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2. Global Study on the Accuracy of Human Epidermal Growth Factor Receptor 2-Low Diagnosis in Breast Cancer

Author

Ruschoff, Josef, Penner, Alexander, Ellis, Ian O., Hammond, M. Elizabeth Hale, Lebeau, Annette, Osamura, Robert Y., Penault-Llorca, Frederique, Rojo, Federico, Desai, Chirag, Moh, Akira, Atkey, Neil, Baenfer, Gudrun, Scheel, Andreas H., D'Arrigo, Corrado, Schildhaus, Hans- Ulrich, and Viale, Giuseppe

Subjects
Accuracy and precision -- Evaluation, Gene expression -- Health aspects, Clinical competence -- Evaluation, Pathologists -- Evaluation -- International aspects, Breast cancer -- Diagnosis
Abstract

Context.--Recently, a new type of antibody-drug conjugate, trastuzumab-deruxtecan (T-DXd), has been approved for the treatment of metastatic breast cancer with low level of human epidermal growth factor receptor 2 (HER2) gene expression. Thereby, eligibility relies on an accurate diagnosis of HER2-low status defined by immunohistochemistry IHC 1+/2+ with no gene amplification. Objective.--To assess pathologists' accuracy and training efficacy in the diagnosis of HER2-low. Design.--Agreement rates of HER2-low scoring in breast cancer tissue were assessed between expert consensus and real-world pathologists (n = 77 from 14 countries) before and after a specific 4-hour training for HER2-low detection. Two assays were evaluated, the Ventana Pathway 4B5 CDx and the Dako HercepTest (polyclonal). Concordance of the pathologists with consensus score and efficacy of training were measured by Cohen k, overall rater agreement, and receiver operating characteristic (ROC) curve statistics. Results.--In the Ventana 4B5 HER2-low category, baseline agreement rates were >80% but Conclusions.--The ability of pathologists to achieve acceptable diagnostic accuracy in identifying patients with HER2-low breast cancer could be enhanced by short-term training. Potential routes to improve the quality of HER2-low scoring in clinical practice have been identified. doi: 10.5858/arpa.2024-0052OA, During the past 20 years, diagnosis of human epidermal growth factor receptor 2 (HER2) status has been essential in determining eligibility of breast cancer patients for HER2-targeted therapies. (1,2) Although [...]

Published
2024
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4. Prevalence and types of cancer in older Indians: A multicentric observational study across 17 institutions in India

Author

Noronha, Vanita, Rao, Abhijith Rajaram, Pillai, Anupa, Kumar, Anita, Rajappa, Senthil, Kapoor, Akhil, Mishra, B.K., Gupta, Tarachand, Desai, Chirag, Pavithran, Keechilat, Goel, Alok, Vora, Chakor, Mailankody, Sharada, Hingmire, Sachin, Saha, Rajat, Kumar, Amit, Sahoo, T.P., Chandrasekharan, Arun, Kothari, Rushabh, Kumar, Lalit, Ramaswamy, Anant, Banavali, Shripad, and Prabhash, Kumar

Published
2024
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9. Arguments against the Requirement of a Biological License Application for Human Pancreatic Islets: The Position Statement of the Islets for US Collaborative Presented during the FDA Advisory Committee Meeting

Author

Witkowski, Piotr, Odorico, Jon, Pyda, Jordan, Anteby, Roi, Stratta, Robert J, Schrope, Beth A, Hardy, Mark A, Buse, John, Leventhal, Joseph R, Cui, Wanxing, Hussein, Shakir, Niederhaus, Silke, Gaglia, Jason, Desai, Chirag S, Wijkstrom, Martin, Kandeel, Fouad, Bachul, Piotr J, Becker, Yolanda Tai, Wang, Ling-Jia, Robertson, R Paul, Olaitan, Oyedolamu K, Kozlowski, Tomasz, Abrams, Peter L, Josephson, Michelle A, Andreoni, Kenneth A, Harland, Robert C, Kandaswamy, Raja, Posselt, Andrew M, Szot, Gregory L, Ricordi, Camillo, and On Behalf Of The Islets For Us Collaborative

Subjects
Medical Biotechnology, Biomedical and Clinical Sciences, Autoimmune Disease, Diabetes, Transplantation, allogenic islet cell transplantation, pancreas, Food and Drug Administration, Clinical Sciences, Biomedical and clinical sciences
Abstract

