Phase II Randomized Study of Dose-Dense Docetaxel and Cisplatin Every 2 Weeks With Pegfilgrastim and Darbepoetin Alfa With and Without the Chemoprotector BNP7787 in Patients With Advanced Non-small Cell Lung Cancer (CALGB 30303)

Miller, Antonius A.; Wang, Xiaofei F.; Gu, Lin; Khatri, Jamil; Dunphy, Frank; Edelman, Martin J.; Bolger, Michael J.; Vokes, Everett E.; Green, Mark R.

doi:10.1097/jto.0b013e318186fb0d

Cited by 16 publications

(14 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In this study, dose-dense chemotherapy was associated with high degree of treatment related toxicities and a response rate lower than that observed in a prior multi-institutional study (1). This limits interest in future studies utilizing the dose-dense cisplatin and docetaxel regimen for unselected patients.…”

Section: Discussioncontrasting

confidence: 66%

See 1 more Smart Citation

Phase II trial of dose-dense chemotherapy followed by dose-intense erlotinib for patients with newly diagnosed metastatic non-small cell lung cancer

Petty

Laudadio

Brautnick

et al. 2013

International Journal of Oncology

Self Cite

View full text Add to dashboard Cite

This phase II study investigated dose-intense erlotinib maintenance after dose-dense chemotherapy for patients with metastatic non-small cell lung cancer and examined two cell cycle biomarkers. Patients with newly diagnosed metastatic non-small cell lung cancer received docetaxel 75 mg/m2 and cisplatin 75 mg/m2 on day 1 and pegfilgrastim on day 2 every 14 days for four cycles. Patients then received erlotinib with initial doses based on smoking status. Doses were increased in 75 mg increments every two weeks depending on toxicities until each patient's maximal tolerable dose (MTD) was achieved. Cyclin D1 and D3 biomarkers were measured by immunohistochemistry. The objectives of the study were to evaluate time to progression (TTP) and overall survival (OS) for the entire population and biomarker subgroups. Forty-five patients were enrolled. Intra-patient erlotinib MTD ranged from 0 to 525 mg. Median MTD achieved in smokers was higher than in non-smokers (300 vs. 150 mg; P=0.019). TTP for the entire cohort was not significantly improved compared to historical controls. Patients with high cyclin D1 expressing tumors demonstrated improved TTP on erlotinib (8.2 vs. 4.7 months; hazard ratio, 4.1; 95% CI, 1.6–0.6; P=0.003) and improved OS (20.5 vs. 8.0 months; hazard ratio 2.8; 95% CI, 1.2–6.3; P=0.016). Intratumoral cyclin D3 expression did not impact clinical outcomes. Current smokers but not former smokers exhibit a higher erlotinib MTD. High cyclin D1 expression was associated with favorable TTP and OS.

show abstract

Section: Discussioncontrasting

confidence: 66%

“…Dose-dense docetaxel and cisplatin was previously investigated as a first line treatment for patients with metastatic non-small cell lung cancer (1). The toxicities included significant neuropathy, nausea and dehydration.…”

Section: Introductionmentioning

confidence: 99%

Phase II trial of dose-dense chemotherapy followed by dose-intense erlotinib for patients with newly diagnosed metastatic non-small cell lung cancer

Petty

Laudadio

Brautnick

et al. 2013

International Journal of Oncology

Self Cite

View full text Add to dashboard Cite

show abstract

“…The results of this meta-analysis are supported by a number of individual pegfilgrastim studies [82,83,84,85,86,87,88]. A fixed pegfilgrastim 6-mg dose provided sufficient neutrophilic support to patients with breast cancer or other malignancies receiving dose-dense chemotherapy regimens (typically using one dose of pegfilgrastim in each 2-week chemotherapy cycle) [83,84,85,86,88]. The use of pegfilgrastim or other G-CSF agents has also been shown to facilitate maintenance of chemotherapy dose intensity in elderly patients [89,90,91].…”

Section: Chemotherapy-induced Neutropenia Managementmentioning

confidence: 50%

“…In an analysis of several clinical trials using various G-CSF agents, maintenance of the planned relative dose intensity was associated with G-CSF use [8]. The results of this meta-analysis are supported by a number of individual pegfilgrastim studies [82,83,84,85,86,87,88]. A fixed pegfilgrastim 6-mg dose provided sufficient neutrophilic support to patients with breast cancer or other malignancies receiving dose-dense chemotherapy regimens (typically using one dose of pegfilgrastim in each 2-week chemotherapy cycle) [83,84,85,86,88].…”

