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Smith, Caleb J.

https://orcid.org/0000-0003-1974-0175

Mayo Clinic

Mayo Clinic

Citations 26

636 BASECAMP-1: A master prescreening study to identify patients with high-risk or metastatic solid tumors with HLA loss of heterozygosity (LOH) in preparation for Tmod CAR T-cell therapy trials
Hecht, J. Randolph, Smith, Caleb J. , Welling, Theodore H., Morelli, Maria Pia , Grierson, Patrick , Vu, Peter , Dahiya, Saurabh , Jacobson, Caron A. , Lozac’hmeur, Ariane, Tebbets, Jessica , Ong, Gayanie, Go, William Y., Welch, John S. , Maloney, David G. , Molina, Julian R. , Simeone, Diane M. , Fakih, Marwan , Garon, Edward B. , Kirtane, Kedar , Locke, Frederick L. , Dorigo, Oliver , Park, Jong Chul , Specht, Jennifer M. , Dragovich, Tomislav , Ng, Eric W, Maus, Marcela V

Regular and Young Investigator Award Abstracts | October 31, 2023 | Volume: No volume available | Issue: No issue available | Pages: A727-A728

10.1136/jitc-2023-sitc2023.0636 Get It

634 EVEREST-1: A seamless phase 1/2 study of CEA logic-gated Tmod CAR T-cell therapy (A2B530) in patients with solid tumors associated with CEA expression also exhibiting HLA loss of heterozygosity (LOH)
Welling, Theodore H., Hecht, J. Randolph , Molina, Julian R. , Smith, Caleb J. , Morelli, Maria Pia , Grierson, Patrick , Patel, Sandip Pravin , Ward, Jeffrey D. , Lozac’hmeur, Ariane, Nikiforow, Sarah , Weng, Wen‐Kai , Vong, Judy, Mardiros, Armen, Liechty, Kirstin B., Go, William Y., Welch, John S. , Maloney, David G. , Punekar, Salman R. , Garon, Edward B. , Fakih, Marwan , Kirtane, Kedar , Lin, Yi , Kopetz, Scott , Locke, Frederick L. , Ward, Jeffrey, Frigault, Matthew J. , Specht, Jennifer M. , Dragovich, Tomislav , Ng, Eric W, Maus, Marcela V , Simeone, Diane M.

Regular and Young Investigator Award Abstracts | October 31, 2023 | Volume: No volume available | Issue: No issue available | Pages: A724-A725

10.1136/jitc-2023-sitc2023.0634 Get It

534 Responses to immunotherapy based on programmed death-ligand 1 (PD-L1) copy number variation (CNV) status in patients with advanced non-small cell lung cancer (NSCLC)
Smith, Caleb J. , Parikh, Kaushal , Molina, Julian R. , Leventakos, Konstantinos , Desai, Aakash , Naso, Julia , Ashara, Yash P. , Pitel, Beth A. , Dimou, Anastasios , Mansfield, Aaron S. , Lo, Ying‐Chun

Regular and Young Investigator Award Abstracts | October 31, 2023 | Volume: No volume available | Issue: No issue available | Pages: A608-A609

10.1136/jitc-2023-sitc2023.0534 Get It

P903: CLINICAL UTILITY OF MONOCLONAL GAMMOPATHY SCREENING IN THE EVALUATION OF PERIPHERAL NEUROPATHY
Maberry, Mackenzie, Smith, Caleb J. , Go, Ronald S.

HemaSphere | August 9, 2023 | Volume: 7 | Issue: S3 | Pages: e65762dc

10.1097/01.hs9.0000970516.65762.dc Get It

A population‐based study of acute panmyelosis with myelofibrosis in the United States: 2004–2015
McLaughlin, N , Ruan, Gordon , Day, Courtney N. , Harmsen, William S. , Smith, Caleb J. , Binder, Moritz , Gangat, Naseema , Tefferi, Ayalew , Shah, Meera , McLaughlin, Nicole , Tefferi, Ayalew , Shah, Mithun V , Binder, Moritz , Go, Ronald S.

