P-246 - Feasibility study of sequential adjuvant chemotherapy with three months oxaliplatin-based regimen followed by three months capecitabine in patients...

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anticancer Agents
Colon and Rectal Cancer
Biological Therapy
Presenter H. Tanioka
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors H. Tanioka1, A. Tsuji2, K. Yamashita1, H. Okumura3, Y. Oka3, A. Tsuruta3, M. Inukai4, T. Yamakawa5, T. Yamatsuji6, M. Yoshimitsu7, K. Toyota8, T. Yamano9, Y. Yamamoto10, T. Nagasaka11, M. Okajima12
  • 1Okayama Rosai Hospital, Okayama/JP
  • 2Kobe City Medical Center General Hospital, Kobe/JP
  • 3Kawasaki Medical School Hospital, Kurashiki/JP
  • 4Kagawa University Hospital, Kida-gun/JP
  • 5Kagawa Prefectural Central Hospital, Takamatsu/JP
  • 6Kawasaki Medical School, Okayama/JP
  • 7Hiroshima City Asa Hospital, Hiroshima/JP
  • 8National Hospital Organization Higashihirosima Medical Center, Higashihirosima/JP
  • 9Kurashiki Medical Center, Kurashiki/JP
  • 10Ehime University Hospital, Touon/JP
  • 11Okayama University Hospital, Okayama/JP
  • 12Hiroshima City Hospital, Hiroshima/JP



Six months oxaliplatin (OX)-based chemotherapy (modified FOLFOX6 or CAPOX) is the standard adjuvant chemotherapy for completely resected stage III colorectal cancer (CRC) in Japan. OX induced neurotoxicity is well known to be appeared by dose-dependently and progresses to irreversible in some cases. In this study, we prospectively investigated the feasibility of sequential approach with three months OX-based regimen followed by three months capecitabine in Japanese patients with stage III CRC, in addition to high-risk stage II CRC.


CRC patients with completely resected stage III and high risk stage II, aged over 20 years and PS 0-1 were eligible for this study. Patients were treated with mFOLFOX6 or CAPOX for 3 months followed by capecitabine (2500mg/m2 on day1-14, q 3 weeks) for 3 months. Primary endpoint was the frequency and the grade of OX-induced neurotoxicity evaluated by physician-based CTCAE grading and patient-based scale, self-reported questionnaires (Patient Neurotoxicity Questionnaire: PNQ). Secondary endpoints were proportion of completion of OX-based therapy and all treatments of adjuvant chemotherapy.


Between March 2011 and March 2014, 91 patients were enrolled and 86 patients (male/female, 49/37: median age, 65 years (range36-81): PS 0/1, 81/5) were assessed. 84% of patients completed the planned OX-based therapy for 3 months and then 63% of patients completed the all treatments for 6 months. The Median dose of OX received was 479 mg/m2. The overall incidence of CTCAE grade 3-4 peripheral sensory and motor neuropathy were 3.5% and 1.2% respectively. In sensory component, the frequency of PNQ (Grade C-E) and CTCAE (Grade2-4) at 1.5, 3, 6 month were 11.3%, 22.1%, 29.4% and 5.3%, 4.4%, 11.3%, respectively (Spearman correlation coefficient: 0.47).


Sequential approach for adjuvant chemotherapy with three months OX-based regimen followed by three months capecitabine was a tolerant feasible regimen with low incidence of neuropathy. Our findings suggested that PNQ could detect OX sensory neurotoxicity with the higher sensitivity than CTCAE. Clinical trial information: UMIN000004934