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Showing 3601 - 3650Final Analysis of BCIRG-006 Supports Use of Non–Anthracycline-Containing Regimen in Treatment of Women With Early Breast Cancer
The final analysis of the BCIRG-006 trial confirmed the long-term efficacy of trastuzumab (Herceptin) in early breast cancer and also validated the concept that anthracyclines increase toxicity and they are not always necessary for a good outcome.1 The 10-year follow-up of the landmark trial was...
Patient and Provider Engagement With Healthy Lifestyle Information
Most young women diagnosed with breast cancer are not physically active in the months after a cancer diagnosis, but physical activity increased over time. According to data presented at the 2016 Cancer Survivorship Symposium, higher levels of physical activity were seen among women whose oncology...
Hypofractionation Is Ready for Prime Time in Prostate Cancer, but Will It Be Adopted?
Separate phase III trials presented at the 2016 Genitourinary Cancers Symposium demonstrated that modest hypofractionated radiotherapy is noninferior to conventional radiotherapy for men with intermediate- and low-risk prostate cancer and should be considered a new standard of care.1,2 However, it...
Radiolabeled Somatostatin Analog May Represent A Paradigm Change in the Treatment of Neuroendocrine Tumors
A radiolabeled somatostatin analog compound, 177Lu-DOTA0-Tyr3-Octreotate (Lu-177 dotatate), reduced the risk of disease progression or death by 79% in the international phase III NETTER-1 population of previously treated, advanced neuroendocrine tumors of midgut origin.1 Lu-177 dotatate belongs to...
FDA Approves Everolimus for Neuroendocrine Tumors of Gastrointestinal or Lung Origin
The U.S. Food and Drug Administration today approved everolimus (Afinitor) for the treatment of adult patients with progressive, well-differentiated nonfunctional neuroendocrine tumors of gastrointestinal or lung origin with unresectable, locally advanced, or metastatic disease. ...
FDA Approves Obinutuzumab in Follicular Lymphoma
The U.S. Food and Drug Administration (FDA) today approved obinutuzumab (Gazyva) for use in combination with bendamustine (Bendeka, Treanda) followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab...
Selected Abstracts From 2015 ASH Annual Meeting: Part 3
Here are several more abstracts selected from the proceedings of the 2015 American Society of Hematology (ASH) Annual Meeting and Exposition, focusing on newly diagnosed multiple myeloma, relapsed/refractory multiple myeloma, and amyloid light-chain (AL) amyloidosis. For other selected abstracts...
Management of Advanced Lung Cancer in the Elderly: A Reason to Rejoice or a Cause for Concern?
There is ample evidence to suggest that older adults with a good performance status (0 or 1) with advanced non–small cell lung cancer (NSCLC) should be treated with combination chemotherapy akin to younger patients.1,2 However, older adults comprise a heterogeneous group that has been...
Adjuvant Chemoradiotherapy in Locally Advanced Bladder Cancer: Hint of Benefit That Needs Confirmation
Adjuvant sequential chemotherapy plus radiation therapy and adjuvant radiation therapy alone significantly improved local tumor control compared with adjuvant chemotherapy alone in locally advanced bladder cancer but the improvement in disease-free survival (3-year disease-free survival of 68% vs...
Expert Point of View: Daniel V.T. Catenacci, MD
In his discussion of the presentation, Daniel V.T. Catenacci, MD, Assistant Professor of Medicine at the University of Chicago, said that conclusions cannot be drawn from the results of NEOSCOPE, which is underpowered to show differences. “On the surface, we see an improvement in the CarPacRT...
Carboplatin/Paclitaxel Tops Oxaliplatin/Capecitabine as Neoadjuvant Regimen for Esophageal Cancer
The United Kingdom’s phase II NEOSCOPE trial compared the toxicity and efficacy of two preoperative chemoradiation regimens—carboplatin/paclitaxel and oxaliplatin/capecitabine—and judged one to be the winner. “CarPacRT passed the prespecified efficacy criteria for taking forward to phase III, but...
Expert Point of View: Claus Rödel, MD
Claus Rödel, MD, of the Department of Radiotherapy, University of Frankfurt, Germany, discussed the study at the 2016 Gastrointestinal Cancers Symposium. “The main strength of the Polish II study is clearly its innovative design,” he said. “It sequentially combines effective local radiotherapy and...
