Initial Treatment Modality Research Articles

Survival trends of men and women with metastatic clear cell renal cell carcinoma.

4566 Background: Clear cell renal cell carcinoma (ccRCC) is nearly twice as common in men as in women, and women with non-metastatic RCC have a better prognosis than men. The etiology for these disparities is not known, though sex-specific differences in risk factor prevalence and tumor biology have been reported. The differential impact of systemic therapies, including tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs), on prognosis in women and men with metastatic ccRCC is not defined. Methods: Clinicopathologic features and survival of patients with clinical stage IV ccRCC were obtained from the National Cancer Database (NCDB). Patients were grouped by date of metastatic diagnosis into three eras that correspond to major advances in systemic therapy: 2004-2005 (pre-TKI), 2006-2014 (TKI), and 2015-2016 (ICI). Uni- and multi-variable chi-square, logistic regression, and survival analyses were used for comparisons. Survival differences were assessed using Kaplan-Meier curves. Results: 15,025 male and 7,100 female patients with metastatic ccRCC were identified. Demographic features were similar between cohorts though females were slightly older (median 64.8 vs 62.7 mo, p < 0.0001), more likely to be black (6.5% vs 6.0%, p = 0.0119) or receiving Medicare benefits (46.4% vs 39.9%, p < 0.0001). In the combined cohort, median overall survival (OS) was higher in patients diagnosed in the ICI vs TKI (23.0 vs 16.5 mo) and pre-TKI eras (14.4 mo, log-rank p < 0.0001). Compared with men of the same age groups, OS was inferior for women age 50-64 yr (median 18.4 vs 21.1mo, p = 0.0084) and > 64 yr (15.3 vs 12.6mo, p = 0.0001), but not < 50 yr (20.3 vs 21.7mo, p = 0.6290). In the ICI era, median OS improved by a lesser absolute but similar relative amount for women compared to men (+5.6mo [+39%] and +7.2mo [+41%]), respectively). After controlling for age, race, Charlson-Deyo score, initial treatment modality, and insurance and socioeconomic status, women remained at increased risk of death in both the ICI era (HR 1.12 [95% CI 1.04-1.22], p = 0.004) and the TKI era (HR 1.08 [1.04-1.12], p < 0.001). Conclusions: Women with metastatic ccRCC have a worse prognosis than men which is not explained by demographic differences. This disparity is observed in both the TKI and ICI eras. This finding contrasts with previous studies suggesting women with localized RCC have a favorable prognosis compared with men. Further investigation into the sex-specific biology of metastatic ccRCC is warranted.

Impact of COVID-19 on initial treatment of breast and colorectal cancers in one integrated healthcare system.

e18806 Background: There has been a significant decline in office visits and cancer screening interventions such as mammograms and colonoscopies during the COVID-19 pandemic. The aim of this study is to analyze treatment patterns and to identify if there was also a delay in time to treatment for breast and colorectal cancers diagnosed during the pandemic. Methods: We utilized a dataset linking the institutional tumor registry and electronic health records from a large ambulatory group practice in Northern California. We analyzed data from 1,047 patients with newly diagnosed breast and colorectal cancers between 1/2019 and 8/2020 who received care at Sutter Health-Palo Alto Medical Foundation until 12/2020. We performed a T-test to examine whether patterns of treatment status (surgery vs chemotherapy vs neither) and time-to-treatment are different in pre-COVID vs pandemic eras. Results: The proportion of patients who did not receive surgery or chemotherapy during the pandemic was significantly higher, compared to the pre-COVID era (34.5% vs. 13.0%, p < 0.01). Among the breast and colorectal cancer patients who received care, the time to initial treatment did not significantly vary in the pre-COVID (median 34 days, mean 36.8 days) era as compared to during the pandemic (median 30 days, mean 32.2 days) (p = 0.15). There was no difference when accounting for surgery (p = 0.15) vs chemotherapy (p = 0.52) as the initial treatment modality. A statistically significant difference was seen amongst the 888 breast cancer cases identified during the study period, but the mean time to treatment during the pandemic (31 days) was actually shorter than the mean time to treatment identified prior to the pandemic (38 days). This difference in breast cancer time to treatment was mainly driven by a statistically shorter time to surgery (p = 0.04) in the pandemic era with no statistically significant difference in time to chemotherapy following a breast cancer diagnosis in the pandemic era as compared to the pre-COVID era (p = 0.99). Conclusions: There was a significant difference in the number of patients who did not receive surgery or chemotherapy during the pandemic for newly diagnosed breast and colorectal cancers. However, amongst those patients who did receive treatment, there were no significant delays observed in time to initial treatment, regardless of treatment modality.[Table: see text]

A multicenter analysis of treatment and outcomes in neuroendocrine carcinoma of the uterine cervix (NCUC).

