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2. Additional file 4 of Risk of seizures in a population of women with BRCA-positive metastatic breast cancer from an electronic health record database in the United States

Author

Liede, Alexander, Sebby, Wendy, Miriyala, Ashok Kumar Reddy, Potluri, Ravi, Mazumder, Debasish, Ghosh, Anirban, Papademetriou, Eros, Kilpatrick, Ryan, and Tyczynski, Jerzy E.

Abstract

Additional file 4: Supplementary Table 4. List of anticonvulsants and PARP inhibitors included in the analyses.

Published
2023
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3. Additional file 1 of Risk of seizures in a population of women with BRCA-positive metastatic breast cancer from an electronic health record database in the United States

Author

Liede, Alexander, Sebby, Wendy, Miriyala, Ashok Kumar Reddy, Potluri, Ravi, Mazumder, Debasish, Ghosh, Anirban, Papademetriou, Eros, Kilpatrick, Ryan, and Tyczynski, Jerzy E.

Abstract

Additional file 1: Supplementary Table 1. Diagnosis codes used to identify patients with malignancies.

Published
2023
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4. Additional file 2 of Risk of seizures in a population of women with BRCA-positive metastatic breast cancer from an electronic health record database in the United States

Author

Liede, Alexander, Sebby, Wendy, Miriyala, Ashok Kumar Reddy, Potluri, Ravi, Mazumder, Debasish, Ghosh, Anirban, Papademetriou, Eros, Kilpatrick, Ryan, and Tyczynski, Jerzy E.

Abstract

Additional file 2: Supplementary Table 2. SDS information used to identify patients with metastases but without ICD codes in their EHRs.

Published
2023
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5. Additional file 3 of Risk of seizures in a population of women with BRCA-positive metastatic breast cancer from an electronic health record database in the United States

Author

Liede, Alexander, Sebby, Wendy, Miriyala, Ashok Kumar Reddy, Potluri, Ravi, Mazumder, Debasish, Ghosh, Anirban, Papademetriou, Eros, Kilpatrick, Ryan, and Tyczynski, Jerzy E.

Abstract

Additional file 3: Supplementary Table 3. SDS terms used to identify patients with seizures.

Published
2023
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7. Long‐term safety and efficacy of the PI3K inhibitor copanlisib in patients with relapsed or refractory indolent lymphoma: 2‐year follow‐up of the CHRONOS‐1 study

Author

Dreyling, Martin, primary, Santoro, Armando, additional, Mollica, Luigina, additional, Leppä, Sirpa, additional, Follows, George, additional, Lenz, Georg, additional, Kim, Won Seog, additional, Nagler, Arnon, additional, Dimou, Maria, additional, Demeter, Judit, additional, Özcan, Muhit, additional, Kosinova, Marina, additional, Bouabdallah, Krimo, additional, Morschhauser, Franck, additional, Stevens, Don A., additional, Trevarthen, David, additional, Munoz, Javier, additional, Rodrigues, Liana, additional, Hiemeyer, Florian, additional, Miriyala, Ashok, additional, Garcia‐Vargas, Jose, additional, Childs, Barrett H., additional, and Zinzani, Pier Luigi, additional

Published
2020
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8. Copanlisib, a PI3K Inhibitor, Demonstrates a Favorable Long-Term Safety Profile in a Pooled Analysis of Patients with Hematologic Malignancies

Author

Zinzani, Pier Luigi, primary, Santoro, Armando, additional, Mollica, Luigina, additional, Leppä, Sirpa, additional, Follows, George A, additional, Lenz, Georg, additional, Kim, Won Seog, additional, Nagler, Arnon, additional, Panayiotidis, Panayiotis, additional, Demeter, Judit, additional, Morschhauser, Franck, additional, Munoz, Javier, additional, Miriyala, Ashok, additional, Benson, Alice, additional, Garcia-Vargas, Jose, additional, Childs, Barrett H, additional, and Dreyling, Martin, additional

Published
2019
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9. Long-term follow-up of patients (pts) with relapsed or refractory (r/r) follicular lymphoma (FL) treated with copanlisib.

Author

Leppä, Sirpa, primary, Santoro, Armando, additional, Demeter, Judit, additional, Follows, George, additional, Lenz, Georg, additional, Kim, Won Seog, additional, Mollica, Luigina, additional, Nagler, Arnon, additional, Diong, Colin Phipps, additional, Provencio, Mariano, additional, Stevens, Don A., additional, Trevarthen, David R., additional, Wang, MingLu, additional, Wirtz, Oliver, additional, Miriyala, Ashok, additional, Garcia Vargas, Jose, additional, Childs, Barrett H., additional, Zinzani, Pier Luigi, additional, and Dreyling, Martin H., additional

Published
2019
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10. Outcomes for Patients with Pre-Existing Diabetes or Hypertension Treated with Copanlisib from the CHRONOS-1 Study in Patients with Relapsed or Refractory Indolent B-Cell Lymphoma

Author

Zinzani, Pier Luigi, primary, Santoro, Armando, additional, Mollica, Luigina, additional, Leppä, Sirpa, additional, Follows, George A, additional, Lenz, Georg, additional, Kim, Won Seog, additional, Nagler, Arnon, additional, Panayiotidis, Panayiotis, additional, Demeter, Judit, additional, Morschhauser, Franck, additional, Rodrigues, Liana, additional, Reeves, John, additional, Hiemeyer, Florian, additional, Miriyala, Ashok, additional, Garcia-Vargas, Jose, additional, Childs, Barrett H., additional, and Dreyling, Martin H., additional

Published
2018
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11. Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study

Author

Van Cutsem, Eric, primary, Martinelli, Erika, additional, Cascinu, Stefano, additional, Sobrero, Alberto, additional, Banzi, Maria, additional, Seitz, Jean-François, additional, Barone, Carlo, additional, Ychou, Marc, additional, Peeters, Marc, additional, Brenner, Baruch, additional, Hofheinz, Ralf Dieter, additional, Maiello, Evaristo, additional, André, Thierry, additional, Spallanzani, Andrea, additional, Garcia-Carbonero, Rocio, additional, Arriaga, Yull E., additional, Verma, Udit, additional, Grothey, Axel, additional, Kappeler, Christian, additional, Miriyala, Ashok, additional, Kalmus, Joachim, additional, Falcone, Alfredo, additional, and Zaniboni, Alberto, additional

Published
2018
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12. Copanlisib treatment in patients with relapsed or refractory indolent B-cell lymphoma: Subgroup analyses of diabetic patients from the phase II CHRONOS-1 study.

Author

Dreyling, Martin H., primary, Leppa, Sirpa, additional, Comeau, Terrance, additional, Kosinova, Marina, additional, Lenz, Georg, additional, Nagler, Arnon, additional, Heo, Dae Seog, additional, Oh, Sung Yong, additional, Huang, Liping, additional, Wirtz, Oliver, additional, Miriyala, Ashok, additional, Garcia-Vargas, Jose E., additional, Childs, Barrett H., additional, and Zinzani, Pier Luigi, additional

Published
2018
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13. Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single‐Arm, Open‐Label Phase IIIb CONSIGN Study.

Author

Van Cutsem, Eric, Martinelli, Erika, Cascinu, Stefano, Sobrero, Alberto, Banzi, Maria, Seitz, Jean‐François, Barone, Carlo, Ychou, Marc, Peeters, Marc, Brenner, Baruch, Hofheinz, Ralf Dieter, Maiello, Evaristo, André, Thierry, Spallanzani, Andrea, Garcia‐Carbonero, Rocio, Arriaga, Yull E., Verma, Udit, Grothey, Axel, Kappeler, Christian, and Miriyala, Ashok

