bluuebunny/crossref_metadata_2025 huggingface dataset:
Immunological and mutational characterization of non-uterine leiomyosarcoma: A pilot study.
Authors: Seliga Katarzyna , Teterycz Pawel , Szumera-Cieckiewicz Anna , Tysarowski Andrzej , Wagrodzki Michal , Kosela Hanna Melania , Kozak Katarzyna , Goryn Tomasz , Siedlecki Janusz A , Rutkowski Piotr
Published: March 2020

e22529

Background: Data from many studies in cancer studies suggest that factors such as expression of PD-L1, tumor infiltrating lymphocytes (TILs) and high mutational burden (TMB) in the tumor cells are connected with better response to immune check-point blockage and may have prognostic value. Little is known about those factors in other neoplasms. Methods: In this retrospective study, we have included 31 patients with leiomyosarcoma (LMS) localized on extremity (21) or in retroperitoneal space (10) treated in our center between 2002-2018 with available biopsy specimens obtained before treatment. Mean age was 58 year (SD: 17). Male:Female ratio was 0.82. 14(45%) lesions were deemed high-grade sarcomas. 3 patients had metastases at the time of diagnosis. Immunohistological assays for TILs, tumor associated macrophages (TAMs), PD-1 and PD-L1. TMB was assessed in Tumor Mutational Burden Panel in the formalin-fixed paraffin-embedded samples. 7 cases were excluded from TMB analysis due to poor specimens quality. Fisher exact test was used to compare discrete variables while Kaplan-Meier estimate and stratified log-rank test were used to examine impact of explored factors on survival. Results: The median overall survival in this cohort was 33.4 months (95% confidence intervals, CI: 32-NA). TMB > = 10 mutations/Mb was present in 33% high-grade (HG) and in 25% cases of low-grade (LG) LMS (p = 0.067). PD-L1 expression was present in 54% of HG lesions and in 31% of LG LMS (p = 0.43). TILs and TAMs were highly correlated and present in 40% and 50% of HG LMS and LG LMS respectively (p = 0.722). Among explored factors only TILs and TAMs had significant influence on survival as deemed by log-rank test stratified by tumor grade (p = 0.004) with 3-year survival rate of 100% in groups without TILs/TAMs regardless of grade and 0% in HG TILs/TAMs(+) group and 60% (95% CI: 31-100%) in LG TILs/TAMs(-) group. Conclusions: Significant percentage of LMS exhibit immunohistological and molecular traits which potentially are connected with good response to check-point blockage agents. The immunological infiltration of primary LMS may be strong negative prognostic factor, what is interesting in sarcoma. Future expansion of this study cohort is warranted.
Renal Ewing's sarcoma: A single institute experience of seven patients.
Authors: Shishak Sorun , Rastogi Sameer , Panday Rambha , Sharma Dayanand , Barwad Adarsh , Aggarwal Aditi , Dhamija Ekta , Gupta Anshul , Balan Soorej , Deo Svs , Dutta Rimlee , Manasa Parisa , Kumar C Santosh , Kumar Pankaj
Published: March 2020

e22538

Background: Renal Ewing’s sarcoma constitutes a rare subset of extraskeletal ewings with aggressive clinical course and dismal outcomes. The purpose of our study was to review our experience in the management of patients with Renal Ewing’s Sarcoma. Methods: We retrospectively analysed patients with Renal Ewing’s Sarcoma who were registered in Sarcoma Medical Oncology Clinic at AIIMS, New Delhi between September 2016 and January 2019. Results: A total of eight patients were registered in the study period, one of which was diagnosed with wilms tumor post nephrectomy and was excluded from our study. Of seven patients included in analysis, five (71.4%) were males. The commonest symptoms were flank pain (57.1%) and hematuria (57.1%). The median age was 28 years (range, 18 to 50 years). The mean Hemoglobin was 10.4 g/dl (range, 6-14 g/dl). The median tumor size was 13 cm (range, 5-25 cm). Four patients (57.1%) were non-metastatic while three (42.9%) had metastases in bone, lung and liver, and peritoneum respectively. Diagnosis was established by an upfront nephrectomy in four patients (57.1%) and biopsy in three patients (42.9%). Translocation for EWSR1 was done in 5 patients of which four (80%) were positive and one patient (20%) were negative. The test was not carried out in two patients due to inadequate tissue sampling. Three patients received neoadjuvant chemotherapy with VAC and the rest (four) received it after surgery. Ifosfamide-etoposide (IE) was added to VAC regimen in first two patients, in one being added post nephrectomy. This patient developed Ifosfamide-induced renal failure resulting in death. Radiotherapy was given in two patients, one pre-operative owing to large inoperable mass, and post operative in the other due to positive margins. At last follow up, three patients (42.9%) are alive and are on chemotherapy after radical nephrectomy. Four patients (57.1%) have died, three due to disease (all metastatic) and one due to chemotoxicity. The median survival was 15 months. Conclusions: Unlike extremity, renal ewings sarcoma more commonly presents in higher age and with advanced disease. Translocation studies are a prerequisite in a suspected case of Renal Ewings Sarcoma, especially due to possibility of discrepancies in pre and post-operative diagnoses. Our institutional protocol does not recommend the use of Ifosfamide in the subset of patients with single kidney, post nephrectomy. Caution must be exercised before instituting the drug and should be given only pre-operatively in absence of renal dysfunction.
Angiosarcoma treated with checkpoint inhibitors: A single-institution experience.
Authors: Florou Vaia , Wilky Breelyn A. , Trent Jonathan C.
Published: March 2020

