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breast cancer

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 ...

breast cancer

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....

breast cancer

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...

breast cancer

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...

breast cancer

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...

breast cancer

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...

breast cancer

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...

breast cancer

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...

breast cancer

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...

breast cancer

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...

breast cancer

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 ...

breast cancer
genomics/genetics

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...

breast cancer

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

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...

prostate cancer

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...

prostate cancer

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...

gynecologic cancers
immunotherapy

Camrelizumab/Apatinib for High-Risk Chemorefractory or Relapsed Gestational Trophoblastic Neoplasia

In a Chinese single-institution phase II trial (CAP 01) reported in The Lancet Oncology, Cheng et al found that the PD-1 inhibitor camrelizumab in combination with the antiangiogenic agent apatinib produced a high rate of complete responses in women with high-risk chemorefractory or relapsed...

340B Needs Reforms, Not Cuts, to Improve Low-Income Americans’ Access to Care

In comments to the Centers for Medicare & Medicaid Services (CMS), ASCO expressed significant concerns that several provisions in the 2022 Hospital Outpatient Prospective Payment System proposed rule have the potential to undermine access to cancer care for Medicare beneficiaries. ASCO does,...

Administration Outlines Plan to Address High Prescription Drug Costs

On September 9, 2021, the U.S. Department of Health and Human Services (HHS) released a report titled, “Comprehensive Plan for Addressing High Drug Prices: A Report in Response to the Executive Order on Competition in the American Economy.” The report comes following President Biden’s July 2021...

breast cancer

Reduction in Ipsilateral Recurrence Risk With Radiotherapy vs Observation After Lumpectomy for Good-Risk DCIS

In an analysis of long-term outcomes from the phase III NRG/RTOG 9804 trial reported in the Journal of Clinical Oncology, Beryl McCormick, MD, of Memorial Sloan Kettering Cancer Center, and colleagues found that whole-breast irradiation vs observation was associated with a reduced risk of all and...

issues in oncology

Totally Implanted Ports Associated With Reduced Complication Rates vs Other Central Venous Access Devices Used in Anticancer Therapy

In a UK trial (CAVA) reported in The Lancet, Jonathan G. Moss, MBChB, FRCR, of the Institute of Cardiovascular and Medical Sciences, University of Glasgow, and colleagues found that among central venous access devices, totally implanted ports (PORTs) were associated with significantly reduced rates ...

thyroid cancer

Cabozantinib Prolongs Progression-Free Survival in Previously Treated Radioiodine-Refractory Differentiated Thyroid Cancer

As reported in The Lancet Oncology by Marcia S. Brose, MD, Abramson Cancer Center, University of Pennsylvania, and colleagues, the phase III COSMIC-311 trial has shown that cabozantinib produced a numerically higher objective response rate and significantly prolonged progression-free survival vs...

lung cancer
immunotherapy

Neoadjuvant Atezolizumab Under Study in Mesothelioma

Neoadjuvant atezolizumab combined with pemetrexed and cisplatin, with maintenance atezolizumab, proved to be safe and feasible, offering a hint of benefit in patients with resectable pleural mesothelioma, in a small multicenter study presented at the International Association for the Study of Lung...

lung cancer

Expert Point of View: Charles M. Rudin, MD, PhD

Charles M. Rudin, MD, PhD, Hassenfeld Professor and Chief of the Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, commented that although ATLANTIS1 “unfortunately joins the ranks of negative phase III studies in patients with recurrent small cell lung cancer,” there are “some...

lung cancer

Benefits Seen With Lurbinectedin Plus Doxorubicin in Small Cell Lung Cancer—but Primary Endpoint Missed

As a second-line treatment for patients with small cell lung cancer, lurbinectedin plus doxorubicin failed to improve overall survival in the multicenter ATLANTIS trial but did provide other benefits, including better tolerability, researchers reported at the 2021 World Conference on Lung Cancer,...

skin cancer
immunotherapy

Adjuvant Pembrolizumab Shows Efficacy in High-Risk Stage II Melanoma in Adults and Children Older Than 12

Adjuvant pembrolizumab reduced the risk of recurrence in adults and children older than age 12 with high-risk stage II (AJCC 8th edition, stage IIB/IIC) melanoma vs placebo, according to a late-breaking interim analysis of the phase III KEYNOTE-716 trial, presented during the European Society for...

