tbuckley/cabot-search huggingface dataset:
Treatment patterns and characteristics in the second and third-line therapy setting for real-world small cell lung cancer patients.
Authors: Patricia Prince, Adina Estrin, Dylan Supina, Rami Ben-Joseph, Anne Boccuti, Kobby Asubonteng, Badri Rengarajan, Moshe Fridman, Raj Hanvesakul, Benjamin Taylor
Journal: Journal of Clinical Oncology (2021)

e20576 Background: With emerging treatment options for small-cell lung cancer (SCLC) patients after initial treatment failure, the real-world management of this disease should be assessed. This study aims to describe treatment patterns of real-world SCLC patients in the second-line therapy (2L) and third-line therapy (3L) setting. Methods: This was a descriptive study of real-world data sourced from ConcertAI electronic medical records, including data from CancerLinQ, an initiative of the American Society of Clinical Oncology of adults (age ≥ 18 years) with confirmed SCLC between January 1, 2016 and December 31, 2018. Patients were excluded based on evidence of other primary cancer at baseline, missing stage, death prior to diagnosis, or clinical trial participation. Patients entered the cohort on their SCLC diagnosis date and were followed through three tumor progressions to assess treatment patterns. Treatment patterns were assessed in 2L and 3L. Baseline characteristics were assessed in the 6 months prior to each line. Patients were classified as having unknown treatment if they had a gap in medical records &gt; 90 days or no recorded tumor response or death within 180 days. Results: Overall, 538 patients were identified; 131 with unknown treatment, 108 with no treatment, 299 with 1st line therapy (1L), 124 with 2L, and 44 3L. The majority (76%) of patients were diagnosed in a community hospital setting. The most common comorbidities were chronic obstructive pulmonary disease (2L 25%, 3L 16%), diabetes (2L 15%, 3L 14%), congestive heart failure (2L 7%, 3L 9%), and myocardial infarction (2L 3%, 3L 2%). Radiation therapy was commonly used in 2L and 3L (2L 48%, 3L 43%) as were immunotherapies (2L 23%, 3L 23%). The most common systemic therapy in 2L and 3L was nivolumab (19% and 16%). Topotecan accounted for 11% of patients treated in 2L and 7% of those in 3L. Conclusions: During this treatment era (pre-immunotherapy 1L approval) there were limited treatment options available for SCLC patients. Radiation therapy and immunotherapies were frequently used as 2L and 3L therapy.[Table: see text]
Population-based estimates of the age-specific cumulative risk of breast cancer for pathogenic variants in <i>CHEK2</i>: Findings from the Australian Breast Cancer Family Registry.
Authors: Tu Nguyen-Dumont, James Dowty, Jason A Steen, Anne-Laure Renault, Fleur Hammet, Maryam Mahmoodi, Derrick Theys, Amanda Rewse, Helen Tsimiklis, Ingrid Winship, Graham G. Giles, Roger L Milne, John L. Hopper, Melissa C Southey
Journal: Journal of Clinical Oncology (2021)

551 Background: Case-control studies of breast cancer have consistently shown that pathogenic variants in CHEK2 are associated with about a 3-fold increased risk of breast cancer. Information about the recurrent protein truncating variant CHEK2c.1100delC dominates this estimate. There have been no formal estimates of age-specific cumulative risk of breast cancer for all CHEK2 pathogenic (including likely pathogenic) variants combined. Methods: We conducted a genetic screen of CHEK2 in an Australian population-based case-control-family study of breast cancer. This study is focused on disease at an early age and participants were unselected for family history. The age-specific cumulative risk (penetrance) of breast cancer was estimated using segregation analysis. Results: The estimated hazard ratio for carriers of pathogenic CHEK2 variants (combined) was 4.9 (95% CI 2.5-9.5; p &lt; 0.0001) relative to non-carriers. The HR for carriers of the CHEK2 c.1100delC variant was estimated to be 3.5 (95% CI 1.02-11.6) and the HR for carriers of all other CHEK2 variants combined was estimated to be 5.7 (95% CI 2.5-12.9). The age-specific cumulative risk of breast cancer was estimated to be 18% (95% CI 11-30%) and 33% (95% CI 21-48%) to age 60 and 80 years, respectively. Conclusions: These findings provide important information for the clinical management of breast cancer risk for women carrying pathogenic variants in CHEK2.
Pan-cancer analysis of fear of cancer recurrence in cancer survivors.
Authors: Jacob J. Adashek, Zachary Thompson, Dina Martinez Tyson, Smitha Pabbathi
Journal: Journal of Clinical Oncology (2021)