The Food and Drug Administration (FDA) has been regulating human islets for allotransplantation as a biologic drug in the US. Consequently, the requirement of a biological license application (BLA) approval before clinical use of islet transplantation as a standard of care procedure has stalled the development of the field for the last 20 years. Herein, we provide our commentary to the multiple FDA's position papers and guidance for industry arguing that BLA requirement has been inappropriately applied to allogeneic islets, which was delivered to the FDA Cellular, Tissue and Gene Therapies Advisory Committee on 15 April 2021. We provided evidence that BLA requirement and drug related regulations are inadequate in reassuring islet product quality and potency as well as patient safety and clinical outcomes. As leaders in the field of transplantation and endocrinology under the "Islets for US Collaborative" designation, we examined the current regulatory status of islet transplantation in the US and identified several anticipated negative consequences of the BLA approval. In our commentary we also offer an alternative pathway for islet transplantation under the regulatory framework for organ transplantation, which would address deficiencies of in current system.

Published
2021

10. International Liver Transplantation Society Global Census: First Look at Pediatric Liver Transplantation Activity Around the World

Author

Rodriguez-Davalos, Manuel I., Lopez-Verdugo, Fidel, Kasahara, Mureo, Muiesan, Paolo, Reddy, Mettu S., Flores-Huidobro Martinez, Angel, Xia, Qiang, Hong, Johnny C., Niemann, Claus U., Seda-Neto, Joao, Miloh, Tamir A., Yi, Nam-Joon, Mazariegos, George V., Ng, Vicky L., Esquivel, Carlos O., Lerut, Jan, Rela, Mohamed, Botha, Jean, Mehta, Naimish N., Bakar Hafeez Bhatti, Abu, Zamora-Valdes, Daniel, Anand, Superina, Riccardo, de Kleine, Ruben, Matamoros, Maria A., Bedregal-Mendoza, Tayana, Steve Bynon, J., Rodriguez-Sancho, Luis C., Langnas, Alan, Dhawan, Anil, Ogura, Yasuhiro, Vianna, Rodrigo, Ilyassova, Bibigul, Tantemsapya, Niramol, Bellemare, Sarah, Ovchinsky, Nadia, Bhalerao, Suryabhan, Balci, Deniz, Dip, Marcelo, Imventarza, Oscar, Mangus, Richard S., Fawcett, Jonathan, Antonini, Teresa M., Shrimal, Anurag, Zhu, Zhi-Jun, Rivera, Jairo, Dayangac, Murat, McCall, John, Utz Melere, Melina, Stormon, Michael, Mizuta, Koichi, Gao, Wei, Hening Rahayatri, Tri, Costaguta, Alejandro, Gautier, Sergei, Kazemi, Kourosh, Martinez-Castillo, Jorge, Apinyachon, Worapot, Rastogi, Mukul, Restrepo, Juan C., Takahito, Yagi, Ravichandra, Srinivasa, Vanin, Anabel, Vieira, Sandra, Luque, Carlos, Gondolesi, Gabriel, Hashimoto, Koji, Yazigi, Nada, Lebel, Sylvie, Mavis, Alisha, Arnon, Ronen, Chavez-Vargas, Ricardo, Elisofon, Scott, Desai, Dev M., Okajima, Hideaki, Chinnakotla, Srinath, Hsu, Evelyn, Reyes, Jorge, Orgoi, Sergelen, Raut, Vikram, Hee Oh, Seak, Valentino, Pamela, Emre, Sukru, Spada, Marco, Leung, Dan, Charco, Ramon, Ericzon, Bo-Goran, Fischer, Ryan, Del Rio-Martin, Juan V., Cillo, Umberto, Soliman, Hossam, Varela-Fascinetto, Gustavo, de Villa, Vanessa, Haberal, Mehmet, Covarrubias, Joshue, Colledan, Michele, de Ville de Goyet, Jean, Desai, Chirag, Sundaram, Shikha, Fronek, Jiri, Nadig, Satish N., Mali, Vidyadhar P., Tandoi, Francesco, Kohli, Rohit, Mohan, Neelam, Goyal, Neerav, Santhosh, Drisya, Debray, Dominique, Durmaz, Ozlem, De Bruyne, Ruth, Kaliciński, Piotr, Hierro, Loreto, Venick, Robert, Perito, Emily, Mozer-Glassberg, Yael, Chen, Chao-Long, Rand, Elizabeth, Nikeghbalian, Saman, Kelly, Deirdre, Boillot, Olivier, and Book, Linda S.

