tbuckley/cabot-search huggingface dataset:
Key features to ensure sustainability of a tele-oncology program at a national cancer center.
Authors: Chevon Rariy, Lynn Truesdale, Jennifer Greenman, Julian C. Schink
Journal: Journal of Clinical Oncology (2021)

e13613 Background: Prior to COVID-19, there were few telehealth services offered in the oncology specialty area. During the pandemic, we at a national cancer center rapidly scaled our oncology telehealth program to meet the needs of our patients. At the peak of the pandemic, telehealth initially served as a risk-mitigation strategy providing continued care to our patients while socially distancing, yet additionally, we have embedded necessary processes in place to create a sustained a telehealth oncology program that encompasses a hybrid model including face to face visits augmented with telehealth visits, where appropriate. Here we describe the key telehealth program features that have enabled a national cancer center to evolve into a hybrid model of oncology care across its five geographically distinct hospitals. Methods: Transitioning into a sustainable hybrid telehealth model of care involves a foundation of clinical leadership and partnerships among multiple departments. The telehealth oncology program leaders collaborate with the operations, technology, finance, clinical care teams, and governance council to implement telehealth growth initiatives and nimbly troubleshoot and ameliorate issues. A concierge service provides telehealth readiness checks to ensure timely resolution of issues. Workflows are followed to standardize processes. Telehealth use-cases ensure patients who need on-site services keep their in-person appointments, allowing telehealth visits for symptom management to enhance patient outcomes. A provider education session includes training on telehealth technology and “webside manner” training to ensure we preserve the personal touch with our patients in each telehealth encounter. Program data is regularly collected and reviewed to track the program’s success and opportunities for improvement. Results: After the initial peak of telehealth visits driven by the COVID pandemic, we continue to see a sustained 10-fold increase in service volume versus Jan/Feb 2020. There were 25,328 total telehealth visits from Mar. 2020-Jan. 2021, 75 clinical trial visits between July-Dec. 2020, and 848 readiness check escalations from Nov. 2020-Dec. 2021. Service lines expanded from 2 to 33, including growing rural health partnerships and a home chemotherapy infusion model. Use-cases expanded to bridge to on-site care, rapid initial visits, preop/postop checks, symptom management, and surveillance. Press Ganey patient satisfaction rates are as high as 92% and 90% of providers reported overall satisfaction with the telehealth consultations. Conclusions: Our key program features have enabled the growth and success of our enterprise tele-oncology program. One of the most promising indicators of success is the positive provider and patient satisfaction rates. Telehealth provides an effective means to provide a bridge to onsite cancer care even for our complex oncology patients.
Healthcare professionals’ perspectives on unique communication and care needs for Chinese American cancer patients.
Authors: Courtney Schroeder, Emma Ernst, Tamara Vesel
Journal: Journal of Clinical Oncology (2021)

