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prostate cancer

Interim Analysis of the ARCHES Trial: Enzalutamide Plus Androgen-Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer

ADDING ENZALUTAMIDE to androgen-deprivation therapy (ADT) significantly prolonged radiographic progression-free survival in men with metastatic hormone-sensitive prostate cancer, reducing the risk of progression or death by 61% compared with ADT plus placebo, according to results of the phase III...

kidney cancer
immunotherapy

CALYPSO: Savolitinib Plus Durvalumab in Metastatic Papillary Renal Cell Carcinoma

THE COMBINATION of savolitinib and durvalumab achieved durable responses in approximately one-fourth of patients with metastatic papillary renal cell carcinoma in the phase II CALYPSO study.1 Treatment options are limited for papillary renal cell carcinoma. Clinical guidelines recommend enrollment...

kidney cancer
immunotherapy

Pembrolizumab/Cabozantinib Shows Activity in Previously Treated Renal Cell Carcinoma

THE COMBINATION of pembrolizumab and cabozantinib demonstrated antitumor activity in patients with previously treated metastatic renal cell carcinoma and both drugs were tolerable at their approved doses, according to data from a dose-escalation cohort of a phase I study.1 Among eight patients with ...

kidney cancer
immunotherapy

JAVELIN Renal 101: Avelumab Plus Axitinib vs Sunitinib in the First-Line Treatment of Advanced Kidney Cancer

THE PROGRAMMED cell death-ligand 1 (PD-L1) inhibitor, avelumab, was combined with the multitargeted vascular growth endothelial factor (VEGF) agent, axitinib, and compared to monotherapy with sunitinib in the first-line treatment of patients with metastatic renal cell carcinoma. Toni K. Choueiri,...

kidney cancer
immunotherapy

Expert Point of View: Lori Wood, MD

LORI WOOD, MD, of Dalhousie University in Halifax, Nova Scotia, Canada was the formal discussant for the KEYNOTE 426 study presented at the 2019 Genitourinary Cancers Symposium.1,2 Dr. Wood called the KEYNOTE 426 phase III trial “practice-changing,” and added, “The majority of patients with...

kidney cancer
immunotherapy

KEYNOTE 426: Pembrolizumab Plus Axitinib vs Sunitinib in First-Line Therapy for Advanced Renal Cell Carcinoma

AS REPORTED at the 2019 Genitourinary Cancers Symposium by Thomas Powles, MD, and as published in The New England Journal of Medicine by Brian Rini, MD, and colleagues, significant benefits in overall and progression-free survival were achieved with the combination of pembrolizumab plus axitinib...

kidney cancer
bladder cancer
prostate cancer
hepatobiliary cancer

Conference Highlights From the 2019 Gastrointestinal and Genitourinary Cancers Symposiums

THIS YEAR saw a huge turnout and a large number of scientific abstracts presented at both the 2019 Gastrointestinal (GI) Cancers Symposium, held on January 17–19, and the 2019 Genitourinary (GU) Cancers Symposium, held on February 14–16, both in San Francisco. The GU Cancers Symposium attracted...

cns cancers
leukemia
multiple myeloma

FDA Pipeline: Designations in Glioblastoma, Neurofibromatosis, Multiple Myeloma, and AML

This week, the U.S. Food and Drug Administration (FDA) granted designations for treatments for recurrent glioblastoma, neurofibromatosis type 1 and plexiform neurofibromas, multiple myeloma, and relapsed or refractory FLT3-ITD acute myeloid leukemia (AML). Fast Track Designation for Ad-RTS-hIL-12...

skin cancer

Patient-Reported Outcomes in the COMBI-AD Trial

In a study focused on the phase III COMBI-AD trial reported in The Lancet Oncology, Schadendorf et al found no difference in patient-reported outcomes with adjuvant dabrafenib plus trametinib vs placebo in patients with resected BRAF V600E– or BRAF V600K–mutant stage III melanoma. The...

