Anti-Pegfilgrastim ELISA Kit (DEIABL218)

Regulatory status: For research use only, not for use in diagnostic procedures.

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Size
2x96T
Sample
serum, plasma
Species Reactivity
human
Intended Use
The Anti-Pegfilgrastim ADA ELISA kit is a direct sandwich assay for the determination of antibodies against pegfilgrastim in serum and plasma samples. Assay is capable of detecting IgG, IgM and IgA antibodies specific to pegfilgrastim.
Storage
Store the unopened kit at 2-8°C.
Precision
Intra-assay precision (CV%): 9% - 18%. Inter-assay precision (CV%): 16%.
Detection Range
No significant interference was observed for up to 200 ng/mL of pegfilgrastim.
Detection Limit
143-208 ng/mL

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References


Phase II trial of docetaxel, bevacizumab, lenalidomide and prednisone in patients with metastatic castration-resistant prostate cancer

BJU INTERNATIONAL

Authors: Madan, Ravi A.; Karzai, Fatima H.; Ning, Yang-Min; Adesunloye, Bamidele A.; Huang, Xuan; Harold, Nancy; Couvillon, Anna; Chun, Guinevere; Cordes, Lisa; Sissung, Tristan; Beedie, Shaunna L.; Dawson, Nancy A.; Theoret, Marc R.; McLeod, David G.; Rosner, Inger; Trepel, Jane B.; Lee, Min-Jung; Tomita, Yusuke; Lee, Sunmin; Chen, Clara; Steinberg, Seth M.; Arlen, Philip M.; Gulley, James L.; Figg, William D.; Dahut, William L.

Objective To determine the safety and clinical efficacy of two anti-angiogenic agents, bevacizumab and lenalidomide, with docetaxel and prednisone. Patients and methods Eligible patients with metastatic castration-resistant prostate cancer enrolled in this open-label, phase II study of lenalidomide with bevacizumab (15 mg/kg), docetaxel (75 mg/m(2)) and prednisone (10 mg daily). Docetaxel and bevacizumab were administered on day 1 of a 3-week treatment cycle. To establish safety, lenalidomide dosing in this combination was escalated in a conventional 3 + 3 design (15, 20 and 25 mg daily for 2 weeks followed by 1 week off). Patients received supportive measures including prophylactic pegfilgrastim and enoxaparin. The primary endpoints were safety and clinical efficacy. Results A total of 63 patients enrolled in this trial. Toxicities were manageable with most common adverse events (AEs) being haematological, and were ascertained by weekly blood counts. Twenty-nine patients (46%) had grade 4 neutropenia, 20 (32%) had grade 3 anaemia and seven (11%) had grade 3 thrombocytopenia. Despite frequent neutropenia, serious infections were rare. Other common non-haematological grade 3 AEs included fatigue (10%) and diarrhoea (10%). Grade 2 AEs in > 10% of patients included anorexia, weight loss, constipation, osteonecrosis of the jaw, rash and dyspnoea. Of 61 evaluable patients, 57 (93%), 55 (90%) and 33 (54%) had PSA declines of > 30, > 50 and > 90%, respectively. Of the 29 evaluable patients, 24 (86%) had a confirmed radiographic partial response. The median times to progression and overall survival were 18.2 and 24.6 months, respectively. Conclusions With appropriate supportive measures, combination angiogenesis inhibition can be safely administered and potentially provide clinical benefit. These hypothesis-generating data would require randomized trials to confirm the findings.

FIRST PEGFILGRASTIM BIOSIMILAR APPROVED

AMERICAN JOURNAL OF NURSING

Authors: Aschenbrenner, Diane S.

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