bluuebunny/crossref_metadata_2025 huggingface dataset:
Integration of the stem cell biology-based genomic tool, StemPrintER, with clinicopathological parameters for the prediction of distant recurrence in ER+/HER2- breast cancer (BC) patients.
Authors: Pece Salvatore , Maisonneuve Patrick , Disalvatore Davide , Freddi Stefano , Veronesi Paolo , Colleoni Marco , Viale Giuseppe , Di Fiore Pier Paolo
Published: May 2020

1057

Background: The StemPrintER risk score (SPRS) is a 20 gene-based predictor that estimates the “degree of stemness” of the primary tumor and provides additional prognostic information regarding distant metastasis (DM) risk in early stage ER+/HER2- breast cancer (BC) patients beyond that obtained from standard clinicopathological parameters. Here we describe a further refined model, that combines prognostic information from SPRS with tumor size (pT) and nodal status (pN), termed SPARE (SPRS for Personalized Adjuvant therapy in Receptor-Expressing patients). SPARE was compared to the clinical treatment score (CTS) for 10-year risk of DM in a consecutive-retrospective ER+/HER2- BC patient cohort (n=1,827) with 15-year complete follow-up from the European Institute of Oncology (IEO) in Milan. Methods: The SPARE model was developed in patients randomly assigned to a training set (n=609), using the ridge-penalized Cox regression, and tested in an independent validation set (n=1,218). Likelihood χ2 (LRχ2) and Kaplan-Meier survival analysis were used to compare the prognostic information from SPARE and CTS (based on age, pN, pT, endocrine treatment). Comparative analyses were made for the DM risk over the 10-year follow-up, as well as in the early (0-5 years) or late (5-10 years) interval, according to nodal status. Results: SPARE outperformed CTS in providing prognostic information for 10-year DM risk (LRχ2: SPARE = 141.2, P<0.0001; CTS=118.1, P<0.0001), with even greater differences in node-negative patients (LRχ2: SPARE=47.6, P<0.0001; CTS=27.5, P<0.0001) and in 1-3 node-positive patients (LRχ2: SPARE=30.6, P<0.0001; CTS=15.1, P<0.0001). When reciprocally adjusted for each other, SPARE added prognostic information to CTS (ΔLRχ2: CTS+SPARE vs. CTS = 25.2; P<0.0001), while CTS did not provide any statistically significant information to SPARE (SPARE+CTS vs. SPARE = 2.1, P=0.14). Using predefined cut-offs to stratify chemo-naïve patients clinically estimated at low recurrence risk, SPARE identified low, intermediate and high risk patients based on their annual rate of DM in the early (low, 0.2%, intermediate, 0.8%, high, 3.3%) and late (low, 0.3%, intermediate, 0.9%, high, 1.6%) interval. Conclusions: SPARE represents a more refined clinical tool, compared to standard clinicopathological parameters, that could be used for personalized therapeutic decision making in ER+/HER2- BC patients.
A phase II trial of cabozantinib in hormone receptor-positive breast cancer with bone metastases.
Authors: Xu Jing , Higgins Michaela Jane , Tolaney Sara M. , Come Steven E. , Smith Matthew Raymond , Fornier Monica N. , Mahmood Umar , Yeap Beow Y. , Chabner Bruce Allan , Isakoff Steven J.
Published: May 2020

1062

Background: We assessed the antitumor activity of cabozantinib, a potent multi-receptor oral tyrosine kinase inhibitor with activity against MET, RET, VEGFR2, and AXL, in patients with hormone-receptor positive (HR+) breast cancer with bone metastases. Methods: In this single-arm multicenter phase II study, patients with HR+, HER2- metastatic breast cancer and ≥ 1 prior line of therapy received an initial starting dose of 100 mg cabozantinib, later reduced to 60 mg per day. The primary endpoint was bone scan response rate determined by independent central review and defined as percent change of bone scan area from baseline. The target bone scan response rate was 30% compared to a null response rate of 10%. Secondary endpoints included objective response rate (ORR) by RECIST v1.1, progression free (PFS) and overall survival (OS). Bone scan and CT were obtained every 12 weeks. Results: Among 52 enrolled patients, median age was 55, and 54% and 42% had > 2 lines prior endocrine and chemotherapy, respectively and 18 (35%) had bone-only disease. 20 (38%) experienced a partial bone scan response and 6 (12%) had stable disease (SD). 16 (31%) patients discontinued study prior to week 12 assessment for early clinical progression or toxicity, and three (6%) had missing follow-up scans. Best extra-osseous overall response revealed SD in 26 (50%), but no objective responses. In 25 patients with bone scan disease control at 12 weeks, only 3 (12%) developed extra-osseous progression. Median PFS was 4.3 months (90% CI 2.8 - 5.5) and OS was 19.6 months (90% CI 18.0 – 26.8). In a landmark analysis, patients with bone scan disease control at 12 weeks had longer OS (median 24.2 months, 90% CI 16.4 – 31.7) than those without (median OS 13.3 months, 90% CI 9.5 – 18.2), with a hazard ratio of 0.37 (90% CI 0.21 – 0.65). Most common grade 3 or 4 toxicities were hypertension (10%), anorexia (6%), diarrhea (6%), fatigue (4%) and hypophosphatemia (4%). Dose reduction or delay occurred in 42 (81%) patients. Conclusions: This study met its primary endpoint with bone scans improved in 38% of patients with metastatic HR+ breast cancer and remained stable in an additional 12% with cabozantinib treatment. Bone scan response correlated with improved OS. This is the first reported study in breast cancer to use bone scan response as a primary endpoint. Further studies with cabozantinib in HR+ breast cancer and additional validation of bone scan response as a surrogate for clinical benefit in breast cancer are warranted. Clinical trial information: NCT01441947 .
Pazopanib (PZ) plus endocrine therapy as treatment for hormone resistant advanced breast cancer (ABC).
Authors: Gumusay Ozge , Majure Melanie Catherine , Deal Travis , Renslo Jonathan R. , Wabl Chiara A. , Melisko Michelle E. , Chien Amy Jo , Goga Andrei , Moasser Mark , Park John , Hwang Jimmy , Rugo Hope S.
Published: May 2020

