Sorafenib in liver function impaired advanced hepatocellular carcinoma.

OBJECTIVE: To explore the efficacy and safty of sorafenib in Child-Pugh class B to class C hepatocellular carcinoma (HCC). METHODS: In this three-center open-label study from November 2011 to May 2013, we randomly assigned 189 patients with advanced Child-Pugh class B or C HCC patients into two groups, one group with 95 patient to receive sorafenib (400 mg a time, twice a day) and the other group with 94 patients to receive best supportive care. The primary end points were progression-free survival and overall survival. RESULTS: The median progression-free survival was 2.2 months and 1.9 months in the sorafenib group and best supportive care group respectively (Hazard ratio in the sorafenib group, 0.55; 95% confidence interval, 0.40-0.75; P=0.002). The median overall survival was 4.0 months and 3.5 months in the sorafenib group and best supportive care group respectively (Hazard ratio in the sorafenib group, 0.48; 95% confidence interval, 0.35-0.68; P<0.001). The main adverse effect of sorafenib was rash and acne of the skin (in 51.7% patients). The incidences of severe rash, diarrhea, and dry skin were 5.6%, 5.6%, and 2.2% in the sorafenib group. One patient reached partial response in the sorafenib group. CONCLUSIONS: Sorafenib is safe in patients with liver function impaired advanced HCC. It is effective in terms of progression-free survival and overall survival compared with best supportive care. Liver functions are the important predictive factors.

[Combination of EP regimen and split-course hyperfractionated accelerated irradiation in locally advanced non-small cell lung cancer].

BACKGROUND: To investigate the efficacy of EP regimen combined with split-course hyperfractionated accelerated irradiation for locally advanced non-small cell lung cancer. METHODS: The treatment was composed of 3 cycles of combined chemoradiotherapy at 4-week intervals. Chemotherapy with cisplatin ( 30 mg/m²) and etoposide (60 mg/m²) was administrated intravenously on days 1-3, followed by radiotherapy on days 4-8. A course of radiotherapy consisted of 1.5 Gy per fraction, twice a day (3 Gy per day) for 5 consecutive days, for a total dose of 15 Gy. In the third cycle, additional irradiotherapy consisted of 2 Gy once a day was performed on days 11-15, for a total dose up to 55 Gy during 10 weeks. After three cycles, patients were given 2 additional cycles of chemotherapy with MVP regimen. RESULTS: Of the 43 patients, 12 had a complete remission and 22 a partial response, resulting in an overall response rate of 79.1%. Of the 152 chemotherapeutic cycles administrated, there were 40 during which grade III-IV toxicities occurred, mainly consisting of leukopenia and vomiting. The 1- and 2-year survival rates were 66.7% and 57.2%, respectively. CONCLUSIONS: EP regimen combined with split-course hyperfractionated accelerated irradiation is effective and well tolerated for advanced locally non-small celll lung cancer. It should be investigated further.