| Disease | 60 ADULT PATIENTS WITH ADVANCED PREVIOUSLY TREATED CANCER (BREAST, 16 PATIENTS; COLORECTAL, 16 PATIENTS; LUNG,14 PATIENTS; PROSTATE, 8 PATIENTS; NON-HODGKIN LYMPHOMA, 3 PATIENTS; BRAIN, 1 PATIENT; AND UNKNOWN PRIMARY TUMOR, 2 PATIENTS) WERE
ENROLLED. ELIGIBILITY CRITERIA INCLUDED CONFIRMATION OF DIAGNOSIS, RESISTANCE TO CONVENTIONAL THERAPY, OBJECTIVE MEASURABLE DISEASE, LIFE EXPECTANCY OF 12 WEEKS OR GREATER, EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS OF 0 TO 2,
NO RECENT OR CONCOMITANT ANTICANCER THERAPY, NO PRIOR SC, AND INFORMED CONSENT. PATIENTS UNDERWENT EVALUATION OF THE EXTENT OF DISEASE, QUALITY-OF-LIFE SCORE (FUNCTIONAL ASSESSMENT OF CANCER THERAPY-GENERAL [FACT-G] SCALE), AND HEMATOLOGIC
BIOCHEMICAL, AND SELECTED IMMUNE FUNCTION STUDIES OF BASE-LINE AND AFTER 6 AND 12 WEEKS OF SC THERAPY. THE DOSE OF SC WAS 1 G/KG DAILY ORALLY IN 3 DIVIDED DOSES. STANDARD CRITERIA WERE USED TO EVALUATE ADVERSE EVENTS AND RESPONSE. UNDER THE
SPECIFIC CONDITIONS OF THIS STUDY, SC AS A SINGLE AGENT WAS INACTIVE IN PATIENTS WITH ADVANCED-STAGE CANCER AND HAD NO SALUTARY EFFECT ON QUALITY OF LIFE. THE 16.7% RATE OF SD WAS SIMILAR TO RESULTS IN PATIENTS WITH ADVANCED CANCER TREATED WITH
SUPPORTIVE CARE ALONE. |