tbuckley/cabot-search huggingface dataset:
Ipilimumab + nivolumab in people with rare variant renal cell carcinoma refractory to nivolumab alone: Part 2 of UNISON (ANZUP 1602) nivolumab then ipilimumab + nivolumab in advanced non-clear cell renal cell carcinoma.
Authors: Craig Gedye, David William Pook, Laurence Eliot Miles Krieger, Carole A. Harris, Jeffrey C. Goh, Ganessan Kichenadasse, Howard Gurney, Craig Underhill, Francis Parnis, Anthony M. Joshua, Tom Ferguson, Felicia Roncolato, Michelle L. Harrison, Stephen Begbie, Michelle Frances Morris, Elizabeth J. Hovey, Mathew George, Prashanth Prithviraj, Emma Link, Ian D. Davis
Journal: Journal of Clinical Oncology (2021)

4565 Background: Immunotherapy targeting PD1 is active across many cancers, but many people are failed by PD1 inhibition alone. UNISON (ANZUP 1602/NCT03177239) has previously reported the activity and outcomes of nivolumab monotherapy in people with nccRCC (OTRR 17%, PFS6 45%; part 1), and here we report the outcomes of combining ipilimumab (I) and nivolumab (N), in people whose cancers are refractory to N alone (part 2). Methods: Participants (pts) with advanced nccRCC with good performance status (ECOG 0/1), were initially enrolled and took N alone. 41 pts refractory to N were offered the combination I (1mg/kg) + N (3mg/kg) every 3 weeks for up to 4 doses. Pts with disease control after N, or N + I could continue N for up to 1 year. UNISON was powered to distinguish a clinically relevant improvement in objective tumour response rate (OTRR) from 15% to 30% in people taking I+N in part 2. Results: 85 pts were enrolled and received N. 41 pts were refractory to N, were well enough to take I+N, and had a representative spectrum of nccRCC histologies (n=41; papillary 44%, chromophobe 20%, Xp11 translocation 12%, RCC unclassified 7%, other 17%). The median time on treatment was 2.1 months, the median number of doses was 3; median follow up at the time of reporting was 20.3 months. The OTRR of I+N in pts refractory to N was 10% with 1 complete and 3 partial responses. Stable disease was experienced by 36% of pts and disease progression by 52%. The disease control rate at 6 months was 45% (95% CI: 34%, 56%). The median PFS was 2.6 months (95% CI: 2.2, 3.8). The 6 month progression-free survival (PFS) was 25% (95% CI: 13-39). Only 14% of patients were free of progression at 12 months. The safety of I+N appeared similar to previous reports. 68% of pts experienced serious adverse events, 34% treatment related SAE. One pt died from refractory pneumonitis. 11 pts (27%) experienced treatment delays or permanent treatment discontinuation. Conclusions: The primary endpoint of the study was not met. A minority of pts with nccRCC refractory to nivolumab derive benefit from combination I+N but many pts remain refractory to immunotherapy. No new safety issues were identified. More effective therapeutic options are needed for people with rare variant renal cell carcinoma. Clinical trial information: NCT03177239.
CIB2 and CIB3 are auxiliary subunits of the mechanotransduction channel of hair cells
Authors: Xiaoping Liang, Xufeng Qiu, Gilman Dionne, Christopher L. Cunningham, Michele L. Pucak, Guihong Peng, Ye-Hyun Kim, Amanda Lauer, Lawrence Shapiro, Ulrich Müller
Journal: Neuron (2021)
Comments and Concerns on the LASER Trial
Authors: Emma S. Lumley, Arslan Pannu, Saba P. Balasubramanian
Journal: JAMA Surgery (2021)

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Modified FOLFIRINOX versus S-1 as second-line chemotherapy in patients with gemcitabine-failed metastatic pancreatic cancer: A randomized phase III trial (MPACA-3).
Authors: Se-Il Go, Sang-Cheol Lee, Woo Kyun Bae, Dae Young Zang, Hyun Woo Lee, Joung Soon Jang, Jun Ho Ji, Jung Hoon Kim, Sanggon Park, Sun Jin Sym, Yaewon Yang, So Yeon Jeon, Sung Yong Oh, Jung Hun Kang
Journal: Journal of Clinical Oncology (2021)

