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kidney cancer
immunotherapy

Novel Indications and New Drugs for the Treament of Patients With Renal Cell Carcinoma

Pembrolizumab Plus Axitinib: On April 19, 2019, pembrolizumab (Keytruda) was approved for use in combination with the small-molecule tyrosine kinase inhibitor axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma. Approval was based on findings in the phase...

prostate cancer

Addition of Apalutamide to Androgen-Deprivation Therapy in Metastatic Castration-Sensitive Prostate Cancer

As reported in The New England Journal of Medicine by Kim N. Chi, MD, of BC Cancer and Vancouver Prostate Centre, and colleagues, the first analysis of the phase III TITAN trial has shown that the addition of apalutamide to androgen-deprivation therapy improved radiographic progression-free and...

prostate cancer

Nonmetastatic Castration-Resistant Prostate Cancer

Nonmetastatic castration-resistant prostate cancer arises in the subset of men with biochemically recurrent disease (ie, rising prostate-specific antigen [PSA] level after definitive therapy in the absence of metastases) who develop PSA progression after chronic exposure to androgen-deprivation...

prostate cancer

Phase III Study of AR Antagonist in Nonmetastatic Castration-Resistant Prostate Cancer

In the phase III ARAMIS trial reported in The New England Journal of Medicine,1 Karim Fizazi, MD, PhD, of the Institut Gustave Roussy, Universite Paris-Sud, Villejuif, France, and colleagues found that the androgen-receptor (AR) antagonist darolutamide significantly prolonged metastasis-free...

prostate cancer

Novel Indications and New Drugs for Castration-Resistant or Castrate-Sensitive Prostate Cancer

The past year has witnessed the U.S. Food and Drug Administration (FDA) approval of a number of drugs for treatment of patients with metastatic castrate-resistant prostate cancer or castrate-sensitive prostate cancer. Castrate-Resistant Prostate Cancer Olaparib: On May 19, 2020, olaparib...

prostate cancer

Phase II TRITON2 Study in Metastatic Castration-Resistant Prostate Cancer

The single-arm TRITON2 study demonstrated the efficacy of the poly (ADP-ribose) polymerase (PARP) inhibitor rucaparib in patients with metastatic castration-resistant prostate cancer.1,2 Results from the study (ClinicalTrials.gov identifier NCT02952534) led to the approval of rucaparib in this...

prostate cancer

Final Analysis of the ARAMIS Trial in Men With Nonmetastatic Castration-Resistant Prostate Cancer

A year ago, initial results from the double-blind, multicenter, randomized phase III ARAMIS clinical trial evaluating the efficacy and safety of darolutamide, a structurally unique androgen-receptor antagonist, in men with nonmetastatic castration-resistant prostate cancer, were published in The...

prostate cancer

Final Overall Survival Analysis of the PROSPER Trial in Nonmetastatic Castration-Resistant Prostate Cancer

In the final overall survival analysis of the phase III PROSPER trial reported at the ASCO20 Virtual Scientific Program1 and published in The New England Journal of Medicine,2 Cora N. Sternberg, MD, and colleagues found that enzalutamide plus androgen-deprivation therapy (ADT) significantly...

prostate cancer

Androgen Deprivation With Oral Relugolix vs Leuprolide in Advanced Prostate Cancer: HERO Trial

As reported at the ASCO20 Virtual Scientific Program1 and in The New England Journal of Medicine2 by Neal D. Shore, MD, FACS, of Carolina Urologic Research Center, Myrtle Beach, South Carolina, and colleagues, the phase III HERO trial showed sustained castrate testosterone levels and lower risk of...

prostate cancer

In Biochemically Recurrent Prostate Cancer, PSMA-Targeted PET/CT Imaging May Be Useful

Positron-emission tomography/computed tomography (PET/CT) imaging with the prostate-specific membrane antigen (PSMA)-targeted radiotracer fluorine F-18 DCFPyL (PyL) successfully identified areas of occult metastasis in men with biochemically recurrent metastatic castration-resistant prostate...

