bluuebunny/crossref_metadata_2025 huggingface dataset:
Prospective cohort study of Kaposi sarcoma treated under real-world conditions in Malawi.
Authors: Kasonkanji Edwards , Gondwe Yolanda , Dewey Morgan , Gumulira Joe , Painschab Matthew , Hosseinipour Mina , Dittmer Dirk
Published: June 2021

11569

Background: Kaposi sarcoma (KS) is the leading cancer in Malawi (34% of cancers). Outside of clinical trials, prospective KS studies from sub-Saharan Africa (SSA) are few and limited by loss to follow up. We conducted a prospective KS cohort study of standard of care bleomycin/vincristine (BV) at Lighthouse HIV clinic, in Lilongwe, Malawi. Methods: We enrolled pathologically confirmed, newly diagnosed, HIV+ KS patients from Feb 2017 to Jun 2019. We collected clinical and treatment characteristics, toxicity, and outcomes of KS with follow-up censored Jun 2020. Patients were treated with bleomycin (25 mg/m2) and vincristine (0.4 mg/m2) every 14 days for a planned maximum of 16 cycles. STATA v13.0 was used to calculate descriptive statistics and Kaplan Meier survival analysis. Toxicity was graded using NCI CTCAE v5.0. Results: We enrolled 138 participants, median age 36 (IQR 32-44) and 110 (80%) male. By ACTG staging, 107 (78%) were T1 (tumour severity), 46 (33%) were S1 (illness severity) and 46 (33%) had Karnofsky performance status ≤70. Presenting symptoms included edema in 69 (53%), visceral disease in 9 (7%), and oral involvement in 43 (33%). Prior to KS diagnosis, 70 (51%) participants were aware of being HIV+ for median 17 months (IQR 6-60) and had been on ART for median 16 months (IQR 6-60). Median CD4 count was 197 (IQR 99-339), median HIV-viral load was 2.6 log copies/mL (IQR 1.6 – 4.8) and 57% were HIV-suppressed ( < 1000 HIV copies/ml). The median number of cycles was 16 (IQR 7-16). 62 (45%) participants missed at least one dose due to stock out. Amongst patients with missed doses, the median number was 3 (IQR 2-4) for bleomycin and 2 (IQR 1-3) for vincristine. 14 (10%) participants experienced at least one reduced dose due to toxicity. 5 (4%) participants suffered grade ≥3 anaemia, 13 (9%) grade ≥3 neutropenia, and one participant had grade 4 bleomycin-induced dermatitis. There was no reported grade ≥3 bleomycin lung toxicity or vincristine-induced neuropathy. Of 115 evaluable participants, responses at the end of therapy were: complete response in 52 (45%), partial response in 27 (23%) stable disease in 5 (4%), and progressive disease in 31 (28%). Median duration of follow-up was 20 months. At censoring, 69 (50%) were alive, 36 (26%) dead, and 33 (24%) lost to follow-up. Overall survival is shown Table as crude and worst-case scenario; worst-case assumes all participants lost to follow up died. Conclusions: Here, we present one of the most complete characterizations of KS presentation and treatment from SSA. As in other studies from the region, the majority of patients presented with advanced disease, chemotherapy stock-outs and loss to follow up were common, and mortality was high. Studies are planned to understand the virologic characteristics, improve therapies, and better implement existing therapies.[Table: see text]
‘I’m being forced to make decisions I have never had to make before’: Oncologists and the conundrums created by COVID-19.
Authors: Perumalswami Chithra R. , Chen Emily , Martin Carly , Goold Susan Dorr , De Vries Raymond G. , Griggs Jennifer J. , Jagsi Reshma
Published: June 2021

12001

Background: The COVID-19 pandemic has created conundrums for physicians. This study examines the experiences of oncologists who engage in complex decision-making regarding the use of chemotherapy in seriously ill persons in the context of the COVID-19 pandemic. Methods: Between January 2020 and August 2020, the authors conducted semi-structured, in-depth individual interviews with 22 purposefully sampled oncologists from practices enrolled in the Michigan Oncology Quality Consortium. Transcripts were double-coded and reconciled by consensus using qualitative data analysis software for thematic analysis. Results: Among the thematic clusters we identified, one was related to conundrums created by the COVID-19 pandemic. In this presentation, we report the results pertaining to three themes within this cluster: (1) the ethical dilemmas faced by oncologists due to the COVID-19 pandemic, (2) the need for both patients and oncologists to manage uncertainty and emotions, and (3) the importance and complexity of integrating technology and communication for seriously ill persons. Oncologists grappled with several conundrums including resource scarcity, resource allocation, delays in care, a duty to promote equity and non-abandonment, high levels of uncertainty and fear, and the importance of advanced care directives and end-of-life care planning. Non-abandonment featured as a coping mechanism for increased stress, and integration of communication with telemedicine was frequent and necessary. Conclusions: This study offers an in-depth exploration of the conundrums faced by oncologists due to the COVID-19 pandemic and how they navigated them. Optimal decision-making for seriously ill persons with cancer during the COVID-19 pandemic must include open acknowledgement of the ethical dilemmas faced, the heightened emotions experienced by both patients and their oncologists, and the urgent need for integrating technology with compassionate communication in determining patient preferences.
Feasibility of a virtual hybrid resistance and balance training program for older patients with cancer and its preliminary effects on lower body strength and balance.
Authors: Sattar Schroder , Effa Corrie , Nedeljak Joni , Haase Kristen R , Alibhai Shabbir M.H. , Kuster Shawn , Amir Eitan , Campbell Diane , McNeely Margaret
Published: June 2021

