Background: Dose-modified chemotherapy for AR-NHL in the pre-HAART era has been shown to be equally efficacious and less myelotoxic [

N Engl J Med 1997;336:1641 (mBACOD)
;
J Clin Oncol 2001;19:2171 (mCHOP)
]. In resource-constrained settings, intravenous chemotherapy and supportive care of the AIDS / cancer patient are challenging (
J Natl Cancer Inst 2002;94:718
).

Methods: We embarked on a pilot feasibility trial of dose-modified oral chemotherapy [lomustine 50 mg/m2 D1 (C#1 only); VP-16 100 mg/m2 D1–3; and cyclophosphamide / procarbazine 50 mg/m2 each D22–26 at 6-week intervals (1 cycle) for 2 cycles] in HIV-infected patients with biopsy-proven AR-NHL in East Africa.

Results: A total of 49 pts (21 Uganda; 28 Kenya) were treated on study. The majority of pts were female (59%) with median age 39 yrs (range 18–64); poor PS (2 or 3) − 63%; high grade lymphoma (69%); advanced stage (III or IV) − 69%; and B symptoms (79%). At study entry median CD4 count was 200/μL and HIV-1 viral load 97,973 copies/ml. Eighteen pts (36%) had access to ARV. A total of 78 cycles of therapy were administered to 49 pts (median 2; range 0.5–2). The regimen was well tolerated. There were 4 episodes of febrile neutropenia and 3 treatment-related deaths (6% mortality rate). Overall objective response rate is 77% (CR/uCR 56%); median survival 12.3 months; and 18 patients remain alive as of 7/11/06.

Conclusions: Dose-modified oral chemotherapy is efficacious, has comparable outcome to that in the US in pre-HAART era, an acceptable safety profile, and is pragmatic in the resource-limited setting. Further investigation of the oral regimen vs. mCHOP is warranted.

Disclosures: Supported in part by NIH grants: CA83528, AI36219, CA70081, and TW00011. Bristol-Myers Squibb and Sigma Tau Pharmaceuticals provided the chemotherapy drugs for this trial.

[Supported in part by NIH grants: CA83528, AI36219, CA70081, and TW00011. Bristol-Myers Squibb and Sigma Tau Pharmaceuticals provided the chemotherapy drugs for this trial.]

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