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

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Journal of Clinical Oncology, 2011 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 29, No 15_suppl (May 20 Supplement), 2011: e13044
© 2011 American Society of Clinical Oncology

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

A. Chatterjee, J. Biswas, S. Bhattacharya, A. K. Chatterjee, A. Chakraborty and R. S. Bhakta

Critical Cancer Management Research Centre and Clinic, Kolkata, India; Chittaranjan National Cancer Institute, Kolkata, India; R. G. Kar Medical College and Hospital, Kolkata, India

Abstract Disclosures

Abstract

e13044

Background: We prospectively studied the clinical efficacy of an alternative cancer treatment "psorinum therapy" in patients with advanced esophageal carcinoma (ECA).Methods: Our study was phase- II, open level, single arm and single stage. Participants’ eligibility criteria included (1) histopathology confirmation of ECA; (2) inoperable tumor (3) no prior conventional cancer treatments (4) Karnofsky performance status between 40- 70%. The primary outcome measures of the study were (1) to assess the radiological tumor response rate (using CT scanning 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 anti- cancer drug (psorinum) if any. The drug psorinum (an alcoholic extract of scabies, 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: 65 participants included in the final analysis at the end of the study. According to the RECIST criteria, complete tumor response occurred in 11 (16.92%) cases and partial response occurred in 20 (30.77%) cases. 44 (67.69%) of them survived at least 1 yr, 32 (49.23%) survived at least 2 yrs, 24 (36.92%) survived at least 3 years, 21 (32.31%) survived at least 4 years and 17 (26.15%) of them survived at least 5 years. These participants did not receive conventional or any other investigational cancer treatments. Conclusions: The results of the study show clinical efficacy of psorinum therapy in treating patients with advanced esophageal carcinoma. The investigational drug psorinum is non- toxic. Randomized controlled clinical trial should be conducted for further investigation of this alternative cancer treatment in treating esophageal carcinoma