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16-01-2024 | Gastric Cancer | Original Article

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

Authors: Tomono Kawase, Hiroshi Imamura, Ryohei Kawabata, Jin Matsuyama, Kazuhiro Nishikawa, Kazuhiro Yanagihara, Kazuyoshi Yamamoto, Noriyuki Hoki, Junji Kawada, Hisato Kawakami, Daisuke Sakai, Yukinori Kurokawa, Toshio Shimokawa, Taroh Satoh

Published in: International Journal of Clinical Oncology | Issue 2/2024

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Abstract

Background

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.

Methods

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%.

Results

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%).

Conclusions

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.
Literature
1.
go back to reference 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] 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]
2.
go back to reference 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):1006–1019CrossRef 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):1006–1019CrossRef
3.
go back to reference Cunningham D, Starling N, Rao S et al (2008) Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 358(1):36–46CrossRefPubMed Cunningham D, Starling N, Rao S et al (2008) Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 358(1):36–46CrossRefPubMed
4.
go back to reference 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):4991–4997CrossRefPubMed 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):4991–4997CrossRefPubMed
5.
go back to reference 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):215–221CrossRefPubMed 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):215–221CrossRefPubMed
6.
go back to reference Japanese Gastric Cancer Association (2021) Japanese gastric cancer treatment guidelines (Ver. 6). Kanehara, Tokyo Japanese Gastric Cancer Association (2021) Japanese gastric cancer treatment guidelines (Ver. 6). Kanehara, Tokyo
7.
go back to reference 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 21:792–801CrossRefPubMed 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 21:792–801CrossRefPubMed
8.
go back to reference 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):141–148CrossRefPubMed 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):141–148CrossRefPubMed
9.
go back to reference 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 94:1803–1808CrossRefPubMedPubMedCentral 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 94:1803–1808CrossRefPubMedPubMedCentral
10.
go back to reference 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 12:3402–3407CrossRefPubMed 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 12:3402–3407CrossRefPubMed
11.
go back to reference 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):3657–3663CrossRefPubMed 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):3657–3663CrossRefPubMed
12.
go back to reference 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):242–245CrossRefPubMed 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):242–245CrossRefPubMed
13.
go back to reference 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 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
14.
go back to reference 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):228–247CrossRefPubMed 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):228–247CrossRefPubMed
15.
go back to reference 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):319–328CrossRefPubMed 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):319–328CrossRefPubMed
16.
go back to reference 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):57–61CrossRefPubMed 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):57–61CrossRefPubMed
17.
go back to reference 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):687–697CrossRefPubMed 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):687–697CrossRefPubMed
18.
go back to reference 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 42:2683–2687CrossRefPubMed 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 42:2683–2687CrossRefPubMed
21.
go back to reference 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 17:29–34CrossRefPubMed 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 17:29–34CrossRefPubMed
22.
go back to reference 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 56:94–100CrossRefPubMed 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 56:94–100CrossRefPubMed
23.
go back to reference 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 37:141–146PubMed 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 37:141–146PubMed
24.
go back to reference 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 73:799–806CrossRefPubMedPubMedCentral 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 73:799–806CrossRefPubMedPubMedCentral
Metadata
Title
Phase II study of S-1 plus docetaxel as first-line treatment for older patients with advanced gastric cancer (OGSG 0902)
Authors
Tomono Kawase
Hiroshi Imamura
Ryohei Kawabata
Jin Matsuyama
Kazuhiro Nishikawa
Kazuhiro Yanagihara
Kazuyoshi Yamamoto
Noriyuki Hoki
Junji Kawada
Hisato Kawakami
Daisuke Sakai
Yukinori Kurokawa
Toshio Shimokawa
Taroh Satoh
Publication date
16-01-2024
Publisher
Springer Nature Singapore
Published in
International Journal of Clinical Oncology / Issue 2/2024
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI
https://doi.org/10.1007/s10147-023-02437-4

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