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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...

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 ...

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...

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...

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

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

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
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...

New Certification Pilot Focuses on Patient-Centered Cancer Care, Equips Practices With Evidence-Based Approach to Value-Based Care Delivery

The Association for Clinical Oncology (the Association) launched the ASCO Patient-Centered Cancer Care Certification, a new pilot that certifies outpatient oncology group practices and health systems that meet a single set of comprehensive, expert-backed standards for patient-centered care...

Breast Cancer Research Foundation®, Conquer Cancer, and ASCO Celebrate 20th Year of Collaboration

2021 marks the 20th year of collaboration between ASCO; Conquer Cancer®, the ASCO Foundation; and the Breast Cancer Research Foundation® (BCRF). BCRF’s pivotal support during the past 2 decades has been critical to both organizations’ shared achievements in funding breakthroughs in breast cancer...

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 ...

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

Expert Point of View: Omid Hamid, MD

“The U.S. Food and Drug Administration is currently examining pembrolizumab for the adjuvant treatment of stage IIB and IIC melanoma; if approved, we would be introducing immunotherapy earlier in the patient journey,” commented invited discussant Omid Hamid, MD (@OmidHamidMD), who was an...

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

Expert Point of View: Mansoor Raza Mirza, MD

“The standard of care [in advanced cervical cancer] has been the addition of bevacizumab to platinum-based chemotherapy since 2014. Even with the addition of bevacizumab, we still need to do better. There is a substantial unmet need for new therapies,” said invited discussant Mansoor Raza Mirza,...

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
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...

Francis S. Collins, MD, PhD, to Step Down as Director of the National Institutes of Health

On October 5, Francis S. Collins, MD, PhD, announced his decision to end his tenure as Director of the National Institutes of Health (NIH) by the end of the year. Dr. Collins is the longest-serving presidentially appointed NIH Director, having served three U.S. presidents over more than 12 years....

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...

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...

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...

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...

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 ...

kidney cancer
immunotherapy

Rates of Postprotocol Immunotherapy Use in Patients Enrolled in Kidney Cancer Clinical Trials

In an analysis reported in JAMA Network Open, Sharp et al identified the frequency of use of postprotocol PD-1/PD-L1 inhibitors in control group patients receiving the tyrosine kinase inhibitor sunitinib in randomized trials comparing PD-1/PD-L1 inhibitor–containing combination therapy vs sunitinib ...

lung cancer
immunotherapy

Adjuvant Atezolizumab Following Adjuvant Chemotherapy for Resected Stage IB to IIIA NSCLC

In the phase III IMpower010 trial reported in The Lancet, Enriqueta Felip, MD, and colleagues found that the use of adjuvant atezolizumab after adjuvant platinum-based chemotherapy significantly improved disease-free survival vs best supportive care in patients with resected stage II to IIIA...

hematologic malignancies
leukemia
immunotherapy
global cancer care

A Look at Tomorrow’s CAR T-Cell Therapy Today

Some of the most impressive data on chimeric antigen receptor (CAR) T-cell therapy have come from studies conducted in China. Attendees at the 2021 Pan Pacific Lymphoma Conference heard from one of the leading Chinese investigators, Peihua (Peggy) Lu, MD, of Lu Daopei Hospital, who described the...

gynecologic cancers

Trends in Use of Neoadjuvant Chemotherapy and Association With Overall Survival in Patients With Advanced Ovarian Cancer

In a study reported in JAMA Oncology, Alexander Melamed, MD, MPH, and colleagues found that improvements in median overall survival have been similar in patients from U.S. cancer programs that did vs did not increase their use of neoadjuvant chemotherapy for women with advanced ovarian cancer in...

prostate cancer

Characteristics of and Outcomes in Luminal and Basal Subtypes of Metastatic Castration-Resistant Prostate Cancer

In a retrospective cohort study reported in JAMA Oncology, Aggarwal et al found that metastatic castration-resistant prostate cancer could be categorized into luminal and basal subtypes, and that androgen-signaling inhibitor treatment was associated with better outcomes in patients diagnosed with...

lung cancer

Classifying EGFR Mutations by Structure and Function May Help to Match Patients With NSCLC to More Effective Treatments

Researchers have discovered that grouping EGFR mutations by structure and function provides an accurate framework to match patients with non–small cell lung cancer (NSCLC) to the right drugs. The findings, published by Robichaux et al in Nature, identify four subgroups of mutations and introduce a...

skin cancer

Overall Survival With the Bispecific Fusion Protein Tebentafusp for Metastatic Uveal Melanoma

In an interim analysis of the phase III IMCgp100-202 trial reported in The New England Journal of Medicine, Nathan et al found that tebentafusp, a bispecific protein consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector, significantly improved overall survival vs...

hepatobiliary cancer
issues in oncology

Are Rates of Hepatocellular Carcinoma Rising in Rural Areas of the United States?

Historically, rates of hepatocellular carcinoma (HCC) have been lower in rural areas than urban regions. However, a recent study published by Zhou et al in Clinical Gastroenterology and Hepatology shows that while cases of HCC have begun slowing in urban communities in the United States, the...

colorectal cancer

Capecitabine Maintenance After First-Line Therapy for Metastatic Colorectal Cancer

In the FOCUS4-N trial reported in the Journal of Clinical Oncology, Adams et al found that capecitabine maintenance improved progression-free—but not overall—survival vs active monitoring in patients with stable disease or objective response after first-line therapy for metastatic colorectal...

The Wistar Institute Recruits Vaccine Researcher Amelia Escolano, PhD, and Immunologist Nan Zhang, PhD, as Assistant Professors

The Wistar Institute, an international biomedical research leader in cancer, immunology, and infectious diseases, has appointed Amelia Escolano, PhD, and Nan Zhang, PhD, as Assistant Professors. Dr. Escolano’s research focuses on the development of novel vaccine approaches against highly mutating ...

lymphoma
geriatric oncology

Older Adults With Primary CNS Lymphoma: Treatment Opportunities and Challenges

The ASCO Post is pleased to present the Hematology Expert Review, an ongoing feature that quizzes readers on issues in hematology. In this installment, Drs. Abutalib, Desai, and DeAngelis explore the treatment of older patients with primary central nervous system lymphoma (PCNSL), which pose...

gynecologic cancers
immunotherapy

Pembrolizumab and Lenvatinib in Advanced Endometrial Carcinoma

On July 21, 2021, pembrolizumab in combination with lenvatinib was granted regular approval for treatment of patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair–deficient who have disease progression following prior systemic therapy in any...

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