e22543

Background: Angiosarcoma (AS) is a rare endothelial malignancy with only 2–3 new cases per one million diagnosed yearly but is among the most aggressive soft tissue sarcomas. Some cutaneous angiosarcomas may have a mutational landscape similar to UV light exposed melanoma. These findings offer a rationale for the early limited evidence of checkpoint inhibitor activity in cutaneous angiosarcomas. Methods: This is a retrospective review of patients with locally advanced or metastatic angiosarcoma, who were treated with checkpoint inhibitors at our institution. Descriptive statistics were used to analyze our findings. Results: Since 2016, we have treated seven angiosarcoma patients with checkpoint inhibitors either in the context of clinical trials or off label [Pembrolizumab + Axitinib (NCT02636725; n = 1), a CTLA-4 inhibitor (NCT02694822; n = 2), Pembrolizumab (n = 4)]. Five patients had cutaneous AS, one primary breast AS and one radiation associated breast AS. The average age was 66 years old and 5/7 (71%) patients were females. All patients had received prior systemic therapies (range 1-7, mean 3) and 2/7 (29%) patients had metastatic disease at the time of treatment. The mean number of checkpoint inhibitor doses was 6. At twelve weeks, 5/7 patients (71%) had partial response, by RECIST, of their lesions either on imaging or clinical exam and two (29%) had progressive disease. 6/7 patients are alive to date and, thus far, 3/7 patients (43%) progressed (median 3.4 months)- one achieved partial response after pembrolizumab was switched to ongoing Nivolumab/Ipilimumab, one died of progressive disease at 31 weeks (primary breast AS) and one was placed on subsequent therapy. No patient experienced any toxicities more than grade 2. Conclusions: This is a single institution, retrospective review of patients with AS treated with checkpoint inhibitors, first reported in the literature. Checkpoint inhibitors may be an effective and safe treatment option for this aggressive sarcoma. Prospective clinical trials are needed to systemically study this effect.
Activity of chemotherapy in inflammatory myofibroblastic tumor (IMT): A retrospective analysis within the Italian Rare Tumours Network (RTR).
Authors: Baldi Giacomo Giulio , Gronchi Alessandro , Vincenzi Bruno , De Pas Tommaso Martino , Pantaleo Maria A. , D'Ambrosio Lorenzo , Grignani Giovanni , Casanova Michela , Ferrari Andrea , Simeone Noemi , Provenzano Salvatore , Dei Tos Angelo Paolo , Sbaraglia Marta , Collini Paola , Dagrada Gianpaolo , Morosi Carlo , Casali Paolo Giovanni , Stacchiotti Silvia
Published: March 2020

e22545

Background: IMT is a rare soft tissue tumour often curable with surgical resection. Nonetheless, in advanced cases a medical therapy is needed. Few data are available on the role of conventional chemotherapy. We report on a retrospective study on the activity of cytotoxic chemotherapy in pts with IMT treated within the RTR. Methods: Patients (pts) of any age with a centrally confirmed diagnosis of IMT treated with anthracycline-based or methotrexate (MTX) and vinorelbine/vinblastine-based regimens between 2008 and 2018 were reviewed. ALK status was evaluated by immunohistochemistry and FISH. Response was assessed by RECIST 1.1. Results: Twenty pts were retrospectively identified (ALK positive = 12, under assessment = 8); median age at the time of treatment start = 38, range = 5-77; disease extent: local disease = 2, locally advanced = 9, metastatic disease = 9. Thirteen pts (65%) received an anthracycline-based regimen, 7 (35%) MTX and vinorelbine/vinblastine. In the anthracycline-based group, 6 (46%) and 7 (54%) pts were treated for localized and advanced disease, respectively. Twelve pts were evaluable for response. Best responses were: 1 CR (8%), 6 PR (50%), 2 SD (17%), 3 PD (25%), for an ORR = 58%. 8 pts received a complete surgical resection at the end of the medical treatment and 6 are disease free. At 39 mos median follow-up, mPFS for 7 pts treated for advanced disease was 5.4 mos (IQR: 1.9-18.8). In the MTX and vinorelbine/vinblastine group, 2 (28%) and 5 (72%) pts were treated for localized disease and advanced disease, respectively. All pts were evaluable for response. Best responses were: 5 PR (50%), 3 SD (30%), 2 PD (20%), for an ORR = 50%. Two pts received a complete surgical resection after the end of chemotherapy and both are disease free. At 56.4 mos median follow-up, mPFS for pts with advanced disease was not reached, with disease progression reported only in 1 pt. Conclusions: Chemotherapy is an option in localised IMT when tumour shrinkage is needed as well as for tumour control in advanced disease. Clearly, its efficacy should be compared with ALK inhibitors, although of course both groups of agents may be resorted to stepwisely in advanced cases in need for medical therapy.
Clinical benefit of next generation sequencing in soft tissue and bone sarcoma: Rush University Medical Center’s experience.
Authors: Weiss Mia C. , Blank Alan , Gitelis Steven , Fidler Mary J. , Batus Marta
Published: March 2020

