Evaluation of a somatostatin analog in the treatment of lymphoproliferative disorders: results of a phase II North Central Cancer Treatment Group trial.
OBJECTIVE
Malignant cells from non-Hodgkin's lymphomas (NHL) have been shown to express the somatostatin receptor on their cell surface and most NHL are visible on somatostatin radioscintigraphy scans. This provided the rationale to conduct a phase II trial of a somatostatin analog in patients with B- and T-cell lymphoproliferative disorders.


METHODS
Sixty-one patients with measurable or assessable lymphoproliferative disorders (31 stage III or IV low-grade NHL; 21 chronic lymphocytic leukemia [CLL]; and nine cutaneous T-cell NHL [CTCL]) were enrolled. Patients were treated with somatostatin 150 micrograms subcutaneously (SQ) every 8 hours for 1 month. Patients with stable or responding disease received 2 additional months of therapy; those who responded after 3 months were treated for an additional > or = 3 months.


RESULTS
Sixty patients were assessable for toxicity and 56 for response. There were no complete remissions. In the low-grade NHL group, 36% (10 of 28 patients; 95% confidence interval [CI], 19% to 56%) had a partial remission. Forty-four percent (four of nine; 95% CI, 14% to 79%) of patients with CTCL had a partial response. No patients with CLL had a partial remission. Among 45 patients with stable disease or a partial remission, the mean time to progression (TTP) was 10.9 months (median, 6.2; range, 1.6 to 48.5). The drug was well tolerated, with the most common side effects being diarrhea and hyperglycemia.


CONCLUSIONS
Somatostatin at a dose of 150 micrograms every 8 hours is well tolerated and has activity in low-grade NHL.
Witzig
T E
TE
Mayo Clinic, Rochester, MN 55905, USA.
Letendre
L
L
Gerstner
J
J
Schroeder
G
G
Mailliard
J A
JA
Colon-Otero
G
G
Marschke
R F
RF
Windschitl
H E
HE
D003967:Diarrhea / Q000139:chemically induced; D006801:Humans; D006943:Hyperglycemia / Q000139:chemically induced; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy; D008232:Lymphoproliferative Disorders / Q000188:drug therapy*; D012074:Remission Induction; D013004:Somatostatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States
D013004:Somatostatin