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

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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.