e17518 Background: Morbidity and mortality for patients with cervical cancer has improved significantly over the past few decades with modern multimodal therapy. However, neuroendocrine carcinoma of the uterine cervix (NCUC), which accounts for 1-2% of cervical cancers, remains a deadly subtype. In this study, we combine data from Mayo Clinic (MC) and the University of Iowa Hospitals and Clinics (UIHC) to provide information on tumor characteristics, treatment, and outcomes. Methods: The electronic medical record was reviewed for patients with NCUC from MC and UIHC. Data on diagnosis, treatment, and outcomes were collected through chart review. Primary endpoints included progression-free survival (PFS) and overall survival (OS). Secondary endpoints included median survival, survival at 1 year after surgery, and survival at 1 year by first line chemotherapy agent. Kaplan-Meier survival analysis was used to estimate median PFS, median survival, and OS. Fisher’s test analysis was used to calculate survival at 1 year after surgery and by first line chemotherapy agent. Results: There were 62 patients (MC: 26, UIHCC: 36) with NCUC stage I-IV (stage I: 29, stage II: 9, stage III: 7, stage IV: 14, unknown: 3). Median age of diagnosis was 47 years (range 21-77 years). By subtype, 47 were small cell (76%), 9 were large cell (15%), and 6 were unknown/undetermined (9%). The initial treatment modalities for each patient are outlined in the table. 28 patients had complete/partial response or stable disease from first line treatment, while 10 patients had disease progression. Of the patients who initially responded or had stable disease, 16 later progressed (57%) with a median time to progression of 15 months. Median follow up was 65.1 months with a median OS of 28.5 months. Median survival for those with stage I was 40.9 months, stage II: 54.6 months, stage III: 8.75 months, and stage IV: 11.7 months. There was a significant difference in overall survival at 1 year between those who received surgery and those who did not in stage I/II ( p = 0.01). There was no significant difference in overall survival at 1 year for those who received surgery in stage III/IV. There was no statistical difference in survival at 1 year for carboplatin or cisplatin in combination with etoposide as first line chemotherapy agent. Conclusions: NCUC is an aggressive malignancy that is usually progressive despite multimodal therapy. Our study demonstrated a median overall survival of 28.5 months and 5-year survival rate of 21%. Our study showed a survival benefit at 1 year for those who receive surgery with stage I/II NCUC. There was no significant survival benefit at 1 year between carboplatin or cisplatin in combination with etoposide as first line agent.[Table: see text]

Pulmonary sarcomatoid carcinoma: Retrospective analysis from a single center.

e21188 Background: Pulmonary sarcomatoid carcinoma (PSC) constitutes a heterogeneous group of poorly differentiated non-small cell lung cancer (NSCLC). Since these are rare tumors, no definitive randomized trials or clinical guidelines are available for management. This is the largest single centre study of patients with pulmonary sarcomatoid carcinoma. Methods: We retrospectively evaluated all patients with pulmonary sarcomatoid carcinoma between January 2013 to September 2020 at the Tata Memorial Hospital, Mumbai, India. Cases were identified from the pathology database. Baseline demographic, treatment data and outcomes were obtained from a prospectively maintained database in the Department of Medical Oncology. Results: A total of 151 patients with PSC were diagnosed during this period. Among these, 129 patients were included for survival analysis. The median age at diagnosis was 61 years (range, 18-87) with a majority of them being males (81.5%) and smokers (73%). A significant percentage of patients presented with poor performance status (PS was 2-4 in 48%). A majority of patients had T4 (73%) or N3 nodal status (44%). The clinical stage was stage I in 2%, stage II in 2.7%, stage III in 25.9%, and stage IV in 69.4%. The initial treatment modalities include surgery (10.9%), radical chemoradiotherapy (CRT, 3.9%), palliative chemotherapy (46.5%), palliative radiotherapy (7%), and best supportive care (31.8%). The median follow-up duration for the entire cohort was 32 months (95% CI 15.0 to 48.9). The median OS for the entire patient cohort was 5 months (95% CI 3.4 to 6.5). The median OS of patients who received curative surgery was 18 months (95% CI: 2.59 to 33.4) and the corresponding 1- and 5-year survival rates for patients who underwent surgery were 64% and 33% respectively. The median OS for patients who received CRT was 11 months (95% CI: 2.99 to 19). The median OS for the patients who received palliative radiotherapy alone was 4 months (95% CI: 1.91 to 6.08), for palliative chemotherapy was 8 months (95% CI: 5.24 to 10.75) and for patients who received only best supportive care was 1 month (95% CI: 0.43 to 1.57, p = 0.001). The median PFS and ORR for first, second- and third-line palliative chemotherapies were 4 months (95% CI: 2.95 to 5.04) and 15.1%, 4 months (95% CI: 0.33 to 7.67) and 13.3%, and 1 month (95% CI 0.21 to 1.78) and 0%. In a multivariate analysis, independent prognostic factors included the presence of brain metastasis (p 0.018, HR, 2.47, 95% CI 1.34-4.49) and administration of palliative chemotherapy (p = 0.037, HR2.2, 95% CI 1.04-4.94). Conclusions: PSC usually presents in advanced stages and carries a poor prognosis. Effective therapeutic options are required to improve the outcomes.

778 Management of Colorectal Anastomotic leaks: The East of England Experience

Abstract Introduction Colorectal anastomotic leaks (AL) are an unfortunate occurrence and are associated with a high mortality. The aim of this multi-centre study is to explore the different management strategies used and compare outcomes in the management of AL. Method All patients who had an AL were included at seven hospitals across the East of England. Morbidity, mortality, and survival were compared across the different management strategies. Results A total of 247 consecutive patients were included of which 60.3% were male and the median age was 68 (IQR 57-77). Half of patients were initially managed conservatively, a further 10.5% had a radiological procedure. 39.7% required surgery as an initial treatment. Of those who initially did not have a surgical intervention (n = 149), 10.7% (n = 16/149) eventually required laparotomy. Ultimately, 42.7% (n = 106/248) required a laparotomy. The 30- and 90-day across the entire population mortality were 3.6% and 4.9% respectively. There were no significant differences in mortality or long-terms survival between the different initial treatment modalities. Conclusions Despite initial conservative, antibiotic and radiological intervention being successful in the majority of patients, two out of five patients will still require a laparotomy. A consensus approach is required to standardise management in these difficult scenarios.

