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Showing 15451 - 15500FDA Approves T-DM1 for HER2-Positive Early Breast Cancer
On May 3, the U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (T-DM1; Kadcyla) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based treatment. Patients should be...
Alterations in the RB1 Gene and Outcomes in Metastatic Castration-Resistant Prostate Cancer
Scientists have identified a genetic mutation in the tumors of some men with prostate cancer that is linked to very poor survival, and which could be used to help select certain patients for more intensive treatment. These findings were published by Abida et al in the Proceedings of the...
Expert Point of View: David Gandara, MD
“MYSTIC is the second phase III trial to compare a first-line immune checkpoint inhibitor with platinum that failed to meet the primary endpoint. However, both MYSTIC and CheckMate 026 identified patients who benefited from an immune checkpoint inhibitor based on tumor mutational burden,”...
Evidence Mounts for Tumor Mutational Burden as Biomarker of Immune Checkpoint Inhibitor Benefit in NSCLC
The search for biomarkers to identify patients who are likely to respond to immunotherapy continues. According to biomarker tissue and blood analysis of patients enrolled in the phase III MYSTIC trial, high tumor mutational burden in both tissue and blood identified patients with non–small cell...
TRINOVA-3: Addition of Trebananib to Carboplatin/Paclitaxel as First-Line Treatment for Advanced Ovarian Cancer
In a phase III trial (TRINOVA-3/ENGOT-ov2/GOG-3001) reported in The Lancet Oncology, Vergote et al found that addition of the antiangiogenic agent trebananib to carboplatin/paclitaxel did not improve progression-free survival in first-line treatment of advanced ovarian cancer. Trebananib is a...
Digital Breast Tomosynthesis vs Digital Mammography in a Breast Cancer Screening Program
In a Norwegian study (To-Be) reported in The Lancet Oncology, Hofvind et al found that digital breast tomosynthesis (including synthetic 2D mammograms) did not perform better than standard digital mammography in a population-based breast cancer screening program. Study Details BreastScreen Norway ...
2019 Updates to NCCN Clinical Practice Guidelines in Genitourinary Oncology
The 24th Annual Conference of the National Comprehensive Cancer Network® (NCCN®) was held this past March in Orlando, Florida. Updates to a number of Clinical Practice Guidelines (NCCN Guidelines®) were reported, including three relevant to the field of genitourinary oncology: kidney cancer,...
Lenvatinib Plus Pembrolizumab Shows Activity in Advanced Urothelial Cancer
THE COMBINATION of lenvatinib plus pembrolizumab has demonstrated antitumor activity in patients with advanced urothelial cancer, including patients receiving later-line treatment. Results of a phase Ib/II trial showed an objective response rate of 25% and a median progression-free survival of 5.4...
Sacituzumab Govitecan Shows Activity in Heavily Pretreated Bladder Cancer
PRELIMINARY EVIDENCE suggests that the antibody-drug conjugate sacituzumab govitecan is active in patients previously treated with chemotherapy or checkpoint inhibitor therapy for metastatic urothelial cancer. These results from a phase I/II basket study of this agent were presented at the 2019...
Adjuvant Sequential Chemotherapy Plus Radiotherapy vs Radiotherapy Alone for Locally Advanced Bladder Cancer
A phase III Egyptian trial presented by Mohamad S. Zaghloul, MD, et al at the 2019 Genitourinary Cancers Symposium focused on the benefit of adjuvant chemotherapy in patients with locally advanced bladder cancer treated with postoperative radiotherapy.1 Researchers compared postoperative...
New Drugs and Novel Indications for Genitourinary Cancers, FDA Approved 2017–2019
May 14, 2019: Avelumab (Bavencio) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). April 19, 2019: Pembrolizumab (Keytruda) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). April 12,...
Enzalutamide Plus Androgen Deprivation Therapy in Metastatic Hormone-Sensitive Prostate Cancer
Adding enzalutamide to androgen-deprivation therapy (ADT) significantly prolonged radiographic progression-free survival in men with metastatic hormone-sensitive prostate cancer, reducing the risk of disease progression or death by 61% compared with ADT plus placebo, according to the results of the ...
Expert Point of View: Efrat Dotan, MD, and Colin D. Weekes, MD, PhD
Efrat Dotan, MD, Associate Professor, Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, commented on this study. “This abstract presents the interim analysis of a phase II study evaluating the use of maintenance therapy with the poly (ADP-ribose) polymerase PARP inhibitor...