prostate cancer

Lutetium-177–Labeled PSMA-617 Improves PSA Response in First Analysis From TheraP Trial in Metastatic Prostate Cancer

Initial results of the randomized phase II TheraP trial showed that therapy directed to prostate-specific membrane antigen (PSMA) with lutetium-177–labeled PSMA-617 (LuPSMA) significantly improved prostate-specific antigen (PSA) response compared with cabazitaxel in men with metastatic...

prostate cancer
kidney cancer
bladder cancer
immunotherapy

Genitourinary Oncology Highlights 2019–2020 Almanac

Over the past year, we have seen significant advances in the treatment of prostate, kidney, and urothelial cancers that will benefit patients now and in the future. We have learned about the final results of important clinical trials across multiple genitourinary cancers disease states leading to...

head and neck cancer

Addition of Locoregional Radiotherapy to Chemotherapy for Metastatic Nasopharyngeal Carcinoma

In a Chinese phase III trial reported in JAMA Oncology, You et al found that the addition of locoregional radiotherapy to chemotherapy improved overall survival in patients with chemotherapy-sensitive metastatic nasopharyngeal carcinoma. Study Details The open-label trial included 126 previously...

neuroendocrine tumors

Update on Detecting and Treating Biologically Diverse Neuroendocrine Tumors

Neuroendocrine tumors are rare malignancies that arise in neuroendocrine cells, which can occur throughout the body but are most commonly found in the gastrointestinal tract, lungs, and pancreas. Although most neuroendocrine tumors are indolent and take years to grow, some are aggressive and grow...

Conquer Cancer Donors Provide Key Resources for Patients and Providers During the COVID-19 Pandemic

Before there was funding, there was a need.  “Patients with cancer needed to understand immediately what COVID-19 meant [for] their health. Providers and practices needed guidance on how to offer safe care,” recalled Howard A. Burris III, MD, FACP, FASCO, Chair of the ASCO Board of Directors, of...

issues in oncology

Physicians, New Drugs, and Pharma

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have approved record numbers of new cancer drugs recently. This is extraordinarily good news for physicians, patients, and drug companies, but it raises important questions as to how effective these drugs are, whether...

NRG Oncology Biospecimen Bank Awarded NCI Funding for Next 6 Years

The NRG Oncology Biospecimen Bank will be awarded an additional 6 years of funding from the National Cancer Institute (NCI). This grant will provide biospecimen banking support for the NCI National Clinical Trials Network (NCTN) group NRG Oncology. During the peer-review grant-renewal process, the...

leukemia
immunotherapy

Gemtuzumab Ozogamicin in Pediatric Patients With Newly Diagnosed CD33-Positive AML

On June 16, 2020, the indication of gemtuzumab ozogamicin (Mylotarg) for newly diagnosed CD33-positive acute myeloid leukemia (AML) was extended to include pediatric patients aged 1 month and older.1,2 Supporting Efficacy Data Approval was supported by findings from the phase III AAML0531 trial...

lymphoma
immunotherapy

Highlights of Research in Lymphomas Presented During the EHA25 Virtual Congress

To complement The ASCO Post’s continued coverage of the virtual edition of the 25th European Hematology Association Annual Congress (EHA25 Virtual), here are a few abstracts selected from the meeting proceedings focusing on clinical research in Hodgkin and marginal zone lymphomas. Omission of...

cardio-oncology

NCCN Clinical Practice Guidelines in Oncology: 2020 Updates

In 1996, the National Comprehensive Cancer Network (NCCN) published its first set of Clinical Practice Guidelines in Oncology®, covering eight tumor types. Guidelines are now published for more than 60 tumor types and topics. During the NCCN’s 25th Annual Conference, which was held virtually during ...