1068

Background: A major limitation of endocrine therapy in hormone receptor positive (HR+) ABC is the development of resistance. Preclinical data suggests that higher levels of vascular endothelial growth factor (VEGF) are associated with endocrine therapy resistance. We conducted a phase II trial to evaluate the clinical benefit (CB) of PZ, a VEGF receptor tyrosine kinase inhibitor (TKI) combined with nonsteroidal aromatase inhibitors (NSAIs) in pts with ABC resistant to NSAIs. Methods: Eligibility included postmenopausal women with HR+ ABC and progressive disease (PD) after at least one month of NSAIs. Treatment was PZ 800 mg/day plus either letrozole or anastrozole. The primary endpoint was clinical benefit rate at 12 weeks (CBR12, wks). Secondary endpoints were PFS and safety. A CBR of 20% was considered a clinically meaningful comparison to the expected CBR of < 5% with continued NSAIs after PD. Using a 2-stage design, stable disease in at least 1 of the first 13 pts allowed continued enrollment to a planned 28. Results: 32 pts were enrolled; 28 are evaluable for study endpoints and all patients completed the study. The median age was 58 years (range: 41-77). Pts were heavily pre-treated, with a median of 2 prior hormone therapies (range 1-6) and 1 prior chemotherapy (range 0-8). 8 pts (28.6%) stopped treatment due to adverse events (AE) including hypertension (HTN), fever, transaminitis, nausea, vomiting, rash, hand foot syndrome and pulmonary embolism (PE); 6 pts progressed before wk 12. CBR12 was 46.4% (12 SD, 1 PR); CBR24 was 25% (5 SD, 2 PR). Median PFS was 20 wks (95% CI 11-48, and median PFS for pts with CBR12 was 24 wks. 7 pts had PFS > 6 months (24, 32, 36, 36, 48, 184 and 274 wks); 2 pts had PFS > 3 years (184 and 274 weeks). The most common grade 1/2 AE were nausea (48.2%), fatigue (33.3%), diarrhea (29.6%), back pain (22.2%), and arthralgias (22.2%). Grade 3/4 AEs included HTN (3/28; 11.1), transaminitis (3/28; 11.1%), headache (2/28; 7.4), heart failure, vertigo, nausea, oral pain, vomiting, fever, fatigue, and hypokalemia (one patient each: 3.7%). Conclusions: The addition of PZ to NSAIs resulted in a CBR12 of 46.4%, and a CBR24 of 25% in pts with heavily pre-treated ABC resistant to NSAIs. These results support clinical efficacy of antiangiogenic TKI in HR+ ABC, and suggest benefit in hormone resistant disease. Expected toxicities resulted in early discontinuation in 28.6%, which limited drug exposure. Clinical trial information: NCT 01466972 .
Frequency of brain metastases in patients with locally advanced triple negative breast cancer after neoadjuvant platinum-based chemotherapy: Impact of BRCA1/2 mutations.
Authors: Glazkova Elena , Stenina Marina , Frolova Mona A. , Ignatova Ekaterina , Rumyantsev Alexey , Petrovsky Alexander , Tjulandin Sergei
Published: May 2020

1079

Background: patients with triple negative breast cancer has poor survival outcomes. Achievement of pathological complete response (pCR) after neoadjuvant chemotherapy can significantly improve survival of these patients, however some patients will relapse even after pCR. Methods: we reviewed prospectively-maintained outcomes database of N.N. Blokhin NMRCO. We extracted information about patients with locally advanced non-metastatic (stage IIIA-IIIC) triple negative breast cancer who were treated with neoadjuvant platinum based chemotherapy in 2014-2018 years. All included patients were tested for the presence of BRCA1/2 mutation with whole-exome next-generation sequencing or for “founder” hot-spot mutations. Results: we identified 80 patients who received neoadjuvant treatment with various platinum-based regimens. Pathological complete response rate was 62.5%. BRCA-mutations was found at 22 (27.5%) patients. Median follow-up time was 35.6 months (17.0 – 61.3). 2-year DFS was 77.3%, and 3-year DFS was 70.0%, there was significant differences in DFS in patients, who achieved and patients with residual tumor – 85,2% vs 64,3% (p=0,028). 2-year OS was 91%, 3-year OS was 78,5%. 18 patient had disease progression, the most common sites of disease progression were brain (9 [50.0%]), lungs (5 [27.8%]), 3 (16.7%) patients had locoregional relapses and 1 (5,6%) liver metastases. We separately analysed characteristics of patients with brain metastases (table). There were no significant differences in tumour pathologic response and patient age. All patients, who relapced after pCR, had brain metastases. We also found, that 7 of 9 patients with brain metastases had different BRCA mutations. Brain metastases developed in 40,9% (9/22) of patients with BRCA1 mutations and 3,4% (2/58) of patients with wild type BRCA1 (p<0,00001). Conclusions: BRCA1 mutation is significant prognostic factor for brain metastases development in locally advanced triple negative breast cancer. [Table: see text]
FOENIX-CCA2: A phase II, open-label, multicenter study of futibatinib in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or other rearrangements.
Authors: Goyal Lipika , Meric-Bernstam Funda , Hollebecque Antoine , Valle Juan W. , Morizane Chigusa , Karasic Thomas Benjamin , Abrams Thomas Adam , Furuse Junji , He Yaohua , Soni Nital , Benhadji Karim A. , Bridgewater John A.
Published: May 2020

108

Background: Patients (pts) with intrahepatic cholangiocarcinoma (iCCA) have a 5-year survival rate of 24%. There is no standard treatment for advanced disease after first-line chemotherapy. Fibroblast growth factor receptor-2 ( FGFR2) gene fusions occur in 10% to 20% of pts with iCCA, offering a promising therapeutic avenue for this disease. Futibatinib is a highly selective irreversible FGFR1-4 inhibitor given as a continuous once-daily (QD) oral regimen. This phase 2 registrational trial was initiated because of results from a phase 1 dose escalation/expansion study showing tolerability and preliminary efficacy of futibatinib in pts with iCCA with FGFR2 fusions. Methods: FOENIX-CCA2 (NCT02052778), a single-arm multicenter phase 2 study, enrolled pts with locally advanced/metastatic unresectable iCCA harboring FGFR2 gene fusions or other rearrangements, disease progression after ≥1 line of systemic therapy (including gemcitabine plus platinum-based chemotherapy), no prior FGFR inhibitor treatment, and an ECOG performance status of 0 or 1. Pts received futibatinib 20 mg QD until disease progression/unacceptable toxicity. The primary endpoint is objective response rate (ORR) based on independent central radiology review. Secondary endpoints include disease control rate (DCR), duration of response (DOR), and safety. Results: A total of 103 pts were enrolled. For this interim analysis, data are reported for the 67 pts (65%) with ≥6 months of follow-up. Of these, 82.1% of pts had tumors harboring an FGFR2 fusion. One, 2, or ≥3 prior therapies were received by 44.8%, 28.4%, and 26.9% of pts, respectively. ORR was 34.3% (all partial response, n = 23), and DCR was 76.1%; assessment was pending for 8 pts. Median time to response was 1.6 months (range, 1.0-4.9), and median DOR was 6.2 months (range, 2.1-14.2). The most common treatment-related adverse events (AEs; all grade, grade ≥3) were hyperphosphatemia (79.1%, 25.4%), diarrhea (37.3%, 0%), and dry mouth (32.8%, 0%). Any-cause grade ≥3 AEs were reported in 73.1% of pts. Dose delay or dose reduction was required in 65.7% and 53.7% of pts, respectively; 6.0% of pts discontinued treatment because of AEs. Conclusions: Preliminary assessment of these phase 2 data indicate efficacy and tolerability of futibatinib for treatment of pts with iCCA harboring FGFR2 fusions or other rearrangements who have progressed after chemotherapy. Continued analysis of the study population is underway. Clinical trial information: NCT02052778.
Induction bevacizumab, etoposide and cisplatin followed by whole brain radiotherapy (WBRT) versus WBRT alone in breast cancer with untreated brain metastases: Results of a randomized phase II A-PLUS trial.
Authors: Lu Yen-Shen , Dai Ming-Shen , Tseng Ling-Ming , Chen Shin-Cheh , Chen Wei-Wu Tom , Chao Tsu-Yi , Chao Ta-Chung , Chang Yuan-Ching , Chiu Chang-Fang , Liu Chien-Ting , Lin Chingh-Hung , Liu Chun-Yu , Chen Ya-Fang , Chang Twan Ying , Yu Jyh-Cherng , Rau Kun-Ming , Hsieh Yao-yu , Shen Shih-Che , Huang Shu-Min , Cheng Ann-Lii
Published: May 2020

1082

Background: Our previous study ( Clin Cancer Res. 2015;21(8):1851) demonstrated that bevacizumab preconditioning followed by etoposide and cisplatin (BEEP) is a highly effective treatment for breast cancer (BC) patients (pts) with brain metastases (BM) progressing from WBRT. We conducted a randomized phase II study A-PLUS (NCT02185352) to test whether using BEEP as an induction therapy could enhance the efficacy of WBRT and provide systemic control. Methods: BC pts with measurable BM not suitable for surgery/radiosurgery and had not received WBRT were randomized (2:1) to experimental arm: induction BEEP for 3 cycles (~2 months [ms]) followed by WBRT or control arm: upfront WBRT. The BEEP regimen consists of bevacizumab 15 mg/kg on day 1, and etoposide 70 mg/m2/day on days 2-4, cisplatin 70 mg/m2 on day 2, followed by prophylaxis GCSF, every 21 days. After WBRT in both arms, pts received treatment of physician’s choice except BEEP until BM progression. Stratification was based on the Graded Prognostic Assessment score. Primary endpoint was brain-specific progression free survival (BS-PFS) based on RECIST 1.1, with a total of 108 pts, power of 0.8 at the 2-sided α level of 0.2. Results: Of 112 enrolled pts, 74 were in experimental arm and 38 in control arm. Baseline patient characteristics were generally balanced between arms. With median follow up of 28.7 ms, median BS-PFS was 8.1 vs. 6.5 ms ( p= 0.146; HR 0.71 [95% CI 0.44-1.13]), which met the primary endpoint (pre-defined α level of 0.2). Results of preplanned analysis included: 2-month brain-specific objective response rate of BEEP alone vs. WBRT was 41.9% vs. 52.6% ( p= 0.613); 8-month BS-PFS rate was 48.7% vs. 26.3% ( p= 0.027); median PFS was 6.4 vs. 4.7 ms ( p= 0.071; HR 0.67 [95% CI 0.43-1.04]), and extra-BM PFS was 7.9 vs. 5.0 ms ( p= 0.141; HR 0.71 [95% CI 0.46-1.12]). Median overall survival was 15.6 vs. 13.6 ms ( p= 0.855; HR 0.96 [95% CI 0.59-1.55]), with 31.6% of pts in control arm received BEEP regimen treatment after BM progression. The most common all-grade adverse events (AEs) in experimental arm were neutropenia (30.2%), nausea (27.9%), anemia (27.4%), and leukopenia (24.2%). Most AEs were mild to moderate in severity. Two pts discontinued BEEP treatment due to grade 4 nephrotoxicity and grade 3 infection, respectively. Conclusions: BEEP as induction treatment followed by WBRT for BC pts with BM may improve control of both BM and systemic disease. Further validation by a phase III study is necessary. Clinical trial information: NCT02185352 .
Mutation profile differences in younger and older patients with advanced breast cancer using circulating tumor DNA (ctDNA).
Authors: Clifton Katherine , Luo Jingqin , Tao Yu , Saam Jennifer , Rich Thereasa A. , Roshal Anna , Frith Ashley Elizabeth , Rigden Caron E. , Ademuyiwa Foluso Olabisi , Weilbaecher Katherine N. , Hernandez-Aya Leonel Fernando , Peterson Lindsay Leuthen , Bagegni Nusayba Ali , Suresh Rama , Opyrchal Mateusz , Bose Ron , Wildes Tanya Marya , Ma Cynthia X.
Published: May 2020

1089

Background: Although the noninvasive nature of ctDNA testing is attractive in an older adult population, less is known regarding the mutation profiles of ctDNA in the older adult breast cancer population as this population is often excluded from studies. Previous tissue testing has shown differences in mutation profiles between older and younger adults with breast cancer. The objective of this study is to assess differences in mutation profiles in the older and younger adult breast cancer population using a ctDNA assay. Methods: Patients (pts) with advanced breast cancer underwent molecular profiling using a plasma-based ctDNA NGS assay (Guardant360) between 5/2015-10/2019 at Siteman Cancer Center. Clinicopathological histories were obtained from the medical record. The results of a multicenter database of pts with advanced breast cancer who had undergone molecular profiling using Guardant360 were obtained. Associations between mutations and age were measured using a Fisher’s exact test. Results: In the single institution cohort, of the 214 patients who underwent testing, 148 (69.16%) were < 65 and 66 (30.84%) ≥ 65 years-old. The most frequently mutated genes in age < 65 pts were TP53 (48.65%), PIK3CA (35.81%), and ESR1 (30.41%) while the most frequently mutated genes in age≥65 pts were PIK3CA (56.06%), TP53 (51.52%), ESR1 (25.76%), and ATM (21.21%). ATM, BRAF and PIK3CA mutations were found more frequently in age≥ 65 pts with ER+ HER2- breast tumors (p < 0.01). MYC and ESR1 mutations were not significantly associated with age, overall or within subtype. Overall ctDNA resulted in change in management in 19.8% pts (40/202). In the larger multicenter cohort, of the 8803 pts who underwent testing, 5367 (61.0%) were < 65 and 3417 (38.8%) ≥ 65 years-old. ATM, ESR1 and PIK3CA mutations were more common in age≥65 pts (p < 0.0001) and MYC mutations were less common in age≥65 pts (p < 0.0001). Conclusions: This study found that ctDNA is a feasible, attractive alternative to traditional biopsies and may identify actionable mutations in older adults with breast cancer. When controlling for subtype, results from a single institution were similar to the larger multicenter cohort showing ATM and PIK3CA were more common in the older adult population. This data suggests there may be additional molecular differences between breast cancer in older compared to younger adults that warrants further investigation.
Efficacy and safety of liposomal mitoxantrone (Lipo-MIT) in advanced breast cancer (ABC): A randomized, open label, active-controlled, single-center, phase II clinical trial.
Authors: Wang Leiping , Zhao Yannan , Li Ting , Cao Jun , Du Yiqun , Tao Zhonghua , Peng Wenxia , Wang Biyun , Zhang Jian , Wang Zhonghua , Huan Xiulin , Dou Jing , Hao Chunyan , Li Xiaojing , Wang Xiaodong , Meng Zhibin , Lv Yanan , Gao Cuixia , Hu Xi-Chun
Published: May 2020

