Phase II Trial of S-1 and Oxaliplatin Plus Cetuximab for Colorectal Cancer Patients with Initially Unresectable or Not Optimally Resectable Liver Metastases (KSCC1002)

Eiji Oki, Yasunori Emi, Yuji Miyamoto, Akira Kabashima, Hidefumi Higashi, Yutaka Ogata, Masahiko Ikebe, Hiroshi Saeki, Shoji Tokunaga, Ken Shirabe, Toru Beppu, Shinji Uchida, Mitsuhisa Takatsuki, Masahiko Sakoda, Susumu Eguchi, Yoshito Akagi, Yoshihiro Kakeji, Hideo Baba, Shoji Natsugoe, Yoshihiko Maehara

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Abstract

Background: The Kyushu Study Group of Clinical Cancer (KSCC) conducted phase II trials of KSCC1002 (UMIN000001308) concerning liver resectability after first-line treatment of initially unresectable or not optimally resectable colorectal liver metastases in a prospective, multicenter study. Methods: Patients with wild-type KRAS received 4–6 cycles of S-1 and oxaliplatin (SOX) plus cetuximab. Liver resectability was evaluated subsequently with the liver resection rate as the primary endpoint. Results: Of the 33 patients enrolled between March 2010 and July 2013, the median number of administration cycles was 4 (range 0–10). The overall response rate was 63.6 % (95 % confidence interval [CI] 45.1–79.6 %). Liver resection was possible in 16 of 33 (48.5 %) patients, and there were 13 R0 cases (39.4 %). We conducted a central review of liver resectability evaluated by five liver surgeons, and the resectability increased from 18.2 to 66.7 % after chemotherapy, based on imaging. The median overall survival for all 33 cases was 31.6 months (95 % CI 14.8–not reached). The median progression-free survival was 9.7 months (95 % CI 6.2–11.8). Conclusions: SOX plus cetuximab is safe and effective for advanced colorectal cancer with limited liver metastasis, and may lead to high liver resectability.

Original languageEnglish
Pages (from-to)1067-1074
Number of pages8
JournalAnnals of Surgical Oncology
Volume22
DOIs
Publication statusPublished - Dec 1 2015

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oxaliplatin
Colorectal Neoplasms
Neoplasm Metastasis
Liver
Confidence Intervals
Cetuximab

All Science Journal Classification (ASJC) codes

  • Surgery
  • Oncology

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Phase II Trial of S-1 and Oxaliplatin Plus Cetuximab for Colorectal Cancer Patients with Initially Unresectable or Not Optimally Resectable Liver Metastases (KSCC1002). / Oki, Eiji; Emi, Yasunori; Miyamoto, Yuji; Kabashima, Akira; Higashi, Hidefumi; Ogata, Yutaka; Ikebe, Masahiko; Saeki, Hiroshi; Tokunaga, Shoji; Shirabe, Ken; Beppu, Toru; Uchida, Shinji; Takatsuki, Mitsuhisa; Sakoda, Masahiko; Eguchi, Susumu; Akagi, Yoshito; Kakeji, Yoshihiro; Baba, Hideo; Natsugoe, Shoji; Maehara, Yoshihiko.

In: Annals of Surgical Oncology, Vol. 22, 01.12.2015, p. 1067-1074.

