Dose-finding study of hepatic arterial infusion of oxaliplatin-based treatment in patients with advanced solid tumors me
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ORIGINAL ARTICLE
Dose-finding study of hepatic arterial infusion of oxaliplatin-based treatment in patients with advanced solid tumors metastatic to the liver Apostolia M. Tsimberidou • Mark B. Leick • Joann Lim • Siqing Fu • Jennifer Wheler • Sarina A. Piha-Paul • David Hong • Gerald S. Falchook • Aung Naing • Ishwaria M. Subbiah Adoneca Fortier • Rony Avritscher • Razelle Kurzrock
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Received: 7 September 2012 / Accepted: 16 October 2012 / Published online: 11 November 2012 Ó Springer-Verlag Berlin Heidelberg 2012
Abstract Background Liver metastases in patients with cancer are associated with poor survival. We hypothesized that hepatic arterial infusion (HAI) of oxaliplatin combination therapy would have antitumor activity in these patients. Patients and methods Patients with advanced cancer and predominant liver metastases were treated on a phase I study of HAI oxaliplatin in combination with systemic bevacizumab, with or without HAI or systemic fluorouracil and/or leucovorin and/or cetuximab. Patients were divided into two treatment arms according to KRAS mutational status and physician choice. A ‘‘3 ? 3’’ design was used. Results Among 76 patients (median age 61 years; 34 women; median number of prior therapies 4), the most common cancer was colorectal (CRC) (n = 58). Overall, the only dose-limiting toxicity was Grade 3 diarrhea (n = 2). The most common treatment-related toxicities were hypertension (n = 40), nausea (n = 29), fatigue (n = 28), and transaminitis (n = 26). Of 76 patients, one (1 %) had a complete response (CR), 12 (16 %) had a partial response (PR), and 12 (16 %) had SD for C6 months (total CR/PR/SD C6 months 25/76 = 33 %). In CRC (n = 58), total CR/PR/SD C6 months was 31 %
A. M. Tsimberidou (&) M. B. Leick J. Lim S. Fu J. Wheler S. A. Piha-Paul D. Hong G. S. Falchook A. Naing I. M. Subbiah A. Fortier R. Kurzrock Phase I Program, Department of Investigational Cancer Therapeutics, Unit 455, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA e-mail: [email protected] R. Avritscher Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
(n = 18). Both patients with pancreatic neuroendocrine tumors achieved a PR (24? months) and a CR (6? months). Time to treatment failure (TTF) on the current regimen was 3.5 versus 2.8 months on patients’ prior systemic treatment (p = 0.37). Conclusions HAI oxaliplatin combination therapy with 5-fluorouracil, leucovorin, bevacizumab, and/or cetuximab was well tolerated and had antitumor activity in selected heavily pretreated patients with predominant liver disease. Keywords
Liver Cancer Metastases Infusion
Introduction Treatment outcomes for patients with metastatic colorectal cancer (CRC) have improved over the last 20 years. The overall survival is 5 months with supportive care [1] and [20 months with recent regimens [2]. Approximately 50 % of patients with CRC develop liver metastases (liver as single metastatic site 30 %) [3, 4
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