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Showing 8301 - 8350FDA Perspective on Drug-Dosing in Oncology: From ‘More Is Better’ to ‘Less Can Be More’
In a perspective article published in The New England Journal of Medicine entitled “The Drug-Dosing Conundrum in Oncology—When Less Is More,” four authors from the U.S. Food and Drug Administration (FDA) argue for the need to jettison the “more is better” paradigm in dose selection for oncology...
Abiraterone for Castration-Resistant, Androgen Receptor–Expressing Salivary Gland Cancer
In an Italian single-institution phase II trial reported in the Journal of Clinical Oncology, Locati et al found that abiraterone acetate showed activity in patients with androgen deprivation therapy (ADT)-resistant, androgen receptor (AR)-overexpressing salivary gland carcinoma. As stated by the...
Final Analysis of iNNOVATE: Addition of Ibrutinib to Rituximab for Waldenström’s Macroglobulinemia
As reported in the Journal of Clinical Oncology by Buske et al, the final analysis of the pivotal phase III iNNOVATE trial has shown a continued progression-free survival benefit with the addition of ibrutinib to rituximab in patients with Waldenström’s macroglobulinemia after 50 months of...
Neeraj Agarwal, MD, on Advanced Prostate Cancer: Data on Cabozantinib Plus Atezolizumab
Neeraj Agarwal, MD, of Hunstman Cancer Institute at the University of Utah, discusses efficacy and safety results from the COSMIC-021 study, in which cabozantinib plus atezolizumab demonstrated clinically meaningful activity and a manageable safety profile in patients with metastatic...
FDA Approvals in Breast and Cervical Cancers
This week, the FDA approved new indications for two drugs. The first approval was for abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive, early breast...
Nodal Recurrence With Sentinel Node Biopsy Alone Following Neoadjuvant Chemotherapy for Node-Positive Breast Cancer
In a single-center cohort study reported in JAMA Oncology, Barrio et al evaluated nodal recurrence rates in patients with clinically node-negative breast cancer following neoadjuvant chemotherapy for biopsy-proven node-positive disease. The investigators found an extremely low incidence of nodal...
Study Examines Potential Link Between Cancer and Physical Inactivity
A new report finds that more than 46,000 cancer cases annually in the United States could be prevented if Americans met the 5 hours per week of moderate-intensity activity recommended in the American Cancer Society’s physical activity guidelines. Recent findings published by Minihan et al in the...
FDA Approves Atezolizumab as Adjuvant Treatment for NSCLC
On October 15, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as...
Genomic Profiling of Lung Adenocarcinoma in Never-Smokers vs Smokers
In a study reported in the Journal of Clinical Oncology, Devarakonda et al found that never-smokers with lung adenocarcinoma had a high frequency of RTK/RAS/RAF pathway driver alterations—similar to smokers with lung adenocarcinoma—but also harbored a significantly higher total frequency of...
Characteristics of Genomically Targeted Single-Patient Use Requests for Pediatric Cancers
In a study reported in the Journal of Clinical Oncology, Sabnis et al analyzed characteristics of genomically targeted single-patient use requests for investigational agents for the treatment of pediatric cancers. These requests were made from pediatric cancer programs over a 5-year period. As...
WHO Director-General Grants Posthumous Award to Henrietta Lacks
World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus, MD, honored the late Henrietta Lacks with a WHO Director-General’s award, recognizing her world-changing legacy. Ms. Lacks, a Black American woman, died of cervical cancer 70 years ago, on October 4, 1951. While she...
AACR Cancer Progress Report 2021 Showcases 50 Years of Advances in Cancer Research and Treatment
The AACR Cancer Progress Report 2021 celebrates the gains made in cancer research since the National Cancer Act was signed into law on December 23, 1971. The report also recognizes the negative impact the COVID-19 pandemic has had on cancer research and patient care, the disproportionate toll both...
International Study of the Effects of COVID-19 Lockdowns on Planned Cancer Surgeries
In a prospective cohort study reported in The Lancet Oncology, members of the COVIDSurg Collaborative found that substantial proportions of patients did not undergo planned surgery for cancer in regions with moderate or full COVID-19–related lockdowns. Study Details The study included 20,006...
Risk of Cancer in Children With Fanconi Anemia and Ataxia-Telangiectasia
In a German nationwide register-based cohort study reported in the Journal of Clinical Oncology, Dutzmann et al found that risk of developing cancer by age 18 exceeded 10% in children with Fanconi anemia or ataxia-telangiectasia. Study Details The study involved data on 421 patients with Fanconi...