Shorter Radiation Course May Benefit Patients With Locally Advanced Rectal Cancer
As neoadjuvant treatment for locally advanced rectal cancer, a shorter course of radiation therapy followed by chemotherapy may be as good as, or better than, standard chemoradiotherapy, according to a study from the Polish Colorectal Study Group presented at the 2016 Gastrointestinal Cancers...
Alectinib in ALK-Positive Metastatic NSCLC After Crizotinib
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 December 11, 2015, alectinib (Alecensa) was granted...
Selected Abstracts From 2015 ASH Annual Meeting: Part 2
Here are several more abstracts selected from the proceedings of the 2015 American Society of Hematology (ASH) Annual Meeting and Exposition, highlighting therapeutics in acute leukemias and myelodysplastic syndromes. For five other top abstracts on therapies for acute leukemias and myelodysplastic ...
FDA Approves Ofatumumab for Patients With Chronic Lymphocytic Leukemia in Complete or Partial Response
The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra), a CD20-directed cytolytic monoclonal antibody, for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia...
Defibrotide Under Review for Transplant-Related Complication
A potentially fatal complication of hematopoietic stem cell transplantation may be reversed with the use of a novel drug currently under priority review at the U.S. Food and Drug Administration (FDA). Hepatic veno-occlusive disease/sinusoidal obstruction syndrome is usually a serious complication...
For Postmenopausal Women With Ductal Carcinoma in Situ: NSABP B-35 and IBIS-II DCIS Trials Offer a Choice of Endocrine Therapy
The past year has produced an embarrassment of riches regarding the value of aromatase inhibitors for women with ductal carcinoma in situ of the breast. The long-awaited NSABP B-35 study matured and was reported by Margolese and colleagues at the 2015 ASCO Annual Meeting this past summer, followed...
Neoadjuvant HER2 Inhibitor Therapy and Effect of Molecular Heterogeneity on Response in HER2-Positive Breast Cancer
In the phase III CALGB 40601 trial, reported in the Journal of Clinical Oncology by Lisa A. Carey, MD, of University of North Carolina at Chapel Hill, and colleagues, pathologic complete response rate was not significantly increased by adding neoadjuvant trastuzumab (Herceptin) plus lapatinib...
Selected Abstracts From 2015 San Antonio Breast Cancer Symposium
The 2015 San Antonio Breast Cancer Symposium (SABCS), hosted by the American Association for Cancer Research, the Cancer Therapy & Research Center at The University of Texas Health Sciences Center at San Antonio, and Baylor College of Medicine, was held in December 2015. As has been true for...
High Pathologic Complete Response Rates Observed With Neoadjuvant Ado-Trastuzumab Emtansine
Neoadjuvant treatment with a chemotherapy-free, anti-HER2 regimen yielded high rates of pathologic complete response in patients with HER2-positive, hormone receptor-positive early breast cancer in the phase II WSG-ADAPT HER2+/HR+ (ADAPT) trial presented at the 2015 San Antonio Breast Cancer...
Studies Confirm and Extend the Benefits of Ixazomib in Multiple Myeloma
Patients with multiple myeloma now have access to an all-oral regimen, with the recent approval of the oral proteasome inhibitor ixazomib (Ninlaro) in previously treated patients. New pairings for the drug in relapsed/refractory and newly diagnosed patients are being studied, with investigators...
Pembrolizumab Label Updated With New Clinical Trial Information
Late in 2015, the U. S. Food and Drug Administration (FDA) expanded the label for pembrolizumab (Keytruda), a humanized antibody, to include the initial treatment of patients with unresectable or metastatic melanoma. Previously, pembrolizumab had received accelerated approval in patients with...
Atezolizumab in Urothelial Cancer: Ushering in a New Standard of Care
Atezolizumab achieved excellent results in a cohort of patients with platinum-resistant urothelial cancer enrolled in a large phase II trial known as IMvigor 210.1 Overall response rates were greatly improved over those with historical controls, and responses were durable. Although expression of...
Hagop Kantarjian, MD, on Blinatumomab in Precursor B-Cell ALL
Hagop Kantarjian, MD, of The University of Texas MD Anderson Cancer Center, offers his thoughts on abstract 379, “BLAST: A Confirmatory, Single-Arm, Phase II Study of Blinatumomab, a Bispecific T-Cell Engager (BiTE) Antibody Construct, in Patients With Minimal Residual Disease B-Precursor Acute...
