A pilot study of S-1 plus cisplatin versus 5-fluorouracil plus cisplatin for postoperative chemotherapy in histological stage IIIB-IV (M0) gastric cancer

Sung Sook Lee, Hei Cheul Jeung, Hyuncheol Chung, Sung Hoon Noh, WooJin Hyung, Ji Yeong Ahn, SunYoung Rha

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background Although its efficacy is unproven, 5-fluorouracil plus cisplatin (FP) is used to prevent postoperative relapse in gastric cancer. We investigated the safety and feasibility of S-1 plus cisplatin (SP) vs. FP for stage IIIB-IV (M0) gastric cancer. Methods Following curative resection, 41 stage IIIB-IV (M0) gastric cancer patients were assigned to SP (eight 14-day cycles of S-1 [40 mg/m 2 twice daily] plus cisplatin [60 mg/m 2day 1] administered every 3 weeks) or FP (six 3-day cycles of FU [1 g/m 2 per day] plus cisplatin [80 mg/m 2day 1] every 4 weeks). Doses were reduced based on predefined criteria. Results Patient characteristics were balanced between the two arms. In total, 124 cycles of SP (N=20, median=7, range 1-8) and 113 cycles of FP (N=21, median 6, range 1-6) were administered. The median relative dose intensity per patient was 75% (49.99-100%) for S-1, 100% (75- 100%) for cisplatin in SP, and 100% (64-100%) for 5-FU, 100% (60-100%) for cisplatin in FP. The relative dose intensity of FP was stable, while that of SP decreased during treatment. After median follow-up of 7.9 months (3.8-14.55), the median RFS was not reached. Relapse occurred in two (10%) patients on SP and five (23.8%) in the FP arm (P=0.24). The incidence of grade 3-4 granulocytopenia was 36.8% with SP and 14.3% with FP. Grade 3-4 non-hematologic toxicities included fatigue (5.2% with SP vs. 4.8% with FP), vomiting (10.5% with SP vs. 0% with FP), and infection (5.2% with SP vs. 0% FP). Conclusion S-1 plus cisplatin was feasible and tolerable as adjuvant treatment for stage IIIB-IV (M0) gastric cancer. However, because of decreased relative dose intensity during treatment, further study is warranted to determine optimal dosage and combination.

Original languageEnglish
Pages (from-to)357-363
Number of pages7
JournalInvestigational New Drugs
Volume30
Issue number1
DOIs
Publication statusPublished - 2012 Feb 1

Fingerprint

Fluorouracil
Cisplatin
Stomach Neoplasms
Drug Therapy
Recurrence

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)
  • Oncology

Cite this

@article{a9ba5ea9ea674841baacbb40b80c6b41,
title = "A pilot study of S-1 plus cisplatin versus 5-fluorouracil plus cisplatin for postoperative chemotherapy in histological stage IIIB-IV (M0) gastric cancer",
abstract = "Background Although its efficacy is unproven, 5-fluorouracil plus cisplatin (FP) is used to prevent postoperative relapse in gastric cancer. We investigated the safety and feasibility of S-1 plus cisplatin (SP) vs. FP for stage IIIB-IV (M0) gastric cancer. Methods Following curative resection, 41 stage IIIB-IV (M0) gastric cancer patients were assigned to SP (eight 14-day cycles of S-1 [40 mg/m 2 twice daily] plus cisplatin [60 mg/m 2day 1] administered every 3 weeks) or FP (six 3-day cycles of FU [1 g/m 2 per day] plus cisplatin [80 mg/m 2day 1] every 4 weeks). Doses were reduced based on predefined criteria. Results Patient characteristics were balanced between the two arms. In total, 124 cycles of SP (N=20, median=7, range 1-8) and 113 cycles of FP (N=21, median 6, range 1-6) were administered. The median relative dose intensity per patient was 75{\%} (49.99-100{\%}) for S-1, 100{\%} (75- 100{\%}) for cisplatin in SP, and 100{\%} (64-100{\%}) for 5-FU, 100{\%} (60-100{\%}) for cisplatin in FP. The relative dose intensity of FP was stable, while that of SP decreased during treatment. After median follow-up of 7.9 months (3.8-14.55), the median RFS was not reached. Relapse occurred in two (10{\%}) patients on SP and five (23.8{\%}) in the FP arm (P=0.24). The incidence of grade 3-4 granulocytopenia was 36.8{\%} with SP and 14.3{\%} with FP. Grade 3-4 non-hematologic toxicities included fatigue (5.2{\%} with SP vs. 4.8{\%} with FP), vomiting (10.5{\%} with SP vs. 0{\%} with FP), and infection (5.2{\%} with SP vs. 0{\%} FP). Conclusion S-1 plus cisplatin was feasible and tolerable as adjuvant treatment for stage IIIB-IV (M0) gastric cancer. However, because of decreased relative dose intensity during treatment, further study is warranted to determine optimal dosage and combination.",
author = "Lee, {Sung Sook} and Jeung, {Hei Cheul} and Hyuncheol Chung and Noh, {Sung Hoon} and WooJin Hyung and Ahn, {Ji Yeong} and SunYoung Rha",
year = "2012",
month = "2",
day = "1",
doi = "10.1007/s10637-010-9515-2",
language = "English",
volume = "30",
pages = "357--363",
journal = "Investigational New Drugs",
issn = "0167-6997",
publisher = "Kluwer Academic Publishers",
number = "1",

}

A pilot study of S-1 plus cisplatin versus 5-fluorouracil plus cisplatin for postoperative chemotherapy in histological stage IIIB-IV (M0) gastric cancer. / Lee, Sung Sook; Jeung, Hei Cheul; Chung, Hyuncheol; Noh, Sung Hoon; Hyung, WooJin; Ahn, Ji Yeong; Rha, SunYoung.

