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151. Phase II Study of Pembrolizumab in Combination with Doxorubicin in Metastatic and Unresectable Soft-Tissue Sarcoma

Author

Livingston, Michael B., primary, Jagosky, Megan H., additional, Robinson, Myra M., additional, Ahrens, William A., additional, Benbow, Jennifer H., additional, Farhangfar, Carol J., additional, Foureau, David M., additional, Maxwell, Deirdre M., additional, Baldrige, Emily A., additional, Begic, Xhevahire, additional, Symanowski, James T., additional, Steuerwald, Nury M., additional, Anderson, Colin J., additional, Patt, Joshua C., additional, Kneisl, Jeffrey S., additional, and Kim, Edward S., additional

Published
2021
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152. Abstract LBA035: Canakinumab or Pembrolizumab as Monotherapy or in Combination as Neoadjuvant Therapy in Patients With Resectable Non-Small Cell Lung Cancer: CANOPY-N Trial

Author

Lee, Jay M., primary, Pujol, Jean-Louis, additional, Garrido, Pilar, additional, Kim, Edward S., additional, Tsuboi, Masahiro, additional, Bitton, Rafael Caparica, additional, Duan, Jiawei, additional, Blin, Cecile, additional, Savchenko, Alexander, additional, and Mok, Tony, additional

Published
2021
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154. Characterization of KRAS Mutation Subtypes in Non–small Cell Lung Cancer

Author

Judd, Julia, primary, Abdel Karim, Nagla, additional, Khan, Hina, additional, Naqash, Abdul Rafeh, additional, Baca, Yasmine, additional, Xiu, Joanne, additional, VanderWalde, Ari M., additional, Mamdani, Hirva, additional, Raez, Luis E., additional, Nagasaka, Misako, additional, Pai, Sachin Gopalkrishna, additional, Socinski, Mark A., additional, Nieva, Jorge J., additional, Kim, Chul, additional, Wozniak, Antoinette J., additional, Ikpeazu, Chukwuemeka, additional, de Lima Lopes, Gilberto, additional, Spira, Alexander I., additional, Korn, W. Michael, additional, Kim, Edward S., additional, Liu, Stephen V., additional, and Borghaei, Hossein, additional

Published
2021
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155. Abstract CT237: Canakinumab or pembrolizumab as monotherapy or in combination as neoadjuvant therapy in patients with surgically resected non-small cell lung cancer: CANOPY-N trial

Author

Lee, Jay M., primary, Mok, Tony, additional, Garrido, Pilar, additional, Kim, Edward S., additional, Arslan, Çağatay, additional, Tsuboi, Masahiro, additional, Dong, Tuochuan, additional, Blin, Cecile, additional, Rodrik-Outmezguine, Vanessa, additional, Mookerjee, Bijoyesh, additional, Passos, Vanessa, additional, and Pujol, Jean-Louis, additional

Published
2021
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156. Institutional Factors affecting Academic Performance of Marketing Students in Nueva Ecija

Author

Kim Edward S. Santos and Antonio Jose D. Celis

Subjects
Marketing management, media_common.quotation_subject, Quality education, ComputingMilieux_COMPUTERSANDEDUCATION, Minor (academic), Marketing, Psychology, Affect (psychology), Diversity (politics), media_common
Abstract

With the growing diversity of students attending university, the factors affecting academic performance are becoming increasingly relevant.This paper described the institutional factors and the major category of the institutional factor affecting academic performance of marketing students in Nueva Ecija. This paper used descriptive method of research as itutilized survey questionnaire with likert-scale responses. A total 213 college students from private universities and colleges in Nueva Ecija were surveyed in this paper. Based on the findings, the researchers concluded that institutional factors categorized as instructional material and utility have minor affect to the academic performance of students. While the people and infrastructure category have moderate affect. Thus, the researchers recommended to improve the people and infrastructure categories of institutional factors to further uplift the academic performance of the marketing students.In the foregoing findings, the researchers specifically found out that method of lecture delivery as one of the institutional factors is the most influential affecting the performance of the students academically. Thus, the researchers recommended to focus on the development of methodologies of lecture delivery to further improve the academic performance which results to quality education.