e22552

Background: The overall survival for metastatic sarcoma has remained at only 18-20%. In the era of next generation sequencing (NGS), much research is ongoing on identifying optimal treatments. The MULTISARC trial aims to determine if NGS can lead to improved overall survival by randomizing patients with metastatic STS to receive NGS (followed by possible NGS-guided therapy) or not. We present our center’s experience with NGS in sarcomas patients. Methods: Patients with soft tissue and bone sarcomas at Rush that had the Foundation Medicine assay sent on tumor samples between August 2017 and August 2018 were analyzed retrospectively. The impact of NGS on clinical decision making was determined based on patients being prescribed off-label FDA-approved therapy targeting identified mutation. Results: Thirty-four patients with bone/soft tissue sarcomas that had NGS sent on specimens were identified. Median age at diagnosis: 43 (18-78 years); 18 males, 16 females. Histologic subtypes: synovial sarcoma, myxofibrosarcoma, leiomyosarcoma, chondrosarcoma, sclerosing epitheloid fibrosarcoma, PEcoma, pleomorphic undifferentiated sarcoma, MPNST, liposarcoma- well and de-differentiated, angiosarcoma, osteosarcoma. 16/34 patients had targetable mutations with approved therapies in tumor types other than sarcoma. Four of these patients had therapy changed based on NGS results, 1 patient with metastatic chondrosarcoma (PTEN mutation, everolimus added), 1 patient with metastatic liposarcoma (CDK4 mutation, palbociclib added), 1 patient with metastatic osteosarcoma (CCD1/CDK4 and a PDGFRA mutation for which palbociclib followed by imatinib was added), and 1 patient with metastatic pleomorphic undifferentiated sarcoma (CDK4 mutation, palbociclib added). Targetable mutations for which clinical trials are available were identified in 25/34 (73%) of the cases. Conclusions: NGS was readily able to identify actionable mutations in close to 50% of patients with clinical trial opportunities in close to 75%. Four patients had therapy changed as a result of NGS testing. Although our study size is small, our data show potential for the use of genomic profiling to identify actionable targets, tailor therapy, and hopefully improve outcomes. [Table: see text]
Efficacy of low dose pazopanib in advanced soft tissue sarcoma (STS): Experience from a dedicated sarcoma medical oncology clinic in India.
Authors: Kumar C Santosh , Rastogi Sameer , Prajapati Ramjas , Barwad Adarsh , Aggarwal Aditi , Dhamija Ekta , Panday Rambha , Gupta Anshul , Dutta Rimlee , Deo SVS , Manasa Parisa , Kumar Pankaj , Shishak Sorun
Published: March 2020

e22555

Background: The approved dose of pazopanib in advanced STS is 800 mg/day and is not weight based. After initial patients who couldn’t tolerate pazopanib we started pazopanib at lower doses escalating to higher doses. There is already preliminary data about low dose pazopanib in asian patients. Methods: We retrospectively analysed the prospectively kept data base of patients with advanced non adipocytic STS who were treated with pazopanib at AIIMS sarcoma medical oncology clinic between September 2015 and February 2019. After start of pazopanib we get CT scan done every 3 monthly as institutional protocol. Statistical analysis was done by SPSS 23. Results: There were total of 66 patients with median age 40 yrs (17 – 81)and majority were males who (60). ECOG Performance status (PS) was PS 1 in 63% and PS 2 in 23%. Most common diagnosis was synovial sarcoma (22%), leiomyosarcoma (18 %), angiosarcoma (9%), MPNST(8%) and others (43%). Most of the patients received pazopanib as second line (59%) and third line (31%). 90% of patients received dose of 400 mg and remaining 10% of the patients received 600 mg of dose (in which it could be escalated after 1 month). Median weight was 63kg and median height in our patients was 160cm while the median BSA was 1.6. Dose escalation was attempted, but was not feasible due to toxicities. Out of total 66 patients, 57 were available for response assessment. RECIST responses were complete response (CR) was present in 2.9%, partial response (PR) in 17% , stable disease (SD) in 28%. The median progression free survival (PFS) was 5 months and median overall survival was 18 months after a median duration of follow up of 20 months. Grade 3 and grade 4 toxicities were present in 31% of the patients. Grade 3 hand foot syndrome (HFS) was present in 12% of patients.4.5% had hypertension. Other grade 3 and 4 toxicities were oral mucositis (6%) , transaminitis (4%) Cardiomyopathy (3%) and cholestasis jaundice (1.5%) with bilirubin elevated to the level on 19.1 mg/dl. This resolved after stoppage of Pazopanib. Conclusions: Pazopanib at low doses in our series was as efficacious and with similar toxicity as previous literature The option of lower dose pazopanib needs to be explored in Asian population who have lower body weight.
Prevalence of symptom clusters among sarcoma patients in active treatment.
Authors: Copeland Vanessa C. , Phun Jennifer , Segal Eve M. , Hammer Kathryn J. , Loggers Elizabeth T.
Published: March 2020

e22561

Background: Cancer patients (pt) frequently experience symptoms from cancer or its treatment. Two or three co-occurring, uncontrolled symptoms (symptom clusters, SC), can worsen cancer pt morbidity and mortality. Although SC have been characterized in other cancer pts, little research has been conducted in sarcoma pts. Methods: SC were studied via retrospective chart review of adult sarcoma pts receiving treatment between 09/2018-01/2019 in a dedicated sarcoma clinic. Pts completed a 33-item, modified Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (mPRO-CTCAE)-based review of systems (hereafter “form”) for ongoing clinical care with presence of individual symptoms defined as ≥“occasionally.” Demographic, disease and treatment specific data was collected; descriptive data (%’s) are presented. Results: Pts (n = 153 completing 321 forms) were median 57 years (range 20-81), 48% male, 68% white, with lower extremity (29%) or abdomen (46%) sarcoma with 67% receiving IV chemo (33% oral chemo), with the majority at full dose (77%). Most had leiomyosarcoma 18%, liposarcoma 14%, GIST 12%, or NOS 24% with 59% metastatic disease. Five SC triads occurring in > 25% of pts who fully completed one form were identified (see Table). Eighty-one pts completed 2 or more forms (mean 26.7 days from first to second form [std dev 17.7, range 2-77]) with 50-67% of evaluable pts having ongoing SC triads. Conclusions: Symptom clusters are common among sarcoma patients on active treatment. Future research should address optimal management of these clusters. Additional data, including severity/interference of symptoms, longitudinal changes and predictors of SC, will be presented.[Table: see text]
Bridging the information gap: A scoping review of radiation oncology patient education scholarship.
Authors: Rosenberg David M. , Rooney Michael Kevin , Arya Ritu , Abrams Matthew J. , Braunstein Steve E. , Croke Jennifer M. , Giuliani Meredith Elana , Gunther Jillian Rebecca , Hirsch Ariel , Ingledew Paris-Ann , Turner Sandra , Golden Daniel William
Published: March 2020

