Effect of Salvestrol as an Adjunct in the Treatment of Head & Neck, GIT, Ovary, Breast and Lung Malignancies Undergoing Conventional Treatment in an Indian Population

Abstract

Background: Previous studies have elucidated that Salvestrols are a class of phytonutrients that, function through an extremely targeted mechanism that hinges on their metabolism by the universal cancer marker CYP1B1, causing cell apoptosis. Unfortunately, modern-day cultivation practices have severely limited the obtainability of these specific phytonutrients in the modern food regime. These phytonutrients are all phytoalexins and are not induced in abundance until the plants are exposed to predation or infection as a part of their defense mechanism. Hence this investigation aims to study the effect of Salvestrol as an adjunct to routine cancer therapy on five different types of malignancies and to assess its impact on survival and quality of life has been studied. Patients and Methods: This is a two-arm study comprising of a cohort of 102 patients having cancers of the head and neck, lung, ovary, breast, and GIT. The patients in both the arms were randomized to receiving chemotherapy, radiotherapy, and surgery or in combination. The test group received the above along with Salvestrol (6000 salvestrol units as leader dose for 1 month followed by maintenance 4000 salvestrol units till death or discontinuation). The control arm received the same treatment as the test arm minus the salvestrol. Vitamin C and B complex was given to both groups. Results: The mean overall survival in the head and neck cancer salvestrol arm was 15.91 ±10.73 months and that of the controls was 8.0 ± 5.83 months, which was statistically significant (P=0.0441). The mean overall survival in the lung cancer salvestrol arm was 8.708 ± 9.006 months and in the controls was 2.292 ±1.484 months, which was statistically significant (p=0.0234). The mean overall survival in the GIT salvestrol arm was 10.000 ± 10.317 months and that in the control arm was 3.550 ± 3.700 months which was statistically significant (p=0.0792). The mean survival in the ovary salvestrol arm was 17.63 ± 7.19 months and in the control, the arm was 6.63 ± 7.56, which is very statistically significant (p=0.0099). The mean survival in the breast salvestrol arm was 21.80 ± 6.96 months and that of the control group was 22.10 ± 4.01 months (p=0.9073), which was statistically insignificant. The overall survival among the salvestrol patients was 14.480 ± 10.036 months as compared to 8.333 ± 8.507 months in the control arm (p=0.0012). The mean ECOG score was 1.12 ± 0.773 in the salvestrol arm (n=60) and 1.58 ± 0.8593 in the control arm (n=60), which was statically significant (p=.00591). The HAM-A scores were 2.4314 ± 2.9138 in the salvestrol arm (n=60) and 3.0612 ± 3.4666 in the control arm (n=60), which was statically insignificant (p=0.97). The mean PGSGA scores in the salvestrol arm (n=60) were 6.4688 ± 2.8959 and that in the control arm (n=60) was 7.625 ± 5.7291, which was also statistically insignificant (p=.312209). Conclusion: To date, there have been a case or series of reports on the efficacy of salvestrols in cancer. No randomized control trial has been undertaken with conventional treatment and salvestrol. Hence it was imperative to study the role of salvestrol in a randomized controlled fashion. This study was designed to compare the survival of 102 patients with five types of cancer by adding salvestrol in the prescribed treatment regime to one arm. As the results of the study showed improved overall survival in cancers of the head and neck, lung, GIT, and ovary, it may consider that salvestrols have played a role in survival, as both groups, received the same TNM based treatment. Salvestrols improved ECOG scores but not HAM –A or PGSGA. The use of salvestrol as an adjunct to surgery, radiotherapy and chemotherapy in GIT, lung, Head & neck and ovarian malignancies may prolong the overall survival and improve the ECOG status. CYP1B1 pathways and salvestrol were found to be promising solutions to improve cancer treatment with no added side effects or toxicity. Larger randomized studies are required to further confirm the role of salvestrols.