1093

Background: Anthracyclines are associated with cardiotoxicity and myelosuppression in breast cancer (BC) patients. A new drug delivery system, liposomal preparation has shown higher anti-cancer effect and lower toxicity due to modified drug release and particle shape. This trial aimed to evaluate the efficacy and safety of Lipo-MIT in ABC. Methods: This is a randomized, open label, active-controlled, single-center, phase II clinical trial. Eligible patients were randomized in a ratio of 1:1 to receive Lipo-MIT or mitoxantrone hydrochloride injection (MIT) intravenously. The dosage was 20 mg/m2 for Lipo-MIT and 14 mg/m2 for MIT, once every four weeks (i.e., one treatment cycle). The primary endpoint was objective response rate(ORR). The secondary endpoints were progression free survival (PFS) and safety. Results: From Oct 2015 through Jul 2017, 60 patients were randomized to Lipo-MIT group (n = 30) or MIT group (n = 30). The Median (Q1,Q3) age was 56.0 (41.0,62.0) years in Lipo-MIT group and 54.5 (44.0,62.0) years in MIT group. Nineteen patients in Lipo-MIT group and 23 in MIT group received < 4 cycles of treatment, 11 patients in Lipo-MIT group and 7 in MIT group were treated for 4 or more cycles. When Lipo-MIT group was compared with MIT group, ORR was 13.3% (4/30) and 6.7% (2/30), disease control rate (PR+SD) was 50% (15/30) and 30% (9/30), median PFS was 2.30 (95% CI: 1.74-3.91) and 1.86 (95% CI: 1.74-2.40) months ( P> 0.05). Lipo-MIT showed significantly lower incidence of all-grade white blood cell decreased (86.7% vs 96.7%), neutrophil count decreased (80.0% vs 96.7%), conjugated bilirubin increased (53.3% vs 56.7%), aspartate aminotransferase increased (40.0% vs 53.3%), and troponin T increased (3.3% vs 36.7%) than MIT, but higher incidence of anemia (76.7% vs 46.7%), skin hyperpigmentation (66.7% vs 3.3%), and platelet count decreased (56.7% vs 53.3%) than MIT. Conclusions: Lipo-MIT provided numerically better ORR, DCR, and PFS than MIT in ABC. Lower incidence of troponin T increased might suggest lower cardiotoxicity of Lipo-MIT. It is worthwhile to further explore the clinical utility of Lipo-MIT in ABC. Clinical trial information: NCT02596373 .
Social media use among NCI designated cancer centers: Where is the diversity?
Authors: Velazquez Manana Ana I. , Leibrandt Ryan , Wu Lesley , Bernabe Ramirez Carolina , Olazagasti Coral , Nguyen Nina Thuha , Rodriguez Bonilla Carlos , Duma Narjust
Published: May 2020

11003

Background: The NCI-Designated Cancer Centers (NCC) are recognized for their leadership, research, and education of health care professionals (HCP). NCC are required to study and improve cancer disparities in their communities. Since the introduction of social media (SM), online platforms have become a source of health information and peer support among patients with cancer, leading to its adoption by NCC across the nation. We aimed to analyze the use of SM among NCC and how the racial/ethnic (RE) diversity represented in their SM messaging compares to their communities. Methods: We reviewed all original SM posts from adult NCC-specific Facebook (FB) and Twitter (TW) pages between 1/1/2019 to 12/31/2019. Basic laboratory NCC pages and retweets were excluded. A 1-year time period was selected to account for variation during health campaigns months. We analyzed each post’s language and content, and the gender and RE of individuals presented in images and videos (IV). Content was categorized into: screening, clinical trials, HCP, or patient story. Data was analyzed using chi-square and Wilcoxon signed-rank tests. Results: We reviewed the FB and TW pages of 56 NCC. The median account age was 10 years for FB and 9 years for TW with a median number of followers of 9,861 and 6,066, respectively. The median number of posts per NCC was 250 in FB and 332 in TW. Only 5 NCC posted in a non-English language (range 1 – 5 posts). Among SM IV, >60% of pages displayed females in ≥50% of their posts, African Americans (AA) were presented in 12-14% and Hispanics in 5%. When compared to their city demographics, Whites and Asians were significantly over-represented while Hispanics and AA were under-represented in NCC’s SM messaging (Table). When compared to the US census, over-representation of Asians and under-representation of Hispanics persisted. Cities with ≥20% AA or Hispanics displayed a higher proportion of IV presenting the respective RE group (p<0.05). Content was not associated with RE makeup. Conclusions: By analyzing the IV posted by NCC on 2 SM platforms, we identified that Hispanics and AA were under-represented in NCC’s SM messaging. Furthermore, SM outreach for non-English speakers was abysmal. Equitable visual representation of diverse RE in NCC’s SM messaging has the potential to serve as a tangible means to demonstrate cultural competency and close the gap in cancer disparities. [Table: see text]
Design-based bone marrow biopsy training.
Authors: Brondfield Sam , Harmon Derek , Romero Dylan , Tai Jenny , Hsu Gerald
Published: May 2020

11007

Background: Hematology/oncology fellows must achieve bone marrow biopsy proficiency. However, a cost-effective, high-fidelity system to practice these procedures has not been described. Other specialties utilize 3D printing to practice procedures. Using design thinking, we developed, implemented, and evaluated a bone marrow biopsy training session with 3D pelvis models. Methods: We printed two models using an NIH template and optimized them through iterative prototyping. We covered a hole at the intended biopsy site with a replaceable cap simulating cortical bone, used cork as medullary bone, and used sand and water as marrow. Caps of two densities simulated softer and harder bone. Fellows could lift silicone skin pads to view anatomy. A flat base minimized movement. In July 2019, we conducted a one-hour practice session (“3D session”) with eight fellows during orientation. After an anatomy review, fellows practiced biopsies using the models with faculty feedback. Fellows also attended a one-hour session with a hematologist demonstrating a biopsy on a patient (“patient session”), the only session offered in previous years. We used a t-test to compare course ratings and pre/post-orientation self-assessed comfort with biopsies (5-point scales). Six months later, we surveyed attendings about fellow biopsy skill and success rate compared to prior years. S.B. conducted a content analysis of a focus group with four fellows and email feedback from one fellow. Results: Fellows rated the 3D and patient sessions highly (4.50 vs 4.75, p = 0.51). Procedural comfort improved significantly after orientation (2.13 to 3.63, p = 0.03). Attendings noted no difference between the 2019 fellows and prior years. Fellows called the 3D session “helpful” and “high-yield.” They praised the opportunity to practice repeatedly with high-fidelity anatomy, rehearse mechanics, receive feedback, and internalize anatomy and muscle memory for later recall. Fellows noted that the model did not allow for patient positioning practice and that the denser cap was too hard. Fellows suggested incorporating a female pelvis and more soft tissue. Conclusions: We developed, implemented, and evaluated a design-based bone marrow biopsy training session. Though we did not find outcome differences compared to traditional training, 3D printing represents a feasible, cost-effective, and high-fidelity educational tool. 3D sessions, in conjunction with patient sessions, may augment understanding of anatomy and provide opportunities for practice and feedback. Future iterations should incorporate user feedback to optimize model fidelity and utility.
The Matilda effect: Under-representation of women in hematology and oncology awards.
Authors: Patel Shruti R , St-Pierre Frederique , Velazquez Manana Ana I. , Ananth Snegha , Durani Urshila , Anampa-Guzmán Andrea Carolina , Castillo Katerina , Dhawan Natasha , Ruddy Kathryn Jean , Oxentenko Amy S , Duma Narjust
Published: May 2020