e23164

Background: Patient education (PE), the use of educational interventions to improve patient knowledge of healthcare, has been shown to reduce patient anxiety and facilitate shared decision making. In contrast to many other medical specialties, the state of radiation oncology (RO) PE is unclear. This scoping review aims to characterize the state of ROPE peer-review scholarship to describe strengths, identify gaps and guide future ROPE research. Methods: Predetermined medical subject headings and search terms were used to search PubMed for ROPE articles. Additional terms were identified from these articles and the search was repeated until no further articles were found. In-press articles in major RO and medical education (ME) journals were searched. English language articles published after 1/1/1990 that had a primary ROPE focus were included. Two independent reviewers performed the search and determined eligibility. Articles were categorized using the most predominant step of Kern’s six-step conceptual framework for ME curriculum development and the country and year of publication. Results: Of 11,756 identified articles, 182 met inclusion criteria. Articles per year increased over time (p < 0.01): 1990-1994 (5.5%); 1995-1999 (11.0%); 2000-2004 (13.7%); 2005-2009 (10.4%); 2010-2014 (25.8%); 2015-2019 (33.5%). Conceptual framework categorization was as follows: problem identification (22.0%); needs assessment (23.6%); goals and objectives (4.9%); education strategies (9.9%); implementation (7.7%); evaluation and feedback (31.9%). Regional breakdown was as follows with some articles spanning regions: Africa (1.1%); South America (2.2%); Asia (6.0%); Australia (15.4%); Europe (30.2%); North America (45.6%). Conclusions: Nearly half of articles are primarily problem identification or needs assessment (45.6%) which are descriptive in nature and only identify or clarify ROPE needs. Additionally while these results are limited to English language scholarship, there are significant regional maldistributions. Although there is an encouraging trend of increasing ROPE publications over time, this study identifies opportunities to further develop, implement and evaluate ROPE scholarship.
What type of information is needed by AYA cancer survivors in Japan?
Authors: Yamaki Chikako , Nakatani Yuki , Sato Toshiko , Taniguchi Hikaru , Takayama Tomoko
Published: March 2020

e23165

Background: Cancer patients and survivors in the adolescents and young adults (AYA) generation often have a wide range of unmet needs, which include health related matters, communication problems, relationship difficulties, and life roles. Japanese AYA cancer survivors supposedly have these same unmet needs, but it is not clear which specific types of needs should be provided. The purpose of this study was to explore the support needs of Japanese AYA cancer survivors and to propose what type of information they should be provided. Methods: Eleven AYA cancer survivors and their families participated in group interviews. All participants were recruited from the Cancer-Civil Panel of Center for Cancer Control and Information Services, National Cancer Center Japan (NCC-CIS), which is commissioned by the NCC president to support NCC-CIS activities. Participants were asked about their 1) difficulties and painful issues during their cancer history, 2) information needs to handle those difficulties, and 3) willingness to support AYA patients suffering from cancer. Interviews were audio recorded and transcribed verbatim. Three researchers coded the transcripts and constructed the categories to be assessed. Results: Difficulties and painful issues were compiled into four categories: (1) physical and psychological pain that come directly from cancer, (2) uncertainty of the situation and the future, (3) isolation and alienation that come from his/her unique experiences, and (4) distress of facing painful families. Information and support needs included three categories: (1) detailed experiences from the patient’s view, (2) ways to face his/her cancer and life role as a survivor, and (3) role models or companies for sharing the same experiences. All participants expressed the willingness to support someone by the disclosure of their own experiences. Conclusions: Japanese AYA survivors had unmet information needs for both medical and lifelong psycho-social issues. They would like to have information about a variety of personal and subjective experiences in order to recommend possible future solutions. These findings suggest that personal and narrative experiences would support AYA survivors in their efforts to confront their uncertain future with cancer.
Risk factors in pregnant women with an oncological diagnosis and their impact in the post-partum period.
Authors: Faccio Flavia , Ionio Chiara , Mascheroni Eleonora , Peccatori Fedro , Ongaro Giulia , Cattaneo Elena , Pisoni Camilla , von Wunster Silvia , Nastasi Giuseppe , Pravettoni Gabriella , Beretta Giordano D. , Bonassi Lucia
Published: March 2020

e23166

Background: An oncological diagnosis during pregnancy, or the choice of motherhood following cancer may be accompanied by anxiety, distress and depression. The aim of the study is to explore the possible risk factors in the perinatal period in women who experienced an oncological diagnosis before or during pregnancy. Methods: 32 pregnant women (25 breast, 3 cervix, 1 lung, 1 Hodgkin's lymphoma, 1 perivascular epithelial cell neoplasia, 1 epatic PEComa) were assessed during their 3rd trimester (T1) and three months’ post-partum (T2). At T1 mood states and post-traumatic symptoms were evaluated, at T2 parenting stress and perceived quality of life (QoL). Results: Depression, anger and anxiety correlated with lower physical and psychological QoL in the post-partum. Moreover, mothers who expressed higher levels of fatigue and confusion during pregnancy are associated to lower levels of perceived psychological QoL. Women who manifested hypervigilance and hyperarousal during pregnancy were more likely to perceive lower psychological QoL three months after birth. Finally, post-traumatic symptoms of intrusiveness during pregnancy correlated with higher levels of parenting stress and higher risk of dysfunctional parenting, together with a stronger perception of having a child with a difficult temperament in the post-partum period. Conclusions: Mood states and post-traumatic symptoms can decrease the mother’s quality of life and heighten parental distress. These preliminary results suggest implementing psychological support for women with current or previous oncological diagnosis during pregnancy in order to prevent the onset of dysfunctional parenting and/or problem behaviours in their children. [Table: see text]
Evaluation of mental and social adaptation of patients with breast cancer.
Authors: Kondrateva Kristina , Semiglazova Tatiana , Kasparov Boris , Vagaitseva Margarita , Zernova Margarita , Krutov Anton , Alekseenko Anna , Krivorotko Petr , Semiglazov Vladimir , Belyaev Aleksey , Semiglazov Vladislav ,   Petrov Research Institute of Oncology Authors' Group
Published: March 2020