Expert Point of View: Daniel George, MD
The CARMENA trial presented at the 2018 ASCO Annual Meeting, published simultaneously in The New England Journal of Medicine,1,2 and reported in this supplement to The ASCO Post, evaluated the role of nephrectomy in patients with metastatic renal cell carcinoma. Formal discussant of the trial,...
LATITUDE Trial in Newly Diagnosed, Metastatic Prostate Cancer: Final Overall Survival Analysis
As reported in The Lancet Oncology by Karim Fizazi, MD, PhD, and colleagues, the final overall survival analysis in the phase III LATITUDE trial has shown a significant benefit with the addition of abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) in newly diagnosed,...
Cytoreductive Nephrectomy in Patients With Metastatic RCC Treated With Sunitinib
In a trial with a modified primary endpoint due to slow accrual reported in JAMA Oncology,1 Axel Bex, MD, PhD, and colleagues found that deferred cytoreductive nephrectomy after sunitinib did not improve the 28-week progression-free rate vs immediate nephrectomy followed by sunitinib in patients...
Retrospective Study Evaluates Cabozantinib in Advanced Non–Clear Cell Renal Cell Carcinoma
Cabozantinib, a kinase inhibitor, is approved in metastatic renal cell carcinoma on the basis of studies in clear cell histology. Its activity in non–clear cell renal cell carcinoma is poorly defined. In a retrospective cohort study, Nieves Martinez Chanzá, MD, and colleagues reported that...
Study Shows Rucaparib Active as Maintenance Therapy in Pancreatic Cancer
The poly (ADP-ribose) polymerase (PARP) inhibitor rucaparib holds promise as maintenance therapy for advanced, platinum-sensitive, BRCA- or PALB2-mutated pancreatic cancer, according to an interim analysis of an ongoing phase II clinical trial presented at the 2019 Annual Meeting of the American...
TIVO-3: Tivozanib vs Sorafenib in Refractory Advanced Renal Cell Carcinoma
The TIVO-3 trial was conducted to confirm progression-free survival results from the TIVO-1 trial, which found an improvement in median progression-free survival in patients with metastatic renal cell carcinoma treated with tivozanib vs sorafenib. Findings from TIVO-3 were presented by Rini et al...
Early Tumor Shrinkage and Outcomes Following Cabozantinib or Everolimus
IN A RETROSPECTIVE analysis of median overall survival from the phase III METEOR trial,1 Ignacio Duran, MD, PhD, and colleagues sought to determine whether early tumor shrinkage following therapy with cabozantinib or everolimus could be an early indicator of prognosis for patients with...
ASCO Clinical Opinion Recommends Germline Testing for All Patients With Pancreatic Cancer
The recently released ASCO Clinical Practice Provisional Clinical Opinion on Evaluating Susceptibility to Pancreatic Cancer highlights the importance of emerging data indicating a relatively high rate of germline mutations in pancreatic cancer.1 Recent studies have demonstrated that up to 1 in 10...
Front-Line Therapy in Advanced Renal Cell Carcinoma: Developing a New Standard
THE FRONT-LINE systemic treatment landscape for metastatic renal cell carcinoma has undergone tremendous movement over the past several years. A better understanding of the current management paradigm for therapy-naive patients warrants a reflection of historic landmark clinical trials that have...
First-Line Therapy for Advanced Kidney Cancer: Combination Treatment vs Sunitinib
TWO RECENTLY reported phase III trials have shown the benefits of combination therapy vs sunitinib in the first-line treatment of advanced renal cell carcinoma. As reported in The New England Journal of Medicine by Brian I. Rini, MD, of Cleveland Clinic Taussig Cancer Institute, and colleagues,...
NCCN Clinical Practice Guidelines in Oncology: 2019 Updates
In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®), covering eight tumor types. NCCN Guidelines are now published for more than 70 tumor types and topics. Some of the key updates for 2019 were presented...
Expert Point of View: Armin Shahrokni, MD
“Older and frail adults with cancer are the types of patients we deal with every day,” said Armin Shahrokni, MD, a geriatric oncologist at Memorial Sloan Kettering Cancer Center in New York. “The GO2 study is important, and I suspect it will be practice-changing,” he predicted. Older and frail...
