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Committed to Excellence: Oncology Drug Development Marches on Amid a Pandemic

Instituted as part of the 21st Century Cures Act, the Oncology Center of Excellence (OCE) fosters a unified interaction between three U.S. Food and Drug Administration (FDA) centers: Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Center for Devices and...

lung cancer

Liquid Biopsy: Mounting Evidence Shows Clinical Utility in Tumor Monitoring

A “blood-first” approach could soon shift the diagnostic paradigm in advanced lung cancer, replacing tissue biopsy with minimally invasive assays. According to Natasha B. Leighl, MD, MMSc, FRCPC, FASCO, there is rapidly mounting evidence that liquid biopsy serves a prognostic function in advanced...

issues in oncology
supportive care

Expert Point of View: Sonali M. Smith, MD, FASCO

Sonali M. Smith, MD, FASCO, the Elwood V. Jensen Professor in Medicine, Interim Chief of Hematology/Oncology, and Director of the Lymphoma Program at the University of Chicago Medical Center, told The ASCO Post that communication between the patient and the caregiving team has become increasingly...

issues in oncology
cost of care

Medical Financial Hardship: Pervasive and Possibly Linked to Mortality Among Patients With Cancer

Reducing the financial impact of cancer diagnosis and treatment may save not only bank accounts but lives as well, according to recent data. Two separate survey studies presented during the 2020 ASCO Quality Care Symposium have highlighted the pervasiveness and deadliness of financial toxicity,...

After Leaving His Home in Syria to Train Abroad, an Oncologist Makes a Tough Decision to Return

For this installment of the Living a Full Life series, guest editor Jame Abraham, MD, FACP, spoke with Nedal Estfan, MD, a noted Syrian oncologist who was at the forefront of his county’s earliest efforts to establish a national cancer care system during a time of political and military turmoil....

leukemia

Chronic Lymphocytic Leukemia: New Treatments Achieve Deeper Remissions

At the National Comprehensive Cancer Network® (NCCN®) 2020 Virtual Congress: Hematologic Malignancies, William Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, reviewed current data on chronic lymphocytic leukemia (CLL), including promising new combinations of modern...

lung cancer

Fragment Analysis as a MET Exon 14 Screening Strategy in NSCLC Tumors

Comparison of two techniques used in screening non–small cell lung cancer (NSCLC) tumor samples demonstrated that fragment analysis could detect large MET exon 14 skipping deletions that were missed by next-generation sequencing, according to findings presented at the Molecular Analysis for...

lymphoma
immunotherapy

Do All Patients With Refractory Diffuse Large B-Cell Lymphoma Need CAR T-Cell Therapy?

Chimeric antigen receptor (CAR) T-cell therapy has made great strides in treating patients with relapsed or refractory diffuse large-B cell lymphoma (DLBCL) and refractory mantle cell lymphoma (MCL), but there may be newer strategies that can produce equivalent outcomes, and not all patients with...

prostate cancer

No Biochemical Progression-Free Survival Benefit With Adjuvant vs Salvage Radiotherapy After Radical Prostatectomy for Prostate Cancer

As reported in The Lancet by Christopher C. Parker, MD, of Royal Marsden NHS Foundation Trust, Sutton, United Kingdom, and colleagues, initial findings in the phase III RADICALS-RT trial have shown no biochemical progression-free survival benefit with adjuvant radiotherapy vs a policy of salvage...

issues in oncology
covid-19

Results From ASCO’s 2020 National Cancer Opinions Survey

As in past years, the results from ASCO’s 2020 National Cancer Opinions Survey showed a startling dichotomy in the perceptions of Americans on a variety of health-care issues. As expected, the two major events this year, the COVID-19 pandemic and a national reckoning over racial injustice,...

lung cancer
immunotherapy

Lung Cancer: Precision Therapies at the Forefront

What a difference 20 years have made! In the year 2000, the results of the ECOG 1594 trial were reported at the plenary session of the ASCO Annual Meeting. The study demonstrated comparable outcomes between four different platinum-based chemotherapy regimens for the treatment of metastatic...

breast cancer
geriatric oncology

Surgery Improves Survival in Older Women With Early Estrogen Receptor–Positive Breast Cancer

Older women with estrogen receptor–positive breast cancer have poorer survival than younger women, but this gap might be closed by offering surgery to women over age 70 who are fit and have resectable tumors. According to a study presented at the 12th European Breast Cancer Conference (EBCC 12),...

colorectal cancer

After Surgery for Colorectal Cancer, Intensive Monitoring of Little Benefit: PRODIGE 13

Is intensive monitoring of patients after curative colorectal cancer resection warranted? Not necessarily, according to the findings of PRODIGE 13, reported at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.1 “After curative surgery, the addition of CEA [carcinoembryonic...