e24104 Background: Fear of cancer recurrence (FCR) in cancer survivors is an understudied phenomenon estimated to one-third to over half of all cancer survivors. FCR has been shown to contribute to treatment noncompliance and portend a decrease in overall survival (OS). The purpose of this study was to examine factors associated with needs related to FCR among patients seen at a solid tumor survivorship clinic at a National Cancer Institute designated center. Methods: Data collected as part of a patients’ needs assessment that is administered to patients (n = 657) with solid tumors such as breast, genitourinary, gastrointestinal malignancies at their initial clinic visit were analyzed. Correlations between responses were calculated and univariable and multivariable logistic regression was used to identify predictors of met or unmet needs related to FCR. Results: There were a total of 657 patients included 442 (67.3%) female and 215 (32.7%) male. The majority of patients (84.5%) were white (n = 555), followed by 9.74% black (n = 64), the remaining patients identified as ‘other’ or Asian. The patients median age was 67 years, median age of diagnosis 55 years, and median years since diagnosis 10 years. 613 patients had recorded distress scores ranging from 0 (n = 214), 1-4 (n = 255), 5-7 (n = 106), or 8-10 (n = 38). Of 647 patients, 241 (37.2%) reported FCR was not a need and 386 (59.7%) reported FCR was a met need. According to univariate logistic regression gender had no impact on FCR (p = 0.8427) nor did years since diagnosis (p = 0.1014). Results of multivariable regression indicate the odds ratio of reporting FCR as an unmet need (vs not a need) decreases by 6% (p = 0.0023) for every year increase in age. For each unit increase in distress score the odds ratio of reporting FCR as an unmet need is increased by 32% (p = 0.0007). Conclusions: Our data suggests that patients reporting higher distress scores are more likely to report FCR as an unmet need. Therefore, survivors with high distress scores reported in clinic visits should be evaluated for FCR. FCR reported as an unmet in our study is significantly less. Further stratification of FCR can be helpful for providers caring for survivors to identify and address FCR more effectively in clinical care. Further study is needed to learn how survivors have come to identify the need as being met.
Phase 3, randomized, single-dose, open-label study to investigate the safety and efficacy of pafolacianine sodium injection (OTL38) for intraoperative imaging of folate receptor positive ovarian cancer.
Authors: Janos Laszlo Tanyi, Hye Sook Chon, Mark Aloysuis Morgan, Setsuko K. Chambers, Ernest Soyoung Han, Kristina A. Butler, Carrie L. Langstraat, Matthew A. Powell, Leslie M. Randall, Alexander L. Vahrmeijer, Ira Seth Winer, Robert Michael Wenham
Journal: Journal of Clinical Oncology (2021)

5503 Background: Pafolacianine sodium is under investigation as an adjunct to visual inspection and palpation by providing intra-operative imaging of folate receptor positive (FR+) ovarian cancer. Since complete resection (R0) is the strongest predictor of overall survival, methods to enhance detection of lesions are expected to benefit patient outcomes. Methods: For this phase 3, randomized, multicenter, single dose, open-label pivotal trial (NCT03180307), patients with ovarian cancer who were scheduled to undergo cytoreductive surgery were recruited from 11 sites in the US and Netherlands from March 2018 through April 2020. The study objectives were to confirm efficacy and safety of pafolacianine sodium (0.025 mg/kg i.v., ≥1 h prior to imaging) in combination with intraoperative near-infrared fluorescence (NIRF) imaging to detect additional lesions not detected by palpation and normal white light alone. Results: Pafolacianine sodium was administered to 150 total patients (safety analysis set); 109 patients comprised the full analysis set for efficacy analyses. Patients had primarily serous adenocarcinoma (n = 72; 68.6%) and advanced stage disease (n = 83; 76.1%). In 33% of patients (36 of 109), NIRF imaging with pafolacianine sodium identified additional lesions that were not planned for resection and were not detected by normal white light and palpation ( P &lt; 0.001, 95% CI [0.243, 0.427]). Among patients who underwent interval debulking surgery, the rate was higher, at 39.7% of patients (23 of 58; 95% CI [0.270, 0.534]). At the individual lesion level, the accuracy of pafolacianine sodium with NIRF to detect ovarian cancer is reflected by sensitivity of 83% (95% CI [73.9, 89.4]) and a false positive rate of 32.7% (95% CI [25.6, 40.7]). Investigators reported achieving complete resection (R0) in 62.4% (68 of 109) of patients. Drug-related adverse events (AEs) were reported by 30% of patients (45 out of 150). The most frequently reported drug-related AEs were nausea (18.0%), vomiting (5.3%), and abdominal pain (4.7%). Infusion reactions at the time of the procedure were mostly (96%) mild or moderate in severity; 89% resolved within 24 hours of onset. No drug-related serious AEs or deaths were reported. Conclusions: This phase 3 trial of pafolacianine sodium with NIRF imaging met its primary endpoint, intraoperatively identifying additional cancer not planned for resection in a statistically significant number of patients. Therefore, pafolacianine sodium may offer a novel real-time adjunct to current surgical imaging practice in ovarian cancer surgery. Clinical trial information: NCT03180307.
Development and validation of a nomogram for distant metastasis in esophageal cancer based on radiomics and clinical factors.
Authors: Zhu Chao, Qingtao Qiu, Youxin Ji, Songping Wang, Jialin Ding, Linlin Wang
Journal: Journal of Clinical Oncology (2021)