11012

Background: The proportion of women in the field of hematology and oncology (H&O) has increased over recent decades, but representation by women in leadership positions remains a challenge. Our aim was to examine representation of winners of recognition awards by gender and race from the major international hematology and oncology societies. Methods: Published award recipients from the seven major H&O societies were reviewed, with 26 years of data included (1994-2019). Awardee demographics and academic rank were collected and included in the analysis. Gender was determined based on awardee full name and verified by public data. Chi-square and Cochran-Armitage tests were used to analyze the data. Results: Over the past 26 years, 942 awards were presented at the 7 major H&O societies. We excluded 27 gender specific awards from the analysis. Of the 915 awardees included in analysis, award recipients were overwhelmingly men (77.9%) and non-Hispanic white (84.7%). Gender breakdown by society is described in table. ESMO and ASTRO represented the lowest distribution of women at 9.1% and 11.1%, respectively. Women awardees received 30.3% of the awards categorized as humanistic and education-related, while only receiving 16.0% of awards in the basic sciences category (p<0.01). The Cochran-Armitage test demonstrated an upward trend in the number of women awardees, from 10% between 1994-1998 to 25.6% between 2014-2019 (p=0.0004). Over the past five years, the average proportion of women medical oncologists was 35.6% per the AAMC. In this time period, women oncologists have received only 24.0% of all awards, suggesting the awardees included in the study period do not represent the proportion women in the field (p=0.00424). Black, Hispanic, and Asian awardees represented 3.7%, 3.3%, and 6.8% of the total awardees, respectively. Of the 64 Black and Hispanic awardees, 60.9% of the awards were for investigating healthcare disparities and only 4.6% were given for basic science research. Conclusions: During our study period, women physicians and investigators were less likely to receive recognition awards from the seven major H&O societies compared to men. We also observed a considerable low proportion of minority awardees in all oncology subspecialties. While the proportion of women awardees has increased over time, significant underrepresentation remains. [Table: see text]
Gender differences in faculty rank and subspecialty choice in academic medical oncology.
Authors: Graham Laura , Khaki Ali Raza , Sokolova Alexandra , Davidson Nancy E.
Published: May 2020

11013

Background: The gender gap in the United States healthcare field has been closing. In 2000 women made up 45% of medical school matriculants and by 2017 outnumbered men. Based on our personal observations at academic meetings, however, we hypothesized that gender differences persist in faculty rank and subspecialty choice in academic medical oncology. Methods: We created a database of medical oncologists at the top 15 cancer centers as ranked by the U.S News and World Report in 2019. We identified all medical oncology faculty in the subspecialty fields of breast, gastrointestinal (GI), genitourinary (GU) and thoracic oncology from institution websites (12/2019-1/2020). Faculty working only at satellite clinics (i.e. non-research appointments), and the few faculty in more than one subspecialty group, were excluded. Gender (determined by pictures), subspecialty and academic rank were recorded based on data from institution websites and professional social networking sites. Proportions of men and women in each subspecialty and at each faculty rank were calculated; odds ratios (OR) and χ2 tests were used for comparisons. Results: 346 men and 244 women were identified as subspecialty medical oncologists, comprising 59% and 41% of faculty members, respectively. Gender representation by subspecialty and academic rank are shown in the Table. Breast oncology had more women oncologists than men (OR 2.9, p < 0.001); GU oncology had fewer women (OR 0.3, p < 0.001). The representation of women and men was comparable at the lower academic ranks (instructor, assistant and associate professors). But at the top rank of full professor, only 31% were women (OR 0.54, p = 0.001). Notably, even in breast oncology, the one subspecialty with a greater proportion of women, women still comprised a lower proportion of full professors than men. Conclusions: Gender differences persist in academic medical oncology. At the top 15 US cancer centers, gender differences are seen in subspecialty representation, with more men in GU oncology and more women in breast oncology. Fewer women than men achieve the rank of full professor, even in breast oncology. Additional research is needed to explore the causes of, and contributors to, these differences as well as their impact. [Table: see text]
Effect of participation in the annual Immuno-oncology Young Investigators’ Forum (IOYIF) on the competency and performance of young researchers.
Authors: Fowler Joan B. , Taylor Bryan Carson , Gitzinger Susan H. , Carranza Vanessa
Published: May 2020