Expert Point of View: David Sallman, MD

David Sallman, MD, an assistant member of the Malignant Hematology Department of Moffitt Cancer Center and Research Institute, Tampa, Florida, commented on the IMerge and QUAZAR studies for The ASCO Post. As background, he noted the “predominant struggle” of patients with lower-risk myelodysplastic ...

myelodysplastic syndromes

Novel Treatments Emerge for Patients With Lower-Risk Myelodysplastic Syndromes

Patients with lower-risk myelodysplastic syndromes (MDS) who are dependent on red blood cell transfusions have limited options, especially if they are no longer responding to erythropoiesis-stimulating agents. Research presented during the virtual edition of the 25th European Hematology Association ...

lymphoma

Can Radiotherapy Be Omitted for Some Patients With PET-Negative, Early-Stage Unfavorable Hodgkin Lymphoma?

The overwhelming majority of patients with early-stage unfavorable Hodgkin lymphoma may no longer require radiotherapy to treat their disease, according to data presented during the virtual edition of the 25th European Hematology Association (EHA) Annual Congress.1 The findings of the randomized,...

lung cancer
immunotherapy

Incorporating Immunotherapy Into Treatment of Early-Stage NSCLC

There is a strong rationale for incorporating immunotherapy into the treatment of early-stage non–small cell lung cancer (NSCLC), given the breakthrough results with PD-1 checkpoint inhibitors as monotherapy, combined with immunotherapy, or combined with chemotherapy in advanced-stage NSCLC. As...

issues in oncology

Pediatric Hematologist/Oncologist Yoram Unguru, MD, MS, MA, Explains the Economic Origins of Drug Shortages and Other Ethical Issues

Improvements in protocol-driven clinical trials and supportive care for children and adolescents with cancer have markedly reduced mortality rates over the past 5 decades. Yet, along with clinical advances, oncologists and their young patients with cancer face a host of ethical issues, made more...

breast cancer

Association of Pathologic Complete Response With 3-Year Outcomes in I-SPY 2 Trial of Neoadjuvant Therapy for Stage II or III Breast Cancer

In a 3-year follow-up analysis of the phase II I-SPY 2 trial reported in JAMA Oncology, researchers in the I-SPY 2 Trial Consortium found that pathologic complete response was associated with improved event-free and distant recurrence–free survival—irrespective of molecular subtype or neoadjuvant...

kidney cancer
lung cancer
myelodysplastic syndromes
solid tumors
skin cancer
lymphoma
pancreatic cancer
breast cancer
immunotherapy

FDA Pipeline: Designations in Kidney and Lung Cancers, Myelodysplastic Syndromes, and More

Over the past few weeks, the U.S. Food and Drug Administration (FDA) has issued designations and accepted applications for novel agents, as well as approved companion diagnostics. We summarize these regulatory movements below. Breakthrough Therapy Designation for MK-6482 in von Hippel-Lindau...

pancreatic cancer

Addition of Pegvorhyaluronidase Alfa to Nab-paclitaxel and Gemcitabine in Hyaluronan-High Metastatic Pancreatic Cancer

In the phase III HALO 109-301 trial reported in the Journal of Clinical Oncology, Eric Van Cutsem, MD, PhD, and colleagues found that the addition of pegvorhyaluronidase alfa (PEGPH20) to nab-paclitaxel plus gemcitabine (AG) did not improve overall survival or progression-free survival in patients...

supportive care
immunotherapy

ASCO Guideline Supports Continued Use of Dexamethasone for Patients Receiving Checkpoint Inhibitors and Emetogenic Chemotherapy

The ASCO guideline on the use of antiemetics has been updated to include new anticancer agents, antiemetics, and regimens.1 The guideline also addresses a growing concern among some oncologists that corticosteroids and their immunosuppressive abilities could potentially compromise the efficacy of...

colorectal cancer

Second-Look Surgery Plus HIPEC vs Surveillance for Patients at High Risk for Colorectal Peritoneal Metastases

In a French phase III trial (PROPHYLOCHIP–PRODIGE 15) reported in The Lancet Oncology, Goéré et al found that second-look surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) did not improve disease-free survival vs standard surveillance in patients at high risk of developing colorectal...

cns cancers

Outcomes With Adjuvant Postradiation Chemotherapy vs Radiotherapy in High-Risk, Low-Grade Glioma

In a post hoc analysis from the phase III NRG Oncology/RTOG 9802 trial reported in the Journal of Clinical Oncology, Bell et al found that postradiation chemotherapy was associated with a better outcome vs radiotherapy alone in patients with IDH-mutant, high-risk, low-grade glioma, irrespective of...

prostate cancer

Does Adding Neoadjuvant Chemohormonal Therapy to Surgery in Patients With Localized High-Risk Prostate Cancer Improve Biochemical Progression–Free Survival?

