bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluating perceived barriers to optimal care in head and neck cancer: A mixed-methods study.
Authors: Powell Steven Francis , Beadle Beth Michelle , Watts Tammara L , Maxwell Jessica H. , Hutkin-Slade Linda , Haynes-Lewis Hilda , Demirhan Kimberly , Plotkin Elana , Rush Angie , Dibble Jacqueline , Kim Joseph 
Published: June 2024

6079 Background: Head and neck cancer (HNC) is a complex disease that requires multidisciplinary care and poses significant challenges for patients and healthcare providers. Despite the availability of evidence-based guidelines, achieving optimal HNC care faces many barriers. This mixed-methods study explores the perceived barriers by patients and clinicians to optimal HNC care. Methods: The Association of Cancer Care Centers (ACCC) collaborated with the Head and Neck Cancer Alliance and the American Society for Radiation Oncology (ASTRO), along with an expert steering committee of multidisciplinary roles representing diverse cancer care centers, to evaluate the current landscape of HNC care delivery. Using an explanatory sequential design, ACCC conducted patient (n= 247) and provider (n=206) surveys and four focus groups which included patients with HNC and clinicians to capture barriers to optimal HNC care. Results: Barriers were classified as patient-related, provider-related, and system-related factors. Survey highlights include: 32% of patients received multimodal treatment including surgery, radiation, and medications; 50% of clinicians were at centers that utilized multidisciplinary clinics for HNC; 60% of patients “strongly agreed” they were satisfied with their care; 48% of patients felt members of their treatment team communicated and coordinated care “very well”; and 56% of patients “strongly agreed” clinicians explained their diagnosis comprehensibly. Clinicians and patients differed in their perspectives on how care was delivered in a few areas: 52% of clinicians vs. 40% of patients agreed that side effects of treatment were explained in ways that patients could understand; 29% of clinicians vs. 21% of patients felt that emotional concerns and mental health needs were addressed. Clinicians identified key areas that needed improvement to provide more effective care: financial resources (62%), dedicated navigation (45%), and coordination across members of the care team (45%). Qualitative analysis of focus group responses identified travel logistics to care centers, inadequate health insurance coverage, and lack of dental insurance delaying care as major systems-related barriers to optimal HNC care. Conclusions: This study revealed insights into the delivery of optimal care in HNC in the US, including being a high-volume center, having dedicated HNC nurse navigators, and multidisciplinary meetings for care coordination. Multifactorial barriers to optimal HNC care were also identified and will be used to inform future educational programming and the development of interventions to improve care.
Induction chemotherapy followed by concurrent chemoradiotherapy combined with toripalimab and Endostar in high-risk locally advanced nasopharyngeal carcinoma: A multicenter, randomized, phase 2 trial.
Authors: Kang Min , Yang Kunyu , Lu Ying , Yu Jinming , Ma Daiyuan , Tang Shuang , Gao Jianquan , Zhang Tingting , Yang Zhendong , Lv Jun , Qin Yutao , Wu Fang , Ruan Lin , Liu Kang , Dong Huan , Meng Zhen , Qin Yating , Wang Rensheng 
Published: June 2024

6086 Background: Even though induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT) can improve the survival rate of patients with locally advanced nasopharyngeal carcinoma (LA-NPC), the recurrence and/or metastasis rates for patients with stage IV (T4 and/or N3) diseases remain high. This study investigates the efficacy and safety of adding Toripalimab (PD-1 inhibitor) and Endostar (recombinant human endostatin) to IC-CCRT in patients with high-risk LA-NPC. Methods: High-risk LA-NPC patients were randomly divided (1:1) into either the IC-CCRT+TE group (gemcitabine and cisplatin induction chemotherapy followed by concurrent chemoradiotherapy combined with Toripalimab and Endostar) or the IC-CCRT group (gemcitabine and cisplatin induction chemotherapy followed by concurrent chemoradiotherapy). Toripalimab (240mg, d1) was administered intravenously every 3 weeks for up to 12 cycles (3 induction, 2 concurrent, and 7 adjuvant). Endostar (7.5mg/m2, d1-10) was continuously injected intravenously every 3 weeks for a total of 5 cycles (3 induction and 2 concurrent). The primary endpoint was 3-year progression-free survival (PFS), and the secondary endpoints included 3-year overall survival (OS), 3-year locoregional relapse-free survival (LRFS), 3-year distant metastasis-free survival (DMFS), objective response rate (ORR) and safety. Results: From September 7, 2020, to August 23, 2022, a total of 106 eligible patients were randomly assigned to the IC-CCRT+TE group (n = 53) and IC-CCRT group (n = 53). At a median follow-up of 25 months, the PFS was significantly improved in the IC-CCRT+TE group compared to the IC-CCRT group (HR=0.36, p=0.041). 28 patients (52.8%) in the IC-CCRT+TE group and 5 patients (9.4%) in the IC-CCRT group achieved complete response (CR) after induction chemotherapy, and the difference was statistically significant (P < 0.001). The incidence of grade ≥3 acute adverse events in the IC-CCRT+TE group and IC-CCRT group was 66.0% and 62.3%, respectively. The incidence of grade ≥3 late adverse events in two groups was 5.8% and 5.7%, respectively. The incidence of grade ≥3 immune-related adverse events was only 4.7%. Conclusions: IC-CCRT combined with Toripalimab and Endostar significantly improved PFS in patients with high-risk locally advanced nasopharyngeal carcinoma, and the adverse events are manageable. Clinical trial information: NCT04447326 .