e16071 Background: Distant metastasis with an incidence of 25% in esophageal cancer(EC) represents a poor prognosis. However, there was few study for prediction of distant metastasis in EC, due to unsatisfactory specificity of clinical factors and lack of reliable biomarkers. Methods: Two hundred and ninety-nine patients were enrolled and randomly assigned to a training cohort(n = 207) and a validation cohort(n = 92). Logistic univariate and multivariate regression analyses were used to identify clinical independent predictive factors and construct a clinical nomogram. Radiomic features were extracted from contrast-enhanced CT performed before treatment, and Lasso regression was used to screen the optimal features, which were developed a radiomics signature subsequently. Four machine learning algorithms were used to establish radiomics models respectively based on the screened features. The joint nomogram incorporating radiomics signature and clinical independent predictors was developed by logical regression algorithm. All models were further validated by discrimination,caliberation, reclassification and clinical usefulness. Results: The joint nomogram had a better performance [AUC(95%CI): 0.827(0.742-0.912)] than clinical nomogram [AUC(95%CI): 0.731(0.626-0.836)]and radiomics predictive models[AUC(95%CI): 0.747(0.642-0.851),SVM algorithms]. Caliberation curve, and decision curve analysis also revealed joint nomogram outperformed the other models. Compared with the clinical nomogram, net reclassification Improvement(NRI) of the joint nomogram was improved by 0.114(0.075, 0.345),and integrated discrimination Improvement (IDI) was improved by 0.071(0.030-0.112), P= 0.001. Conclusions: We constructed and validated the first joint nomogram for distant metastasis in EC based on radiomics signature and clinical independent predictive factors, which could help clinicians to identify patients with high risk of distant metastasis.
Chemotherapy-based stem cell mobilization in multiple myeloma patients treated with novel agents: The Mayo Clinic experience.
Authors: Iuliana Vaxman, Eli Muchtar, Prashant Kapoor, Shaji Kumar, Angela Dispenzieri, Francis Buadi, David Dingli, Wilson I. Gonsalves, Taxiarchis Kourelis, Rahma M. Warsame, Martha Lacy, William J. Hogan, Morie A. Gertz
Journal: Journal of Clinical Oncology (2021)

e20000 Background: In the novel agents’ era, refractoriness to induction in Multiple Myeloma (MM) is relatively rare. This population remain an unmet need and are often excluded from clinical trials. In the current era, chemotherapy-induced stem cell collections are used at Mayo Clinic in “poor responders” to induction, such as patients that progress prior to ASCT or patients with significant disease burden after induction. Methods: This is a retrospective study that includes all MM patients the underwent chemo-mobilization between January 2012 and September 2020 at Mayo Clinic. We compared our cohort to a cohort of 125 matched patients that were transplanted over the same time period and underwent mobilization with G-CSF and “on-demand” plerixafor. We matched the cohorts by level of response by IMWG at pre-transplant evaluation. Results: 125 newly diagnosed MM patients who received novel agents’ induction and had a poor response to induction were mobilized using IV intermediate-dose cyclophosphamide (83%) or VDT-PACE (17%) plus G-CSF and “on-demand” plerixafor. The median PFS and OS of the chemo-mobilized cohort were 16 months (95% CI 11-20) and 47 months (95% CI 37-71), respectively. Patients receiving chemo-mobilization had higher stem cell yields than the growth factor only cohort (median 9.88X10 6 cells/kg versus median 8.77X10 6 cells/kg, respectively (P&lt;0.001)). The safety profile of chemo-mobilization was favorable, with no difference between the two groups in length of hospitalization during ASCT (P=0.95), days to neutrophil or platelet engraftment, and risk of bacteremia (P=0.38). 29% of the chemo-mobilized cohort and 66% of the matched cohort required plerixafor for adequate mobilization (P&lt;0.001). Conclusions: Chemo-mobilization enhances stem cell collection in MM patients with a suboptimal response to induction and reduces the need for plerixafor without adversely impacting the post-transplant clinical course. [Table: see text]
Persistent Hypoglossal Artery
Journal: JAMA (1963)