4119 Background: Modified FOLFIRINOX (mFOLFIRINOX) consisting of 5-fluorouracil/leucovorin, irinotecan, and oxaliplatin has been assessed as second-line treatment of patients with advanced pancreatic cancer in retrospective and phase II studies. However, the result was not confirmed by randomized controlled trial. Methods: A randomized, open-label, phase III trial was conducted at 9 institutions in Korea. Patients with metastatic pancreatic adenocarcinoma (mPAC) and Eastern Cooperative Oncology Group performance status of 0-1 who failed to first-line gemcitabine-based chemotherapy were randomly assigned to receive mFOLFIRINOX or S-1. The primary endpoint was overall survival. Results: A total of 80 patients were enrolled from March 2017 to December 2019. The accrual of patients was early terminated due to clear difference of efficacy in the interim analysis and expectation of poor recruitment due to conflicting adjuvant regimens. Objective response and disease control rates were 15.4% vs. 2.4% ( p= 0.041) and 66.7% vs. 36.6% ( p= 0.007) in the mFOLFIRINOX and S-1 arms, respectively. The median progression-free survival was 5.2 and 2.2 months in the mFOLFIRINOX and S-1 arms, respectively ( p= 0.002). The median overall survival was 9.2 and 4.9 months in the mFOLFIRINOX and S-1 arms, respectively ( p= 0.048). The adjusted hazard ratio of the mFOLFIRINOX arm to the S-1 arm for overall survival was 0.402 (95% confidence interval 0.223-0.725, p= 0.002). All grade 3-4 adverse events occurred in 56.5% and 17.1% in the mFOLFIRINOX and S-1 arms, respectively ( p&lt; 0.001). However, only one patient in each arm prematurely discontinued treatment due to toxicity and there was no treatment-related mortality in both arms. Minimally important differences in the health-related quality of life were not observed in both arms. Conclusions: mFOLFIRINOX as second-line treatment in mPAC patients failed to gemcitabine-based chemotherapy demonstrated a survival benefit versus S-1 alone with acceptable toxicities. Clinical trial information: KCT0003534.
Conversion hepatectomy for hepatocellular carcinoma with inadequate future- remnant- liver after portal vein ligation in combination with apatinib plus camrelizimab: A single-arm prospective pilot study (PLACES).
Authors: Zhiming Zeng, Guangzhi Zhu, Huasheng Huang, Yangfeng Jiang, Xinping Ye, Jie Zeng, Cuizhen Liu, Hao Su, Ming Su, Ning Mo, Xiwen Liao, Fuchao Ma, Minhao Peng, Jie Ma, Tao Peng
Journal: Journal of Clinical Oncology (2021)

e16132 Background: A variety of staged hepatic resection has been applied in patients (pts) with hepatocellular carcinoma (HCC) who had an inadequate future-remnant-liver (FRL), but the clinical outcomes remain unsatisfactory. Based on the clinical data of apatinib (a highly selective VEGFR-2 inhibitor) and camrelizimab (anti‐PD‐1 antibody) in HCC pts, we therefore evaluated the safety and efficacy of portal vein ligation (PVL) in combination with apatinib plus camrelizimab for primary HCC with insufficient residual liver volume. Methods: Pts aged 18-75, with HCC, Child-Pugh A status, BCLC stage A-C, preoperative indocyanine green retention rate at 15 min &lt; 10%, and preoperative FLR/standardized liver volume (SLV) &lt; 30% (for pts without cirrhosis ) and &lt; 40% (for pts with cirrhosis ) were enrolled. Pts received PVL followed by camrelizimab (200mg, iv, d1 q2w) plus apatinib (250mg, po, pd, q2w) until surgical criteria were met. Pts underwent second-stage hepatic resection 4 weeks after treatment discontinuation, and continued treatment with apatinib plus camrelizimab for 1 year or endpoints occurred. The primary endpoints were resection rate of conversion surgery and ORR (objective response rate). Results: Between Apr 21, 2020 to Jan 20, 2021, 14 pts were enrolled in this trial. The estimated median preoperative FLR/SLV for all pts was 34.6%. Among the 10 evaluable pts, 7 met the criteria for surgery and 5 completed second-stage hepatectomy except for 2 pt who refused and waited for surgery, respectively. The median interval time of the two stages of surgery was 138.8 days. ORR was 40%, and disease control rate (DCR) was 100% (4 pts with partial response and 6 pts with stable disease). The other 4 pts are waiting for the evaluation. No adverse events (AEs) of grade 3 or worse occurred after PVL. The most common treatment-related AEs in pts during treatment with apatinib plus camrelizimab included hypoalbuminemia (36%), increased aspartate aminotransferase (AST) (100%) and rash (29%). Major AEs in pts underoing second-stage hepatectomy were pneumonia (100%), increased AST (100%), increased alanine transaminase (100%) and anemia (100%). One patient died of postoperative pulmonary infection. Conclusions: PVL in combination with apatinib plus camrelizimab followed by staged resection may be a safe and effective treatment option for HCC pts with insufficient FLR. Clinical trial information: ChiCTR2000033692.
Real-world treatment patterns and outcomes in patients with follicular lymphoma in the United States.
Authors: Jamie T. Ta, Taha Itani, Sheila Shapouri, Stella Arndorfer, Cristina Julian, Giovanni d’Ario, Cheryl Sud
Journal: Journal of Clinical Oncology (2021)

