bluuebunny/crossref_metadata_2025_split huggingface dataset:
Sintilimab plus oxaliplatin/capecitabine (CapeOx) as neoadjuvant therapy in patients with locally advanced, resectable gastric (G)/esophagogastric junction (GEJ) adenocarcinoma.
Authors: Jiang Haiping , Yu Xiongfei , Kong Mei , Ma Zhiming , Zhou Donghui , Wang Weibing , Wang Haohao , Li Ning , Wang Haiyong , He Kuifeng , Li Zhongqi , Lu Yiming , Zhang Jing , Zhao Kui , Zhang Yafei , Xu Nong , Teng Lisong 
Published: January 2021

211 Background: The application of anti-programmed death 1 (PD-1) antibodies in neoadjuvant setting has not been well established. This phase 2 study (NCT04065282) was conducted to evaluate the efficacy and safety of sintilimab plus CapeOx as neoadjuvant therapy for resectable G/GEJ adenocarcinoma. Methods: Patients with histologically confirmed resectable G/GEJ adenocarcinoma (stage cT3-4NxM0) were enrolled to receive neoadjuvant therapy with sintilimab (3mg/kg for wt < 60kg, 200mg for wt ≥60kg, Q3W) plus CapeOx (oxaliplatin 130mg/m2 iv D1, capecitabine 1000mg/m2 bid po D1-14, Q3W) for 3 cycles. Gastrectomy was scheduled within 4 weeks after last dose of neoadjuvant treatment. Tumor imaging evaluation was performed at baseline and within 1 week before gastrectomy. The primary endpoint was pathological complete response (pCR) per Becker criteria. Results: As of August 4, 2020, 36 pts were enrolled. Patients who had received gastrectomy after neoadjuvant treatment (n = 26) were included in this analysis. 25 (96.2%) pts completed 3 cycles of neoadjuvant treatment, except one completed 2 cycles due to grade 3 AST increased. All pts received complete resection (R0). 6 (23.1%) pts achieved pCR (TRG1a) and 14 (53.8%) pts achieved major pathologic response (MPR, TRG1a/b). 3 pts had partial response (ORR was 3/5 among pts with target lesions) and no patients progressed per RECIST 1.1 before surgery. Among 18 pts who received PET-CT evaluation per PERCIST, 11 (61.1%) achieved partial metabolic response (PMR). Neoadjuvant treatment-related AEs (neoTRAEs) to any drug were reported in 25 (96.2%) pts. Mostly TRAEs were grade 1-2, and only 6 (23.1%) pts experienced grade 3 TRAEs (Neutropenia in 4 pts, Leukopenia, Thrombocytopenia, AST increased, and GGT increased in 1 pt each). One patient experienced grade 1 hypothyroidism which is considered to be immune-related AE. There is no serious peri-operative complication and mortality. Conclusions: Sintilimab plus oxaliplatin/capecitabine showed promising efficacy with high pCR and MPR rate and well-tolerated safety profile in neoadjuvant settings. This combination regimen might present a new option for patients with locally advanced, resectable G/GEJ adenocarcinoma. Clinical trial information: NCT04065282.
Exploring the diagnostic journey and life impact of patients with cholangiocarcinoma (CCA): Results from a large patient survey in the United States.
