in the three patients with breast tumours, while a clinical benefit was achieved in other 4 patients (1 with melanoma and 3 with lung cancer).
All the OR were obtained in breast cancer (hypothetically more sensitive to anthracyclins) and in one of these patients a remission of a neoplastic pleural effusion was observed.
Another pt. with PR was in PD after radiotherapy.
The pt. with brain metastases from melanoma was in grade II choma prior chemotherapy, but she achieved a recovery of the sensitivity after 2 cycles of hemotherapy.
In conclusion, the schedule was a well tolerated treatment (also in elder pts.) and has suggested an encouraging activity in brain metastases from breast even if further clinical investigations are required.

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