Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Updated analysis: observational cohort study of 1st line bevacizumab combined with chemotherapy in metastatic colorectal cancer (HGCSG0802): Comparison of infusional FU/oxaliplatin (OX) + BV and oral FU/OX + BV

Date

19 Dec 2015

Session

Poster presentation 1

Presenters

Yoshito Komatsu

Citation

Annals of Oncology (2015) 26 (suppl_9): 42-70. 10.1093/annonc/mdv523

Authors

Y. Komatsu1, S. Yuki2, H. Nakatsumi1, K. Sawada2, K. Hatanaka3, T. Kato4, T. Meguro4, M. Nakamura5, I. Iwanaga6, M. Uebayashi6, M. Tateyama7, K. Eto8, M. Kudo9, K. Kato10, H. Okuda11, S. Sogabe12, T. Miyagishima12, K. Miyashita13, N. Sakamoto2, Y. Sakata14

Author affiliations

  • 1 Cancer Center, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 2 Gastroenterology And Hepatology, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 3 Gastroenterology, Hakodate Municipal Hospital, Hakodate/JP
  • 4 Internal Medicine, Hokkaido Gastroenterology Hospital, Sapporo/JP
  • 5 Gastroenterology, Sapporo City General Hospital, 060-8604 - Sapporo/JP
  • 6 Medical Oncology, Japanese Red Cross Kitami Hospital, Kitami/JP
  • 7 Internal Medicine, Tomakomai Nisshou Hospital, Tomakomai/JP
  • 8 Gastroenterology, Tomakomai City Hospital, Tomakomai/JP
  • 9 Gastroenterology, Sapporo Hokuyu Hospital, Sapporo/JP
  • 10 Gastroenterology, Iwamizawa Municipal General Hospital, Iwamizawa/JP
  • 11 Medical Oncology, Keiyukai Sapporo Hospital, 003-0027 - Sapporo/JP
  • 12 Medical Oncology, Kushiro Rosai Hospital, Kushiro/JP
  • 13 Gastroenterology, Aiiku Hospital, Sapporo/JP
  • 14 Ceo, Misawa City Hospital, 033-0022 - Misawa/JP
More

Resources

Aim/Background

Some studies had reported that oral FU/Oxaliplatin (OX) was non-inferior to infusional FU/OX as 1st line treatment for metastatic colorectal cancer (mCRC). We conducted observational cohort study (HGCSG0802) which investigated Japanese patients (pts) treated with bevacizumab (BV) containing regimen. Therefore, we had performed analysis in order to investigate whether there was a difference in safety and efficacy of infusional FU/OX (mFOLFOX6 + BV: iFU) and oral FU/OX (CapeOX/SOX + BV: oFU) using the HGCSG0802 database.

Methods

The key eligibility criteria of HGCSG0802 were with evaluable lesions, older than 20 years, ECOG PS 0-2, and this analysis used the cohort treated with OX-based regimens. In this analysis, pts characteristics, RR and safety were compared using Fisher's exact test. PFS, TTF and OS were compared using log-rank test for comparison of the iFU and oFU.

Results

Of 108 pts (the full analysis set), 95 pts were evaluable for treated with OX-based regimens. Forty-eight pts (50.5%) were treated with iFU and 47 pts (49.5%) were treated with oFU (CapeOX + BV 42 pts/SOX + BV 5 pts). The pts characteristics between those were generally balanced except for PS 0-1 (72.9% in iFU/93.6% in oFU; p = 0.012) and synchronous liver metastases (93.8% in iFU/78.8% in oFU; p = 0.040). Adverse events ≥ Grade 3 were balanced except for leucopenia (25.0% in iFU versus 2.1% in oFU; p = .002) and neutropenia (43.5% in iFU and 10.9% in oFU; p = .001). Hand-foot skin reaction was not different between two cohorts. RR was 62.5% in iFU versus 71.1% in oFU (p = 0.835). The median PFS was 8.3 months in iFU versus 8.2 months in oFU (p = 0.970) and median OS was 18.3 months in iFU versus 23.5 months in oFU (p = 0.247).

Conclusions

As a result of this analysis, in Japanese daily practice, efficacy was no significant difference between iFU and oFU, and the profiles of adverse events varied from each regimens. This analysis had been presented at the European Cancer Congress 2015 (Nakatsumi H, et al. Abstract number was 2 092).

Clinical trial identification

Disclosure

Y. Komatsu: Honoraria: Yakult Honsha Co., Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd. Research fund: Yakult Honsha Co., Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd. Y. Sakata: Honoraria: Daiichi Sankyo Co., Ltd., Yakult Honsha Co., Ltd. All other authors have declared no conflicts of interest.

Resources from the same session

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings