bluuebunny/crossref_metadata_2025_split huggingface dataset:
Relative risk of pneumonitis or interstitial lung disease (ILD) associated with the use of cyclin-dependent kinase inhibitors (CDK4/6i): A systematic review and meta-analysis of phase 3 randomized controlled trials.
Authors: Jahan Nusrat , Wongsaengsak Sariya , Rehman Shabnam , Vinan-Vega Myrian , Tijani Lukman Aderoju , Hardwicke Fred L. 
Published: June 2021

1072 Background: All three currently approved cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) such as palbociclib, abemaciclib, and ribociclib are reported to cause significant pulmonary toxicities including fatal pneumonitis or interstitial lung disease (ILD). We conducted a systematic review and meta-analysis of phase 3 randomized controlled trials (RCTs) to determine the relative risk of pneumonitis or ILD associated with CDK4/6i. Methods: We conducted a systematic search using PRISMA guidelines in PubMed, EMBASE, American Society of Clinical Oncology and San Antonio Breast Cancer Symposium meeting abstracts from inception through Jan 30, 2021. Phase 3 RCTs using CDK4/6i in the intervention arm and reporting the number of events for pneumonitis or ILD were included in the analysis. The Cochran-Mantel-Haenszel method and random effects model were used to calculate the pooled risk ratio (RR) with 95% confidence interval (CI). Heterogeneity was tested by Cochran’s Q test and I2 value. Results: Five phase 3 RCTs — MONALEESA-3, MONALEESA-7, MONARCH plus, monarchE, and PALLAS — reported the number of events for any grade pneumonitis or ILD and were included in the final analysis. A total of 13,191 patients — 6,758 in the CDK4/6i arm and 6,433 in the control arm — were analyzed. Following regimens were used in CDK4/6i arms — MONALEESA-3: ribociclib + fulvestrant; MONALEESA-7: ribociclib + tamoxifen or a non-steroidal aromatase inhibitor + goserelin; MONARCH plus: in cohort A, abemaciclib + anastrozole or letrozole, and in cohort B, abemaciclib + fulvestrant; MonarchE: abemaciclib + standard-of-care adjuvant endocrine therapy (ET); PALLAS: Palbociclib + ET. In the control arms, all studies used placebo and respective endocrine therapies. Any grade pneumonitis or ILD was reported in 1.64% of patients in the CDK4/6i arm versus 0.68% of patients in the control arm. The pooled RR of any grade pneumonitis or ILD was 2.26, 95% CI: 1.60-3.19, P < 0.00001, I2 = 0%. Grade 3/4 pneumonitis or ILD was reported in 0.28% of patients in the CDK4/6i arm and 0.06% of patients in the control arm with pooled RR of 2.35, 95% CI: 0.37-15.08, P = 0.37, I2 = 34%. One grade 5 pneumonitis was reported in the monarchE. Conclusions: Cyclin-dependent kinase 4/6 inhibitors are associated with increased risk of any grade pneumonitis or ILD. Early detection and prompt initiation of appropriate interventions are vital to reduce the morbidity and mortality associated with CDK4/6i induced pneumonitis or ILD.
Novel approach to improve the diagnosis of pediatric cancer in Kenya via telehealth education.
Authors: Severance Tyler , Olbara Gilbert Kipruto , Njuguna Festus , Treff Marjorie , Loehrer Patrick J. , Vik Terry A. 
