Maternal anthropometric measurements and correlation to maternal and fetal outcomes in late pregnancy.

BACKGROUND: Body mass index does not distinguish between lean and fat body mass; therefore, its utility defining body composition is limited in pregnancy. Anthropometric measurements may better represent variation in body composition among women who are overweight or obese. We sought to examine body fat composition using maternal anthropometric measurements in late pregnancy and correlate with mode of delivery. METHODS: A prospective study of pregnant patients who were overweight (body mass index: 25-29.9 kg/m2) or obese (body mass index ⩾ 30 kg/m2) with singleton pregnancies who underwent anthropometric measurements between 27 weeks, 0 days to 34 weeks, 6 days gestation. Maternal skinfold thicknesses from eight sites were used to estimate body fat mass. Correlation of skinfold thickness, anthroprometric measurements, and estimated body fat percentage on mode of delivery were analyzed with p < .05 as significant. RESULTS: A total of 41 women with overweight (34.1%) or obese (65.9%) body habitus were included. Mean age was 29.9 years, and the majority (43.9%) were Black and 31.7% identified Hispanic/Latinx. The average gestational age at recruitment was 30 weeks, 2 days and 38 weeks, 6 days at delivery. A greater weight at recruitment (94.2 vs 81.8 kg, p = .023), waist circumference (47.1 vs 43.5 inches, p = .010), Huston-Presley body fat percentage (36.4% vs 31.8%, p = .030), triceps skinfold thickness (20.1 vs 15.7 mm, p = .030), biceps skinfold thickness (18.6 vs 15.0 mm, p = .042), and skinfold thickness, as well as sum of skinfold sites (83.3 vs 68.8 mm, p = .049) were associated with cesarean delivery compared to vaginal delivery on univariate analysis. CONCLUSION: Third-trimester anthropometric measurements may help predict increased risk for c-section in women with obesity. Further research may elucidate utility in nutritional counseling and delivery planning.

Addressing Disparities in Prenatal Care via Telehealth During COVID-19: Prenatal Satisfaction Survey in East Harlem.

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: · Telehealth allowed for continuation of satisfactory prenatal care in Hispanic patients.. · Hispanic patients are at risk for reduced access to care.. · Telehealth was a useful tool for achieving patient-perceived satisfactory care..

Adjuvant Hepatic Artery Infusion Chemotherapy is Associated With Improved Survival Regardless of KRAS Mutation Status in Patients With Resected Colorectal Liver Metastases: A Retrospective Analysis of 674 Patients.

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 and 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 versus 57% for patients without HAI [hazard ratio (HR) 0.51, P < 0.001]. In KRAS-MUT tumors, 5-year survival was 59% for patients treated with HAI versus 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 clinicopathologic factors. CONCLUSION: Adjuvant HAI after resection of CRLM is independently associated with improved outcomes regardless of KRAS mutational status. Adjuvant HAI may mitigate the worse outcomes seen in patients with resectable KRAS-MUT CRLM.

Assessment of Hepatic Arterial Infusion of Floxuridine in Combination With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma: A Phase 2 Clinical Trial.

IMPORTANCE: Unresectable intrahepatic 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 PARTICIPANTS: A 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 MEASURES: The primary outcome was progression-free survival (PFS) of 80% at 6 months. RESULTS: For 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 RELEVANCE: Hepatic arterial infusion plus systemic chemotherapy appears to be highly active and tolerable in patients with unresectable IHC; further evaluation is warranted.

Genomic stratification beyond Ras/B-Raf in colorectal liver metastasis patients treated with hepatic arterial infusion.

