P-249 - Safety analysis of FOLFOX as adjuvant chemotherapy for stage III colon cancer in phase II study (NORTH/HGCSG1003) - an analysis of surgeons vs oncol...

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anticancer agents
Colon and Rectal Cancer
Therapy
Biological therapy
Presenter I. Iwanaga
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors I. Iwanaga1, S. Yuki1, H. Fukushima2, N. Takahashi2, T. Shichinohe1, T. Kusumi3, F. Nakamura4, S. Sogabe5, K. Hatanaka6, K. Oomori7, K. Misawa8, N. Senmaru9, K. Iwai10, T. Shinohara11, M. Koike12, K. Miyashita13, T. Amano2, Y.M. Ito14, N. Sakamoto1, A. Taketomi2, S. Hirano1, Y. Komatsu2
  • 1Japanese Red Cross Kitami Hospital, Kitami/JP
  • 2Hokkaido University Hospital, Sapporo/JP
  • 3Keiyukai Sapporo Hospital, Sapporo/JP
  • 4Teine Keijinkai Hospital, Sapporo/JP
  • 5Kushiro Rosai Hospital, Kushiro/JP
  • 6Hakodate Municipal Hospital, Hakodate/JP
  • 7Keiwakai Ebetsu Hospital, Ebetsu/JP
  • 8Sapporo City General Hospital, Sapporo/JP
  • 9Steel Memorial Muroran Hospital, Muroran/JP
  • 10Oji General Hospital, Tomakomai/JP
  • 11Hokkaido Cancer Center, Sapporo/JP
  • 12KKR Sapporo Medical Center, Sapporo/JP
  • 13Aiiku Hospital, Sapporo/JP
  • 14Hokkaido University Graduate School of Medicine, Sapporo/JP

Abstract

Introduction

The efficacy of oxaliplatin (l-OHP)-containing regimens were confirmed in large randomized phase III trials in which they were superior to fluorouracil and leucovorin as adjuvant setting for patients with stage III colon cancer. In Japan, not only medical oncologists but also surgeons practice chemotherapy. In this analysis, we investigated differences in adverse events and relative dose intensity (RDI) between surgeons and medical oncologists from NORTH/HGCSG1003 study.

Methods

NORTH/HGCSG1003 is a multicenter phase II study. This study enrolled patients with resected stage III colon cancer. Patients received FOLFOX4 or mFOLFOX6 repeated every 2 weeks for 12 cycles. Primary endpoint is disease-free survival, and secondary endpoints were overall survival, safety, RDI and so on. In this analysis, pts characteristics and safety were compared using Fisher's exact test. Dose intensity was compared using Student's t-test, and cumulative incidence of peripheral sensory neuropathy using log-rank test.

Results

From September 2010 to March 2013, 273 patients at 28 institutions were enrolled. In the safety analysis set (n = 265), 160 patients were treated with chemotherapy by medical oncologists (group O) and 105 patients by surgeons (group S). Patients' characteristics between two groups were well balanced except for bowel obstruction before surgery (8.8% in group O vs 23.8% in group S; p = 0.001). Median RDI (group O vs group S) of l-OHP was 0.632 vs 0.751 (p < 0.001) and that of bolus 5-FU was 0.641 vs 0.797 (p < 0.001). The difference in completion treatment rate of 12 cycles between two groups was not statistically significant (83.1% vs 76.2%; p = 0.206).

Conclusion

RDI of l-OHP and bolus 5-FU were significantly lower in group O than group S. There was no significant difference in adverse events. Less l-OHP dosing until presence of peripheral neuropathy was administered in group O than group S. We have a plan to analyze the efficacy after the further follow up.