EVALUATION OF A SOMATOSTATIN ANALOG IN THE TREATMENT OF LYMPHOPROLIFERATIVE DISORDERS - RESULTS OF A PHASE-II NORTH CENTRAL CANCER-TREATMENT GROUP TRIAL

Purpose: Malignant cells from non-Hodgkin's lymphomas (NHL) have been shown to express the somatostatin receptor on their cell surface and m ost NHL are visible on somatostatin radioscintigraphy scans. This prov ided the rationale to conduct a phase II trial of a somatostatin analo g in patients with B- and T-cell lymphoproliferative disorders. Patien ts and Methods: Sixty-one patients with measurable or assessable lymph oproliferative disorders (31 stage III or IV law-grade NHL; 21 chronic lymphocytic leukemia [CLL]; and nine cutaneous T-cell NHL [CTCL]) wer e enrolled. Patients were treated with somatostatin 150 mu g subcutane ously (SQ) every 8 hours for 1 month. Patients with stable or respondi ng disease received 2 additional months of therapy; chose who responde d after 3 months were treated for an additional greater than or equal to 3 months. Results: Sixty patients were assessable for toxicity and 56 for response. There were no complete remissions, In the low-grade N HL group, 36% (10 of 28 patients; 95% confidence interval [Cl], 19% to 56%) had a partial remission. Forty-four percent (four of nine; 95% C l, 14% to 79%) of patients with CTCL held a partial response. No patie nts with CLL had a partial remission. Among 45 patients with stable di sease or a partial remission, the mean time to progression (TTP) was 1 0.9 months (median, 6.2; range, 1.6 to 48.5). The drug was well tolera ted, with the most common side effects being diarrhea and hyperglycemi a. Conclusion: Somatostatin at a dose of 150 mu g every 8 hours is wel l tolerated and has activity in low-grade NHL. (C) 1995 by American So ciety of Clinical Oncology.