Time to Treatment Initiation for Breast Cancer During the 2020 COVID-19 Pandemic.

PURPOSE:The COVID-19 pandemic has posed significant pressures on healthcare systems, raising concern that related care delays will result in excess cancer-related deaths. Because data regarding the impact on patients with breast cancer are urgently needed, we aimed to provide a preliminary estimate of the impact of COVID-19 on time to treatment initiation (TTI) for patients newly diagnosed with breast cancer cared for at a large academic center.METHODS:We conducted a retrospective study of patients with newly diagnosed early-stage breast cancer between January 1, 2020, and May 15, 2020, a time period during which care was affected by COVID-19, and an unaffected cohort diagnosed between January 1, 2018 and May 15, 2018. Outcomes included patient volume, TTI, and initial treatment modality. Adjusted TTI was compared using multivariable linear regression.RESULTS:Three hundred sixty-six patients were included. There was an 18.8% decrease in patient volume in 2020 (n = 164) versus 2018 (n = 202). There was no association between time of diagnosis (pre-COVID-19 or during COVID-19) and adjusted TTI (P = .926). There were fewer in situ diagnoses in the 2020 cohort (P = .040). There was increased use of preoperative systemic therapy in 2020 (43.9% overall, 20.7% chemotherapy, and 23.2% hormonal therapy) versus 2018 (16.4% overall, 12.4% chemotherapy, and 4.0% hormonal therapy) (P < .001).CONCLUSION:TTI was maintained among patients diagnosed and treated for breast cancer during the COVID-19 pandemic at a single large academic center. There was a decrease in patient volume, specifically in patients with in situ disease and a shift in initial therapy toward the use of preoperative hormonal therapy.

Factors predicting long-term outcomes of early-stage hepatocellular carcinoma after primary curative treatment: the role of surgical or nonsurgical methods

BackgroundWe quantified the elusive effects of putative factors on the clinical course of early hepatocellular carcinoma (HCC) after primary surgical or nonsurgical curative treatment.MethodsPatients with newly diagnosed early HCC who received surgical resection (SR) or percutaneous radiofrequency ablation (RFA) with or without transcatheter arterial chemoembolization (TACE) from January 2003 to December 2016 were enrolled. The cumulative overall survival (OS) and disease-free survival (DFS) rates were compared. A polytomous logistic regression was used to estimate factors for early and late recurrence. Independent predictors of OS were identified using Cox proportional hazard regression.ResultsOne hundred twenty-five patients underwent SR, and 176 patients underwent RFA, of whom 72 were treated with TACE followed by RFA. Neither match analysis based on propensity score nor multiple adjustment regression yielded a significant difference in DFS and OS between the two groups. Multivariate analysis showed high AFP (> 20 ng/mL), and multinodularity significantly increased risk of early recurrence (< 1 year). In contrast, hepatitis B virus, hepatitis C virus and multinodularity were significantly associated with late recurrence (> 1 year). Multivariate Cox regression with recurrent events as time-varying covariates identified older age (HR = 1.55, 95% CI:1.01–2.36), clinically significant portal hypertension (CSPH) (HR = 1.97, 95% CI:1.26–3.08), early recurrence (HR = 6.62, 95% CI:3.79–11.6) and late recurrence (HR = 3.75, 95% CI:1.99–7.08) as independent risk factors of mortality. A simple risk score showed fair calibration and discrimination in early HCC patients after primary curative treatment. In the Barcelona Clinic Liver Cancer (BCLC) stage A subgroup, SR significantly improved DFS compared to RFA with or without TACE.ConclusionHost and tumor factors rather than the initial treatment modalities determine the outcomes of early HCC after primary curative treatment. Statistical models based on recurrence types can predict early HCC prognosis but further external validation is necessary.

Pre-orchiectomy serum tumor markers as a predictor of recurrence in stage I germ cell tumors.

389 Background: Organ confined (stage IA/IB) testicular cancer has a high cure rate regardless of initial treatment modality, making it important to weigh the toxicities of treatment against potential benefits. While many clinicians routinely obtain serum tumor markers (STMs) prior to radical orchiectomy, their role in predicting recurrence in stage IA and IB testicular cancer has not been studied. Methods: A multi-institutional database of stage I testicular cancer patients diagnosed between 2006 and 2018 was created. Univariate and multivariate regression models were created to understand which factors predict recurrence. Recurrence analyses using Kaplan-Meier curves for elevated and normal pre-orchiectomy STMs were also generated. Results: 150 patients met the study criteria, of whom 16 (11%) relapsed (Table). 9 (56%) patients with recurrence had elevated pre-orchiectomy STMs, and 7 (44%) had normal pre-orchiectomy STMs. Similarly, 75 patients (56%) without relapse had elevated pre-orchiectomy STMs. Of 9 patients with elevated pre-orchiectomy STMs, 6 (67%) had normal STMs at recurrence; of 7 with normal pre-orchiectomy STMs, 4 patients (57%) had elevated STMs at recurrence. On Kaplan-Meier analysis, no association between level of pre-orchiectomy STMs and recurrence free survival was observed. Conclusions: Pre-orchiectomy STMs were not independently associated with recurrence in stage I testis cancer. Interestingly, there was also no association between positivity of pre-orchiectomy STMs and whether or not STMs were elevated at recurrence. These findings support the continued use of standard-of-care imaging and STMs in surveillance of stage IA/IB testicular cancer patients regardless of pre-orchiectomy STMs. [Table: see text]

