Meeting
2016 Gastrointestinal Cancers Symposium
Updated analysis of phase II trial of irinotecan/s-1/cetuximab (IRIS/Cet) as second-line treatment in patients with KRAS exon2 wild type metastatic colorectal cancer (mCRC): HGCSG0902—Comparison of administration interval in cetuximab treatment.
Authors
Tomohiro Kondo
KKR Tonan Hospital, Sapporo, Japan
Tomohiro Kondo , Satoshi Yuki , Yasuyuki Kawamoto , Yasushi Tsuji , Ayumu Hosokawa , Michio Nakamura , Osamu Muto , Takashi Kato , Ichiro Iwanaga , Atsushi Sato , Kazunori Eto , Kouichi Furukawa , Hideyuki Hayashi , Miki Tateyama , Yasuo Takahashi , Susumu Sogabe , Takuya Honda , Yuh Sakata , Yoshito Komatsu
Organizations
KKR Tonan Hospital, Sapporo, Japan, Hokkaido University Hospital, Sapporo, Japan, Department of Gastroenterology, Sapporo Medical Center, Sapporo, Japan, Department of Medical Oncology, Tonan Hospital, Sapporo, Japan, Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, Japan, Department of Gastroenterology, Sapporo City General Hospital, Sapporo, Japan, Department of Medical Oncology, Japanese Red Cross Akita Hospital, Akita, Japan, Department of Internal Medicine, Hokkaido Gastroenterology Hospital, Sapporo, Japan, Department of Medical Oncology, Japanese Red Cross Kitami Hospital, Kitami, Japan, Department of Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan, Department of Gastroenterology, Tomakomai City Hospital, Tomakomai, Japan, Niigata City General Hospital, Niigata, Japan, Department of Gastroenterology, Abashiri-Kosei General Hospital, Abashiri, Japan, Department of Medical Oncology, Tomakomai Nisshou Hospital, Tomakomai, Japan, Department of Gastroenterology, Hokkaido Cancer Center, Sapporo, Japan, Department of Medical Oncology, Kushiro Rosai Hospital, Kushiro, Japan, Department of Gastroenterology and Hepatology, Nagasaki University Hospital, Nagasaki, Japan, Misawa City Hospital, Misawa, Japan, Hokkaido University Hospital Cancer Center, Sapporo, Japan
Research Funding
Other Foundation
Background: HGCSG0902 is the multicenter phase II study to investigate the safety and efficacy of irinotecan, S-1 (IRIS) plus cetuximab as second line treatment in patients with KRAS exon2 wild type mCRC. Response rate (RR) was 33.3% (95%CI 20.8-45.9%), therefore primary endpoint was met (Muto O, et al. ESMO 2014). Here we report an exploratory analysis of outcomes based on administration interval of cetuximab (every week [EW] vs bi-weekly [BW]). Methods: Eligibility includes histologically confirmed mCRC, previously received oxaliplatin-contained chemotherapy, PS: 0-1, EGFR positive and KRAS exon2 wild type. Patients received S-1 80-120 mg/day p.o. on days 1-14 and irinotecan 100mg/m2 on day 1 and 15 repeated every 28 days. Cetuximab was administrated 400mg/m2 as loading dose and continued 250mg/m2 every week or 500mg/m2 bi-weekly. The primary endpoint was RR and the secondary endpoints were disease control rate, PFS, OS and safety. To compare with EW and BW, Fisher’s exact test was used in terms of patient characteristics, AE, RR, and Log-rank test was used in terms of PFS and OS. Results: Between Mar 2010 and Sep 2013, 58 pts were enrolled. One patient was not administered (57 pts were safety analysis set), and 3 pts were ineligible (54 pts were efficacy analysis set). Based on each physician’s choice, 34 patients of EW and 23 of BW were included in the full safety analysis set. RR was 34.4% in the EW and 31.8% in the BW (p = 1.000). Median PFS was 4.2 months in the EW and 6.1 months in the BW (HR 0.752, p = 0.350). Median OS was 8.9 months in the EW and 10.7 months in the BW (HR 0.902, p = 0.737). The most common non-hematological adverse events of grade 3 or higher were diarrhea (23.5% in the EW vs 52.2% in the BW: p = 0.005) and stomatitis (2.9% in the EW vs 30.4% in the BW group: p = 0.046), these were significantly more common in the BW. Conclusions: IRIS/Cet appeared to be highly effective with RR, PFS and OS in the both treatment schedule. Diarrhea and stomatitis were significantly more common in the BW. Therefore, in case of treatment with IRIS/Cet should be administered in the EW. Clinical trial information: UMIN000004882.
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session C: Cancers of the Colon, Rectum, and Anus
Track
Cancers of the Colon, Rectum, and Anus
Sub Track
Multidisciplinary Treatment
Clinical Trial Registration Number
UMIN000004882
Citation
J Clin Oncol 34, 2016 (suppl 4S; abstr 771)
DOI
10.1200/jco.2016.34.4_suppl.771
Abstract #
771
Poster Bd #
O2
Abstract Disclosures
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