Pilot study of a specific dietary supplement in tumor-bearing mice and in stage IIIB and IV non-small cell lung cancer patients

Previously, a specific dietary supplement, selected vegetables (SV), was fo und to be associated with prolonged survival of stage III and IV non-small cell lung cancer (NSCLC) patients. In this study, several anticancer compon ents in SV were measured; the anticancer activity of SV was assessed using a lung tumor model, line I in BALB/c mice. SV was also used in conjunction with conventional therapies by stage IIIB and IV NSCLC patients whose survi val and clinical responses were evaluated A daily portion (283 g) of SV was found to contain 63 mg of inositol hexaphosphate, 4.4 mg of daidzein, 2.6 mg of genistein, and 16 mg of coumestrol. Mouse food containing 5% SV (wt/w t) was associated with a 53-74% inhibition of tumor growth rate. Fourteen o f the 18 patients who ingested SV daily for 2-46 months were included in th e analyses; none showed evidence of toxicity. The first lead case remained tumor free for > 133 months; the second case showed complete regression of multiple brain lesions after using SV and radiotherapy. The median survival time of the remaining 12 patients was 33.5 months, and one-year survival w as > 70%. The median survival time of the 16 "intent-to-treat" patients (in cluding ineligible patients) was 20 months, and one-year survival was 55%. The Karnofsky performance status of eligible patients was 55 +/- 13 at entr y but improved to 92 +/- 9 after use of SV for five months or longer (p < 0 .01). Five patients had stable lesions for 30, 30, 20, 12, and 2 months; tw o of them, whose primary tumor was resected, used SV alone and demonstrated an objective response of their metastatic tumors. In addition to the two l ead cases, eight patients had no new metastases after using SV. Three patie nts had complete regression of brain metastases after using radiotherapy an d SV. In this study, daily ingestion of SV was associated with objective re sponses, prolonged survival, and attenuation of the normal pattern of progr ession of stage IIIB and IV NSCLC A large randomized phase III clinical tri al is needed to confirm the results observed in this pilot study.