Abstract SS1-10: Impact of Medicaid expansion on racial disparities in time to adjuvant chemotherapy administration among breast cancer (BC) patients

Abstract BACKGROUND: Delays in adjuvant chemotherapy initiation have a detrimental effect in outcomes and are more frequently seen among racial/ethnic minorities, uninsured patients and those with low socioeconomic status. A provision in the Affordable Care Act called for expansion of Medicaid eligibility in order to cover more low-income Americans. In this study we evaluate the impact of Medicaid expansion on racial disparities in time to adjuvant chemotherapy administration in a large cohort of BC patients.METHODS: Women (aged 40-64) diagnosed with primary invasive BC (stage I-III) between 01/01/2007 and 12/31/2016 were identified in the National Cancer Database. All patients underwent surgery as initial treatment modality and received adjuvant chemotherapy within 6 months of surgery. Chemotherapy delay was defined as &amp;gt;60 days from surgery to the first dose of chemotherapy. The cohort was limited to those residing in states that underwent Medicaid expansion in 2014 (KY, NV, CO, OR, NM, WV, AR, RI, AZ, MD, MA, ND, OH, IA, IL, VT, HI, NY, DE). For comparison purposes, 2007-2013 was considered the pre-expansion period and 2014-2016 the post-expansion period. We calculated difference-in-difference (DID) estimates using multivariable linear regression models. Results are presented as adjusted differences (in % points) between race/ethnicity groups in the pre and post-expansion periods, and as adjusted DID with 95% CI. A negative DID estimate indicates that Medicaid expansion reduces the racial/ethnic disparity in chemotherapy administration delay. The parallel trend assumption was tested. Variables in the final model included age, comorbidities, BC subtype, insurance status, distance to treatment facility, region, education, household income, facility type and facility case volume. RESULTS: 105,385 patients were included (median age 53), of them 75,663 (71.8%) were diagnosed in the pre- and 29,722 (28.2%) in the post-expansion period. 77.5% of the patients were White, 11.7% Black and 4.9% Hispanic. The proportion of patients experiencing chemotherapy initiation delays was greater among Blacks and Hispanics in both study periods compared to Whites. The proportion of chemotherapy delays decreased for all races between the pre and the post-expansion period. We observed a statistically significant decrease in the chemotherapy initiation racial disparity. The adjusted DID was -2% (95%CI -3.8 to -0.3, P=0.02) between Whites and Blacks was and -3% (95%CI -5.5 to -0.5, P=0.02) between Whites and Hispanics. In a subgroup analysis among 10,777 Medicaid patients the parallel trend assumption was not valid, therefore we estimated the DID between Whites and Blacks using a propensity-score based weight sample, identifying a reduction in the racial disparity of even greater magnitude (DID -9.1% [-14.4 to -3.8, P&amp;lt;0.001]). CONCLUSIONS: We demonstrate that Medicaid expansion reduced racial disparities by decreasing the proportion of Blacks and Hispanics experiencing delays in adjuvant chemotherapy initiation and decreasing the gap that exists when compared to Whites. These important results highlight the positive impact of policies aimed at improving equity and increasing access to health care. Pre-ExpansionPost-ExpansionRaceNAdjusted Rate of Delayed Chemo &amp;gt; 60 daysAdjusted Difference Between White Race (% points)NAdjusted Rate of Delayed Chemo &amp;gt; 60 daysAdjusted Difference Between White Race, (%points)Adjusted DID (95% CI), Percentage PointsPWhite5930527.202232524.20RefRefBlack856036.18.9372031.16.9-2.0 (-3.8 to -0.3)0.02Hispanic343232.35.1170426.32.1-3.0 (-5.5 to -0.5)0.02 Citation Format: Mariana Chavez-MacGregor, Xiudong Lei, Hui Zhao, Tina Shih, Sharon H Giordano. Impact of Medicaid expansion on racial disparities in time to adjuvant chemotherapy administration among breast cancer (BC) patients [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr SS1-10.

Clinical manifestations and outcomes of patients with scirrhous hepatocellular carcinoma.

The scirrhous hepatocellular carcinoma (HCC) is a rare subtype characterized by prominent fibrous stroma separating nests of tumor cells histologically. The clinical characteristics of scirrhous HCC have not been clearly elucidated due to limited literatures. We aimed to investigate the clinical manifestations and outcomes of patients with scirrhous HCC. A total of 4012 patients with histologically proven HCC from the Cancer Registry Database (2004-2016) of the National Taiwan University Hospital (NTUH) were enrolled; whereas, 30 patients with scirrhous HCC were identified from the pathology database of NTUH. We matched 120 patients with non-scirrhous HCC through propensity score according to sex, age, Barcelona Clinic Liver Cancer stage and initial treatment modality for comparison. No significant difference in baseline characteristics and presentations was observed between the patients with scirrhous and non-scirrhous HCC except baseline alpha-fetoprotein level. The overall survival was comparable in these two groups. For the patients undergoing curative therapy, the risk of recurrence in the patients with scirrhous HCC was significantly higher within 24months after curative therapy (hazard ratio [HR], 2.88, 95% confidence interval [CI], 1.43-5.80, p value, 0.003) as compared with those with non-scirrhous HCC. The overall recurrence rate was comparable in these two groups. Using propensity score matching, the risk of recurrence in the patients with scirrhous HCC was significantly higher in the first 2years after curative therapy as compared to those with non-scirrhous HCC. An individualized post-curative treatment monitoring strategy should be considered for the patients with scirrhous HCC.