Survey of long term survivors of oral cancer: Looking beyond cancer biology.
Authors: Nair Sudhir Vasudevan Vasudevan , Bavaskar Manasi , Singhavi Hitesh , Shetty Rathan , Singh Arjun 
Published: June 2024

6087 Background: While surgery is the main stay of treatment for early stage oral cancers, advanced stages require adjuvant treatments in the form of radiotherapy or concurrent radiotherapy. Yet, the effectiveness of these interventions is not solely determined by clinical measures but also by personal factors such as individual motivation, support from loved ones, and financial security. These aspects might explain the survival rate variations among patients who, despite having similar prognostic categories and stages of disease, show differing outcomes. The role of social determinants in influencing patient survival, apart from the acknowledged impact of disease biology, is not well understood. Methods: All treatment-naive oral cavity cancer patients who underwent definitive treatment during 2014 to 2018 at our institute and are alive for more than five years were selected for this study. A custom investigator-administered questionnaire was developed and it had 32 questions under six domains- personal, habit history, financial, social, functional, and emotional. The study was approved by the institutional ethics committee. Of the 1787 potential participants, we found that 219 had expired, only 442 patients agreed to answer the questionnaire, while 45 refused to participate. The rest of the patients were not reachable telephonically. Results: This survey had 442 patients, of which 90% were males, with a mean age of 52.1 years. The most common site of the presentation was buccal mucosa (60%), and 59% presented in the locally advanced stage. Post-operatively, 71% received adjuvant therapy. All patients were motivated to undergo the radical treatments and had their family support. However, post-treatment, about 10% of individuals experienced a change in marital status. Financial constraints did affect 20% of patients during and after treatment, and more than 70% had their out-of-pocket expenditure above 50% of the total cost. While 80% did not have trouble attending social functions, 46% reported trouble eating socially. However, this was more common for patients who received adjuvant treatment (p < 0.001). About 21% reported shoulder dysfunction and body discomfort. However, no statistically significant associations could be drawn for any of the domains of the questionnaire when compared to patients between the early and late stages. Shoulder discomfort was experienced more by patients who were treated for tongue cancer (p-value 0.010). Conclusions: The results of this study shed light on the challenges faced by long-term survivors of oral cancer following radical treatment regimens. More than half of patients reported that out-of-pocket expenses constituted more than half of their total treatment costs. A notable minority of people suffer from shoulder dysfunction, suggesting there is a clear opportunity for advancements in reconstruction and rehabilitation.
Validation of a prognostic nomogram for locally advanced oropharyngeal carcinoma (OPC) treated with intensity modulated radiation therapy (IMRT) ± systemic therapy (ST).