Published
2023
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22. The demise of islet allotransplantation in the United States: A call for an urgent regulatory update

Author

Witkowski, Piotr, Philipson, Louis H., Kaufman, Dixon B., Ratner, Lloyd E., Abouljoud, Marwan S., Bellin, Melena D., Buse, John B., Kandeel, Fouad, Stock, Peter G., Mulligan, David C., Markmann, James F., Kozlowski, Tomasz, Andreoni, Kenneth A., Alejandro, Rodolfo, Baidal, David A., Hardy, Mark A., Wickrema, Amittha, Mirmira, Raghavendra G., Fung, John, Becker, Yolanda T., Josephson, Michelle A., Bachul, Piotr J., Pyda, Jordan S., Charlton, Michael, Millis, J. Michael, Gaglia, Jason L., Stratta, Robert J., Fridell, Jonathan A., Niederhaus, Silke V., Forbes, Rachael C., Jayant, Kumar, Robertson, R. Paul, Odorico, Jon S., Levy, Marlon F., Harland, Robert C., Abrams, Peter L., Olaitan, Oyedolamu K., Kandaswamy, Raja, Wellen, Jason R., Japour, Anthony J., Desai, Chirag S., Naziruddin, Bashoo, Balamurugan, Appakalai N., Barth, Rolf N., and Ricordi, Camillo

Published
2021
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23. Clinical Evaluation of T-AYU-HM Premium in Sickle Cell Disease (HbSS) Patients: A Retrospective Study.

Author

Desai, M., Desai, Kavita A., Hemshree, Desai, Desai, Rutvij A., and Desai, Chirag K.

Subjects
SICKLE cell anemia, ERYTHROCYTES, CLINICAL trials, BLOOD transfusion, RETICULOCYTES
Abstract

Background: Sickle cell disease (HbSS) is one of the main hemoglobinopathies that affect the indigenous tribes and is a significant cause of morbidity and mortality. The effectiveness and safety of alternative medicines for sickle cell disease patients require further scientific study. The proposed study was conducted to clinically evaluate the safety and effectiveness of T-AYU-HM Premium Tablet (300 mg). Materials and Methods: This is a single-arm observational retrospective cohort study of 100 sickle cell disease subjects. Based on inclusion and exclusion criteria, the clinical and vital information of the patients was acquired, assessed, and reported. A follow-up period of 120±10 days was deemed sufficient. Data were analysed using a statistical package for the social sciences (SPSS). Results: The levels of haemoglobin (g/dL) (9.43±1.83 to 10.11±1.37) and red blood cells (/mm3) (3.89±0.81 to 4.18±0.64) were significantly improved (p<0.05). Reticulocyte count (%) changed significantly from 4.51±3.20 to 2.84±2.34. The number of blood transfusions (7.12±26.80 to 00) and the percentage of hospitalisations (76% to 00) that occurred more than six times prior to presentation were significantly reduced. Conclusion: In this retrospective analysis, there were no reported adverse consequences. Patient's responses and all the clinical parameters like haematology, liver function parameters, clinical, and pain-associated symptoms with the disorder showed T-AYU-HM Premium to be an effective and safer therapy in the treatment of sickle cell anemia. Further well-planned interventional studies may become useful to justify the same. [ABSTRACT FROM AUTHOR]

Published
2024
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29. A review on mechanisms of resistance to PARP inhibitors

Author

Desai, Chirag, Pathak, Anand, Limaye, Sewanti, Maniar, Vashishth, and Joshi, Archita

Subjects
AstraZeneca Pharmaceuticals L.P., Gene mutations -- Health aspects, Antineoplastic agents -- Health aspects, Sugars -- Health aspects, Chemotherapy -- Health aspects, DNA damage -- Health aspects, Monosaccharides -- Health aspects, Cancer -- Chemotherapy, Ovarian cancer -- Development and progression, Antimitotic agents -- Health aspects, Health
Abstract

Byline: Chirag. Desai, Anand. Pathak, Sewanti. Limaye, Vashishth. Maniar, Archita. Joshi Standard therapy for advanced ovarian cancer (OC) consists of radical debulking cytoreductive surgery followed by adjuvant chemotherapy. An important [...]