Low energy amplitude modulated radiofrequency electromagnetic fields in combination with standard treatment or as monotherapy to show improvement in quality of life in patients with advanced hepatocellular carcinoma.

290 Background: Hepatocellular carcinoma (HCC) is a fatal cancer without curative option for most patients. Hence the importance to improve health related quality of life (HRQoL). Amplitude-modulated radiofrequency electromagnetic fields (EMF), as a novel and non-toxic therapy, has potential for improving HRQoL in advanced HCC patients. Methods: An open-label, single center, prospective clinical protocol was performed in advanced HCC patients as an initial and salvage treatment modality. Systemic exposure to EMF was used in combination with a systemic conventional treatment or as a single treatment. A spoon-shaped antenna placed in the oral cavity delivered EMF over 90 minutes with monthly repetitions until death or consent withdrawal. The effect on HRQoL was the primary objective of this study. Patients answered the EORTC-C30 v3.0 questionnaires prior to every EMF exposure. Clinically meaningful change (CMC) and time to deterioration (TTD) for Global Health (QoL), Role Functioning (RF) and Physical Functioning (PF) were used in the analysis. Results: From March 2018 to April 2020, 55 advanced HCC patients were submitted to 373 EMF exposures. 41/55 (75%) patients had repetitive exposures (mean # 4, ranging from 2-16). 87% were male, median age was 67, 84% were BLCL-C, 16% were Child-Pugh B, 29% had extra-hepatic metastasis, 55% had failed previous treatment and 71% had documented radiological progression. 31(56%) patients received EMF in combination with systemic therapy (28 TKI and 3 anti-PDL1). 24 patients received EMF as a single treatment modality. The mean baseline score was 68.1 for QoL and 77.1 for RF and PF. 61%, 76% and 49% of patients experienced positive change in QoL, RF and PS scores immediately prior to the second exposure, respectively. +CMC was reported in 20%, 17% and 32% of patients, respectively for QoL, RF and PS. The median QoL TTD was not reached. The median RF TTD was 7.2 month and the median PF TTD was 11.9 month. The median RF TTD for patients in combination treatment was 11.4 months and in a single treatment was 13.5 month. The median PF TTD for patients in combination treatment was 12.8 months and in single treatment was 14.5 month. Conclusions: Advanced HCC patients showed positive changes in QoL, RF and PF HRQoL scores after single exposure to EMF. The benefit from EMF in HRQoL was durable both in combination with TKI or as a single modality in advanced HCC patients. These results support future development as a novel palliative treatment modality in advanced HCC patients. Clinical trial information: NCT 01686412.

Low energy amplitude modulated radiofrequency electromagnetic fields to show antitumor effect in combination with standard treatment or as monotherapy in patients with advanced hepatocellular carcinoma.

332 Background: Exposure to amplitude-modulated radiofrequency electromagnetic fields (EMF) in immortalized hepatocellular carcinoma (HCC) cell cultures and xenograft models demonstrated anti-tumor effect. Patients with advanced HCC exposed to systemic EMF showed objective response with potential survival benefit. Methods: An open-label, single center, prospective clinical protocol was performed in advanced HCC patients as an initial, second or third treatment modality. Systemic exposure to EMF modulated at patient-specific frequencies was applied as an add-on strategy (combination) to systemic conventional treatment or as a single therapeutic modality. A spoon-shaped antenna placed in the oral cavity delivered EMF over 90 minutes with monthly repetitions until death or consent of withdrawal. The primary objective was overall survival (OS) in comparison with historical control group of 45 advanced patients HCC from the same institution. Retrospective radiological review was conducted by two independent radiologists for objective response (OR) using RECIST1.1 criterion. Results: From March 2018 to April 2020, 55 advanced HCC patients were submitted to 373 EMF exposures. 87% were male, median age of 67, 84% were BLCL-C, 16% were Child-Pugh B, 29% had extra-hepatic metastasis, 55% had failed previous treatment and 71% had documented radiological progression. 31(56%) patients received EMF in combination with systemic therapy (25 sorafenib, 3 lenvatinib, 3 nivolumab). 24 patients received EMF as single treatment modality. The median OS for the entire patient cohort was 11.5 months. The median OS for combination treatment was 12.0 month and the median OS for single modality was 11.3 months. The median OS for the historical control was 5.3 month. The median OS from the entire cohort and the historical control were significant different (p = 0.0026) but the median OS from combination and single modality were not (p = 0.3434). Radiological images were available from 38(69%) patients. There were 6/38 (16%) documented objective responses (1 CR and 5 PR) and 30/38 (79%) patients experienced disease control. 4/21 (19%) OR were in patients using TKIs + EMF and 2/17 (12%) OR were in patients using EMF alone. Conclusions: EMF showed objective anti-tumor effect in combination with TKI or as single modality in advanced HCC patients. EMF showed improvement in overall survival in comparison with the historical control group supporting future development as a novel systemic treatment modality in advanced HCC patients. Clinical trial information: NCT 01686412.