Authors: Bibeau Kristen , Bachini Melinda , Lindley Anouk , Barkey Natalie Marie , Lindsey Stacie 
Published: January 2021

277 Background: Patients (pts) with CCA typically present with advanced disease and face a poor prognosis and impaired quality of life (QoL). Despite improvements in therapies, the impact of CCA on pts’ daily lives has been rarely studied. This pt-focused survey explored the diagnostic journey, life impact including work status, QoL and psychosocial impacts of CCA. Methods: Pts with CCA were recruited in partnership with the Cholangiocarcinoma Foundation from Aug 23 through Sept 20, 2019, and were categorized by AJCC stage. Pts participated in a 30-min online survey to assess disease staging, symptoms, demographics, diagnosis journey, daily life impact, mental health, and sexual function. The survey included the validated disease specific European Organization for Research and Treatment of Cancer (EORTC) QLQ-BIL21, the Patient Health Questionnaire-9 (PHQ-9), and the Work Productivity and Activity Impairment (WPAI) questionnaire. Results: Of 1,286 pts invited, 707 (55%) completed the survey (male, 77%; age ≥55 y, 13%; currently employed, 78%; perihilar CCA, 47%; intrahepatic CCA, 41%; distal CCA, 12%; stage 1–2, 22%, stage 3a, 51%, stage 3b–4, 20%, in remission, 4%, unknown stage, 2%). Median duration from symptom onset to CCA diagnosis was 19 months (range, 1–241), and median duration from diagnosis to completing survey was 24 months (0–744). Initial misdiagnosis occurred in 35% of pts (n=247); among whom the most common misdiagnosis was gall bladder cancer (52% [n=129]); misdiagnosis of cancer of unknown origin occurred in 9% of pts (n=21). CCA was most frequently first suspected and diagnosed by oncologists (38% [n=269] and 70% [n=492]); among non-specialty physicians, more first suspected than diagnosed CCA (eg, primary care physicians, 22% [n=156] vs 3% [n=22]). Pts’ primary considerations in treatment decisions were physician judgment (38% [n=272]), QoL (16% [n=111]), time spent in hospital (11% [n=75]), laboratory results (11% [n=79]), other pt experiences (6% [n=42]). On the EORTC QLQ-BIL21, pts reported negative life impact from anxiety (mean [SD], 52.9 [19.2]), tiredness (52.3 [19.3]), and treatment (51.3 [28.8]). On the WPAI, 61% of pts (n=429) reported some, and 28% (n=200) reported considerable impact on work status. On the PHQ-9, 58% (n=408) of pts reported significant impact of depression on daily life, with 72% (n=506) and 25% (n=177) reporting that depression makes daily life somewhat, or very difficult, respectively. Pts also reported considerable or some impact on sexual desire (51% [n=362]; 36% [n=255]) and intimacy (47% [n=332]; 39% [n=273]). Conclusions: Pts with CCA who participated in this survey were mostly <55 y of age and had experienced CCA symptoms for an extended time (2 y) before diagnosis, at which time CCA was often initially misdiagnosed. The burden of CCA symptoms on daily lives, work productivity, and mental health is immense.
The impact of changes in service delivery in patients with colorectal cancer during the first peak of the COVID-19 pandemic.
Authors: Kamposioras Konstantinos , Lim Kok Haw Jonathan , Saunders Mark P. , Marti Kalena , Anderson Daniel , Cutting Mark , McCool Danielle , Connell Jacqueline , Simpson Lilly , Hasan Jurjees , Braun Michael , Lavin Victoria , Mullamitha Saifee , Barriuso Jorge 
Published: January 2021

28 Background: Increased levels of anxiety and distress in both patients and physicians have been reported in response to the significant impact COVID-19 has on cancer service delivery globally. We aimed to investigate how these changes have been perceived by patients diagnosed with colorectal cancer and identify determinants of increased anxiety. Methods: Survey (32-item) of consecutive patients diagnosed with colorectal cancer attending a large tertiary comprehensive cancer centre in the United Kingdom (18 May to 1 July 2020). Self-reported GAD-7 (both paper/electronic forms) was used as a screening tool for anxiety. Statistical analyses of associations:Chi-square, Fisher’s exact, and uni- and multi-variable analyses were performed using SPSS v19 and R. Results: A total of 143 patients (response rate 67%), 82% male, and median age of 61-70 years were included. Majority of patients had telephone consultation (78%), including 40% who had scan results discussed over the phone; with favourable feedback received with both respectively. Twenty-three patients (18%) were considered to have anxiety, with 7 (6%) scoring for moderate or severe anxiety. Three items asked patients if they had concerns about getting COVID-19, were worried that COVID-19 would have effect on mental health, and affect their experience of cancer care. Patients answering positively to any of these items were most likely to have anxiety; multivariate analysis – OR 2.361 (95% CI 1.187-4.694, p=0.014), 3.219 (95% CI 1.401-7.395, p=0.006) and 3.206 (95% CI 1.036-9.920, p=0.043), respectively. Majority of the patients did not feel that they needed support during the pandemic period and hence the available well-being services were not used. Patients felt that friends and family had been very supportive but less so the primary care services (p<0.05). However, they felt they were supported by the clinical team. Conclusions: At our centre, during the first-peak of COVID-19 pandemic in the UK, patients with colorectal cancer did not display increased rates of significant anxiety. The findings of this survey suggests that some service changes implemented, including increased telephone follow-up, may have already improved the overall experience of cancer care. Importantly, patients were much more concerned about their cancer treatment than COVID-19, emphasising the need to continue to provide comprehensive cancer care even if we get a “2nd wave” of COVID-19.