breast cancer
immunotherapy

First-Line Pembrolizumab Delays Disease Progression in PD-L1–Expressing Metastatic Triple-Negative Breast Cancer

In the phase III KEYNOTE-355 trial, pembrolizumab combined with several chemotherapy partners yielded a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in patients with previously untreated locally advanced or metastatic...

covid-19

Impact of COVID-19 on Well-Being in the Oncology Workforce: COVID-NOW Survey Results

The results of a survey of 1,038 doctors, nurses, pharmacists, administrators, and allied health professionals (such dietitians and physiotherapists) working in oncology in the United Kingdom’s National Health Service (NHS) during the spring wave of COVID-19 were presented by Susana N. Banerjee,...

covid-19

UK-Based Study Finds Evidence of COVID-19 Infection, Antibody Presence in Oncology Health-Care Staff

A study of oncology staff carried out immediately after the spring peak of the COVID-19 pandemic in the United Kingdom indicated that many had been infected with the coronavirus, including those who did not show any symptoms. The study—presented by Favara et al at the NCRI (National Cancer Research ...

immunotherapy
leukemia
lymphoma

Bispecific Anti-CD20/Anti-CD19 CAR T Cells for Patients With Relapsed B-Cell Malignancies

In a single-institution phase I dose-escalation and -expansion trial reported as a letter in Nature Medicine, Shah et al found that treatment with tandem bispecific anti-CD20/anti-CD19 4-1BB–CD3ζ lentiviral (LV20.19) chimeric antigen receptor (CAR) T cells produced high response rates in adult...

immunotherapy

Nivolumab Plus Ipilimumab for Metastatic Uveal Melanoma

In a single-institution phase II trial reported in the Journal of Clinical Oncology, Pelster et al found that nivolumab plus ipilimumab produced durable responses and improved survival outcomes in patients with metastatic uveal melanoma. Study Details The trial enrolled 35 patients at The...

breast cancer

Recently Approved and Emerging Therapies for Triple-Negative Breast Cancer

“Triple-negative breast cancer has multiple different subtypes, and there are targeted therapies that can be used based on the biomarkers that we identify for each patient,” Kari B. Wisinski, MD, noted in a review of recently approved and emerging therapies at the 2020 Lynn Sage Breast Cancer...

head and neck cancer

Second-Line Pembrolizumab Improves Overall Survival vs Chemotherapy in Patients with Advanced Esophageal Cancer

As reported in the Journal of Clinical Oncology by Takashi Kojima, MD, of the National Cancer Center Hospital East, Kashiwa, Japan, and colleagues, the phase III KEYNOTE-181 trial has shown that second-line pembrolizumab improved overall survival vs the investigator choice of chemotherapy in...

head and neck cancer

Selpercatinib Shows Activity in RET Fusion–Positive NSCLC and RET-Altered Thyroid Cancer

As reported inThe New England Journal of Medicine by Alexander Drilon, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues and by Lori J. Wirth, MD, of Massachusetts General Hospital, and colleagues, the phase I/II LIBRETTO-001 trial has shown marked activity of the RET kinase ...

solid tumors

Avelumab Maintenance Therapy Improves Overall Survival in Advanced or Metastatic Urothelial Carcinoma

As reported in The New England Journal of Medicine by Thomas Powles, MD, Barts Cancer Institute, Queen Mary University of London, and colleagues, the phase III JAVELIN Bladder 100 trial found that maintenance treatment with avelumab plus best supportive care significantly improved overall survival...

gynecologic cancers

Expert Point of View: Andreas du Bois, MD, PhD

The invited discussant of the phase III INOVATYON trial was Andreas du Bois, MD, PhD, Chairman of the Department of Gynecology and Gynecologic Oncology at Kliniken Essen Mitte, Germany, and Chairman of the AGO Study Group. As Dr. du Bois explained, the study “dealt with an old question: Does...

gynecologic cancers

INOVATYON: Platinum-Based Regimens Remain Standard of Care in Recurrent Platinum-Sensitive Ovarian Cancer

Yet another blow has been dealt for the alkylating agent trabectedin in advanced ovarian cancer. The international phase III INOVATYON study found no improvement in overall or progression-free survival for trabectedin plus pegylated liposomal doxorubicin (PEG-LD) vs carboplatin/PEG-LD in patients...

symptom management
geriatric oncology

Reducing Symptomatic Toxicity Burden in Older Patients With Advanced Cancer Via Geriatric Assessment

As the number of older patients with cancer continues to rise, interventions that reduce the high rates of symptoms, toxicity, and distress in this population are urgently needed. Research presented during the 2020 ASCO Quality Care Symposium has added to the growing body of evidence supporting...

breast cancer
genomics/genetics

Olaparib for Patients With Metastatic Breast Cancer and Mutations in Homologous Recombination–Related Genes

