Improvement in quality of life and symptom control with MYCOBACTERIUM W (CADI-05) in head and neck cancer

Abstract

21186 Background: Recurrent, radiated and chemotherapy given patients are having many unmanageable symptoms and problems. This condition is worsened by malnutrion, infection, pain and immuno suppression. Modifying immune mechanism of the body is the last and best weapon to fight against such diseases. Role of immunotherapy in the treatment of malignant diseases is on experimental level. Dr George Thyphrontis & Michael Kousilers have produced good results in carcinoma of urinary bladder, melanoma & lung cancer with Immunotherapy. At GCRI, we have tried vaccine, prepared from mycobacterium-W in 100 cases of Head & Neck Cancer. Methods: As a prospective nonrandomized study, to see beneficiary effect on quality of life and symptom control, we have done a trial during Jan. 2004 to Dec.2005. Informed consent and ethical clearance was obtained. Study was made to find out any side effect or adverse reactions of the vaccine. After fulfilling the criteria of inclusion and exclusion the case was selected for study and 0.1 ml vaccine (CADI-05) was injected intradermally with all aseptic precautions. Four injections, weekly and later on four injections monthly were given. Patient was followed up for 6 months. Results: Total No. of cases -100. M / F - 89/11. age distribution - Maximum No. were in 5th decade -(34%) followed by 6th decade (21%)Site of primary - Commonest site was Buccal mucosa (29%) followed by tongue (17%). There was no major side effect. Only 5% Patients developed constitutional symptoms and infection at injection site. 27% patients had pain relief. Symptom control was seen in 15% patients. Improvement in quality of life was observed in 82% of patients. 4% of patients had no effect. The beneficiary effect lasted for three month in 27% patients and more than six months in 13% patients. The effect was more marked in dysphagia, ulcer and fistula. Effect was insignificant in strider, change in voice and metastatic nodes. Four patients are living with Immuvac in spite of disease symptom free for more than one year. Conclusions: Immunotherapy with Mycobacteium W can safely be used to improve quality of life and control of symptom in terminally ill Head & Neck cancer. No significant financial relationships to disclose.

A Comparative Evaluation of Mycobacterium w Vaccine Based Immunotherapy plus Concomitant Chemoradiation versus Concomitant Chemoradiation alone in Locally Advanced Head and Neck Cancer

“…The above trials are in accordance with the present study and have reported better locoregional control (tumor clinical response) along with reduced treatment induced toxicity in the Mw vaccine based immunotherapy groups along with CCRT (MwCCRT group) as compared to the CCRT alone groups (control group) [16,18].…”

“…The present study using Mw vaccine immunotherapy along with CCRT in the management of LASCCHN has demonstrated the reduction in treatment induced toxicity with improvement in clinical response. Similar results have been reported by Dave et al who conducted a randomized controlled study to evaluate the effect of vaccine containing Mw administered for 6 months in 100 patients of head and neck cancer patients and concluded that immunotherapy may be useful as a safe therapy in head and neck cancer patients for better clinical response, reducing side effects and improving quality of life [18].…”

“…Immunotherapy in the form of Mw vaccine may be useful as concurrent therapy with radical intent concomitant chemoradiation treatment to improve response rate with less side effects in patients suffering from locally advanced head and neck squamous cell carcinoma [15][16][17][18].…”

Mycobacterium w Immunotherapy for Treating Pulmonary Tuberculosis - a Systematic Review

“…In a non-randomised trial of M w adjuvant treatment as palliative care for advanced head and neck cancers, M w was considered safe and beneficial for improving the quality of life 55 .…”