breast cancer

Final Overall Survival Results With Fulvestrant Plus Anastrozole in Metastatic Breast Cancer

As reported in The New England Journal of Medicine by Mehta et al, the final overall survival results of the phase III SWOG S0226 trial show that the addition of first-line fulvestrant to anastrozole was associated with improved overall survival in postmenopausal women with hormone...

breast cancer

FDA Expands Palbociclib Indication in HR-Positive, HER2-Negative Breast Cancer to Include Male Patients

Today, the U.S. Food and Drug Administration (FDA) extended the indication of palbociclib (Ibrance) capsules in combination with specific endocrine therapies for hormone receptor (HR)–positive, HER2-negative advanced or metastatic breast cancer to include male patients. “Today, we are...

solid tumors

AACR 2019: Phase I Trial Evaluates LOXO-195 in Patients With NTRK-Positive Solid Tumors

The investigational anticancer therapeutic LOXO-195, which targets a family of proteins called tropomyosin receptor kinases (TRKs), was safe, tolerable, and showed signs of clinical activity in patients who had solid tumors that harbored NTRK gene fusions and had become resistant to other...

gynecologic cancers
immunotherapy

Lenvatinib Plus Pembrolizumab in Advanced Endometrial Cancer

In an interim analysis of a phase II study reported in The Lancet Oncology, Makker et al found that lenvatinib plus pembrolizumab was active in advanced endometrial cancer. Study Details In the study, 54 patients from 11 sites with metastatic endometrial cancer unselected for microsatellite...

lymphoma
immunotherapy

AUGMENT: Addition of Lenalidomide to Rituximab in Relapsed or Refractory Indolent Lymphoma

In the phase III AUGMENT trial reported in the Journal of Clinical Oncology, Leonard et al found that the addition of lenalidomide to rituximab significantly prolonged progression-free survival in patients with relapsed or refractory indolent lymphoma. Study Details The double-blind trial...

head and neck cancer
symptom management

AACR 2019: Effect of Timing of Radiotherapy on Mucositis in Patients With Head and Neck Cancer

New research presented by Gu et al at the American Association for Cancer Research (AACR) Annual Meeting 2019 found that administering radiation treatments in the morning as opposed to later in the day may significantly reduce the severity of mucositis and its related impacts (Abstract 4860).  ...

issues in oncology
survivorship

Geriatric Assessment, Hospitalization, and Long-Term Care Use in Older Cancer Survivors

In a study reported in the Journal of Oncology Practice, Williams et al found that items in geriatric assessment were significantly predictive of hospitalization frequency and long-term care use among older cancer survivors. Study Details The study included 125 patients aged ≥ 65 years from...

colorectal cancer
immunotherapy

BEACON Colorectal Cancer Trial: Safety Lead-in With Triplet Therapy for BRAF V600E–Mutant Metastatic Disease

As reported in the Journal of Clinical Oncology by Van Cutsem et al, treatment with encorafenib, binimetinib, and cetuximab for BRAF V600E–mutant metastatic colorectal cancer was associated with a manageable safety profile and evidence of activity in the safety lead-in to the phase III BEACON ...

skin cancer
immunotherapy

AACR 2019: Entinostat Plus Pembrolizumab in Patients With Melanoma Previously Treated With Anti–PD-1 Therapy

A combination of the experimental histone deacetylase (HDAC) inhibitor entinostat with the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab showed clinical responses in patients with melanoma that had progressed on prior anti–PD-1 treatment, according to results from the phase...

pancreatic cancer
immunotherapy

AACR 2019: CD40 Antibody Combined With Chemotherapy in Advanced Pancreatic Cancer

An interim analysis of a small phase Ib study by O’Hara et al evaluating the CD40 agonistic monoclonal antibody APX005M in combination with gemcitabine and nab-paclitaxel with or without the programmed cell death protein 1 (PD-1) inhibitor nivolumab in untreated patients with metastatic...