e19534 Background: Despite the availability of new therapies for follicular lymphoma (FL), there are limited data on the real-world treatment (tx) of FL in a contemporary cohort of patients (pts). We examined tx patterns and outcomes in pts who received FL therapy in the US. Methods: This retrospective cohort study used the nationwide Flatiron Health electronic health record-derived de-identified database. During the study, the de-identified data originated from ̃280 cancer clinics (̃800 sites of care) in the US. We selected pts aged ≥18 years, with an initial FL diagnosis (ICD-9-CM: 202.0x; ICD-10-CM: C82.0x) between January 2011 and July 2020, who had received ≥1 line of therapy (LOT) for FL (follow-up ended September 2020). The initiation date of a LOT was considered the index date for analyses by LOT. Pts with evidence of clinical trial participation during the study period, high-grade (3b) FL at diagnosis, transformed aggressive lymphoma at any time before first-line (1L) FL tx, or chemotherapy/immunotherapy or stem cell transplant 12 months before 1L FL tx, were excluded. Pt characteristics at diagnosis were assessed using descriptive statistics. Tx patterns and clinical outcomes (time to next tx [TTNT] and overall survival [OS]) were reported by LOT. Median TTNT and OS were estimated using Kaplan–Meier methods. Results: Overall, 2383 pts met all eligibility criteria. Median age at FL diagnosis was 66 years; 49.2% were male, 77.5% had low-grade (1–2) FL, and 75.2% had advanced stage (III/IV) FL at diagnosis. Median follow-up was 43.1 months, and median time from diagnosis to 1L FL tx was 38 days. Most pts received up to 2 LOTs (n=2258 [94.8%]). The most common regimens across all LOTs were rituximab-bendamustine (R-benda; n=1256 [52.7%]), R monotherapy (n=812 [34.1%]), R-CHOP (n=483 [20.3%]), R-CVP (n=172 [7.2%]), and obinutuzumab (G)-benda (n=77 [3.2%]). The use of newer FL therapies was limited across all LOTs, but more common in the third-line onwards (3L+): chemotherapy-free combinations (R-/G-lenalidomide): 2.3% (all LOTs) and 19.2% (3L+); and phosphoinositide 3-kinase inhibitors: 1.6% (all LOTs) and 21.6% (3L+). In total, 111 (4.7%) pts received G-based regimens. Median TTNT after 1L and second-line onwards (2L+) was 79.4 months and 38.3 months, respectively. Median OS was not reached (NR) and 82.9 months after 1L and 2L+, respectively (Table). Conclusions: We provide a comprehensive update on real-world tx patterns and clinical outcomes in pts with FL in the US. Chemoimmunotherapy remains the standard of care across all LOTs, though the shorter durations of TTNT and OS in 2L+ may support the role of novel therapies in this setting. Tx outcomes by LOT.[Table: see text]
Health-related quality of life (HRQoL) in patients (pts) with myelodysplastic syndromes (MDS) in the Connect Myeloid Disease Registry.
Authors: Dennis A. Revicki, David L. Grinblatt, Rami S. Komrokji, Guillermo Garcia-Manero, Michael R. Savona, Bart L. Scott, Mikkael A. Sekeres, E. Dawn Flick, Adeola Y. Makinde, Pavel Kiselev, Chrystal U. Louis, Melissa Nifenecker, Irene S. DeGutis, Christopher R. Cogle
Journal: Journal of Clinical Oncology (2021)

