Phase II study of docetaxel, oxaliplatin, and S-1 therapy in patients with metastatic gastric cancer

• Published in: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association Vol. 19; no. 2; pp. 579 - 585
• Main Authors: Kim, Hyeong Su, Ryu, Min-Hee, Zang, Dae Young, Ryoo, Baek-Yeol, Yang, Dae Hyun, Cho, Ji Woong, Lim, Man Sup, Kim, Min-Jeong, Han, Boram, Choi, Dae Ro, Kim, Jung Han, Jung, Joo Young, Song, Hunho, Park, Choong Kee, Kang, Yoon-Koo
• Format: Journal Article
• Language: English
• Published: Tokyo Springer Japan 01-04-2016; Springer Nature B.V
• Subjects: Abdominal Surgery; Adenocarcinoma - drug therapy; Adenocarcinoma - mortality; Adenocarcinoma - pathology; Administration, Intravenous; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer Research; Disease-Free Survival; Docetaxel; Drug Combinations; Female; Gastric cancer; Gastroenterology; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Oncology; Organoplatinum Compounds - administration & dosage; Original Article; Oxaliplatin; Oxonic Acid - administration & dosage; Oxonic Acid - therapeutic use; Stomach Neoplasms - drug therapy; Stomach Neoplasms - mortality; Stomach Neoplasms - pathology; Surgical Oncology; Taxoids - administration & dosage; Tegafur - administration & dosage; Tegafur - therapeutic use; Treatment Outcome; Oxaliplatin; Phase II clinical trial; Stomach neoplasm; S-1; Docetaxel
• ISSN: 1436-3291; 1436-3305
• DOI: 10.1007/s10120-015-0503-2

Background
Although the docetaxel, 5-fluorouracil, and cisplatin triplet has yielded significant improvements in time to progression, overall survival, and overall response rate, the high incidence of severe adverse events limits the use of the docetaxel, 5-fluorouracil, and cisplatin triplet. To overcome this limitation, we evaluated the efficacy and safety of the combination of docetaxel, oxaliplatin, and S-1 for the treatment of metastatic gastric cancer.
Methods
Chemotherapy-naive patients with pathologically proven unresectable recurrent or metastatic gastric adenocarcinoma were assessed for eligibility. Docetaxel at 52.5 mg/m
2
and oxaliplatin at 105 mg/m
2
were administered intravenously on day 1, and S-1 was administered orally at 80 mg/m
2
on days 1–14 of every 21-day cycle.
Results
Forty-four patients (median age 54.5 years) were enrolled. All patients had metastatic disease. A total of 340 cycles of chemotherapy were administered (median of eight cycles per patient; range 1–36 cycles). Toxicities were evaluated in 43 patients, and the responses were evaluated in 40 patients. Major toxicities included grade 3/4 neutropenia (37.2 %) and leukopenia (27.9 %). The overall response rate was 54.5 % [95 % confidence interval (CI) 40.1–68.3 %] in the intention-to-treat population. The median progression-free survival and overall survival were 7.6 months (95 % CI 6.2–9.0 months) and 12.0 months (95 % CI 6.9–17.2 months), respectively.
Conclusion
These data suggest that the docetaxel, oxaliplatin, and S-1 combination regimen is effective and relatively well tolerable, and it seems to have potential to be a reasonable therapeutic strategy in patients with metastatic or recurrent gastric cancer.