OBJECTIVE: The purpose of this study was to investigate the effect of Haishengsu, an extract from Tegillarca L. granosa, on the effects and side-effects of immunotherapy in patients with advanced renal cell cancer. METHODS:Fifty-five (55) patients with renal cell cancer were randomly divided into a Haishengsu group (n = 27, 2.4 mg, intravenously for 15 days) and a control group (n = 28). All patients were also treated with interleukin-2, interferon-alpha, and fluorouracil. RESULTS: In the Haishengsu group, the prevalence of gastrointestinal reactions to the immunotherapy was lower than in the control group (18.5% versus 64.3%, p < 0.01). In comparison with the control group, more patients from the Haishengsu group had increased food intake (74.1% versus 14.3%, p < 0.01), weight gain (77.8% versus 10.7%, p < 0.01) or an increase in Karnofsky Performance Status score (55.6% versus 17.9%, p < 0.01). The remission rate of cancer in the Haishengsu group was higher than in the control group (51.9% and 21.4%, p < 0.01). CONCLUSIONS: Addition of Haishengsu to the conventional immunotherapy is associated with an increased remission rate in patients with advanced renal cell cancer. Haishengsu was also associated with a reduced rate of gastrointestinal side-effects from the immunotherapeutic agents, and an improvement in the physical functionality of the patients.
RCT Entities:
OBJECTIVE: The purpose of this study was to investigate the effect of Haishengsu, an extract from Tegillarca L. granosa, on the effects and side-effects of immunotherapy in patients with advanced renal cell cancer. METHODS: Fifty-five (55) patients with renal cell cancer were randomly divided into a Haishengsu group (n = 27, 2.4 mg, intravenously for 15 days) and a control group (n = 28). All patients were also treated with interleukin-2, interferon-alpha, and fluorouracil. RESULTS: In the Haishengsu group, the prevalence of gastrointestinal reactions to the immunotherapy was lower than in the control group (18.5% versus 64.3%, p < 0.01). In comparison with the control group, more patients from the Haishengsu group had increased food intake (74.1% versus 14.3%, p < 0.01), weight gain (77.8% versus 10.7%, p < 0.01) or an increase in Karnofsky Performance Status score (55.6% versus 17.9%, p < 0.01). The remission rate of cancer in the Haishengsu group was higher than in the control group (51.9% and 21.4%, p < 0.01). CONCLUSIONS: Addition of Haishengsu to the conventional immunotherapy is associated with an increased remission rate in patients with advanced renal cell cancer. Haishengsu was also associated with a reduced rate of gastrointestinal side-effects from the immunotherapeutic agents, and an improvement in the physical functionality of the patients.
Authors: Kodappully S Siveen; Kirti S Prabhu; Iman W Achkar; Shilpa Kuttikrishnan; Sunitha Shyam; Abdul Q Khan; Maysaloun Merhi; Said Dermime; Shahab Uddin Journal: Mol Cancer Date: 2018-02-19 Impact factor: 27.401