e24122 Background: Effective clinician-patient discussions of cancer diagnoses and prognoses are essential to enhance health outcomes in diverse oncology populations. To provide guidance on communication preferences and needs among Chinese Americans, one of the fastest growing yet understudied ethnic groups in the United States, we explored considerations and observations from healthcare providers experienced in caring for this oncologic population. Methods: In this inductive, emergent qualitative study, we completed 20 semi-structured virtual interviews with providers from assorted healthcare disciplines with experience caring for Chinese American cancer patients in Boston’s Chinatown. Responses were systematically collected and analyzed using open and focused coding, constant comparative methods, and thematic analysis. Results: Twenty healthcare professionals with experience working with the Chinese American patients were interviewed including medical oncologists, radiation oncologists, primary care physicians, nurses, nurse practitioners, social workers, case managers, patient navigators and dietitians. Fifteen were female, 5 were male, and 11 participants self-identified as Asian. Six key themes were identified: (1) Discussing cancer diagnoses and prognoses is taboo and often avoided by Chinese Americans in family, community, and healthcare settings. (2) A cancer diagnosis may be considered a death sentence by Chinese Americans, regardless of cancer location or stage. This could be related to the meaning implied by direct translation of the word “cancer.” (3) In settings where cancer diagnoses and prognoses are discussed, Chinese American patients often prefer indirect communication approaches including use of expressions such as “tumor,” “mass,” or “illness” to avoid the use of the word “cancer.” (4) The family centered role in medical decision making for Chinese American cancer patients and the preference of some family units to protect the patient from their diagnoses present unique challenges in the context of standard care. (5) Obtaining a detailed psychosocial history is important to guide communication approaches, as patient characteristics like age, generation since immigration, and education play a foundational role in communication preferences. (6) Karma and nutritional beliefs should be considered and addressed in oncologic care, as they play a critical role in health and disease management for Chinese American cancer patients. Conclusions: Further exploration of these insights and confirmation of their accuracy by discussing directly with Chinese American patients is imperative. If these findings are corroborated through further investigation, this knowledge can be used develop educational tools and implement clinical practice changes to enhance care outcomes and communication with Chinese American cancer patients.
Long-term follow up of patients with mesothelioma treated with dendritic cell therapy in three phase I trials.
Authors: Daphne W Dumoulin, Robin Cornelissen, Koen Bezemer, Sara Baart, Joachim Aerts
Journal: Journal of Clinical Oncology (2021)

2618 Background: Immunotherapy targeting PD-(L)1 has become indispensable in the treatment of many malignant tumors. Recently, checkpoint inhibition using anti-PD-1 in combination with anti-CTLA-4 was proved to be effective in patients with malignant pleural mesothelioma (MPM). However, the minority of patients benefit from this treatment. The lack of immunotherapy efficacy in the majority of patients with mesothelioma can be explained by the fact that mesothelioma is a tumor with an “immune-desert” phenotype, meaning a non-inflamed tumor characterized by low T-cell infiltration. By administration of dendritic cells (DCs), which were cultured, activated, and exposed to antigens ex-vivo, this “immune-desert” phenotype might be turned into an “inflamed” phenotype. Previously, we performed and published three phase I trials using activated DCs, which support this concept. Here, we report the long-term survival of the patients treated with DCs in these three phase 1 studies. Methods: We collected the survival data of the phase 1 trials using DC therapy in patients with MPM. In the first two trials, DCs loaded with autologous tumor lysate were used, while in the third allogeneic tumor lysate was used to load the DCs (Mesopher). Results: Between 2006 and 2015, in the three studies combined, 29 patients with MPM were treated with DC vaccination. At data cut-off, the median OS was 27 months (95% confidence interval (CI): 21 – 47 months). OS at 2 years was 55.2% (95% CI: 39.7%-76.6%), OS at 5 years was 20.7% (95% CI: 10.1%-42.2%). Conclusions: The long-term follow up of MPM patients treated with DC vaccination in the three separate phase 1 trials show a promising signal, with a 2-year OS of over 50% and a 5-year OS of over 20%. In addition, 2 patients are alive after 10 years of treatment. In our opinion, these findings show the potency of DC vaccination therapy in long-term activation of the immune system. DC vaccination therapy in patients with MPM is currently being investigated in a large, randomized phase II-III trial (NCT03610360) and in pancreatic cancer. Additional biomarker studies, as well as treatment combinations with for example ICI, could further improve the outcomes of DC-vaccination therapy. Clinical trial information: NCT02395679. [Table: see text]
Longevity of seropositivity and neutralizing antibodies in recovered MERS patients: a 5-year follow-up study
Authors: Shinhye Cheon, Uni Park, Hyoree Park, Yuri Kim, Yen Thi Hai Nguyen, Abdimadiyeva Aigerim, Ji-Young Rhee, Jae-Phil Choi, Wan Beom Park, Sang Won Park, Yeonjae Kim, Dong-Gyun Lim, Jeong-Sun Yang, Joo-Yeon Lee, Yeon-Sook Kim, Nam-Hyuk Cho
Journal: Clinical Microbiology and Infection (2021)

