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Pilot study of a specific dietary
supplement in tumor-bearing mice and in stage IIIB and IV non-small cell lung
cancer patients.
Sun
AS, Yeh
HC, Wang
LH, Huang
YP, Maeda
H, Pivazyan
A, Hsu
C, Lewis
ER, Bruckner
HW, Fasy
TM.
Connecticut Institute for Aging and Cancer, Milford, CT
06460, USA.
Previously, a specific dietary supplement, selected
vegetables (SV), was found to be associated with prolonged survival of stage
III and IV non-small cell lung cancer (NSCLC) patients. In this study, several
anticancer components in SV were measured; the anticancer activity of SV was
assessed using a lung tumor model, line 1 in BALB/c mice. SV was also used in
conjunction with conventional therapies by stage IIIB and IV NSCLC patients
whose survival 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/wt) was associated with a 53-74% inhibition of tumor growth rate.
Fourteen of the 18 patients who ingested SV daily for 2-46 months were
included in the 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 was > 70%. The median survival time of the 16
"intent-to-treat" patients (including ineligible patients) was 20 months, and
one-year survival was 55%. The Karnofsky performance status of eligible
patients was 55 +/- 13 at entry 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; two of them, whose primary tumor was resected, used
SV alone and demonstrated an objective response of their metastatic tumors. In
addition to the two lead cases, eight patients had no new metastases after
using SV. Three patients had complete regression of brain metastases after
using radiotherapy and SV. In this study, daily ingestion of SV was associated
with objective responses, prolonged survival, and attenuation of the normal
pattern of progression of stage IIIB and IV NSCLC. A large randomized phase
III clinical trial is needed to confirm the results observed in this pilot
study.
PMID: 11588907 [PubMed - indexed for MEDLINE]