Safety, tolerability and efficacy of transarterial chemoembolization using anthracyclines-loaded drug eluting microspheres for treatment of patients with unresectable hepatocellular carcinoma: Pooled analyses.
Authors: De Baere Thierry , Veloso Gomes Filipe , Verset Gontran , Tovar-Felice Gerardo , Malagari Katerina , Coimbra Elia , Bruix Jordi 
Published: January 2021

287 Background: Transarterial chemoembolization either with Lipiodol (cTACE) or with drug eluting microspheres (DEM-TACE) is indicated for the treatment of hepatocellular carcinoma (HCC) not amenable to curative treatments in patients with preserved liver function. Safety of TACE is becoming more important with its increased use as a bridge to transplant or downstaging to resection, but also for preservation of liver function in case of subsequent immuno-combination therapies. LifePearl microspheres is a novel DEM comprised of polyethylene-glycol with reported good safety profile and efficacy in smaller series. Our purpose was to assess safety and efficacy of TACE using anthracycline loaded LifePearl for the treatment of patients with unresectable HCC in a pooled analysis of studies with available more than 500 patient’s level data. Methods: We pooled patient level data from 5 single arm studies. Safety was assessed by close monitoring of adverse events according to CTCAE (v4.03). Tumor response was assessed, according to mRECIST and RECIST1.1 and analyzed as best overall response to account for differences in time of imaging follow-up between studies. The Kaplan-Meier method was used to estimate event rates for time to event outcomes: progression free survival (PFS), time to unTACEable progression (TTUP) and overall survival (OS) censoring patients at time of surgery or transplantation. Results: Out of 586 patients, 85.5%, 13.5% and 1.0% were Child Pugh A, B and C, respectively. BCLC stages 0, A, B and C were 13.6%, 43.4%, 41.1% and 1.9% respectively. The mean number of HCC lesions was 2.1±1.5 and mean sum of tumor diameters was 49.3±32.9mm. In 19% of patients alpha-feto protein level was > 200ng/ml. A mean of 1.9±1.3 DEM-TACEs were performed per patient. A total of 197 events were reported including 2.6 % grade 4 and 1.5% grade 5, mostly related to post-embolization syndrome. Complete response, partial response and stable disease were 60.2%, 27.1% and 7.4% respectively providing an objective response and disease control rates of 87,3% and 94,7% respectively. 10% of patients were transplanted or resected. Median OS, PFS and TTUP is indicated in the table below. OS was 89.2%, 80.2% and 69.7% at 12, 18 and 24 months respectively. Conclusions: The treatment of patients with unresectable HCC with anthracycline loaded LifePearl showed good tolerance with acceptable toxicity and high tumor response rate that translated into promising PFS, TTUP and OS. [Table: see text]
Understanding the impact of COVID-19 on the colorectal cancer community: Barriers and opportunities for care.
Authors: Garcia Reese , Dwyer Andrea , McDonnell Molly 
Published: January 2021

29 Background: The novel coronavirus (COVID-19) has caused numerous disruptions across the cancer prevention and treatment landscape. Conservative modeling studies examining the effect of COVID-19 on cancer screening and treatment for breast and colorectal cancer (CRC) suggest that there will be 10,000 excess deaths from both cancers combined over the next decade. The goal of this analysis was to better understand the impact of COVID-19 on the CRC community, including gaps and opportunities for improving access to care and survivorship needs, and to advocate for the best possible care through policy, education and engagement of the entire cancer ecosystem. Methods: In April 2020, Fight Colorectal Cancer (Fight CRC) distributed an online survey to the colorectal cancer community. The survey was distributed through social media channels and targeted emails from April 24-May 5, 2020. Virtual focus groups were also conducted to gather rich qualitative data from cancer patients and caregivers about their experiences during the novel coronavirus pandemic. Results: In total, 222 individuals responded to the survey (survivors = 68%, caregiver = 12%, first degree family member = 8%, other = 8%), and 10 CRC survivors participated in focus groups (stage III = 30%, stage IV = 70%). Treatment disruptions and mental health were prevalent themes in both the survey and focus group. Over one-third of survey respondents indicated facing treatment disruptions (37%) and a majority (78%) of colorectal cancer patients reported feeling nervous and anxious. Another primary concern among respondents was access to care. Patients on Medicare were more likely than patients on private insurance to report having difficulties affording food and basic supplies. People living in rural areas were more likely to have greater concerns about maintaining a supportive network than those living in suburban areas. Conclusions: People with cancer face unique challenges as a result of the novel coronavirus, including treatment disruptions, increased feelings of anxiety, and financial concerns. Numerous health inequities also exist among low-income and rural patient groups. Identifying the barriers that patients face provides an opportunity to address the nuanced needs of the colorectal cancer community. Clinicians, supportive care providers, and advocacy organizations can tailor care delivery, increase access to care, and prepare patients for the future with reliable and accurate resources amidst a pandemic.
