Neoadjuvant CAPOX and bevacizumab alone for locally advanced rectal cancer: long-term results from the N-SOG 03 trial

  • Akihiro Tomida
  • Keisuke UeharaEmail author
  • Kazuhiro Hiramatsu
  • Atsuyuki Maeda
  • Eiji Sakamoto
  • Yoshito Okada
  • Yasuhiro Kurumiya
  • Goro Nakayama
  • Masanao Nakamura
  • Toshisada Aiba
  • Masato Nagino
  • Of the Nagoya Surgical Oncology Group
Original Article



Neoadjuvant chemotherapy (NAC) alone for locally advanced rectal cancer (LARC) remains an experimental treatment, and the efficacy in terms of long-term outcome has not been fully elucidated. The N-SOG 03 trial examined the safety and efficacy of neoadjuvant CAPOX and bevacizumab (Bev) without radiotherapy in patients with poor-risk LARC.


Thirty-two patients with MRI-defined LARC received neoadjuvant CAPOX and Bev followed by curative resection between 2010 and 2011. The overall survival (OS), progression-free survival (PFS), and local-relapse rate (LRR) were calculated using the Kaplan–Meier method, and the risk factors were evaluated by multivariate analysis using the Cox proportional hazard models. This trial is registered with UMIN, number 000003507.


In the entire cohort, the 5-year OS was 81.3%. Because of disease progression during chemotherapy, 3 patients ultimately did not undergo curative surgery. As a result, 29 patients underwent R0/1 resection. Among these 29 patients, the 5-year OS, PFS, and LRR were 89.7%, 72.4% and 13.9%, respectively. In multivariate analysis, cT4b tumor was an independent poor prognostic factor for OS and LRR, and ypT4b tumor and absence of N down-staging were independent poor prognostic factors for PFS.


Patients with cT4b tumor were not suitable for NAC alone. However, the long-term outcomes of the other patients were satisfactory, and NAC alone might be an option for treatment of LARC. N down-staging was likely to bring favorable PFS, even in patients with cStage III.


Rectal cancer Neoadjuvant chemotherapy Phase II trial Outcome 



We are grateful to many other members of the Nagoya Surgical Oncology Group during the study.


We have no funding support.

Compliance with ethical standards

Conflict of interest

All authors declare no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.


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Copyright information

© Japan Society of Clinical Oncology 2018

Authors and Affiliations

  • Akihiro Tomida
    • 1
  • Keisuke Uehara
    • 1
    Email author
  • Kazuhiro Hiramatsu
    • 2
  • Atsuyuki Maeda
    • 3
  • Eiji Sakamoto
    • 4
  • Yoshito Okada
    • 5
  • Yasuhiro Kurumiya
    • 6
  • Goro Nakayama
    • 7
  • Masanao Nakamura
    • 8
  • Toshisada Aiba
    • 1
  • Masato Nagino
    • 1
  • Of the Nagoya Surgical Oncology Group
  1. 1.Division of Surgical Oncology, Department of SurgeryNagoya University Graduate School of MedicineNagoyaJapan
  2. 2.Department of SurgeryToyohashi Municipal HospitalToyohashiJapan
  3. 3.Department of SurgeryOgaki Municipal HospitalGifuJapan
  4. 4.Department of SurgeryNagoya Daini Red Cross HospitalNagoyaJapan
  5. 5.Department of SurgeryHanda City HospitalHandaJapan
  6. 6.Department of SurgeryToyota Kosei HospitalToyotaJapan
  7. 7.Department of Gastroenterological SurgeryNagoya University Graduate School of MedicineNagoyaJapan
  8. 8.Department of GastroenterologyNagoya University Graduate School of MedicineNagoyaJapan

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