A phase II, single-arm clinical trial involving an alternative cancer treatment psorinum therapy in patients with advanced non-s

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A phase II, single-arm clinical trial involving an alternative
cancer treatment psorinum therapy in patients with advanced non-small
cell lung cancer (NSCLC).
Category: Developmental Therapeutics -
Clinical Pharmacology and Immunotherapy
2010 ASCO Annual

Citation: J Clin
Oncol 28:7s, 2010 (suppl; abstr 2592)
No: 2592
Author(s): A. Chatterjee, J. Biswas,
A. K. Chatterjee, S. Bhattacharya, B. P. Mukhopadhyay, A. Chakraborty,
S. Das, R. S. Bhakta; Critical Cancer Management Research Centre and
Clinic, Kolkata, India; Chittaranjan National Cancer Institute, Kolkata,
India; National Institute of Technology, Durgapur, India; R. G. Kar
Medical College and Hospital, Kolkata, India
Background: We
prospectively studied the clinical efficacy of an alternative cancer
treatment "psorinum therapy" in patients with advanced non-small cell
lung carcinoma (NSCLC).
Methods: Our study was phase II, open-
level, single arm, and single stage. Participants' eligibility criteria
included (1) histopathological or cytopathological confirmation of
NSCLC; (2) inoperable; (3) no prior chemotherapy or radiation therapy;
(4) Karnofsky performance status between 40 and 60. The primary outcome
measures of the study were (1) to assess the radiological tumor response
rates (using CT scan procedure and following the RECIST criteria); (2)
to assess how many participants survived at least 1 yr, 2 yrs, 3 yrs, 4
yrs, and finally, after 5 yrs of the study. The secondary outcome
measure was to assess the side effects of the investigational
anticancer drug (psorinum) if any. The drug psorinum (an alcoholic
extract of scabies, scrub, slough, and pus cells) was administered
orally at 0.02ml/Kg body weight/day as a single dose in empty stomach
and ongoing for complete course duration of 2 years to all the
participants along with allopathic and homeopathic supportive cares.
95 participants included in the final analysis at the end of the
study. According to the AJCC TNM staging system, 58 (61.05%) of them
diagnosed at stage IV. According to the RECIST criteria, complete tumor
response occurred in 19 (20%) cases and partial tumor response occurred
in 28 (29.47%) cases. 82 (86.32%) of them survived at least 1 yr, 70
(73.68%) survived at least 2 yrs, 58 (61.05%) survived at least 3 yrs,
49 (51.58%) survived at least 4 yrs, and 42 (44.21%) of them survived at
least 5 yrs. These participants did not receive chemotherapy, radiation
therapy, or any other investigational cancer treatments. Participants
reported no side effects from the drug psorinum.
Conclusions: The
results of this study show clinical efficacy of psorinum therapy in
treating patients with advanced NSCLC. The investigational drug psorinum
is non-toxic. Randomized double-blinded clinical trial should be
conducted for further investigation of this alternative cancer therapy
in treating NSCLC.