Phase II multicenter study of adjuvant S-1 for colorectal liver metastasis

Survival analysis of N-SOG 01 trial

Takehiro Kato, Keisuke Uehara, Atsuyuki Maeda, Eiji Sakamoto, Kazuhiro Hiramatsu, Eiji Takeuchi, Hidenari Goto, Yuichiro Tojima, Hiroshi Yatsuya, Masato Nagino

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Purpose: We previously showed that S-1 after curative resection of colorectal liver metastasis had acceptable toxicity and a high rate of completion of therapy in a prospective phase II trial. We here reported the primary endpoint of disease-free survival (DFS). Methods: Between October 2008 and August 2010, 60 patients were eligible for this study and received S-1 for 28 days followed by a 2-week rest period. Treatment was started within 8 weeks after surgery and repeated for eight cycles. Results: Median follow-up was 41 months. Among 60 patients, 45 had solitary metastasis, and the median maximum tumor diameter was 2.6 cm. The 3-year DFS and overall survival were 47.4 and 80.0 %, respectively. Recurrences developed in 31 patients, with the remnant liver the most common site (19 patients). Multivariate analysis showed that positive lymph node metastasis around the primary site (p = 0.013) and early liver metastasis (synchronous disease or metachronous disease within 12 months) (p = 0.041) were independent poor prognostic factors for DFS. Patients having both risk factors had a significantly worse DFS than those without these risk factors (p < 0.001). Early liver metastasis was an independent indicator of early recurrence within 1 year. Conclusions: S-1 after curative liver resection yielded promising survival in patients with a low tumor burden. Outcome in patients having both positive lymph node metastasis around the primary site and early liver metastasis was much worse than in patients without these conditions; therefore, they might warrant more aggressive therapy.

Original languageEnglish
Pages (from-to)1281-1288
Number of pages8
JournalCancer Chemotherapy and Pharmacology
Volume75
Issue number6
DOIs
Publication statusPublished - 26-06-2015

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Survival Analysis
Liver
Multicenter Studies
Neoplasm Metastasis
Disease-Free Survival
Tumors
Lymph Nodes
Recurrence
Surgery
Survival
Toxicity
Tumor Burden
Therapeutics
Multivariate Analysis
Neoplasms

All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

Cite this

Kato, Takehiro ; Uehara, Keisuke ; Maeda, Atsuyuki ; Sakamoto, Eiji ; Hiramatsu, Kazuhiro ; Takeuchi, Eiji ; Goto, Hidenari ; Tojima, Yuichiro ; Yatsuya, Hiroshi ; Nagino, Masato. / Phase II multicenter study of adjuvant S-1 for colorectal liver metastasis : Survival analysis of N-SOG 01 trial. In: Cancer Chemotherapy and Pharmacology. 2015 ; Vol. 75, No. 6. pp. 1281-1288.
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abstract = "Purpose: We previously showed that S-1 after curative resection of colorectal liver metastasis had acceptable toxicity and a high rate of completion of therapy in a prospective phase II trial. We here reported the primary endpoint of disease-free survival (DFS). Methods: Between October 2008 and August 2010, 60 patients were eligible for this study and received S-1 for 28 days followed by a 2-week rest period. Treatment was started within 8 weeks after surgery and repeated for eight cycles. Results: Median follow-up was 41 months. Among 60 patients, 45 had solitary metastasis, and the median maximum tumor diameter was 2.6 cm. The 3-year DFS and overall survival were 47.4 and 80.0 {\%}, respectively. Recurrences developed in 31 patients, with the remnant liver the most common site (19 patients). Multivariate analysis showed that positive lymph node metastasis around the primary site (p = 0.013) and early liver metastasis (synchronous disease or metachronous disease within 12 months) (p = 0.041) were independent poor prognostic factors for DFS. Patients having both risk factors had a significantly worse DFS than those without these risk factors (p < 0.001). Early liver metastasis was an independent indicator of early recurrence within 1 year. Conclusions: S-1 after curative liver resection yielded promising survival in patients with a low tumor burden. Outcome in patients having both positive lymph node metastasis around the primary site and early liver metastasis was much worse than in patients without these conditions; therefore, they might warrant more aggressive therapy.",
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Kato, T, Uehara, K, Maeda, A, Sakamoto, E, Hiramatsu, K, Takeuchi, E, Goto, H, Tojima, Y, Yatsuya, H & Nagino, M 2015, 'Phase II multicenter study of adjuvant S-1 for colorectal liver metastasis: Survival analysis of N-SOG 01 trial', Cancer Chemotherapy and Pharmacology, vol. 75, no. 6, pp. 1281-1288. https://doi.org/10.1007/s00280-015-2752-5