12002

Background: Falls are a major issue among older patients with cancer and can lead to interruption in cancer treatment. Ample evidence shows resistance and balance training can prevent falls in older adults; however, there is a paucity of evidence regarding exercise on fall prevention in the older cancer population, who often have unique risk factors for falls. Given the new reality of the COVID-19 pandemic, minimizing group gatherings and its associated risks is imperative for older patients, who are a vulnerable population. This study sought to investigate the feasibility of an 8-week, virtual exercise program and its preliminary effects on lower body strength and balance in community-dwelling cancer patients. Methods: Study participants were recruited for this pretest-posttest intervention study using consecutive sampling over a one-year period from the Cross Cancer Institute in Edmonton, Alberta. The intervention entailed leg muscle strengthening and balance training exercises that progressed in difficulty as outlined by the Otago program, and involved a virtual component (facilitated live by a certified exercise physiologist via Zoom meeting platform once a week) and independent at-home training component (twice a week). Lower body strength and balance were assessed using the 5-times chair-stand and the 4-stage balance test, respectively, and were analyzed using the Wilcoxon Signed Rank test. Results: Twenty-seven older patients (mean age 70.1, range 65-76) participated. The most common cancer sites were breast (48%) and prostate (41%). One participant withdrew due to personal reasons unrelated to the program. The remaining 26 participants completed the intervention. Attendance rate for the virtual component was 97.6% and independent component 84.7%. Participants perceived the program as rewarding and enjoyable (100%), felt this program prepared them to exercise on their own (92%), were confident to continue exercising on their own (81%), and would recommend the program to other patients (100%). At baseline, 33% (n = 9) ≥1 fall over the past 6 months. A statistically significant improvement in lower body strength was detected post-intervention ( p =.001), whereas no difference was detected in balance ( p =.059). Conclusions: This virtual, hybrid resistance and balance training program was feasible, overwhelmingly accepted by our older participants, and appeared effective in improving lower body strength. Findings from this study may have potential to inform design of a larger, randomized multi-site study.
Polymorphisms rs4673 and rs28714259 as predictors of anthracycline-mediated cardiotoxicity in patients with breast cancer.
Authors: Gvaldin Dmitry Yu. , Timoshkina Natalya N. , Omelchuk Ekaterina P. , Vashchenko Larisa N. , Ratieva Anastasia S. , Ryadinskaya Ludmila A. , Tikhanovskaya Natalia M. , Abramova Natalia A. , Popova Irina L. , Novoselova Kristina A. , Myagkova Valeriya S , Agieva Aza A. , Teplyakova Maria A. , Alieva Faina V. , Sergeeva Marina M. , Vladimirova Liubov Yu
Published: June 2021

12005

Background: Numerous pharmacogenetic studies have led to the identification of genetic polymorphisms associated not only with the development of cardiovascular disease, but also increase the risk of complications due to the use of anthracycline drugs, widely used in the treatment of cancer. The purpose of this study was to study the frequency of rs4673 and rs28714259 and possible associations with the risk of cardiovascular changes in patients with breast cancer during anthracycline therapy (anthracycline-mediated cardiotoxicity — AMC). Methods: The study included 256 Caucasian patients (median age - 55 years) with a diagnosis of breast cancer without diagnosed cardiovascular changes, who were treated with anthracyclines at the National Medical Research Center of Oncology in 2019-2020. For genotyping of rs4673 and rs28714259, DNA was extracted from blood using DNA-sorb-B (AmpliSens, Russia) and HRM-PCR was performed on a CFX96 amplifier (Bio-Rad, USA). The presence of polymorphisms was confirmed by Sanger sequencing on a Genetic Analyzer 3500 (ABI, USA). Results: During the follow-up period 21 (8.2%) patients were diagnosed with signs of subacute (changes developed within several weeks after the last course of therapy) or early chronic AMC (changes developed within a year after completion of anthracycline therapy). In the group of patients without AOC the allelic frequency of rs4673 (c.214T > C CYBA) was 0.38, the frequency of genotypes C/C – 0.4, C/T – 0.43, and T/T – 0.17. In the same group, the frequency of the A allele rs28714259 was 0.07, the frequency of the G/G genotypes – 0.87, G/A – 0.13, and A/A – 0. The prevalence of genotypes T/T rs4673 and allele G rs28714259 in a cohort of Russian patients differed from the European population (p = 0.014 and p = 0.05, respectively). The risk of cardiovascular changes on the background of anthracycline therapy increased in the presence of the rs4673 polymorphic allele by 6.49 times, in the case of the G/A and A/A rs28714259 genotypes - by 3.27 times. The results of the ROC-analysis suggested high quality of the tests based on the dominant models rs4673 and rs28714259 (AUC was 71.9% and 76.3% correspondingly). Conclusions: In this study the prognostic efficiency of the genetic markers rs4673 and rs28714259 was shown for the prompt detection of the risks of AMC development in the management of cancer patients. However, population characteristics should be taken into consideration for risk assessment.
Incidence of venous thromboembolism in advanced lung cancer and efficacy and safety of direct oral anticoagulant: A multicenter, prospective, observational study (Rising-VTE/NEJ037 Study).
Authors: Tsubata Yukari , Hotta Takamasa , Hamai Kosuke , Furuya Naoki , Yokoyama Toshihide , Saito Ryota , Nakamura Atsushi , Masuda Takeshi , Hamaguchi Megumi , Kuyama Shoichi , Honda Ryoichi , Nakano Kikuo , Nakanishi Masamoto , Yamasaki Masahiro , Ishikawa Nobuhisa , Fujitaka Kazunori , Kubota Tetsuya , Ohtsu Hiroshi , Kobayashi Kunihiko , Isobe Takeshi
Published: June 2021

