Phase I study of neoadjuvant chemoradiotherapy with S-1 for clinically resectable type 4 or large type 3 gastric cancer in elderly patients aged 75 years and older (OGSG1303).

Publisher: Springer Country of Publication: United States NLM ID: 9435512 Publication Model: Electronic Cited Medium: Internet ISSN: 1559-131X (Electronic) Linking ISSN: 13570560 NLM ISO Abbreviation: Med Oncol Subsets: MEDLINE

Publication: 2011- : New York : Springer
Original Publication: Northwood, Middlesex, England : Science and Technology Letters, c1994-

Stomach Neoplasms*/therapy ; Stomach Neoplasms*/pathology ; Stomach Neoplasms*/mortality ; Tegafur*/administration & dosage ; Tegafur*/therapeutic use ; Tegafur*/adverse effects ; Oxonic Acid*/administration & dosage ; Oxonic Acid*/therapeutic use ; Drug Combinations* ; Neoadjuvant Therapy*/methods; Humans ; Aged ; Male ; Female ; Aged, 80 and over ; Antimetabolites, Antineoplastic/therapeutic use ; Antimetabolites, Antineoplastic/administration & dosage ; Chemoradiotherapy/methods

Purpose The prognosis for type 4 and large type 3 gastric cancer (GC) is extremely poor, especially in elderly patients (≥ 75 years). To improve the prognosis of these types of GC, we performed a phase I study to determine the recommended dose (RD) of S-1 combined with neoadjuvant radiotherapy. Methods Patients with clinically resectable type 4 and large type 3 GC were enrolled to successive cohorts in a conventional 3 + 3 design. Three dose levels were designed, as follows: level 0: S-1 60 mg/m ² /day on Days 1-14; level 1: S-1 80 mg/m ² /day on Days 1 -14; level 2: S-1 80 mg/m ² /day on Days 1-14 and Days 22-35. The starting dose was level 1. Radiotherapy was delivered at a total dose of 40 Gy in fractions for 4 weeks. Results Ten patients were enrolled from July 2014 to August 2018. Six patients were registered at level 1, and one patient developed a dose limiting toxicity as gastric stenosis (grade 3). Two of four patients enrolled at level 2 developed dose limiting toxicity (inability to receive S-1 for hematological reasons). Therefore, the RD was determined as level 1. All patients underwent the protocol surgery; one patient underwent R1 resection because of positive peritoneal washing cytology. There were no treatment-related deaths, and the pathological response rate was 80%. The 5-year overall- and progression-free survival rates were both 60.0%. Conclusion The RD was determined as level 1. A phase II trial using the RD should be initiated.
Competing Interests: Declarations. Conflict of interest: The authors declare no competing interests. Ethical approval: All procedures were performed in accordance with the ethical standards of the committee on human experimentation and with the Helsinki Declaration of 1964 and later versions. This study was approved by the institutional review and ethics board of each participating hospital and registered in the University Hospital Medical Information Network (UMIN) database (UMIN000013821). Consent to participate: Informed consent or substitute consent was obtained from all patients included in the study. Consent for publication: The authors have approved publication.
(© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

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Keywords: Chemoradiotherapy; Elderly; Gastric cancer; Large Type 3; S-1; Type 4

1548R74NSZ (Tegafur)
5VT6420TIG (Oxonic Acid)
150863-82-4 (S 1 (combination))
0 (Drug Combinations)
0 (Antimetabolites, Antineoplastic)

Date Created: 20241219 Date Completed: 20241219 Latest Revision: 20241220

20241221

10.1007/s12032-024-02583-3

39699794