Research output: Contribution to journalArticle

Oki, E, Emi, Y, Miyamoto, Y, Kabashima, A, Higashi, H, Ogata, Y, Ikebe, M, Saeki, H, Tokunaga, S, Shirabe, K, Beppu, T, Uchida, S, Takatsuki, M, Sakoda, M, Eguchi, S, Akagi, Y, Kakeji, Y, Baba, H, Natsugoe, S & Maehara, Y 2015, 'Phase II Trial of S-1 and Oxaliplatin Plus Cetuximab for Colorectal Cancer Patients with Initially Unresectable or Not Optimally Resectable Liver Metastases (KSCC1002)', Annals of Surgical Oncology, vol. 22, pp. 1067-1074. https://doi.org/10.1245/s10434-015-4771-1
Oki, Eiji ; Emi, Yasunori ; Miyamoto, Yuji ; Kabashima, Akira ; Higashi, Hidefumi ; Ogata, Yutaka ; Ikebe, Masahiko ; Saeki, Hiroshi ; Tokunaga, Shoji ; Shirabe, Ken ; Beppu, Toru ; Uchida, Shinji ; Takatsuki, Mitsuhisa ; Sakoda, Masahiko ; Eguchi, Susumu ; Akagi, Yoshito ; Kakeji, Yoshihiro ; Baba, Hideo ; Natsugoe, Shoji ; Maehara, Yoshihiko. / Phase II Trial of S-1 and Oxaliplatin Plus Cetuximab for Colorectal Cancer Patients with Initially Unresectable or Not Optimally Resectable Liver Metastases (KSCC1002). In: Annals of Surgical Oncology. 2015 ; Vol. 22. pp. 1067-1074.
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abstract = "Background: The Kyushu Study Group of Clinical Cancer (KSCC) conducted phase II trials of KSCC1002 (UMIN000001308) concerning liver resectability after first-line treatment of initially unresectable or not optimally resectable colorectal liver metastases in a prospective, multicenter study. Methods: Patients with wild-type KRAS received 4–6 cycles of S-1 and oxaliplatin (SOX) plus cetuximab. Liver resectability was evaluated subsequently with the liver resection rate as the primary endpoint. Results: Of the 33 patients enrolled between March 2010 and July 2013, the median number of administration cycles was 4 (range 0–10). The overall response rate was 63.6 {\%} (95 {\%} confidence interval [CI] 45.1–79.6 {\%}). Liver resection was possible in 16 of 33 (48.5 {\%}) patients, and there were 13 R0 cases (39.4 {\%}). We conducted a central review of liver resectability evaluated by five liver surgeons, and the resectability increased from 18.2 to 66.7 {\%} after chemotherapy, based on imaging. The median overall survival for all 33 cases was 31.6 months (95 {\%} CI 14.8–not reached). The median progression-free survival was 9.7 months (95 {\%} CI 6.2–11.8). Conclusions: SOX plus cetuximab is safe and effective for advanced colorectal cancer with limited liver metastasis, and may lead to high liver resectability.",
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T1 - Phase II Trial of S-1 and Oxaliplatin Plus Cetuximab for Colorectal Cancer Patients with Initially Unresectable or Not Optimally Resectable Liver Metastases (KSCC1002)

AU - Oki, Eiji

AU - Emi, Yasunori

AU - Miyamoto, Yuji

AU - Kabashima, Akira

AU - Higashi, Hidefumi

AU - Ogata, Yutaka

AU - Ikebe, Masahiko

AU - Saeki, Hiroshi

AU - Tokunaga, Shoji

AU - Shirabe, Ken

AU - Beppu, Toru

AU - Uchida, Shinji

AU - Takatsuki, Mitsuhisa

AU - Sakoda, Masahiko

AU - Eguchi, Susumu

AU - Akagi, Yoshito

AU - Kakeji, Yoshihiro

AU - Baba, Hideo

AU - Natsugoe, Shoji

AU - Maehara, Yoshihiko

PY - 2015/12/1

Y1 - 2015/12/1

N2 - Background: The Kyushu Study Group of Clinical Cancer (KSCC) conducted phase II trials of KSCC1002 (UMIN000001308) concerning liver resectability after first-line treatment of initially unresectable or not optimally resectable colorectal liver metastases in a prospective, multicenter study. Methods: Patients with wild-type KRAS received 4–6 cycles of S-1 and oxaliplatin (SOX) plus cetuximab. Liver resectability was evaluated subsequently with the liver resection rate as the primary endpoint. Results: Of the 33 patients enrolled between March 2010 and July 2013, the median number of administration cycles was 4 (range 0–10). The overall response rate was 63.6 % (95 % confidence interval [CI] 45.1–79.6 %). Liver resection was possible in 16 of 33 (48.5 %) patients, and there were 13 R0 cases (39.4 %). We conducted a central review of liver resectability evaluated by five liver surgeons, and the resectability increased from 18.2 to 66.7 % after chemotherapy, based on imaging. The median overall survival for all 33 cases was 31.6 months (95 % CI 14.8–not reached). The median progression-free survival was 9.7 months (95 % CI 6.2–11.8). Conclusions: SOX plus cetuximab is safe and effective for advanced colorectal cancer with limited liver metastasis, and may lead to high liver resectability.

AB - Background: The Kyushu Study Group of Clinical Cancer (KSCC) conducted phase II trials of KSCC1002 (UMIN000001308) concerning liver resectability after first-line treatment of initially unresectable or not optimally resectable colorectal liver metastases in a prospective, multicenter study. Methods: Patients with wild-type KRAS received 4–6 cycles of S-1 and oxaliplatin (SOX) plus cetuximab. Liver resectability was evaluated subsequently with the liver resection rate as the primary endpoint. Results: Of the 33 patients enrolled between March 2010 and July 2013, the median number of administration cycles was 4 (range 0–10). The overall response rate was 63.6 % (95 % confidence interval [CI] 45.1–79.6 %). Liver resection was possible in 16 of 33 (48.5 %) patients, and there were 13 R0 cases (39.4 %). We conducted a central review of liver resectability evaluated by five liver surgeons, and the resectability increased from 18.2 to 66.7 % after chemotherapy, based on imaging. The median overall survival for all 33 cases was 31.6 months (95 % CI 14.8–not reached). The median progression-free survival was 9.7 months (95 % CI 6.2–11.8). Conclusions: SOX plus cetuximab is safe and effective for advanced colorectal cancer with limited liver metastasis, and may lead to high liver resectability.

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