Abstract
143 Background: To improve survival of AGC, practitioners of traditional Chinese medicine (TCM) prescribe a combination of plant species/minerals, called formulae, based on their clinical experiences. WCA, a Chinese “Jianpi” herbal formula, could inhibit gastric cancer cells MKN-45, SGC-7901 growth in vivo on our previous studies. All the herbs formed the formula have been used for thousands of years in Chinese clinical practices. Methods: A nonrandomized concurrent control trial was performed to investigate the role of WCA for AGC. Patients (pts) with gastric adenocarcinoma (locally advanced, recurrent, or metastatic) were prospectively enrolled. All pts were assigned to receive WCA+CT q3w for 3 or more than 3 cycles or CT alone. WCA was formulated as following: Radix pseudoxtellariae 12g, Stir-fried Rhizoma atractylodis macrocephalae 12g, Poria cocos 30g, Sargentodoxa cuneata 30g, Concha ostreae 30g, Prunellae vulgaris 9g. It was given orally every day until disease progression. The primary end point was overall survival (OS). The baseline comparison was analyzed by using chi-squared test. Results: 270 eligible pts had been histologically confirmed adenocarcinoma. At the time of last follow-up, 197 pts (73.0%) had died of disease, and 67 pts (26.7%) had censored, 1 patient (0.3%) had died of unrelated cause. The median follow-up of pts was 39.9 months. Baseline characteristics (gender; age of onset; primary tumor site; histological type; initial CT scheme; cycle of CT) were well balanced across arms. Median OS was significantly improved in WCA+CT arm (n=127) compared to that in CT (n=143) alone: 19.3 vs. 13.1 months, respectively (HR 0.550; 95% CI 0.412, 0.734; p=0.000). The treatment was generally well tolerated. There were no WCA-related adverse events observed. No patient died related to WCA treatment. Conclusions: This prospectively concurrent control trial investigating Chinese herbal therapy in advanced GC showed that WCA+CT be a promising candidate treatment for GC superior to CT alone. A randomized controlled trial is needed to further evaluate the value of WCA in improving the OS of AGC.
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