Factors that Affecting the Skin Necrotic due to Extravasation Injury and Modality Theraphy at Pediatric Inpatient Ward dr. Soetomo Hospital Surabaya (Januari - Desember 2019)

Background: Extravasation injury is the most common complication of intravenous therapy in children. Research in the NICU at UK, found extravasation injury caused skin necrotic 38/1000 neonates, 70% of preterm neonates. Extravasation injuries and their sequels can be more serious morbidity than the underlying disease, potentially for amputation. The research objective was to determine the factors that influence the incidence of skin necrotic due to extravasation injury and the types of treatment modalities in the pediatric hospital Dr. Soetomo Hospital Surabaya for the period January - September 2019.Methods: This research is descriptive analytic with cross sectional approach with collected data from medical records. The medical records of 44 pediatric patients undergoing treatment at the pediatric inpatient ward of Dr. Soetomo Hospital Surabaya with skin necrotic due to extravasation injury which was brought to the Reconstructive and Aesthetic Plastic Surgery Dr. Soetomo Hospital Surabaya for the January - December 2019 period was reviewed retrospectively. We analyzed patient characteristics, risk factors, types of wound care therapy modalities, and case outcomes.Results: There were 44 cases of skin necrotic injury due to extravasation injury, with the largest percentage of neonates group (34%), male gender (66%), hypertonic fluids / drugs (73%), most regions of dorsum and wrist dextra (17%) and the most used therapeutic modality was autolytic debridement (45%).Conclusions: From this study, several conclusions can be drawn regarding the prevalence of skin necrotic due to extravasation injury, there was a relationship between the incidence of skin necrotic injury due to extravasation injury with age, types of fluid/drug given, and the location of the peripheral venous line, whereas the incidence was not related to gender. The initial treatment modality that is still frequently used today is autolytic debridement.

Prognosis of hepatocellular carcinoma patients diagnosed under regular surveillance: potential implications for surveillance goal

Aims The goal of hepatocellular carcinoma (HCC) surveillance is to diagnose cancer at an early stage when treatment is likely to provide the best outcome and thereby, reduce mortality. However, no specific criteria define the ‘early stage’ for tumors diagnosed under HCC surveillance. We aimed to analyze factors that determined the outcome of HCC patients diagnosed under regular surveillance, to find out how early it is necessary to detect tumors during surveillance. Methods A retrospective cohort of 874 HCC patients with preserved liver function (Child-Pugh A) who were diagnosed under regular HCC surveillance at Samsung Medical Center from 2014 to 2016 and did not receive liver transplantation as an initial treatment were analyzed. The primary outcome was overall survival (OS). Results Tumor size, presence of vascular invasion, albumin-bilirubin grade, and initial treatment modality were independent factors for OS in multivariable analysis. When categorized according to the tumor size, the risk of mortality increased for tumors of > 3 cm, while tumors of 2–3 cm showed similar mortality risks as tumors of ≤2 cm. When categorized according to the tumor factors, curative-intent treatment (resection or ablation) can be applied to 84.5% with excellent outcomes (5-year OS rate, 93.4%), for tumors of ≤3 cm without vascular invasion. Conclusions When tumors of ≤3 cm were detected and had no vascular invasion, curative-intent treatment was applied for most patients and showed excellent OS. This finding suggests that to detect tumors of <3 cm without vascular invasion may be considered as the goal of HCC surveillance.

Epley’s Maneuver versus Semont’s Maneuver in the Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo: A Cohort Study

Introduction: Benign Paroxysmal Positional Vertigo (BPPV) is the most common cause of vertigo in otorhinolaryngological practice. Canalolithiasis and cupulolithiasis are the main theories which describe the pathophysiology of BPPV. Particle repositioning maneuvers are non invasive, simple, bedside procedure that are better tolerated by patients and give symptomatic relief. Aim: To compare the effectiveness of Epley’s vs Semont’s maneuver in the treatment of Posterior Semicircular Canal (PSC) BPPV. Materials and Methods: A cohort study was conducted in Otorhinolaryngology Department of Chettinad Hospital and Research Institute from October 2020-March 2021. A total of 108 patients who reported to the outpatient department and were diagnosed with PSC BPPV were included in this study. A detailed clinical history was recorded audio vestibular examination was conducted and Dix-Hallpike maneuver were performed to confirm the diagnosis. Following which, patients were subjected to treatment with either Epley’s maneuver or Semont’s maneuver. A total of 54 patients were treated with Epley’s maneuver and 54 patients were treated with Semont’s maneuver. Patients were followed-up one week after performing the maneuver. In case of presence of persistent symptoms, the maneuver was repeated upto a maximum of three times. Successful treatment was assessed based upon the patient’s symptomatic improvement of vertigo and a negative Dix-Hallpike test which was performed at the follow-up. Data was presented in proportion (descriptive statistics) and chi-square test was used. The p-value &lt;0.05 was considered as statistically significant. Results: In a total of 108 cases, the most common age group affected by BPPV was that of 21-40 years. Left side BPPV was noted in 50 (46.3%) patients, right side BPPV in 48 (44.4%) patients and 10 (9.3%) patients were found to have bilateral BPPV. Fifty two patients responded well for Epley’s maneuver and had complete resolution of symptoms on first follow-up and 46 patients responded to Semont’s maneuver and improved symptomatically. Conclusion: Greater number of patients improved symptomatically in the first visit itself with Epley’s maneuver compared to Semont’s maneuver. Hence, Epley’s maneuver is the preferred initial treatment and effective modality for PSC BPPV.

