Five-year outcomes of a phase II study of adjuvant chemotherapy with S-1 plus docetaxel for stage III gastric cancer after curative D2 gastrectomy (OGSG1002).

Abstract

BACKGROUND:

Adjuvant S-1 monotherapy is standard of care for stage II and III gastric cancer (GC), but there is still a need to improve the efficacy of treatment for stage III disease. We conducted phase II study of eight cycles of S-1 plus docetaxel (DS) followed by S-1 monotherapy for up to 1 year after D2 gastrectomy for stage III GC.

PATIENTS AND METHODS:

Sixty-two patients with stage III GC were enrolled. They received oral S-1 (80 mg/m2/day) for 2 consecutive weeks and intravenous docetaxel (40 mg/m2) on day 1, repeated every 3 weeks for 8 cycles, followed by S-1 until 1 year postgastrectomy. Treatment safety, tolerability, and survival were evaluated.

RESULTS:

The completion rate for eight cycles of DS therapy was 77.4% [95% confidence interval (CI) 65.0-87.1%]. Subsequent S-1 monotherapy for 1 year was feasible in 71.0% (95% CI 58.1-81.8%) of patients. The incidence of neutropenia, leukopenia, anorexia, and fatigue of grade 3 or higher was 10% or higher. There were no treatment-related deaths. The 5-year overall survival (OS) and disease-free survival (DFS) rates were 72.4% (95% CI 62.1-84.5%) and 60.0% (95% CI 48.8-73.9%), respectively. Subgroup analyses by disease stage showed 5-year OS and DFS rates of 74.5% (95% CI 60.7-91.5%) and 59.3% (95% CI 43.8-80.2%) for stage IIIA and 70.0% (95% CI 55.4-88.5%) and 60.0% (95% CI 44.8-80.4%) for stage IIIB, respectively.

CONCLUSIONS:

Adjuvant eight cycles of DS therapy might be safe and manageable and has promising OS and DFS for stage III GC.

• Authors: Kazumasa Fujitani, Shigeyuki Tamura, Yutaka Kimura, Jin Matsuyama, Hiroshi Imamura, Kazuyoshi Yamamoto, Junya Fujita, Shohei Iijima, Shugo Ueda, Yukinori Kurokawa, Toshio Shimokawa, Taroh Satoh, Osaka Gastrointestinal Cancer Chemotherapy Study Group
• Journal: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association (Gastric Cancer) Vol. 23 Issue 3 Pg. 520-530 (05 2020) ISSN: 1436-3305 [Electronic] Japan
• PMID: 31667688 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Drug Combinations
• S 1 (combination)
• Tegafur
• Docetaxel
• Oxonic Acid

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Chemotherapy, Adjuvant (mortality)
• Docetaxel (administration & dosage)
• Drug Combinations
• Female
• Follow-Up Studies
• Gastrectomy
• Humans
• Male
• Middle Aged
• Neoplasm Staging
• Oxonic Acid (administration & dosage)
• Prospective Studies
• Stomach Neoplasms (drug therapy, pathology)
• Survival Rate
• Tegafur (administration & dosage)