Published
2020

157. Impact of Microfinancing in Nueva Ecija

Author

Kim Edward S. Santos

Subjects
Microfinance, Economic growth, 050208 finance, 05 social sciences, Per capita income, law.invention, Balance (accounting), law, Scale (social sciences), Public participation, 0502 economics and business, Business, 050207 economics, Disadvantage
Abstract

There are significant disparities between ASEAN's ' business ' economies, both in the incidence of deprivation that could promote microfinance initiatives as a solution to disadvantage, and in the balance between private and public participation in the process.The study described the impact of Micro Financing to the business industry in terms of: Impact on per capita income, expenditure, and savings on business and family; Impact on other loans and personal savings; and Impact on the number of enterprises and employment. Survey questionnaire with liker-type scale questions were used in the study. The finding of the study in summary to the aspects is that there is a positive impact of microfinancing to Family and Business industry.

Published
2020

165. Brigatinib (BRG) in ALK+ crizotinib (CRZ)-refractory non-small cell lung cancer (NSCLC): Final results of the phase 1/2 and phase 2 (ALTA) trials.:Journal of Clinical Oncology

Author

Gettinger, Scott N., Huber, Rudolf M., Kim, Dong-Wan, Bazhenova, Lyudmila, Holmskov Hansen, Karin, Tiseo, Marcello, Langer, Corey J., Paz-Ares, Luis G., West, Howard, Reckamp, Karen L., Weiss, Glen J., Smit, Egbert F., Hochmair, Maximilian, Kim, Sang-We, Ahn, Myung-Ju, Kim, Edward S., Groen, Harry J.M., Pye, Joanna, Vranceanu, Florin, and Camidge, D. Ross

Abstract

9071Background: BRG is a kinase inhibitor approved for the treatment of patients (pts) with ALK+ metastatic NSCLC; specific details for BRG use vary by indication and country. We report long-term efficacy and safety results of the Phase 1/2 and Phase 2 (ALTA) trials of BRG. Methods: The Phase 1/2 study was a single-arm, open-label trial (NCT01449461) of BRG 30?300 mg/d in pts with advanced malignancies. ALTA (NCT02094573) randomized pts with CRZ-refractory ALK+ NSCLC to receive BRG at 90 mg qd (arm A) or 180 mg qd with 7-d lead-in at 90 mg (arm B). For the Phase 1/2 study, investigator assessments of confirmed objective response rate (cORR; RECIST v1.1), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety in pts with ALK+ NSCLC are reported. The primary endpoint of ALTA was cORR per investigator; secondary endpoints included cORR per independent review committee (IRC), DoR, PFS, and OS. Results: In the Phase 1/2 study, 137 pts received BRG; of these, 79 pts had ALK+ NSCLC (71/79 had prior CRZ; 28/79 received 180 mg qd [7-d lead-in at 90 mg]; 14/79 received 90 mg qd). In ALTA, 222 pts with CRZ-refractory ALK+ NSCLC were randomized (n = 112/110, arm A/B). At the end of the Phase 1/2 study (Feb 18, 2020), with median 27.7 mo follow-up (?67 mo after last pt enrolled), 4 pts remained on BRG. At the end of ALTA (Feb 27, 2020), with median 19.6/28.3 mo follow-up in arm A/B (?53 mo after last pt enrolled), 10/17 pts in arm A/B were still on treatment. Table shows efficacy results from final analyses with long-term follow-up. In ALTA, the IRC-assessed intracranial cORR in pts with measurable baseline brain metastases was 50% (13/26) in arm A and 67% (12/18) in arm B; Kaplan-Meier (KM) estimated median intracranial DoR was 9.4 mo (95% CI, 3.7, not reached [NR]) in arm A and 16.6 mo (3.7, NR) in arm B. With long-term follow-up, no new safety signals were identified. Treatment-emergent adverse events led to dose interruption (Phase 1/2: 59%; ALTA arm A/B: 49%/61%), dose reduction (13%; 8%/33%), or discontinuation (10%; 4%/13%). Conclusions: BRG showed sustained long-term activity, PFS, and manageable safety in pts with CRZ-refractory ALK+ NSCLC. The 180 mg/d dose after 7-d lead-in at 90 mg/d led to numerically higher median PFS and OS. Final results are similar to those reported for other approved ALK tyrosine kinase inhibitors in this setting. Clinical trial information: NCT01449461, NCT02094573.Phase 1/2(n = 79)ALTA: A(n = 112)ALTA: B(n = 110)cORR, n (%) [95% CI]Per investigator53 (67) [56, 77]51 (46) [36, 55]63 (57) [48, 67]Per IRC?58 (52) [42, 61]62 (56) [47, 66]Median DoR (95% CI),a moPer investigator14.9 (9.9, 29.5)12.0 (9.2, 19.4)13.8 (10.8, 17.6)Per IRC?19.4 (9.2, 24.9)15.7 (13.6, 22.1)Median PFS (95% CI),a moPer investigator14.5 (10.8, 21.2)9.2 (7.4, 11.1)15.6 (11.1, 18.5)Per IRC?9.9 (7.4, 12.8)16.7 (11.6, 21.4)Median OS (95% CI),a mo47.6 (28.6, NR)25.9 (18.2, 45.8)40.6 (32.5, NR)OS at 5 yearsa42%31%43%aKM estimates.