e23167

Background: In 2018, in the N.N. Petrov National Medical Research Center of Oncology, there was conducted a study of the effectiveness of a mental and social adaptation of patients to the disease and treatment in the framework of The International Classification of Functioning, Disability and Health (ICF). Methods: The patients with breast cancer (n = 28, mean age 31 ±7) were examined at the stages of diagnosis and admission to the hospital. The basis of the study is the «Narcissism Evaluation Test», EORTC QLQ-C30, as well as the following ICF domains: Body function - global psychosocial functions (b122), temperament and personality functions (b126), energy and drive functions (b130), sleep functions (b134), attention functions (b140), psychomotor functions (b147), emotional functions (b152), thought functions (b160), higher-level cognitive functions (b164). Activity and participation- doing housework (d640), family relationships (d760), intimate relationships (d770), acquiring, keeping and terminating a job (d845). Results: The increase in values (7.26–13.61; p < 0.05) on the “Depersonalization” scale indicates an attempt to dissociate from threatening processes in oneself by means of dissociation and splitting, to preserve the coherence of the personality structure. This tendency can be viewed as an attempt by the patient to deny that destabilization affects his personality and lifestyle, which leads to the experience of melancholia as an attempt at destruction of Self-Concept. Such reactions are classified by us within the framework of psychogenic, i.e. conditionally normal in the situation of cancer, however, it was shown that the pathology of “psychogeny” significantly reduces the quality of life and social adaptation. For example, in 11 patients, there is a decrease in the quality of life (62.85; p < 0.05), disturbed sleep, emotions, energy and drive functions (b134, b152, b130), and there are difficulties in the resumption of labor activities (d845). Conclusions: Experiencing the threat to the integrity of Self-Concept launches psychological defenses, as a result of which a rapid regression of Self-Concept occurs before the primary narcissism. Psychogenic reactions during pathologization contribute to the patient’s social and mental maladjustment.
Mindfulness and concerns about adjuvant endocrine therapy (AET).
Authors: Henry Norah Lynn , Iacob Eli , Mooney Kathi , Garland Eric
Published: March 2020

e23170

Background: Poor adherence to AET for early stage breast cancer is associated with increased recurrence and mortality. Interventions to improve adherence have been minimally effective. Mindfulness is paying attention on purpose in the present moment with an attitude of openness and acceptance. In this cross-sectional study, we examined clinicopathologic, and psychosocial factors, including dispositional mindfulness, associated with increased concerns about medication. Methods: Women with stage 1-3 breast cancer who had taken at least one dose of AET within 2 years of enrollment completed questionnaires to examine medication beliefs (Beliefs about Medication Questionnaire), symptoms (FACT-ES), treatment satisfaction (Treatment Satisfaction Questionnaire for Medication II), and mindfulness (Five Facet Mindfulness Questionnaire-15). Descriptive statistics were used for demographic and clinical variables. Linear regression was used to examine the associations between medication concerns and both treatment satisfaction and mindfulness measures. Results: Of the 101 enrolled patients, 43 were taking tamoxifen, 46 an aromatase inhibitor (AI), and 12 had discontinued AET; average time on AET was 11 months (SD 6.3). 32% had stage 2 disease and 22% had stage 3. Concerns about medications was moderately negatively correlated with mindfulness (ρ = -0.349, p < 0.001). In the baseline model, medication concerns were associated with increased side effects but not with age at diagnosis, stage, or current AET status. When controlling for age, stage, current AET status, and side effects, there was a trend towards increased mindfulness and decreased medication concerns. Conclusions: Dispositional mindfulness may be associated with fewer concerns about medication. If mindfulness is shown to influence medication adherence, interventions such as mindfulness training to improve compliance with AET could be investigated.
Coping with end-of-life stress (EOLS): Poetry as a therapeutic communication intervention.
Authors: Meyskens Frank L. , Shapiro Johanna F , Lupton Julia Reinhart
Published: March 2020