lung cancer
immunotherapy

AACR 2019: Data Analysis Shows Activity of Pembrolizumab in Pretreated Patients With Advanced Small Cell Lung Cancer

The results of an analysis of pooled data from the phase Ib KEYNOTE-028 trial and the phase II KEYNOTE-158 study of the anti–programmed cell death protein 1 monoclonal antibody pembrolizumab in the treatment of advanced small cell lung cancer has found that the therapy provided antitumor...

sarcoma
immunotherapy

AACR 2019: HER2-Targeted CAR T-Cell Therapy Plus Chemotherapy in Advanced Sarcoma

A small phase I study by Navai et al investigated a combination of lymphodepletion chemotherapy and HER2-specific chimeric antigen receptor (CAR) T-cell therapy for pediatric and adult patients with advanced HER2-positive sarcoma. The combination showed promising antitumor activity and was found to ...

FDA Oncology Center of Excellence Issues Annual Report

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has issued its 2018 Annual Report, including updates on regulatory reviews and initiatives, OCE programs, guidances, and more. Regulatory Reviews The OCE is tasked with clinical medical oncology reviews, irrespective...

leukemia

Venetoclax Plus Low-Dose Cytarabine in Older Patients With Previously Untreated AML Ineligible for Intensive Chemotherapy

In a phase Ib/II trial reported in the Journal of Clinical Oncology, Wei et al found that the combination of venetoclax and low-dose cytarabine produced a high response rate in previously untreated older patients with acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy. In...

Conquer Cancer Honors Researchers With Merit Awards

ASCO’S CONQUER CANCER FOUNDATION is pleased to announce the recipients of the Gastrointestinal Cancers, Genitourinary Cancers, and Clinical Immuno-Oncology Symposium Merit Awards. Conquer Cancer Merit Awards recognize oncology fellows’ and trainees’ high-quality research submitted in abstracts to...

issues in oncology

New ASCO Guideline Makes Safe Handling of Hazardous Drugs a Priority

ASCO HAS PUBLISHED a new guideline, “Safe Handling of Hazardous Drugs: ASCO Standards,” to promote the safety of pharmacists, nurses, and all staff who handle potentially dangerous medicines, such as chemotherapy compounds.1 Safety is pivotal in the entire drug workflow, including drug mixing and...

prostate cancer

ASCO Endorses Active Surveillance Guideline for Low-Risk Prostate Cancer

ASCO ENDORSES and reinforces the evidence-based American Urological Association (AUA), American Society for Radiation Oncology (ASTRO), and the Society of Urologic Oncology (SUO) Guideline published in 2018 in the Journal of Urology. ASCO’s endorsement of a guideline on clinically localized...

prostate cancer

Prostatectomy vs Watchful Waiting: Clinical Dilemma Centers on Aggressive vs Indolent Disease

THE MANAGEMENT of localized prostate cancer remains controversial. Although the widespread use of prostate-specific antigen (PSA) testing has resulted in a dramatic increase in the diagnosis and treatment of prostate cancer, many men do not benefit from intervention because the disease is either...

prostate cancer

Radical Prostatectomy or Watchful Waiting: 29-Year Follow-up of Scandinavian Trial

AS REPORTED in The New England Journal of Medicine by Anna Bill-Axelson, MD, PhD, Lars Holmberg, MD, PhD, both of Uppsala University Hospital, and and colleagues, the 29-year follow-up of the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) trial has shown that radical prostatectomy is...

multiple myeloma

Maintenance Ixazomib Delays Disease Progression in Newly Diagnosed Myeloma

IN PATIENTS with newly diagnosed multiple myeloma who responded well to induction therapy and underwent transplant, 2 years of maintenance therapy with ixazomib led to a 38% improvement in progression-free survival compared with placebo, according to the results of the phase III TOURMALINE-MM3...

