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A phase 1 study of biweekly nab-paclitaxel/oxaliplatin/S-1/LV for advanced upper gastrointestinal cancers: TCOG T1216 study.
Tsai, Hui-Jen; Yang, Shih-Hung; Hsiao, Chin-Fu; Kao, Hsiang-Fong; Su, Yung-Yeh; Shan, Yan-Shen; Yen, Chia-Jui; Du, Jeng-Shiun; Hsu, Chiun; Wu, I-Chen; Chen, Li-Tzong.
Afiliação
  • Tsai HJ; National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
  • Yang SH; Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
  • Hsiao CF; Division of Hematology and Oncology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
  • Kao HF; Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
  • Su YY; Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan.
  • Shan YS; Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
  • Yen CJ; National Taiwan University Cancer Center, Taipei, Taiwan.
  • Du JS; National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
  • Hsu C; Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
  • Wu IC; Division of Hematology and Oncology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
  • Chen LT; Center for Cancer Research, Kaohsiung Medical University, Kaohsiung, Taiwan.
Oncologist ; 2024 Jun 21.
Article em En | MEDLINE | ID: mdl-38902994
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Oncologist Assunto da revista: NEOPLASIAS Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Taiwan

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Oncologist Assunto da revista: NEOPLASIAS Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Taiwan