Log in to search using one of your social media accounts:


Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies.

Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies. Oncologist. 2018 Jan 09;: Authors: Harbeck N, Gascón P, Krendyukov A, Hoebel N, Gattu S, Blackwell K Abstract BACKGROUND: Evaluation of adverse events (AEs) in pivotal registration trials and ongoing postmarketing surveillance is important for all biologics, including biosimilars. A combined analysis of two pivotal registration studies was performed to strengthen evidence on safety for biosimilar filgrastim EP2006 in patients with breast cancer receiving myelosuppressive chemotherapy, a sensitive clinical setting to confirm biosimilarity of filgrastim. MATERIALS AND METHODS: Data were combined from two phase III studies of biosimilar filgrastim EP2006. The U.S. registration study was a randomized, double-blind comparison of biosimilar and reference filgrastim in women aged ≥18 years with breast cancer, receiving (neo)adjuvant treatment with TAC (docetaxel + doxorubicin + cyclophosphamide). The European Union registration study was a single-arm, open-label study of biosimilar filgrastim in women aged ≥18 years with breast cancer receiving doxorubicin + docetaxel. Patients received filgrastim as a subcutaneous injection on day 2 of each cycle for
Source: The Oncologist - Category: Cancer & Oncology Authors: Tags: Oncologist Source Type: research

Related Links:

Immunotherapy is a promising method of treatment for a number of cancers. Many of the curative results have been seen specifically in advanced-stage melanoma. Despite this, single-agent therapies are only successful in a small percentage of patients, and relapse is very common. As chemotherapy is becoming a thing of the past for treatment of melanoma, the combination of cellular therapies with immunotherapies appears to be on the rise in in-vivo models and in clinical trials. These forms of therapies include tumor-infiltrating lymphocytes, T-cell receptor, or chimeric antigen receptor-modified T cells, cytokines [interleuk...
Source: Melanoma Research - Category: Cancer & Oncology Tags: Review Article Source Type: research
In this study, we investigated TRAF3IP3 tumorigenic function. TRAF3IP3 protein was present in several cancer cell lines, with highest levels in melanoma. In addition, tumor microarray analysis on 23 primary melanoma and nine positive lymph nodes revealed that 70% of human primary melanoma and 66% of lymph node metastases were positive for TRAF3IP3. Importantly, TRAF3IP3 downregulation correlated with an 83% reduction of tumor growth in a subcutaneous xenograft mouse model (n=10, P=0.005). Immunohistochemistry analysis of the tumors revealed that TRAF3IP3-shRNA tumors had increased apoptosis (n=4, P
Source: Melanoma Research - Category: Cancer & Oncology Tags: ORIGINAL ARTICLES: Basic research Source Type: research
This study, the first to examine potential adverse health effects in users of vaginal estrogen compared with non-users, suggests that vaginal estrogen therapy is a safe treatment for genitourinary symptoms such as burning, discomfort, and pain during intercourse associated with menopause.AUTHORSThe paper ’s authors are Dr. Carolyn Crandall of UCLA; Kathleen Hovey of the State University of New York at Buffalo; Christopher Andrews of the University of Michigan; Dr. Rowan Chlebowski of City of Hope; Marcia Stefanick of Stanford University; Dr. Dorothy Lane of the State University of New York at Ston y Brook; Dr. Jan Sh...
Source: UCLA Newsroom: Health Sciences - Category: Universities & Medical Training Source Type: news
We report on a 42-year-old woman who was diagnosed with recurrent breast cancer that was detected due to the presence of PTTM. Eleven months after surgery for heterochronous bilateral cancer of the left breast, she developed progressive dyspnea but computerized tomography showed no pulmonary thromboembolism, and a transthoracic echocardiography revealed mild pulmonary hypertension. She was diagnosed with PTTM by cytology from pulmonary artery catheterization and perfusion lung scintigraphy. Also, the patients complained of back pain after admission, bone scintigraphy showed multiple bone metastases. Despite the early diagn...
Source: Case Reports in Oncology - Category: Cancer & Oncology Source Type: research
I first met her in the urgent care at the cancer center when I was on call one night. She was beautiful: 53 years old, four adult sons, and in incredible pain. She had stage 4 breast cancer, and unbeknownst to her, she had a metastatic lesion in her femoral neck, which she had fractured about four weeks ago. But she’d just had a spine operation for mets in her lumbar vertebral bodies a month before that, so she thought it was a complication of surgery. Like the pulmonary embolism she’d had. She squirmed and winced on the bed, clearly uncomfortable, but she had it; as an intern, my chief resident called it spark...
Source: Kevin, M.D. - Medical Weblog - Category: Journals (General) Authors: Tags: Physician Cancer Source Type: blogs
MedTech Innovator, the medtech industry’s annual start-up competition and virtual accelerator, has just announced their 20 semi-finalists. 430 companies from around the globe applied for these coveted spots, and were reviewed by 90 reviewe...
Source: Medgadget - Category: Medical Equipment Authors: Tags: Exclusive News Source Type: blogs
The approval of first-of-a-kind drugs rose last year to forty-one, resulting in the highest level of newly approved U.S. drugs in nineteen years. The total number of new drugs approved last year was even higher at sixty-nine. The rising figures reflect an industry-wide desire to research and develop drugs for rare and hard-to-treat diseases. The newly approved drugs serve to advance medical care and the health of patients suffering from many ailments, including various forms of cancer, heart failure, and cystic fibrosis. Additionally, more than 40% of the new therapies were approved for treatment of rare or "orphan&...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs
A key element of the palliative care of cancer patients is the management of chronic pain [1]. Opioids continue to be a mainstay in the management of cancer pain in all treatment guidelines [2], and morphine is regarded as the “gold standard” [3–6]. Considered as broad-spectrum analgesics, opioids have multiple side effects and potential complications [7]. Our previous studies indicated that morphine treatment is associated with subdural hemorrhage [8], pulmonary embolism [9], and acute coronary syndrome [10] in cancer patients, as well as increased stroke incidence in prostate cancer patients [11].
Source: Diabetes Research and Clinical Practice - Category: Endocrinology Authors: Source Type: research
CONCLUSION: The tolerability rate of a dose-density regimen with FEC followed by weekly paclitaxel was considered not promising for completing the accrual of this study. PMID: 25637379 [PubMed - as supplied by publisher]
Source: The Oncologist - Category: Cancer & Oncology Authors: Tags: Oncologist Source Type: research
A 60-year-old woman with breast cancer with brain and bone metastases presented to the emergency department with complaints of cough, progressive dyspnea, and hemoptysis. Initial vitals signs revealed a heart rate of 80 beats/min, respiratory rate of 26 breaths/min, blood pressure of 120/80 mm Hg, and room air pulse oxygenation of 88%. The patient also noted pain and swelling in her right lower extremity. When measured, the right lower extremity had a 4 cm greater diameter compared to the left. Because of the leg swelling, dyspnea, tachypnea, and an electrocardiogram (ECG) showing right heart strain, a transthoracic echoca...
Source: The Journal of Emergency Medicine - Category: Emergency Medicine Authors: Tags: Visual Diagnosis in Emergency Medicine Source Type: research
More News: Breast Cancer | Cancer | Cancer & Oncology | Chemotherapy | Docetaxel | Filgrastim | Neulasta | Neupogen | Pain | Pulmonary Thromboembolism | Study | Taxotere | Women