BACKGROUND: Resection of colorectal liver metastases (CLM) can cure disease, but many patients with extensive disease cannot be fully resected and others recur following surgery. Hepatic arterial infusion (HAI) chemotherapy can convert extensive liver disease to a resectable state or decrease recurrence risk, but response varies and no biomarkers currently exist to identify patients most likely to benefit. METHODS: We performed a retrospective cohort study of CLM patients receiving HAI chemotherapy whose tumors underwent MSK-IMPACT sequencing. The frequency of oncogenic alterations and their association with overall survival (OS) and objective response rate were analyzed at the individual gene and signaling pathway levels. RESULTS: Three hundred and seventy patients met inclusion criteria: 189 (51.1%) who underwent colorectal liver metastasectomy followed by HAI + systemic therapy (Adjuvant cohort), and 181 (48.9%) with unresectable CLM (Metastatic cohort) who received HAI + systemic therapy, consisting of 63 (34.8%) with extrahepatic disease and 118 (65.2%) with liver-restricted disease. Genomic alterations were similar in each cohort, and no individual gene or pathway was significantly associated with objective response. Patients in the adjuvant cohort with concurrent Ras/B-Raf alteration and SMAD4 inactivation had worse prognosis while in the metastatic cohort patients with co-alteration of Ras/B-Raf and TP53 had worse OS. Similar findings were observed in a validation cohort. CONCLUSIONS: Concurrently altered Ras/B-Raf and SMAD4 mutations were associated with worse survival in resectable patients, while concurrent Ras/B-Raf and TP53 alterations were associated with worse survival in unresectable patients. The mutual exclusivity of Ras/B-Raf, SMAD4, and TP53 may have prognostic value for CLM patients receiving HAI.

Prospective phase II trial of combination hepatic artery infusion and systemic chemotherapy for unresectable colorectal liver metastases: Long term results and curative potential.

BACKGROUND/OBJECTIVES: Combination hepatic artery infusion (HAI) and systemic (SYS) chemotherapy for unresectable CRLM results in high tumor-response rates. This study represents an update of long-term survival and conversion to resectability in patients with unresectable CRLM treated with HAI and SYS chemotherapy in a phase II study. METHOD: The primary endpoint was complete resection. Multivariate and landmark analysis assessed the effect of complete resection on progression-free (PFS) and overall survival (OS). RESULTS: From 2007 to 2012, 64 patients with median of 13 tumors were enrolled; 67% had prior chemotherapy. 33 patients (52%) were converted to resection. Median follow-up among survivors was 81 months. Median PFS and OS were 13 and 38 months, respectively, with 5-year-OS of 36%. Chemotherapy-naïve patients had 5-year-OS of 51%. Conversion to resection was the only independent factor prognostic of improved PFS and OS. Nine of 64 patients (14%) are NED (five since initial resection, three after resection of recurrent disease, one from chemotherapy alone) at median follow-up of 86 months from treatment initiation, and 72 months from last operative intervention. CONCLUSION: 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.

A Comparison of Yttrium-90 Microsphere Radioembolization to Hepatic Arterial Infusional Chemotherapy for Patients with Chemo-refractory Hepatic Colorectal Metastases.

OPINION STATEMENT: Patients with unresectable hepatic colorectal metastases who become chemo-refractory have limited treatment options. Systemic chemotherapies such as TAS102 and regorafenib have been used in the refractory setting, but with only modest improvement in overall survival compared to best supportive care. In patients with liver-only or liver-dominant disease, direct chemotherapy to the liver such as hepatic artery infusional (HAI) chemotherapy and radioembolization (yttrium-90 (Y90)) should be considered. Due to the difficulty of HAI therapy post Y90 for technical reasons, we recommend HAI therapy prior to Y90.

Treatment Options in Colorectal Liver Metastases: Hepatic Arterial Infusion.

BACKGROUND: The liver is the most common site for metastases from colorectal cancer (CRC) with the majority of these patients having unresectable disease. METHODS: This is a retrospective review of studies using hepatic arterial infusion (HAI) therapy to treat liver metastasis from CRC. A PubMed search of randomized controlled trials and retrospective studies from 2006 to present was conducted using the search terms 'hepatic arterial infusion (HAI) therapy', 'colorectal cancer', and 'treatment of liver metastases'. RESULTS: The first randomized studies comparing HAI to systemic therapy with 5-fluorouracil/leucovorin produced significantly higher response rates of 41 versus 14%. Systemic therapy has improved with the addition of irinotecan and oxaliplatin; however, the responses with HAI and these modern agents have also increased, with responses as high as 80%. For patients with wild-type KRAS, HAI and systemic therapy produced a median survival of 68 months. In patients with refractory disease, response rates are in the 30% range with a median survival of 20 months. Adjuvant HAI after liver resection has shown an increase of hepatic disease-free survival and overall disease-free survival when compared to systemic therapy alone in three of four randomized trials. A recent update of the adjuvant trials after liver resection at Memorial Sloan Kettering Cancer Center has shown a 5-year survival of 78%. CONCLUSION: HAI therapy has a role in treating hepatic metastases from CRC in both the resectable and unresectable setting.

