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Postoperative XELOX therapy for patients with curatively resected high-risk stage II and stage III rectal cancer without preoperative chemoradiation: a prospective, multicenter, open-label, single-arm phase II study.
BMC Cancer 2019; 19(1):929BC

Abstract

BACKGROUND

Preoperative 5-FU-based chemoradiation is currently a standard treatment for advanced rectal cancer, particularly in Western countries. Although it reduced the local recurrence, it could not necessarily improve overall survival. Furthermore, it can also produce adverse effects and long-term sphincter function deficiency. Adjuvant oxaliplatin plus capecitabine (XELOX) is a recommended regimen for patients with curatively resected colon cancer. However, the efficacy of postoperative adjuvant therapy for rectal cancer patients who have not undergone preoperative chemoradiation remains unknown. We aimed to evaluate the efficacy of surgery and postoperative XELOX without preoperative chemoradiation for treating rectal cancer.

METHODS

We performed a prospective, multicenter, open-label, single arm phase II study. Patients with curatively resected high-risk stage II and stage III rectal cancer who had not undergone preoperative therapy were treated with a 120 min intravenous infusion of oxaliplatin (130 mg/m2) on day 1 and capecitabine (2000 mg/m2/day) in 2 divided doses for 14 days of a 3-week cycle, for a total of 8 cycles (24 weeks). The primary endpoint was 3-year disease-free survival (DFS).

RESULTS

Between August 2012 and June 2015, 60 men and 47 women with a median age was 63 years (range: 29-77 years) were enrolled. Ninety-three patients had Eastern Cooperative Oncology Group performance status scores of '0' and 14 had scores of '1'. Tumors were located in the upper and lower rectums in 54 and 48 patients, respectively; 8 patients had stage II disease and 99 had stage III. The 3-year DFS was 70.1% (95% confidence interval, 60.8-78.0%) and 33 patients (31%) experienced recurrence, most commonly in the lung (16 patients) followed by local recurrence (9) and hepatic recurrence (7).

CONCLUSIONS

Postoperative XELOX without preoperative chemoradiation is effective for rectal cancer and provides adequate 3-year DFS prospects.

TRIAL REGISTRATION

This clinical trial was registered in the University Hospital Medical Information Network registry system as UMIN000008634 at Aug 06, 2012.

Authors+Show Affiliations

Multi-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan. tmizushima@gesurg.med.osaka-u.ac.jp. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 E2 Yamadaoka, Suita, Osaka, 565-0871, Japan. tmizushima@gesurg.med.osaka-u.ac.jp.Multi-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 E2 Yamadaoka, Suita, Osaka, 565-0871, Japan. Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan. Department of Surgery, National Hospital Organization, National Hospital, 2-1-14 Hoenzakka, Chuo-ku, Osaka, Osaka, Japan.Multi-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan. Department of Surgery, National Hospital Organization, National Hospital, 2-1-14 Hoenzakka, Chuo-ku, Osaka, Osaka, Japan.Multi-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 E2 Yamadaoka, Suita, Osaka, 565-0871, Japan.Multi-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan. Department of Gastroenterological Surgery, Osaka Prefectural Hospital Organization, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, Japan.Multi-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan. Department of Surgery, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki, Hyogo, Japan.Multi-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 E2 Yamadaoka, Suita, Osaka, 565-0871, Japan.Multi-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan. Department of Frontier-Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Yamadaoka 2-2, Suita, Osaka, Japan.Multi-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan. Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan.Multi-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 E2 Yamadaoka, Suita, Osaka, 565-0871, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31533662

