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Previous Volume 329:1608-1614 November 25, 1993 Number 22 Next

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ABSTRACT

Background Interferon alfa and cytotoxic drugs have synergistic effects in patients with non-Hodgkin's lymphoma. In 1986, we designed a clinical trial to evaluate the benefit of concomitant administration of recombinant interferon alfa with a regimen containing doxorubicin in patients with follicular non-Hodgkin's lymphoma.

Methods The trial involved 242 patients with advanced low-grade follicular non-Hodgkin's lymphoma selected on the basis of clinical, radiographic, and biologic criteria. All patients were treated with a regimen consisting of cyclophosphamide, doxorubicin, teniposide, and prednisone (CHVP), given monthly for six cycles and then every two months for one year. After randomization, 123 patients also received interferon alfa-2b at a dosage of 5 million units three times weekly for 18 months. The remaining 119 patients received chemotherapy alone.

Results As compared with the patients treated with CHVP only, the patients treated with CHVP plus interferon alfa had a higher overall rate of response (85 percent vs. 69 percent, P = 0.006), a longer median event-free survival (34 months vs. 19 months, P<0.001), and a higher rate of survival at 3 years (86 percent vs. 69 percent, P = 0.02). Granulocyte toxicity was greater in the patients treated with CHVP plus interferon alfa than in those treated with CHVP alone. There were no treatment-related deaths. Interferon alfa had to be stopped because of toxic effects (fatigue and hepatitis) in 13 patients (11 percent).

Conclusions The addition of interferon alfa to a regimen containing doxorubicin increased the rate of response, event-free survival, and overall survival in patients with advanced follicular non-Hodgkin's lymphoma, without serious toxicity, although some patients were unable to tolerate the side effects.

Source Information

From the Departments of Hematology (P.S.-C., P.B., C.G.) and Biostatistics and Medical Information Systems (E.L.), Hopital Saint-Louis, Paris; the Department of Pathology, Hopital Necker, Paris (N.B., M.P.); Hopital Henri Mondor, Creteil, France (F.R., C.H.); Centre Hospitalo-Universitaire de Caen, Caen, France (M.L.); Universite Catholique de Louvain, Louvain, Belgium (A.B.); Centre Hospitalier Lyon-Sud, Pierre Benite, France (B.C.); and Schering-Plough, Levallois, France (Y.P.).

Address reprint requests to Dr. Solal-Celigny at Centre Hayem, Hopital Saint-Louis, 1 Ave. Cl. Vellefaux, 75010 Paris, France.

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