title: Assessment of Tumor Response and Resection Rates in Unresectable Colorectal Liver Metastases Following Neoadjuvant Chemotherapy with Cetuximab.
abstract: To investigate efficacy and safety of cetuximab combined with neo adjuvant chemotherapy regimen in patients with unresectable colorectal liver. This was a prospective trial with rate of Ro liver metastases resection as primary end point. Between January 2010 and December 2014, 46 patients with unresectable liver metastases from colon or rectum were enrolled. Patients received Cetuximab along with neoadjuvant chemotherapy where 34 (74 %) and 12 (2 6 %) patients received FOLFOX and FOLFIRI, respectively. They were assessed for response after 2-3 cycles by CT scan. Patients with resectable disease were offered liver surgery within 3-6 weeks of the last treatment cycle. The primary end point was resection rate of liver metastases, which was evaluated in all patients. Secondary end points were response rate according to Response evaluation criteria in solid tumors (RECIST) criteria, perioperative morbidity and mortality. An objective response was observed in 28 (60.9 %) patients. Seven (15.2 %) patients were reported radiologically to have a complete response (CR); 21 (45.7 %) patients had radiological partial response (PR). An additional 12 patients (26.1 %) demonstrated stable disease (SD) and only six patients (13.0 %) had disease progression (PD). Microscopically complete resections (R0 resection) was performed in all 28 patients (60.9 %). The most frequent toxicities were skin rash and diarrhoea. There was no operative mortality. Chemotherapy with cetuximab yields high response rates compared with historical controls, and leads to significantly increased resectability. Complete resection of previously unresectable colorectal liver metastases can be performed with minimal morbidity and mortality. This therapeutic strategy involves a multimodal approach.
authors.affiliation: Manipal Comprehensive Cancer Center, Business Advisory Board of MHEPL Manipal Hospital, Bangalore, 560017 India.
authors.forename: S P
authors.initials: SP
authors.lastname: Somashekhar
authors.affiliation: Manipal Comprehensive Cancer Centre, No 8, second Anjaneya temple street Seshadripurum, Bangalore, 560020 India.
authors.forename: K R
authors.initials: KR
authors.lastname: Ashwin
authors.affiliation: Department of Surgical Oncology, Manipal Comprehensive Cancer Centre, #98 HAL airport road, Bangalore, 560017 India.
authors.forename: Shabber S
authors.initials: SS
authors.lastname: Zaveri
authors.affiliation: Department of Medical Oncology, Manipal Comprehensive Cancer Centre, #98 HAL airport road, Bangalore, 560017 India.
authors.forename: Amit
authors.initials: A
authors.lastname: Rauthan
authors.affiliation: Department of Medical Oncology, Manipal Comprehensive Cancer Centre, #98 HAL airport road, Bangalore, 560017 India.
authors.forename: Poonam
authors.initials: P
authors.lastname: Patil
keywords: Cetuximab; Colorectal; Indian study; Liver metastases; mCRR