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Comprehensive genomic and transcriptomic profiling (CGTP) to predict pembrolizumab (P) benefit in patients (pts) with advanced solid tumors (STs).
Authors: Dan Rhodes, Daniel H Hovelson, Malek M. Safa, Mark E. Burkard, Eddy Shih-Hsin Yang, William Jeffery Edenfield, Travis Reeder, Hana Vakil, Kat Kwiatkowski, Khalis Mitchell, Bryan Johnson, Scott A. Tomlins
Journal: Journal of Clinical Oncology (2021)

2609 Background: P is approved in many ST types, however predictive biomarkers and the proportion of pts who benefit vary widely. Biomarkers beyond PD-L1 immunohistochemistry and comprehensive genomic profiling (CGP) based tumor mutation burden (TMB) may improve benefit prediction. We determined if treatment data and CGTP collected in an ongoing observational trial (NCT03061305) could predict pan-ST P benefit. Methods: Eligible advanced ST pts had QC-passing TMB and expression data from multiplex PCR based tissue CGTP on FFPE tissue (StrataNGS and an investigational test) and documented P treatment &gt; 1 month. Real-world time to next treatment (TTNT) was defined as time in months from therapy start to new therapy start (after stopping initial therapy) or death. TMB and gene expression biomarker association with P TTNT was evaluated. Backward stepwise regression was performed to fit a multivariate Cox proportional hazards model; pts were assigned to four score groups (IRS 1-4) based on overlapping TTNT curves from 8 equal bins. P TTNT were compared between IRS groups by log-rank test. A chemotherapy (C) comparator cohort was established from C TTNT for pts in this cohort. Results were stratified by ST type, P mono vs. C combo, and TMB status. Results: 610 pts (254 [41.6%] NSCLC; 356 [58.4%] from 23 other ST types) with CGTP and P treatment were identified; P TTNT was highly correlated to overall survival (n=146; Pearsons r 2 =0.75). By univariate analysis of TMB and 9 expression biomarkers, TMB, two independent PD-L1 expression amplicons, and PD-L2 expression were significantly associated with P TTNT (all p ≤ 0.002). The most significant multivariate model included 5 variables, with 1) increasing TMB, PD-L1, and PD-L2, and 2) decreasing TOP2A (proliferation) and GZMA as P TTNT predictors. Median P TTNT, but not C TTNT (345 courses from 254 pts), differed significantly by IRS group (Table). Median P TTNT by IRS group did not significantly differ by non-small cell lung vs. other ST type or P mono vs. C combo (both p &gt; 0.05); excluding TMB-high patients, median P TTNT was still significantly longer in IRS groups 3/4 vs. 1/2 (p = 5.0e-4). Across 19,623 total evaluable pts in NCT03061305, 12.2% were in IRS groups 3/4 and outside of P approved ST types/TMB-low. Conclusions: CGTP in an observational trial cohort demonstrated that TMB, PD-L1 and PD-L2 independently predicted pan-ST P benefit as assessed by OS-validated TTNT. A multivariate CGTP signature predicted P benefit relative to C across ST types. If further validated, such a signature may enable improved P benefit prediction. P versus C TTNT by IRS group. Clinical trial information: NCT03061305. [Table: see text]
Combination ozone therapy as an effective method of radiomodification in chemoradiation treatment of patients with cervical cancer.
Authors: Olga G. Rodionova, Marina A. Gusareva, Elena A. Sheiko, Vitaliy I. Voshedskiy, Pavel G. Sakun, Ekaterina O. Vasilieva, Elena A. Karnaukhova, Anna A. Solntseva, Natalia G Kosheleva, Yulia N. Krokhmal, Alla V. Pustovalova, Tatiana G. Chalabova, Vladimir A. Dontsov, Sergey N. Kabanov, Stanislav G. Vlasov
Journal: Journal of Clinical Oncology (2021)