12021

Background: Venous thromboembolism (VTE) is a well-known kind of cancer-associated thrombosis and a common complication of malignancy. However, little is known about the incidence of VTE and the effectiveness of direct oral anticoagulants (DOACs) associated with lung cancer chemotherapy. Methods: The Rising-VTE/NEJ037 study was a multicenter, prospective, observational study with 40 participating Japanese institutions. A total of 1,021 patients diagnosed with lung cancer that was unsuitable for radical resection or radiation were enrolled and followed up for two years. The diagnosis of VTE was confirmed through a central review by two radiologists. Patients with VTE at the time of lung cancer diagnosis started treatment with edoxaban. The primary endpoint of this trial was the rate of newly diagnosed VTE after enrollment or the recurrence rate 6 months after the start of treatment with edoxaban. Results: Of the 1,021 enrolled patients, data were available for 1,008 patients. The median age was 70 years (range: 30-94 years), and 70.8% were males. Eighty-six percent of patients had non-small cell lung cancer, and 13.6% had small cell lung cancer. Histological types included adenocarcinoma (N = 641, 63.6%), squamous cell carcinoma (N = 187, 18.6%), and others (N = 42, 4.2%). Sixty-two patients (6.2%) had VTE at the time of lung cancer diagnosis, and 42 patients (4.2%) developed VTE during two years follow-up, making a total of 104 patients (10.3%). No cases of VTE recurrence were found 6 months after the start of treatment with edoxaban. Major and minor bleeding occurred in 95 patients (9.4%) and increased to 23% in the edoxaban treatment group. The two-year survival probability was 0.43 in the non-VTE group and 0.48 in the VTE with edoxaban treatment group, showing no difference. Conclusions: This study shows a high cumulative incidence of VTE, suggesting that attention should be paid to VTE during treatment for lung cancer. Treatment with edoxaban was highly effective in preventing recurrence of VTE, and there was no difference in survival with or without VTE, but treatment should be considered more carefully because of the high bleeding rate associated with DOAC. Clinical trial information: jRCTs061180025.
Racial disparities in follow-up care of early-stage lung cancer survivors.
Authors: Malhotra Jyoti , Paddock Lisa E. , Lin Yong , Pine Sharon , Jabbour Salma K. , Stroup Antoinette , Manne Sharon
Published: June 2021

12025

Background: Follow-up care and surveillance in lung cancer survivors is essential formanagement of treatment- and disease-related symptoms as well as for the early detection of cancer recurrence. To investigate if race impacts receipt of follow-up care in lung cancer survivors, we conducted a cross-sectional study in lung cancer survivors recruited through the New Jersey State Cancer Registry (NJSCR). Methods: Between May 2019 and December 2019, survivors of early-stage NSCLC were identified and recruited from the NJSCR. Participants were eligible if they had surgery for stage I or II NSCLC between 2014 and 2017 and, completed all treatment at least one year prior to enrollment. Eligible participants were asked to complete a paper survey questionnaire and medical record release form sent to them by mail. The survey had questions about demographics, smoking, cancer history and treatment, quality of life, follow-up care, barriers to care and informational needs. Study measures were compared between the groups using t-test or chi-square test as applicable. Results: Of the 482 survivors contacted, 23% (n = 114) mailed back the survey questionnaire. Of the 112 survivors who returned a completed survey; 78 (70%) were non-Hispanic (NH) Whites and 34 (30%) were NH Blacks. Mean age was 67 years, 61% were female, 92% had cancer in remission. 82% of participants reported receiving a surveillance scan (CT or PET) within one year of completing the study survey. More NH White survivors received a scan within a year compared to NH Black survivors (89% vs 64%; p = 0.006). Also, 88% of survivors reported that they were informed of the need for follow-up care by their provider with more NH White survivors reporting receiving this information (94%) compared to NH Blacks (71%; p = 0.002). About 57% of the survivors reported receiving a written treatment summary and 92% reported being seen by a physician within the past year; no racial differences in these measures were noted.There was also no racial difference in receipt of age-appropriate cancer screening; 66% and 80% reported receiving regular colon and breast cancer screening, respectively. A significantly higher percentage of NH Blacks reported currently smoking compared to NH Whites (16% vs 12%). The most significant barriers to care for both populations were concern for out-of-pocket costs (26% NH Whites, 19% NH Blacks), non-coverage of test (14% NH Whites, 10% NH Blacks) and lack of insurance (8% NH Whites, 16% NH Blacks). Conclusions: Significant racial disparity was identified between NH Blacks and NH Whites in receipt of surveillance scans, guidance about follow-up care and smoking cessation. The most significant barriers to follow-up care was lack of insurance in NH Blacks and financial concerns about cost and coverage of tests in NH Whites. Future interventions to increase survivorship care should target these specific needs in survivor populations.
Trajectories of functional status among older adults receiving treatment for gastrointestinal (GI) malignancies: A report from the CARE study.
Authors: Giri Smith , Barlow Brett , Al-Obaidi Mustafa , Harmon Christian , Dai Chen , Pergolotti Mackenzi , Gbolahan Olumide B. , Bhatia Smita , Williams Grant Richard
Published: June 2021

