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Clinical Trial
. 2024 Oct 3;29(10):e1396-e1405.
doi: 10.1093/oncolo/oyae109.

A phase 1 study of biweekly nab-paclitaxel/oxaliplatin/S-1/LV for advanced upper gastrointestinal cancers: TCOG T1216 study

Hui-Jen Tsai  1   2   3 , Shih-Hung Yang  4 , Chin-Fu Hsiao  5 , Hsiang-Fong Kao  4   6 , Yung-Yeh Su  1   2   3   7 , Yan-Shen Shan  8 , Chia-Jui Yen  2 , Jeng-Shiun Du  3 , Chiun Hsu  4 , I-Chen Wu  7   9 , Li-Tzong Chen  1   2   7   9
Affiliations
Clinical Trial

A phase 1 study of biweekly nab-paclitaxel/oxaliplatin/S-1/LV for advanced upper gastrointestinal cancers: TCOG T1216 study

Hui-Jen Tsai et al. Oncologist. .

Abstract

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.

Keywords: S-1/leucovorin; nab-paclitaxel; oxaliplatin; phase 1; upper gastrointestinal cancers.

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Conflict of interest statement

Li-Tzong Chen has received research funding from TTY and BMS. The other authors indicated no financial relationships.

Figures

Figure 1.
Figure 1.
The treatment response, treatment duration, and response duration of each patient.
Figure 2.
Figure 2.
Waterfall plot.
Figure 3.
Figure 3.
Kaplan-Meier plot.
See this image and copyright information in PMC

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