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

A phase II, single-arm clinical trial involving an alternative cancer treatment psorinum therapy in patients with advanced non-small cell lung cancer (NSCLC).

Sub-category: Other

Category: Developmental Therapeutics - Clinical Pharmacology and Immunotherapy

Meeting: 2010 ASCO Annual Meeting

Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr 2592)

Abstract 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

Abstract:

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.

Results: 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.