Phase II multicenter study of adjuvant S-1 for colorectal liver metastasis : Survival analysis of N-SOG 01 trial. / Kato, Takehiro; Uehara, Keisuke; Maeda, Atsuyuki; Sakamoto, Eiji; Hiramatsu, Kazuhiro; Takeuchi, Eiji; Goto, Hidenari; Tojima, Yuichiro; Yatsuya, Hiroshi; Nagino, Masato.

In: Cancer Chemotherapy and Pharmacology, Vol. 75, No. 6, 26.06.2015, p. 1281-1288.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II multicenter study of adjuvant S-1 for colorectal liver metastasis

T2 - Survival analysis of N-SOG 01 trial

AU - Kato, Takehiro

AU - Uehara, Keisuke

AU - Maeda, Atsuyuki

AU - Sakamoto, Eiji

AU - Hiramatsu, Kazuhiro

AU - Takeuchi, Eiji

AU - Goto, Hidenari

AU - Tojima, Yuichiro

AU - Yatsuya, Hiroshi

AU - Nagino, Masato

PY - 2015/6/26

Y1 - 2015/6/26

N2 - Purpose: We previously showed that S-1 after curative resection of colorectal liver metastasis had acceptable toxicity and a high rate of completion of therapy in a prospective phase II trial. We here reported the primary endpoint of disease-free survival (DFS). Methods: Between October 2008 and August 2010, 60 patients were eligible for this study and received S-1 for 28 days followed by a 2-week rest period. Treatment was started within 8 weeks after surgery and repeated for eight cycles. Results: Median follow-up was 41 months. Among 60 patients, 45 had solitary metastasis, and the median maximum tumor diameter was 2.6 cm. The 3-year DFS and overall survival were 47.4 and 80.0 %, respectively. Recurrences developed in 31 patients, with the remnant liver the most common site (19 patients). Multivariate analysis showed that positive lymph node metastasis around the primary site (p = 0.013) and early liver metastasis (synchronous disease or metachronous disease within 12 months) (p = 0.041) were independent poor prognostic factors for DFS. Patients having both risk factors had a significantly worse DFS than those without these risk factors (p < 0.001). Early liver metastasis was an independent indicator of early recurrence within 1 year. Conclusions: S-1 after curative liver resection yielded promising survival in patients with a low tumor burden. Outcome in patients having both positive lymph node metastasis around the primary site and early liver metastasis was much worse than in patients without these conditions; therefore, they might warrant more aggressive therapy.

AB - Purpose: We previously showed that S-1 after curative resection of colorectal liver metastasis had acceptable toxicity and a high rate of completion of therapy in a prospective phase II trial. We here reported the primary endpoint of disease-free survival (DFS). Methods: Between October 2008 and August 2010, 60 patients were eligible for this study and received S-1 for 28 days followed by a 2-week rest period. Treatment was started within 8 weeks after surgery and repeated for eight cycles. Results: Median follow-up was 41 months. Among 60 patients, 45 had solitary metastasis, and the median maximum tumor diameter was 2.6 cm. The 3-year DFS and overall survival were 47.4 and 80.0 %, respectively. Recurrences developed in 31 patients, with the remnant liver the most common site (19 patients). Multivariate analysis showed that positive lymph node metastasis around the primary site (p = 0.013) and early liver metastasis (synchronous disease or metachronous disease within 12 months) (p = 0.041) were independent poor prognostic factors for DFS. Patients having both risk factors had a significantly worse DFS than those without these risk factors (p < 0.001). Early liver metastasis was an independent indicator of early recurrence within 1 year. Conclusions: S-1 after curative liver resection yielded promising survival in patients with a low tumor burden. Outcome in patients having both positive lymph node metastasis around the primary site and early liver metastasis was much worse than in patients without these conditions; therefore, they might warrant more aggressive therapy.

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