e17515 Background: The purpose of the study was to evaluate advantages of combination ozone therapy as an effective factor of radiomodification and radioprotection in the treatment of patients with cervical cancer. Methods: The study included 20 patients with stage IIIb cervical cancer T 3 б N х M 0 , the mean age 52 years. Controls (n = 10) received standard chemoradiation therapy; the main group (n = 10) received combination ozone therapy in addition to chemoradiation therapy. Systemic ozone therapy involved intravenous administration of 250 ml ozonized solution of 0.9% sodium chloride, 15 sessions during external beam radiotherapy. Local ozone therapy involved 15-minute instillations into the vagina during brachytherapy. All patients received standard chemoradiation therapy, total irradiation dose to the primary focus 80 Gy, plus weekly cisplatin 40 mg/m2. Results: In the main group, pain and discomfort in the lower abdomen were managed in 20% patients by the 5th session of ozone therapy; 30% - on the 10th day; in 50% - on the 14th day. In the control group, such symptoms in 40% of patients were reduced after 20 days. The main group showed a more rapid regression of tumor infiltration, disappearance of purulent discharge, relief of intoxication syndrome. Manifestations of gastrointestinal toxicity were observed in 10% of the main group and in 100% controls; leukopenia developed in 7 patients in the control group and was not registered in the main group. MRI showed complete clinical regression in 90% in the main group and in 65% in the control group. The treatment was completed within 7 weeks in the main group and 8.5 weeks in the control group. Conclusions: Combination ozone therapy causes a more pronounced antitumor effect, and its radioprotective effects significantly reduce the severity of chemotherapy-induced disorders. It does not aggravate concomitant pathology and shortens the treatment period.
Assessing the use of low value oncology care following the release of Choosing Wisely guidelines.
Authors: Alexander Gunn, Melissa Sarver, Samantha J Kaplan, Yousuf Zafar, Rachel Adams Greenup
Journal: Journal of Clinical Oncology (2021)

e18861 Background: Low -value care contributes to the high costs of cancer treatment. Almost a decade has passed since the American Society of Clinical Oncology (ASCO) Choosing Wisely campaign identified costly diagnostic testing, radiographic imaging, and therapies that are routinely utilized in cancer care despite lacking evidence of benefit. We sought to evaluate the impact of ASCO Choosing Wisely guidelines and to identify barriers to and facilitators of guideline adherence. Methods: A systematic review of published literature from 2012-2021 was performed in accordance with PRISMA guidelines on the trend in use of low value oncology care. All ten of ASCO Choosing Wisely Guidelines were selected for inclusion; these included recommendations focused on cancer screening, staging and surveillance imaging, and systemic treatment and support. The following databases were searched for original research based in the United States: PubMed, CINAHL, Embase, Web of Science, Scopus, and ASCO Meeting abstracts. Eligible studies were examined for information on design, population, and study outcomes, which included guideline adherence and facilitators and barriers to implementation. All citations were independently dual-screened in a blinded fashion by authors (AG, MS). Results: 35 independent studies were identified from 3,590 unique citations and included n = 1,130,216 patients. Data sources captured large claims database analyses (13 studies, n = 1,069,289), institutional studies (14 studies, n = 53,358), patient-reported surveys (2 studies, n = 915), and interventional studies (6 studies, n = 6654). Adherence to ASCO Choosing Wisely guidelines ranged from 13% to 100% overall. Use of low value oncology care varied depending on the area of recommendation, such as cancer screening (44% to 77%), staging and surveillance imaging (30% to 100%), and systemic treatment and support (13% to 100%). Adherence was facilitated by: (a) physician awareness of and education around the recommendations; (b) patient engagement; (c) embedded EHR best practice alerts; (d) guideline alignment with insurance payer requirements; and (e) integrated healthcare systems. Barriers to guideline incorporation included perceived patient anxiety and concerns about patient satisfaction; illness-specific practices; and time needed for patient-provider conversations regarding low value care. Conclusions: Adherence to the ASCO Choosing Wisely guidelines is variable across the cancer care continuum. Health system and policy-level interventions are needed to further reduce the overuse of low value care in oncology.