BackgroundThe clinical benefit of cetuximab combined with oxaliplatin-based chemotherapy remains under debate. The aim of the present multicenter open-label Phase II study was to explore the efficacy and safety of biweekly administration of cetuximab and mFOLFOX-6 or XELOX as first-line chemotherapy in patients with metastatic colorectal cancer.MethodsSixty-two patients with previously untreated KRAS/BRAF wild-type metastatic colorectal cancer were recruited to the study between April 2010 and May 2011. Patients received one of two treatment regimens, either cetuximab plus mFOLFOX-6 (FOLFOX + Cmab) or cetuximab plus biweekly XELOX (XELOX + Cmab), according to their own preference. Treatment was continued until disease progression or the appearance of intolerable toxicities. The primary endpoint was response rate; secondary endpoints were progression-free survival, overall survival, disease control rate, dose intensity, conversion rate to surgical resection, and safety.ResultsThe response rates in the FOLFOX + Cmab (n = 37) and XELOX + Cmab (n = 25) groups were 64.9 % (24/37) and 72.0 % (18/25), respectively. The median PFS in the FOLFOX + Cmab and XELOX + Cmab groups was 13.1 months (95 % confidence interval [CI] 12.1–17.5) and 13.4 months (95 % CI 10.1–17.9), respectively. Neutropenia was the most frequent grade 3/4 adverse event in both groups (33.9 %), followed by anorexia, acneiform eruption, skin fissure and paronychia. A waterfall plot of tumor diameter showed prominent shrinkage of the tumors in 88.7 % of patients.ConclusionsThe results of the present study indicate that biweekly cetuximab plus mFOLFOX-6/XELOX is an effective and tolerable treatment regimen. Biweekly administration of cetuximab requires only one hospital visit every 2 weeks, and may become a convenient treatment option for patients with KRAS/BRAF wild-type metastatic colorectal cancer.Trial registrationThis study is registered with University Hospital Medical Information Network (UMIN 000003253). Registration date is 02/24/2010.Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-015-1685-z) contains supplementary material, which is available to authorized users.

: A 69-year-old man with a right inguinal mass was admitted on January 23, 2002. He underwent an ileocecal excision for treatment of cecum cancer (pT3 N1 MO) in December 2000. The mass contained a cystic component and had a saccular tumor protruding from the inner wall. The operative findings revealed that the mass extruded from the external inguinal ring, and a modified Bassini's operation was performed on February 1, 2002. The cystic component was completely separated from the peritoneal cavity, and was found to contain high levels of CEA and CA19-9. Pathological examination revealed that this saccular tumor was an adenocarcinoma similar to that seen in cecum cancer. Saccular tumors originating from cecum cancer are very rare and the prognosis is usually poor. However, the prognosis for the case reported in this study was favorable, and recurrence was still not seen 33 months after surgery. The possibility of peritoneal metastasis should be considered in inguinal hernia patients with a history of intraperitoneal malignancy.

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