Published
2022

37. Avelumab first-line maintenance plus best supportive care (BSC) vs. BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Asian subgroup analysis

Author

Lee, Jae-Lyun, primary, Desai, Chirag, additional, Park, Se Hoon, additional, Tsuchiya, Norihiko, additional, Su, Po-Jung, additional, Chan, Timothy Tim Wai, additional, Gurney, Howard, additional, Gao, Seasea, additional, Wang, Jing, additional, Sandner, Robin, additional, di Pietro, Alessandra, additional, and Eto, Masatoshi, additional

Published
2023
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41. Data from Metabolomic Characterization of Hepatocellular Carcinoma in Patients with Liver Cirrhosis for Biomarker Discovery

Author

Di Poto, Cristina, primary, Ferrarini, Alessia, primary, Zhao, Yi, primary, Varghese, Rency S., primary, Tu, Chao, primary, Zuo, Yiming, primary, Wang, Minkun, primary, Nezami Ranjbar, Mohammad R., primary, Luo, Yue, primary, Zhang, Chi, primary, Desai, Chirag S., primary, Shetty, Kirti, primary, Tadesse, Mahlet G., primary, and Ressom, Habtom W., primary

Published
2023
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42. Supplementary Tables S1-S3 and Figure S1-S3. from Metabolomic Characterization of Hepatocellular Carcinoma in Patients with Liver Cirrhosis for Biomarker Discovery

Author

Di Poto, Cristina, primary, Ferrarini, Alessia, primary, Zhao, Yi, primary, Varghese, Rency S., primary, Tu, Chao, primary, Zuo, Yiming, primary, Wang, Minkun, primary, Nezami Ranjbar, Mohammad R., primary, Luo, Yue, primary, Zhang, Chi, primary, Desai, Chirag S., primary, Shetty, Kirti, primary, Tadesse, Mahlet G., primary, and Ressom, Habtom W., primary

Published
2023
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43. Abstract HER2-13: HER2-13 Proficiency assessment of HER2-low breast cancer scoring with the Ventana PATHWAY 4B5 and Dako HercepTest HER2 assays and the impact of pathologist training

Author

Rüschoff, Josef, primary, Penner, Alexander, additional, Ellis, Ian O., additional, Hammond, M. Elizabeth H., additional, Lebeau, Annette, additional, Osamura, Robert Y., additional, Penault-Llorca, Frédérique, additional, Rojo, Federico, additional, Atkey, Neil, additional, Scheel, Andreas H., additional, D´Arrigo, Corrado, additional, Schildhaus, Hans-Ulrich, additional, Moh, Akira, additional, Desai, Chirag, additional, and Viale, Giuseppe, additional

Published
2023
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45. Management of Locally Advanced Unresectable or Metastatic Urothelial Carcinoma: Expert Opinion from an Indian Panel via Delphi Consensus Method

Author

Rajappa, Senthil, additional, Raja, T., additional, Desai, Chirag, additional, Joshi, Amit, additional, Dattatreya, Palanki Satya, additional, Agarwal, Mohit, additional, Sud, Rahul, additional, Ramesh, Anita, additional, Vaid, A. K., additional, Talwar, Vineet, additional, Rauthan, Amit, additional, Kaushal, Ashish, additional, Mohapatra, Prabrajya, additional, and Kapoor, Akhil, additional

Published
2023
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49. Perioperative Management of Patients Undergoing Total Pancreatectomy with/without Islet Cell Autotransplantation: A Single Center Experience

Author

Madduri, Supradeep S., Agala, Chris B., McEwan, Sasha, Weng, Chengyu, Desai, Chirag S., and Reid, Trista D.

Abstract

Total pancreatectomy (TP) and islet cell autotransplantation (IAT) are complex operations that require intensive postoperative monitoring with standardized protocols. There are few studies detailing immediate perioperative management. The purpose of this study was to describe the perioperative management of post-pancreatectomy patients in the first week following surgery to guide clinicians in addressing salient points from different organ systems. This is a retrospective cohort review of prospectively collected data from September 2017 to September 2022 at a single institution, including patients 16 years and older who underwent TP or TPIAT for chronic pancreatitis. Patients were maintained on a heparin drip (TPIAT), insulin drip, and ketamine infusion. Primary outcomes were complications in the first 5 days following surgery and ICU length of stay (LOS). Secondary outcomes included overall LOS and mortality. Of 31 patients, 26 underwent TPIAT, and 5 underwent TP. Median ICU LOS was five days (IQR 4–6). The most common immediate postoperative complications were reintubation [n = 5 (16%)] and bleeding [n = 2 (6%)]. Median insulin drip use was 70 h (IQR 20–124). There was no mortality. Patients were extubated quickly and progressed well on the protocol. Immediate postoperative complications were generally minor and without long-term effects.

Published
2023
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