Published
2021

166. Impact of a Clinical Genomics Program on Trial Accrual for Targeted Treatments: Practical Approach Overcoming Barriers to Accrual for Underserved Patients.

Author

Farhangfar, Carol J., Scarola, Gregory T., Morris, Victoria A., Farhangfar, Farhang, Dumas, Kathryn, Symanowski, James, Hwang, Jimmy J., Mileham, Kathryn F., Carrizosa, Daniel R., Naumann, R. Wendel, Livasy, Chad, Kim, Edward S., and Raghavan, Derek

Subjects
CLINICAL decision support systems, GENOMICS, PHYSICIAN services utilization, CLINICAL trials
Abstract

PURPOSE: Clinical trials of novel and targeted agents increasingly require biomarkers for eligibility. Precision oncology continues to evolve, but challenges hamper broad use of molecular profiling (MP) that could increase the number of patients benefiting from targeted therapy. We implemented an integrated clinical genomics program (CGP), including a virtual Molecular Tumor Board (MTB), and examined its impact on MP use and impact on clinical trial accrual in a multisite regional-based cancer system with an emphasis on effects for isolated clinicians. METHODS: We assessed MP and MTB use from 2010 to 2020 by practice location, physician experience, and patient characteristics. Use of MTB-recommended treatments was assessed. Clinical trial enrollment was evaluated for patients with MP versus MP and MTB review. RESULTS: After CGP implementation, the number of physicians using MP and the number of MP tests increased ≥ 10-fold. The proportion of Hispanic patients with MP was the same as that in the system (both 2%) with marginal differences observed in the proportion of African Americans tested compared with the system population (16% v 19%). Physicians followed MTB treatment recommendations in 74% of cases. Rapid clinical decline was the most common reason why physicians did not follow MTB recommendations. Clinical trial accrual was 15% (669 of 4,459) for patients with MP alone and 28% (94 of 334) with both MP and MTB review. Clinical trial availability and patient out-of-pocket costs affected MP use. CONCLUSION: Integrating CGP into clinical workflow with decision support tools, trial matching, and management of patient costs led to increased use of MP by physicians with all levels of experience, enhanced clinical trial accrual, and has the potential to reduce disparities in MP. [ABSTRACT FROM AUTHOR]

Published
2022
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168. Risk factors for hospitalization for cancer patients with SARS-CoV-2 infection.

Author

Shahid, Zainab, primary, Baldrige, Emily, additional, Trufan, Sally, additional, Schepel, Courtney, additional, Tan, Antoinette R., additional, Hwang, Jimmy J., additional, Musselwhite, Laura W., additional, Kim, Edward S., additional, Chai, Seungjean, additional, Sumrall, Ashley Love, additional, Ragon, Brittany K., additional, Voorhees, Peter Michael, additional, Grunwald, Michael Richard, additional, Ghosh, Nilanjan, additional, Usmani, Saad Zafar, additional, Copelan, Edward Alan, additional, and Raghavan, Derek, additional

Published
2021
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169. Brigatinib (BRG) in ALK+ crizotinib (CRZ)-refractory non-small cell lung cancer (NSCLC): Final results of the phase 1/2 and phase 2 (ALTA) trials.

