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2016年6月3-7日，一年一度的美国临床肿瘤学会（American SocietyofClinicalOncology, ASCO）年会将在芝加哥举办。本次大会将吸引30000名全世界的肿瘤领域专家学者和参会人员，会议摘要收录了多个我国学者主导的肿瘤前沿研究。

中山大学肿瘤防治中心院长徐瑞华教授带领的研究团队开展了一项单臂、开放标签的Ⅱ期临床研究，评价替吉奥+纳米白蛋白结合型紫杉醇作为一线方案治疗晚期胃癌的疗效和安全性。

替吉奥（S-1）是口服氟尿嘧啶衍制剂，由替加氟（Tegafur, FT）、吉美嘧啶（Gimeracil, CDHP）、奥替拉西（Potassium oxonate, OXO）复合形成。其中FT是5-Fu的前体药物，也是S-1的主要抗肿瘤成分。

纳米白蛋白结合型紫杉醇（Nanoparticle Albumin-boundPaclitaxel，Nab-PTX）是传统紫杉醇在形态上的创新改良。临床常用的溶剂型紫杉醇对水的亲和力差，而脂性助溶剂会降低紫杉醇化疗效果，增加副作用。Nab-PTX可以更好的分布于肿瘤组织，药代动力学呈线性关系，抗肿瘤活性更强，副作用更小。目前Nab-PTX已经批准可用于治疗晚期乳腺癌、胰腺癌和非小细胞肺癌。2015年ASCO年会上公布了一项Nab-PTX单药二线治疗晚期胃癌的研究，在小样本基础上表现出一定的疗效且毒性耐受良好。

摘要编号：4049

时间：6月4日，上午8:00-11:30

报告形式：壁报展示

胃癌患者全部来自中山大学肿瘤防治中心，主要入组标准：

◆年龄18-75岁

◆组织学确诊胃腺癌，且局部晚期、复发和（或）转移

◆先前未行化疗，或自前次化疗至少6个月以上

◆根据RECIST标准有可测量的病灶

◆ECOG PS≤2

◆血液、肝肾功能足够

2011年至2015年，共入组73名晚期胃癌患者。治疗方案：

◆第1-14天每天口服S-1两次，根据体表面积（BSA）给予三种S-1剂量：40mg（BSA＜1.25 m²）、50mg（1.25≤BSA＜1.50 m²）、60mg（BSA≥1.50 m²）。

◆第1天和第8天给予Nab-PTX，200-240 mg/m2静脉注射30min。

21天为一周期，计划治疗时间4-6周期。疾病进展、不能耐受药物毒性以及其他原因导致可中断治疗。

主要终点为无进展生存（PFS），次要终点为总缓解率（ORR）、总体生存（OS）和不良反应（AE）。

结果

在73例患者中，完全缓解4例（CR=5.5%），部分缓解35例（PR=47.9%），疾病稳定25例（SD=34.2%），肿瘤进展4例（5.5%），无法评估5例（6.8%）。中位治疗周期数为4。

◆客观缓解率（ORR）=CR+PR=53.4%。

◆疾病控制率（DCR）=ORR+SD=87.7%。

◆中位PFS为8.77个月，中位OS为14.7个月。

在不良反应方面，大多数AE较为温和，无治疗相关死亡。3-4级AE发生率30.1%（22/73）。

◆3级AE按发生率依次为白细胞减少（13.7%）、中性粒细胞减少（12.3%）、贫血（5.5%）、血小板减少（1.4%）、腹泻（6.8%）、呕吐（2.7%）、周围神经疾病（1.4%）、手足综合征（1.4%）。

◆4级AE仅有1例，为中性粒细胞减少。

治疗2-6个周期后，7名患者达到良好的PR并能够接受手术治疗（胃切除+转移灶切除）；30名患者（41.1%）接受S-1单药维持治疗（中位治疗周期数为4）。

结论

该研究初步证实了S-1联合Nab-PTX作为一线方案治疗晚期不可手术胃癌具有一定的疗效和良好的安全性，或可成为一种新的治疗选择。

会议专题》》》2016年ASCO年会专题报道

摘要阅读

Abstract No: 4049

PhaseII clinical trial of S-1 plus nanoparticle albumin-bound paclitaxel asfirst-line chemotherapy for patients with metastatic gastric cancer

Session: Gastrointestinal(Noncolorectal) Cancer

Type: Poster Session

Author(s): Rui-hua Xu,Ming-mingHe,Dong-sheng Zhang,et al.

Background: Little was knownabout nanoparticle albumin-bound paclitaxel (Nab-PTX) in gastric cancer. As the first phaseII trial, it aimed to evaluate the efficacy and safety of S-1 plus Nab-PTX asfirst-line treatment for patients with metastatic gastric cancer.

Methods: A total of 73gastric cancer patients with metastatic and measurable lesions (M/F 45/28,median age 53, ECOG 0-2) were enrolled in first-line setting from Sun Yat-senUniversity Cancer Center between 2011 and 2015. They were orally treated withS-1 in doses of 40 mg (BSA < 1.25 m2), 50 mg (1.25 ≤ BSA < 1.50 m2) and60 mg (BSA ≥ 1.50 m2) b.i.d. on days 1-14 in combination with Nab-PTX (200-240mg/m2, divided on days 1 and 8, intravenously during 30 minutes) of each 21-daycycle. Treatment was planned for 4-6 cycles, or until progression, unacceptabletoxicity, and discontinuation. Primary endpoint was progression-free survival(PFS) and secondary endpoints were overall response rate (ORR), overallsurvival (OS), and adverse events (AEs).

Results: Of the 73patients, 4 (5.5%) had complete responses, 35 (47.9%) had partial responses(PRs), 25 (34.2%) had stable diseases, 4 (5.5%) progressed and 5 (6.8%) werenot evaluable, with median number of cycles as 4 (range 1-6). The ORR and DCRwere 53.4% and 87.7%, accordingly. The median PFS was 8.77 months (95%confidence interval (CI) 6.88–10.66). The median OS was 14.70 months (95% CI9.57–19.83). Most AEs were mild without treatment-related death. Grade 3 to 4AEs occurred in 22 patients (30.1%) and grade 4 AE (neutropenia) occurred inonly one of them. Grade 3 AEs included leukopenia (13.7%), neutropenia (12.3%),anemia (5.5%), thrombocytopenia (1.4%), diarrhea (6.8%), vomiting (2.7%),stomatitis (1.4%), peripheral neuropathy (1.4%), and hand-foot syndrome (1.4%).After 2 to 6 cycles, 7 patients (6 lymph node, 1 liver) achieved good PRs andreceived gastrectomy plus metastasectomy. 30 (41.1%) patients had S-1monotherapy as maintenance with median number of cycles as 4 (range 1–20).

Conclusions: S-1 plus Nab-PTXis an encouraging option in first-line treatment for patients with metastaticgastric cancer, with promising efficacy, safety, and convenience. Clinicaltrial information: NCT02229058

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医脉通编译自：Rui-hua Xu ,et al. PhaseII clinical trial of S-1 plus nanoparticle albumin-bound paclitaxelas first-line chemotherapy for patients with metastatic gastric cancer.JClin Oncol 34,2016 (suppl; abstr 4049).