Is Baseline Brain White Matter Microstructure Associated With Cognitive Decline After Chemotherapy for Breast Cancer?
In a Dutch study reported in the Journal of Clinical Oncology, de Ruiter et al found that white matter microstructure at baseline was associated with cognitive decline after chemotherapy for breast cancer. Study Details The study included 49 patients with breast cancer who received...
FDA Approves Pembrolizumab Combination for the First-Line Treatment of Cervical Cancer
On October 13, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score [CPS] ≥ 1), as...
FDA Approves Abemaciclib in Combination With Endocrine Therapy for Early Breast Cancer
On October 12, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, node-positive early breast cancer...
Thomas Powles, MD, PhD, on Urothelial Carcinoma: Erdafitinib, Cetrelimab, and FGFR Alterations
Thomas Powles, MD, PhD, of Queen Mary University of London, discusses phase II results from the NORSE study, which showed that the kinase inhibitor erdafitinib plus the monoclonal antibody cetrelimab produced meaningful responses in cisplatin-ineligible patients with first-line metastatic or...
Joseph M. Unger, PhD, on the Impact of NCI-Sponsored Treatment Trials
Joseph M. Unger, PhD, of Fred Hutchinson Cancer Research Center, discusses findings from his study of the National Cancer Institute’s Clinical Trials Network, which has conducted publicly funded cancer research for more than 50 years. The substantial gains in life years for patients with cancer, he ...
Jonathan Lim, MBBS, MRCP: The Future of the Oncology Workforce Since the COVID-19 Pandemic
Jonathan Lim, MBBS, MRCP, of Christie NHS Foundation Trust and the Francis Crick Institute, discusses results of an ESMO survey, which showed that the risk of poor well-being, distress, and burnout has continued to rise since the onset of the COVID-19 pandemic, despite improved job performance and...
Recent FDA Approvals in Breast Cancer
In the past year, the U.S. Food and Drug Administration (FDA) approved five treatment options for patients with breast cancer, which are summarized herein. Abemaciclib Combination On October 12, 2021, the FDA approved abemaciclib (Verzenio) with endocrine therapy (tamoxifen or an aromatase...
Expert Point of View: Yuan Yuan, MD, PhD and Elizabeth Mittendorf, MD, PhD
Yuan Yuan, MD, PhD, a medical oncologist at City of Hope, Duarte, California, weighed in on the KEYNOTE-355 findings. “The study presented by Dr. Rugo on KEYNOTE-355 reconfirms the utility of adding immune checkpoint inhibitors to chemotherapy as front-line treatment for metastatic triple-negative ...
KEYNOTE-355: Pembrolizumab Plus Chemotherapy Improves Progression-Free Survival in PD-L1–Enriched Advanced Triple-Negative Breast Cancer
Pembrolizumab plus chemotherapy improved progression-free survival vs chemotherapy alone as first-line treatment of advanced or metastatic triple-negative breast cancer, according to the results of KEYNOTE-355.1 Progression-free survival was significantly improved with pembrolizumab plus...
Expert Point of View: Melinda L. Telli, MD
EA1131 study discussant, Melinda L. Telli, MD, Associate Professor of Medicine at Stanford University, Director of the Breast Cancer Program at the Stanford Cancer Institute, and Associate Director of the Stanford Women’s Cancer Center, commented: “At this point, capecitabine remains preferred as...
EA1131 Trial: Platinum Not Equal to Capecitabine for Residual Disease in Triple-Negative Breast Cancer
In patients with triple-negative breast cancer who have residual disease after neoadjuvant chemotherapy, adjuvant capecitabine remains the standard of care. In the multicenter randomized noninferiority EA1131 trial, which included primarily basal tumors, noninferiority of adjuvant platinum over...
Sacituzumab Govitecan-hziy Improves Survival vs Single-Agent Chemotherapy in Metastatic Triple-Negative Breast Cancer
As reported in The New England Journal of Medicine by Aditya Bardia, MD, of the Division of Medical Oncology, Massachusetts General Hospital Cancer Center, and colleagues, the phase III ASCENT trial has shown prolonged progression-free and overall survival with the Trop-2–directed antibody-drug...