Author

Gettinger, Scott N., primary, Huber, Rudolf M., additional, Kim, Dong-Wan, additional, Bazhenova, Lyudmila, additional, Holmskov Hansen, Karin, additional, Tiseo, Marcello, additional, Langer, Corey J., additional, Paz-Ares, Luis G., additional, West, Howard, additional, Reckamp, Karen L., additional, Weiss, Glen J., additional, Smit, Egbert F., additional, Hochmair, Maximilian, additional, Kim, Sang-We, additional, Ahn, Myung-Ju, additional, Kim, Edward S., additional, Groen, Harry J.M., additional, Pye, Joanna, additional, Vranceanu, Florin, additional, and Camidge, D. Ross, additional

Published
2021
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171. Canakinumab with and without pembrolizumab in patients with resectable non-small-cell lung cancer: CANOPY-N study design

Author

Garrido, Pilar, primary, Pujol, Jean-Louis, additional, Kim, Edward S, additional, Lee, Jay M, additional, Tsuboi, Masahiro, additional, Gómez-Rueda, Ana, additional, Benito, Amparo, additional, Moreno, Nicolas, additional, Gorospe, Luis, additional, Dong, Tuochuan, additional, Blin, Cecile, additional, Rodrik-Outmezguine, Vanessa, additional, Passos, Vanessa Q, additional, and Mok, Tony SK, additional

Published
2021
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174. Efficacy of Brigatinib in Patients With Advanced ALK-Positive NSCLC Who Progressed on Alectinib or Ceritinib: ALK in Lung Cancer Trial of brigAtinib-2 (ALTA-2)

Author

Ou, Sai-Hong Ignatius, Nishio, Makoto, Ahn, Myung-Ju, Mok, Tony, Barlesi, Fabrice, Zhou, Caicun, Felip, Enriqueta, de Marinis, Filippo, Kim, Sang-We, Pérol, Maurice, Liu, Geoffrey, Migliorino, Maria Rita, Kim, Dong-Wan, Novello, Silvia, Bearz, Alessandra, Garrido, Pilar, Mazieres, Julien, Morabito, Alessandro, Lin, Huamao M., Yang, Hui, Niu, Huifeng, Zhang, Pingkuan, and Kim, Edward S.

Abstract

Brigatinib is a potent next-generation ALK tyrosine kinase inhibitor approved for treatment-naive and crizotinib-refractory advanced ALK-positive (ALK+) NSCLC. We evaluated brigatinib after other next-generation ALK tyrosine kinase inhibitors.

Published
2022
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175. Rationale and design of ON-TRK: a novel prospective non-interventional study in patients with TRK fusion cancer treated with larotrectinib.

Author

Yang, James C. H., Brose, Marcia S., Castro, Gilberto, Kim, Edward S., Lassen, Ulrik N., Leyvraz, Serge, Pappo, Alberto, López-Ríos, Fernando, Reeves, John A., Fellous, Marc, Penault-Llorca, Frédérique, Rudzinski, Erin R., Tabatabai, Ghazaleh, Vassal, Gilles, Drilon, Alexander, and Trent, Jonathan

Abstract

Background: Tropomyosin receptor kinase (TRK) fusion proteins resulting from neurotrophic tyrosine receptor kinase (NTRK) gene fusions are rare primary oncogenic drivers in a wide array of tumors. Larotrectinib is a first-in-class, highly selective, central nervous system-active TRK inhibitor approved by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and over 40 countries for the treatment of TRK fusion solid tumors in adult and pediatric patients. Due to the rarity of TRK fusion cancer, larotrectinib was granted accelerated approval based on a relatively small number of patients enrolled in three early phase trials. ON-TRK aims to evaluate the safety profile of larotrectinib in a broader population and over extended time periods.Methods: ON-TRK is a prospective, non-interventional, open-label, multicenter, multi-cohort, post-approval study in adult and pediatric patients with locally advanced or metastatic TRK fusion cancer treated with larotrectinib that will describe the safety and effectiveness of larotrectinib in real-world practice conditions. Adult patients will be grouped by tumor type and followed for at least 2 years. Patients < 18 years old will be enrolled under a 'pediatric' cohort regardless of tumor type and will be followed for 5 years to evaluate the risk of potential long-term adverse effects of larotrectinib on their growth and development. The effectiveness of larotrectinib in the overall study population as well as in patient subgroups will also be evaluated. Procedures avoided in patients with infantile fibrosarcoma (e.g., amputation) and the number of patients who were able to undergo surgery with a curative intent (excluding amputation) because of the use of larotrectinib will be described. Larotrectinib treatment patterns in real-world practice, including dosing and duration of treatment, will be described.Discussion: The FDA Accelerated Approval Program allows for earlier approval of and patient access to drugs that treat serious conditions and fill an unmet medical need. This study is designed to fulfill post-approval requirements set by the FDA as well as post-marketing requirements set forth by local regulatory bodies and is part of the risk management plan for the EMA.Study Registration: This study is registered at ClinicalTrials.gov ( NCT04142437 ).Protocol Version: v2.5, 25 March 2021. [ABSTRACT FROM AUTHOR]