11021

Background: Advancing the fight against cancer involves many types of research across different disciplines and professions, from PhD-trained scientists to medical oncology physicians. The IOYIF is a competitive academic research program where oncology junior faculty, clinical and post-doctoral fellows who are pursuing a career in academic research in IO are invited to submit an abstract of their unpublished, original research to a panel of expert judges for assessment. Methods: Performance and confidence change were objectively assessed by analyzing pre- and post-test results before and after the presentation of research. Statistical testing between pre- and post-participation were conducted via chi square analysis with a priori significance set at 0.05. Results: Participants experienced an improvement in mean abstract score following participation in the forum. The mean abstract score improvement was statistically significant for All Participants ( P< 0.001) and all sub-groups ( P< 0.001), with the sole exception of Clinician Scientists. Overall, PhD/Postdoctoral Research participants demonstrated the most improvement. The mean abstract score improvement was statistically significant for those who attended presentation coaching ( P< 0.001) as well as for those that did not ( P= 0.001); the magnitude of improvement was greater among those who attended coaching. Participant self-reported mean confidence scores increased with statistical significance from pre- to post-participation in the forum ( P< 0.001); this increase was noted across all participants and all sub-groups, and was observed in relation to both presentation skills and research defense. Young Investigators reported that lack of experience with grant writing is the most significant barrier they face to obtaining grant funding; they also listed lack of mentorship/guidance in publishing as a prominent barrier. Conclusions: This analysis demonstrates that an IO research forum designed for young investigators can improve the performance and confidence of these scientists. These findings highlight the robust, multifaceted impact of the IOYIF on advancing the professional development of the next generation of IO researchers. Identification of barriers demonstrates the tangible value of the IOYIF in providing needed mentorship to further research efforts, deliver axioms of grant writing guidance, and bridge the gap young researchers face in obtaining funding and publishing their work.
Introduction of a patient communication course to postgraduate oncology training in Russia.
Authors: Kotov Maxim
Published: May 2020

11022

Background: Communication skills are an obligatory part of postgraduate oncology education in European and Western countries and its benefits for doctors, patients, and the healthcare system are well-known. However, teaching efficient patient communication is challenging in developing countries where the paternalistic model is still spread and medical professionals are unaware that these skills are lacking. We hypothesize that a short simulation-based course for oncology residents introduces communication skills and raises awareness about its value. Methods: A 2-day communication course based on the Calgary-Cambridge model was taught to a cohort of PGY2 oncology residents. Lectures, seminars, and clinical simulations emphasizing a patient-centered approach, including open questions, active listening, identifying patient concerns, empathy, summarizing, and bad news delivery were conducted by certified teacher. A simulation exam was administered to those who completed the communication course and those who did not complete the course. Scores (max. 130) from two clinical scenarios assessed by the examiner, actors, and participant were compared between groups. Results: Ten PGY2 residents completed the course and seven did not complete the course. Medians scores for the first scenario given by the examiner, actor and resident were 99 (IQR: 90 – 122), 125 (IQR: 122 – 127) and 102 (IQR: 91 – 108) for course participants and 15 (IQR: 7-35), 18 (IQR: 12-34) and 61 (IQR: 41-83) for non-participants, respectively. Medians scores for the second scenario were also higher in participant group: 113.5 (IQR: 100-117), 107 (IQR: 98-118) and 104 (IQR: 99-112) vs. 22 (IQR: 12-50), 18 (IQR: 10 - 44) and 66 (IQR: 43-81), respectively. Four (40%) course participants and seven (100%) non-participants evaluated themselves higher than the examiner and actor. Conclusions: A short patient communication course for young oncologists effectively improves communication skills and provider self-awareness in developing countries.
Oncology fellows’ survivorship clinic: An opportunity for education and multidisciplinary care delivery.
Authors: Latif Hira , Graves Kristi D , Dilawari Asma Ali
Published: May 2020

11023

Background: Cancer survivors in the U.S. are expected to exceed 20 million by 2026. Most fellows do not receive formal training in survivorship during oncology fellowship despite cancer survivorship comprising 2% of the American Board of Internal Medicine's Oncology examination and the recent accreditation standards related to survivorship care from the Commission on Cancer. Methods: We developed a survivorship curriculum and a multidisciplinary survivorship clinic staffed by a medical oncologist and physiatrist in September 2018. Oncology fellows rotated during their ambulatory block and completed surveys assessing skills and perceptions of competence at the beginning and end of the academic year. Results: 8 fellows completed the pre-survey and 6 of them completed the post-survey. While only a quarter had delivered a survivorship care plan/treatment summary prior to starting clinic, all fellows had delivered these (median=2, range=2-8) at the end of the year. Most fellows had seen survivors of breast, colorectal and hematologic malignancies prior to starting clinic; few had seen survivors with lung (12.5%), GU (0%) or head and neck (25%) cancer. These numbers increased, particularly with fellows’ seeing survivors of GU (50%) and head and neck cancers (100%) at the end of the year. Prior to the rotation less than half the fellows had assisted with managing cancer survivors’ treatment consequences or provided continuity of care through a multidisciplinary team. Similarly, only 25% had counseled cancer survivors with psychosocial concerns. On the post-survey, 100% of fellows reported practicing and feeling experienced in these domains. Post- survey showed improvement in self-reported competence levels in caring for cancer survivors (see Table). Conclusions: Participating in a survivorship clinic has a positive impact on oncology fellows’ experience and competence in caring for cancer survivors. Future directions are geared toward expansion of fellows’ skills to include areas related to cardiovascular and physical medicine. [Table: see text]
Just-in-Time Teaching (JiTT) screencasts for the resident inpatient oncology service: A pilot study evaluating feasibility and effectiveness.
Authors: Kuhlman Patrick , Williams Donna , Amornmarn Amy , Harbaugh Joshua , Lycan Thomas
Published: May 2020