Expert Point of View: Melinda L. Telli, MD
The invited discussant of GeparNuevo,1 Melinda L. Telli, MD, Associate Professor of Medicine at Stanford University School of Medicine, Director of the Breast Cancer Program at the Stanford Cancer Institute, and Associate Director of the Stanford Women’s Cancer Center, welcomed the additional data...
Neoadjuvant Durvalumab Improves Long-Term Outcomes in the GeparNuevo Trial
In the phase II GeparNuevo trial, patients with early triple-negative breast cancer receiving the PD-L1 inhibitor durvalumab in addition to chemotherapy as neoadjuvant therapy saw improvements in long-term outcomes. The results were presented at the 2021 ASCO Annual Meeting by Sibylle Loibl, MD,...
Expert Point of View: Giuseppe Curigliano, MD, PhD
Invited discussant Giuseppe Curigliano, MD, PhD, Associate Professor of Medical Oncology at the University of Milan, Italy, and Head of the Division of Early Drug Development at the European Institute of Oncology, said the “clear” findings of KEYNOTE-5221 are “practice-changing.” However, the ideal ...
KEYNOTE-522: Neoadjuvant Pembrolizumab Improves Event-Free Survival in Triple-Negative Breast Cancer
The latest analysis of the phase III KEYNOTE-522 trial demonstrated significant improvements in clinical outcomes with pembrolizumab plus chemotherapy vs chemotherapy alone as a neoadjuvant/adjuvant treatment of triple-negative breast cancer.1 This is the first large, randomized, phase III trial to ...
Early Triple-Negative Breast Cancer: Are Checkpoint Inhibitors Ready for Neoadjuvant or Adjuvant Use?
Recent clinical trials have been encouraging for the neoadjuvant or adjuvant use of immune checkpoint inhibitors in triple-negative breast cancer, but is this approach ready for the clinic? This question was addressed at the 38th Miami Breast Cancer Conference, held virtually this year, by Adam M....
Margetuximab-cmkb Plus Chemotherapy Prolongs Progression-Free Survival in Heavily Pretreated HER2 Positive Breast Cancer
As reported in JAMA Oncology by Hope S. Rugo, MD, of the University of California San Francisco Helen Diller Family Comprehensive Cancer Center, and colleagues, the phase III SOPHIA trial has shown significantly prolonged progression-free survival with margetuximab-cmkb plus chemotherapy vs...
ADAPT Trial: ‘Excellent’ Outcomes Reported With Neoadjuvant Dual HER2 Therapy in Breast Cancer
The first overall survival analysis of the WGS-ADAPT HER2+/HR– study, which evaluated neoadjuvant therapy in patients with hormone receptor–negative, HER2-positive disease, showed that treatment with pertuzumab and trastuzumab plus paclitaxel—or with the chemotherapy-free regimen of...
Expert Point of View: Evandro de Azambuja, MD, PhD
Invited discussant of the Short-HER trial, Evandro de Azambuja, MD, PhD, Head of the Medical Support Team at the Institut Jules Bordet, Brussels, acknowledged the good outcomes in low- and intermediate-risk patients treated with either a short or long duration of trastuzumab but said 1 year of the...
Long-Term Analysis of Short-HER Trial of Adjuvant Trastuzumab
Long-term analysis of the Short-HER trial showed that 9 weeks of adjuvant trastuzumab conveyed benefits comparable to a 1-year course in patients with early HER2-positive breast cancer deemed to be at low or intermediate risk for recurrence. High-risk patients, however, derived considerably more...
Novel HER2-Targeted Therapies Pose Sequencing Challenges
With three new HER2-targeted therapies approved over the past year or two alone, the treatment landscape for patients with metastatic breast cancer has become increasingly crowded. In the third-line setting and beyond, there are now at least eight HER2-targeted agents approved by the U.S. Food and...
Expert Point of View: C. Kent Osborne, MD
C. Kent Osborne, MD, Founding Director of the Dan L. Duncan Comprehensive Cancer Center and the Dudley and Tina Sharp Chair for Cancer Research, Baylor College of Medicine, Houston, said in a press briefing that the results of the study were clear, but the explanation for the findings is less so....
RxPONDER: Many Postmenopausal Patients With Node-Positive Breast Cancer Can Avoid Chemotherapy
The SWOG S1007 RxPONDER trial evaluated the benefit of chemotherapy in women with early-stage hormone receptor–positive, HER2-negative breast cancer and node-positive disease.1 The data showed that many postmenopausal women can skip adjuvant chemotherapy, based on a 46% reduction in the risk of...
