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OP0002 A randomised, single-centre phase 2 study of ginsenoside Rg3 plus transarterial chemoembolisation (TACE) versus TACE alone in Chinese patients with advanced hepatocellular carcinoma
European Journal of Cancer (2015) 51, e1– e36
Available at www.sciencedirect.com
ScienceDirect journal homepage: www.ejcancer.com
7th Annual Asian Oncology Summit and 11th Annual Conference of the Organisation for Oncology and Translational Research
OP0002 A RANDOMISED, SINGLE-CENTRE PHASE 2 STUDY OF GINSENOSIDE RG3 PLUS TRANSARTERIAL CHEMOEMBOLISATION (TACE) VERSUS TACE ALONE IN CHINESE PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA Bo Zhou *, Zhiping Yan, Rong Liu, Sheng Qian, Xudong Qu, Liang Zhu, Jiemin Cheng, Gaoquan Gong, Yi Chen, Qingxin Liu, Jianjun Luo, Lingxiao Liu, Wen Zhang, Changyu Li, Wei Zhang, Jianhua Wang. Department of Interventional Radiology, Fudan University Zhongshan Hospital, Shanghai, China Background: Ginsenoside Rg3 is a low toxic inhibitor of vascular endothelial growth factor (VEGF), which is implicated in angiogenesis in hepatocellular carcinoma (HCC). This single-centre, open-label, randomised, controlled trial evaluated the efficacy and safety of ginsenoside Rg3 plus transarterial chemoembolisation (TACE) in patients with advanced HCC. Methods: Advanced HCC patients (Child-Pugh A) who had no prior systemic therapy were randomly assigned (2:1 ratio) to receive 20 mg twice daily orally (n = 152) combined with TACE or TACE alone (n = 76). The primary endpoint was overall survival (OS). Secondary endpoints included time to progression (TTP), time to untreatable progression (TTUP), disease control rate (DCR) based on modified Response Evaluation Criteria in Solid Tumors, and safety. Results: Median overall survival was 13.2 months (95% confidence interval (CI) 11.15–15.26) in the TACE + Rg3 group compared with 10.1 months (95% CI 9.14–11.06) for those receiving TACE alone (hazard ratio (HR) 0.63 [95% CI 0.46–0.85], p = 0.002). Median TTP was 4.3 months (95% CI 3.32–5.28) in the TACE + Rg3 group compared with 3.2 months (95% CI 2.51–3.89) in the TACE group (HR 0.82 [95% CI 0.62–1.08], p = 0.151). Patients in the TACE + Rg3 group had longer median TTUP (8.3 months [95% CI 7.05–9.55]) than in the TACE group (7.3 months [95% CI 6.40–8.20]; HR 0.76 [95% CI 0.57–1.02], p = 0.063). The most frequently reported Rg3-related grade 3–4 adverse events in 152 patients were constipation (two [1.3%]) and hypertension (six [3.9%]). The incidence of ascites was lower in the TACE + Rg3 group than in the TACE group (23.7% versus 48.7%, p = 0.002), as was the incidence of anorexia [12.5% versus 44.7%, p = 0.000], fatigue (9.9% versus 50.0% p = 0.000), anaemia (36.8% versus 51.3%, p = 0.037), leukopenia (46.7% versus 76.3%,
p = 0.000), thrombocytopenia (32.9% versus 50.0%, p = 0.012), and hyperbilirubinaemia (17.8% versus 34.2%, p = 0.028). Interpretation: In patients with advanced HCC and sufficient liver function, median survival was nearly 3 months longer for patients treated with TACE and ginsenoside Rg3 than for those who received TACE only.
http://dx.doi.org/10.1016/j.ejca.2015.06.007
OP0003 FEASIBILITY AND EFFICACY CHEMOTHERAPY IN LOCALLY CANCER: A RANDOMISED TRIAL
OF NEOADJUVANT ADVANCED GASTRIC
Banday Manzoor Ahmed *, Khursheed Alam Wani, Majid Wani. Shere-e-Kashmir Institute of Medical Sciences, Kashmir, India Background: Long term survival after curative resection for locally advanced gastric cancer is still low; 5-year survival after diagnosis is 10–21%. Neoadjuvant chemotherapy allows higher curative (R0) resection rates to be achieved and treats micrometastases early. The present study was undertaken to evaluate the feasibility and efficacy of NACT in gastric cancer. Methods: Fifty patients were enrolled and randomised into two groups. Group A received epirubicin, cisplatin, and fluorouracil (ECF regimen) and group B received cisplatin, calcium leucovorin, and fluorouracil (CCF regimen). The aim of this study was compare the efficacy of the two neoadjuvant regimens in terms of curative resection rate. Findings: Twenty four of 25 patients in group A and 22 of 25 patients in group B received three to four cycles of chemotherapy. No deaths were reported in either group. Haematological adverse effects were seen more in group A whereas non-hematological effects were seen more in group B, with the exception of nausea and alopecia, which were more common in group A. Complete responses were seen in two patients in group A. Partial responses were seen in 17 (68%) patients in group A and 14 (56%) in group B. Two (8%) patients in group A and four (16%) patients in group B progressed to metastatic disease. Curative resection was achieved in 18 (72%) patients in group A and 16 (64%) in group B. Partial pathological responses were seen