Published: June 2021

11000 Background: Childhood cancer has an annual incidence of 150-160 cases per million children worldwide but remains vastly under-diagnosed in low to middle income countries (LMIC) such as in Sub-Saharan Africa. Moi Teaching and Referral Hospital (MTRH) is the only tertiary referral hospital in western Kenya and serves a population of 25 million people, including 10 million children. The average number of pediatric cancer diagnoses was 216 cases annually in 2017-2019, well below the anticipated 1500 cases based on cancer epidemiology data. We recently completed a comprehensive Needs Assessment suggesting that due to inadequate pediatric oncology education, many clinical diagnoses are missed and correct diagnostic tests are not obtained at county hospitals. Local medical staff expressed interest in educational programs to help augment their understanding and diagnostic evaluation of pediatric oncology. Methods: To address these disparities in medical knowledge, we implemented Project ECHO – a validated virtual guided practice and telementoring model – to connect multidisciplinary specialists at MTRH with staff in medically underserved communities in western Kenya for ongoing training, technical assistance, and mentorship. The ECHO program follows a Hub-and-Spoke design where the specialists at MTRH and pediatric oncologists at Riley Hospital functioned as the “hub” team and the health care workers at county hospitals were the “spokes”. Sessions were freely available on Zoom twice monthly and featured both a didactic topic presented by experts and a spoke-led case-based discussion. The discussion utilized dialogue education to promote learning and engagement among the spokes with mentorship from the hub team. Results: The ECHO program launched successfully in January 2020 with a curriculum focused on pediatric oncology for general health care workers. A total of 22 sessions occurred with an average of 23 learners (primarily staff at community hospitals within the referral region) per session. Despite the COVID-19 pandemic, the year-end analysis in January 2021 demonstrated 286 new pediatric patients were diagnosed with cancer at MTRH representing a 33% increase over the 3-year average. Conclusions: The implementation of a telehealth education platform – Project ECHO – focused on diagnosing pediatric cancer in medically underserved communities in Kenya, is a useful model to increase the recognition and earlier referral of childhood cancer in LMICs.
Analysis of hematology and oncology fellowship website content and diversity representation.
Authors: Muthiah Arun , Aggarwal Vanya , Wei Chapman , Muthiah Chandrasekar , Quesenberry Matthew I. , Dizon Don S. 
Published: June 2021

11004 Background: Fellowship in hematology and oncology (HO) is widely sought after but lags behind all other internal medicine subspecialties in attracting applicants underrepresented in medicine (URM). An approach to appealing to URMs involves preexisting in-person strategies but also adapting virtual tools to promote inclusion. Specifically, program websites serve as the first impressions of a program, as well as influence the perception of diversity and inclusion. We evaluated the content and diversity representation of HO program websites to facilitate a generally more informed and URM-considerate recruitment. Methods: The websites of 2019-2020 ACGME accredited HO programs were assessed between June 1st to July 1st, 2020. Data focused on 30 informational categories, derived from published methodology, along with three additional categories concerning diversity, based on suggestions for inclusive graduate medical education recruitment strategies, were compared using two-tailed t tests. We defined websites with 70% or more of the 30 informational categories as “comprehensive websites.” Affiliation with a National Cancer Institute (NCI) Designated Cancer Center, NCI Designated Cancer Center + National Cancer Center Network (NCCN) member institution, and a top 50 ranked cancer hospital by U.S. News was also considered in the analysis. Results: A total of 156 program websites were analyzed: 37.2% NCI; 19.9% NCCN; 29.5% U.S. News ranked. Only 31 (19.9%) were “comprehensive websites,” and 34 (21.8%) had information pertaining to at least one of the diversity categories. There was a significant association between inclusion of diversity content and being a “comprehensive website” (p = 0.001). Compared to those that were neither designated nor ranked, programs designated by NCI, NCCN, or ranked by U.S. News were more likely to have more complete information available (p < 0.001, = 0.008, and < 0.001, respectively). However, only programs ranked by U.S. News were more likely to include information about diversity on their websites (p = 0.006). Conclusions: The vast majority of HO fellowship program websites were not comprehensive, including a lack of diversity and inclusivity content. NCI designation, NCCN participation, and US News ranking were significantly associated with more complete fellowship websites. Given the context of the COVID-19 pandemic in which institution visitation is restricted, program websites may have elevated importance in recruitment. HO programs should direct resources to offering more complete and inclusive websites to better inform applicants, including URM residents.
NCI Awardee Skills Development Consortium (NASDC): Applicant profiles.