multiple myeloma
immunotherapy

Expert Point of View: Ajay K. Nooka, MD, MPH

THE ASCO POST asked Ajay K. Nooka, MD, MPH, Associate Professor, Division of Bone Marrow Transplant at Winship Cancer Institute, Emory University, to comment on studies involving daratumumab. “After the phase III SWOG S0777 trial demonstrated a survival benefit with a 3-drug induction regimen...

immunotherapy
multiple myeloma

ASH Reports Show Benefit of Adding Daratumumab to Initial Therapy in Multiple Myeloma

DARATUMUMAB APPEARS to be the “gift that keeps on giving” to the myeloma community. “It seems we can add daratumumab to almost anything and make the regimen better. It’s got good activity and a good safety profile,” said Kenneth Shain, MD, PhD, Director of the Myeloma Working Group at Moffitt...

breast cancer
immunotherapy

IMpassion130 Substudy: Atezolizumab/Nab-Paclitaxel Survival Benefits Limited to PD-L1–Positive Triple-Negative Breast Cancer

THE PHASE III IMpassion130 trial, first reported at the European Society for Medical Oncology (ESMO) 2018 Congress1 and published in The New England Journal of Medicine,2 found that the combination of front-line atezolizumab plus nab-paclitaxel significantly improved disease-free and overall...

breast cancer
genomics/genetics

American Society of Breast Surgeons Recommends Genetic Testing for Newly Diagnosed Patients With Breast Cancer

IN A MOVE that is a significant departure from current testing recommendations, the American Society of Breast Surgeons (ASBrS) recommends that genetic testing be available to all individuals newly diagnosed with breast cancer.1 The new recommendations expand on common restrictions by the National...

prostate cancer

PARP Inhibitors Moving Ahead in Prostate Cancer

MULTIPLE POLY (ADP-ribose) polymerase (PARP) inhibitors are under study in metastatic prostate cancer and no clear winner has emerged yet. Some studies suggest that the best use of PARP inhibitors may be in patients whose cancers harbor DNA-repair defects and BRCA1/2 mutations, but other data...

breast cancer

Trastuzumab Biosimilar for HER2-Overexpressing Breast Cancer

ON DECEMBER 14, 2018, trastuzumab-pkrb (Herzuma) was approved as a biosimilar to trastuzumab for patients with HER2-overexpressing breast cancer.1 Trastuzumab-pkrb is indicated for adjuvant treatment of HER2-overexpressing breast cancer and metastatic HER2-overexpressing breast cancer.2 Health-care ...

bladder cancer

Antibody-Drug Conjugate Shows Activity in Heavily Pretreated Bladder Cancer

PRELIMINARY EVIDENCE suggests that the antibody-drug conjugate sacituzumab govitecan is active in patients previously treated with chemotherapy or checkpoint inhibitor therapy for metastatic urothelial cancer. These results from a phase I/II basket study of this agent were presented at the 2019...

colorectal cancer
neuroendocrine tumors
gastrointestinal cancer
hepatobiliary cancer

New Data in Colorectal, Neuroendocrine, Gastric, and Hepatocellular Cancers

THE ANNUAL GASTROINTESTINAL CANCERS SYMPOSIUM took place earlier this year in San Francisco. In addition to important studies captured in our past few issues, The ASCO Post here briefly summarizes additional interesting studies. Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Colon Cancer...

lung cancer
immunotherapy

CheckMate 384 Supports More Convenient Dosing of Nivolumab in Advanced NSCLC

PATIENTS WITH advanced non–small cell lung cancer (NSCLC) may no longer have to come to the clinic every 2 weeks for treatment. According to a descriptive analysis of the phase IIIb/IV CheckMate 384 study, a more convenient dosing option of nivolumab has demonstrated convincing short-term safety...

prostate cancer

Addition of Docetaxel to Androgen Suppression and Radiotherapy for Localized High-Risk Prostate Cancer

As reported in the Journal of Clinical Oncology by Rosenthal et al, the phase III NRG Oncology RTOG 0521 trial showed that the addition of docetaxel to androgen suppression and radiotherapy improved overall and disease-free survival as well as the distant metastasis rate in patients with high-risk...