12045

Background: Preservation of functional independence while undergoing treatment is of utmost importance to older adults with cancer, in addition to being associated with healthcare utilization and survival. Yet, such data are not readily available from published clinical trials. We sought to examine functional status trajectories and risk factors associated with functional decline among older adults receiving treatment for GI malignancies. Methods: This study included older adults (≥60y) treated at the UAB GI oncology clinic and enrolled in a prospective Cancer and Aging Resilience Evaluation (CARE) registry. All patients completed a geriatric assessment (GA) that included an assessment of activities of daily living (ADL) and instrumental activities of daily living (IADL). Participants were approached for a repeat assessment three months after baseline GA. Change in functional status was classified as one or more points decline or improvement in IADL and/or ADL from baseline to follow up. We measured the proportion with functional decline or improvement and constructed 95% confidence interval (95%CI) using binomial exact methods. We built multivariable logistic regression models to study the impact of baseline predictors on functional decline. Putative risk factors included age, sex, race/ethnicity, cancer type & stage, baseline CARE frailty index, fatigue, pain, malnutrition and CT-based muscle mass indices (Skeletal Muscle Index [SMI] and Skeletal Muscle Density [SMD]) at the time of diagnosis. Results: This study included 184 patients. The median age at first visit was 68y (IQR 64-74); 55% were males, 71% white. Primary cancer diagnoses included colorectal cancer (29%), pancreatic cancer (28%) and other GI cancers (43%); 73% presented with advanced stage disease (III/IV). Most patients were receiving first line therapy (91%), with systemic chemotherapy (95%). The median duration between the baseline and follow up assessment was 109 days (IQR 84-154 days). Overall, 38% (95%CI, 30-45%) experienced a functional decline, whereas functional improvement was seen in 22% (95%CI, 16-29%). In a multivariable analysis, baseline frailty (odds ratio [OR] = 2.37; 95%CI, 1.05-5.38; p =0.03) was associated with significantly increased odds of functional decline; a trend towards increased odds was seen for pancreatic cancer (OR = 2.23; 95%CI, 0.90-5.53; p= 0.08; reference group: colorectal cancer). Conclusions: One in three older adults with GI malignancies experienced functional decline while a quarter experienced functional improvement in the first 3 months following treatment. Baseline frailty was associated with higher odds of functional decline. Early identification of such patients may allow targeted interventions to preserve functional independence and optimize quality of life of older adults with cancer.
Associations of quality of social support and beliefs in curability among older adults with advanced cancer.
Authors: Kehoe Lee , Sohn Michael , Wang Lu , Mohile Supriya Gupta , Patil Amita , Wells Megan , Plumb Sandy , Pang Yiping , Gilmore Nikesha , Kleckner Amber , Belcher Elizabeth , Gudina Abdi , Burnette Brian Leslie , Bradley Thomas Paul , Melnyk Nataliya , Loh Kah Poh
Published: June 2021

12049

Background: Prior studies suggest that social support plays a role in disease understanding of older patients with advanced cancer. In this study, we examined the association of quantity and quality of social support with belief in curability among older patients with advanced incurable cancer. Methods: We performed a secondary analysis of a cluster-randomized geriatric assessment trial (URCC 13070: PI Mohile) that recruited older adults (≥70) with advanced incurable cancer and caregivers. At enrollment, patients completed the Older Americans Resources and Services (OARS) Medical Social Support form to measure both quantity (number of close friends and relatives) and quality of social support. Quality of social support was measured using twelve questions, each ranged from 1 (none of the time) to 5 (all of the time). Higher cumulative scores indicated greater quality of support. For beliefs in curability, patients were asked, “What do you believe are the chances that your cancer will go away and never come back with treatment?” Responses were 0%, <50%, 50/50, >50%, and 100%. Ordinal logistic regression was used to investigate the association of social support with beliefs in curability, adjusting for adjusting for age, gender, education, race, number of Geriatric Assessment (GA) impairments, cancer type, and locality (rural versus urban). Results: We included 347 patients; mean age was 76.4 years, 91% were white, 52% were male, 46% had household income <$50,000, and 55% had high school degree or higher. For every unit increase in OARS Medical Social Support score, the odds of believing in curability decreases by 36.4% [Adjusted Odds Ratio (AOR) 0.733, 95% Confidence Interval (CI): (0.555, 0.969)], after controlling for covariates. Quantity of social support was not associated with belief in curability [AOR 1.033 95% CI: (0.921, 1.156)]. Conclusions: Our study revealed that older patients with advanced cancer who felt more supported by their social network were more likely to report that their cancer was not curable. Interventions that improve quality of social support may also affect disease understanding. Funding: Patient-Centered Outcomes Research Institute (PCORI) 4634 and NIH K24 AG056589 to SGM, NCI UG1CA189961, T32CA102618, NCI K99CA237744 to Loh.
COVID-related anxiety is prevalent and accurately reflects serious COVID risks in breast cancer patients.
Authors: Weiss Marisa C. , Kjelstrom Stephanie , Buckley Meghan , Leitenberger Adam , Jenkins Melissa , Aliano Ruiz Katherine , Berk Alexandra , Manasseh Donna-Marie , Larson Sharon
Published: June 2021

