Prognostic significance of real-world (RW) recurrence patterns after resection or ablation of early-stage hepatocellular carcinoma (HCC): Insights from the US Medicare population.

person Shishir K. Maithel Division of Surgical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA info_outline Shishir K. Maithel, Rongrong Wang, Joanna Harton, Adam C. Yopp, Shimul Shah, Flavio G. Rocha, Sairy Hernandez, Spencer Cheng, Sarika Ogale, Amie Tan

Authors person Shishir K. Maithel Division of Surgical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA info_outline Shishir K. Maithel, Rongrong Wang, Joanna Harton, Adam C. Yopp, Shimul Shah, Flavio G. Rocha, Sairy Hernandez, Spencer Cheng, Sarika Ogale, Amie Tan Organizations Division of Surgical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, Genentech, Inc., South San Francisco, CA, Genesis Research Group, Hoboken, NJ, Division of Surgical Oncology, UT Southwestern Medical Center, Dallas, TX, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH, Department of Surgical Oncology, Oregon Health & Science University, Portland, OR Abstract Disclosures Research Funding Genentech Inc Background: The prognosis after curative-intent resection or ablation of early-stage HCC remains poor, largely due to high rates of recurrence. We aimed to characterize real-world recurrence patterns and determine whether the timing of recurrence was associated with overall survival (OS). Methods: Patients (pts) with early-stage HCC who underwent resection and/or ablation were identified from the SEER-Medicare database (2010-2019). Pts who received liver transplant were excluded. A proxy for recurrence was defined as the receipt of new HCC treatments (surgery, locoregional therapy, systemic therapy) or a secondary malignant neoplasm claim (excluding liver). Pseudo-recurrence dates were assigned to pts without recurrence to match the distribution of time between initial resection/ablation and recurrence in the recurrence cohort, to avoid immortal time bias. Early vs late recurrence was defined as occurring within 1 year vs after 1 year of initial resection/ablation. Primary outcome was OS as measured both from the time of recurrence/pseudo-recurrence and initial resection/ablation. Results: 1,146 eligible pts with early-stage HCC were identified. 63% were male, mean age was 74 yrs, and initial therapy was resection (39%), ablation (50%), or both (11%). 736 (64%) experienced recurrence. Among them, 53% received ablation, 37% surgery, and 11% received both. Median OS from recurrence or pseudo-recurrence was 22 months (mo) vs 67 mo (p < 0.001) for pts with vs without recurrence, respectively. When measured from resection/ablation date, median OS was 39 mo vs 83 mo (p < 0.001). After adjusting for relevant demographic and clinico-pathologic factors, including type of index therapy, in a multivariable Cox regression model, recurrence remained significantly associated with an increased risk of death (hazard ratio [HR]: 2.24; 95% CI: 1.85-2.71; p < 0.001). Among pts who recurred, 380 (52%) had early recurrence and 356 (48%) had late recurrence. Median OS from recurrence was 17 mo vs 30 mo (p < 0.001) for early vs late recurrence, respectively, and 23 mo vs 63 mo when measured from resection/ablation The adjusted HR for the risk of death associated with early recurrence was 1.39 (95% CI: 1.14-1.68; p < 0.001) compared to late recurrence. Other significant prognostic factors associated with reduced OS included larger tumor size ( > = 5cm), greater extent of disease, and poor differentiation (grade III and above). Conclusions: In this study among US Medicare pts, early recurrence within one year after curative-intent treatment of early-stage HCC was significantly associated with decreased OS compared to pts who recur later or without recurrence. This highlights the need for developing and utilizing effective adjuvant therapy regimens to delay or avoid recurrence.