Wang Xiaobo, Pang Liangxi, Feng Jifeng
Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Cancer Research Institute, Baiziting 42, Nanjing 210009, People's Republic of China.
Am J Clin Oncol. 2002 Feb;25(1):71-5. doi: 10.1097/00000421-200202000-00015.
Many phase II studies have reported improved response rates with severe toxicity of etoposide, doxorubicin (Adriamycin), and cisplatin in advanced gastric cancer. In an attempt to obtain a better regimen with high efficacy and less toxicity, a combination regimen of etoposide, doxorubicin, and carboplatin (EAC) had been developed and evaluated in this phase II study. Forty-six patients with advanced gastric cancer were enrolled in the study. The treatment consisted of doxorubicin 20 mg/m2 given intravenously on days 1 and 7, etoposide 70 mg/m2 intravenously on days 4, 5, and 6, and carboplatin 200 mg/m2 intravenously on days 2 and 8. Therapy was repeated every 4 weeks. Patients who had stable disease or who responded, received an additional two to six cycles of therapy. Among 45 patients evaluable for response and toxicity, there was a 49% objective response rate, including 7% complete remission and 42% partial response. There was 11% stable disease and 27% progressive disease. Among 11 patients with lymph node metastasis only after a curative gastrectomy, there was an 82% objective response rates with 27% having complete remission and 55% having partial response. The median follow-up was 16 months. The median survival duration of all 45 patients was 11 months. The median time to progression was 5 months. The main toxicity was myelosuppression, with a high incidence of 82% leukopenia but only 9% of grades III to IV. Gastrointestinal toxicity was mild, with a low incidence of 42% nausea and vomiting and only 2% of grades III to IV. There were no chemotherapy-related deaths. With mild and tolerable toxicity, the EAC regimen in our study has active antitumor activity in advanced gastric cancer, which may have a positive influence on long-term survival time. It has a high efficacy, especially in patients with lymph node metastasis only after a curative gastrectomy. This regimen deserves further clinical studies for testing activity and toxicity in advanced gastric cancer.
许多II期研究报告称，在晚期胃癌中，依托泊苷、多柔比星（阿霉素）和顺铂联合使用时，缓解率有所提高，但毒性严重。为了获得一种疗效更高、毒性更小的更好方案，在此II期研究中开发并评估了依托泊苷、多柔比星和卡铂的联合方案（EAC）。46例晚期胃癌患者入组该研究。治疗方案为：第1天和第7天静脉注射多柔比星20mg/m²，第4、5、6天静脉注射依托泊苷70mg/m²，第2天和第8天静脉注射卡铂200mg/m²。每4周重复治疗。病情稳定或有反应的患者接受额外2至6个周期的治疗。在45例可评估反应和毒性的患者中，客观缓解率为49%，包括7%完全缓解和42%部分缓解。病情稳定率为11%，疾病进展率为27%。在11例仅在根治性胃切除术后出现淋巴结转移的患者中，客观缓解率为82%，其中27%完全缓解，55%部分缓解。中位随访时间为16个月。45例患者的中位生存期为11个月。中位疾病进展时间为5个月。主要毒性为骨髓抑制，白细胞减少发生率高达82%，但III至IV级仅占9%。胃肠道毒性较轻，恶心呕吐发生率为42%，III至IV级仅占2%。无化疗相关死亡。本研究中的EAC方案毒性轻微且可耐受，在晚期胃癌中具有积极的抗肿瘤活性，这可能对长期生存时间产生积极影响。它具有较高的疗效，尤其是对仅在根治性胃切除术后出现淋巴结转移的患者。该方案值得进一步开展临床研究，以测试其在晚期胃癌中的活性和毒性。
