Adjuvant spleen ultrafiltrate immunotherapy in unresectable advanced non small cell lung cancer

The purpose of this study was to assess the possible benefit of adjuvant spleen ultrafiltrate immunotherapy in advanced lung cancer patients on chemotherapy. Twenty-six patients with inoperable non-small cell lung carcinoma were eligible to this study and randomised divided into two groups. The two groups received additionally to standard chemotherapy--three times once a month--placebo or spleen ultrafiltrate (Prosplen), respectively, given to the patients for 14 days beginning from the 7th day after each chemotherapy. To evaluate the effects of spleen ultrafiltrate, the time of haematological recovery and profile of peripheral blood lymphocytes and clinically number of days with fever and oncological response were documented. During the observation time patients receiving spleen ultrafiltrate had a higher number of leukocytes (p = 0.01) and higher counts (p = 0.03) and percentage of granulocytes (p < 0.001) including nadir values (p = 0.05) in blood. The positive effect was also seen in natural killer cells (p = 0.005) but not in T cells compartment. This could be of clinical significance because patients receiving spleen ultrafiltrate presented less frequently febrile episodes than patients in the placebo group (75 vs. 127 days with body temperature > 38 degrees C, p = 0.007) and had less frequently highly elevated serum C-reactive-protein levels (p = 0.02). Notably, 2 out of 12 patients receiving in addition to chemotherapy spleen ultrafiltrate and 7 out of 14 lacking this adjuvant treatment showed tumor progression during the treatment. Serum C3 levels were associated with progression of disease in both groups (p = 0.03). Overall, spleen ultrafiltrate receiving patients had lower serum C3 values than placebo receiving patients. Serum IgM levels were rather high in the placebo group (p = 0.033). Spleen ultrafiltrate is thought to benefit patients on palliative chemotherapy in advanced metastatic cancers.