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Evidence-Based Oncology July 2017
Daratumumab With Standard Regimen Improves PFS, ORR Independent of Cytogenetic Risk in Multiple Myeloma
Surabhi Dangi-Garimella, PhD
Phase 1 Study Results at ASCO Support First-Line Use of Daratumumab in Multiple Myeloma
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Daratumumab-Based Combination Effective in Relapsed/Refractory Multiple Myeloma, Short PFS in Heavily Pretreated Patients
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Patient Selection Vital in Ensuring Improved Response to PD-1, PD-L1 Inhibitors in NSCLC
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An Early Stage Safety, Efficacy Study for Atezolizumab Plus Daratumumab in Advanced NSCLC
Surabhi Dangi-Garimella, PhD
LDH Levels Could Predict irAEs Associated With Checkpoint Inhibition and Radiotherapy in Lung Cancer
Surabhi Dangi-Garimella, PhD
Alectinib May Be a New Standard of Care for Treatment-Naïve ALK-Positive NSCLC
AJMC Staff
Dacomitinib a New First-Line Option for Advanced EGFR MutationŚPositive NSCLC
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Androgen Deprivation, With or Without Radiotherapy, New Standard of Care in High-Risk Prostate Cancer
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Trabectedin and Lurbinectedin Effective in BRCA2-Associated Metastatic Breast Cancer
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HPV Vaccination May Lower Prevalence of Oropharyngeal Cancers in Young Adults
Surabhi Dangi-Garimella, PhD
Physical Activity, Healthy Diet Improve Survival in Colorectal Cancer: Study at ASCO
Surabhi Dangi-Garimella, PhD
Three Months of Oxaliplatin-Based Adjuvant Therapy Noninferior to 6 Months in Stage III Colon Cancer
AJMC Staff
Fas Biomarker Can Predict Response to Second-Line Therapy for Advanced Soft Tissue Sarcoma
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Nivolumab, Alone or With Ipilimumab, Met the Disease Control Rate in Malignant Pleural Mesothelioma
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Ibrutinib vs No Consolidation Are Being Compared Following Autologous HSCT in IRONCLAD Trial
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Web-Based Patient Reporting of Symptoms Shown to Improve Survival in Patients With Metastatic Solid Tumors
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Physician, Regulatory, and Payer Perspectives on the Value of Real-World Data
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Do We Have Adequate Surveillance in Cancer Care?
Surabhi Dangi-Garimella, PhD
MACRA 2.0 and Beyond: Preparing Your Practice to Meet the Quality and Reporting Challenges
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ASCO Study Finds Shift in Diagnosis Stage for Several Cancers Following ACA Implementation
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Currently Reading
Switching Study Reports Equivalence Between Filgrastim, Biosimilar in Breast Cancer
Surabhi Dangi-Garimella, PhD
CT-P6, a Trastuzumab Biosimilar, Shares the Safety and Efficacy Profile of Its Reference
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Can the 4 Ps Devise Interventions to Reduce the Financial Toxicity of Cancer?
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Adjuvant Chemotherapy Reduces Cost, Improves Survival in NSCLC Post-Surgery
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Brazilian Study Queries: Is NGS Cost-Effective in Advanced Lung Cancer?
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SEER-Medicare Database Analysis Notes Higher Resource Utilization Among Patients With Neuroendocrine Tumors
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Switching Study Reports Equivalence Between Filgrastim, Biosimilar in Breast Cancer

Surabhi Dangi-Garimella, PhD
After switching studies, research in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy has found clinical equivalence between filgrastim and its biosimilar, according to results presented at the 2017 Annual Meeting of the American Society of Clinical Oncology.
A PHASE 3, RANDOMIZED, double-blind registration study in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy has found clinical equivalence between filgrastim and its biosimilar after switching studies. The study results were presented during a poster session at the 2017 Annual Meeting of the American Society of Clinical Oncology.

In 2016, Filgrastim EP2006 (Zarxio) became the first biosimilar approved by the FDA for commercial use in the United States.1 The current phase 3 study compared the impact of switching the reference product with the biosimilar and the biosimilar with the reference product in the said patient population.

The 218 German patients receiving 5 μg/kg/day filgrastim over 6 chemotherapy cycles were randomized equally into 4 arms: 2 arms received only 1 product each, either the biosimilar or the reference (unswitched), and 2 arms (switched) received alternating treatments every other cycle (the biosimilar first then reference or vice versa, over cycles 1 to 6). Four patients did not receive treatment: 2 in the reference group, 1 in the switched group, and 1 in the biosimilar group.

A total of 107 patients switched treatment, and 51 patients received the reference drug in all cycles. The incidence of febrile neutropenia (FN) was 3.4% (switched) versus 0% (reference) (95% CI, –9.65% to 4.96%). Infections occurred in 9.3% of the switched cohort compared with 9.9% in the reference cohort. Hospitalization due to FN was low, with 1 patient in cycle 6 (switched).

Treatment emergent adverse events (TEAEs) related to filgrastim were reported in 42.1% of patients in the switched cohort versus 39.2% of reference patients (throughout all cycles). The most frequent TEAEs were musculoskeletal/connective tissue disorders related to filgrastim, which occurred in 35.5% (switched) compared with 39.2% (reference) (all cycles) of patients. These events included bone pain (30.8% vs 33.3%).

No neutralizing or clinically relevant antibodies against recombinant human granulocyte-colony stimulating factor were detected post dose while switching from the reference product to the biosimilar and vice versa. The authors concluded that there was no evidence of clinically meaningful differences related to efficacy, safety, or immunogenicity when patients with breast cancer were switched from reference to biosimilar filgrastim or from biosimilar to reference filgrastim.
REFERENCE

1. Joszt L. FDA approves first biosimilar in US. The American Journal of Managed Care® website. ajmc.com/newsroom/FDA-Approves-First-Biosimilar-in-US. Published March 6, 2015. Accessed June 3, 2017.
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