Study Finds Less Chemotherapy Noninferior to More in Frail and Elderly Patients With Advanced Gastroesophageal Cancer
A large randomized trial has found that frail and elderly patients with advanced gastroesophageal cancer may be safely and successfully treated with dose-reduced chemotherapy. In the GO2 phase III trial, low doses of oxaliplatin/capecitabine performed similarly to intermediate and high doses of the ...
Expert Point of View: Tracy Rose, MD, MPH
THE FORMAL DISCUSSANT of the KEYNOTE-427 trial, Tracy Rose, MD, MPH, of the University of North Carolina, Chapel Hill, told listeners: “I think pembrolizumab should now be considered an option for non–clear cell kidney cancer. Response rates, however, remain inferior to those seen in clear cell...
KEYNOTE-427: Pembrolizumab Shows Activity in Advanced Non–Clear Cell Kidney Cancer
IMMUNOTHERAPY WITH the checkpoint inhibitor pembrolizumab may prove to be an effective option for patients with advanced non–clear cell renal cell carcinoma, according to results in cohort B of the KEYNOTE-427 trial, presented at the 2019 Genitourinary Cancers Symposium.1 Kidney cancers with a...
A Year in Review
The past year has seen groundbreaking advances in the treatment of genitourinary (GU) cancers, which in some cases are resulting in altering the standard of care for patients with renal cell carcinoma, prostate cancer, and urothelial carcinoma. Some of the biggest changes that have occurred are for ...
Marking a Year of Learning From ASCO Members
This past year, I have traveled thousands of miles across the United States meeting with ASCO members and their patients, focusing on members who care for patients in particularly challenging settings. While I am not surprised by the extraordinary work our members are doing in every region of the...
Incoming ASCO President Sets His Sights on Conquering Cancer
For more than 3 decades, Howard A. “Skip” Burris III, MD, FACP, FASCO, has dedicated his medical career to researching the development of chemotherapies for breast cancer, including ado-trastuzumab emtansine, everolimus, and gemcitabine. In addition, he is credited with changing the standard of...
Expert Point of View: Irene Ghobrial, MD, and Monica M. Bertagnolli, MD, FACS, FASCO
Irene Ghobrial, MD, of Dana-Farber Cancer Institute and Harvard Medical School, Boston, who has conducted seminal trials in smoldering myeloma, commented on the phase III E3A06 study. Asked by The ASCO Post whether E3A06 settles the issue of treating smoldering disease, Dr. Ghobrial responded,...
Evidence Builds for Treating Smoldering Myeloma
In patients with intermediate- to high-risk smoldering multiple myeloma, treatment with single-agent lenalidomide, vs observation, led to a 72% reduction in the risk of disease progression at 3 years.1 Results of the phase III E3A06 study were presented at a press briefing in advance of the 2019...
American Cancer Society Sets 2035 Cancer Mortality Reduction Goal
The American Cancer Society (ACS) has set a challenge goal to reduce overall cancer mortality 40% between 2015 and 2035—a goal set by applying favorable cancer mortality trends among college graduates to the population as a whole. A report on the goal was published by Ma et al in CA: A...
ASTRO and AUA Announce Updates to Joint Clinical Guidance for Adjuvant and Salvage Radiotherapy After Prostatectomy
The American Society for Radiation Oncology (ASTRO) and the American Urological Association (AUA) recently announced updates to their joint clinical guideline on adjuvant and salvage radiotherapy after prostatectomy in patients with and without evidence of prostate cancer recurrence to include new...
Treatment-Related Ototoxicity and Reading Impairment in Pediatric Patients With Embryonal Brain Tumors
In a study reported in the Journal of Clinical Oncology, Olivier et al found that pediatric patients with severe sensorineural hearing loss associated with the treatment of embryonal brain tumors experienced greater reading difficulties over time. The study involved data from 260 children and...
Trastuzumab Deruxtecan in Advanced HER2-Positive Gastric and Breast Cancers
Two phase I studies reported in The Lancet Oncology indicate activity of the antibody-drug conjugate trastuzumab deruxtecan in advanced HER2-positive gastric cancer and advanced HER2-positive breast cancer previously treated with trastuzumab emtansine (T-DM1). Trastuzumab deruxtecan (DS-8201a) is a ...