The use of cabozantinib in advanced hepatocellular carcinoma (HCC): Hong Kong multi-center experience.
Authors: Dong Yawen , Leung Thomas Wai-Tong , Kwok Gin Wai , Tang Vikki , Li Bryan , Leung Roland Ching-Yu , Chiu Joanne Wing Yan , Wong Jeffrey Sum Lung , Ma Ka Wing , She Wong Hoi , Tsang Wing Yan Josephine , Cheung Tan To , Yau Thomas 
Published: January 2021

316 Background: In the phase III CELESTIAL trial, cabozantinib showed significant improvement in overall survival with good tolerability in advanced HCC population. We aimed to evaluate the efficacy, survival and tolerability of cabozatinib in advanced hepatocellular carcinoma (HCC) patients in a real life setting. Methods: Between February 2018 and October 2019, consecutive advanced HCC patients who received cabozatinib alone or in combination at University of Hong Kong Health System hospitals were analysed. Cabozantinib was administered at 60 mg continuously daily. Objective response rate (ORR), time-to-progression (TTP), overall survival (OS), and tolerability were evaluated. Results: Overall, 22 patients were included. The median age was 57.1 years (range 48.5-58.6). All patients except one were hepatitis B carriers. More than 80% of the patients had underlying Child-Pugh A cirrhosis. Most patients had metastatic disease (95.5%). More than 70% of patients received cabozantinib beyond second-line, and most of the patients had prior exposure to tyrosine kinase inhibitor (TKI) and/or immunotherapy. The median time from the start of first-line systemic treatment to the start of cabozantinib was 11.2 months. Cabozantinib was administered to 11 patients (50%) as single agent, while the other half received cabozantinib in combination with mostly immune checkpoint inhibitors. The median follow-up was 7.6 months. The table below shows the ORR. The overall median TTP and OS were 4.2 and 8.90 months, respectively. Interestingly, among those who received single agent cabozantinib, the median OS was 5.36 months in contrast to 12.32 months in the patients received combination. Overall, 90.9% of patients experienced treatment related adverse events (TRAEs) with transient liver function occurred in nearly 50% patients. Nevertheless, Grade 3/4 TRAEs was only 12%. Conclusions: Our present study showed that the use of cabozatinib in advanced HCC patients had good anti-tumour activity and survival benefits with acceptable toxicity profile. [Table: see text]
Second-line chemotherapy (2L) in elderly patients with advanced biliary tract cancer (ABC): A multicenter real-world study.
