Phase II Study of Preoperative Capecitabine and Oxaliplatin-based Intensified Chemoradiotherapy With or Without Induction Chemotherapy in Patients With Locally Advanced Rectal Cancer and Synchronous Liver-limited Resectable Metastases

Cho, Hyungwoo MD; Kim, Jeong Eun MD, PhD; Kim, Kyu-pyo MD, PhD; Yu, Chang Sik MD, PhD; Kim, Jin Cheon MD, PhD; Kim, Jong Hoon MD, PhD; Lee, Myung Ah MD, PhD; Jang, Hong Seok MD, PhD; Oh, Seong Taek MD, PhD; Kim, Sun Young MD, PhD; Oh, Jae Hwan MD, PhD; Kim, Dae Yong MD, PhD; Hong, Yong Sang MD, PhD; Kim, Tae Won MD, PhD

American Journal of Clinical Oncology:
doi: 10.1097/COC.0000000000000315
Original Articles: Gastrointestinal
Abstract

Objectives: Controversy surrounds the management of patients with locally advanced rectal cancer with synchronous resectable liver metastases (LMs). This study was designed to improve both systemic and local control in these patients.

Methods: Patients with locally advanced rectal cancer (cT3-4N0 or cTanyN1-2) and synchronous resectable liver-limited metastases (cM1a) were randomly assigned to receive either preoperative treatments of induction CapeOx, followed by chemoradiotherapy with CapeOx (CapeOx-RT) (arm A) or CapeOx-RT alone (arm B). Induction CapeOx consisted of oxaliplatin 130 mg/m2 on day 1 and capecitabine 1000 mg/m2 twice daily on days 1 to 14, every 3 weeks for 2 cycles; CapeOx-RT consisted of radiotherapy with 45 Gy/25 daily fractions±5.4 Gy/3 fractions, oxaliplatin 50 mg/m2 weekly for 5 weeks, and capecitabine 825 mg/m2 twice daily on days 1 to 38. Total mesorectal excision and simultaneous liver metastasectomy were planned within 6 weeks after completion of preoperative treatments. The primary endpoint was R0 resection rate of both the primary tumor and LMs.

Results: Thirty-eight patients were randomly assigned to the present study, 18 to arm A and 20 to arm B. The overall R0 resection rate for both the primary tumor and LMs was 77.8% in arm A and 70.0% in arm B (P=0.72). The median progression-free survival was 14.2 versus 15.1 months (P=0.422) and the 3-year overall survival rate was 75.0% versus 88.8% (P=0.29), respectively.

Conclusions: Both treatment strategies showed considerable R0 resection rates; however, further study will be warranted to apply these intensified strategies in clinical practice.

Author Information

*Department of Internal Medicine, Asan Medical Center

Departments of Oncology

Surgery

§Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine

Departments of Medical Oncology

Radiation Oncology

#Colorectal Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul

**Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea

Y.S.H. and T.W.K. are designated as joint corresponding authors.

Supported by a grant of the Korea Health 21 R&D Project Ministry of Health and Welfare and Family Affairs, Republic of Korea (HI06C0868), the Korea Health Technology R&D Project Ministry of Health & Welfare, Republic of Korea (HI14C1731), and the Asan Institute for Life Sciences, Asan Medical Center, Seoul, Republic of Korea (2015-0753).

The authors declare no conflicts of interest.

Reprints: Tae Won Kim, MD, PhD, Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, Korea. E-mail: twkimmd@amc.seoul.kr.

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