Long-Term Results With Local Consolidative Therapy vs Maintenance Therapy or Observation in Oligometastatic NSCLC
In long-term follow-up of a phase II study reported in the Journal of Clinical Oncology, Gomez et al confirmed superior outcomes with local consolidative therapy vs maintenance therapy or observation in patients with oligometastatic non–small cell lung cancer (NSCLC). In the open-label,...
Predicting Response to Immunotherapy in Squamous Cell Carcinoma
According to a study published by Kacew et al in the European Journal of Cancer, copy number alterations in the chromosome 3q arm may be linked to immunotherapy response in patients with cutaneous squamous cell carcinoma. In fact, this and other genetic markers may prove to be useful...
FDA Pipeline: Designations in Myeloma, Adenoid Cystic Carcinoma, and Kaposi Sarcoma, Plus ODAC Votes
This week, the U.S. Food and Drug Administration granted designations in relapsed or refractory multiple myeloma, adenoid cystic carcinoma, and Kaposi sarcoma; and the FDA’s Oncologic Drugs Advisory Committee (ODAC) held votes on treatments for tenosynovial giant cell tumor and acute...
Rate of 'Textbook Outcomes' in Curative-Intent Resection of Intrahepatic Cholangiocarcinoma
In a multi-institutional international analysis reported in JAMA Surgery, Merath et al found that a textbook outcome was achieved in a minority of patients undergoing curative-intent resection of intrahepatic cholangiocarcinoma. Study Details The study involved data on 687 patients from 15 major...
Impact of Establishment of Cancer Urgent Care Clinic on Emergency Department Visits
In a study reported in the Journal of Oncology Practice, Hong et al found that the establishment of a cancer urgent care clinic slowed the increasing rate of visits to regional emergency departments among adults newly diagnosed with cancer. Study Details The study involved data on 33,316...
Control Arm Quality in Randomized Oncology Trials Leading to FDA Approval
In a study reported in JAMA Oncology, Hilal et al found that 17% of recent cancer drug approvals based on randomized controlled trials featured a suboptimal control arm. Study Details The study involved analysis of a total of 145 studies that led to 143 drug approvals between January 2013 and...
Does Quitting Smoking Affect Risk of Bladder Cancer in Postmenopausal Women?
A large study of postmenopausal women indicated that quitting cigarette smoking was associated with significantly reduced risk of bladder cancer. The most significant reduction in risk occurred in the first 10 years after quitting, with a modest but continued decline in later years. These results...
FDA Approves Dalteparin Sodium for VTE in Pediatric Patients
On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium (Fragmin) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older. This is the first FDA-approved therapy to treat VTE in pediatric patients....
FDA Approves Chemotherapy-Free Regimen, Venetoclax Plus Obinutuzumab, as First-Line Treatment for CLL/SLL
The U.S. Food and Drug Administration (FDA) has approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The approval is based on the results of the...
2019 ASCO: Reduced Chemotherapy Dosages in Elderly Patients With Advanced Gastroesophageal Cancer
A phase III randomized clinical study evaluating the optimum dose of a combination chemotherapy regimen of oxaliplatin and capecitabine in the treatment of advanced gastroesophageal cancer in frail and elderly patients has found that the patients prescribed the lowest dose tested experienced less...
2019 ASCO: Nearly One-Quarter of Participants in the Pediatric MATCH Trial Have an Actionable Molecular Alteration
A study investigating the frequency of targetable molecular alterations in pediatric cancer among patients enrolled in the National Cancer Institute–Children’s Oncology Group Pediatric Molecular Analysis for Therapy Choice (MATCH) trial has found that about one-quarter of patients with...
2019 ASCO: Entrectinib in Children and Adolescents With Recurrent or Refractory Solid or Central Nervous System Tumors
A phase I/IB study evaluating the activity of entrectinib in children and adolescents with recurrent or refractory solid tumors, including central nervous system (CNS) tumors, has found that the agent produced responses in children with tumors harboring target aberrations...
2019 ASCO: Low-Fat Diet May Reduce the Risk of Death From Breast Cancer in Postmenopausal Women
Excluding skin cancer, breast cancer is the most common cancer diagnosed in women in the United States. In 2019, the American Cancer Society estimates that about 268,600 new cases of breast cancer will be diagnosed in women, and about 41,760 women will die from their disease. ...