Authors: Bossi Paolo , Gili Riccardo , Calza Stefano , Licitra Lisa F. , Maddalo Marta , Bacigalupo Almalina , Belgioia Liliana , Cacicedo Jon , Facchinetti Nadia , Garcia Almudena , Oliva Marc , Bonomo Pierluigi , Sanguineti Giuseppe , Franco Pierfrancesco , Argiris Athanassios , Psyrri Amanda , Orlandi Ester 
Published: June 2024

6088 Background: The interplay among prognosticators in OPC patients (pts) may be influenced by sociodemographic, geographic, epidemiologic and genetic features. We aimed to validate an existing prognostic nomogram (PN) (Fakhry et al 2017) in a large, independent, geographically homogeneous pt cohort. Methods: We retrospectively collected data on consecutive OPC pts treated with definitive IMRT (66-72 Gy) ± systemic therapy (ST) in 14 South-European Centres from 2007 to 2019. We analysed the role of the nomogram prognostic factors (PF) (T and N stage, age, p16 status, smoking, performance status, weight loss, anemia, education, and marital status) with respect to overall survival (OS) and progression-free survival (PFS), and we also evaluated alcohol abuse, comorbidities according to ACE-27 and the presence of a caregiver as added PF. The PN was evaluated in terms of discrimination performance (Harrel C-index) and calibration (ratio O/E and calibration line). Model was recalibrated evaluated via optimism adjusted C-index. Results: We considered 786 pts, with a median follow-up of 63 months (0-189). The table reports pts characteristics. The PN showed a good discrimination for OS and PFS both at 2- and 5-years, not dissimilar from original external validation, with a C-index of 0.75 (CI 95% 0.70-0.79,) and 0.68 (0.64-0.72), respectively. Adding alcohol abuse, comorbidities and caregiver presence did not change the PN. Regarding OS, the model estimated risk was slightly higher than the observed, with an O/E ratio of 0.73 (CI 95% 0.57-0.93) and 0.60 (0.49-0.74) at 2- and 5- years and calibration slope of 1.07 (0.83-1.31). For PFS, the O/E ratio was 0.48 (0.40-0.58) at 2 years and 0.50 (0.42-0.58) at 5 years, and a calibration slope of 0.89 (0.66-1.12). Both for OS and PFS rescaling of baseline hazard and model coefficients resulted in a better calibrated model. Model was validated also after missing data imputation, via MCE (m=5) showing consistent estimates. Conclusions: We validated the prognostic nomogram developed by Fakhry et al. in a large independent European cohort, demonstrating its applicability. These real-life data may represent the benchmark for the design of new prospective clinical trials.[Table: see text]
Mosunetuzumab with polatuzumab vedotin: Subgroup analyses in patients (pts) with primary refractory or early relapsed large B-cell lymphoma (LBCL).
Authors: Assouline Sarit , Budde Lihua Elizabeth , Chavez Julio C. , Diefenbach Catherine S. , Dorritie Kathleen Anne , Ghosh Nilanjan , Olszewski Adam J , Lossos Izidore S. , Mehta Amitkumar , Modi Dipenkumar , Naik Seema , Smith Stephen Douglas , Makadia Sneha , Pham Song , Wu Hao , Batlevi Connie Lee , To Iris , Wei Michael C. , Kamdar Manali 
Published: June 2024

7021 Background: The primary analysis of mosunetuzumab with polatuzumab vedotin (mosun-pola) in the Phase Ib/II study (NCT03671018) demonstrated durable responses and manageable safety in pts with relapsed or refractory (R/R), transplant-ineligible LBCL (Budde et al. Nat Med 2023). Here, we present results for primary refractory (refr) or early relapse (rel) subgroups from this study after a median follow-up of 23.9 months. Methods: Pts with R/R LBCL (diffuse LBCL not otherwise specified [NOS], high-grade B-cell lymphoma [HGBCL], transformed follicular lymphoma (FL), and FL grade 3b) and who received ≥1 prior line of therapy (including an anti-CD20 antibody) were treated with mosun-pola. Refr was defined as SD, PD, PR, or CR with relapse <3 months after first-line (1L) therapy. Rel was defined as CR with relapse ≥3 and ≤12 months after 1L therapy. The primary endpoint was best overall response rate (ORR) by IRC using Lugano 2014 response criteria. Key secondary endpoints included CR rate, duration of response (DOR), duration of CR (DOCR), progression-free survival (PFS), overall survival (OS), and safety. Results: As of July 6, 2023, of the 98 pts in the overall population, 45 (46%) and 27 (28%) pts had refr or rel LBCL, respectively. At baseline, the median age in the refr and rel subgroups was 68 and 70 years respectively; 23/45 pts (51%) and 6/27 pts (22%) were treated with mosun-pola as second-line, respectively. The majority of refr/rel pts had DLBCL NOS (71%; 78%) or HGBCL (24%; 19%), Ann Arbor stage III/IV (80%; 89%), elevated LDH (55%; 48%), and extranodal involvement (67%; 59%). In refr pts, the ORR was 49%, which was generally consistent with the overall population (59%); although the sample size was limited, higher responses (ORR: 74%) were observed in rel pts. Additional clinical outcomes are reported (Table). The safety profile was consistent with the overall population. Grade 3 CRS occurred in one pt in each subgroup. Treatment-related ICANS-like events occurred in 2/45 pts (4%; refr) and 3/27 pts (11%; rel). Conclusions: Mosun-pola demonstrated durable benefits in ORR and CR rates irrespective of a poor response to 1L treatment. Outcomes for pts with refr or rel LBCL are encouraging. Clinical trial information: NCT03671018 . [Table: see text]
Carfilzomib plus rituximab, ifosfamide, carboplatin and etoposide (C-RICE) led to higher response, OS, and PFS in patients with transplant-eligible relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Authors: Amin Mody , Niu Alex , Attwood Kristopher , George Anthony , Azad Farhan , Wong Jerry , Schofield Grant , Pan Dorothy C. , Sait Sheila N. J. , Block Anne Marie W. , Przespolewski Eugene , Connors Carolyn , Demarco Joseph , Gauch Keryn , Gjorgievski Nikolina , Johnson Michael , Manth Linda , McWhite Kenneth , Cortese Matthew Joseph , Hernandez-Ilizaliturri Francisco J. 
