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benefit. As an example, the demonstration of efficacy for G-CSF agents may include absolute neutrophil counts, CD34 + cell counts, the duration of severe neutropenia (neutrophils <500 cells/μL), and rates of febrile neutropenia. However, surrogates may be

DLTs of grade 3 fatigue and grade 4 febrile neutropenia. 25 Based on the DLT noted in this trial and other phase II data available that showed no difference in toxicity or efficacy between the 2 doses of pertuzumab, the recommended phase II doses were

, to overcome any hesitancy among clinicians about the efficacy and safety of biosimilars, the new agent must have adequate clinical data showing comparability to the established agents in reducing the risk of severe febrile neutropenia. In anticipation

years) had improved median PFS and RR but no improvement in median OS. 11 The most common grade 3 or higher AEs in the bevacizumab arm were neutropenia (26%), hypertension (7%), febrile neutropenia (5%), and bleeding events (4%). 9 Compared with

treated with docetaxel had significantly higher rates of febrile neutropenia and neuropathy, whereas in patients treated with carboplatin, vomiting appeared to be somewhat more common,” explained Dr. Telli. Furthermore, she said, “disappointingly, there

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

Kuderer N Greene J . The economics of febrile neutropenia: implications for the use of colony-stimulating factors . Eur J Cancer 1998 ; 34 : 1857 – 1864 . 17 Blay JY Chauvin F Le Cesne A . Early lymphopenia after cytotoxic

associated with a 5% improvement in modified PFS but also higher rates of febrile neutropenia and neuropathy. The FDA indication approval recommends growth factor support with BV‐AVD. 8 The other issue to consider with these regimens is cost. Because of the

for oncologic emergencies are identified, such as evolving risk stratification paradigms for febrile neutropenia, observation status will likely play an increasing role. 20 The NCI has identified the management of oncologic emergencies as an important

. Crawford J Wolff DA Culakova E . First cycle risk of severe and febrile neutropenia in cancer patients receiving systemic chemotherapy: results from a prospective nationwide study [Abstract] . Blood 2004 ; 104 : 607a – 608a . Abstract #2210 . 75