12053

Background: A current cancer diagnosis is a risk factor for serious COVID-19 complications (CDC). In addition, the pandemic has caused major disruptions in medical care and support networks, resulting in treatment delays, limited access to doctors, worsening health disparities, social isolation; and driving higher utilization of telemedicine and online resources. Breastcancer.org has experienced a sustained surge of new and repeat users seeking urgent information and support. To better understand these unmet needs, we conducted a survey of the Breastcancer.org Community. Methods: Members of the Breastcancer.org Community were invited to complete a survey on the effects of the COVID-19 pandemic on their breast cancer care, including questions on demographics, comorbidities (including lung, heart, liver and kidney disease, asthma, diabetes, obesity, and other chronic health conditions); care delays, anxiety due to COVID-related care delays, use of telemedicine, and satisfaction with care during COVID. The survey was conducted between 4/27/2020-6/1/2020 using Survey Monkey. Results were tabulated and compared by chi square test. A p-value of 0.05 is considered significant. Data were analyzed using Stata 16.0 (Stata Corp., Inc, College Station, TX). Results: Our analysis included 568 breast cancer patients of whom 44% had ≥1 other comorbidities associated with serious COVID-19 complications (per CDC) and 37% had moderate to extreme anxiety about contracting COVID. This anxiety increased with the number of comorbidities (p=0.021), age (p=0.040), and with a current breast cancer diagnosis (p=0.011) (see table). Anxiety was significantly higher in those currently diagnosed, ≥65, or with ≥3 other comorbidities, compared to those diagnosed in the past, age <44, or without other comorbidities. Conclusions: Our survey reveals that COVID-related anxiety is prevalent at any age regardless of overall health status, but it increased with the number of other comorbidities, older age, and a current breast cancer diagnosis. Thus, reported anxiety is proportional to the risk of developing serious complications from COVID. Current breast cancer patients of all ages—especially with other comorbidities—require emotional support, safe access to their providers, and prioritization for vaccination.[Table: see text]
Prevalence and predictors of peripheral neuropathy after chemotherapy: Outcomes from the Detroit Research on Cancer Survivorship (ROCS) cohort.
Authors: Sreeram Kalyan , Seaton Randell , Kamgar Mandana , Assad Hadeel , Greenwald Mark K. , Ruterbusch Julie J. , Beebe-Dimmer Jennifer Lynn , Schwartz Ann G. , Simon Michael S.
Published: June 2021

12069

Background: Increased life expectancy for cancer survivors following advances in treatment has led to a greater likelihood of developing long-term complications. Among them is chemotherapy-induced peripheral neuropathy (CIPN), which adversely impacts the functional capacity of survivors. We assessed prevalence and predictors of CIPN in a cohort of African-American (AA) cancer survivors. Methods: The study population included 633 breast, colorectal, prostate and lung cancer survivors who received chemotherapy and participated in the Detroit Research on Cancer Survivorship (ROCS) study. Presence of CIPN was based on self-reported pain, numbness or tingling in the hands or feet, occurring either for the first time or worsening after chemotherapy. If participants reported continued CIPN at the time of survey, their symptoms were reported as persistent. CIPN severity was self-reported as mild, moderate or severe. Logistic regression analysis was used to evaluate socio-demographic and clinical factors (including 12 common comorbid conditions) associated with CIPN prevalence, persistence and severity. Results: Overall, 67% of the cohort reported CIPN at a mean time of 25.3 months (range 2-74 months) after cancer diagnosis, and 51% reported persistent CIPN. The distribution of CIPN severity consisted of 32.2% with mild, 30.8% with moderate, and 36.9% with moderate to severe symptoms. Diagnosis of primary breast (OR 3.99, 95% CI 1.52-10.46) or colorectal cancers (OR 5.24, 95% CI 2.17-12.69) conferred greater CIPN prevalence relative to a diagnosis of prostate cancer. The presence of each additional comorbid condition among those outlined in the survey also conferred a 20% greater prevalence of CIPN (OR 1.2, 95% CI 1.03-1.39). Similar trends were seen among those who reported persistent CIPN. Using age > 65 at diagnosis as the reference group, age < 50 (OR 2.64, 95% CI 1.43-4.88) and age 51-64 (OR 1.96, 95% CI 1.14-3.35) resulted in an increased risk of moderate or severe compared to mild CIPN. Conclusions: In the Detroit ROCS cohort, CIPN was reported in two-thirds of cancer survivors receiving chemotherapy. Out of them, more than one-third reported moderate to severe symptoms, more commonly seen among those age < 65. Consideration of CIPN as a prominent long-term complication of cancer treatment should play a role in treatment decisions and development of new chemotherapy regimens.
The moderating role of informal caregiver’s involvement on the relationship between patient activation and adherence to treatment: Implications for self-management intervention in cancer care.
Authors: Acquati Chiara , Hibbard Judith , Miller-Sonet Ellen , Zhang Anao , Ionescu Elena
Published: June 2021

