Effect of lc9018 combined with radiation therapy on carcinoma of the uterine cervix. A phase iii, multicenter, randomized, controlled study

Abstract

Background. The failure rate with radiation therapy alone for Stage III cervical cancer is quite high, and therefore other modalities are being pursued as adjuvants to radiation therapy in hopes of improving the results. Methods. A randomized, controlled, comparative study on the efficacy and safety of radiation therapy combined with LC9018 (a biologic response modifier prepared from heat‐killed Lactobacillus casei YIT9018) was conducted using 228 patients with Stage IIIB cervical cancer. Results. LC9018 enhanced tumor regression (P < 0.1) by radiation after both 30 Gy of external radiation and at the completion of radiation therapy. The combination therapy also prolonged survival and the relapse‐free interval (P < 0.05) compared to radiation alone. Analysis of survival using the Cox proportional hazard model indicated that use of LC9018 was a significant factor related to survival duration. Major side effects of combined LC9018 included fever and skin lesions at the injection site, but no severe symptoms were noted. Radiation‐induced leukopenia was significantly less severe (P < 0.05) in the LC9018‐combined group than in the radiation‐alone group, suggesting that this agent might help to prevent leukopenia during radiation therapy. Conclusions. LC9018 was shown to be an effective agent for adjuvant immunotherapy when combined with radiation therapy.

The role of tumor necrosis factor (TNF)-? in the antitumor effect of intrapleural injection of Lactobacillus casei strain Shirota in mice

“…It has been also reported that i.pl. injection of LC 9018 eectively inhibited the exudation of thoracic uid caused by transplanted tumors and revealed a survival-prolonging eect in animals [14,16] and clinical trials [12,23]. In the present work, we investigated the cytokines responsible for the mechanism of action of the antitumor eect of LC 9018 using a murine malignant pleurisy model.…”

Palliative Treatment of Advanced Cervical Cancer with Radiotherapy and Thai Herbal Medicine as Supportive Remedy - Analysis of Survival

“…4) Immunomodulation enhancement through LC 9018, a biologic response modifier prepared from heat-killed Lactobacillus casei YIT9018 that results in the delayed or inhibited process of metastases in various cell types of cancers and the delayed process of cancer recurrences have been reported (Okawa et al, 1993;Matsuzaki, 1998). 5) The clinical reports of LC9018 as an adjuvant with radiotherapy demonstrated an enhancement of tumor regression, prolonged survival and relapse -free survival compared with radiotherapy alone (Okawa et al, 1993).…”

Nanotechnology and its Partnership with Synbiotics

“…As seen in evidence-based practices, studies have shown reducing the risk of colon carcinogenesis; impart to the fatty acid chains created in the fermentation process to form probiotics [27]. The synergistic effect exerts alternations to the tumor expressing genes [28]. A randomized, controlled, comparative study utilize heat -killed L.casei in 228 patients with stage III cervical cancer, it reports antitumor effects caused by the macrophage activation by the L.casei.…”