lung cancer

Ultradeep Next-Generation Sequencing in Patients With Lung Cancer

A new method of determining the sequence of molecules in DNA can be used to detect small fragments of cancerous genetic material in blood samples from patients with lung cancer with a high degree of accuracy, according research published by Li et al in Annals of Oncology. Liquid Biopsies and...

colorectal cancer
immunotherapy

Pertuzumab Plus Trastuzumab in HER2-Amplified Metastatic Colorectal Cancer

As reported in The Lancet Oncology by Meric-Bernstam et al, the combination of pertuzumab and trastuzumab showed activity in HER2-amplified metastatic colorectal cancer in the phase IIa multiple basket study MyPathway. The study is evaluating activity of targeted therapies in nonindicated tumor...

skin cancer
immunotherapy

Immunotherapy Directed Against Precancerous Skin Lesions May Prevent Squamous Cell Carcinoma

A treatment previously shown to treat the precancerous skin lesions called actinic keratosis now appears to also reduce the chance that these pretreated lesions will develop into squamous cell carcinoma. In a report published by Rosenberg et al in JCI Insight, researchers found that treatment with...

gynecologic cancers
survivorship

Persistent Long-Term Fatigue and Impact on Quality of Life Among Epithelial Ovarian Cancer Survivors

A study among epithelial ovarian cancer survivors from 25 cooperative Gynecologic Cancer Intergroup centers in France showed similar quality of life compared to healthy controls who were randomly selected from the electoral rolls, but persistent long-term fatigue. The researchers found depression,...

issues in oncology

Infertility in Women and Low Absolute Risk of Cancer

A study of over 64,000 women of childbearing age in the United States has found that infertility is associated with a higher risk of developing cancer compared to a group of over 3 million women without fertility problems—although the absolute risk is very low, at just 2%. These findings ...

breast cancer
issues in oncology

Number of Pregnancies May Influence Breast Cancer Risk in Women With BRCA Mutations

Researchers have found the lower risk of breast cancer associated with multiple pregnancies and breastfeeding in the general population extends to those at the highest risk of breast cancer. These results were published by Terry et al in the JNCI Cancer Spectrum. Methods and Findings The...

breast cancer

Neratinib Plus Capecitabine Active Against HER2-Positive Breast Cancer Brain Metastases

In the phase II TBCRC 022 trial reported in the Journal of Clinical Oncology, Freedman et al found that the combination of neratinib and capecitabine was active against brain metastases in women with HER2-positive breast cancer. Modest activity of neratinib monotherapy had been found in previous...

solid tumors

Coming In Future Issues of The ASCO Post

Watch upcoming issues of The ASCO Post for news reports from the 2019 Multidisciplinary Thoracic Cancers Symposium, taking place March 14-16, 2019, in San Diego. Watch for reports on these presentations, plus much more.            “Improved Overall Survival with Local Consolidative Therapy in...

prostate cancer

Docetaxel Plus Androgen-Deprivation Therapy After Primary Local Therapy in High-Risk Prostate Cancer

In a French phase III trial reported in JAMA Oncology, Stéphane Oudard, MD, PhD, of Hôpital Européen Georges Pompidou, and colleagues found that the addition of docetaxel to androgen-deprivation therapy (ADT) did not improve prostate-specific antigen (PSA) progression-free survival in men with...

Use Technology and Appreciate the Importance of Partners

Most oncologists are comfortable treating lesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ) patients with cancer, according to a survey of 149 oncologists from 45 National Cancer Institute–designated Comprehensive Cancer Centers, but not as confident in their knowledge of the...

breast cancer

Restarting My Life After Terminal Cancer

At the end of 2015, I was dying. I was just 50 years old and a wife and mother of 2 teenage boys. Twelve years earlier, I had been diagnosed with ductal carcinoma in situ in my left breast. Despite a modified radical mastectomy and removal of nearly all of the lymph nodes in my left underarm—which ...

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