Published
2022
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176. Pan-cancer analysis of RNA expression of ANGIOTENSIN-I-CONVERTING ENZYME 2 reveals high variability and possible impact on COVID-19 clinical outcomes

Author

Elliott, Andrew, primary, Saul, Michelle, additional, Zeng, Jia, additional, Marshall, John L., additional, Kim, Edward S., additional, Nagasaka, Misako, additional, Lenz, Heinz-Josef, additional, Schwartzberg, Lee, additional, Spetzler, David, additional, Abraham, Jim, additional, Xiu, Joanne, additional, Stafford, Phillip, additional, and Michael Korn, W., additional

Published
2021
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177. Continuing to Broaden Eligibility Criteria to Make Clinical Trials More Representative and Inclusive: ASCO–Friends of Cancer Research Joint Research Statement

Author

Kim, Edward S., primary, Uldrick, Thomas S., additional, Schenkel, Caroline, additional, Bruinooge, Suanna S., additional, Harvey, R. Donald, additional, Magnuson, Allison, additional, Spira, Alexander, additional, Wade, James L., additional, Stewart, Mark D., additional, Vega, Diana Merino, additional, Beaver, Julia A., additional, Denicoff, Andrea M., additional, Ison, Gwynn, additional, Ivy, S. Percy, additional, George, Suzanne, additional, Perez, Raymond P., additional, Spears, Patricia A., additional, Tap, William D., additional, and Schilsky, Richard L., additional

Published
2021
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178. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO–Friends of Cancer Research Prior Therapies Work Group

Author

Osarogiagbon, Raymond U., primary, Vega, Diana Merino, additional, Fashoyin-Aje, Lola, additional, Wedam, Suparna, additional, Ison, Gwynn, additional, Atienza, Sol, additional, De Porre, Peter, additional, Biswas, Tithi, additional, Holloway, Jamie N., additional, Hong, David S., additional, Wempe, Madison M., additional, Schilsky, Richard L., additional, Kim, Edward S., additional, and Wade, James L., additional

Published
2021
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179. Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO-Friends Recommendations

Author

Harvey, R. Donald, primary, Bruinooge, Suanna S., additional, Chen, Li, additional, Garrett-Mayer, Elizabeth, additional, Rhodes, Whitney, additional, Stepanski, Edward, additional, Uldrick, Thomas S., additional, Ison, Gwynn, additional, Khozin, Sean, additional, Rubinstein, Wendy S., additional, Schenkel, Caroline, additional, Miller, Robert S., additional, Komatsoulis, George A., additional, Schilsky, Richard L., additional, and Kim, Edward S., additional

Published
2021
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180. CRESTONE: Clinical study of response to seribantumab in tumors with neuregulin-1 (NRG1) fusions—A phase II study of the anti-HER3 mAb for advanced or metastatic solid tumors (NCT04383210).

Author

Bendell, Johanna C., primary, Lim, Kian-Huat, additional, Burkard, Mark E., additional, Klempner, Samuel J, additional, Socinski, Mark A., additional, Gadgeel, Shirish M., additional, Reckamp, Karen L., additional, Leland, Shawn Michael, additional, Plessinger, Doug, additional, Kunkel, Lori A., additional, Dotan, Efrat, additional, Otterson, Gregory Alan, additional, Ou, Sai-Hong Ignatius, additional, Patil, Tejas, additional, Heymach, John, additional, and Kim, Edward S., additional

Published
2021
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182. Impact of socioeconomic status (SES) on colorectal cancer patient survival: An analysis of 890,867 patients in the National Cancer Database (NCDB).