Subjects
DIARRHEA, HYPERTENSION risk factors, LIVER injuries, FATIGUE risk factors, HYPOPHOSPHATEMIA, HAND-foot syndrome, ASPARTATE aminotransferase, BILIRUBIN, CLINICAL trials, CONFIDENCE intervals, COLON tumors, DRUG side effects, CLINICAL drug trials, HEALTH services accessibility, LONGITUDINAL method, MARKETING, METASTASIS, RECTUM tumors, SURVIVAL, TERMINATION of treatment, ALANINE aminotransferase, TREATMENT effectiveness, SEVERITY of illness index, DISEASE progression, TREATMENT duration, PROTEIN kinase inhibitors, PROGNOSIS, DISEASE risk factors, THERAPEUTICS
Abstract

Copyright of Oncologist is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2019
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14. Regorafenib in previously treated metastatic colorectal cancer (mCRC): Analysis of age subgroups in the open-label phase IIIb CONSIGN trial.

Author

Van Cutsem, Eric, primary, Ciardiello, Fortunato, additional, Ychou, Marc, additional, Seitz, Jean Francois, additional, Hofheinz, Ralf, additional, Arriaga, Yull Edwin, additional, Verma, Udit, additional, Garcia-Carbonero, Rocio, additional, Grothey, Axel, additional, Miriyala, Ashok, additional, Kalmus, Joachim, additional, Kappeler, Christian, additional, Falcone, Alfredo, additional, and Zaniboni, Alberto, additional

Published
2016
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15. Pooled Safety Analysis from Phase I and II Studies for Patients with Relapsed Indolent Non-Hodgkin's Lymphoma Treated with Intravenous Copanlisib

Author

Zinzani, Pier Luigi, Patnaik, Amita, Morschhauser, Franck, Salles, Gilles Andre, Santoro, Armando, Mollica, Luigina, Bouabdallah, Krimo, Cunningham, David, Leppa, Sirpa, Follows, George, Benson, Alice, Bonata, Peter, Genvresse, Isabelle, Miriyala, Ashok, Mehra, Aruna, Garcia-Vargas, Jose, Childs, Barrett H., and Dreyling, Martin

Published
2017
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16. Updated Safety and Efficacy from the Copanlisib CHRONOS-1 Trial in Patients with Relapsed or Refractory Indolent B-Cell Lymphoma: Low Incidence of Late-Onset Severe Toxicities

Author

Dreyling, Martin, Santoro, Armando, Mollica, Luigina, Leppa, Sirpa, Follows, George, Lenz, Georg, Kim, Won Seog, Nagler, Arnon, Panayiotidis, Panayiotis, Demeter, Judit, Ozcan, Muhit, Kosinova, Marina, Bouabdallah, Krimo, Morschhauser, Franck, Stevens, Don A, Trevarthen, David, Magagnoli, Massimo, Ishida, Tatiane, Lu, Cindy, Hiemeyer, Florian, Miriyala, Ashok, Garcia-Vargas, Jose, Childs, Barrett H., and Zinzani, Pier Luigi

Published
2017
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18. Long-term safety and efficacy of the PI3K inhibitor copanlisib in patients with relapsed or refractory indolent lymphoma: 2-year follow-up of the CHRONOS-1 study

Author

Pier Luigi Zinzani, Maria Dimou, J. Garcia-Vargas, Arnon Nagler, Judit Demeter, Sirpa Leppä, Liana Rodrigues, Georg Lenz, Muhit Ozcan, Javier Munoz, Luigina Mollica, David Trevarthen, George A Follows, Barrett H. Childs, Florian Hiemeyer, Franck Morschhauser, Marina Kosinova, Ashok Miriyala, Armando Santoro, Won Seog Kim, Martin Dreyling, Krimo Bouabdallah, Don A. Stevens, Dreyling, Martin, Santoro, Armando, Mollica, Luigina, Leppä, Sirpa, Follows, George, Lenz, Georg, Kim, Won Seog, Nagler, Arnon, Dimou, Maria, Demeter, Judit, Özcan, Muhit, Kosinova, Marina, Bouabdallah, Krimo, Morschhauser, Franck, Stevens, Don A, Trevarthen, David, Munoz, Javier, Rodrigues, Liana, Hiemeyer, Florian, Miriyala, Ashok, Garcia-Vargas, Jose, Childs, Barrett H, Zinzani, Pier Luigi, Department of Oncology, HUS Comprehensive Cancer Center, Doctoral Programme in Clinical Research, Doctoral Programme in Biomedicine, Sirpa Marianne Leppä / Principal Investigator, Clinicum, and Research Programs Unit

