Third International Congress Drug Therapy in HIV Infection 3-7 November 1996 Glasgow, UK

EVIDENCE OF ACTIVITY OF VINORELBINE IN PATIENTS (PTS) WITH PREVIOUSLY TREATED AIDS-ASSOCIATED KAPOSI'S SARCOMA

G. Nasti, D. Errante, M. Fasan, G. Rizzardini, G. Landonio, L. Pagani, C. Zeroli and U. Tirelli for the Italian Cooperative Group on AIDS and Tumors
C.R.O. Aviano

Int Cong Drug Therapy HIV 1996 Nov 3-7;3:Abstract No. OP5.1
AIDS 1996, Vol. 10 (Suppl. 2);S13

Vinorelbine is a new semisynthetic vinca alkaloid that seems to disorganise microtubules of the mytotic figure at a lower concentration than other vinca alkaloids and one at which it fails to affect the axonal microtubules. In addition it is known that vinca alkaloids are active agents in the treatment of epidemic KS and form the basis for combination regimens.

From December 1994 and March 1996, within the Italian Cooperative Group on AIDS and Tumors (GICAT) we treated 22 pts with disseminated epidemic KS with 30 mg/m² vinorelbine given intravenously every two weeks. Eligible pts must have relapsed after first-line chemotherapy or progressed during their first cytotoxic regimen for KS, including anthracyclines or vinca alkaloids. Granulocyte colony-stimulating factor (G-CSF) was given subcutaneously at a dose of 5 mcg/kg/day beginning on day 2 at the discretion of the treating physicians to pts experiencing severe granulocytopenia in the previous cycle. Assessments of toxicity and response were performed according to the World Health Organization and AIDS Clinical Trial Group criteria, respectively. All pts were males with a median age of 36 years (27-55). Sixteen were homosexuals, 3 were intravenous drug users, and 3 were heterosexuals. The median entry CD4+ lymphocyte count was 13/mm³ (1-356). Fourteen pts had prior ABV; 7 had VCR + BLM; and 1 had liposomal doxorubicin. One pt was not evaluable for response because he was lost to follow-up after receiving the second cycle of vinorelbine. The toxic effects of vinorelbine consisted predominantly of myelosuppression. In particular, grade 3 and 4 leukopenia was observed in 7 and 5 pts respectively. Fourteen pts actually received G-CSF for secondary prophylaxis. Grade 3 thrombocytopenia occurred in one pt and grade 3 anaemia in one pt. We did not observe neurotoxicity. In no pt treatment was discontinued due to toxicity. The median number of cycles actually administered was 4 (range, 1 to 11 cycles). Complete remission (CR) occurred in 3 of 21 evaluable pts (14%; exact 95% confidence interval; 3-36%) with a duration of 4+, 5, and 11+ months. We observed 8 partial remissions (38%) with a median duration of 3 months (range, 1 to 6 ). All other pts had stable (5 pts) or progressive (5 pts) disease.

In conclusion, our results suggest that vinorelbine is active and well tolerated also in previously treated pts with AIDS-associated KS. Vinorelbine can be considered also for studies as first-line single agent or as a potential component of combination chemotherapy regimens for KS pts.

Supported by ISS and AIRC grants.

Presenting author: G. Nasti

1996-11-03
OP5.1

Originally published in AIDS Volume 10, Supplement 2 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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