12083

Background: With increasing demands for a more active role on the part of individuals with cancer and their families in cancer care, patient activation (PA) is emerging as a key factor to promote self-management, adherence to treatment, and satisfaction with treatment planning. The present work investigated the relationship between patient activation and treatment decision making. Given the role informal caregivers play on patient-reported outcomes, it was additionally assessed whether caregiver involvement acted as a moderator of this relationship. Methods: Survey data collected from 504 cancer survivors recruited through online consumer panels were utilized. The survey contained questions concerning treatment options, quality of life, adherence to treatment, next to presence and involvement of informal caregivers. Additionally, the Patient Activation Measure (PAM), sociodemographic and clinical questions were included. A path analysis Structural Equation Modeling (SEM) controlling for covariates was used to examine the relationship between Patient Activation Measure (PAM), caregiver involvement, and the identified outcomes. Moderator analysis was conducted using multiple group SEM. Results: Respondents were mostly women (57.1%), non-Hispanic white (72.9%), middle aged or older adults (68% ≥ 55 y.o.) The four largest cancer type groups were prostate (16.3%), early stage breast (9.7%), gynecological (8.9%), and colorectal cancer (8.3%). Most of the respondents were diagnosed more than 4 years earlier (52.0%). Participants were evenly split between those who received care at an academic cancer center (29.4%) and those treated at community hospital (31.7%). Patient activation was significantly associated with treatment planning being reflective of survivors ’goals and values ( p < 0.001); adherence to treatment ( p = 0.011); and satisfaction ( p < 0.001). Caregiver’s involvement significantly moderated the association between activation and adherence to treatment. Conclusions: Patient activation was positively associated with all three selected outcomes. However, for cancer survivors reporting low rates of caregiver involvement, patient activation was not associated with treatment adherence. Research is needed to deliver and test patient activation interventions inclusive of informal caregivers to improve self-management.
Assessing duration of breakthrough chemotherapy-induced nausea and vomiting (CINV): A pooled study analysis of NEPA versus aprepitant.
Authors: Navari Rudolph M. , Binder Gary , Bonizzoni Erminio , Clark-Snow Rebecca , Olivari Tilola Silvia , Roeland Eric
Published: June 2021

12091

Background: The historical standard clinical trial endpoint for preventing chemotherapy-induced nausea and vomiting (CINV) has been assessment of complete response (CR: no emesis and no rescue medication use) over five days. Recent evaluations focused on the duration of breakthrough CINV suggest that long duration of CINV results in more lost work time and impaired activity and is also a strong predictor for CINV in subsequent cycles. A recent pooled analysis of three similarly designed registration trials of NEPA, a fixed oral combination NK1 receptor antagonist (RA) (netupitant)/5-HT3RA (palonosetron), showed significantly higher CR rates during the delayed phase (≥24-120h) for NEPA compared to an aprepitant (APR) regimen. In this post-hoc analysis, we evaluated the extent and duration of breakthrough CINV in these pooled studies. Methods: Chemotherapy-naïve patients who received cisplatin-based chemotherapy and antiemetic prophylaxis of either a single dose of NEPA plus dexamethasone (DEX) or a 3-day APR/5-HT3 RA/DEX regimen from three randomized, double-blind pivotal trials were included. Patients without a CR were defined as treatment failures. Extent of CINV was evaluated using proportions of patients with treatment failure, emesis, and significant nausea (defined as >25 mm on a 100 mm visual analog scale). Over the 5-day overall phase, duration was categorized as 1-2, and ≥3 days. Pearsons chi-square test was employed to compare risks between treatments for each duration category in each of the previously mentioned endpoints. Results: Among all 621 NEPA and 576 APR patients, a significantly greater proportion of APR patients experienced treatment failure, emesis, and significant nausea for ≥3 days. Specifically, among patients with treatment failure, 31% (41/134) who received NEPA and 43% (61/143) who received APR experienced breakthrough CINV for ≥3 days. Conclusions: Expanding on data suggesting single-day NEPA is more effective than 3-day APR in preventing delayed CINV, NEPA is also more effective in minimizing the extent and duration of CINV in patients with breakthrough emesis and nausea.[Table: see text]
Noninferiority study evaluating dexamethasone (DEX)-sparing regimens administered with NEPA, a fixed combination of netupitant and palonosetron, for the prevention of chemotherapy-induced nausea and vomiting (CINV) caused by high-dose cisplatin.
Authors: Celio Luigi , Bonizzoni Erminio , Bria Emilio
Published: June 2021

12093

Background: Corticosteroids such as DEX continue to play a key role for the prevention of CINV. Although they are generally considered safe when used in combination with other anti-emetic agents, corticosteroids can cause a range of side effects. To reduce the overall exposure to DEX in patients receiving cisplatin-based chemotherapy, we evaluated the non-inferiority of DEX on day 1, with or without low-dose DEX on days 2 and 3, combined with oral NEPA, a fixed combination of the NK1 receptor antagonist (RA), netupitant and 5-HT3 RA, palonosetron, compared with NEPA plus the guideline-recommended use of 4-day DEX (reference arm). Non-inferiority was met for both DEX-sparing regimens and the reference arm for the primary endpoint of complete response (CR: no emesis and no rescue use) during the overall (0-120h) phase post-chemotherapy. In this analysis secondary efficacy endpoints were evaluated for the single-dose DEX-sparing group versus the 4-day DEX arm. Methods: In this analysis from an open-label, multicenter study (ClinicalTrials.gov NCT04201769) chemotherapy-naïve patients undergoing high-dose cisplatin (≥70 mg/m2) received either NEPA and DEX (12 mg) on day 1 only or NEPA and DEX [12 mg on day 1 plus 4 mg twice daily on days 2-4 (DEX4)]. Efficacy endpoints included complete protection (CR plus no significant nausea), no emesis, and no significant nausea (<25 mm on a 100 mm visual analog scale) during the acute (0-24h), delayed (>24-120h) and overall phases. The non-inferiority margin was set at -15% difference (DEX1 minus DEX4). Results: One-hundred fifty-two patients, 76 in each arm, were included. Non-inferiority was met for the DEX1 arm and the DEX4 reference arm for all efficacy endpoints (Table). Conclusions: A simplified regimen of NEPA plus single-dose DEX offers comparable CINV prevention throughout 5 days post-chemotherapy with the advantage of sparing patients additional doses of DEX in the high emetic risk setting of cisplatin-based chemotherapy. Clinical trial information: NCT04201769. [Table: see text]
The equivalency study of novel current standard 3-drugs combination regimen (ondansetron, dexamethasone and olanzapine) to netupitant containing regimen for preventing high dose cisplatin induce nausea and vomiting treatment, double blind placebo control trial.
Authors: Lertanansit Chalermchai , Mahaparn Wasamol , Sriuranpong Virote , Sitthideatphaiboon Piyada , Sintawichai Nattaya , Tanasanvimon Suebpong , Vinayanuwattikun Chanida
Published: June 2021