Expert Point of View: C. Kent Osborne, MD, and Ruth M. O’Regan, MD
Commentary for monarchE and PENELOPE-B was provided by C. Kent Osborne, MD, and Ruth M. O’Regan, MD, respectively. Dr. Osborne is Professor of Medicine, Hematology, and Oncology and the Dudley and Tina Sharp Chair for Cancer Research at Baylor College of Medicine, as well as Founding Director of...
A Tale of Two CDK4/6 Inhibitors in Early Breast Cancer
The primary outcome analysis of the phase III monarchE trial, an update of previous data, continued to show significant benefit for abemaciclib in the adjuvant setting, reducing the risk for invasive disease recurrence by 28.7%. Meanwhile, the first results of the phase III PENELOPE-B trial of...
Addition of Adjuvant Palbociclib to Ongoing Endocrine Therapy in HR-Positive, HER2-Negative Early Breast Cancer: PALLAS Trial
As reported in The Lancet Oncology by Erica L. Mayer, MD, and colleagues, the second interim analysis of the phase III PALLAS trial showed no improvement in invasive disease–free survival with the addition of adjuvant palbociclib to ongoing endocrine therapy in patients with hormone receptor...
Expert Point of View: Nadine M. Tung, MD
Formal discussant of the OlympiA trial, Nadine M. Tung, MD, Director of Breast Medical Oncology and the Cancer Genetics and Prevention Program at Beth Israel Deaconess Medical Center and Harvard Medical School, was enthusiastic about the ability of olaparib to improve invasive disease–free survival ...
OlympiA Trial: Adjuvant Olaparib Extends Disease-Free Survival in BRCA-Mutated Early Breast Cancer
Adjuvant therapy with the PARP inhibitor olaparib for 1 year extended disease-free survival in patients with high-risk early-stage HER2-negative breast cancer with BRCA1/2 germline (inherited) mutations, according to a prespecified interim analysis of the phase III OlympiA trial presented at the...
Beyond CDK4/6 Inhibitors in Metastatic Breast Cancer: What’s Next?
Because of their well-established efficacy, inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6) are the standard of care in the treatment of hormone receptor–positive, HER2-negative metastatic breast cancer. The question now is this: After disease progresses on a CDK4/6 inhibitor and endocrine...
Breast Cancer 2020–2021 Almanac
The past decade has seen an explosion of novel agents for breast cancer across subtypes. Although each new advance improves therapeutic options for patients, it also brings forth a challenging question: Who needs what treatment? Not all cancers are created equally, and similarly not all patients...
John V. Cox, DO, MBA, on Reshaping Practice Models to Better Care for Patients With Cancer
John V. Cox, DO, MBA, of The University of Texas Southwestern Medical Center, summarizes his Joseph V. Simone Lecture, in which he stressed the need for coordinated care among practices. The concept of oncology medical homes, he says, has evolved to a broader-based model in which oncologists...
Expert Point of View: Eleni Efstathiou, MD
Invited discussant of the PEACE-1 trial, Eleni Efstathiou, MD, of the Houston Methodist Cancer Center and Athens Medical Center, Greece, reminded listeners: “Androgen signaling inhibition is the prevailing therapeutic strategy in advanced prostate cancer, with reproducible outcomes. Many studies...
PEACE-1: Abiraterone Plus Androgen-Deprivation Therapy and Docetaxel Boosts Survival in Metastatic Castration-Sensitive Prostate Cancer
The addition of abiraterone acetate plus prednisone on top of androgen-deprivation therapy plus docetaxel improved survival in patients with de novo metastatic castration-sensitive prostate cancer vs androgen-deprivation therapy plus docetaxel alone. These results were from the phase III PEACE-1...
ACIS Trial: Addition of Apalutamide to Abiraterone Acetate/Prednisone for Metastatic Castration-Resistant Prostate Cancer
As reported in The Lancet Oncology by Fred Saad, MD, FRCS, and colleagues, the phase III ACIS trial has shown that the addition of apalutamide to abiraterone acetate and prednisone significantly prolonged radiographic progression–free survival in men with metastatic castration-resistant prostate...
Study Examines Cost of Cancer Care in the United States in 2018
Care for the 15 most prevalent types of cancer in the United States cost approximately $156.2 billion for about 402,000 privately insured adult patients in 2018, according to a report published by Nicholas G. Zaorsky, MD, and colleagues in JAMA Network Open. The research team also found that...