As reported in the Journal of Clinical Oncology by Eastham et al, the phase III CALGB 90203/Alliance trial has shown no improvement in 3-year biochemical progression-free survival (BPFS) with the addition of neoadjuvant chemohormonal therapy to radical prostatectomy in patients with localized...

breast cancer

NALA Trial: Neratinib/Capecitabine vs Lapatinib/Capecitabine for Pretreated Patients With HER2-Positive Metastatic Breast Cancer

As reported in the Journal of Clinical Oncology by Cristina Saura, MD, and colleagues, the phase III NALA trial has shown significantly prolonged progression-free survival with neratinib/capecitabine vs lapatinib/capecitabine in patients with HER2-positive metastatic breast cancer who had received...

skin cancer
immunotherapy

FDA Approves Atezolizumab Plus Cobimetinib/Vemurafenib for Advanced BRAF V600–Mutated Melanoma

On July 30, the U.S. Food and Drug Administration (FDA) approved the PD-L1 inhibitor atezolizumab (Tecentriq) plus the MEK inhibitor cobimetinib (Cotellic) and the selective BRAF kinase inhibitor vemurafenib (Zelboraf) for the treatment of patients with advanced BRAF V600 mutation–positive...

gastrointestinal cancer

First-Line S-1 Plus Leucovorin and Oxaliplatin vs S-1 Plus Cisplatin in Advanced Gastric Cancer

As reported in The Lancet Oncology by Kang et al, the Japanese-Korean phase III SOLAR trial showed that oral tegafur/gimeracil/oteracil, a combination known as S-1, plus leucovorin and oxaliplatin was associated with a modest but significant improvement in overall survival vs S-1 plus cisplatin in...

breast cancer
genomics/genetics
survivorship

Impact of Pregnancy After Breast Cancer in Women With Deleterious Germline BRCA Mutations

In a retrospective cohort study reported in the Journal of Clinical Oncology, Matteo Lambertini, MD, PhD, and colleagues found that pregnancy after breast cancer in women harboring deleterious germline BRCA mutations did not appear to be associated with worsened maternal prognosis or fetal...

Expert Point of View: Michele Teng, PhD

Study discussant Michele Teng, PhD, of QIMR Berghofer Medical Research Institute, Brisbane, Australia, commented: “Cancer immunotherapy is a new pillar of cancer treatment. The aim is to improve the overall survival of patients with cancer, but there is room for improvement, and various...

lung cancer
immunotherapy

Anti-TIGIT Antibody Plus Atezolizumab Move Forward in Advanced NSCLC

Tiragolumab, an anti-TIGIT antibody, plus the PD-L1 inhibitor atezolizumab exhibited early clinical activity and was tolerated in patients with advanced solid tumors, including those with metastatic non–small cell lung cancer (NSCLC) that was PD-L1–positive and untreated with prior checkpoint...

multiple myeloma
immunotherapy

CANDOR Trial: Carfilzomib, Dexamethasone, and Daratumumab vs Carfilzomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

As reported in The Lancet by Meletios Dimopoulos, MD, and colleagues, the phase III CANDOR trial has shown prolonged progression-free survival with carfilzomib, dexamethasone, and daratumumab (KdD) vs carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma....