Linda J. Burns, MD, on the BLAST Study
2014 ASH President Linda J. Burns, MD, of the University of Minnesota, offers her thoughts on abstract 379, “BLAST: A Confirmatory, Single-Arm, Phase II Study of Blinatumomab, a Bispecific T-Cell Engager (BiTE) Antibody Construct, in Patients with Minimal Residual Disease B-Precursor Acute...
Could a Screening Test That Would Reduce Deaths From Ovarian Cancer Be on the Way?
"A solid triple but not a home run” is how Karen H. Lu, MD, characterized a study in The Lancet reporting a reduction in deaths from ovarian cancer with the use of multimodal ovarian cancer screening.1 Dr. Lu’s remark was one of several, mostly but not universally, favorable and optimistic comments ...
Acupuncture for Cancer Symptom Clusters
Acupuncture has been practiced for thousands of years in Eastern Asian cultures as a component of traditional Chinese medicine.1 In the United States, acupuncture became known to the public as a complementary and alternative medicine technique in the 1970s, but it took many years before it was...
Ibrutinib in Relapsed Mantle Cell Lymphoma
Treatment of mantle cell lymphoma continues to evolve, both in the front-line and relapsed settings. Key advances include better use of established agents, such as the incorporation of high-dose cytarabine into initial induction regimens and application of rituximab (Rituxan)...
The Evolving Treatment Landscape of ALK-Positive NSCLC
Since the initial discovery of ALK rearrangement in non–small cell lung cancer (NSCLC) in 2007,1 small molecule tyrosine kinase inhibitors of ALK have transformed the course of disease for those patients with ALK-rearranged (ie, ALK-positive) NSCLC. Crizotinib (Xalkori), a multitargeted tyrosine...
Study Confirms Benefit of Triplet vs Doublet in Newly Diagnosed Multiple Myeloma
Triplets should be the standard of care in most newly diagnosed multiple myeloma patients, according to a study that validated a practice that has become common in the United States, though not necessarily elsewhere. The use of three drugs led to significant reductions in disease progression and...
Exploratory Analysis of ExteNET Trial Shows Consistency of Benefit With Neratinib
An exploratory analysis of the ExteNET study of neratinib in early HER2-positive breast cancer after treatment with trastuzumab (Herceptin) upheld the findings previously reported for the 2-year analysis, according to the study’s principal investigator Arlene Chan, MD, of the Breast Cancer...
Uridine Triacetate Granules for Fluorouracil or Capecitabine Overdose or Early Severe Toxicity
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 December 11, 2015, uridine triacetate (Vistogard) was approved...
Expert Point of View: Lisa Carey, MD
For the most part, the cardiotoxicity with trastuzumab appears to be largely reversible, unlike anthracyclines, which cause permanent cardiac damage,” said Lisa Carey, MD, Distinguished Professor at the UNC Lineberger Breast Center, Chapel Hill, North Carolina. “In this small study, they saw no...
Prophylactic Beta-Blocker Preserves Left-Ventricular Function in Patients Receiving Trastuzumab
The beta-blocker bisoprolol was able to prevent trastuzumab (Herceptin)-associated declines in left-ventricular ejection fraction, whereas the effect of the angiotensin-converting–enzyme (ACE) inhibitor perindopril was less robust. Use of bisoprolol reduced dose interruptions for trastuzumab due to ...
PI3K Inhibitor Buparlisib Extends Progression-Free Survival in Advanced Breast Cancer
Addition of the oral investigational pan-PI3K inhibitor buparlisib to the endocrine agent fulvestrant (Faslodex) improved progression-free survival among postmenopausal women with advanced hormone receptor–positive/HER2-negative advanced breast cancer. “We are happy to announce that the phase III...
Myeloablative Conditioning for Stem Cell Transplantation Remains Standard of Care in Patients With MDS and AML
A randomized trial from the Bone and Marrow Transplant Clinical Trials Network was halted early after concluding that allogeneic stem cell transplantation after a reduced-intensity conditioning regimen resulted in higher relapse rates compared to myeloablative conditioning. The phase III randomized ...