Published: June 2024

7042 Background: The CORAL study highlighted the need to develop novel salvage regimens for R/Rr/r DLBCL previously treated with R+CHOP. Overall response rate (ORR) to second line immuno-chemotherapy was 51% with a 3-year progression free survival (PFS) of 30% following high-dose chemotherapy and autologous stem cell support (HDC-ASCS). Optimal disease control (complete remission [CR] or partial remission [PR]) prior to HDC-ADCS and more recently to chimeric antigen receptor T-cell therapy (CAR T), correlates with improved outcomes. Dysregulation of Bcl-2 family members has been associated with acquired resistance to rituximab and chemotherapy which we have previously shown may be mitigated by co-treatment with proteasome inhibition in pre-clinical model. Subsequently, we conducted a Phase I/II clinical trial evaluating the safety and efficacy of CRICE as salvage therapy for R/R DLBCL (Blood Adv. 2023 7:1146-1155). Methods: Here we retrospectively compared the clinical outcomes of R/R DLBCL patients treated with CRICE (N=28) versus RICE (N=38) on our prior clinical trial (NCT01959698). Demographic, clinical, and pathological characteristics were collected for both groups (Table). Study endpoints consisted of differences in overall response rate (ORR), CR/PR rates, median progression free survival (PFS) and overall survival (OS) between the two cohorts. Results: The addition of Carfilzomib to RICE resulted in improved clinical outcomes. A higher ORR (92.9 vs 76.3, P=0.073) and CR rates (82.1 vs. 44.7, P=0.002) were observed in CRICE vs. RICE treated patients. Multivariate analysis confirmed the higher CR rates in CRICE vs. RICE when adjusted by DLBCL subtype (GCB vs. nNon-GCB, P=0.003). More CRICE patients proceeded to HDC-ASCS (52.6% vs. 47.4%, P=0.618). The 3yr PFS rate was higher in CRICE (54%, 32-72%) vs. RICE treated patients (35%, 19-51%). While the median PFS was longer in CRICE treated patients 36.8m (0.8, 73.2) vs. 3.2m (0.5, 54.2) (RICE), it did not reach statistical significance (P=0.714). No differences in OS were observed between CRICE & RICE patients, median OS 67.3m vs. 71.8m. Conclusions: The CRICE outcomes were more striking in patients with non-GCB r/r DLBCL (ORR 85%, mPFS and OS not reached). CRICE led to high CR rates and longer PFS among r/r DLBCL patients, especially in non-GCB DLBCL patients. CRICE could be an attractive regimen to achieve disease control in r/r DLBCL patients undergoing consolidation therapy with HDC-ASCT or CAR T-cell therapy. [Table: see text]
Real world incidence, prevention, and management of tumor lysis syndrome in patients with chronic lymphocytic leukemia treated with venetoclax in the inpatient and outpatient settings.