Expert Point of View: Philip A. Philip, MD, PhD, FRCP

The study’s invited discussant, Philip A. Philip, MD, PhD, FRCP, Professor of Oncology, Pharmacology, and Medicine and the Kathryn Cramer Endowed Chair in Cancer Research at Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, asked whether another triplet regimen was...

pancreatic cancer

First-Line Liposomal Irinotecan–Containing Regimen Studied in Advanced Pancreatic Cancer

In patients with newly diagnosed locally advanced or metastatic pancreatic adenocarcinoma, treatment with liposomal irinotecan plus fluorouracil (5-FU), leucovorin, and oxaliplatin (NALIRIFOX) resulted in a median progression-free survival of 9.2 months and a median overall survival of 12.6 months, ...

Expert Point of View: David Sallman, MD

David Sallman, MD, Assistant Member of the Malignant Hematology Department at Moffitt Cancer Center and Research Institute, Tampa, Florida, commented on these findings for The ASCO Post. “Although the hypomethylating agent azacitidine represents a standard of care for higher-risk myelodysplastic...

Prominent Surgeon and Teacher LaSalle D. Leffall, Jr, MD, Promotes Hard Work and Education to Overcome Boundaries

LaSalle D. Leffall, Jr, MD, the Charles R. Drew Professor of Surgery at Howard University College of Medicine in Washington, DC, died on May 25, 2019, at the age of 89. The ASCO Post paid tribute to Dr. Leffall in its July 10, 2019, issue. Here, as part of our 10-Year Anniversary Series, we...

lymphoma
immunotherapy

Role of Rituximab in the Treatment of Children and Adolescents With Mature B-Cell Non-Hodgkin Lymphoma

Minard-Colin et al recently reported for the European Intergroup for Childhood Non-Hodgkin Lymphoma/Children’s Oncology Group (EICNHL/COG) a significant improvement in event-free survival among children and adolescents (aged 6 months to 18 years) with high-risk mature B-cell non-Hodgkin lymphoma...

head and neck cancer

New Guideline for Locally Advanced Esophageal Cancer Supports Multimodality Therapy and Multidisciplinary Treatment

ASCO has released a new guideline for the treatment of locally advanced esophageal cancer that will provide a context for the current standards of care, fill gaps in clinicians’ knowledge of therapy options, and help define future treatment.1 An expert panel developed the guideline based on 17...

lymphoma
immunotherapy

Addition of Rituximab to Standard Chemotherapy Improves Event-Free and Overall Survival in Children With High-Risk, Mature B-Cell Non-Hodgkin Lymphoma

In a European Intergroup for Childhood Non-Hodgkin Lymphoma/Children’s Oncology Group phase III trial reported in The New England Journal of Medicine, Véronique Minard‑Colin, MD, PhD, of Gustave Roussy, Université Paris-Saclay, Villejuif, France, and colleagues found that the addition of rituximab...

gastroesophageal cancer
immunotherapy

Nivolumab in Previously Treated Esophageal Squamous Cell Carcinoma

On June 10, 2020, nivolumab was approved for treatment of patients with unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.1,2 Supporting Efficacy Data Approval was based on findings from the open-label,...

breast cancer

Phase III PADA-1 Trial Examines the Impact of ESR1 Mutations in Metastatic Breast Cancer

ESR1 mutations are known to confer resistance to endocrine therapy in the metastatic breast cancer setting. These mutations herald a poor prognosis, so their clearance early in the treatment course may greatly reduce the risk of recurrence, according to the early results of the prospective phase...

Expert Point of View: Komal Jhaveri, MD

“Surprisingly, the phase II PARSIFAL trial did not show a statistical superiority in progression-free survival for fulvestrant plus palbociclib over letrozole plus palbociclib in the first-line treatment of patients with endocrine-sensitive, metastatic breast cancer. The noninferiority hypothesis...

covid-19
solid tumors
hematologic malignancies

In Case You Missed It: Quick Takes on Novel Therapies for Solid and Hematologic Malignancies

Because of the COVID-19 pandemic, oncology providers from around the world had to forgo their annual trip to McCormick Place—but the show did go on. We all realized important research can still be presented, clinicians and fellow researchers will still listen, and ASCO presentations will still...

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