A phase II clinical trial utilizing maximum medical and surgical cytoredutive treatments for patients with metastatic colorectal cancer to the liver

Abstract

e15130 Background: The median overall survival (‘OS‘) for patients with mCRC treated with chemotherapy is about 20.4 months. Combination chemotherapy with surgical cytoreduction for patients with liver metastases are evaluated in a phase II clinical trial. Methods: Patients with newly diagnosed mCRC to the liver or recurrent CRC after 5FU failure were consented to receive further chemotherapy with at least irinotecan-based chemotherapy, oxaliplatin-based chemotherapy, and with the intention to treat the liver metastases with either RFA and/or liver resection between chemotherapy regimens whenever possible. Bevacizamab and cetuximab were considered options for treatment after their respective FDA approvals. Chemotherapy was given until there was treatment failure. The primary endpoint was OS. Results: Between 2001 and 2004 thirty-seven patients aged 41 to 79 were consented. One remained alive by December 2008. Only patients with an ECOG performance status of 0–1 were consented. Twenty had been treated with 5FU for a stage III CRC befored developing mCRC. All patients received irinotecan in the form of FOLFIRI, IFL, or as a single agent. Thirty-six also received oxaliplatin in the form of either FOLFOX4 or 6. Twenty-two patients received cetuximab as a single agent. Some regimens were augmented with bevacizumab. Fourteen patients could not undergo resection or RFA because of performance status or progression. Three required radiation to the CNS or distant bone. There were eleven patients who underwent RFA of at least one liver metastasis. There were ten patients who underwent liver resection. One patient underwent both RFA and liver resection at two different times. Another patient underwent RFA, adrenalectomy and wedge resection of the lung at three different times. He remained alive at 78 months at the time of submission. Median OS was 34.5+ months at the time of submission. Patient survival ranged from 15 to 86 months. There were no deaths associated with any surgical intervention. Conclusions: OS was improved in mCRC patients or recurrent CRC patients who had potentially ablatable or resectable liver lesions at the time of their diagnosis and who were treated with available aggressive medical and surgical therapies. [Table: see text]