一项关于nab-紫杉醇/奥沙利铂/S-1/LV 双周方案治疗晚期上消化道癌的 1 期研究：TCOG T1216 研究。
A phase 1 study of biweekly nab-paclitaxel/oxaliplatin/S-1/LV for advanced upper gastrointestinal cancers: TCOG T1216 study.
机构信息
National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
出版信息
Oncologist. 2024 Oct 3;29(10):e1396-e1405. doi: 10.1093/oncolo/oyae109.
BACKGROUND
Oxaliplatin- and fluoropyrimidine-based triplet regimens have demonstrated feasibility and efficacy in the treatment of upper gastrointestinal (UGI) cancers. Herein, we evaluate the feasibility and preliminary efficacy of biweekly nab-paclitaxel plus oxaliplatin and S-1/leucovorin (SOLAR) in chemonaïve UGI cancers.
METHODS
A 3 + 3 phase 1 study was conducted to determine the maximal tolerated dose (MTD) of oxaliplatin in SOLAR (nab-paclitaxel [150 mg/m2 in D1], oxaliplatin [60, 75, or 85 mg/m2 in D1], and oral S-1/leucovorin [35 mg/m2 and 30 mg bid from D1 to D7]). The secondary endpoints were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS
Thirteen and 6 accruals were in the dose-escalation and MTD expansion cohorts, respectively. One of 6 patients at level III experienced dose-limiting toxicity (grade 3 diarrhea), which revealed that the MTD of oxaliplatin was 85 mg/m2. After a mean of 15.9 cycles of treatment, the most common treatment-related grade 3/4 toxicities were neutropenia (57.9%) and diarrhea (21.1%). The ORR was 63.2%. The median PFS and OS were 12.5 and 24.7 months, respectively.
CONCLUSION
The current study revealed the MTD of oxaliplatin and demonstrated the preliminary efficacy of SOLAR in UGI cancers, which deserves further investigation.
CLINICALTRIALS.GOV IDENTIFIER: NCT03162510.
背景
奥沙利铂和氟嘧啶类三联方案已被证明在治疗上消化道（UGI）癌症方面具有可行性和疗效。在此，我们评估了nab-紫杉醇联合奥沙利铂和 S-1/亚叶酸（SOLAR）在未经化疗的 UGI 癌症中的可行性和初步疗效。
方法
进行了一项 3+3 期的 1 期研究，以确定 SOLAR 中奥沙利铂的最大耐受剂量（MTD）（nab-紫杉醇[D1 时 150mg/m2]，奥沙利铂[D1 时 60、75 或 85mg/m2]，以及口服 S-1/亚叶酸[D1 至 D7 时 35mg/m2 和 30mg bid]）。次要终点为总缓解率（ORR）、无进展生存期（PFS）、总生存期（OS）和安全性。
结果
分别在剂量递增和 MTD 扩展队列中入组了 13 例和 6 例患者。在 III 级水平的 6 例患者中有 1 例发生剂量限制毒性（3 级腹泻），表明奥沙利铂的 MTD 为 85mg/m2。在平均接受 15.9 个周期的治疗后，最常见的治疗相关 3/4 级毒性为中性粒细胞减少症（57.9%）和腹泻（21.1%）。ORR 为 63.2%。中位 PFS 和 OS 分别为 12.5 和 24.7 个月。
结论
本研究揭示了奥沙利铂的 MTD，并证实了 SOLAR 在 UGI 癌症中的初步疗效，值得进一步研究。
临床试验.gov 标识符：NCT03162510。
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