12100

Background: Prevention of chemotherapy-induced nausea and vomiting (CINV) is vital in cancer treatment. Here, we compared the efficacy of netupitant-containing regimen; composed of NEPA, dexamethasone, and olanzapine (NEPAs), which is recommended for preventing CINV from high-emetogenic chemotherapy (HEC) to standard 3-drugs; ondansetron, dexamethasone, olanzapine for preventing CINV from high-dose cisplatin (≥75 mg/m2). Methods: This randomized, double-blind, placebo-control trial randomly assigned untreated patients who were received high-dose cisplatin in a 1:1 ratio to either NEPAs or standard 3-drugs combination regimen. Dose of dexamethasone in NEPAs regimen was modified after preplanned interim safety analysis to increase from 4 to 8 mg per day on days 2-4. The stratification factors were concurrent treatment with radiation and sex. The primary endpoint was the overall complete response (CR) rate defined as no vomiting and no use of rescue antiemetic drugs. The protocol allowed crossover to NEPAs for those who received standard 3-drugs and did not reach CR in the first cycle. We collected outcome in the first 2-cycle of treatment. Results: Between January 2019 and December 2020, hundred patients were randomly assigned to either NEPAs (n = 51) or in-house standard 3-drugs (n = 49). Demographic characteristics were well-balanced in both arms. Total events in both arms were 101 events for NEPAs and 78 events for standard 3-drug. Overall CR rate were 70% and 69% in NEPAs and standard 3-drugs, ( p-value 0.87) respectively. According to emesis phase, CR in acute (0- 24 hrs.) and delay phase (24-120 hrs.) were not different in both arms; 91% vs. 89% and 72% vs. 71% in NEPAs and standard 3-drugs respectively. However, mean nausea VAS score was significantly lower in NEPAs (1.63 vs. 2.02, p-value = 0.001). The ad hoc subgroup analysis shown similar efficacy between before and after protocol amendment of NEPAs regimen in term of delay emesis CR rate; 70.9% vs. 73.9% ( p-value 0.73). Conclusions: The NEPA-containing regimen did not show superiority compare to standard 3-drug in terms of complete response rate for CINV prevention among patients receiving high-dose cisplatin. Furthermore, the dexamethasone dosage of 4 vs. 8 mg per day might not affect the efficacy of delay emesis of the NEPAs regimen. Clinical trial information: TCTR20190508001. [Table: see text]
CD4+ T-cell count eligibility by HIV status among participants receiving immunotherapy for cancer diagnoses.
Authors: Odeny Thomas A , Rosenthal Matthew Harry , Lurain Kathryn Anne , Strauss Julius , Uldrick Thomas S. , Gulley James L. , Yarchoan Robert , Ramaswami Ramya
Published: June 2021

12104

Background: The Food and Drug Administration recommends that patients living with HIV (PLWH) with a CD4+ T cell count (CD4) ≥350 cells/µL should generally be eligible for any cancer clinical trial, but there has been a reluctance to enter patients with lower CD4 counts. Patients with relapsed or refractory cancers may also have low CD4 due to initial cancer therapies, irrespective of HIV status. Immune checkpoint inhibitors (ICI) are safe among PLWH with advanced cancer receiving antiretroviral therapy and CD4 >100 cells/µL. We examined the outcomes of immunotherapy trials by HIV and CD4 status among patients receiving ICI for relapsed/refractory cancers. Methods: We conducted a retrospective cohort study of participants who received ICI for relapsed/refractory cancers in 2 trials (1 specifically in PLWH with CD4 >100 only) from the National Cancer Institute. Primary outcomes were to assess relationship between HIV status and baseline CD4 (<350 vs ≥350 cells/µL) and other characteristics. We stratified 3-year survival by CD4 in PLWH and HIV-negative participants with HPV-related cancers. The Kaplan-Meier method was used to estimate survival rates. Results: Eighty-three participants were included: 26 (31.3%) were HIV-positive and received pembrolizumab and 57 (68.7%) were HIV-negative and received bintrafusp alfa. HIV-negative participants had relapsed HPV related malignancies (cervix, anal, head and neck) whereas participants with HIV had both viral and non-viral associated cancers (Table). While the median screening CD4 was significantly lower among PLWH than HIV-negative participants, there was no difference in the proportion with CD4 <350 (p=0.1). When restricted to HPV related malignancies, 3-year survival rates were 32.2% for CD4 <350 and 21.2% for CD4 ≥350 (p=0.7). Conclusions: In this retrospective study of ICI clinical trials in relapsed and refractory malignancies, there was no significant difference in baseline CD4 (<350 vs ≥350 cells/µL) by HIV status; 50% of HIV-negative participants had CD4<350 cells/µL. Patients with HIV should be included in ICI studies, and CD4 thresholds lower than 350 cells/µL should be considered as to not unfairly exclude PLWH with cancer.[Table: see text]
The enduring negative effects of financial toxicity in young adult cancer survivors.
Authors: Thom Bridgette , Benedict Catherine , Friedman Danielle Novetsky , Watson Samantha , Zeitler Michelle , Chino Fumiko
Published: June 2021