In: Investigational New Drugs, Vol. 30, No. 1, 01.02.2012, p. 357-363.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A pilot study of S-1 plus cisplatin versus 5-fluorouracil plus cisplatin for postoperative chemotherapy in histological stage IIIB-IV (M0) gastric cancer

AU - Lee, Sung Sook

AU - Jeung, Hei Cheul

AU - Chung, Hyuncheol

AU - Noh, Sung Hoon

AU - Hyung, WooJin

AU - Ahn, Ji Yeong

AU - Rha, SunYoung

PY - 2012/2/1

Y1 - 2012/2/1

N2 - Background Although its efficacy is unproven, 5-fluorouracil plus cisplatin (FP) is used to prevent postoperative relapse in gastric cancer. We investigated the safety and feasibility of S-1 plus cisplatin (SP) vs. FP for stage IIIB-IV (M0) gastric cancer. Methods Following curative resection, 41 stage IIIB-IV (M0) gastric cancer patients were assigned to SP (eight 14-day cycles of S-1 [40 mg/m 2 twice daily] plus cisplatin [60 mg/m 2day 1] administered every 3 weeks) or FP (six 3-day cycles of FU [1 g/m 2 per day] plus cisplatin [80 mg/m 2day 1] every 4 weeks). Doses were reduced based on predefined criteria. Results Patient characteristics were balanced between the two arms. In total, 124 cycles of SP (N=20, median=7, range 1-8) and 113 cycles of FP (N=21, median 6, range 1-6) were administered. The median relative dose intensity per patient was 75% (49.99-100%) for S-1, 100% (75- 100%) for cisplatin in SP, and 100% (64-100%) for 5-FU, 100% (60-100%) for cisplatin in FP. The relative dose intensity of FP was stable, while that of SP decreased during treatment. After median follow-up of 7.9 months (3.8-14.55), the median RFS was not reached. Relapse occurred in two (10%) patients on SP and five (23.8%) in the FP arm (P=0.24). The incidence of grade 3-4 granulocytopenia was 36.8% with SP and 14.3% with FP. Grade 3-4 non-hematologic toxicities included fatigue (5.2% with SP vs. 4.8% with FP), vomiting (10.5% with SP vs. 0% with FP), and infection (5.2% with SP vs. 0% FP). Conclusion S-1 plus cisplatin was feasible and tolerable as adjuvant treatment for stage IIIB-IV (M0) gastric cancer. However, because of decreased relative dose intensity during treatment, further study is warranted to determine optimal dosage and combination.

AB - Background Although its efficacy is unproven, 5-fluorouracil plus cisplatin (FP) is used to prevent postoperative relapse in gastric cancer. We investigated the safety and feasibility of S-1 plus cisplatin (SP) vs. FP for stage IIIB-IV (M0) gastric cancer. Methods Following curative resection, 41 stage IIIB-IV (M0) gastric cancer patients were assigned to SP (eight 14-day cycles of S-1 [40 mg/m 2 twice daily] plus cisplatin [60 mg/m 2day 1] administered every 3 weeks) or FP (six 3-day cycles of FU [1 g/m 2 per day] plus cisplatin [80 mg/m 2day 1] every 4 weeks). Doses were reduced based on predefined criteria. Results Patient characteristics were balanced between the two arms. In total, 124 cycles of SP (N=20, median=7, range 1-8) and 113 cycles of FP (N=21, median 6, range 1-6) were administered. The median relative dose intensity per patient was 75% (49.99-100%) for S-1, 100% (75- 100%) for cisplatin in SP, and 100% (64-100%) for 5-FU, 100% (60-100%) for cisplatin in FP. The relative dose intensity of FP was stable, while that of SP decreased during treatment. After median follow-up of 7.9 months (3.8-14.55), the median RFS was not reached. Relapse occurred in two (10%) patients on SP and five (23.8%) in the FP arm (P=0.24). The incidence of grade 3-4 granulocytopenia was 36.8% with SP and 14.3% with FP. Grade 3-4 non-hematologic toxicities included fatigue (5.2% with SP vs. 4.8% with FP), vomiting (10.5% with SP vs. 0% with FP), and infection (5.2% with SP vs. 0% FP). Conclusion S-1 plus cisplatin was feasible and tolerable as adjuvant treatment for stage IIIB-IV (M0) gastric cancer. However, because of decreased relative dose intensity during treatment, further study is warranted to determine optimal dosage and combination.

UR - http://www.scopus.com/inward/record.url?scp=84856555924&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84856555924&partnerID=8YFLogxK

U2 - 10.1007/s10637-010-9515-2

DO - 10.1007/s10637-010-9515-2

M3 - Article

VL - 30

SP - 357

EP - 363

JO - Investigational New Drugs

JF - Investigational New Drugs

SN - 0167-6997

IS - 1

ER -