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Multicenter phase III trial of S-1 and cisplatin versus S-1 and oxaliplatin combination chemotherapy for first-line treatment of advanced gastric cancer (SOPP trial).
- Source :
-
Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association [Gastric Cancer] 2021 Jan; Vol. 24 (1), pp. 156-167. Date of Electronic Publication: 2020 Jun 28. - Publication Year :
- 2021
-
Abstract
- Background: In East Asia, S-1 plus cisplatin (SP) is one of the standard first-line chemotherapy regimens for metastatic or recurrent gastric cancer (MRGC). Oxaliplatin is generally less toxic and more convenient to administer than cisplatin.<br />Patients and Methods: This was a multicenter, phase III study assessing whether S-1/oxaliplatin (SOX) was non-inferior/superior to SP in terms of progression-free survival (PFS). Patients with MRGC were randomized 1:1 to receive either SOX (S-1 80 mg/m <superscript>2</superscript> /day on days 1-14; oxaliplatin 130 mg/m <superscript>2</superscript> on day 1; every 3 weeks) or SP (S-1 80 mg/m <superscript>2</superscript> /day on days 1-14; cisplatin 60 mg/m <superscript>2</superscript> on day 1; every 3 weeks [SP3]).<br />Results: Between October 2012 and October 2014, 338 patients were randomized. The median age was 56 years, and 51% of patients had measurable lesions. SOX was significantly non-inferior but not superior to SP3 in terms of PFS [median 5.6 versus 5.7 months; hazard ratio (HR) 0.85; 95% confidence interval (CI) 0.67-1.07]. In patients with measurable disease, objective response rates were similar between SOX and SP3 (58% versus 60%). Overall, the survival in both groups did not differ (median 12.9 versus 11.4 months; HR 0.86; 95% CI 0.66-1.11). Treatment was well tolerated in both arms. Anemia, leucopenia, neutropenia, febrile neutropenia, and oral mucositis were more common with SP3. In contrast, thrombocytopenia, nausea, vomiting, and peripheral neuropathy were more common with SOX.<br />Conclusions: SOX was non-inferior to SP3. The two regimens were well tolerated with different toxicity profiles. The SOX regimen can be recommended as a first-line treatment for MRGC.<br />Trial Registration: ClinicalTrials.gov: NCT01671449.
- Subjects :
- Adult
Aged
Aged, 80 and over
Drug Combinations
Female
Humans
Male
Middle Aged
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Cisplatin administration & dosage
Oxaliplatin administration & dosage
Oxonic Acid administration & dosage
Stomach Neoplasms drug therapy
Tegafur administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1436-3305
- Volume :
- 24
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association
- Publication Type :
- Academic Journal
- Accession number :
- 32596783
- Full Text :
- https://doi.org/10.1007/s10120-020-01101-4