4 results on '"I. Amanam"'
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2. Lower tumor mutational burden (TMB) and hepatic metastases may predict for lack of response to PD-1 blockade in MSI-H metastatic colorectal cancer (MCRC)
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Marwan Fakih, S. Rahmanuddin, Janelle Saluja, D. Lim, S.M. Ali, Alexa B. Schrock, E. Harris, I. Amanam, Chongkai Wang, Joseph Chao, Dawnyel Chevalier, and Cecilia Lau
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0301 basic medicine ,Colorectal cancer ,business.industry ,Hematology ,medicine.disease ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,Oncology ,030220 oncology & carcinogenesis ,Cancer research ,medicine ,Pd 1 blockade ,business - Published
- 2018
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3. Risk of Major Bleeding in Cancer Patients Receiving Chemotherapy
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J. Kim, M. Naghiby Sustany, Connie Chen, A. Ruiz-Valdepeñas, S. Perrin, A. Chaslerie, C. Terret, Nichole Young-Lin, K. Kim, H. Hoeffkes, M. Carvalho-Verlinde, L.C. Park, M. Kroez, Omneya Hassanain, T. van Gelder, L. Xiong, T.K. Kiet, S. Dacosta Byfield, J. Goswami, C.K. Bose, H. Bourgeois, J. Metges, A. Fani Pakdel, L. Marelli, Y. Lou, D.S. Kapp, S. Bercier, E. Lugatti, A. Costantini, R.P. Riechelmann, S. Patel, Q. Dong, J. Finek, H. Ghazal, K. Chatterjee, B. Chatterjee, G. Fasola, Z. Hu, E. Minvielle, S. J. Mukhopadhyay, W.K. Redekop, S. Abouelnaga, J.K. Chan, P. Pronzato, R. Laporta, J.H. Zong, Gary H. Lyman, M. Ghielmini, D.H.S. Brundel, A. Zimmermann, Jun Suk Kim, R. Barroso-Sousa, J. Ma, P.M. Hoff, W. Baumann, S. Banerjee, U.R. Kleeberg, François Lemare, F.K. Tauchert, M. Hipp, C. Atchison, Y. Tang, J. Menis, C. Locher, B. Cantos, S. Nawrocki, L. Zhang, E. De Droogh, M. Irwin, P. Das, G.A.M.S. (Guus) van Dongen, S.K. Sarkar, A. Olaverri Hernandez, R.W.F. van Leeuwen, G. Hebert, P. Martin Martorell, F.G.A. Jansman, A. Fourcade, B.K. Mohanti, H.J. Conter, G. Streich, J. Piquet, G. Iacono, P. Bycott, C. Bighin, C. Pedrazzani, A. Carrato, JA Santiago Crespo, A. Baitar, S. Pizzolitto, D. Debieuvre, O. Gunther, T. Collon, E. Jaeger, B. Han, I. Duran, L. Testa, M. Lambertini, J. Gutsch, J.W. Lee, D. Galdermans, S. Negrier, D. Mauri, N. Nakayama, K. Veerabudun, T. Teague, G. Spahn, M. Jofre-Bonet, Z. Brixi, M. Maglakelidze, H. Li, R. Ferreira, H. Ryu, R. Zaim, L.H. Martinez, D. Lorusso, R. Cardiga, J. Liu, F. Poggio, C. Herbstreit, M. Rezazadeh, R. von Moos, J. Pivette, J. Mebis, F. Ceia, A. Ohtsu, A. Le Thuaut, F. Blanchon, M. Weber, V. Tozzi, F. van Fraeyenhove, A.C.R.C. Ferrari, D-W. Ye, D. Pastorelli, M. Gaiardo, L. Gurrieri, S. Al-Batran, R. Eckert, A. Happe, L. Del Mastro, M.V. Karamouzis, W. Hwu, R. Li, A. Zhou, V. Petry Helena, C. Neef, J.R. Puyol, M. Laurent, C. Ortega Ruiperez, G. D'Addario, C. Fonseca, R. de Bree, M. Zaegel, M. Provencio Pulla, Sabine Tejpar, G. Rosti, L. De Fiore, Y.J. Choi, M. Fink, E. Terpos, M. Precivale, T.K. Takahashi, Tetsuji Takayama, David M. Burger, J. Feliu, M. Debus, K. Tamas, C.A. Uyl-de Groot, A. Voigt, C. Fu, E. Molinas, C. Maximiano, L. Eckert, C.O. Ruiperez, D. Bertwistle, T. Mossman, A. De Maria, C.T. Carvalho, V. Raina, C. Guillen-Ponce, H. Matthes, Arijit Mukhopadhyay, M. Muñoz Sanchez, G.M. Bariani, D. Pérez Callejo, J. Lebreton, D. Hoth, Florence Netzer, E. Liuu, A. Leitão, P. Ussetti, A. Gu, A.C. Palozzo, N. Maniadakis, Sameera