Subjects
Male, Follicular lymphoma, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Multicenter Studies as Topic, Medicine, IDELALISIB, Phosphoinositide-3 Kinase Inhibitors, Aged, 80 and over, 0303 health sciences, Hematopoietic Stem Cell Transplantation, Hematology, Middle Aged, Allografts, Combined Modality Therapy, Progression-Free Survival, 3. Good health, PI3K-DELTA, BAY 80-6946, Treatment Outcome, 030220 oncology & carcinogenesis, Hypertension, Female, Adult, Diarrhea, medicine.medical_specialty, Lymphoma, B-Cell, Neutropenia, PHOSPHATIDYLINOSITOL 3-KINASE INHIBITION, 3122 Cancers, PI3K inhibitor, copanlisib, indolent lymphoma, Transplantation, Autologous, Drug Administration Schedule, 03 medical and health sciences, Clinical Trials, Phase II as Topic, Internal medicine, Humans, DOSE-ESCALATION, Progression-free survival, Adverse effect, Survival analysis, Aged, 030304 developmental biology, Copanlisib, Pneumonitis, Salvage Therapy, business.industry, ALPELISIB, PHASE IB, medicine.disease, Survival Analysis, Transplantation, Pyrimidines, chemistry, P110-ALPHA, Hyperglycemia, Quinazolines, business, Follow-Up Studies, BUPARLISIB
Abstract

Safety profiles of oral PI3K inhibitors have resulted in US FDA black box warnings regarding fatal/serious toxicities. The approved intravenous PI3K inhibitor copanlisib has low incidence of severe toxicities and no black box warnings, but chronic treatment effects were unknown. We provide an update on safety and efficacy of copanlisib with a minimum 2-year follow-up of the CHRONOS-1 study. A total of 142 patients with histologically confirmed indolent B-cell lymphoma who had relapsed after or were refractory to >= 2 prior treatments received intravenous copanlisib 60 mg on days 1, 8, and 15 (28-day cycle). The primary efficacy endpoint was objective response rate (ORR) after >= 4 cycles (independent assessment). The predominant histology was follicular lymphoma (n = 104). The ORR was 60.6% (seven additional complete responses since primary analysis). Secondary endpoints of median duration of response, progression-free survival, and overall survival were 14.1 months (median follow-up, 16.1 months), 12.5 months (median follow-up, 14.0 months), and 42.6 months (median follow-up, 31.5 months), respectively. Median safety follow-up was 6.7 months; 26% of patients received treatment for >1 year. Common treatment-emergent adverse events (TEAEs) (all grade/grade 3/grade 4) were transient hyperglycemia (50.0%/33.1%/7.0%), diarrhea (35.2%/8.5%/0%), transient hypertension (29.6%/23.9%/0%), and neutropenia (28.9%/9.2%/14.8%). Serious AEs were largely unchanged, with no new cases of pneumonitis (4.2%), diarrhea (2.8%), or grade 5 events. Note, TEAEs showed no evidence for increased incidence or worsening following longer exposure in patients treated >1 year. Long-term follow-up of patients with relapsed/refractory indolent B-cell lymphoma treated with intravenous copanlisib demonstrated durable, enhanced responses without evidence of worsening TEAEs, as reported for orally administered PI3K inhibitors.

Published
2020

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