We aimed to assess the longevity of spike-specific antibody responses and neutralizing activity in the plasma of recovered Middle East respiratory syndrome (MERS) patients.We traced the antibody responses and neutralizing activity against MERS coronavirus (MERS-CoV) in peripheral blood samples collected from 70 recovered MERS patients for 5 years after the 2015 MERS outbreak in South Korea. We also measured the half-life of neutralizing antibody titres in the longitudinal specimens.The seropositivity rate persisted for up to 4 years (50.7-56.1%), especially in MERS patients who suffered from severe pneumonia, and then decreased (35.9%) in the fifth year. Although the spike-specific antibody responses decreased gradually, the neutralizing antibody titres decreased more rapidly (half-life: 20 months) in 19 participants without showing negative seroconversion during the study period. Only five (26.3%) participants had neutralizing antibody titres greater than 1/1000 of PRNT50, and a high neutralizing antibody titre over 1/5000 was not detected in the participants at five years after infection.The seropositivity rate of the recovered MERS patients persisted up to 4 years after infection and significantly dropped in the fifth year, whereas the neutralizing antibody titres against MERS-CoV decreased more rapidly and were significantly reduced at 4 years after infection.
Sunitinib in metastatic clear cell renal cancer (CCRC): A real life Chilean single institution experience.
Authors: Luis J. Orlandi, Pedro Pablo Galaz, Robert Melo Holloway, Belkys Melina Linares, Vicente Larrain Garcia
Journal: Journal of Clinical Oncology (2021)

e16562 Background: The introduction of biologic and immunologic therapy has produced a profound change in the management of metastatic CCRC but there is no definitive indication on drug selection and therapeutic sequences based on efficacy, toxicity, costs and access. Methods: We report 50 consecutive stage IV CCRC patients treated at our Institution from 12/2007 to 11/2020 with sunitinib at recommended dosage. Median age at stage IV diagnoses was 62.5 months (39 to 79). Sex distribution was 5 women (10%) and 45 (90%) men. Under MSKCC criteria 35 patients were medium + high risk (70%) and 15 (30%) low risk. Results: On an intent to treat basis the complete + partial response rate was 56% (28/50) for the entire group , 45.7% (16/35) for the high-risk group and 80% (12/15) for the low-risk group. Actuarial 5 year survival was 24% for the entire group, 11.4% for the high-risk group and 53.3% for the low -risk group. We explored the effect of metastases-free time on survival. We found that 15 patients were metastatic at the moment of initial diagnoses versus 26 patients who developed metastatic disease at 12+ months after primary tumor diagnoses. Mean survival was 32.7 months (1 - 97) for the first group and 49.5 months (6 - 156) for the second group (p&lt;0.5). Subsequent therapies consisted of pazopanib (25 patients), axitinib (17 patients), everolimus (9 patients), nivolumab (6 patients) and cabozantinib (1 patient). Secondary reactions consisted of emesis (20%), diarrhea (16%), asthenia (14%), skin dispigmentation (12%), mucositis (10%), disgeusia (10%), dermatitis (10%), neutropenia (8%), hand and foot syndrome (4%). Conclusions: Sunitinib is a good choice in low-risk metastatic CCRC and we adopted this regimen as standard therapy in this group of patients at our Institution.
Delayed bleeding and intratunnel hematoma after peroral endoscopic myotomy: salvage endoscopy management with full recovery
Authors: Ignacio Omella Usieto, José Santiago García, Diego de Frutos Rosa, Belen Agudo, Alberto Herreros-de-Tejada
Journal: Endoscopy (2021)