7040 Background: At diagnosis, disease risk and transfusion burden (TB) can impact HRQoL in pts with MDS. The impact of disease status and higher transfusion requirements on HRQoL has not been well studied. We used data from the Connect Myeloid Disease Registry, an ongoing, prospective, observational cohort study that includes adult pts with lower-risk (LR) and higher-risk (HR) MDS, to investigate factors influencing baseline (BL) and subsequent HRQoL. Methods: BL and Month 6 (M6) data from pts enrolled from Dec 12, 2013 to Mar 6, 2020 (data cutoff) were analyzed. Pts were stratified by International Prognostic Scoring System (IPSS) risk (LR, HR), treatment (Tx) within 45 days post-enrollment (no Tx, best supportive care [BSC], active Tx), and TB 16 weeks post-BL (non-transfusion dependent [NTD], low TB [LTB]; 1−3 transfusions, high TB [HTB]: ≥4 transfusions). Pts completed EQ-5D, FACT-An trial outcome index (TOI), and FACT-Fatigue (FACT-F) questionnaires at BL and quarterly thereafter. Clinically meaningful change, based on minimally important differences, was defined as a change of ±0.07 for EQ-5D, ±6 for FACT-An TOI, and ±3 for FACT-F. Results: At data cutoff, 830 (489 LR, 341 HR) pts were enrolled. Median age was 74 years. 278 pts received no initial Tx, 161 BSC, and 378 active Tx. At BL, 470 were NTD, 197 LTB, and 163 HTB. Of 670 pts still on-study at M6, 462 completed the questionnaires at both BL and M6. At BL , clinically meaningful differences were observed in FACT-An TOI and FACT-F scores, but not EQ-5D, between LR- and HR-MDS and the Tx subgroups . From BL to M6, no clinically meaningful changes were observed in mean scores for each questionnaire. For the TB subgroups, meaningful differences were observed at BL in FACT-An TOI and FACT-F scores, but not EQ-5D (Table). From BL to M6, meaningful decreases in scores were reported by 26%, 30%, and 35% of NTD, LTB, and HTB pts in EQ-5D, 41%, 43%, and 48% for FACT-An TOI, and 40%, 42%, and 48% for FACT-F; increases were reported by 19%, 19%, and 20% pts for EQ-5D, 31%, 32%, and 39% for FACT-An TOI, and 30%, 39%, and 40% for FACT-F. Conclusions: This preliminary analysis suggests that pts with HR-MDS, and transfusion-dependent pts, generally had worse HRQoL at BL, providing further support to initiating active Tx in pts with TB. Possible limitations of the analysis are lower completion rates in pts with more severe disease, and EQ-5D may not capture changes in these subgroups at M6. A longer follow-up may help delineate the impact of Tx on HRQoL assessments in pts with MDS. Clinical trial information: NCT01688011. [Table: see text]
Neuropsychological functioning of first-episode schizophreniform patients
Authors: A L Hoff, H Riordan, D W O'Donnell, L Morris, L E DeLisi
Journal: American Journal of Psychiatry (1992)

This study compared 32 consecutively admitted first-episode schizophreniform patients, 26 patients with chronic schizophrenia according to the DSM-III-R criteria, and 25 normal comparison subjects on a comprehensive battery of neuropsychological tests to determine the degree of cognitive impairment existing at the onset of schizophrenic illness. Patients were tested within 2 weeks of admission to the hospital, after their medication had been stabilized.With age and education controlled, the first-episode and chronic patients performed significantly worse than the normal subjects on neuropsychological summary measures of executive function, verbal memory, spatial memory, concentration/speed, and global cognitive function and on left and right hemisphere function scales. The first-episode patients were as cognitively impaired as the chronic patients on all summary scales and many of the individual tests. Both groups showed relatively greater left than right hemisphere dysfunction.These findings suggest that substantial cognitive deficits, comparable to those of chronic patients, are present early in the course of psychotic illness.
Impact of primary care providers (PCPs) on care receipt and satisfaction in adolescent and young adult (AYA) oncology patients.
Authors: Eric Hess, Amanda Marie Parkes
Journal: Journal of Clinical Oncology (2021)