11025

Background: Just-in-Time Teaching (JiTT) screencasts have been viewed positively in some undergraduate and graduate medical settings. JiTT screencast effectiveness has not yet been evaluated for medical trainees in the inpatient adult hematology/oncology setting. Objectives: Our pilot study’s goal was to identify relevant learning objectives, to assess feasibility of screencast development, and to optimize screencast delivery. Methods: To identify key clinical topics, a mixed methods approach first utilized institutional retrospective data (6/1/2018-6/30/2019) to determine the most common inpatient medical problems followed by qualitative interviews of teaching faculty and senior residents. The following six topics were identified for inclusion: 1. Metastatic disease to spine 2. Brain metastases 3. Oncologic emergencies 4. Cancer associated venous thromboembolism 5. Hematologic emergencies 6. Sickle cell disease: inpatient management For each topic, a literature review was performed to develop teaching points which were then refined with input from clinician experts. Each screencast went through several rounds of edits by faculty and trainees prior to submission to the instructional design team for final editing. Screencast length ranged from 13 – 25 minutes (mean of 18 minutes). Qualitative and quantitative feedback was obtained from residents by structured focus group session and online surveys. Results: All residents reported that educational content was “just right.” The series of 6 screencasts was completed within 2 months of dedicated fellow research time. Preferred screencast length was 10-20 minutes and preferred viewing speed was 1.5x original speed (7/10). All residents reported that a screencast database would be a helpful resource for future clinical rotations. All residents (n = 10) reported that screencasts improved medical oncology knowledge base and will improve care provided to cancer patients. Conclusions: Creation of a screencast series was feasible for a hematology-oncology fellow. Systematic identification of key clinical topics led to materials which were confirmed by faculty and trainees to be important for internal medicine medical education on inpatient oncology services. This pilot data indicate that JiTT screencasts may be an effective educational intervention and directly informed a randomized educational research study which is currently enrolling participants.
GI oncology molecular tumor board: Fostering collaboration and clinical education for personalized therapy.
Authors: Grossman Joseph Elan , Bullock Andrea J. , Angarita Susana , Bockorny Bruno , Dayyani Farshid , Hurley Molly , McGregor Kimberly , Pectasides Eirini , Peters Mary Linton Bounetheau , Reddy Venkataprasanth P. , Schlechter Benjamin L. , Tavallai Mehrad , Zerillo Jessica A.
Published: May 2020

11029

Background: In recent years, genomic profiling has become standard of care for several gastrointestinal (GI) cancers. In addition to standard of care indications, comprehensive genomic profiling has led to novel and expanded applications of targeted therapy, chemotherapy, and immunotherapy and facilitated identification of potential clinical trials. A GI molecular tumor board (MTB) was developed with a goal of improving understanding of the biological effects of genomic alterations and their therapeutic implications to enhance personalized therapy. Methods: Foundation Medicine (FM) collaborated with physicians in the GI oncology group of an academic medical center to develop a GI MTB starting March 2019. As of December 2019, 27 GI oncology cases were presented where FoundationOneCDx testing was performed and a clinical question was posed. Cases were discussed by faculty, fellows, research staff, and a clinical genomic scientist and oncologist from FM. Impacted signaling pathways and biomarkers were discussed for each case alongside clinical content so that physicians could consider therapeutic options and clinical trials. Presenting faculty were asked to complete a questionnaire for each case presented to assess the impact of the MTB discussion on clinician knowledge and patient-level treatment recommendations. Results: Of 27 questionnaires sent to 7 providers, 17 (63%) were completed. Respondents indicated that as a result of the MTB, the treatment plan was changed in 2 cases (12%), reinforced in 9 cases (53%) and in 6 cases (35%) there was no effect. On a Likert scale of 1-4 where 1 is “rare/poorly” and 4 is “great” mean scores were as follows: Did this MTB help you understand the biological effects of the main genomic alteration(s) reported in the case presented? 3.3. Did this MTB help you understand the possible therapeutic implications of the main genomic alterations in the case presented? 3.3. Did this MTB improve your understanding of the role of next generation sequencing and comprehensive genomic profiling in making treatment decisions? 3.4. Conclusions: The results of our questionnaire indicate that treatment decisions were changed in a minority of cases based on the MTB. In most cases, clinical decision making was reinforced and understanding of the biological effects of genomic alterations and their therapeutic implications were improved. Based on this feedback we will continue to refine and integrate the GI MTB into clinical care for patients with GI malignancies, and share our experience locally with other disease groups.
Micro-learning: A new approach to upskilling and professional development on the management of patients on immunotherapy.
Authors: Winter Helen , Bal Jessica , Shaw Gemma , Leney Nick , Herbert Christopher
Published: May 2020

11036

Background: Advances in cancer management are rapidly evolving . The introduction of immunotherapy across many tumour types and the potential of effector T cell therapies for patients requires upskilling in the wider health care team. This requires developing learning aimed at understanding the new mechanisms of action, potential side effects and how we educate and manage our patients receiving these therapies. Methods: Five stand alone micro-learning sessions on Immunotherapy were designed aimed at the acquisition of new skills and knowledge in a concise and targeted way. These sessions covered the key areas identified by the Systemic Therapy Day and Acute Oncology Units. These topics developed covered: What is Immunotherapy (IO) (its not chemo); How to interpret thyroid function for patients on IO; Get to know your Cortisol levels and adrenal insufficiency in patients with IO; Proactive management of IO Colitis; Liver function for patients on IO. These were delivered and evaluated during the working day in brief bite-sized sessions. Results: Attendance at formal training sessions - including annual study days and monthly study sessions are not keeping pace with the requirements for upskilling of staff. We present the evaluation of micro-learning delivered within the working day in short sessions. Conclusions: In the era of precision medicine, immunotherapy and effector T cell therapies a new approach to learning and upskilling in the wider health care team is needed. An integrated approach to learning on-the -job with short micro-learning sessions may embed the acquisition of new skills. More importantly, vocational education seeks to change habits, behaviour and culture. This needs to be accessible and flexible to adapt to the current patterns of work.