Citation

Mizushima, Tsunekazu, et al. "Postoperative XELOX Therapy for Patients With Curatively Resected High-risk Stage II and Stage III Rectal Cancer Without Preoperative Chemoradiation: a Prospective, Multicenter, Open-label, Single-arm Phase II Study." BMC Cancer, vol. 19, no. 1, 2019, p. 929.
Mizushima T, Ikeda M, Kato T, et al. Postoperative XELOX therapy for patients with curatively resected high-risk stage II and stage III rectal cancer without preoperative chemoradiation: a prospective, multicenter, open-label, single-arm phase II study. BMC Cancer. 2019;19(1):929.
Mizushima, T., Ikeda, M., Kato, T., Ikeda, A., Nishimura, J., Hata, T., ... Doki, Y. (2019). Postoperative XELOX therapy for patients with curatively resected high-risk stage II and stage III rectal cancer without preoperative chemoradiation: a prospective, multicenter, open-label, single-arm phase II study. BMC Cancer, 19(1), p. 929. doi:10.1186/s12885-019-6122-2.
Mizushima T, et al. Postoperative XELOX Therapy for Patients With Curatively Resected High-risk Stage II and Stage III Rectal Cancer Without Preoperative Chemoradiation: a Prospective, Multicenter, Open-label, Single-arm Phase II Study. BMC Cancer. 2019 Sep 18;19(1):929. PubMed PMID: 31533662.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Postoperative XELOX therapy for patients with curatively resected high-risk stage II and stage III rectal cancer without preoperative chemoradiation: a prospective, multicenter, open-label, single-arm phase II study. AU - Mizushima,Tsunekazu, AU - Ikeda,Masataka, AU - Kato,Takeshi, AU - Ikeda,Atsuyo, AU - Nishimura,Junichi, AU - Hata,Taishi, AU - Matsuda,Chu, AU - Satoh,Taroh, AU - Mori,Masaki, AU - Doki,Yuichiro, Y1 - 2019/09/18/ PY - 2019/06/19/received PY - 2019/09/02/accepted PY - 2019/9/20/entrez PY - 2019/9/20/pubmed PY - 2019/9/20/medline KW - Adjuvant chemotherapy KW - Capecitabine KW - Oxaliplatin KW - Rectal cancer KW - XELOX SP - 929 EP - 929 JF - BMC cancer JO - BMC Cancer VL - 19 IS - 1 N2 - BACKGROUND: Preoperative 5-FU-based chemoradiation is currently a standard treatment for advanced rectal cancer, particularly in Western countries. Although it reduced the local recurrence, it could not necessarily improve overall survival. Furthermore, it can also produce adverse effects and long-term sphincter function deficiency. Adjuvant oxaliplatin plus capecitabine (XELOX) is a recommended regimen for patients with curatively resected colon cancer. However, the efficacy of postoperative adjuvant therapy for rectal cancer patients who have not undergone preoperative chemoradiation remains unknown. We aimed to evaluate the efficacy of surgery and postoperative XELOX without preoperative chemoradiation for treating rectal cancer. METHODS: We performed a prospective, multicenter, open-label, single arm phase II study. Patients with curatively resected high-risk stage II and stage III rectal cancer who had not undergone preoperative therapy were treated with a 120 min intravenous infusion of oxaliplatin (130 mg/m2) on day 1 and capecitabine (2000 mg/m2/day) in 2 divided doses for 14 days of a 3-week cycle, for a total of 8 cycles (24 weeks). The primary endpoint was 3-year disease-free survival (DFS). RESULTS: Between August 2012 and June 2015, 60 men and 47 women with a median age was 63 years (range: 29-77 years) were enrolled. Ninety-three patients had Eastern Cooperative Oncology Group performance status scores of '0' and 14 had scores of '1'. Tumors were located in the upper and lower rectums in 54 and 48 patients, respectively; 8 patients had stage II disease and 99 had stage III. The 3-year DFS was 70.1% (95% confidence interval, 60.8-78.0%) and 33 patients (31%) experienced recurrence, most commonly in the lung (16 patients) followed by local recurrence (9) and hepatic recurrence (7). CONCLUSIONS: Postoperative XELOX without preoperative chemoradiation is effective for rectal cancer and provides adequate 3-year DFS prospects. TRIAL REGISTRATION: This clinical trial was registered in the University Hospital Medical Information Network registry system as UMIN000008634 at Aug 06, 2012. SN - 1471-2407 UR - https://www.unboundmedicine.com/medline/citation/31533662/Postoperative_XELOX_therapy_for_patients_with_curatively_resected_high-risk_stage_II_and_stage_III_rectal_cancer_without_preoperative_chemoradiation:_a_prospective,_multicenter,_open-label,_single-arm_phase_II_study L2 - https://bmccancer.biomedcentral.com/articles/10.1186/s12885-019-6122-2 DB - PRIME DP - Unbound Medicine ER -