Peroral endoscopy myotomy (POEM) is a safe technique for achalasia management [1]. The rate of major complications is commonly < 5 % in the largest series [2] [3] [4]; delayed bleeding with intratunnel hematoma (< 0.5 %) is infrequently reported. Hematoma and local compression effects can induce ischemic phenomena with ulceration, as well as hemodynamic effects triggered by active bleeding. Symptoms begin within 24–48 hours, generally with hematemesis and progressive retrosternal pain after several hours of active bleeding. If suspected, urgent chest computed tomography (CT) can confirm the diagnosis [5]. This complication is not exclusively associated with anticoagulation therapy, thus, we need to be alert.
Adjuvant PD-1 inhibitor versus high-dose interferon α-2b for Chinese patients with cutaneous and acral melanoma: A retrospective cohort analysis.
Authors: Jiuhong Wang, Jingjing Li, Xing Liu, Xizhi Wen, Dandan Li, Ya Ding, Hang Jiang, Fuxue Huang, Xiaoshi Zhang
Journal: Journal of Clinical Oncology (2021)

e21516 Background: The clinical efficacy of PD-1 inhibitors as an adjuvant treatment for Asian melanoma patients has not yet been determined. Methods: Thus, this single-centre, retrospective study analysed the clinical data of 90 Chinese patients with completely resected, stage III cutaneous or acral melanoma who received either adjuvant PD-1 inhibitor or high-dose interferon α-2b (HDI). Propensity score matching (PSM) was used to control baseline differences between the two treatment groups. The primary end point was recurrence-free survival (RFS), and the secondary end points included distance metastasis-free survival (DMFS) and incidence of first distant metastatic sites. Results: Anti-PD-1 treatment resulted in significantly longer RFS (18-month RFS, 53.3% versus 26.7%; 95% CI, 0.097-0.975; P &lt; 0.05) and DMFS (18-month DMFS, 70.9% versus 46.1%; 95% CI, 0.13-0.945; P &lt; 0.05) than HDI in cutaneous melanoma patients. However, adjuvant anti-PD-1 treatment had no advantage over HDI in acral melanoma patients (18-month RFS, 30.0% versus 35.9%; P &gt; 0.05; 18-month DMFS, 36.5% versus 63.6%; P &gt; 0.05). The incidence of lung metastasis at first in the anti-PD-1 group was found to be significantly lower (12.5% versus 48.5%; P &lt; 0.05) in cutaneous melanoma patients than in acral melanoma patients, but no difference in metastatic sites were observed between the two treatment groups among acral melanoma patients. The incidence of treatment-related AEs was similar between the two treatment groups. Conclusions: In conclusion, adjuvant anti-PD-1 treatment was well tolerated and yielded a significantly better prognosis than HDI in Chinese patients with stage IIIB/C cutaneous melanoma, but a significant difference was not observed in those with acral melanoma.
Oncologists’ (ONCs) perceptions of tumor genomic profiling (TGP) and barriers to communicating secondary hereditary risk to African American (AA) patients.
Authors: Michael J. Hall, Sarah Bauerle Bass, Yana Chertock, Jesse A Brajuha, Paul D'Avanzo
Journal: Journal of Clinical Oncology (2021)