gynecologic cancers
immunotherapy

Study Shows Pembrolizumab Plus Chemotherapy Improves Survival in Advanced Cervical Cancer

The addition of pembrolizumab to chemotherapy prolonged survival in recurrent, persistent, or metastatic cervical cancer, according to the results of the first interim analysis of the ­KEYNOTE-826 trial, presented at a Presidential Symposium during the European Society for Medical Oncology (ESMO)...

breast cancer

Expert Point of View: Monica Arnedos, MD, PhD

Monica Arnedos, MD, PhD, Head of the Breast Cancer Research Program at the Institut Bergonié, Bordeaux, France, commented on the study findings on extended treatment with letrozole. “We cannot ignore the results of the GIM4 trial.1 It provides additional strong evidence to support extended...

breast cancer

Phase III Trial Supports Adjuvant Endocrine Therapy for 7 Years in Early-Stage Breast Cancer

For patients with early-stage hormone receptor–positive breast cancer, extending the duration of letrozole after tamoxifen—for up to 8 years of total endocrine therapy—significantly improved invasive disease–free survival over the standard 5 or so years, according to the final analysis of the...

covid-19

Oncology Care Remains Under Strain in the Ongoing COVID-19 Pandemic

The resurging COVID-19 pandemic has reawakened challenges for patients and physicians—ones we all hoped were over—and presented stressful situations for patients and providers. Hospitals in some states, particularly those with lower vaccination rates, have faced levels of urgent illness that have...

breast cancer
immunotherapy

Expert Point of View: Shanu Modi, MD

Shanu Modi, MD, of the Breast Medicine Service at Memorial Sloan Kettering Cancer Center, New York, called the DESTINY-Breast03 results,1 which showed a highly significant benefit for fam-trastuzumab deruxtecan-nxki (T-DXd) over trastuzumab emtansine (T-DM1), “unprecedented.” She suggested they...

breast cancer
immunotherapy

DESTINY Breast03 Trial Supports Second-Line Use of T-DXd in Metastatic HER2-Positive Breast Cancer

The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) may become a new option as a second-line treatment of patients with HER2-positive unresectable or metastatic breast cancer, based on results from the global phase III DESTINY-Breast03 trial. These findings were presented by Javier...

skin cancer
gynecologic cancers
prostate cancer
breast cancer
solid tumors
hepatobiliary cancer
gastroesophageal cancer
immunotherapy

FDA Pipeline: Recent Reviews, Designations, Applications, and Authorizations in the Oncology Space

Over the past month, the U.S. Food and Drug Administration (FDA) issued several regulatory decisions for novel treatments for patients with cancer. Priority Review for Relatlimab and Nivolumab Fixed-Dose Combination in Unresectable or Metastatic Melanoma The FDA accepted for Priority Review the...

prostate cancer

ARAMIS Analysis: Darolutamide Shows Similar Benefits for Black Patients as Observed in the Overall Population

Black patients with prostate cancer who were treated with the androgen receptor inhibitor darolutamide had clinical outcomes similar to those observed in the overall clinical trial population, according to results from the phase III ARAMIS trial presented by Neal Shore, MD, at the 14th AACR...

Franco M. Muggia, MD, Internationally Regarded Chemotherapy Pioneer, Dies at 85

Today’s life-saving chemotherapeutics originated from the vision and indefatigable work of pioneers in the field whose unwavering vision challenged the status quo. One such pioneer was Franco M. Muggia, MD, who, in a career lasting more than 50 years, had a hand in the development of some of the...

genomics/genetics

Enhanced Surveillance and Risk-Reducing Intervention Options for Individuals With PALB2 Variants

PALB2 germline pathogenic variants are associated with a substantially increased risk for breast cancer and a smaller increased risk for pancreatic and ovarian cancers, warranting enhanced surveillance and the option of risk-reducing interventions, according to a global team of cancer genetic...

