cholangiocarcinoma (IHC) carries a poor prognosis, with a median overall survival (OS) of 11 months. Hepatic arterial infusion (HAI) of high-dose chemotherapy may have potential benefit in these patients.OBJECTIVE To evaluate clinical outcomes when HAI chemotherapy is combined with systemic chemotherapy in patients with unresectable IHC. DESIGN, SETTING, AND PARTICIPANTSA single-institution, phase 2 clinical trial including 38 patients was conducted with HAI floxuridine plus systemic gemcitabine and oxaliplatin in patients with unresectable IHC at Memorial Sloan Kettering Cancer Center between May 20, 2013, and June 27, 2019. A confirmatory phase 1/2 study using the same therapy was conducted during the same time period at Washington University in St Louis. Patients with histologically confirmed, unresectable IHC were eligible. Resectable metastatic disease to regional lymph nodes and prior systemic therapy were permitted. Patients with distant metastatic disease were excluded.INTERVENTIONS Hepatic arterial infusion of floxuridine and systemic administration of gemcitabine and oxaliplatin. MAIN OUTCOMES AND MEASURESThe primary outcome was progression-free survival (PFS) of 80% at 6 months. RESULTSFor the phase 2 clinical trial at Memorial Sloan Kettering Cancer Center, 42 patients with unresectable IHC were included and, of these, 38 patients were treated (13 [34%] men; median [range] age at diagnosis, 64 [39-81] years). The median follow-up was 30.5 months. Twenty-two patients (58%) achieved a partial radiographic response, and 32 patients (84%) achieved disease control at 6 months. Four patients had sufficient response to undergo resection, and 1 patient had a complete pathologic response. The median PFS was 11.8 months (1-sided 90% CI, 11.1) with a 6-month PFS rate of 84.1% (90% CI, 74.8%-infinity), thereby meeting the primary end point (6-month PFS rate, 80%). The median OS was 25.0 months (95% CI, 20.6-not reached), and the 1-year OS rate was 89.5% (95% CI, 80.2%-99.8%). Patients with resectable regional lymph nodes (18 [47%]) showed no difference in OS compared with patients with node-negative disease (24-month OS: lymph node negative: 60%; 95% CI, 40%-91% vs lymph node positive: 50%; 95% CI, 30%-83%; P = .66). Four patients (11%) had grade 4 toxic effects requiring removal from the study (1 portal hypertension, 2 gastroduodenal artery aneurysms, 1 infection in the pump pocket). Subgroup analysis showed significant improvement in survival in patients with IDH1/2 mutated tumors (2-year OS, 90%; 95% CI, 73%-99%) vs wild-type (2-year OS, 33%; 95% CI, 18%-63%) (P = .01). In the Washington University in St Louis confirmatory cohort, 9 patients (90%) achieved disease control at 6 months; the most common grade 3 toxic effect was elevated results of liver function tests, and median PFS was 12.8 months (1-sided 90% CI, 6.4). CONCLUSIONS AND RELEVANCEHepatic arterial infusion plus systemic chemotherapy appears to be highly active and tolerable in patients with unresectable IHC; further evaluation is warranted.

Combination HAI and SYS is an effective therapy for high-volume unresectable CRLM, resulting in a high rate of resection, long-term survival, and the potential for cure.

Objective In the setting of an inner city, safety net hospital, patient satisfaction with prenatal care conducted via telehealth was compared with in-person visits at the height of the novel coronavirus disease 2019 (COVID-19) pandemic. Study Design Through this cross-sectional study, patients were identified who received at least one televisit and one in-person visit during the COVID-19 pandemic. The Short Assessment of Patient Satisfaction (SAPS) survey was used to measure patient satisfaction. Surveys pertaining to in-person and televisits were conducted at the end of a telephone encounter, and overall satisfaction scores were documented. Patients were excluded if they received in-person or virtual care only and not both. The SAPS score correlated with the degree of patient satisfaction. Results A total of 140 patients were identified who received both virtual and in-person prenatal care from March 1, 2020 to May 1, 2020. One hundred and four patients (74%) agreed to be surveyed: 77 (74%) self-identified as Hispanic and 56 (54%) stated that their primary language was Spanish. The overall median satisfaction score for televisits and in-person visits was 20 (interquartile range [IQR]: 20, 25) and 24 (IQR: 22, 26) (p = 0.008, Z score = 2.651). In patients who self-identified as Hispanic or identified their primary language as Spanish, there was no statistically significant difference in their satisfaction scores. Conclusion While there were lower scores in patient satisfaction for televisits in every category, there were no clinically significant differences since all medians were in the “satisfied” range. By lowering patient exposure to severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), especially for those at risk for reduced access to care and higher COVID-19 cases by zip code, telehealth allowed for appropriate continuation of satisfactory prenatal care with no impact on patient perceived satisfaction of care. Key Points

Background and Objectives Patients who undergo liver resection for metastatic colorectal cancer (mCRC) have reported 5-year survivals ranging from 25-50%. The current study updated long-term survival for patients with resected liver metastases treated with adjuvant hepatic arterial infusion (HAI) and systemic (SYS) chemotherapy. Methods Updated survival and recurrence free survival for patients treated on four consecutive adjuvant protocols with HAI and SYS from 1991 to 2009. Patients were divided into two groups: those treated on protocols before 2003 and after 2003. Median follow-up for all patients was 11 years. Results All 287 patients enrolled in four prospective protocols after liver resection are included. Patients treated before 2003 had a median follow-up of 15 years, 5 and 10-year survivals of 56% [95% CI: 49%-64%] and 40% [95% CI: 32%-47%], respectively, and median survival of 71 months. Patients treated after 2003 had a median follow-up of 9 years, 5 and 10-year survivals of 78% [95% CI: 70%-84%] and 61% [95%CI: 51%-70%], respectively, and median survival has not been reached. Conclusions Survival is improving for patients with mCRC who undergo liver resection. These data support the durability of long-term survival in patients who undergo resection followed by adjuvant HAI and SYS therapy.

OBJECTIVE:To investigate the impact of adjuvant hepatic artery infusion (HAI) in relation to KRAS mutational status in patients with resected colorectal cancer liver metastases (CRLM). BACKGROUND:Patients with KRAS-mutated CRLM have worse outcomes after resection. Adjuvant HAI chemotherapy improves overall survival after liver resection. METHODS:Patients with resected CRLM treated at MSKCC with and without adjuvant HAI who had available KRAS status (wild-type, WT; mutated, MUT) were reviewed from a prospectively maintained institutional database. Correlations between KRAS status, adjuvant HAI, clinical factors, and outcomes were analyzed. Cox proportional hazard model was used to adjust for confounders. RESULTS:Between 1993-2012, 674 patients (418 KRAS-WT, 256 MUT) with a median follow up of 6.5 years after resection were evaluated. Fifty-four percent received adjuvant HAI. Tumor characteristics (synchronous disease, number of lesions, clinical-risk score, 2-stage hepatectomy) were significantly worse in the HAI group, however, there were more patients with resected extrahepatic metastases in the no-HAI group. In KRAS-WT tumors, 5-year survival was 78% for patients treated with HAI vs 57% for patients without HAI (HR 0.51, p<0.001). In KRAS-MUT tumors, 5-year survival was 59% for patients treated with HAI vs. 40% for patients without HAI (HR 0.56, p<0.001). On multivariate analysis, HAI remained associated with improved OS (HR 0.53, p<0.002) independent of KRAS status and other clinico-pathologic factors.