Authors: Verschraegen Claire F. , Hashibe Mia , O'Connell Ann , Neill Ushma , Rodriguez Romina , Pirl William F. , Gray Tamryn , Yusufov Miryam , Hexner Elizabeth , Mankoff David A. , Noel Cauleen , Romney Madeline , Korczak Jeannette , Matthews Lindsay , Jedidi Iness , Jackson Rebecca 
Published: June 2021

11030 Background: In 2020, the NCI funded a new educational consortium, NASDC (NCI Awardee Skills Development Consortium, RFA-CA-19-010 and -011), through four institutionally granted UE5 awards to deliver a specific course each and a U24 award as a Coordinating Center. The goal is to teach current early-career faculty NCI grantees skills in areas critical for successful independent academic cancer research careers. Courses focus on leadership and socioemotional skills, health disparities, immuno-oncology, and cell and gene therapy. Teaching will initially be virtual, given the COVID pandemic. Methods: A steering committee and four working groups were established to build the consortium infrastructure, including the NASDC (osu.edu) website. Clientele are early-career faculty PD/PI of a current NCI-funded grant (K01, K07, K08, K22, K23, K25, R00, R21, DP1, DP2, DP5, R01, R23, R29, R37, R56, RF1, RL1, U01), of whom 454 were directly contacted. Blast emails and social media were also used. We are reporting the characteristics of 154 applicants, who completed the RedCap application online. Results: 85% of the applicants are within the first 5 years of a faculty appointment, 87% at the assistant professor rank, and 65% on tenure track. 40% hold an M.D. degree and 72% a Ph.D. 81% are US citizens, 52% females, and 45/33/16/2/4%-11% are White/Asian/Black/Native Americans/Other–Hispanics/Latino. 76% work at NCI-designated comprehensive cancer centers. Mean protected research time is 80%. Non-mutually exclusive fields of research interest are therapeutics (46%), basic science (37%), disparities (34%) prevention (32%), public health (28%), and pediatrics (10%). 66% have received a K-award grant, 13% each an R21 or R00, and 3% an R01. Additionally, 35% had a second NCI grant as PI, 10% a third grant, and 60% had non-NCI grants. Reasons for applying included (1) not quite ready to lead a research team (42%), (2) need for stronger career mentoring (37%), and (3) not being fully confident in research skills (21%). Conclusions: Applicants to the new NCI educational consortium (NASDC) have a successful start to their academic career with a third having obtained more than one NCI award. Most applicants work at NCI-designated comprehensive cancer centers. As cancer research continues to evolve and has the potential to address critical health care needs of the nation, NASDC will strive to equip scientists to be leaders, teach advances in technology, and impart confidence in research skills.
Impact of #ASCO Twitter impressions on the oncology community.
Authors: Morgan Gilberto , Choueiri Toni K. , Patel Ronak , Balaji Kavitha , Subbiah Vivek 
Published: June 2021

11039 Background: The oncology community is embracing social media (SM) platforms like Twitter to gain exposure to research, to network, and to engage in real-time discussions. The emergence of SM activity around the ASCO annual meetings has dramatically increased over the past 5 years, with factors such as the COVID-19 pandemic further accelerating use of digital platforms. This growth in SM engagement within the oncology community has previously been presented by totaling the quantity of tweets within a given time frame. Here, we explore the impact of specific trends through impression data. Methods: To evaluate activity trends among certain oncology stakeholders, we utilized an SM analytics platform, Symplur, to conduct a content analysis around ASCO conferences (2016-2020) using hashtags (#ASCOyy) as the search criterion. We focused our analysis on trends in impressions , defined by the theoretical maximum number of Twitter users a given tweet could have directly reached in a follower's timeline. We gathered impressions data to quantitatively assess overall ASCO engagement and evaluate topics of interest, and to discover common ASCO themes and reach within specific stakeholder groups. Results: Our results show the largest increase in impressions was during #ASCO20, despite a plateauing effect seen in the actual number of tweets (Table). The cumulative number of impressions for #ASCO16 was 468.2 million compared with approximately 1.12 billion for #ASCO20. Differentiating this result from the number of tweets related to ASCO, there was stabilization in the absolute number from #ASCO17 onward. When compiling impressions by doctors and by patient advocates, a similar trend emerged, with the most impressions captured during #ASCO20 (Table). Conclusions: As SM use continues to expand in the oncology community, stakeholders have turned to their digital voice to express views and opinions. The impact of impressions versus absolute number of tweets will continue to grow with a stakeholder’s follower count, thus building on the digital presence in oncology.[Table: see text]
A phase 2 study using ipilimumab, nivolumab, and trabectedin for previously untreated metastatic soft tissue sarcoma.
