E250: Prospective Evaluation of the Safety and Quality of Life in Patients Receiving Hepatic Artery Infusion Pump Chemotherapy

Hepatic Artery Infusion (HAI) Pump placement and subsequent 6+ months of HAI chemotherapy is an intensive treatment regimen available to select patients with colorectal liver metastasis. The quality of life (QOL) of patients undergoing HAI placement, which is often combined with multiple other major synchronous and staged procedures, and subsequent HAI chemotherapy is unknown. We aimed to evaluate the feasibility of using patient-reported outcome (PRO) surveys to measure the quality of life in patients receiving HAI therapy.

Methods:

Patients scheduled for HAI pump placement in 2022 and 2023 were prospectively enrolled. PROs were collected using NIH-validated survey scales (LASA [Linear Analogue Self-Assessment], PROMIS [Patient-Reported Outcomes Measurement Information System]) preoperatively, on postoperative (POD) days 2, 7, 14, 30, and monthly until 6 months. Complications were prospectively recorded using Clavien-Dindo score.

Results:

After excluding two screen failures who did not undergo surgery, 12 patients were included. Median [IQR] age at time of surgery was 56.0 (45.9-62.2) years. Patients underwent synchronous liver resection (75.0%, n=9), liver ablation (33.3%, n=4) cholecystectomy (91.7%, n=11), and colorectal resections (33.3%, n=4). Median length of stay was 4.5 [3.5-6.0] days. There were no mortalities at 30-days (n=11) or 6-months (n=7). One patient experienced atrial fibrillation (Clavien-Dindo Grade 1) and another experienced a pump site hematoma (Clavien-Dindo Grade 3b). All patients successfully initiated HAI and systemic therapy. Median [IQR] days to starting chemotherapy was 28.0 [14.8, 28.0]. Mean (± std. dev) LASA QOL was 8.0 ± 2.0 preoperatively, 6.4 ± 2.0 on POD 2, 7.2 ± 1.3 at 1 month, 8.2 ±1.3 at 3 months, and 7.9 ± 1.9 at 6 months. 7/11 patients had LASA QOL return to baseline by 3 months and 5/8 by 6 months. LASA pain severity and fatigue scores returned to baseline in 10/11 and 8/11 patients at 3 months, respectively while only 4/11 reported return to baseline social activity at 3 months.  At 6 months 1/8, 7/8, and 4/8 patients reported return to baseline social, pain, and fatigue scores. The recovery trajectory of individual patients across PROMIS and LASA scales is shown in Figure.

Conclusions:

Preliminary results of this ongoing trial suggest that the PROMIS and LASA measures are sensitive tools for evaluating PRO in patient undergoing HAI pump placement and subsequent liver directed therapies. These results support the inclusion of PRO’s such as these in future randomized trials to assess efficacy of HAI chemotherapy.