e13512 Background: While there has been ongoing work to define the role of primary care providers (PCPs) in adolescent and young adult (AYA) survivorship models, little has been done to understand the role of PCPs earlier in the care continuum. As PCP-shared models of care have been theorized to help address morbidity related to the physical and psychosocial effects of cancer and its treatment, there is a need to better understand the impact of PCPs on AYAs. Given this, we sought to study the influence of PCPs in the care of AYAs with cancer, comparing care receipt and satisfaction during treatment versus in survivorship. Methods: Electronic health record query identified adult AYA cancer patients 19-39 years with at least two visits at the University of Wisconsin from 3/30/2019-3/29/2020. Identified patients were sent an electronic survey to assess care team members and impact on care. Responses were categorized based on patient-reported presence of a PCP as part of their cancer care team. For the data analysis, all patients who did not self-identify as long-term survivors, defined as 5+ years since diagnosis, were defined as active patients. Given survey answers were not mandated for all questions, the denominator was unique for each question. Results: We found a minority of AYAs responding to our survey considered a PCP as part of their cancer care team (71/173, 41%). PCP presence led to improved satisfaction in all AYAs with addressing the impact of diagnosis/treatment on peer interactions and independence, with 67% (45/67) AYAs with a PCP very or some satisfied versus 55% (53/97) without a PCP. PCPs also decreased the likelihood that supportive care services weren’t received by patients due to a lack of knowledge of the services, seen in 64% (56/88) AYAs without a PCP versus 52% (32/62) with a PCP. As seen in table, there were several findings suggesting that PCP involvement in AYA care was more critical to active patients than long-term survivors, including supportive care service receipt and satisfaction with such services. Conclusions: Overall, we found PCP involvement on cancer care teams was important for AYAs defined as both active patients and long-term survivors. Despite this, less than half of all patients identified PCPs as part of their care team. Our data suggest PCP-shared models of cancer care may improve care utilization and satisfaction in AYAs and support efforts to incorporate PCPs as meaningful members of the care team throughout all phases of care. Survey responses based on PCP inclusion as cancer care team member and patient treatment status.[Table: see text]
Improving admission medication reconciliation at a tertiary cancer center.
Authors: Ed Kheder, Lijo Saji, Ali Zalpour, Samuel Swanson, Sreedhar Mandayam
Journal: Journal of Clinical Oncology (2021)

e18686 Background: Accurate medication reconciliation (MedRec) is a pivotal step ensuring patient safety during transition of care, yet one of the most challenging aspects in healthcare quality and safety. Inaccurate MedRec leads to 40 % of medications errors, 20% of which results in harm. Our aim is to increase rate of accurate MedRec completion at MD Anderson Cancer Center (MDACC), within 24 hours of admission, from 85% to &gt;95% through Best Possible Medication History (BPMH) Methods: During pre-intervention phase, we audited medication review and reconciliation of 50 randomly selected patients within 24 hours from admission to MDACC. Our intervention included: conducting several brain-storming sessions with nursing staff, providers, pharmacists; creating fish bone diagram and process maps; designing educational presentations for nursing staff on how to practice BPMH; educating providers on how to complete medication reconciliation within 24 hours of admissions; assigning nursing champions; and sending email reminders to provider on a daily basis. We audited another 50 patients post intervention. In our project, BPMH accuracy was measured by percentage of patients with zero discrepancies (incorrect dosage, frequency or route; extra medication; discontinued medication not removed from list). Significance was tested for BPMH completion, and MedRec completion using a Binomial Test, while significance for number of discrepancies and audit completion time was tested using a Two Sample t-Test. Results: We collected data on 50 patients pre and 50 post intervention. Our results indicate statistically significant improvement in MedRec rate (100%), reduction of number of discrepancies and audit completion time. Conclusions: Medication review and reconciliation are multi-phased processes. Nurses, Pharmacists and medical providers are the cornerstone of accurate and complete MedRec. Reminder emails to medical providers played a key role in MedRec rate improvement. Additional root cause analysis is needed to further address the medication review completion process in our institution.[Table: see text]