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Role of natural lycopene
and phytonutrients along with radiotherapy and chemotherapy in high
grade gliomas
T. Puri, P. K.
Julka, S. Goyal, O. Nair, D. N.
Sharma and G. K. Rath
All India Institute Medcl Sciences
(AIIMS), New Delhi, India
Objective.
The present study was conducted to determine the effect of
adding lycopene
(antioxidant with potential anticancer activity), to
radiotherapy (RT) and chemotherapy in the adjuvant treatment
of high grade gliomas, with response at 6 months and time
to progression being end points.
Methods. The study was
conducted from Nov’02-Nov’03.
Fifty patients with anaplastic
astrocytoma (AA) or GBM were enrolled who had undergone surgical
excision but had residual disease.
All of them received RT to a
dose of 60Gy in 30 fractions over 6 weeks with concomitant Paclitaxel,
60 mg/m2 i/v weekly.
They were randomized into two groups:
Group A: (n=25) received 8mg of oral lycopene
daily, Group B: (n=25) received placebo; along with
RT.
Informed consent was taken
prior to enrollment.
Response was evaluated with MRI and
brain SPECT at 3 and 6 months post treatment; and 6monthly thereafter.
Pre and post RT plasma lycopene
levels were monitored using high precision liquid
chromatography.
Results. Out of 50
patients, 38 were males and 12 females with a mean age of 38
years.
32 patients had GBM while 18 had AA.
Response at six months post treatment was analyzed using
WHO criteria.
All patients were alive at 6
months.
Pre and post treatment plasma lycopene
levels in patients of Group A were 152 and 316 ng/ml and in
Group B were 93 and 98 ng/ml.
Among Group A (lycopene
group): 10 (40%) patients had complete response (CR), 10
(40%) had partial response (PR), 1 (4%) had stable disease
(SD), 3 (12%) had progressive disease (PD) while response
was not available for 1 patient (4%).
Among Group B (placebo group); 5 (20%)
patients had CR, 6 (24%) had PR, 1 (4%) had SD, 8 (32%) had
PD while response was not available for 5 patients
(20%).
Overall response in Group A was
superior to Group B but was not statistically significant (p
= 0.1).
Median time to disease progression was 39
wks for Group A and 21 wks for Group B patients (p =
0.14).
Conclusions. The
addition of lycopene
to radiotherapy and chemotherapy in patients with high
grade glioma results in positive outcome; both in terms of
response rates at 6 months post treatment and time to
progression.
Further larger studies would be required
to arrive at a more definitive conclusion.
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