American Journal of Hematology | January 13, 2022 | Volume: 97 | Issue: 4 | Pages: No page available

10.1002/ajh.26467 Get It

A population‐based study of outcomes in polycythemia vera, essential thrombocythemia, and primary myelofibrosis in the United States from 2001 to 2015: Comparison with data from a Mayo Clinic single institutional series
Smith, Caleb J. , Thomas, John W., Ruan, Gordon , Hyun, Meredith , Bansal, Radhika , McLaughlin, N , Pardanani, Animesh , Gangat, Naseema , Szuber, Natasha , Tefferi, Ayalew , Hyun, Meredith C , McLaughlin, Nicole , Szuber, Natasha , Shah, Mithun V , Tefferi, Ayalew , Go, Ronald S. , Goyal, Gaurav , Shah, Meera

American Journal of Hematology | October 20, 2021 | Volume: 96 | Issue: 12 | Pages: No page available

10.1002/ajh.26377 Get It

Surgical Reduction of Spondylolisthesis During Lumbar Fusion
Barber, Joshua A, Smith, Caleb J. , Li, Jinpu , Goldstein, Christina L, Leary, Emily , Lambrechts, Mark James , Barber, Joshua A, Beckett, Nathan , Goldstein, Christina L, Cook, James L. , Choma, Theodore J.

Clinical Spine Surgery | July 7, 2021 | Volume: 35 | Issue: 1 | Pages: E1-E6

10.1097/bsd.0000000000001230 Get It

Study Design: This was a retrospective cohort study. Objective: The objective of this study was to quantify the rates of complication following surgical treatment for symptomatic degenerative and isthmic spondylolisthesis and to examine the association between slip reduction and complication rates. Summary of Background Data: It is unclear if the degree of spondylolisthesis reduction during lumbar spine fusion in adults influences the rate of surgical complications. Methods: This is a retrospective cohort study of 1-level and 2-level adult fusion patients with degenerative or isthmic spondylolisthesis. The degree of reduction and complications were calculated, and complication rates between those with and without reduction were compared. Results: The surgical reduction was improved by 1 Meyerding grade in 56.5% of the 140 patients included in this analysis. Of those patients, 60% had a grade 1 spondylolisthesis. In addition, 62.5% of grade 2 slips had an improvement by 1 grade. Surgical reduction during lumbar fusion did not result in a higher rate of complications compared with in situ fusion. Conclusions: During 1-level or 2-level lumbar fusion for degenerative or isthmic spondylolisthesis, a 1-grade reduction of the slip was achieved in 56% of patients in this retrospective case series. Reduction of the spondylolisthesis was not associated with a higher rate of complication when compared with in situ fusion. Level of Evidence: Level IV.
A population-based study of acute panmyelosis with myelofibrosis in the United States: 2004 to 2015.
McLaughlin, N , Ruan, Gordon , Day, Courtney N. , Harmsen, William S. , Smith, Caleb J. , Gangat, Naseema , Tefferi, Ayalew , Binder, Moritz , Go, Ronald S. , Shah, Meera

Journal of Clinical Oncology | June 2, 2021 | Volume: 39 | Issue: 15_suppl | Pages: e19003-e19003