Ezzat, L.G. Fonseca, E. Bria, A.T. Cohen, E.J. Batagelj, T. Yoshino, M. Sabry, A. Jirillo, N. Papadopolous, N. Cherny, I. Amanam, M. Tettamanti, J. Axtner, M.S. Mano, P. Rescigno, D. Conter, T. Tanase, S.K. Mondal, M. Blanco Villalba, Sung Heon Kim, G. Lanzetta, M. Palka, F. Schad, A. Small, D. Lueftner, R. Arai, O. Mora, Jayasri Basak, S. Piau, A. Mahmood, M. Mendez Garcia, D. Romeira, A.M. Martins, S. Schmitz, Y. Huang, S. Imbevaro, N. Marschner, Svs Deo, Ron H.J. Mathijssen, E. Meszko, F. Lobo, E. Ferrat, F. Martin, Johan Vansteenkiste, M. Molina-Garido, M.P. Mak, R.E. Buschmann-Maiworm, I. Bourlaud, A. Bedikian, Ahmad S. Alfaar, R. De Paula Costa, T. Denda, P. Anderson, J. Quidde, J. Lake, Ajay Gogia, M. Grivaux, S-H Lee, S. Vlassak, M.P. Bramajo, C. El Kouri, P. Quadri, Young-Suk Park, P. Donny, S. Gangopadhyay, A. Follador, Francesca Valent, W.S. Dai, E. Almagro Casado, S. Giraudi, J. Guo, A. Pini, M.P. Trojniak, R. Curca, M. Proença, Mohamed Kamal, M. Le Poulain-Doubliez, A. D'Alonzo, J. Pereira, N. Jokhadze, M. Di Maio, H. Hoefeler, C. Rossetto, C. Reyes, C. Hamada, E. Paillaud, Josep Tabernero, R. Gagua, C. Attali, H. Sleeboom, A. Vandebroek, G. Hechmati, J. Body, R. Wei, S. Culine, Fortunato Ciardiello, Robert A. Wolff, R. Hofheinz, P. Caillet, M.L. Gomez, Michel Ducreux, M. Rucinska, P. Hwu, A. Bahl, W. Chang, J. Douillard, Hirofumi Fujii, A. Kieszkowska-Grudny, M. Alface, F. Grude, B.J. Monk, F. Canouï-Poitrine, Nootan Kumar Shukla, A. Levaggi, D. Schrijvers, M. Urbanski, S. Rauh, and S. Bastuji-Garin
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Chemotherapy ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Stomach ,Incidence (epidemiology) ,Rectum ,Cancer ,Retrospective cohort study ,Hematology ,medicine.disease ,medicine.anatomical_structure ,Oncology ,Internal medicine ,Cohort ,medicine ,Ovarian cancer ,business - Abstract
Cancer patients receiving chemotherapy are at increased risk of venous thromboembolism (VTE). The presence of cancer and anticoagulant use are risk factors for bleeding, yet data on bleeding risk are limited in these patients. This analysis evaluated the risk of major bleeding in cancer patients receiving chemotherapy using a US claims database. This retrospective cohort study used the MarketScan® databases, a nationwide database containing data from about 100 payers and covering > 30 million patients annually. Adult cancer patients receiving chemotherapy within 6 months of cancer diagnosis between January 2004 and December 2010 were included. Cancers of interest were: lung, colon/rectum, pancreas, bladder, stomach, and ovary. The index date was the first date of chemotherapy. Patients were followed until the earliest of: 1) first diagnosis of major bleeding; 2) termination of enrolment in the health plan; 3) end of study. The primary outcome was the first occurrence of major bleeding, based on selected ICD-9-CM/CPT codes, following chemotherapy initiation. Of 74,575 patients identified, exclusion of those with prior history of bleeding at baseline (∼5%) resulted in 70,822 patients included in the analysis. Mean age was 62 years, 37% were ≥ 65 years, and 52% were male. Average time of follow up and chemotherapy were 14.3 and 8.6 months, respectively; 6% had a history of VTE within 6 months prior to the index date. Major bleeding occurred in 5.8% of patients and the incidence rate for all cancers combined was 4.9 per 100 person-year (PY) and 10.5, 9.3, 6.2, 4.3, 3.6, and 3.3/100 PY for pancreatic, stomach, lung, bladder, colon/rectum, and ovarian