Relevance of CEA and LDH in relation to KRAS status in patients with unresectable colorectal liver metastases.

BACKGROUND: While the significance of carcinoembryonic antigen (CEA), lactate dehydrogenase (LDH), and Kirsten rat sarcoma (KRAS) status as individual prognostic factors for patients with metastatic colorectal cancer has been addressed, the relationship and interdependence between these prognostic factors on survival is limited. METHODS: Patients with unresectable colorectal liver metastases with known KRAS status, and with baseline CEA and LDH levels who were treated with hepatic arterial infusion and systemic chemotherapy were identified. Patients were divided into two groups: hepatic-only disease and extra-hepatic disease. RESULTS: A total of 193 patients were included: 121 with hepatic-only and 72 with extra-hepatic disease. In the hepatic-only group, median overall survival (OS) was 55 months. On multivariate analysis, KRAS mutated tumors (HR 1.7, P < 0.05), LDH >200 U/L (HR 2.0, P < 0.05), and prior chemotherapy (HR 2.1, P < 0.05) had lower OS. In patients with extra-hepatic disease, median OS was 32 months. On multivariate analysis, baseline CEA >200 ng/mL (HR 2.1, P = 0.051), LDH >200 U/L (HR 3.8, P < 0.05), and right-sided tumors (HR 2.8, P < 0.05) had lower OS. CONCLUSIONS: This analysis verifies two distinct patterns in terms of biomarkers in patients with unresectable colorectal liver metastases. In patients with hepatic-only disease, KRAS mutation and elevated LDH negatively influenced survival. In patients with extra-hepatic disease, elevated LDH negatively impacted survival.

Response rates of hepatic arterial infusion pump therapy in patients with metastatic colorectal cancer liver metastases refractory to all standard chemotherapies.

BACKGROUND AND OBJECTIVES: To evaluate the role of hepatic arterial infusion (HAI) in patients with metastatic colorectal cancer (mCRC) liver metastases (LM) refractory to oxaliplatin, irinotecan, and fluorouracil-based treatments. METHODS: A search identified patients with mCRC treated after tumor progression on at least three standard systemic therapies. RESULTS: One hundred and ten patients met criteria for inclusion (i.e., progression on at least three standard agents). Fifty seven patients had LM-only and 53 patients had LM and low volume extrahepatic metastases (LME). Patients with LM-only and LME had a response rate (RR) of 33% and 36%, median survival of 20 months and 11.4 months, respectively. Patients with LM-only had progression free survival of 6 months and hepatic progression free survival of 7.56 months. In a secondary analysis, 46 patients were RECIST-refractory to all standard therapies: LM-only (n = 24) and LME (n = 22). LM-only and LME had a RR of 29% and 36%, and median survival 17.2 months and 9.1 months, respectively. CONCLUSIONS: Patients with refractory mCRC LM can achieve a response to HAI resulting in antitumor activity and improvement in survival. Responses are rarely seen in such heavily treated patients with systemic therapy alone, suggesting a regional directed approach is useful. J. Surg. Oncol. 2016;114:655-663. © 2016 Wiley Periodicals, Inc.

Updated long-term survival for patients with metastatic colorectal cancer treated with liver resection followed by hepatic arterial infusion and systemic chemotherapy.

BACKGROUND AND OBJECTIVES: Patients who undergo liver resection for metastatic colorectal cancer (mCRC) have reported 5-year survivals ranging from 25% to 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. J. Surg. Oncol. 2016;113:477-484. © 2016 Wiley Periodicals, Inc.