Authors: Gordon Erlinda Maria , Chua Victoria S. , Kim Ted T. , Chawla Neal Shiv , Brigham Don Arlen , Bhuiyan Ishrat , Agulnik Mark , Chow Warren Allen , Chawla Sant P. ,   Sarcoma Oncology Center Staff
Published: June 2021

11562 Background: Sarcoma cells are most immunogenic earlier in the disease course and before treatment when the immune system can recognize and destroy them. Hypothesis: Immune checkpoint inhibitors would be most effective when given to previously untreated patients with metastatic soft tissue sarcoma. Methods: Eligible patients for this Phase 2 study are previously untreated patients ≥ 18 years of age with unresectable or metastatic soft tissue sarcoma, with measurable disease by RECIST v1.1. Immune checkpoint inhibitors Ipilimumab (I) and Nivolumab (N) were given with Trabectedin (T), a marine derived alkaloid with defined doses of I (1 mg/kg i.v. q 12 weeks), N (3 mg/kg i.v. q 2 weeks), and T (1.2 mg/m2 i.v. q 3 weeks). Primary endpoints: (1) Objective response rate by RECIST v1.1 via CT scan or MRI, (2) Progression-free survival (PFS): from first day of treatment to disease progression or death due to any cause; otherwise, it is censored at the time of last follow-up, and (3) Overall survival: from first day of treatment to death due to any cause; otherwise, it is censored at the time of last follow-up. Results: There were eighty-two evaluable subjects, having completed the first cycle of I, N, and T and have had a CT or MRI scan at the 6-week follow-up period. Best Overall Response by RECIST v1.1 = 7 CR (2 surgical CR), 9 PR, 54 SD, and 12 PD. Disease control rate was 85.4%. The median PFS was >6.4 (range: 0-32) months; 6-month PFS rate: 57.3%. The median OS was >12.0 (0-38) months; 6-month OS rate: 78.8%. Safety analysis: The most common Grade 3 TRAEs include increased ALT (26), anemia (11), increased AST (9), and fatigue (8). Common Grade 4 TRAEs include thrombocytopenia (2), increased AST (2), increased ALT (2), and increased CPK (2). There was one Grade 5 TRAE of rhabdomyolysis (1). Conclusions: Taken together, these results suggest that first-line combinatorial therapy with I, N, and T are (1) synergistic, and (2) may be equal or superior to, and safer than, standard first line therapy for advanced/metastatic soft tissue sarcoma. Clinical trial information: NCT03138161.
Comprehensive geriatric assessment and management for Canadian elders with Cancer: The 5C study.