Eozinofilní ezofagitida – 10 let zkušeností pěti českých pediatrických endoskopických center

Background: Eosinophilic esophagitis (EoE) is a chronic, progressive inflammatory disease of the esophagus characterized by local eosinophilic infiltration accompanied by symptoms of esophageal dysfunction. The aim of this study was to characterize features of EoE dia gnosed regionally and to describe local strategies for its treatment. Methods: The observational survey retrospectively analyzed a data set of child patients with histologically proven EoE from five pediatric endoscopy centers. This analysis focused on describing their general situation (age, gender, symptoms) and also aimed to investigate any possible linkage between age and symptoms or length of dia gnosis period. Demographic features; clinical symptoms; laboratory, endoscopic, and histopathological findings; and chosen treatment of patients were recorded and analyzed. Results: From January 2010 to September 2020, 33 new cases of EoE were reported. Strong association of EoE with male sex is consistent with the results from formerly published studies (81.8%). The median age of symptom onset was 7 years, while the median age for dia gnosis was almost 13 years. The most common symptoms were reflux symptoms in general (39.4%), followed by vomiting (36.4%), and dysphagia (33.3%). Examination for sensitization to food allergens was performed on 23 (69.7%) patients with dia gnosed EoE. Out of these, 17 (51.5% of all cases) were found to be sensitive to some allergens. Most of this subgroup (and 48.5% of all cases) were examined by specific IgE testing, and just 2 (6.1% of all cases) patients were tested only by skin prick tests. Another allergic comorbidity was present in 75.8% of patients, and the most common of these were bronchial asthma and allergic rhinoconjunctivitis (45.5% and 42.2%, respectively). More than two-thirds of patients (69.7%) had abnormal macroscopic findings during dia gnostic endoscopy, and the most common were longitudinal furrows and white exudates. The most common initial modality of treatment was to use proton-pump inhibitors (PPI; 93.9%), followed by food elimination (75.8%) and then by corticosteroid administration (63.6%). The vast majority of patients treated with corticosteroids received a topical preparation (90.9%). Conclusion: This is the first retrospective study on pediatric patients with EoE in the Czech Republic. We found similar features of EoE as reported in formerly published works elsewhere. Collecting long-term prospective observational data in a national EoE register of patients in the Czech Republic would significantly improve our knowledge of this disease.

Trends in Pediatric Thyroid Cancer Incidence, Treatment, and Clinical Course in Korea During 2004-2016: A Nationwide Population-Based Study.

Background: The incidence of thyroid cancer has increased worldwide. We investigated nationwide trends in the incidence and treatment course of pediatric thyroid cancer in South Korea. Methods: Using the National Health Information Database, we analyzed 1580 patients (324 males) <20 years of age diagnosed with thyroid cancer during 2004-2016 in South Korea. The annual percentage change (APC) in the age-standardized incidence rate (ASR) was calculated by joinpoint regression analysis. The initial treatment modality was categorized as either surgery only or surgery with radioactive-iodine treatment (surgery+RAIT), and we defined new treatment events as reoperations or additional RAITs among 1464 patients followed up for ≥12 months. Results: During 2004-2016, the mean ASR per 100,000 person-years increased from 0.6 [confidence interval; CI 0.5-0.8] to 0.9 [CI 0.8-1.1], with a mean APC of 4.0% [CI 1.8-6.2]. The ASRs (APCs) among 0-9-, 10-14-, 15-17-, and 18-19-year olds were 0.07 (9.9% [CI 0.08-20.7]), 0.6 (4.6% [CI 0.2-9.2]), 2.2 (3.9 [CI 1.7-6.0]), and 4.2 (3.5% [CI 0.9-6.2]), respectively. The lobectomy and lymph-node-dissection rates increased (from 18.5% to 33.6%, p = 0.0014; and from 29.6% to 84.5%, p < 0.001; respectively), but the RAIT rate decreased (67.9-39.7%, p < 0.001) during the study period. During a median 6.3-year follow-up, two patients died. New treatment events occurred in 56 (10.7%) of patients in the initial surgery-only group (n = 523). In the initial surgery+RAIT group (n = 941), 316 patients received two or more RAITs within 2 years, and 80 (12.8%) of the remaining 625 patients underwent new treatment events. In the surgery+RAIT subgroup, the event-free survival rate was lower in 0-14-year olds than in 18-19-year olds (hazard ratio 2.5 [CI 1.4-4.4]). Conclusions: The pediatric thyroid cancer incidence increased from 2004 to 2012 in South Korea. The lobectomy and lymph-node-dissection rates increased, but the RAIT rate decreased. The higher risk for new treatment events in patients younger than 15 years requiring initial RAIT may be linked to advanced stage at diagnosis, and it needs to be further evaluated.

QOL-27. SWALLOWING ASSESSMENT IN PEDIATRIC PATIENTS WITH BRAIN TUMOR

BACKGROUNDNeurosurgical intervention is the initial modality of treatment for the vast majority of pediatric brain tumors. However, studies on the swallowing process in pediatric patients with brain tumors are scarce, especially comparing changes that can be identified before and after surgery. In clinical practice, it is possible to observe that these patients may present modifications in the swallowing phases both before and after surgery. Therefore, we conducted a longitudinal study with a cohort of 20 patients ranging in age from 0 to 17 years, in order to characterize the swallowing disorders.RESULTS30% of the patients presented some change in orofacial motricity in the organs related to initiation, coordination, and maintenance of swallowing at the time of hospital admission, and 65% of the patients exhibited these changes after surgery. Due to worsening in swallowing after surgery, 40% of the patients required modification of the consistence of oral diet or required the use of an alternative route of feeding.CONCLUSIONSThere is a high prevalence of swallowing disorders in pediatric patients with brain tumors, mainly regarding the proper functioning of organs related to initiation, coordination, and maintenance of swallowing even before the surgical intervention, and these changes increase after surgery - especially in patients with posterior fossa tumors. The role of the speech/language pathologist is of paramount importance, given their role in the assessment and adequacy of the feeding route, identifying patients at risk of pulmonary aspirations, minimizing swallowing complications, and also facilitating communication with patients and their families.