e23172

Background: Attempts to alleviate EOLS via system changes have been variably successful. Manualized psychotherapeutic interventions have been of some usefulness. Participation in narrative communication has been widely adopted to address stress produced by life threatening events, whether by trauma or acute illness. More recently narrative form of communication has been extended to the EOL time period with some early evidence of limited benefit. Poetry involves a different realm of mental involvement and should impact on existential stressors. However, its use in improving the quality of life during the EOL period has not been explored. Methods: Two open symposia entitled “Healing and Hope: An Evening of Poetry by Patients, Family Members, and Health Professionals“ were held at the University of California-Irvine on February 22, 2018 and January 10, 2019. There were 155 attendees(80, 2018; 75,2019). 20 attendees at the 2019 event also participated in a workshop directed toward writing poetry. Results: Event reports from all 11 Medical Humanities students registered for the Symposia as a required colloqium event were very positive as were essays from 3 medical students in the Art of Doctoring class in attendance. The results and impact of the Symposia were eloquently summarized by another one of the medical students who attended: “The poetry tellers read poems that were very powerful and I was able to hear their pains, joys, and regrets. I enjoyed the discussions held after each panel was finished, which allowed me to hear some of the thoughts of the audience and connect with them. The whole experience was amazing: It really felt like we were all connected via poetry and I think that produced an environment where we could cope with emotions brought by illnesses and medicine.” Conclusions: Poetry reading, writing, and speaking should be explored as a novel educational approach and possible therapeutic tool to address existential stressors produced during and by the EOL time period in an increasingly aging patient population that and results in the well-known diminishment or destruction of their quality of life.
Psycho-Oncology: Cancer patients with past suicide attempts, or a family history of suicide.
Authors: Gercovich Daniela , Gil Deza Ernesto , Tognelli Flavio , Garcia Gerardi Carlos Fernando , Acuna Claudia Lorena , Gonzalez Cesar , Morgenfeld Eduardo L. , Morgenfeld Mirta , Rivarola Edgardo G. J. , Gercovich Felipe G.
Published: March 2020

e23173

Background: “The suicide rate in cancer patients is twice that observed in the general population in the United States” (JNCI vol 100, 24, page 1750, 2008). This paper focuses ona population with great psychological risk: cancer patients (Pt) with previous suicide attempts (SA) or a family history of suicide (FS); both grouped under SAFS for the purpose of this study. Methods: Between 9/26/2012 and 11/28/2018 all new patients (Pt) admitted to IOHM filled out a Past Medical History Form (PMHF) (ASCO 2013 ABST. e17539) with their preexisting clinical conditions. The database was locked and anonymized. Those with a history of SAFS before cancer diagnosis were selected. Results: Out of 15,617 Pt, 184 Pt (1.2%) were SAFS(141 Pt were SA, 39 Pt were FS and 4 Pt were both). The relative risk ofSA was ten times larger for those with FS. Psychiatric Medication: Antipsychotics: 15Pt (8%), Antidepressants: 23 Pt (12%) and Benzodiazepines 45 Pt(24%), No treatment 101 Pt (55%). Population Characteristics: Sex: F:144 Pt . M: 40 Pt. Age: 56y (r = 26-88). Tumor Dx: Breast (65 Pt ) - Gastrointestinal (24 Pt) - Urological (21 Pt ) - Lung (21 Pt ) -Gynecological (19 Pt) - Hematological (11 Pt) -Head &Neck (8 Pt) - Endocrine (7 Pt) - Other (8 Pt). Stages: Early (0-I-II-III): 130 Pt, Advanced: 54 Pt. Ob-Gyn history:25 Pt (17%) nulliparous, 18 Pt (12%) with one child, 77 Pt (53%) with 2 or 3 children and 24 Pt (17%) with more than 3 children; 62 Pt (43%) had previous abortions. Average severe comorbidities (respiratory and psychiatric) was 3 per Pt (r = 0-18). Toxic habits: Smoking: 120 Pt (65%), Alcohol: 37 Pt (20%) and Illicit Drugs: 4 Pt (2%). Follow-up: 19 months (r = 0-70). No Pt had any SA, or commited suicide, during the follow-up.Living patients:177 (96%). Conclusions: 1) In our vast cohort, 184 Pt (1.2%) were identified as highly vulnerable psychiatric Pt due to SAFS. 2) Given the high psychological risk and stressful cancer diagnosis, 83 Pt (45%) were prescribed psychiatric drugs. 3) Follow-up of SAFS Pt by a multidisciplinary team is requiredfor adequate Pt and family support.
Understanding patient advance directives status in a community oncology practice using an electronic patient-reported outcomes (ePRO) system.
Authors: Buzaglo Joanne S. , Skinner Karen E , Stepanski Edward , Tankersley Cynthia , Schwartzberg Lee S.
Published: March 2020

e23181

Background: The National Comprehensive Cancer Network and the American Society of Clinical Oncology recommend that providers encourage early advance care planning with their patients1; yet, many cancer patients do not have advance directives (ADs). A potential reason for low AD rates is inadequate communication between the provider and patient. To address this gap, we developed an outpatient clinic AD initiative for any stage cancer patients via an ePRO system. The AD module was designed to ensure that patients are aware of ADs and to assess whether or not the patient had ADs, specifically a Living Will and/or a durable power of attorney. The study purpose was to assess patient AD status at the patient’s initial visit to an oncology clinic. Methods: This study used a retrospective, observational design that involved use of PRO and clinical data collected via the Patient Care Monitor™ (PCM), a web-based ePRO system linked to electronic medical record data. All data used in this study were collected as part of routine clinical care. All patients at an initial visit to an oncology clinic completed the PCM survey, including the AD module, via a handheld e-tablet. Results: Overall, 9,682 patients completed the AD module (mean age 63; 31% male/69% female; 58% married; 62% White, 35% Black). Cancer type was known for 75% of all patients (29% breast, 11% hematologic, 7% lung, 7% colorectal, 3% prostate, 17% other types). One third of all patients (33%) reported having an AD at the time of the initial visit to the oncology clinic, specifically 24% indicated having a Living Will and 9% a durable power of attorney. The remaining two-thirds (67%) indicated either NOT having an AD (56%) or not knowing if they had an AD (11%). Patients with ADs were more likely to be older ( M=68 v. 60 yrs), male (38% v 31%), White (41% v 20% Black) and married/partnered (35% v 29%); ps <.0001. Conclusions: This study demonstrates that the majority of patients do not have ADs at the time of an initial visit to a community-based oncology practice. Using an ePRO system can be an innovative and efficient way to identify unmet needs of patients and link them to resources for developing advance directives. 1Brown AJ, Shen MJ, Urbauer D, et al. Room for improvement: An examination of advance care planning documentation among gynecologic oncology patients. Gynecol Oncol. Sep 2016;142(3):525-530.
National society-supplied patient materials on prostate cancer screening for the general public: A readability analysis.
Authors: Rooney Michael Kevin , Morgans Alicia K. , Meeks Joshua J , Kundu Shilajit , Schaeffer Edward M. , Hussain Maha H. A. , Kalapurakal John A. , Sachdev Sean
Published: March 2020

