Phase II study of S-1 plus docetaxel as first-line treatment for older patients with advanced gastric cancer (OGSG 0902)

International Journal of Clinical Oncology - Trang 1-8 - 2024
Tomono Kawase1, Hiroshi Imamura1, Ryohei Kawabata2,3, Jin Matsuyama4, Kazuhiro Nishikawa2, Kazuhiro Yanagihara5, Kazuyoshi Yamamoto6, Noriyuki Hoki7, Junji Kawada8, Hisato Kawakami9, Daisuke Sakai10, Yukinori Kurokawa6, Toshio Shimokawa11, Taroh Satoh12
1Department of Surgery, Toyonaka Municipal Hospital, Toyonaka-city, Japan
2Department of Surgery, Sakai City Medical Center, Sakai City, Japan
3Department of Surgery, Osaka Rosai Hospital, Sakai-city, Japan
4Department of Gastroenterological Surgery, Higashiosaka City Medical Center, Higashiosaka-city, Japan
5Department of Medical Oncology, Kansai Electric Power Hospital, Osaka-city, Japan
6Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita-city, Japan
7Department of Gastroenterology, Bellland General Hospital, Sakai-city, Japan
8Department of Surgery, Yao Municipal Hospital, Yao-city, Japan
9Department of Medical Oncology, Faculty of Medicine, Kindai University, Sayama-city, Japan
10Department of Medical Oncology, Osaka International Cancer Institute, Osaka-city, Japan
11Clinical Study Support Center, Wakayama Medical University, Wakayama-city, Japan
12Palliative and Supportive Care Center, Osaka University Graduate School of Medicine, Suita-city, Japan

Tóm tắt

Although there is insufficient evidence for the treatment of older patients with advanced gastric cancer, fluorouracil combined with platinum chemotherapy has been recognized as a standard first-line treatment for such populations in Japan despite the lack of efficacy and toxicity data. Patients aged 75 years or older with advanced gastric cancer were enrolled. S-1 plus docetaxel (docetaxel: 40 mg/m2, day 1; S-1: 80 mg/m2, days 1–14; q21 days) was repeated every 3 weeks. The primary endpoint was overall response rate. Secondary endpoints were safety, progression-free survival, time to treatment failure, and overall survival. The sample size was calculated as 30 under the hypothesis of an expected response rate of 40% and a threshold response rate of 20%, at a power of 90% and a two-sided alpha value of 5%. From February 2010 to January 2015, 31 patients were enrolled and assessed for efficacy and toxicity. The response rate was 45.2% (95% CI 27.3%–64.0%; p = 0.001) and it exceeded the expected response rate set at 40%. Median progression-free survival was 5.8 months, the 1-year survival rate was 58.1%, and the median survival time was 16.1 months. The major grade 3/4 adverse events were neutropenia (58%), febrile neutropenia (13%), anemia (10%), anorexia (10%), and fatigue (6%). These findings indicate that S-1 plus docetaxel as first-line treatment for older patients is feasible and that it has promising efficacy against advanced gastric cancer.

Tài liệu tham khảo

Cancer Statistics. Cancer Information Service, National Cancer Center, Japan (Vital Statistics of Japan, Ministry of Health, Labour and Welfare) Available at: https:// ganjoho.jp /reg_stat /statistics /stat/ summary.html [Last accessed on January 7th, 2023] Efrat D, Louise CW, Ilene SB et al (2021) NCCN guidelines insights: older adult oncology, version 1.2021. J Natl Compr Canc Netw. 19(9):1006–1019 Cunningham D, Starling N, Rao S et al (2008) Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 358(1):36–46 Van Cutsem E, Moiseyenko VM, Tjulandin S et al (2006) Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol 24(31):4991–4997 Koizumi W, Narahara H, Hara T et al (2008) S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol 9(3):215–221 Japanese Gastric Cancer Association (2021) Japanese gastric cancer treatment guidelines (Ver. 6). Kanehara, Tokyo Makiyama A, Kunieda K, Noguchi M et al (2018) First-line chemotherapy with S-1 alone or S-1 plus cisplatin for elderly patients with advanced gastric cancer: a multicenter propensity score matched study. Gastric Cancer 21:792–801 Yamada Y, Higuchi K, Nishikawa K et al (2015) Phase III study comparing oxaliplatin plus S-1 with cisplatin plus S-1 in chemotherapy-naive patients with advanced gastric cancer. Ann Oncol 26(1):141–148 Yamaguchi K, Shimamura T, Hyodo I et al (2006) Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer. Br J Cancer 94:1803–1808 Yoshida K, Ninomiya M, Takakura N et al (2006) Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer. Clin Cancer Res 12:3402–3407 Kudoh S, Takeda K, Nakagawa K et al (2006) Phase III study of docetaxel compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer: results of the West Japan Thoracic Oncology Group Trial (WJTOG 9904). J Clin Oncol 24(22):3657–3663 Berthold DR, Pond GR, Freidele S (2008) Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol 26(2):242–245 30th Annual San Antonio Breast Cancer Symposium (2007) Extended follow-up and analysis by age of the US Oncology Adjuvant trial 9735. Breast Cancer Res Treat 106(Suppl 1):Abstract 12 Eisenhauer EA, Therasse P, Bogaerts J et al (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45(2):228–247 Koizumi W, Kim YH, Fujii M et al (2014) Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer: a randomized study (START). J Cancer Res Clin Oncol 140(2):319–328 Imamura H, Kishimoto T, Takiuchi H et al (2014) Phase II study of S-1 monotherapy in patients over 75 years of age with advanced gastric cancer (OGSG0404). J Chemother 26(1):57–61 Bang YJ, Van Cutsem E, Feyereislova A et al (2010) Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): phase 3, open-label, randomised controlled trial. Lancet 376(9742):687–697 Chin K, Takahari D, Kawabata R et al (2022) Initial safety analysis of CapeOx for elderly patients with advanced gastric cancer patients: a phase II trial. Anticancer Res 42:2683–2687 Hall PS, Swinson D, Cairns DA et al (2021) Efficacy of reduced-intensity chemotherapy with oxaliplatin and capecitabine on quality of life and cancer control among older and frail patients with advanced gastroesophageal cancer the go2 phase 3 randomized clinical trial. JAMA Oncol. https://doi.org/10.1001/jamaoncol.2021.0848 Jiang Z, Zhou A, Sun Y et al (2022) Biweekly oxaliplatin plus S1 for Chinese elderly patients with advanced gastric or gastroesophageal junction cancer as the frst-line therapy: a single-arm, phase 2 study. BMC Cancer 22:253. https://doi.org/10.1186/s12885-022-09332-7 Jatoi A, Murphy BR, Foster NR et al (2006) Oxaliplatin and capecitabine in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction and gastric cardia: a phase II study from the North Central Cancer Treatment Group. Ann Oncol 17:29–34 Luo HY, Xu RH, Wang F et al (2010) Phase II trial of XELOX as first-line treatment for patients with advanced gastric cancer. Chemotherapy 56:94–100 Kuo YC, Liu HT, Lin YL et al (2014) Modified biweekly oxaliplatin and capecitabine for advanced gastric cancer: a retrospective analysis from a medical center. Biomed J 37:141–146 Chao Y, Hsieh JS, Yeh HT et al (2014) A multicenter phase II study of biweekly capecitabine in combination with oxaliplatin as first-line chemotherapy in patients with locally advanced or metastatic gastric cancer. Cancer Chemother Pharmacol 73:799–806
Thông tin
Thông tin xuất bản

International Journal of Clinical Oncology

1-8

Thông tin tác giả