The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with breast cancer. The trials are investigating cancer risk based on breast density; novel imaging techniques; fasting and chemotherapy; radiosurgery; lymph node dissection; ...
When David G. Nathan, MD, was admitted to Harvard University in 1947, he had every intention of becoming an English professor. It was only his lack of writing talent that dissuaded him from a life in the classroom and propelled him into a medical career that has spanned more than 5 decades and has...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On September 22, 2015, trifluridine/tipiracil (Lonsurf) was...
California’s Stem Cell Agency (CIRM) has awarded $19.9 million to ImmunoCellular Therapeutics to carry out a phase III clinical trial in patients with newly diagnosed glioblastoma using an immunotherapeutic vaccine. “This kind of deadly disease is precisely why we created CIRM 2.0, our new...
Based on preclinical (in vitro and in vivo) data, there is a strong biologic rationale for the addition of an antiangiogenic drug strategy in the treatment of epithelial ovarian cancer.1 Single-agent trials have confirmed both the biologic and clinical activity of bevacizumab (Avastin) in the...
Final overall survival results of the phase III ICON7 trial reported in The Lancet Oncology by Amit M. Oza, MD, and colleagues indicate no significant improvement with the addition of bevacizumab (Avastin) to standard chemotherapy in women with newly diagnosed ovarian cancer.1 However, an overall...
Lung cancer is the most common, lethal, and costly cancer worldwide, accounting for at least 1.8 million new cases per year (12.9% of the total).1 Over the past decade, there has been a major shift in the treatment of non–small cell lung cancer (NSCLC), especially in adenocarcinoma, accompanied by...
In the phase III SQUIRE trial reported in The Lancet Oncology, Nick Thatcher, PhD, FRCP, of The Christie Hospital NHS Trust, Manchester, UK, and colleagues found that the addition of the second-generation epidermal growth factor receptor (EGFR) antibody necitumumab to first-line...
ASCO’s Community Research Forum (CRF) held its 2015 Annual Meeting September 20–21 at ASCO Headquarters in Alexandria, Virginia. Over 75 physician investigators, program directors, and research staff attended the meeting, representing a wide range of community-based practices and research sites...
Researchers have determined just how many lives are lost when effective investigational drugs are not approved in a timely manner. These delays in the process of anticancer drug approvals result in thousands of premature deaths each year, according to an analysis presented at the 16th World...
Patients with advanced neuroendocrine tumors have two promising new treatment options, according to studies that earned spots in the Presidential Session of the 2015 European Cancer Congress, held recently in Vienna, Austria. The phase III studies evaluated the mTOR inhibitor everolimus (Afinitor)...
This is the first time we have seen data from the BIRCH trial in these three different cohorts using biomarker expression on tumor cells and immune cells,” said formal discussant Luis Paz-Ares, MD, Professor Medicine at the Hospital Universitario 12 de Octubre, Madrid, Spain. “BIRCH confirms the...
The anti–PD-L1 (programmed cell death-ligand 1) antibody atezolizumab (formerly known as MPDL3280A) achieved encouraging outcomes in patients with non–small lung cancer (NSCLC) in two different trials: POPLAR1 and BIRCH.2 PD-L1 has emerged as a predictive biomarker for atezolizumab response in both ...
Cabozantinib (Cometriq) nearly doubled progression-free survival compared with standard everolimus (Afinitor) therapy in patients with advanced renal cell carcinoma, according to the phase III METEOR trial.1 Additionally, a preplanned interim analysis found an encouraging trend toward overall...
Several studies have addressed the risks and benefits of ovarian suppression during chemotherapy for breast cancer in women of childbearing age. A new meta-analysis of randomized trials found that it prevented premature ovarian failure and was associated with a higher number of pregnancies post...
Patients with advanced renal cell carcinoma treated with nivolumab (Opdivo) were 27% less likely to die than those receiving everolimus (Afinitor), in a planned interim analysis of the open-label phase III CheckMate 025 trial.1 These positive results prompted an early termination of the study by...
The U.S. Food and Drug Administration (FDA) has approved the biologics license application for talimogene laherparepvec (Imlygic), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma...
A multivariable analysis of clinical factors associated with tamoxifen use among premenopausal women with hormone receptor–positive breast cancer showed that fertility preservation was a significant factor and “the only predictor of both noninitiation and early cessation” of tamoxifen. “Among...
Endometrial cancer is the most common gynecologic cancer, but there has been little consensus about the appropriate indications for adjuvant therapy. One reason for the lack of consensus is the absence of randomized studies in endometrial cancer that report an overall survival benefit. This may be...
As reported in the Journal of Clinical Oncology by Larissa A. Meyer, MD, MPH, and colleagues, ASCO has endorsed the recently published American Society for Radiation Oncology (ASTRO) guideline on postoperative radiation therapy for endometrial cancer.1 The ASCO clinical practice guideline...
A new article published in the Journal of Oncology Practice evaluates differences between the treatment of patients with metastatic renal cell cancer who participated in clinical trials vs those who received the same therapy in routine clinical practice. Nearly 40% of patients in the real-world...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 9, 2015, the anti–programmed cell death protein 1...
Pfizer recently announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the company’s investigational antibody-drug conjugate inotuzumab ozogamicin for acute lymphoblastic leukemia (ALL). The FDA’s decision was based on the results of the phase III ...
The investigational drug telotristat etiprate was shown to have clinical benefit when added to somatostatin analog therapy for carcinoid syndrome not adequately controlled by long-acting somatostatin analog therapy, the current standard of care, in patients with metastatic neuroendocrine tumors....
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with lung cancer. The trials are investigating DNA, RNA, and protein changes contributing to carcinogenesis; new prevention strategies; combination therapies; radiation,...