Author

Salem, Mohamed E., primary, Trufan, Sally Jeanne, additional, Symanowski, James Thomas, additional, Kadakia, Kunal C., additional, Puccini, Alberto, additional, Musselwhite, Laura W., additional, Graves, Kristi D, additional, Hartley, Marion L., additional, Kim, Edward S., additional, Hwang, Jimmy J., additional, and El-Rayes, Bassel F., additional

Published
2021
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183. Socioeconomic status (SES) and survival outcomes in patients with gastrointestinal (GI) cancers: An analysis of 1.4 million patients in the National Cancer Database (NCDB).

Author

Salem, Mohamed E., primary, Trufan, Sally Jeanne, additional, Symanowski, James Thomas, additional, Kadakia, Kunal C., additional, Hartley, Marion L., additional, Graves, Kristi D, additional, Musselwhite, Laura W., additional, Kim, Edward S., additional, Raghavan, Derek, additional, and Hwang, Jimmy J., additional

Published
2021
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184. Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement

Author

Kurbegov, Dax, primary, Hurley, Patricia, additional, Waterhouse, David M., additional, Robert, Nicholas J., additional, Nowakowski, Grzegorz S., additional, Thompson, Michael A., additional, Bruinooge, Suanna S., additional, Schilsky, Richard L., additional, Byatt, Leslie, additional, Dempsey, Kandie, additional, Dawson, Casey, additional, Hofacker, Janie, additional, Liu, Jane, additional, MacDougall, A. Kate, additional, and Kim, Edward S., additional

Published
2021
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187. Abemaciclib in Combination with Single-Agent Options in Patients with Stage IV Non-Small Cell Lung Cancer: A Phase Ib Study.

Author

Kim, Edward S, Kim, Edward S, Kelly, Karen, Paz-Ares, Luis G, Garrido, Pilar, Jalal, Shadia, Mahadevan, Daruka, Gutierrez, Martin, Provencio, Mariano, Schaefer, Eric, Shaheen, Monte, Johnston, Erica L, Turner, P Kellie, Kambhampati, Siva Rama Prasad, Beckmann, Richard, Hossain, Anwar, John, William J, Goldman, Jonathan W, Kim, Edward S, Kim, Edward S, Kelly, Karen, Paz-Ares, Luis G, Garrido, Pilar, Jalal, Shadia, Mahadevan, Daruka, Gutierrez, Martin, Provencio, Mariano, Schaefer, Eric, Shaheen, Monte, Johnston, Erica L, Turner, P Kellie, Kambhampati, Siva Rama Prasad, Beckmann, Richard, Hossain, Anwar, John, William J, and Goldman, Jonathan W

Abstract

Purpose: Abemaciclib, a dual inhibitor of cyclin-dependent kinases 4 and 6, has demonstrated preclinical activity in non-small cell lung cancer (NSCLC). A multicenter, nonrandomized, open-label phase Ib study was conducted to test safety, MTD, pharmacokinetics, and preliminary antitumor activity of abemaciclib in combination with other therapies for treatment in patients with metastatic NSCLC.Patients and Methods: An initial dose escalation phase was used to determine the MTD of twice-daily oral abemaciclib (150, 200 mg) plus pemetrexed, gemcitabine, or ramucirumab, followed by an expansion phase for each drug combination. Pemetrexed and gemcitabine were administered according to label. The abemaciclib plus ramucirumab study examined two dosing schedules.Results: The three study parts enrolled 86 patients; all received ≥1 dose of combination therapy. Across arms, the most common treatment-emergent adverse events were fatigue, diarrhea, neutropenia, decreased appetite, and nausea. The trial did not identify an abemaciclib MTD for the combination with pemetrexed or gemcitabine but did so for the combination of abemaciclib with days 1 and 8 ramucirumab (8 mg/kg). Plasma sample analysis showed that abemaciclib did not influence the pharmacokinetics of the combination agents and the combination agents did not affect abemaciclib exposure. The disease control rate was 57% for patients treated with abemaciclib-pemetrexed, 25% for abemaciclib-gemcitabine, and 54% for abemaciclib-ramucirumab. Median progression-free survival was 5.55, 1.58, and 4.83 months, respectively.Conclusions: Abemaciclib demonstrated an acceptable safety profile when dosed on a continuous twice-daily schedule in combination with pemetrexed, gemcitabine, or ramucirumab. Abemaciclib exposures remained consistent with those observed in single-agent studies. Clin Cancer Res; 24(22); 5543-51. ©2018 AACR.