12117

Background: Due to disruptions in education, workforce entry, and career development caused by cancer and its treatment, young adult (YA) cancer survivors face financial toxicity (i.e., cancer-related financial distress) at rates higher than older survivors. Financial toxicity in YA survivors is associated with avoiding care and diminished psychosocial well-being, but enduring effects on employment, personal finances, and healthcare use and the association with YA’s financial capability are not well studied. Methods: This was a cross-sectional survey of a national sample of YAs with cancer (n = 214) recruited online and via mailing lists. It included the Comprehensive Score for Financial Toxicity (COST), demographic/clinical self-report, and questions on medical cost-coping and healthcare use. Financial capability questions considered respondents’ knowledge about finances, self-efficacy for managing health expenses, and attitudes and behaviors regarding tracking expenses, budgeting, saving, investing, and bill paying. Multiple linear regression assessed associations among financial toxicity, financial capability, and cost-coping. Results: Mean respondent age was 35.4 years ( sd= 5.40) at survey and 27.5 years ( sd= 7.23) at diagnosis. Breast cancer (28%) and lymphoma (17%) were the most common diagnoses; most respondents were white (79%) women (87%) with college degrees (74%). Financial toxicity, as measured by COST, was high (mean = 13.9, sd= 9.3; possible range 0-44, scores < 26 indicate severe financial toxicity). Nearly all of the sample (96%) had health insurance, but 30% said their insurance does not meet their needs. One-half of the sample lacked confidence to manage health expenses. Cost-coping strategies included skipping/delaying: treatment (23%), survivorship care (35%), or medications (39%); 65% relied on a family member to pay for some/all medical bills. Negative events related to medical expenses included using money from savings (58%), taking on credit card debt (45%), post-cancer credit score decrease (44%), borrowing money to pay bills (42%), debt collection contact (37%), lacking money to pay for basic necessities (23%), loan denial (20%), and thoughts about and/or filing for bankruptcy (15%). In multivariate analyses, greater financial toxicity was associated with lower self-efficacy for managing health expenses (β = -0.88, p =.01), poorer financial behaviors (β = -0.54, p =.001), lower income (β = -5.27, p =.001), and skipping/delaying: treatment (eβ= 1.16, p <.001), survivorship care (eβ= 1.13, p <.001), or prescribed medication (eβ= 1.10, p =.001). Conclusions: Our findings illustrate the profound enduring impact of financial toxicity among YAs after cancer treatment. Multilevel interventions are needed to provide YAs the tools to navigate financial aspects of the healthcare system and connect them with resources toward gaining financial independence.
Oncologist phenotypes and associations with response to a behavioral intervention to increase serious illness conversations.
Authors: Li Eric , Manz Christopher , Liu Manqing , Chen Jinbo , Chivers Corey , Braun Jennifer , Schuchter Lynn Mara , Kumar Pallavi , Patel Mitesh S. , Shulman Lawrence N. , Parikh Ravi Bharat
Published: June 2021

12126

Background: Interventions to increase serious illness conversations (SICs) between oncologists and patients may improve goal-concordant care, patient mood and quality of life. Randomized studies suggest that behavioral nudges to oncologists may prompt more and earlier SICs. Identifying characteristics of oncologists associated with response to such interventions may clarify barriers to SIC adoption. Methods: This was a secondary analysis of a randomized trial showing that machine learning (ML)-based behavioral nudges among 42 oncologist-advanced practice provider (APP) dyads (79 total oncology clinicians total) caring for 14,607 patients in a large academic health system led to a quadrupling of SIC rates (NCT03984773). Latent profile analysis identified oncologist phenotypes based on oncologist, patient, and practice data. We used difference-in-differences analyses among patients with predicted 180-day mortality risk ≥10% (n=2695 [12.6% of cohort]) to test the association between oncologist phenotype and response to the nudge, adjusted for patient and oncologist demographic and practice characteristics. Results: Three oncologist phenotypes were identified: 1) Higher-volume specialists 2) Lower-volume specialists; and 3) Higher-volume generalists. Compared with higher-volume specialists and higher-volume generalists, lower-volume specialists had fewer patients per week (9.2 vs 24.3 vs 53.2), fewer days in clinic per week (1.6 vs 2.5 vs 4.4), a higher proportion of new patients per week (34.9% vs 21.0% vs 17.6%), and higher baseline SIC rates (3.9% vs 1.6% vs 0.8%). Lower-volume specialists had a significantly greater response to the intervention than higher-volume specialists and generalists (see Table), demonstrating a nearly six-fold increase in SIC rate from baseline. Conclusions: Response to an ML-based behavioral nudge to prompt SICs was driven by specialist oncologists with lower patient volume and greater SIC adoption at baseline, although the nudge was associated with significantly higher SIC rates among all phenotypes. While effective among lower-volume oncologists, nudges to prompt supportive care interventions may have limited impact among higher-volume oncologists. Other strategies, including default involvement of specialty palliative care, may be more effective for higher-volume oncologists.[Table: see text]