The clinical course of B-cell chronic lymphocytic leukemia (B-CLL) is variable, and novel biologic parameters need to be added to the clinical staging systems to predict an indolent or aggressive outcome. We investigated the 70-kDa zetaassociated protein (ZAP-70), CD38, soluble CD23 (sCD23), and cytogenetics in 289 patients with B-CLL. Both a shorter progression-free survival (PFS) and overall survival (OS) were observed in ZAP-70 ؉ (P < .001), in CD38 ؉ (P < .001) and in sCD23 ؉ patients (P < .001 and P ‫؍‬ .013, respectively). ZAP-70 ؉ CD38 ؉ or ZAP-70 ؉ patients with an unmutated IgV H status showed both a shorter PFS (P < .001) and OS (P < .001 and P < .001, respectively) as compared with ZAP-70 ؊ /CD38 ؊ or ZAP-70 ؊ patients with mutated IgV H genes. Discordant patients showed an intermediate outcome. Note, ZAP-70 ؉ patients even if CD38 ؊ or mutated showed a shorter PFS, whereas ZAP-70 ؊ patients even if CD38 ؉ or unmutated had a longer PFS. Furthermore, ZAP-70 positivity was associated with a shorter PFS both within normal karyotype (P < .001) and within the poor-risk cytogenetic subset (P ‫؍‬ .02).

Clinical trials of monoclonal antibodies in combination with chemotherapy have reported previously unattained response rates in patients with B-cell chronic lymphocytic leukemia (B-CLL); however, the analysis of ZAP-70 protein and/or CD38 may explain better the discordant outcomes independent of treatment

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