In a phase II Translational Breast Cancer Research Consortium (TBCRC) study (TBCRC 048; Olaparib Expanded) reported in the Journal of Clinical Oncology, Nadine M. Tung, MD, and colleagues found that olaparib produced high response rates in patients with metastatic breast cancer and germline PALB2...

lung cancer

Biomarker-Driven Master Protocol to Test Therapies for Previously Treated Patients With Squamous NSCLC

In an article published in The Lancet Oncology, Redman et al described the conduct of and findings from the Lung Cancer Master Protocol (Lung-MAP; SWOG S1400), a completed biomarker-driven master protocol designed to address the need for improved therapies for previously treated patients with...

lung cancer
gastroesophageal cancer
gastrointestinal cancer
immunotherapy

FDA Pipeline: Priority Reviews in NSCLC, Gastric Cancer

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to a PD-1 inhibitor for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC), and also granted Priority Review to a HER2-directed antibody-drug conjugate for patients with...

kidney cancer
immunotherapy

Extended Follow-up of KEYNOTE-426: First-Line Pembrolizumab/Axitinib vs Sunitinib in Advanced Renal Cell Carcinoma

As reported in The Lancet Oncology by Thomas Powles, MD, PhD, and colleagues, extended follow-up of the phase III KEYNOTE-426 trial shows continued progression-free and overall survival superiority with pembrolizumab/axitinib vs sunitinib in the first-line treatment of advanced renal cell...

breast cancer

Potential Factors in Prognostic Discrepancies Among Tests for Recurrence Risk in Patients With Breast Cancer Receiving Endocrine Therapy

The TransATAC study reported by Buus et al in the Journal of Clinical Oncology sought to identify causes of discrepancies among tests for determining the risk of breast cancer recurrence in patients with estrogen receptor–positive, HER2-negative disease receiving endocrine therapy. The...

pancreatic cancer

An Integrated Framework for Improving Outcomes in Pancreatic Cancer

Drawing on several lines of ongoing research, David A. Tuveson, MD, PhD, has created a theoretical framework to consider while developing clinical trials in pancreatic cancer. In his keynote lecture at the 2020 American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer, ...

bladder cancer
immunotherapy

Checkpoint Inhibitor and Chemotherapy Combinations Fail to Move Bar as First-Line Therapy for Advanced Urothelial Cancer

Two different phase III studies found that combining an anti–PD-1/PD-L1 checkpoint inhibitor (pembrolizumab in KEYNOTE-361) with platinum-based chemotherapy or with another checkpoint inhibitor (the anti–CTLA-4 antibody tremelimumab in DANUBE) failed to significantly improve overall or...

genomics/genetics

Study Finds Universal Genetic Testing Uncovers More Inherited Mutations vs Guideline-Based Genetic Testing

Universal genetic testing may uncover inherited genetic mutations, and could individualize cancer therapies, improve survival, and strengthen the use of precision medicine. In a new study published by N. Jewel Samadder, MD, and colleagues in JAMA Oncology, researchers conducted genetic testing in...

kidney cancer
immunotherapy

Response-Based Management of Nivolumab and Ipilimumab Therapy in Metastatic Renal Cell Carcinoma

In the phase II OMNIVORE study reported in the Journal of Clinical Oncology, Rana R. McKay, MD, and colleagues did not find evidence supporting a strategy of discontinuing nivolumab monotherapy in responders and adding ipilimumab in nivolumab nonresponders among patients with metastatic renal cell...

solid tumors
multiple myeloma

Intermittent Dosing Schedules of RAF/MEK Inhibitor in RAS/RAF-Mutant Solid Tumors and Multiple Myeloma

In a single-center phase I dose-escalation and basket dose-expansion study reported in The Lancet Oncology, Guo et al identified the phase II dose and schedule for the oral RAF/MEK inhibitor CH5126766 in patients with RAS/RAF-mutant cancers. The agent also showed antitumor activity across various...

lymphoma

Outcomes With Second-Line Therapy After Relapse in Patients With Early-Stage, Favorable, Classical Hodgkin Lymphoma

In an analysis of two German Hodgkin Study Group trials reported in the Journal of Clinical Oncology, Bröckelmann et al found that second-line treatment with conventional polychemotherapy resulted in similar second progression–free survival (progression-free survival-2) durations vs high-dose...

solid tumors

Is a High-Dose Intermittent Sunitinib Regimen for Advanced Solid Tumors Linked to Improved Survival?