Authors: Rizzo Alessandro , Salati Massimiliano , Frega Giorgio , Merz Valeria , Caputo Francesco , Ricci Angela Dalia , Palloni Andrea , Messina Carlo , Spallanzani Andrea , Saccoccio Gioconda , Mollica Veronica , Gelsomino Fabio , Benatti Stefania , Luppi Gabriele , Melisi Davide , Dominici Massimo , Brandi Giovanni 
Published: January 2021

322 Background: The ABC-06 trial recently established the role of 2L in ABC progressing after platinum/gemcitabine combination. However, older patients are often under-represented in clinical trials and no data are currently available regarding 2L in elderly ABC. The aim of this real-world study was to explore the treatment pattern, safety and efficacy of 2L in ABC patients aged ≥ 70 years old and to compare their outcomes with younger subjects. Methods: Institutional registries across three academic medical centers were retrospectively reviewed and data of interest retrieved to identify ABC who had received 2L from October 2002 to July 2020. Patients older than 70 years were considered as elderly individuals. The Kaplan-Meier methods was used to estimate survival and the log-rank test to make comparison. The impact of variables on survival was assessed through univariate and multivariate analysis. Results: A total of 190 ABC patients treated with 2L were identified and included in the analysis. Among them, 27.3% (n = 52) were aged ≥ 70 years (range 70-87y), of whom 25 patients had iCCA (48%), 13 GBC (25%) and 15 eCCA (27%). 56% (n = 29) were female and 38 (73%) patients had an ECOG-PS 0-1. The most frequently administered 2L regimens were capecitabine monotherapy (n = 14, 27%), single-agent gemcitabine (n = 9, 17%) and gemcitabine/capecitabine combination (n = 9, 17%). No differences in terms of prior surgery (p = 0.64) and 2L treatment intensity (p = 0.34) were observed compared to patients aged < 70 years. The disease control rate of 2L was 28.8% and 29.7% in elderly and youngers, respectively. No statistically significant differences in both mOS (5.7 months in elderly vs 6.1 months in youngers, HR 0.97; p = 0.86) and mPFS (4.7 vs 4.8 months, HR 0.88; p = 0.44) were recorded. Regarding the safety profile of 2L, grade 3 or 4 treatment-related toxicities occurred more frequently in the older group (48.5% versus 8.2%; OR 6.31; p < 0.001). When looking at prognostic factors, absolute lymphocyte count < 1000/mmc (p < 0.001) and albumin level < 3 g/dL (p < 0.001) were independently associated with worse prognosis. Conclusions: The results of this real-world study, limited by its retrospective nature and small sample size, suggest that for patients aged ≥ 70 years, 2L could be equally effective as for youngers, with survival outcomes aligned to those from ABC-06 trial. Notably, based on the higher incidence of grade 3-4 adverse events, the delivery of 2L should be carefully evaluated and monitored in this patient subset.
Results of a phase Ib study of regorafenib (REG) 80 mg/day plus pembrolizumab (PEMBRO) for first-line treatment of advanced hepatocellular carcinoma (HCC).
Authors: Kim Richard D. , Harris William P. , Sung Max W. , Waldschmidt Dirk Thomas , Cabrera Roniel , Mueller Udo , Menezes Flavia , Ishida Tatiane , Galle Peter R. , El-Khoueiry Anthony B. 
Published: January 2021

323 Background: In a phase Ib study, REG 120 mg/day plus PEMBRO for first-line treatment of advanced HCC showed no unexpected safety signals and encouraging anti-tumor activity. At the maximum tolerated dose (MTD) of REG (120 mg/day), approximately three-quarters of patients (pts) had a REG dose reduction or interruption due to a treatment-emergent adverse event (TEAE). Here, we present preliminary data for the REG 80 mg/day cohort. Methods: This is an ongoing, dose-finding study in pts who had no prior systemic therapy. In the first cohort, pts received REG 120 mg/day orally for 3 weeks on/1 week off plus PEMBRO 200 mg intravenously q 3 weeks. In later cohorts, the REG dose could be escalated (160 mg/day) or reduced (80 mg/day); the PEMBRO dose is fixed. The primary objective is safety and tolerability. Secondary objectives are to define the MTD and recommended phase II dose and assess anti-tumor activity. Results: By July 24, 2020, 16 pts were treated with REG 80 mg/day. Median age was 67 years (range 56–79), 25%/75% were Barcelona Clinic Liver Cancer stage B/C, 100% Child–Pugh A, and 69%/31% had Eastern Cooperative Oncology Group performance status 0/1. Grade (Gr) 3 TEAEs occurred in 8/16 pts (50%) and there were no Gr 4 TEAEs (Table); one pt experienced Gr 5 pneumonitis (not drug related). There were no reports of Gr 3 hand–foot skin reaction or Gr 3 maculopapular rash, and one report (6%) of Gr 3 rash. TEAEs led to a REG dose reduction or interruption in 50% of pts and to a PEMBRO dose interruption in 25% of pts. Median treatment duration (range) including pts ongoing was 4.1 months (0.4–7.1) for REG and 3.8 months (0.03–7.2) for PEMBRO. Of 13 evaluable pts, 2 (15%) had a partial response and 9 (69%) had stable disease (Response Evaluation Criteria in Solid Tumors v1.1); disease control rate was 85%. Conclusions: These preliminary results for the combination of REG 80 mg/day plus PEMBRO for first-line treatment of advanced HCC were consistent with the REG 120 mg/day cohort. The combination showed no unexpected safety signals and encouraging anti-tumor activity. Assessment of REG 80 mg/day plus PEMBRO is ongoing. Clinical trial information: NCT03347292. [Table: see text]