Available at www.sciencedirect.com
ScienceDirect journal homepage: www.ejcancer.com
7th Annual Asian Oncology Summit and 11th Annual Conference of the Organisation for Oncology and Translational Research
OP0002 A RANDOMISED, SINGLE-CENTRE PHASE 2 STUDY OF GINSENOSIDE RG3 PLUS TRANSARTERIAL CHEMOEMBOLISATION (TACE) VERSUS TACE ALONE IN CHINESE PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA Bo Zhou *, Zhiping Yan, Rong Liu, Sheng Qian, Xudong Qu, Liang Zhu, Jiemin Cheng, Gaoquan Gong, Yi Chen, Qingxin Liu, Jianjun Luo, Lingxiao Liu, Wen Zhang, Changyu Li, Wei Zhang, Jianhua Wang. Department of Interventional Radiology, Fudan University Zhongshan Hospital, Shanghai, China Background: Ginsenoside Rg3 is a low toxic inhibitor of vascular endothelial growth factor (VEGF), which is implicated in angiogenesis in hepatocellular carcinoma (HCC). This single-centre, open-label, randomised, controlled trial evaluated the efficacy and safety of ginsenoside Rg3 plus transarterial chemoembolisation (TACE) in patients with advanced HCC. Methods: Advanced HCC patients (Child-Pugh A) who had no prior systemic therapy were randomly assigned (2:1 ratio) to receive 20 mg twice daily orally (n = 152) combined with TACE or TACE alone (n = 76). The primary endpoint was overall survival (OS). Secondary endpoints included time to progression (TTP), time to untreatable progression (TTUP), disease control rate (DCR) based on modified Response Evaluation Criteria in Solid Tumors, and safety. Results: Median overall survival was 13.2 months (95% confidence interval (CI) 11.15–15.26) in the TACE + Rg3 group compared with 10.1 months (95% CI 9.14–11.06) for those receiving TACE alone (hazard ratio (HR) 0.63 [95% CI 0.46–0.85], p = 0.002). Median TTP was 4.3 months (95% CI 3.32–5.28) in the TACE + Rg3 group compared with 3.2 months (95% CI 2.51–3.89) in the TACE group (HR 0.82 [95% CI 0.62–1.08], p = 0.151). Patients in the TACE + Rg3 group had longer median TTUP (8.3 months [95% CI 7.05–9.55]) than in the TACE group (7.3 months [95% CI 6.40–8.20]; HR 0.76 [95% CI 0.57–1.02], p = 0.063). The most frequently reported Rg3-related grade 3–4 adverse events in 152 patients were constipation (two [1.3%]) and hypertension (six [3.9%]). The incidence of ascites was lower in the TACE + Rg3 group than in the TACE group (23.7% versus 48.7%, p = 0.002), as was the incidence of anorexia [12.5% versus 44.7%, p = 0.000], fatigue (9.9% versus 50.0% p = 0.000), anaemia (36.8% versus 51.3%, p = 0.037), leukopenia (46.7% versus 76.3%,
p = 0.000), thrombocytopenia (32.9% versus 50.0%, p = 0.012), and hyperbilirubinaemia (17.8% versus 34.2%, p = 0.028). Interpretation: In patients with advanced HCC and sufficient liver function, median survival was nearly 3 months longer for patients treated with TACE and ginsenoside Rg3 than for those who received TACE only.
http://dx.doi.org/10.1016/j.ejca.2015.06.007
OP0003 FEASIBILITY AND EFFICACY CHEMOTHERAPY IN LOCALLY CANCER: A RANDOMISED TRIAL
OF NEOADJUVANT ADVANCED GASTRIC
Banday Manzoor Ahmed *, Khursheed Alam Wani, Majid Wani. Shere-e-Kashmir Institute of Medical Sciences, Kashmir, India Background: Long term survival after curative resection for locally advanced gastric cancer is still low; 5-year survival after diagnosis is 10–21%. Neoadjuvant chemotherapy allows higher curative (R0) resection rates to be achieved and treats micrometastases early. The present study was undertaken to evaluate the feasibility and efficacy of NACT in gastric cancer. Methods: Fifty patients were enrolled and randomised into two groups. Group A received epirubicin, cisplatin, and fluorouracil (ECF regimen) and group B received cisplatin, calcium leucovorin, and fluorouracil (CCF regimen). The aim of this study was compare the efficacy of the two neoadjuvant regimens in terms of curative resection rate. Findings: Twenty four of 25 patients in group A and 22 of 25 patients in group B received three to four cycles of chemotherapy. No deaths were reported in either group. Haematological adverse effects were seen more in group A whereas non-hematological effects were seen more in group B, with the exception of nausea and alopecia, which were more common in group A. Complete responses were seen in two patients in group A. Partial responses were seen in 17 (68%) patients in group A and 14 (56%) in group B. Two (8%) patients in group A and four (16%) patients in group B progressed to metastatic disease. Curative resection was achieved in 18 (72%) patients in group A and 16 (64%) in group B. Partial pathological responses were seen