Background <p>Large type 3 (≥ 8 cm) and type 4 gastric cancers (GCs) have poor prognoses and necessitate multidisciplinary treatment. A multi-institutional phase II study (OGSG1902) was conducted to assess the efficacy and safety of neoadjuvant chemotherapy (NAC) with docetaxel, oxaliplatin, and S-1 (DOS) in these patients.</p> Methods <p>Patients with large type 3 or type 4 GC without distant metastasis, except for positive peritoneal cytology (CY), were enrolled. Patients received three courses of neoadjuvant DOS therapy (docetaxel 40 mg/m<sup>2</sup> and oxaliplatin 100 mg/m<sup>2</sup> on day 1 via intravenous infusion, and S-1 80 mg/m<sup>2</sup> orally for 14 days, repeated every 3 weeks) followed by gastrectomy. After R0 resection, adjuvant docetaxel/S-1 therapy was administered for 1 year.</p> Results <p>From October 2019 to February 2022, 48 patients were enrolled. NAC was completed in 91.7% of patients. The R0 resection rate was 89.6%. The pathological response rate (Grade 1b–3) was 66.7%. Among patients with measurable lesions, the response rate was 50.0%. The CY-negative conversion rate was 80.0%, and the protocol completion rate was 45.8%. Grade 3 or 4 adverse events during NAC, including neutropenia and appetite loss, occurred in 37.5% of patients. Major postoperative complications (Clavien–Dindo Grade IIIa or higher) were observed in 2.1% of patients.</p> Conclusions <p>NAC with DOS for large type 3 or type 4 GC followed by gastrectomy demonstrated promising efficacy, high pathological response rates, and an acceptable toxicity profile. Further evaluation of long-term survival outcomes is ongoing.</p>

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Neoadjuvant docetaxel, oxaliplatin, and S-1 therapy for patients with large type 3 or type 4 gastric cancer: short-term outcomes of a multicenter, phase II study (OGSG1902)

  • Ryo Tanaka,
  • Shunji Endo,
  • Toshifumi Yamaguchi,
  • Hiromichi Miyagaki,
  • Junji Kawada,
  • Takeshi Omori,
  • Naoki Takahashi,
  • Toru Masuzawa,
  • Haruna Furukawa,
  • Yuya Sato,
  • Atsushi Takeno,
  • Naoki Shinno,
  • Ryohei Kawabata,
  • Shinsuke Katsuyama,
  • Shigeyoshi Higashi,
  • Yukinori Kurokawa,
  • Toshimasa Tsujinaka,
  • Toshio Shimokawa,
  • Taroh Satoh

摘要

Background

Large type 3 (≥ 8 cm) and type 4 gastric cancers (GCs) have poor prognoses and necessitate multidisciplinary treatment. A multi-institutional phase II study (OGSG1902) was conducted to assess the efficacy and safety of neoadjuvant chemotherapy (NAC) with docetaxel, oxaliplatin, and S-1 (DOS) in these patients.

Methods

Patients with large type 3 or type 4 GC without distant metastasis, except for positive peritoneal cytology (CY), were enrolled. Patients received three courses of neoadjuvant DOS therapy (docetaxel 40 mg/m2 and oxaliplatin 100 mg/m2 on day 1 via intravenous infusion, and S-1 80 mg/m2 orally for 14 days, repeated every 3 weeks) followed by gastrectomy. After R0 resection, adjuvant docetaxel/S-1 therapy was administered for 1 year.

Results

From October 2019 to February 2022, 48 patients were enrolled. NAC was completed in 91.7% of patients. The R0 resection rate was 89.6%. The pathological response rate (Grade 1b–3) was 66.7%. Among patients with measurable lesions, the response rate was 50.0%. The CY-negative conversion rate was 80.0%, and the protocol completion rate was 45.8%. Grade 3 or 4 adverse events during NAC, including neutropenia and appetite loss, occurred in 37.5% of patients. Major postoperative complications (Clavien–Dindo Grade IIIa or higher) were observed in 2.1% of patients.

Conclusions

NAC with DOS for large type 3 or type 4 GC followed by gastrectomy demonstrated promising efficacy, high pathological response rates, and an acceptable toxicity profile. Further evaluation of long-term survival outcomes is ongoing.