10.1200/jco.2021.39.15_suppl.e19003 Get It

e19003 Background: Acute panmyelosis with myelofibrosis (APMF) is a rare subtype of acute myeloid leukemia characterized by acute panmyeloid proliferation with increased blasts, cytopenias with bone marrow fibrosis, and absence of splenomegaly. There is a paucity of population-based studies of APMF. Methods: We queried the United States Surveillance, Epidemiology, and End Results (SEER) database and National Cancer Database (NCDB) using the ICD-O-3 code 9931/3. The SEER 17 registries (2004-2015) were used to find data on incidence. For NCDB data, comorbid disease burden was calculated using the Charlson-Deyo Score (CDS). Hazard ratios (HR) with confidence intervals (CI) were calculated using a Cox proportional hazards model. Overall survival (OS) was estimated with the Kaplan-Meier method. Variables significant in univariable analysis were included in a multivariable analysis. Results: We identified 260 APMF patients using the SEER database. Incidence was 0.3 cases/million individuals and did not change significantly from 2004-2015. With a median follow up of 6.9 years (95% CI 6.1-7.8), the median OS was 2.3 years (95% CI 1.7-2.8). We identified 530 APMF patients using the NCDB. The median age at diagnosis was 67 years (range 22-90) and 311 (59%) were male. With a median follow up of 5.0 years (95% CI 3.0-7.6), the median OS was 2.3 years (95% CI: 0.8-6.5). OS was 69%, 31%, and 18% at 1-, 5-, and 10- years, respectively. Patients diagnosed in 2012-2015 had a significantly improved OS compared to those diagnosed in 2004-2007 (HR 0.65, 95% CI 0.49-0.85; p=0.002). 271 patients (53%) patients received chemotherapy. The OS for those that received chemotherapy was 70% at 1 year and 30% at 5 years versus 70% and 32% at 1- and 5- years for those who did not ( p=0.99). The median time to chemotherapy from time of diagnosis was 25 days (range 0-532 days). 52 patients (10%) underwent transplantation and the OS of those patients was 90% at 1 year and 45% at 5 years versus 67% and 29% at 1- and 5- years for those who did not (HR: 1.7 (95% CI: 1.2-2.6), p=0.006). In univariable analysis, factors predicting inferior OS were age ≥ 65 years old at diagnosis (HR 1.8, 95% CI 1.5-2.3; p<0.001), male sex (HR 1.5, 95% CI 1.2-1.8; p<0.001), CDS ≥ 1 (HR: 1.5 (95% CI: 1.2-2.0), p<0.001), government insurance (HR 1.8, 95% CI 1.4-2.3; p<0.001), diagnosis at a non-academic facility (HR 1.6, 95% CI 1.2-2.0, p<0.001), and not receiving a hematologic transplant (HR 1.7, 95% CI 1.2-2.6; p=0.006). Multivariable-adjusted analysis is shown in the Table. Conclusions: The overall incidence of APMF has not changed between 2004 and 2015, but OS for 2012-2015 was improved compared to 2004-2007. Age ≥ 65 years old, male sex, CDS ≥ 1, and diagnosis at a nonacademic facility predicted inferior OS. Multivariable-adjusted analysis.[Table: see text]
A Population-Based Study of Polycythemia Vera, Essential Thrombocythemia, and Primary Myelofibrosis in the United States from 2001-2015
Smith, Caleb J. , Ruan, Gordon , Thomas, John W., Tefferi, Ayalew , Goyal, Guarav, Go, Ronald S. , Shah, Meera

Blood | February 8, 2021 | Volume: 136 | Issue: Supplement 1 | Pages: 48-48

10.1182/blood-2020-137611 Get It

Introduction: Polycythemia Vera (PV), Essential Thrombocythemia (ET), and Primary Myelofibrosis (PMF) are BCR/ABL1-negative myeloproliferative neoplasms (MPN) that are associated with morbidity and increased mortality. Limited data regarding population-based outcomes for these MPNs have been reported. Our aim was to use the Surveillance, Epidemiology, and End Results (SEER) registry to investigate population based outcomes for PV, ET, and PMF. Methods: The SEER 18 registries were used to identify patients with ICD-O-3 diagnosis codes for PV (9950/3), ET (9962/3), and PMF (9961/3) from 2001-2015. For ET and PMF, histologic diagnosis was required for inclusion. Incidence was age-adjusted to the U.S. 2000 standard population. Causes of death were obtained and MPN-related death was defined as death from any myeloid disorder (ET, PV, PMF, acute myeloid leukemia [AML], acute monocytic leukemia, other myeloid/monocytic leukemia, and aleukemic, subleukemic and NOS). Relative survival (RS) was defined as the ratio of the proportion of observed survivors in a cohort of PV, ET, PMF patients to the proportion of expected survivors in a comparable set of individuals that did not respectively have PV, ET, or PMF, adjusting for the general survival of the US population for race, sex, age, and time when the diagnosis was established. Time to leukemic transformation was calculated using the left-truncated life tables session with a 3-month latency period used to prevent misattribution. Overall survival (OS) was calculated between the date of diagnosis and the date of death, date last known to be alive, or date of the study cut-off (31 December 2018). Variables significant in univariate analysis were included in a multivariate analysis. The Kaplan-Meier method was used to calculate overall survival (OS), and Cox regression model was used to identify predictors of survival. Statistical analyses were performed using JMP version 14.0. Results: 10,988 patients with PV, 9,146 with ET, and 4,022 with PMF were identified in SEER. The median age of diagnosis (interquartile range [IQR]) was 65 years (IQR 54-76), 67 years (IQR 54-77), and 69 years (IQR 60-78) for PV, ET, and PMF respectively. Overall incidence rates (cases/100,000) were 0.86 for PV, 0.72 for ET, and 0.30 for PMF. With a median follow up (in years, 95% confidence interval [CI]) of 7.6 (7.4-7.8), 7.9 (7.8-8.2), and 7.25 (7.0-7.5), the median OS was 11.4 (11.2-11.7), 11.75 (11.3-12.0), and 3.5 (3.3-3.7), for PV, ET, and PMF respectively. RS was better than expected survival for PV and ET, while less than expected survival for PMF (Figure 1). 3853 of PV patients died (35.1%) by the end of the study period, with 4.1% and 34.1% of deaths from PV-related and cardiovascular disease respectively (Table 1). 3142 of ET patients died (34.4%), with 7.2% and 32.2% of deaths from ET-related and cardiovascular disease respectively. 2578 patients with MF died (64.1%), with 13.2%, and 51.9% of deaths from PMF-related and other malignancies respectively. 106 patients (1.0%) with PV, 135 patients (1.5%) with ET, and 127 patients (3.2%) with PMF transformed to AML. Median time to transformation was 4.8, 6.3, and 2.3 years for PV, ET, and PMF respectively. Factors indicating inferior OS on multivariate analysis (Table 2) included age ≥ 65, female sex, and year of diagnosis for PV, age ≥ 65, male sex, and year of diagnosis for ET, and age ≥ 65, and male sex for PMF. Conclusion: Incidence rates for PV, ET, and PMF were similar to previous reports. RS was better than expected survival for PV and ET, while less than expected survival for PMF. The majority of deaths in ET and PV occurred from cardiovascular disease; a finding likely related to these MPNs. Patients with PMF were more likely to die from their disease or a subsequent malignancy. Transformation to AML occurred less frequently than prior large case series, noting a limitation in the current study. Patients with PMF were more likely to transform to AML with a shorter time interval. Older age was associated with worse OS in all patients. Male sex was predictive of worse survival for ET and PMF, while female sex was associated with worse survival in PV. Over the years, survival has improved for PV and remained essentially unchanged for ET and PMF. Figure Disclosures Shah: Dren Bio: Consultancy.
Nanoliposomal irinotecan-based chemotherapy after regular irinotecan-based chemotherapy in patients with pancreas cancer.
Smith, Caleb J. , Cook, Kathryn , Hanna, Mina, Jin, Zhaohui , Jochum, Jacob A., Mitchell, Jessica L. , Pitot, Henry C., Jatoi, Aminah , Jin, Zhaohui , Bekaii‐Saab, Tanios , Eiring, Rachel A. , Hálfdánarson, Þorvarður R. , Wee, Wen