Authors: Puts Martine , Alqurini Naser , Strohschein Fay , Monette Johanne , Wan-Chow-Wah Doreen , Koneru Rama , Szumacher Ewa , Mehta Rajin , Mariano Caroline Joy , Li Anson , Hsu Tina , Brennenstuhl Sarah , Mclean Bianca , Wills Aria , Amir Eitan , Krzyzanowska Monika K. , Elser Christine , Pitters Eric , Breunis Henriette , Alibhai Shabbir M.H. ,   5C Study Team
Published: June 2021

12011 Background: Comprehensive Geriatric Assessment (CGA) is recommended by ASCO for older adults with cancer undergoing chemotherapy to identify issues that can interfere with treatment delivery and optimize functional status and quality of life. However, few randomized controlled trials have been completed so far. Our objective is to evaluate the effectiveness of CGA on improving quality of life for older adults receiving cancer treatment. Methods: Eligible patients were aged 70+, diagnosed with a solid tumour, lymphoma or myeloma, referred for first/second line chemotherapy, speaking English/French, and with an Eastern Collaborative Oncology Group Performance Status 0–2. The CGA was done by a nurse and geriatrician followed by monthly phone calls by the study nurse for 6 months. Patients were randomly assigned (1:1) to receive either the intervention (CGA plus follow-up by geriatric trained team in addition to usual oncology care) or usual care alone. All participants received a monthly healthy aging booklet for attention control. Randomization was stratified by center and treatment intent (curative/adjuvant versus palliative). Our primary outcome was health-related quality of life (HRQOL) assessed with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 global health scale (items 29 and 30). Secondary outcomes include functional status (Instrumental Activities of Daily Living). Outcome data collection was completed monthly for the first 6 months, then at 9 and 12 months. For the primary outcome we used a pattern mixture model using an intent-to-treat approach (at 0, 3, and 6 months). The last data collection took place March 8 2021. Results: From May 2017 to March 2020, 351 participants from 8 hospitals across Canada were enrolled. All patients were seen on or after day 1 of treatment for the intervention per patient request. Patient characteristics at baseline were similar in both arms. The average age was 75.7 (SD = 4.8), 60.4% was male and 54.3% had treatment with palliative intent. Change in HRQOL scores did not differ by arm (p =.80). Neither group exceeded the MCID of 10 points. There was also no difference in IADL between the groups (p = 0.82). Conclusion: CGA was not effective in improving quality of life for older adults receiving cancer treatment in this study. CGA may need to be performed prior to treatment initiation to achieve benefits. Clinical trial information: NCT03154671.
Immunotherapy toxicity in patients over 65 years.
Authors: Mendez Miriam , Cantos Blanca , Nuñez García Beatriz , Sanchez Juan Cristobal , Franco Fernando , Maximiano Constanza , Gutiérrez Lourdes , De La Puente Blanca , Ruíz Casado Ana , Provencio Mariano 
Published: June 2021

12027 Background: Cancer patients increasingly present an advanced age at diagnosis; 50% of the new cases are over 65 years old, being underrepresented in clinical trials. The safety of immunotherapy has not been adequately evaluated in the subgroup of elderly patient. In this population, with more comorbidities, adverse events may be less well tolerated and have more serious consequences. Methods: A retrospective observational study was developed, including all patients treated with immunotherapy at our center between January 2015 to February 2020. Of the total (279 patients), the analysis was performed with the 105 patients ≥65 years of age who had received at least one cycle (in routine clinical practice or within an unblinded clinical trial). All clinical and radiological data of the patients were collected. Results: From the total, the majority had a lung carcinoma or melanoma, treated with nivolumab or pembrolizumab either in first or second line. 63% had died at the time of the analysis. The frequency of toxicities: digestive (15%), pneumonitis (12%) and endocrine (9%). We divided the population into 65-75 years (76 patients) or > 75 years (29 patients), analyzing the frequency of toxicity and deaths secondary to it. Those > 75 years had more digestive toxicity (25% vs 11%), but less pneumonitis (3% vs 15%). There were 7 deaths (6%) related to treatment: 2 patients with ipilimumab-nivolumab (28%), 2 nivolumab (28%), 2 pembrolizumab (28%), and 1 ipilimumab (16%). 5 patients were > 75 years old (median 78 years) presenting a higher mortality rate in relation to toxicity (4% vs 20%, p 0.02) and a worse median survival (29 vs 23 months). The fatal toxicities were: 3 neurological (2 meningoencephalitis and 1 acute diffuse axonal denervation), 2 hepatic, 1 hemophagocytic syndrome and 1 myocarditis. Conclusions: The most frequent toxicity was digestive, but those that led to death were neurological, hepatic, hematological and cardiac. In our series, neurological and cardiac adverse events accounted for 57% of immunotherapy deaths in older patients. Our data warn that patients over 75 years have a higher risk of death from immune-mediated events. In addition, these would be mainly neurological and cardiac, which represents a diagnostic and treatment challenge for oncologists.[Table: see text]