Published
2018

188. Relationship between MLH1, PMS2, MSH2 and MSH6 gene-specific alterations and tumor mutational burden in 1057 microsatellite instability-high solid tumors

Author

Salem, Mohamed E., Bodor, J. Nicholas, Puccini, Alberto, Xiu, Joanne, Goldberg, Richard M., Grothey, Axel, Korn, W. Michael, Shields, Anthony F., Worrilow, William M, Kim, Edward S., Lenz, Heinz-Josef, Marshall, John L., and Hall, Michael J.

Subjects
Male, congenital, hereditary, and neonatal diseases and abnormalities, Mutation, Missense, nutritional and metabolic diseases, High-Throughput Nucleotide Sequencing, Sequence Analysis, DNA, Middle Aged, digestive system diseases, Article, DNA-Binding Proteins, Gene Expression Regulation, Neoplastic, MutS Homolog 2 Protein, Neoplasms, Humans, Female, Microsatellite Instability, MutL Protein Homolog 1, neoplasms, Aged, Mismatch Repair Endonuclease PMS2, Retrospective Studies
Abstract

Microsatellite instability-high (MSI-H) and tumor mutational burden (TMB) are predictive biomarkers for immune-checkpoint inhibitors (ICIs). Still, the relationship between the underlying cause(s) of MSI and TMB in tumors remains poorly defined. We investigated associations of TMB to mismatch repair (MMR) protein expression patterns by immunohistochemistry (IHC) and MMR mutations in a diverse sample of tumors. Hypothesized differences were identified by the protein/gene affected/mutated and the tumor histology/primary site. Overall, 1057 MSI-H tumors were identified from the 32 932 tested. MSI was examined by NGS using 7000+ target microsatellite loci. TMB was calculated using only nonsynonymous missense mutations sequenced with a 592-gene panel; a subset of MSI-H tumors also had MMR IHC performed. Analyses examined TMB by MMR protein heterodimer impacted (loss of MLH1/PMS2 vs. MSH2/MSH6 expression) and gene-specific mutations. The sample was 54.6% female; mean age was 63.5 years. Among IHC tested tumors, loss of co-expression of MLH1/PMS2 was more common (n = 544/705, 77.2%) than loss of MSH2/MSH6 (n = 81/705, 11.5%; P < .0001), and was associated with lower mean TMB (MLH1/PMS2: 25.03 mut/Mb vs MSH2/MSH6 46.83 mut/Mb; P < .0001). TMB also varied by tumor histology: colorectal cancers demonstrating MLH1/PMS2 loss had higher TMBs (33.14 mut/Mb) than endometrial cancers (20.60 mut/Mb) and other tumors (25.59 mut/Mb; P < .0001). MMR gene mutations were detected in 42.0% of tumors; among these, MSH6 mutations were most common (25.7%). MSH6 mutation patterns showed variability by tumor histology and TMB. TMB varies by underlying cause(s) of MSI and tumor histology; this heterogeneity may contribute to differences in response to ICI.

Published
2020

189. Effectiveness of Community-Based Disaster Management in Cabanatuan City

Author

Kim Edward S. Santos

Subjects
Community based, EARLY DELIVERY, Alertness, Emergency management, Order (business), business.industry, Business, Natural disaster, Environmental planning, Term (time)
Abstract

Disasters in the Philippines serve as great vanguards defying all existing social divisions and stratifications, influencing all, and uniting communities across boundaries in order to prepare and prevent it. This study focused on the Community Based Disaster Management in selected barangays of Cabanatuan City. The main problem of the study is to determine the effectiveness of Community Based Disaster Management. The respondents of the study were 100 residents and was conducted at ten (10) selected barangays of Cabanatuan City namely: Aduas Centro, Aduas Norte, Aduas Sur, Isla, Sumacab Este, Sumacab Norte, Sumacab Sur, Pagas, Kapitan Pepe, and Valdifuente. The researcher used descriptive method of research. The findings of the study were: early delivery of warning that affects the alertness of the residents had been confirmed effective by the most of the respondents; the prevention and minimizing the impact of natural disasters made by the barangay were properly prepared and necessary actions were taken properly. In terms of conducting short term recovery, there is a sufficient supply of relief goods that helped the respondents to recover faster and the rescue team conducts their job without further delay.

