Sun Yat-sen University Cancer Center, Guangzhou, China.
State Key Laboratory of Oncology in South China, Guangzhou, China.
Cancer Sci. 2018 Nov;109(11):3575-3582. doi: 10.1111/cas.13813. Epub 2018 Oct 26.
The present study is the first phase II clinical trial aimed to evaluate the efficacy and safety of S-1 plus nanoparticle albumin-bound paclitaxel (Nab-PTX) as first-line chemotherapy for advanced gastric cancer (AGC). Previously untreated patients with metastatic gastric adenocarcinoma received S-1 in oral doses of 40 mg (BSA <1.25 m ), 50 mg (1.25 ≤ BSA < 1.50 m ) and 60 mg (BSA ≥1.50 m ) b.i.d. on days 1-14 in combination with Nab-PTX (120 mg/m , on days 1 and 8) for each 21-day cycle. Primary endpoint was progression-free survival (PFS), and secondary endpoints were overall response rate (ORR), overall survival (OS), disease control rate (DCR), and toxicity. A total of 73 gastric cancer patients with metastatic and measurable lesions were enrolled in the first-line setting. Median PFS and OS were 9.63 months and 14.60 months, respectively. Four (5.5%) patients had complete responses, 39 (53.4%) had partial responses (PRs), 21 (28.8%) had stable disease, four (5.5%) progressed and five (6.8%) were not evaluable. ORR and DCR were 58.9% and 87.7%, respectively. Most toxicities were mild, and no treatment-related deaths occurred. Grade 3 to 4 toxicities occurred in 22 patients (30.1%) as follows: 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%). Seven patients achieved good responses and underwent gastrectomy plus metastasectomy. Thirty (41.1%) patients had S-1 maintenance with a median of four cycles. S-1 plus Nab-PTX is an efficient and safe regimen as first-line treatment for patients with AGC.
本研究是首个旨在评估 S-1 联合白蛋白结合型紫杉醇（nab-PTX）作为晚期胃癌（AGC）一线化疗的疗效和安全性的 II 期临床试验。先前未经治疗的转移性胃腺癌患者接受 S-1 口服剂量为 40mg（BSA<1.25m ）、50mg（1.25≤BSA<1.50m ）和 60mg（BSA≥1.50m ）bid，第 1-14 天与 nab-PTX（120mg/m ，第 1 和第 8 天）联合应用，每 21 天为一个周期。主要终点为无进展生存期（PFS），次要终点为总缓解率（ORR）、总生存期（OS）、疾病控制率（DCR）和毒性。共纳入 73 例转移性和可测量病变的胃癌患者，采用一线治疗方案。中位 PFS 和 OS 分别为 9.63 个月和 14.60 个月。4 例（5.5%）患者完全缓解，39 例（53.4%）部分缓解（PR），21 例（28.8%）疾病稳定，4 例（5.5%）进展，5 例（6.8%）无法评估。ORR 和 DCR 分别为 58.9%和 87.7%。大多数毒性反应为轻度，无治疗相关死亡。22 例（30.1%）患者出现 3-4 级毒性，包括白细胞减少（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%）、口腔炎（1.4%）、周围神经病变（1.4%）和手足综合征（1.4%）。7 例患者疗效良好，行胃切除术加转移灶切除术。30 例（41.1%）患者接受 S-1 维持治疗，中位治疗周期为 4 个。S-1 联合 nab-PTX 是 AGC 患者一线治疗的一种有效且安全的方案。