Idelalisib Improves Progression-Free Survival Over Bendamustine Plus Rituximab in Chronic Lymphocytic Leukemia
Idelalisib (Zydelig) combined with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan) was superior to chemotherapy with bendamustine/rituximab plus placebo, reducing the risk of progressive disease and death while improving progression-free survival and overall survival in patients with...
Rituximab Adds Benefit to Chemotherapy in Adult B-Cell Precursor ALL
The addition of rituximab (Rituxan) to the pediatric-inspired chemotherapy protocol for B-cell precursor acute lymphoblastic leukemia (ALL) significantly improved event-free survival in a large European study presented at the 2015 ASH Annual Meeting.1 The GRAALL-R 2005 phase III study is the first...
Plasma-Based Test Identifies Impactful Mutations in BOLERO-2 Population
A plasma-based cell-free DNA test identified mutations in the estrogen receptor 1 gene (ESR1) in 30% of patients from the BOLERO-2 trial of everolimus (Afinitor) plus exemestane, and these mutations were correlated with survival. The results, which support the use of plasma as a source of...
Bevacizumab Plus Chemotherapy Fails to Prolong Survival in Early-Stage Lung Cancer
Overall survival in patients with surgically resected early-stage non–small cell lung cancer (NSCLC) did not improve with the addition of bevacizumab (Avastin) to chemotherapy, according to the findings of a study researchers have called a “top abstract” from the 16th World Conference on Lung...
FDA Approves Eribulin Mesylate in Unresectable or Metastatic Liposarcoma
The U.S. Food and Drug Administration today approved eribulin mesylate (Halaven), an antimicrotubular antineoplastic agent, for the treatment of unresectable or metastatic liposarcoma. This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug....
Risk Factors for Lymphedema in Patients Treated for Breast Cancer
In a study reported in the Journal of Clinical Oncology, Ferguson et al found that cellulitis in the affected arm, but not blood draws, injections, trauma to the affected arm, or air travel, was associated with an increased risk of lymphedema in women treated for breast cancer. Study Details In...
Nivolumab Plus Ipilimumab Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status
Bristol-Myers Squibb announced on January 23 that the U.S. Food and Drug Administration (FDA) has approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation–positive unresectable or metastatic...
FDA Approves Carfilzomib as Single Agent or in Combination in Relapsed/Refractory Multiple Myeloma
Amgen announced on January 21 that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application of carfilzomib (Kyprolis) for injection in combination with dexamethasone or with lenalidomide (Revlimid) plus dexamethasone for the treatment of patients with relapsed or...
2016 GI Symposium: Tumor-Treating Fields Plus Chemotherapy May Be Safe as First-Line Treatment in Advanced Pancreatic Cancer
Novocure presented data from its ongoing phase II PANOVA clinical trial at the 2016 Gastrointestinal Cancers Symposium in San Francisco, showing that tumor-treating fields therapy plus first-line gemcitabine is tolerable and safe in patients with advanced pancreatic cancer. The data also suggest...
2016 GI Symposium: Irinotecan Liposome Injection in Metastatic Pancreatic Cancer: Updated Results of the Phase III NAPOLI-1 Study
Merrimack Pharmaceuticals, Inc, announced that an updated overall survival analysis of the phase III NAPOLI-1 study of irinotecan liposome injection (Onivyde) in combination with fluorouracil (5-FU) and leucovorin achieved a substantial improvement in 12-month overall survival compared to 5-FU and...
2016 GI Symposium: Everolimus Slows Growth of Neuroendocrine Tumors
Researchers report the results of a new analysis from a phase III trial of patients with neuroendocrine tumors that begin in the gastrointestinal (GI) tract or have an unknown origin. Compared to placebo, everolimus (Afinitor) was associated with a 6- to 8-month longer time period before the cancer ...
FDA Approves Ofatumumab for Patients With Chronic Lymphocytic Leukemia in Complete or Partial Response
The U.S. Food and Drug Administration today approved ofatumumab (Arzerra) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the...
Increased Response Rate With Higher Dose of Obinutuzumab Monotherapy for Patients With Chronic Lymphocytic Leukemia
A randomized phase II study in symptomatic, untreated patients with chronic lymphocytic leukemia (CLL) found an increased overall response rate with obinutuzumab (Gazyva) at a dose of 2,000 mg vs 1,000. In addition, the “data demonstrate that obinutuzumab produces a higher response rate in...