cancer, respectively. Approximately 14% of patients (N = 10,456) developed VTE after chemotherapy initiation (> half in the first 3 months of chemotherapy treatment). Of these, 7.8% experienced major bleeding with incidence rates ranging from 5.9-17.7/100 PY after VTE. Major bleeding incidence in cancer patients receiving chemotherapy varies by cancer type with the highest rates in patients with upper gastrointestinal cancer. Compared to the overall cohort, major bleeding risk was higher in cancer patients who developed VTE. Disclosure J.H. Zong: Employee of Sanofi. L. Eckert: Employee of Sanofi. L. Zhang: Employee of Sanofi. W.S. Dai: Employee of Sanofi. A.T. Cohen: Consult: Astellas, AZ, Bayer, BI, BMS, Daiichi, GSK, JJ ResFund: AZ, Bayer, BI, BMS, Daiichi, GSK, JJ BoardSpeakerAdvis comm: Bayer, BI, BMS, Daiichi, GSK, J&J, Mitsubishi, Pfizer, Sanofi. All other authors have declared no conflicts of interest.
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- 2012
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4. Progress and Trends for Cancer Drug Approval – an Analysis of FDA Advisory Committee
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Bradley J. Monk, John K. Chan, Nichole Young-Lin, Tuyen K. Kiet, Daniel S. Kapp, D. Hoth, and I. Amanam
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Drug ,medicine.medical_specialty ,business.industry ,Advisory committee ,media_common.quotation_subject ,Cancer drugs ,Hazard ratio ,Hematology ,Clinical trial ,Oncology ,Internal medicine ,Toxicity ,Clinical endpoint ,Medicine ,Oncology drug ,business ,media_common - Abstract
Objectives To evaluate the progress and trends for cancer drug approval over the last decade. Methods From 2001 to 2011, applications from (Oncologic Drug Advisory committees) ODAC session were reviewed. Results Of 46 applications, 34 (74%) involved solid and 12 (26%) hematologic tumors. These drugs were for leukemia (n = 8, 17%), lymphoma (n = 8, 17%), breast (n = 5, 11%), prostate (n = 5, 11%), and others (n = 20, 44%). 30 (65%) were phase III and 16 (35%) were phase II trials. 67% (n = 31) were full applications and 33% (n = 15) were for accelerated approval. 22 (48%) drugs were not approved with most common concerns being: missing or inadequate data (65%), excessive toxicity (55%) and inappropriate study endpoints (45%). 19 applications used hazard ratios (HR), (median = 0.67) and 18 used response rates (RR) (median = 0.42%). In a predictive model combining efficacy and toxicity, drugs with lower HR or higher RR with lower toxicity were more likely to be approved vs. other drugs (89% vs. 46%; p = 0.025). We then divided applications into 3 periods with their corresponding approval rates: 2001-2004 (n = 11; 55%), 2005-2008 (n = 12; 50%), and 2009-2011 (n = 23; 53%). Over time, there was a significant increase in the proportion of applications using progression-free survival as an endpoint (0% to 50% to 70%; p = 0.01). Conclusion In this analysis of oncology drug applications, our model employing hazard ratio and toxicity correlates with a high rate of approval. The most common concerns of the rejected applications involved missing or inadequate data, excessive toxicity, and inadequate study endpoints. Clinical researchers need to consider these FDA recommendations in the future design of clinical trials. Disclosure All authors have declared no conflicts of interest.
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- 2012
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