In Europe, the field of geriatric oncology has a long history of development, and its organization and implementation continue to improve every day. This would not have happened without the strong commitment of national authorities to health policies, a critical success factor. Four Missions In...
In metastatic HER2-negative breast cancer, several trials have shown that the addition of the anti–vascular endothelial growth factor (VEGF) monoclonal antibody bevacizumab (Avastin) to different chemotherapy regimens significantly improved response rates and progression-free survival by various...
The phase III National Surgical Adjuvant Breast and Bowel Project (NSABP) B-40 (NRG Oncology) trial showed that the addition of bevacizumab (Avastin) to docetaxel + anthracycline-based neoadjuvant chemotherapy improved pathologic complete response rate, the primary endpoint, in patients with early...
Neutropenic complications remain the main dose-limiting toxicity of cancer chemotherapy treatment and are associated with considerable morbidity, mortality, and costs.1 Although patients who have experienced a prior neutropenic event are at increased risk of subsequent events, several studies have...
Molecular categorization of tumors with immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) has become a critical component in the diagnosis and treatment of breast cancer, improving outcomes by assigning the most appropriate therapy to specific tumor pathways. According to a...
Martin Reck, MD, PhD, Head of the Department of Thoracic Oncology at the Lung Clinic Grosshansdorf in Germany, discussed the study at the Presidential Session, calling it “very important work.” This study shows that, with more sensitive assays, T790M mutations are much more frequent than previously ...
Treatment with erlotinib and bevacizumab (Avastin) may help overcome the poor prognosis associated with T790M mutations present at diagnosis in advanced non–small cell lung cancer (NSCLC), according to the results of the phase II BELIEF trial.1 At the 2015 European Cancer Congress, Rolf A. Stahel,...
On October 28, 2015, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody ipilimumab (Yervoy) for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including ...
While inhibitors of programmed cell death protein 1 (PD-1) or its ligand (PD-L1) are becoming established in melanoma, non–small cell lung cancer, and renal cell carcinoma, their efficacy is also being evaluated in numerous other tumor types, with promising results, according to studies presented...
Combined BRAF and MEK inhibition was superior to BRAF inhibition alone in unresectable metastatic melanoma, according to the updated survival analysis of the large randomized COMBI-v trial.1 These findings were reported at the 2015 European Cancer Congress recently held in Vienna, Austria....
Despite the proliferation of new drugs to treat prostate cancer, further progress is proving somewhat elusive, according to three trials presented at the 2015 European Cancer Congress. One study had positive results with orteronel maintenance therapy in patients with metastatic castration-resistant ...
The U.S. Food and Drug Administration has approved the novel chemotherapy drug trabectedin (Yondelis) for the treatment of specific soft-tissue sarcomas—liposarcoma and leiomyosarcoma—that are unresectable or metastatic. Trabectedin is a novel marine antineoplastic alkaloid with a unique mechanism ...
Anita Mahajan, MD, a radiation oncologist at the University of Texas MD Anderson Cancer Center, Houston, moderated the press conference where these findings were discussed. “Use of radiation for atypical meningiomas has been controversial. It has been difficult to put a study together, because we...
Management of the vast majority of meningiomas is straightforward, but treatment of atypical meningiomas has been controversial. Should radiation be part of therapy or not has been the question. The first analysis of Radiation Therapy Oncology Group (RTOG) 0539 suggested that patients will have...
Bone is a common site of metastasis for prostate, breast, and lung cancers, and palliative radiotherapy is often used to treat these metastases. Although it is an effective therapy, severe pain flare following radiation occurs in about one-third of patients. It usually resolves within 10 days, but...
Intensity-modulated radiation therapy appears to be preferable to three-dimensional (3D) conformal radiation therapy as part of treatment for patients with locally advanced (stage III) non–small cell lung cancer (NSCLC). Compared with 3D conformal radiotherapy, intensity-modulated radiotherapy...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 22, 2015, irinotecan liposome injection (Onivyde)...
On November 10, 2015, the U.S. Food and Drug Administration (FDA) approved the MEK inhibitor cobimetinib (Cotellic) in combination with the BRAF inhibitor vemurafenib (Zelboraf) to treat metastatic or unresectable melanoma in patients whose tumors express the BRAF V600E or V600K mutation. Approval...
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with Hodgkin lymphoma, non-Hodgkin lymphoma, and myeloma. The trials are investigating combination treatments; modified chemotherapy regimens; autologous hematopoietic cell...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 23, 2015, trabectedin (Yondelis) was approved for the...
As reported in JAMA Internal Medicine by Estefania Toledo, MD, MPH, PhD, and colleagues, a large Spanish primary prevention nutrition intervention trial in patients at high cardiovascular risk (PREDIMED) showed a large reduction in the risk for invasive breast cancer among women 60 to 80 years of...
In the phase III CheckMate 057 trial, reported in The New England Journal of Medicine by Hossein Borghaei, DO, of Fox Chase Cancer Center, and colleagues, the programmed cell death protein 1 (PD-1) inhibitor nivolumab (Opdivo) improved overall survival vs docetaxel in patients with advanced...
In late August 2015, Gregory A. Masters, MD, and colleagues published an update to the ASCO guidelines for systemic therapy for stage IV non–small cell lung cancer (NSCLC), summarized in this issue of The ASCO Post.1 This builds on the full guidelines published in 20092 and the additional switch...
As reported in The Lancet by Vratislav Strnad, MD, of University Hospital Erlangen, Germany, and colleagues, 5-year results of a phase III noninferiority trial showed no difference in local relapse, disease-free survival, or overall survival with adjuvant accelerated partial breast irradiation...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 27, 2015, talimogene laherparepvec (Imlygic) was...