Glancing Back and Looking Forward in the Fight Against Cancer

“I vividly remember watching television with my older sister, Suzy, and marveling at President Nixon’s signing of the National Cancer Act in December 1971, and thinking ‘for me, this was like a man going to the moon,’” writes Nancy G. Brinker in the foreword to the recently published Centers of the ...

issues in oncology

How ASCO Is Expanding Its Commitment to Diversity and Equity in Cancer Care

Ensuring equitable cancer care for every patient, everywhere has been embedded into ASCO’s mission statement since the Society’s inception nearly 60 years ago. Nevertheless, events of the past year, including the ongoing COVID-19 pandemic, which has disproportionally impacted minority communities, ...

lung cancer

Study Finds Medicaid Expansion May Be Associated With Decrease in Early Lung Cancer Mortality

Medicare expansion under the Affordable Care Act may have improved outcomes for patients with lung cancer, the leading cause of cancer death in the United States, according to data presented at the 2021 ASCO Quality Care Symposium.1 The National Cancer Database analysis of nearly 12,000 patients...

Donations to St. Jude Children’s Research Center Soar; Inspiration4 SpaceX Journey Exceeds $200 Million Goal

On September 15, 2021, SpaceX launched the Inspiration4 mission, sending four civilians on a 3-day trip orbiting the earth. The passengers were the first to travel on an all-civilian space journey in an effort to further scientific and aerospace research while at the same time raise funds for...

genomics/genetics

FDA Recognizes Memorial Sloan Kettering Database of Molecular Tumor Marker Information

On October 7, the U.S. Food and Drug Administration (FDA) granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases.  The FDA recognized a...

covid-19

Resurgence of COVID-19 Infection in a Large Highly Vaccinated U.S. Health System Workforce

In a letter to the editor in The New England Journal of Medicine, Jocelyn Keehner, MD, of the University of California San Diego Health (UCSDH), and colleagues describe a marked resurgence of COVID-19 infections among fully vaccinated workers in the UCSDH workforce in July 2021.1 The resurgence...

hematologic malignancies

Zanubrutinib for Waldenström’s Macroglobulinemia

On August 31, 2021, the Bruton’s tyrosine kinase inhibitor zanubrutinib was approved for treatment of adults with Waldenström’s macroglobulinemia.1 Supporting Efficacy Data Approval was based on findings in patients receiving zanubrutinib in the phase III open-label ASPEN trial (ClinicalTrials.gov...

lung cancer
immunotherapy

Maintenance Durvalumab: Increased Utilization May Improve Outcomes in NSCLC

Maintenance durvalumab, the standard-of-care treatment for patients with unresectable stage III non–small cell lung cancer (NSCLC), remains significantly underutilized, according to data presented at the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung...

lymphoma
immunotherapy

Tackling a Growing Need: Options After CAR T-Cell Therapy for Lymphoma

For aggressive B-cell lymphomas, chimeric antigen receptor (CAR) T-cell therapy saves lives, but relapse remains common, and a second-line standard of care is lacking. During the 2021 Pan Pacific Lymphoma Conference, Grzegorz (Greg) S. Nowakowski, MD, Professor of Medicine and Oncology, Lymphoma...

hepatobiliary cancer

Addition of Ramucirumab or Merestinib to First-Line Chemotherapy in Advanced Biliary Tract Cancer

In a phase II trial reported in The Lancet Oncology, Juan W. Valle, MD, and colleagues found that no progression-free survival benefit was achieved with the addition of either the VEGFR2 inhibitor ramucirumab or the MEK inhibitor merestinib to first-line cisplatin/gemcitabine chemotherapy in...

head and neck cancer
cns cancers

Factors Associated With Risk of Hearing Loss in Pediatric Patients Receiving Radiation and Chemotherapy

In a single-institution cohort study reported in the Journal of Clinical Oncology, Keilty et al identified factors associated with an increased risk of hearing loss in pediatric patients receiving radiation therapy and chemotherapy for central nervous system and head and neck tumors. The study...

Emily K. Bergsland, MD: Specializing in Neuroendocrine Tumors, With a Broad Focus on Collaborative Research

Gastrointestinal oncologist Emily K. Bergsland, MD, was born and spent her formative years in La Crosse, Wisconsin, situated on the banks of the Mississippi River. “No one in my family was in the medical field; however, both my parents valued higher education. In fact, when I was in high school, my ...

lymphoma

DA-EPOCH-R for Children and Adolescents With Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

In a phase II trial reported in the Journal of Clinical Oncology, Burke et al found that dose-adjusted etoposide, doxorubicin, and cyclophosphamide with vincristine and prednisone plus rituximab (DA-EPOCH-R) did not improve event-free survival vs historical controls in children and adolescents with ...

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