A strategy for giving intermittent, high doses of the tyrosine kinase inhibitor sunitinib seemed to be well tolerated by patients with advanced cancer and increased drug concentrations in solid tumors, which was associated with improved survival. This research was presented by Gerritse et al at the ...

prostate cancer
genomics/genetics

Study Finds Distinct Genomic Alterations May Contribute to More Aggressive Prostate Cancer in Black Men

A study by Liu et al published in Molecular Cancer Research investigated why Black men appear to be more likely to develop aggressive prostate cancer than White men. Researchers found that prostate tumors in Black men had higher frequencies of distinct genetic alterations, which may contribute to...

hematologic malignancies
issues in oncology

Are Neighborhood Poverty, Public Insurance Linked to Poorer Outcomes in Children With Cancer Undergoing Stem Cell Transplant?

Despite the increasing use of hematopoietic stem cell transplant as curative therapy for children with cancer and other life-threatening diseases, new research suggests that children who undergo a transplant for cancer may be more likely to die of treatment-related complications if they live in...

hepatobiliary cancer
immunotherapy

Systemic Therapy in the First- and Second-Line Treatment of Advanced Hepatocellular Carcinoma: Review and Meta-analysis

In a systematic review and network meta-analysis of 14 trials reported in JAMA Oncology, Sonbol et al found that atezolizumab plus bevacizumab outperformed other regimens in the first-line treatment of advanced hepatocellular carcinoma and identified preferred treatments in refractory disease. As...

gynecologic cancers
immunotherapy

Novel Treatments Show Activity in Advanced Cervical Cancer

The treatment of recurrent or metastatic cervical cancer has not changed much in recent years, but according to preliminary trials presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, checkpoint inhibitors and antibody-drug conjugates may become new options. In the...

colorectal cancer

Should Patients With a Complete Response to Neoadjuvant Chemoradiation for Rectal Cancer Also Undergo Surgery?

A nonsurgical treatment option for rectal cancer that preserves quality of life may be safe for selected patients, according to a new study comparing it with standard surgical treatment. These findings were published by Beard et al in the Journal of the American College of Surgeons and were...

myelodysplastic syndromes

Imetelstat in Lower-Risk MDS With High Transfusion Dependence

In the phase II portion of the phase II/III MDS3001 study reported in the Journal of Clinical Oncology, David P. Steensma, MD, and colleagues found that imetelstat—a first-in-class competitive inhibitor of telomerase enzymatic activity—markedly reduced the need for red blood cell transfusion in...

prostate cancer

Development of a Clinical Prognostic Stage Group System for Nonmetastatic Prostate Cancer

As reported in JAMA Oncology, Dess et al have developed a novel clinical prognostic stage group system for nonmetastatic prostate cancer that “meets criteria set forth by the American Joint Committee on Cancer [AJCC] Precision Medicine Core committee… [and outperforms] the existing [AJCC] system...

immunotherapy

Effect of Angiotensin II Inhibition on Response to Immunotherapy

Researchers have found that a class of commonly used heart drugs may also improve patients’ responses to PD-L1 inhibitors, according to preliminary findings presented by Strauss et al at the 32th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (Abstract 7). Angiotensin...

bladder cancer

Gemcitabine and Daily Radiation for Patients With Muscle-Invasive Bladder Cancer

Bladder preservation with trimodality therapy may be a safe and effective alternative to cystectomy for selected patients with muscle-invasive bladder cancer, according to results from a phase II trial presented by Coen et al at the virtual 2020 American Society for Radiation Oncology (ASTRO)...

leukemia
immunotherapy

First-Line Dasatinib Plus Blinatumomab for Adult Patients With Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia

In an Italian phase II trial (GIMEMA LAL2116) reported in The New England Journal of Medicine, Foà et al found that first-line induction and consolidation treatment with dasatinib plus blinatumomab produced a high rate of molecular response in adults with Philadelphia chromosome–positive acute...

geriatric oncology

Time at Home vs in Health-Care Institutions for Older Patients After Cancer Surgery

In a Canadian population-based cohort study reported in JAMA Surgery, Chesney et al found that older patients undergoing surgery for cancer were likely to spend a high number of days at home vs in health-care institutions in the years following surgery for cancer, suggesting favorable functional...

breast cancer
immunotherapy

Effect of Early Trastuzumab Interruption on Recurrence-Free Survival in HER2-Positive Breast Cancer

In a single-center analysis reported in a research letter in JAMA Oncology, Copeland-Halperin et al found that early trastuzumab interruption and interruption resulting in a cumulative trastuzumab dose ≤ 56 mg/kg were associated with significantly poorer recurrence-free survival in patients with...

pancreatic cancer

New Maintenance Therapies in Metastatic Pancreatic Cancer Aim to End Perpetual Chemotherapy

The advent of effective combination chemotherapies has changed the treatment landscape for metastatic pancreatic cancer, extending median survival and leading to durable responses in a subset of patients. However, perpetual chemotherapy is cumulatively toxic, leading to progressive bone marrow...

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