e23188

Background: Recent data suggest that prostate cancer mortality may be increasing for the first time in 20 years, possibly related to a decrease in PSA screening. Most professional societies recommend men aged 55 to 69 make screening decisions using a shared-decision making (SDM) model. However the quality and time of SDM can vary significantly, often leaving patients uncertain about the implications of pursuing or foregoing screening. In this setting of individualized decisions, patients may seek supplemental information. However, little is known about the accuracy, breadth and readability of available education materials, which if designed optimally could improve SDM. Methods: For 11 predetermined professional societies (ACP, ACPM, ACS, AFP, AMA, ASCO, AUA, CDC, NCI, NIH, USPSTF), patient education materials designed for prostate cancer screening were queried. Materials were analyzed using seven well-validated readability metrics and evaluated for educational content. For content comparison, 10 materials from academic cancer centers and independent organizations were identified using top public search engine results. Results: We identified 12 professional society materials and 20 from popular non-society sources. Mean readability level for society materials ranged from 9.7 to 11.3 grade, well above AMA and NIH recommended 6th and 8th grade reading levels (P < 0.0001). In comparison to general materials, professional society materials more often discussed the role of risk factors in making screening decisions (70% vs 100%, P = 0.03). However, society materials did often omit important guideline-based content, including statements that decisions should involve patient values and preferences (42%) and can vary by patient age (35%). Conclusions: Widely available prostate cancer screening education materials are written at inappropriately high reading levels and often omit important content. Improvement of such materials would encourage SDM for patients considering screening.[Table: see text]
Physical methods of rehabilitation (PMR) in patients with lung cancer.
Authors: Kasparov Boris , Semiglazova Tatiana , Denis Kovlen , Gennady Ponomarenko , Kluge Valeriya , Krutov Anton , Zernova Margarita , Kondrateva Kristina , Karina Khidishyan , Belyaev Alexey , Donskih Roman , Bahtyar Adhamov , Semiglazov Vladislav , Kharchenko Evgeniya Vladimirovna , Levchenko Nikita , Levchenko Evgeny
Published: March 2020

e23189

Key words: physical therapy, rehabilitation, lung cancer. Background: The strategy of searching evidences for using rehabilitation technologies in patients with lung cancer (LC) is based on scientometric analysis. Methods: Since 1991 to 2018 analysis of 249682 studies was performed. It was completed by using PICO(T) technologies in databases such as PEDro, PubMed, E-library and Cochrane Library. Medical subject headings (lung cancer, rehabilitation, physical therapy, etc) were used to search the information in international databases. The trials were rated by PEDro scale including 10 points of evidence level : randomization, endpoint evaluation, blinding and etc. Results: Almost 55.9% of studies showed the level from 4 to 8 points on the PEDro scale and were verified by distribution profile. One trial had 9 points (0,8 %). Recommended evidence-based use of PRM technology in the rehabilitation of patients with LC (table): Conclusions: This results will form the base of clinical guidelines of new evidence-based Development of Patient Rehabilitation of patients with LC in Russian Federation.[Table: see text]
A randomized phase II study of durvalumab and tremelimumab compared to doxorubicin in patients with advanced or metastatic soft tissue sarcoma (MEDISARC, AIO-STS 0415).
Authors: Grünwald Viktor , Bauer Sebastian , Hermes Barbara , Ivanyi Philipp , Lindner Lars H , Pink Daniel , Reichardt Peter , Richter Stephan , Tuchscherer Armin ,   Sarcoma Working Group of the Working Group Medical Oncology within German Cancer Society
Published: March 2020

TPS11075

Background: Soft tissue sarcomas (STS) are rare tumors and exhibit substantial histological diversity. Efficacious targeted 1st line treatment for advanced or metastatic STS is not available, and the standard therapy has been anthracycline-based for decades. This strategy shows poor efficacy, as demonstrated by a median Overall Survival (OS) of 12-20 months. Several STS subtypes, however, have been shown to express PD-L1, and immune checkpoint inhibitors (ICI) have demonstrated principle anti-tumor activity in pretreated STS. Our ongoing clinical trial tests the activity and safety of ICI combination therapy in the first-line setting. We hypothesize that the dual checkpoint blockade with Durvalumab (PD-L1) and Tremelimumab (CTLA-4) improves overall survival in STS when compared to the standard of care doxorubicin. Methods: MEDISARC is a multi-center phase II trial that is enrolling adult treatment-naïve patients with histologically confirmed STS of intermediate or high grade (FNCLCC grade 2 or 3) not amenable to surgery with curative intent and ECOG performance status 0-2. Chemosensitive histologic STS are eligible. 100 patients will be randomized 1:1, stratified by ECOG status (0 vs. 1/2). Patients in the experimental arm are treated with fixed doses of durvalumab (1.5 g Q4W) and tremelimumab (75 mg Q4W for 3 cycles, then Q12W) until Progressive Disease (PD) or for a maximum of 12 months. Doxorubicin treatment in the standard arm is at 75 mg/m2 Q3W and limited to 6 cycles. OS is the primary endpoint. Secondary endpoints include 2-year OS rate, PFS, ORR according to conventional and modified RECIST 1.1, safety and tolerability and health-related quality of life (EORTC QLQ-C30). OS analysis may be performed when the required number of events (E=70) has been observed. All randomized and treated subjects will be included in the efficacy and safety analysis. The accompanying translational research aims to identify prognostic and predictive biomarkers in blood and tumor tissue. Enrollment of patients started in April 2018 and is ongoing. As of February 2019, 32 patients have been enrolled. The study is sponsored by AIO-Studien-gGmbH, Berlin, Germany. Clinical trial information: 2016-004750-15.
Phase 3 PhALLCON study: Ponatinib (PON) versus imatinib (IM) with reduced-intensity chemotherapy (CT) in patients (pts) with newly diagnosed Philadelphia chromosome–positive (Ph+) ALL.
Authors: Jabbour Elias , Martinelli Giovanni , Vignetti Marco , Ribera Josep-Maria , Gomez-Almaguer David , Minami Yosuke , Xu Jing , Srivastava Shouryadeep , Neumann Frank , Kantarjian Hagop M.
Published: March 2020