10592 Background: TGP identifies targets for precision cancer treatments. TGP may also identify secondary hereditary cancer risks, necessitating complex decision support during informed consent. ONCs are poorly trained in the communication of genetic information, particularly for patients with low health literacy, poor knowledge of genetics, and high medical mistrust. AA patients are especially vulnerable in this setting. Methods: We conducted semi-structured interviews with 10 ONCs to assess perceived barriers related to communication of secondary hereditary risks of TGP, probing barriers unique to AA patients. Informed by results, an Internet-based survey was developed/distributed to a convenience sample of 50 ONCs nationwide to assess TGP knowledge, genomics confidence, and perceptions related to communication of secondary hereditary risk. Results: Six themes emerged from interviews: risk/benefits of TGP, knowledge of genetics, discussing hereditary risk, value/harm of TGP, unique risks in AA, and training needs. Most ONCs felt uncomfortable discussing hereditary risks of TGP w/patients. Seven out of 10 identified socio-economic status, medical mistrust, discrimination, genetic counseling non-compliance, low health literacy and family relationships as factors important to consider with AA patients. Online survey participants were 52% White, 66% male, with median age of 42 years. Education in the interpretation/communication of TGP was largely informal (56% reported only informal training) and 46% reported perceived gaps in their education. Genomic confidence was associated w/higher use of TGP (p = 0.05), but was not associated w/knowledge or years in practice; however, low knowledge was associated w/more perceived barriers to TGP and w/negative attitudes toward the value of TGP and the challenge of communication of possible hereditary risks (p = 0.05). Early-career ONCs were more likely to endorse perceived barriers to communication of genetic risk information from TGP to AA patients. Overall 86% ONCs felt additional online training in communication of secondary hereditary risks of TGP would be useful. Conclusions: ONCs recognize unique needs and barriers for AAs related to communication of secondary hereditary genetic information from TGP. Many feel uncertain about how/whether to address barriers and recognize the need to improve their skillset to do so. Training is critical to ensure informed decision making in vulnerable populations.
Change in HER2 status after neoadjuvant chemotherapy (NAC) with trastuzumab and pertuzumab (HP) in patients with HER2-positive early-stage breast cancer.
Authors: Emanuela Ferraro, Pedram Razavi, Sarat Chandarlapaty, Shanu Modi, Hannah Yong Wen, Edi Brogi, Larry Norton, Mark E. Robson, Chau T. Dang
Journal: Journal of Clinical Oncology (2021)

e12614 Background: Combination of HP with NAC in the neoadjuvant setting leads to an high rate of pathological complete response (pCR) in patients with stage II-III HER2+ breast cancer (BC). The rate of change in HER2-status after NAC reported in literature is between 10-30%, although NAC comprises a various regimens, and the clinical significance of this phenomenon is unclear. Methods: We extracted data on patients with HER2+ BC treated with NAC and HP between September 1, 2013 to November 1, 2019. Only patients with internally verified HER2 status at our center were enrolled. The rate of pCR (ypT0/is ypN0) and the change in HER2 status on residual disease from baseline were evaluated. We used standard definition of HER2 status based on ASCO/CAP guidelines 2018. HER2-low was defined as immunohistochemistry (IHC) 1+ or 2+, FISH non-amplified. Results: Overall, 130 pts were identified. All patients received dose-dense AC-THP, except for 13 patients who received TCHP or other HP-based regimens. The pCR was achieved in 77/130 (59%) of patients and 53/130 (41%) had residual disease. Among 53 patients with residual disease, HER2 status was analyzed in 25 patients and was pending on the remaining patients. In the 25 analyzed patients, 13 had HER2-loss in residual disease. In 4/13 patients, HER2 expression was lost (IHC 0); in 9/13 patients, HER2-low profile was found (IHC 1+ in 6 patients, and IHC 2+, FISH non-amplified in 3). Details on HER2 status change are described in the table below. Conversely, 12/25 had concordant HER2 status after NAC. Conclusions: At single center, the change in HER2 status after NAC with HP appeared frequent. Pathological review of additional cases is ongoing. The clinical significance is still unclear but may open the possibility to investigate tailored approach in post-neoadjuvant setting based on the biological profile of residual disease. [Table: see text]
Pharmaceutical amorphous solid dispersion: A review of manufacturing strategies
Authors: Sonal V. Bhujbal, Biplob Mitra, Uday Jain, Yuchuan Gong, Anjali Agrawal, Shyam Karki, Lynne S. Taylor, Sumit Kumar, Qi (Tony) Zhou
Journal: Acta Pharmaceutica Sinica B (2021)

Amorphous solid dispersions (ASDs) are popular for enhancing the solubility and bioavailability of poorly water-soluble drugs. Various approaches have been employed to produce ASDs and novel techniques are emerging. This review provides an updated overview of manufacturing techniques for preparing ASDs. As physical stability is a critical quality attribute for ASD, the impact of formulation, equipment, and process variables, together with the downstream processing on physical stability of ASDs have been discussed. Selection strategies are proposed to identify suitable manufacturing methods, which may aid in the development of ASDs with satisfactory physical stability.