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Cyclophosphamide plus somatostatin, bromocriptin, retinoids, melatonin and ACTH in the treatment of low-grade non-Hodgkin's lymphomas at advanced stage: results of a phase II trial.

PURPOSE
Somatostatin, prolactin, retinoids, melatonin and ACTH have been shown to influence the lymphatic growth, and the action of the cyclophosphamide in lymphoproliferative disorders is well known. This provided the rationale to conduct, in patients with low-grade non-Hodgkin's lymphomas (NHL), a phase II trial of a combined association of cyclophosphamide, somatostatin, bromocriptin, retinoids, melatonin and ACTH.


PATIENTS AND METHODS
Twenty patients with a diagnosis of low-grade NHL, stage III or IV, were included in this study. Patients received for one month the following treatment: cyclophosphamide, somatostatin, bromocriptin, retinoids, melatonin, and ACTH. The therapy was continued for two additional months in patients with stable or responding disease. After three months, the responding patients continued the therapy for three months and more.


RESULTS
Twenty patients were assessable for toxicity and response; 70% (14 of 20 patients; 95% confidence interval [CI], 50% to 90%) had a partial response; 20% (4 of 20) had stable disease, and 10% (2 of 20) progressed on therapy. Going on with the treatment, none of the 14 patients with partial response had a disease progression (average follow-up time of 21 months, range, 7 to 25), and 50% of these patients had a complete response; among 4 patients with stable disease, 25% (1 of 4) had a partial response and 75% (3 of 4) progressed on therapy (mean time to progression [TTP] 14.3 months, range, 7 to 21). The toxicity was very mild, the most common side effects being drowsiness, diarrhea and hyperglycemia.


CONCLUSIONS
The association of cyclophosphamide, somatostatin, bromocriptin, retinoids, melatonin, and ACTH is well tolerated and effective in treatment of low-grade NHL at advanced stage.