Observational cohort study of first-line bevacizumab combined with chemotherapy in metastatic colorectal cancer (HGCSG0802): Comparison of infusional FU/oxaliplatin(OX)+BV and oral FU/OX+BV.

Authors

null

Kazuteru Hatanaka

Department of Gastroenterology, Hakodate Municipal Hospital, Hakodate, Japan

Kazuteru Hatanaka , Satoshi Yuki , Hiroshi Nakatsumi , Hiraku Fukushima , Hirohito Naruse , Takashi Kato , Takashi Meguro , Michio Nakamura , Ichiro Iwanaga , Minoru Uebayashi , Miki Tateyama , Kazunori Eto , Mineo Kudo , Sosuke Kato , Hiroyuki Okuda , Susumu Sogabe , Kencho Miyashita , Yuh Sakata , Yoshito Komatsu

Organizations

Department of Gastroenterology, Hakodate Municipal Hospital, Hakodate, Japan, Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan, Department of Cancer Center, Hokkaido University Hospital, Sapporo, Japan, Department of Internal Medicine, Hokkaido Gastroenterology Hospital, Sapporo, Japan, Hokkaido Gastroenterology Hospital, Sapporo, Japan, Department of Gastroenterology, Sapporo City General Hospital, Sapporo, Japan, Department of Gastroenterology, Japanese Red Cross Kitami Hospital, Kitami, Japan, Department of Internal Medicine, Tomakomai Nisshou Hospital, Tomakomai, Japan, Department of Gastroenterology, Tomakomai City Hospital, Tomakomai, Japan, Department of Gastroenterology, Sapporo Hokuyu Hospital, Sapporo, Japan, Department of Gastroenterology, Iwamizawa Municipal General Hospital, Iwamizawa, Japan, Department of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan, Department of Internal Medicine, Kushiro Rosai Hospital, Kushiro, Japan, Department of Gastroenterology, Aiiku Hospital, Sapporo, Japan, Misawa City Hospital, Misawa, Japan, Division of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan

Research Funding

No funding sources reported

Background: A few reports have shown no difference between the efficacy of infusional FU and that of oral FU (Capecitabine/S-1) for colorectal cancer, and some studies have reported the non-inferiority between infusional FU/Oxaliplatin (OX) and oral FU/OX for metastatic colorectal cancer (mCRC). We performed a sub-group comparison between infusional FU/OX (mFOLFOX6 + BV: iFU) and oral FU/OX (CapeOX/SOX + BV: oFU) from the HGCSG0802 observational cohort study with investigated Japanese patients (pts) treated with first line BV for mCRC. Methods: The objective of HGCSG0802 was to evaluate progression-free survival (PFS), overall survival (OS), time to treatment-failure (TTF), response rate (RR), safety and so on. 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 and TTF were compared using log-rank test. 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 (mets) (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=0.002) and neutropenia (43.5% in iFU and 10.9% in oFU; p=0.001). 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=0.835). Conclusions: The HGCSG0802 could be a database to investigate first line BV for mCRC in clinical practice. As a result of this analysis, in Japanese daily practice, efficacy was no significant difference between infusional FU/OX and oral FU/OX, and the profiles of adverse events varied from each regimens.

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Abstract Details

Meeting

2015 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session C: Cancers of the Colon, Rectum, and Anus

Track

Cancers of the Colon, Rectum, and Anus

Sub Track

Prevention, Diagnosis, and Screening

Citation

J Clin Oncol 33, 2015 (suppl 3; abstr 527)

DOI

10.1200/jco.2015.33.3_suppl.527

Abstract #

527

Poster Bd #

A21

Abstract Disclosures