Document 1085
 DOCN  M9471085
 TI    Immunologic correlates in patients (pts) with head and neck cancer
       (SCCHN) treated with interferon alpha (IFN): association between natural
       killer cell (NK) activity and prolonged survival (Meeting abstract).
 DT    9409
 AU    Vlock D; Andersen J; Whiteside T; Herberman R; Kirkwood J; Adams G;
       Brigham and Women's Hospital, Harvard Medical School, Boston, MA; 02115
 SO    Proc Annu Meet Am Soc Clin Oncol; 13:A900 1994. Unique Identifier :
       AIDSLINE ICDB/94600896
 AB    71 pts with recurrent or metastatic SCCHN were entered onto a phase II
       noncomparative randomized trial of IFN at 2 dosage schedules (EST
       P-Z386): low dose IFN, 6 x 10(6) U/m2 daily x 3 every 4 wk or high dose
       IFN, 12 x 10(6) U/m2, 3x/wk (Proc ASCO, 10:205). While the overall
       response rates were low (3 CRs) disease stabilization was noted,
       suggesting an antiproliferative, non-cytotoxic role of IFN in this group
       of heavily pre-treated pts. Median survival of pts receiving greater
       than or equal to 6 wk of IFN was 10 and 12 mo for low and high dose IFN,
       respectively. We sought to determine if any immune parameters were
       associated with prolonged survival. Pretreatment levels of NK activity,
       CD3, CD4, CD5, CD8, CD16, CD19, CD56, DR and the CD4/CD8 ratio were
       evaluated. None of the parameters tested was a significant predictor of
       survival when evaluated in all cases entered onto study regardless of
       therapy duration. No difference in baseline NK activity was noted
       between pts who received less than or greater than or equal to 6 wk of
       IFN (p=0.90). Among the 35 pts who received greater than or equal to 6
       wk of therapy, high baseline NK activity was a significant predictor of
       the duration of survival both in a univariate analysis (p=0.04) and when
       proportional hazards regression was adjusted for prior weight loss and
       chemotherapy (p=0.005), the two covariates associated with survival in
       the primary clinical analysis. Survival of pts with median baseline NK
       activity of 192 lytic units was greater than 24 mo (N=7) vs 6-12 mo for
       pts with median NK activity of 67 (N=13). Baseline CD4, CD8 and CD4/CD8
       ratios and the differences between baseline and measurements after 1 wk
       of IFN were not associated with the duration of survival. We conclude
       that elevated baseline NK activity is associated with increased survival
       in pts receiving IFN for greater than or equal to 6 wk.
 DE    Analysis of Variance  Antigens, CD/BLOOD  CD4-CD8 Ratio  Comparative
       Study  Head and Neck Neoplasms/BLOOD/*IMMUNOLOGY/MORTALITY/*THERAPY
       Human  Interferon-alpha/*TOXICITY/*THERAPEUTIC USE  Killer Cells,
       Natural/DRUG EFFECTS/*IMMUNOLOGY  Survival Analysis  Survival Rate
       MEETING ABSTRACT  CLINICAL TRIAL, PHASE II  CLINICAL TRIAL

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