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The Role of Biosimilars

Andrew D. Zelenetz and Pamela S. Becker

indications as filgrastim: to treat patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia (FN); patients with acute myeloid leukemia receiving induction or

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Neutrophil Biology and the Next Generation of Myeloid Growth Factors

David C. Dale

Ozer H Stoller R . Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer . N Engl J Med 1991 ; 325 : 164 – 170 . 13 Pettengell R Gurney H Radford JA

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CLO22-081: Clinical Efficacy and Quality of Life of Oral Cancer Patients Treated With Paclitaxel/Cisplatin/5-FU Vs Paclitaxel/Carboplatin Chemotherapeutic Regimens in a Tertiary Cancer Center in Eastern India

Pranab Kumar Sahoo, Sinjini Sarkar, Sutapa Mahata, Ranita Pal, Tanuma Mistry, Sushmita Ghosh, Trisha Choudhury, Sriparna Datta, Anup Kumar Bhowmick, Kalyan Kusum Mukherjee, and Vilas D Nasare

toxicities like anaemia (13.3%) followed by neutropenia (2.4%) and thrombocytopenia (2.4%) whereas non-hematological toxicities include diarrhoea (30.5%), vomiting (26.6%), fever (23.1%), myalgia (19.7%) and mucositis (5.41%). 82 (40.39%) patients succumbed

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CLO20-053: Plinabulin, a Potent Inducer of Haptoglobin Production for the Prevention of Tissue Iron Overload in Patients Receiving Blood Transfusions Chronically

Ramon Mohanlal and Lan Huang

-106 (NCT03294577) with the small molecule immune modulator Plinabulin (Plin) for the prevention of chemotherapy-induced neutropenia (CIN), we unexpectedly observed an increase in plasma Hp levels with Plin. The positive CIN data this trial was reported

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CLO22-088: Phase II Trial of Trifluridine/Tipiracil in Combination With Irinotecan in Advanced Biliary Tract Cancers (BTCs)

Sri Harsha Tella, Jaclynn Wessling, Foster Nathan, Shi Qian, Tran Nguyen, Robert McWillimas, Alberts Steven, Minetta Liu, Mitesh Borad, Wen Wee Ma, Mindy Hartgers, Leslie Washburn, Fruth Briant, Martin Fernandezzapico, Tara L Hogenson, Henry Pitot, Zhaohui Jin, and Amit Mahipal

endpoint. The ORR and DCR were 20% and 45%, respectively. Median OS was 52.6 weeks (95% CI: 33.6-NE). The most common grade 3/4 toxicities were neutropenia (29%), lymphopenia (15%), hypertension (15%), thrombocytopenia (11%), elevated alkaline phosphatase

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YIA24-003: A Phase I Study of TAS102 Plus Talazoparib in Advanced Colorectal (CRC) and Esophagogastric (EGC) Adenocarcinomas

Christos Fountzilas, Agnieszka Witkiewicz, Sarah Chatley, Victoria Fitzpatrick, Justin Zonneville, Mohammed Alruwaili, Hanna Rosenheck, Donald Mager, Jianxin Wang, Anuradha Krishnamurthy, Benjamin Switzer, Kristopher Attwood, Igor Puzanov, Renuka Iyer, and Andrei Bakin

and 1 EGC pts; DL1 TALA 0.5 mg: 4 pts, DL2 TALA 0.75 mg: 5 pts, DL3 TALA 1 mg: 5 pts). We are currently enrolling patients in DL3. There are no major toxicity signals to this date. There was one dose-limiting toxicity (DLT, grade 4 neutropenia) in DL1

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Navigating the Challenges: Effective Management of Toxicities in CAR T-Cell Therapies

Presented by: Olalekan O. Oluwole and Salyka Sengsayadeth

infection. Dr. Oluwole discussed recommendations for treatment of late effects of therapy, including neutropenia (grade ≥3), anemia (grade ≥3), and thrombocytopenia. For severe neutropenia, granulocyte colony-stimulating factors (G-CSF) are recommended

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CLO20-054: A Phase 2 Trial of Nivolumab and Temozolomide in Advanced Neuroendocrine Tumors (NETs): Interim Efficacy Analysis

Dwight H. Owen, Lai Wei, Ashima Goyal, Ye Zhou, Sheryl-Ann Suffren, Rajani Jacob, Carly Pilcher, Gregory A. Otterson, Claire F. Verschraegen, Manisha H. Shah, and Bhavana Konda

-free survival and overall survival data are not mature. Serious adverse events occurred in 4 patients - one patient had grade 3 bronchopulmonary hemorrhage, 3 patients had grade 4 neutropenia and/or thrombocytopenia. There were no treatment-related deaths

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CLO20-066: Comparative Efficacy, Safety and Acceptability of Single-Agent Poly (ADP-ribose) Polymerase (PARP) Inhibitors in BRCA Mutated HER2-Negative Metastatic or Advanced Breast Cancer: A Network Meta-Analysis

Ju Wang, Ye Zhang, Long Yuan, Lin Ren, Yi Zhang, and Xiaowei Qi

any grade (OR=0.37, 95% CrI=0.02-6.81). In addition, Olaparib also showed a low risk of neutropenia for adverse events of 3-4 grade (OR=0.57, 95% CrI=0.06-5.75) compared with Talazoparib. Both Talazoparib and Olaparib were not associated with high risk

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Will Biosimilars Gain Momentum?

Bradford R. Hirsch and Gary H. Lyman

recombinant human G-CSF made by a subsidiary of Teva Pharmaceuticals that has been approved by the FDA, because the agent has been shown to reduce the duration of severe neutropenia in patients with nonmyeloid malignancies undergoing cancer chemotherapy