Outcomes of Active Surveillance Versus Initial Treatment for Nodular Lymphocyte Predominant Hodgkin Lymphoma: A National Cancer Database (NCDB) Analysis of 2,480 Patients

Introduction Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL) is a unique and clinically distinct subtype of Hodgkin lymphoma (HL), comprising approximately 5% of all HL cases with an annual incidence of about 1-2 cases per million. Compared with classical HL (cHL), NLPHL is more likely to present with limited stage and a more indolent clinical course. Despite these favorable traits, systemic chemoimmunotherapies and/or radiation are often used for initial treatment. Deaths directly from NLPHL are uncommon, with mortality in these patients often attributable to treatment-related toxicities or transformation to aggressive non-Hodgkin B-cell lymphomas. There is emerging evidence that NLPHL can be treated more conservatively. Active Surveillance (AS), a strategy by which initial treatment is deferred in favor of close observation, has been evaluated in single-institution retrospective studies spanning decades. Borchmannet alreported comparable overall survival (OS) for patients managed with AS versus upfront treatment (Blood, 2019). While encouraging, additional contemporary data are needed to determine if AS is a safe option for NLPHL patients, given advances in supportive care, addition of anti-CD20 therapies, improved radiation delivery, and better diagnostic methods. This retrospective National Cancer Database (NCDB) study evaluates the effect of initial treatment modality on overall survival in a contemporary population of patients with NLPHL to determine if initial AS has comparable OS when compared with initial treatment. Methods The National Cancer Database (NCDB) is a nationwide oncology outcomes database for more than 1500 accredited cancer programs in the United States. The NCDB was queried for all patients with the diagnosis of NLPHL, defined by histology code 9659. Filters for inclusion included year of diagnosis from 2010 to 2015, B-cell/pre-B/B-precursor histologic subtype, known treatment status, and with survival data available. Demographic, socioeconomic, treatment modality, and clinical factors such as stage and Charlson-Deyo comorbidity indices were summarized. Chi-square tests were used to correlate factors with treatment status. Kaplan-Meier methods were used to estimate overall survival, and log rank test was used to compare OS between patient groups. Cox proportional hazard model was used to associate patient characteristics with OS, and backwards elimination was used to identify the final Cox model, starting from all factors in univariate analysis. Results A total of 2,480 patients with NLPHL diagnosed between 2010 and 2015 were included. Of these, 553 patients were older than 60 years (22.3%), 1,616 were male (65%), and 2,110 had a Charlson-Deyo score of 0 (85%) while 370 had a score of ≥1 (15%). 1,627 had Stage I-II disease (65.6%) while 731 had Stage III-IV disease (29.5%). Overall, 2,330 patients were alive (94%) and 150 were deceased (6%), with a median follow-up of 36.8 months (range 0.1 to 94.3 months). Initial management options included: treatment (radiation, chemo/immunotherapy, and/or surgery), no treatment (e.g. palliative care only), or AS. 2,309 patients (93.1%) were initially treated (IT), 103 (4.15%) received no treatment (NT) and 68 patients (2.74%) underwent AS. OS by treatment strategy is shown in Figure 1. In univariate analysis, there was no OS difference between IT vs AS (HR 0.71; 95% CI 0.31-1.61, P=0.41) or NT vs. AS (HR 2.03; 95% CI 0.75-5.51; P= 0.16), but there was a significant difference between NT and IT (HR 2.87; 95% CI 1.56-5.32, P=0.0008). In the final Cox multivariate analysis, there was no significant difference between three treatment groups (overall P=0.10). Age &amp;gt;60, male gender, those with government insurance, Charlson-Deyo score ≥1, and Stage IV were all associated with decreased OS (Table 1). Conclusion In this large NCDB outcomes analysis of 2,480 NLPHL patients, those selected for AS had no difference in overall survival compared to patients who were initially treated. This lends support to emerging evidence that AS is a viable option for a subset newly diagnosed NLPHL patients, as is routine for indolent non-Hodgkin Lymphoma. Future study is needed to identify clinical features associated with a more indolent NLPHL phenotype that may be amendable to less intense initial management. Disclosures Hill: Karyopharm:Consultancy, Honoraria, Research Funding;Takeda:Research Funding;Celgene:Consultancy, Honoraria, Research Funding;BMS:Consultancy, Honoraria, Research Funding;Novartis:Consultancy, Honoraria;Kite, a Gilead Company:Consultancy, Honoraria, Research Funding;AstraZenica:Consultancy, Honoraria, Research Funding;Beigene:Consultancy, Honoraria, Research Funding;Pharmacyclics:Consultancy, Honoraria, Research Funding;Abbvie:Consultancy, Honoraria, Research Funding;Genentech:Consultancy, Honoraria, Research Funding.

Management of adult spine deformity in the elderly

Adult spinal deformity represents a growing problem in the elderly population (age 60 or older). A comprehensive examination, including imaging, is critical for guiding treatment. For most, non-operative management represents the initial treatment modality; however, few studies support its clinical utility. The decision to pursue surgery requires comprehensive preoperative evaluation, given the increased risk of surgical complications seen in elderly patients. Despite the increased risk of complications, patients treated surgically demonstrate significant improvement in clinical and radiographic parameters. This paper will review literature evaluating non-operative and operative management of adult spinal deformity in the elderly patient.