Published
2020

190. Hypertonicity triggers RhoA-dependent assembly of myosin-containing striated polygonal actin networks in endothelial cells

Author

Malek, Adel M., Xu, Chang, Kim, Edward S., and Alper, Seth L.

Subjects
Cell metabolism -- Research, Cell physiology -- Research, Vascular endothelium -- Research, Vascular endothelium -- Physiological aspects, Physiological research, Biological sciences
Abstract

Endothelial cells respond to mechanical stresses of the circulation with cytoskeletal rearrangements such as F-actin stress fiber alignment along the axis of fluid flow. Endothelial cells are exposed to hypertonic stress in the renal medulla or during mannitol treatment of cerebral edema. We report here that arterial endothelial cells exposed to hypertonic stress rearranged F-actin into novel actin-myosin II fibers with regular 0.5-[micro]m striations, in which [alpha]-actinin colocalizes with actin. These striated fibers assembled over hours into three-dimensional, irregular, polygonal actin networks most prominent at the cell base, and occasionally surrounding the nucleus in a geodesic-like structure. Hypertonicity-induced assembly of striated polygonal actin networks was inhibited by cytochalasin D, blebbistatin, cell ATP depletion, and intracellular [Ca.sup.2+] chelation but did not require intact microtubules, regulatory volume increase, or de novo RNA or protein synthesis. Striated polygonal actin network assembly was insensitive to inhibitors of MAP kinases, tyrosine kinases, or phosphatidylinositol 3-kinase, but was prevented by C3 exotoxin, by the RhoA kinase inhibitor Y-27632, and by overexpressed dominant-negative RhoA. In contrast, overexpression of dominant-negative Rac or of dominant-negative cdc42 cDNAs did not prevent striated polygonal actin network assembly. The actin networks described here are novel in structure, as striated actin-myosin structures in nonmuscle cells, as a cellular response to hypertonicity, and as a cytoskeletal regulatory function of RhoA. Endothelial cells may use RhoA-dependent striated polygonal actin networks, possibly in concert with cytoskeletal load-bearing elements, as a contractile, tension-generating component of their defense against isotropic compressive forces. mannitol; Rho kinase; blebbistatin; bovine aortic endothelial cells doi:10.1152/ajpcell.00533.2006.

Published
2007

194. Abstract PO-003: CRESTONE – Clinical study of response to seribantumab in tumors with neuregulin-1 (NRG1) Fusions – A phase 2 study of the anti-HER3 mAb for advanced or metastatic solid tumors (NCT04383210)

Author

Bendell, Johanna C., primary, Lim, Kian-Huat, additional, Burkard, Mark E., additional, Lin, Jessica J., additional, Chae, Young Kwang, additional, Socinski, Mark A., additional, Khan, Gazala, additional, Reckamp, Karen L., additional, Leland, Shawn, additional, Plessinger, Douglas, additional, Kunkel, Lori, additional, Dotan, Efrat, additional, Otterson, Gregory, additional, Ou, Sai-Hong Ignatius, additional, Patil, Tejas, additional, Heymach, John V., additional, and Kim, Edward S., additional

Published
2020
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199. Computed Tomography RECIST Assessment of Histopathologic Response and Prediction of Survival in Patients with Resectable Non–Small-Cell Lung Cancer after Neoadjuvant Chemotherapy

Author

William, William N., Jr, Pataer, Apar, Kalhor, Neda, Correa, Arlene M., Rice, David C., Wistuba, Ignacio I., Heymach, John, Lee, J. Jack, Kim, Edward S., Munden, Reginald, Gold, Kathryn A., Papadimitrakopoulou, Vassiliki, Swisher, Stephen G., and Erasmus, Jeremy J.

Published
2013
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