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lung cancer
genomics/genetics

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...

genomics/genetics

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...

issues in oncology
covid-19

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...

issues in oncology

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...

breast cancer

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...

gynecologic cancers
immunotherapy

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...

breast cancer

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...

breast cancer

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...

breast cancer

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...

breast cancer

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...

breast cancer

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 ...

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...

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