Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 3107
© 2004 American Society of Clinical Oncology

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Abstract

Novel methodology of response assessment in hepatocellular carcinoma (HCC) -Assessing response by change in tumor enhancement in distinction from conventional means

Memorial Sloan-Kettering Cancer Center, New York, NY; Bayer Pharmaceuticals, West Haven, CT

3107

Background: The use of anti-angiogenesis agents in HCC may impact on tumor morphology in a manner that is different from what is seen with standard cytotoxic therapies. Tumor necrosis (TN), as evidenced by a decrease in Hounsfeld unit values on IV contrast-enhanced CT scans (IVCT), may better reflect response to therapy than conventional methods, such as undimensional and bidimensional measurements. We developed a semi-automated computerized technique for quantifying TN on IVCT. We then compared this method with standard determinations of response. Methods: Of the16 pts with HCC enrolled at MSKCC in a multicenter phase II trial of the signal transduction inhibitor BAY 43–9006, 11 were assessable for response and are included in this retrospective study. A dominant hepatic mass or masses were selected at baseline and followed serially every two cycles. Response assessment was calculated with both uni and bi dimensional tumor measurements. The degree of TN was calculated at each time point. All assessments were made by a radiologist blinded to the clinical data. Results: At baseline, mean TN was 9.8% (range 0.4 –33.5%), tumor diameter was 6.4 cm (2.5 –14.2) and cross-product was 28.9 cm2 (5.3 –91.3). At follow up mean TN was 27% (0.7 –75%), tumor diameter was 7.2 cm (1.7 –16.0) and cross-product was 36.9 cm2 (2.1 –162.5). There was poor correlation between TN, change in TN and the conventional uni and bi dimensional methods of response assessment. In particular, cases of tumors that increased in size by diameter and cross product, actually demonstrated apparent increase in TN. Conclusions: These results indicate that the conventional methods of response assessment may not accurately reflect the effect of antiangiogenic agents in HCC. Some patients were removed from study, possibly prematurely, based on the conventional criteria of response assessment, potentially undermining the antitumoral effects of BAY 43–9006. Necrosis may be estimated on IVCT and may serve as a marker of response. Larger scale trials are needed to evaluate the potential correlation between TN and oncologic outcome.

Author Disclosure

Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bayer Pharmaceuticals Bayer Pharmaceuticals Bayer