TPS7061

Background: Therapies for adults with newly diagnosed Ph+ ALL are limited and associated with poor outcomes. PON, a potent TKI, is active against native BCR-ABL1 and all identified single resistance mutations, including T315I, which confers resistance to other TKIs (Zhou. Chem Biol Drug Des 2011;77). In the phase 2 PACE study, PON had a 41% major hematologic response rate in heavily pretreated Ph+ ALL, but responses were not durable mainly due to compound mutations (Cortes. Blood 2018;132; Pritchard. Blood 2016;128). As PON suppresses single BCR-ABL1 resistance mutations, resistance in Ph+ ALL is acquired through compound mutations. Decreased likelihood of compound mutations with first-line PON in Ph+ ALL may lead to more durable responses compared with PON in later lines of therapy. In a phase 2 study of PON with CT in newly diagnosed Ph+ ALL, long-term outcomes were improved vs first/second-generation TKIs (Jabbour. Lancet Haematol 2018;5). The PhALLCON trial compares first-line PON vs IM with reduced-intensity CT. Methods: This open-label trial (NCT03589326) is enrolling 230–320 pts (≥18 y) with newly diagnosed Ph+ or BCR-ABL1–positive ALL (p190/p210) and ECOG status ≤2. Pts are randomized 2:1 to PON 30 mg/d or IM 600 mg/d PO with reduced-intensity CT in induction (cycles [C] 1-3), consolidation (C4-9), and maintenance (C10-20). PON dose is reduced to 15 mg once pt achieves minimal residual disease–negative (MRD−) complete remission (CR). After 20C, pts stay on single-agent PON/IM. CNS prophylaxis: 2x/mo in C1-6. Primary endpoint: MRD− (BCR-ABL/ABL1 ≤0.01%) CR (end of induction). Key secondary endpoint: EFS; others in the Table. Subgroup analysis: pts with/without HSCT. Exploratory endpoints include mutation status. Initiated Aug 2018; to include ~110 sites in ≤35 countries. Currently, 5 active sites (4 US, 1 Spain); accrual ongoing. Clinical trial information: NCT03589326. [Table: see text]
ELARA: A phase II, single-arm, multicenter, open-label trial investigating the efficacy and safety of tisagenlecleucel in adult patients with refractory/relapsed follicular lymphoma (r/r FL).
Authors: Dickinson Michael , Popplewell Leslie , Kolstad Arne , Ho Joy , Teshima Takanori , Dreyling Martin H. , Schuster Stephen J. , Thieblemont Catherine , Yateman Nigel , Lehnhoff Katja , Lawniczek Tomasz , Bubuteishvili-Pacaud Lida , Fowler Nathan Hale
Published: March 2020

TPS7573

Background: Tisagenlecleucel is an anti-CD19 chimeric antigen receptor-T cell (CAR-T) therapy that was approved for the treatment of pediatric and young adult patients up to 25 years of age with r/r B-cell acute lymphoblastic leukemia in 2017 (Maude et al. NEJM. 2018), as well as for the treatment of adult patients with r/r diffuse large B-cell lymphoma in 2018 (Schuster et al. NEJM. 2018). FL is the second most common non-Hodgkin lymphoma in the Western hemisphere, with limited treatment options in patients refractory to or relapsing after standard therapies. In a phase 2a study of patients with r/r CD19+ lymphomas, 10 of 14 (71%) patients with r/r FL treated with tisagenlecleucel achieved a durable complete remission at a median follow-up of 28.6 months (Schuster et al. NEJM. 2017). Here we introduce ELARA, a phase 2 study evaluating the efficacy and safety of tisagenlecleucel in patients with r/r FL. Methods: ELARA is a phase 2, single-arm, multicenter, open label trial. Eligible patients must be ≥18 years of age, have radiographically measurable grade 1, 2, or 3A r/r FL that is refractory to a second or later line of systemic therapy (including an anti-CD20 antibody and an alkylator), or relapsed within 6 months after completion of a second or later line of systemic therapy, or relapsed during anti-CD20 antibody maintenance (following ≥2 lines of therapy as above) or within 6 months after maintenance completion, or relapsed after autologous hematopoietic stem cell transplant (HSCT). Patients with central nervous system involvement, or those who received prior anti-CD19 therapy, gene therapy, adoptive T-cell therapy, or allogeneic HSCT are not eligible. The primary endpoint of this study is complete response rate based on Lugano classification response criteria. Secondary outcomes include overall response rate, duration of response, overall survival, cellular kinetics, immunogenicity, safety, and patient-reported outcomes. Estimated enrollment for this study is 113 patients. The study is currently open to patient enrollment. Clinical trial information: NCT03568461.