Authors: Valtis Yannis , Nemirovsky David , Derkach Andriy , Roeker Lindsey Elizabeth , Sharan Saumya , Kabel Charlene , Ortiz Ricardo , Geyer Mark Blaine 
Published: June 2024

7045 Background: Venetoclax (ven) is a BCL2 inhibitor used for the treatment (tx) of chronic lymphocytic leukemia (CLL) which can cause clinical or laboratory (lab) tumor lysis syndrome (TLS). A dose ramp-up schedule and prophylaxis strategies are incorporated into NCCN guidelines and prescribing information. Prior reports have of TLS focused mostly on patients (pts) with relapsed/refractory CLL receiving ven as monotherapy. Methods: We included pts >18y who were diagnosed with CLL or small lymphocytic lymphoma (SLL) and received tx with commercial ven in any line of therapy at our institution from 1/1/2016 to 12/31/2020. TLS was defined using the modified Cairo Bishop Criteria. TLS risk was based on the size of the largest lymph node (LN) on imaging or examination and the absolute lymphocyte count (ALC) as defined by ven prescribing information. Results: We included 616 ven escalations among 136 pts with CLL. Median age was 70 years and 86% were white. Ven was part of first line of tx for 48 pts (35%). 11% had high TLS risk at baseline; 37% among those escalated exclusively inpatient (IP) and 2% among those escalated exclusively outpatient (OP). Among those treated with ven, 47 pts (35%) received ven monotherapy. 74 (54%) of pts were escalated exclusively OP, 35 (26%) had at least one prophylactic hospitalization and 27 (20%) were escalated exclusively IP. During ven initiation, 86% of pts received allopurinol, 71% intravenous hydration, 18% phosphate binders, and 10% prophylactic rasburicase. Among the entire cohort, 8 pts (5.9%) developed lab TLS and zero developed clinical TLS. There were 11 TLS events; 2 pts developed TLS in more than one escalation. Incidence of TLS was 15% for those escalated exclusively IP, 5.7% for those with any prophylactic hospitalization and 2.7% for those escalated exclusively OP. Those who developed TLS were more likely to have a higher TLS risk at baseline, preceding isolated hyperuricemia, or CrCl measurement < 60 mL/min (Table). Conclusions: In this single institution retrospective cohort study, lab TLS was observed, though clinical TLS was not. Baseline hyperuricemia and impaired renal function were more common among those who developed lab TLS compared to those who did not. Prophylactic measures, including use of IV hydration, may have contributed to low rates of observed TLS in the outpatient setting. [Table: see text]
Comparative efficacy of Bruton tyrosine kinase inhibitors in the treatment of relapsed/refractory chronic lymphocytic leukemia: A network meta-analysis (NMA).
Authors: Shadman Mazyar , Brown Jennifer R. , Mohseninejad Leyla , Yang Keri , Burnett Heather , Neupane Binod , Williams Rhys , Lamanna Nicole , O'Brien Susan M. , Tedeschi Alessandra , Tam Constantine S. 
Published: June 2024

7048 Background: Next-generation Bruton’s tyrosine kinase inhibitors (BTKis) have led to changes in the treatment algorithm for patients with high-risk relapsed/refractory (R/R) CLL; defined based on the presence of genetic mutations and a high unmet need. Given the lack of head-to-head trials comparing these treatments in R/R CLL, a NMA was performed to estimate the relative efficacy of BTKis used to treat high-risk patients. Methods: Randomized controlled trials ALPINE (zanubrutinib vs. ibrutinib), ELEVATE-RR (acalabrutinib vs. ibrutinib), and ASCEND (acalabrutinib vs. bendamustine + rituximab/idelalisib + rituximab [BR/IR]) were included in the NMA. High-risk populations were defined based on the pre-specified subgroups within each trial, including patients with del17p and/or TP53 mutations in ALPINE (zanubrutinib: 75/327 and ibrutinib: 75/325), ASCEND (acalabrutinib: 44/155 and BR/IR: 42/155), and del17p/del11q in ELEVATE-RR (acalabrutinib: 268/268 and ibrutinib: 265/265). Bayesian NMAs were used to estimate hazard ratios (HRs) or odds ratios (ORs) with 95% credible intervals (CrIs), and probability better (PB) for zanubrutinib versus all other treatments. Outcomes analysed included investigator-assessed progression-free survival (PFS), overall survival (OS), overall response (ORR), and complete response (CR). Given the timing of the included trials in relation to the COVID-19 pandemic, ALPINE data were analyzed with and without adjustment for COVID-19 related deaths. Results: The NMA found a statistically significant improvement in PFS for zanubrutinib over acalabrutinib in high-risk patients and a trend towards improvement in OS, ORR, and CR (Table). Zanubrutinib led to statistically significant improvements in PFS versus ibrutinib (HR [95% CrI]: 0.49 [0.30, 0.78], PB: 99.9%) and BR/IR (0.12 [0.05, 0.26], PB: 100.0%). For OS, zanubrutinib showed a trend towards improvement versus ibrutinib (0.59 [0.31, 1.12] PB: 94.8%) and BR/IR (0.64 [0.24, 1.74] PB: 80.7%). Conclusions: This NMA found zanubrutinib to be the most efficacious BTKi for patients with high-risk R/R CLL, offering significantly delayed disease progression, and favourable survival and response vs. alternative BTKi treatments. [Table: see text]