Section: Chemotherapy-induced Neutropenia Managementmentioning

confidence: 61%

Prevention of Chemotherapy-Induced Neutropenia with Pegfilgrastim: Pharmacokinetics and Patient Outcomes

2012

View full text Add to dashboard Cite

Patients receiving cytotoxic chemotherapy are at risk for developing chemotherapy-induced neutropenia (CIN). Filgrastim, a recombinant granulocyte colony-stimulating factor (G-CSF) that stimulates the proliferation, differentiation and function of neutrophils, is approved for the prevention of CIN. To eliminate the burden of daily filgrastim injection, pegfilgrastim, a long-acting form of filgrastim, was developed by covalently attaching a 20-kDa polyethylene glycol molecule to filgrastim to increase molecular size and thus reduce renal elimination. Consequently, neutrophil-mediated clearance is the primary mechanism for pegfilgrastim elimination. Therefore, after a single pegfilgrastim injection following chemotherapy treatment, pegfilgrastim concentration is sustained during neutropenia and decreases with neutrophil recovery. Pegfilgrastim has received marketing authorization approval from many regions to reduce the incidence of CIN based on the similar efficacy and safety of a single injection of 6 mg of pegfilgrastim administered once per chemotherapy cycle and 10 to 11 daily injections of filgrastim at 5 µg/kg. The efficient self-regulating clearance of pegfilgrastim allows administration once per chemotherapy cycle, thereby providing a more convenient treatment regimen than filgrastim.

show abstract

“…Alternatively, it may be that the incidence of severe neutropenia was significantly higher in the study arm using longlasting G-CSF in 2-weekly chemotherapy protocols as compared to study arms using short-acting G-CSF in 2-weekly protocols or as compared to the study arms using pegfilgrastim in 3-weekly chemotherapy protocols. Although in most studies investigating dose-dense protocols these questions were not specifically addressed, these trials could demonstrate the safe and effective use of pegfilgrastim to support a variety of chemotherapy regimens with 14-day intervals for the treatment of early stage breast cancer [29][30][31][32][33][34][35][36][37][38][39], small cell lung cancer [40,41], non-small cell lung cancer [42], non-Hodgkin's lymphoma [43,44], Hodgkin's disease [45] and gastric cancer [46]. In none of these trials was there evidence for a potential detrimental effect on neutropoiesis with the use of long-lasting G-CSF.…”

Section: Use Of Long-acting Growth Factors In Dose-dense Chemotherapymentioning

confidence: 99%

How Safe Is the Administration of Long-Acting Granulocyte Colony-Stimulating Factor in Cancer Patients?

2018

View full text Add to dashboard Cite

Long-acting granulocyte colony-stimulating factor (G-CSF) preparations are increasingly used in the management of chemotherapy-associated neutropenia. Due to the fact that they only need to be administered once following chemotherapy, they are more convenient for patients and easier to use in the clinical routine for physicians than short-term G-CSF preparations. Although the efficacy of these growth factors is generally accepted, there remains some concern regarding their safety. In this article we address safety concerns for long-acting growth factors by providing basic information and available data around important clinical issues that may be helpful for the decision to use or not to use these factors in individual clinical situations. After a critical review of the literature, regarding theoretical considerations based on the physiology of hematopoiesis, data from clinical studies show that long-acting G-CSF preparations can be applied safely in approved indications and are broadly beneficial for patients at risk undergoing chemotherapy.

show abstract

Phase II Randomized Study of Dose-Dense Docetaxel and Cisplatin Every 2 Weeks With Pegfilgrastim and Darbepoetin Alfa With and Without the Chemoprotector BNP7787 in Patients With Advanced Non-small Cell Lung Cancer (CALGB 30303)

Abstract: This dose-dense treatment regimen is active, feasible, and tolerable. Its further investigation in the curative setting in non-small cell lung cancer should be considered. BNP7787 did not result in significant protection from neurotoxicity.

Cited by 16 publications

References 23 publications

Phase II trial of dose-dense chemotherapy followed by dose-intense erlotinib for patients with newly diagnosed metastatic non-small cell lung cancer

Phase II trial of dose-dense chemotherapy followed by dose-intense erlotinib for patients with newly diagnosed metastatic non-small cell lung cancer

Prevention of Chemotherapy-Induced Neutropenia with Pegfilgrastim: Pharmacokinetics and Patient Outcomes

How Safe Is the Administration of Long-Acting Granulocyte Colony-Stimulating Factor in Cancer Patients?

Contact Info

Product

Resources

About