Journal of Clinical Oncology | January 22, 2021 | Volume: 39 | Issue: 3_suppl | Pages: 402-402

10.1200/jco.2021.39.3_suppl.402 Get It

402 Background: Pancreas cancer is an aggressive malignancy with limited therapeutic options. Nanoliposomal irinotecan (Nal-IRI) is a preferred second-line treatment, and current guidelines recommend its use in the absence of prior irinotecan. This study aimed to assess whether patients who had received regular irinotecan derive benefit from Nal-IRI. Methods: Medical records of metastatic pancreas cancer patients who had received regular irinotecan and then Nal-IRI were reviewed. The following information was extracted from each medical record: patient demographics, confirmation of a diagnosis of exocrine pancreas cancer, initial cancer stage, dates of administration of the drugs of interest, adverse events that occurred with Nal-IRI treatment, reasons for stopping regular irinotecan, and reasons for starting and stopping Nal-IRI. The primary endpoint was overall survival after the initiation of Nal-IRI (an a priori threshold of > 4 months defined success). Survival data were censored based on date of last follow up. Direct quotes from the medical record were documented to provide insight on prescribing Nal-IRI when guidelines advised the contrary. Results: Sixty four patients met eligibility criteria with a median age of 65 years (range: 36, 80 years). Prior to Nal-IRI, 61 patients had received FOLFIRINOX, and 3 FOLFIRI. Of these, 32 patients manifested progressive disease on regular irinotecan-based therapy. Nal-IRI was prescribed with a fluoropyrimidine; only one patient received monotherapy. At time of analysis, 54 patients had died. Median overall survival from initiation of Nal-IRI was 5.1 months (95% confidence interval (CI): 5.6, 4.3, months). An exploratory comparison, based on no cancer progression with regular irinotecan versus progression, showed improved survival with Nal-IRI in the former group: 6.1 months (95% CI: 9.3, 5.1 months) versus 4.3 months (95% CI: 4.8, 2.3 months); p=0.0006. Nal-IRI adverse events occurred as expected. Qualitative data illustrated several themes, including “limited treatment options,” which appeared to drive the decision to prescribe Nal-IRI. Conclusions: Nal-IRI might be considered in pancreas cancer patients who had received regular irinotecan, particularly in the absence of disease progression with the latter.