A Randomized Study of Chemotherapy Versus Biochemotherapy with Chemotherapy plus Aloe arborescens in Patients with Metastatic Cancer

Background: The recent advances in the analysis of tumor immunobiology suggest the possibility of biologically manipulating the efficacy and toxicity of cancer chemotherapy by endogenous or exogenous immunomodulating substances. Aloe is one of the of the most important plants exhibiting anticancer activity and its antineoplastic property is due to at least three different mechanisms, based on antiproliferative, immunostimulatory and antioxidant effects. The anti- proliferative action is determined by anthracenic and antraquinonic molecules, while the immunostimulating activity is mainly due to acemannan. Patients and Methods: A study was planned to include 240 patients with metastatic solid tumor who were randomized to receive chemotherapy with or without Aloe. According to tumor histotype and clinical status, lung cancer patients were treated with cisplatin and etoposide or weekly vinorelbine, colorectal cancer patients received oxaliplatin plus 5-fluorouracil (5-FU), gastric cancer patients were treated with weekly 5-FU and pancreatic cancer patients received weekly gemcitabine. Aloe was given orally at 10 ml thrice/daily. Results: The percentage of both objective tumor regressions and disease control was significantly higher in patients concomitantly treated with Aloe than with chemotherapy alone, as well as the percent of 3-year survival patients. Conclusion: This study seems to suggest that Aloe may be successfully associated with chemotherapy to increase its efficacy in terms of both tumor regression rate and survival time. The recent formulation of chemo-biochemotherapeutic regimens could represent a very simple but promising strategy in the treatment of human neoplasms (1-3). The chemo- biochemotherapeutic combinations have been developed to associate the cytotoxic action of cancer chemotherapy with molecules capable of modulating the antitumor biological response and to counteract the suppressive effect of cancer chemotherapy on host immunobiological responses, which plays a fundamental role in the control of tumor progression and dissemination (4-7). Hence, the rationale of the association between cancer chemotherapy and biological response modifier agents consists of the prevention of chemotherapy-induced damage of host anticancer immunobiological reaction. A great variety of natural molecules with immunostimulatory activity have been isolated from plants commonly used in traditional medicine in an empirical manner, in particular from Aloe, Cannabis indica and myrrh (8-10). The immunobiological information available up to now may justify the clinical use of these three plants in the palliative therapy of human neoplasms, at least to improve the efficacy and tolerability of the common standard anticancer therapies, including chemotherapy and radiotherapy. Despite differences in the chemical structure of their molecules, the anticancer activity of aloe, cannabis and myrrh is based on very similar mechanisms, consisting of antiproliferative, immunostimulatory, anti-inflammatory and