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issues in oncology

Up-to-Date Labels for Older Drugs Essential for Appropriate Use

  Oncology drug labels, especially those that have been on the market for more than 15 years, may not always be up-to-date. Critical data about safety, efficacy, or prescribing information may be missing. Modernizing the labeling process can correct inaccurate information, add data for indications ...

hematologic malignancies
multiple myeloma
immunotherapy

Daratumumab in Previously Treated Multiple Myeloma

  On June 16, 2017, daratumumab -(Darzalex) was approved for use in combination with pomalidomide (Pomalyst) and dexamethasone for treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (Revlimid) and a proteasome inhibitor.1,2 Supporting...

solid tumors
immunotherapy

Pembrolizumab in MSI-H or dMMR Solid Tumors: ‘First Tissue/Site-Agnostic’ Approval by FDA

  On May 23, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors progressing following prior treatment and who have no...

hematologic malignancies
leukemia

Enasidenib in IDH2-Mutant Relapsed or Refractory Acute Myeloid Leukemia

  On August 1, 2017, the IDH2 inhibitor enasidenib (Idhifa) was granted regular approval for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by a U.S. Food and Drug Administration (FDA)-approved...

hematologic malignancies
leukemia
immunotherapy

Blinatumomab in Relapsed or Refractory B-Cell Precursor ALL

On July 11, 2017, blinatumomab (Blincyto) was approved for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.1,2 Blinatumomab received accelerated approval in December 2014 for the treatment of Philadelphia chromosome (Ph)-negative...

lung cancer

AACR Announces AACR-Johnson & Johnson Lung Cancer Innovation Science Grants

The American Association for Cancer Research (AACR) has announced the launch of the AACR–Johnson & Johnson Lung Cancer Innovation Science Grants to stimulate research aimed at eradicating this malignancy. This new funding opportunity, which is supported by the Johnson & Johnson Lung...

genomics/genetics
issues in oncology

Making Personalized Medicine a Reality for More Patients With Cancer

  This past September, Olivier Elemento, PhD, Associate Director of the Institute for Computational Biomedicine and Director of the Laboratory of Cancer Systems Biology at Weill Cornell Medicine in New York, was named Director of Weill Cornell’s Englander Institute for Precision Medicine. In this...

supportive care
integrative oncology

The State of Integrative Oncology: A New Era

Now that we have entered 2018, let’s take a moment to reflect on how far we have come and what lies ahead in integrative oncology care. Overview To cope with the physical, emotional, and spiritual effects of cancer, and in search of relief from symptoms that their conventional treatments have not...

leukemia
immunotherapy

Updated Analysis of ELIANA Trial Shows Longer-Term Durable Remissions With Tisagenlecleucel in Children, Young Adults With Relapsed/Refractory ALL

Updated results from the ELIANA clinical trial of tisagenlecleucel (Kymriah), formerly CTL019, in relapsed or refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL) have been published by Maude et al in The New England Journal of Medicine. New data include...

leukemia

Addition of Antibody-Drug Conjugate to Low-Intensity Chemotherapy in Older Patients With ALL

In a single-center phase II study reported in The Lancet Oncology, Kantarjian et al found that the addition of inotuzumab ozogamicin (Besponsa) to low-intensity chemotherapy produced promising outcomes in older patients with newly diagnosed Philadelphia chromosome–negative acute lymphoblastic ...

hematologic malignancies

Clinical Hold on BPX-501 Trials in the United States Announced

On January 30, Bellicum Pharmaceuticals announced it has received notice from the U.S. Food and Drug Administration (FDA) that U.S. studies of BPX-501—an agent being studied to improve outcomes for patients undergoing stem cell transplant who lack a matched donor—have been placed...

multiple myeloma
immunotherapy

ASPIRE Trial: Final Overall Survival Results in Relapsed or Refractory Multiple Myeloma

The final overall survival results of the phase III ASPIRE trial indicate significant improvement with carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (KRd) vs lenalidomide plus dexamethasone (Rd) in patients who had received one to three prior lines of therapy for multiple...

solid tumors

Multiple-Basket Study of Targeted Therapy for Advanced Solid Tumors

In a phase IIa multiple-basket study (MyPathway) reported in the Journal of Clinical Oncology, Hainsworth et al found that agents targeting specific molecular alterations produced responses in tumors outside of current labeling for the agents, with high response rates being observed in some tumor...

prostate cancer

Patient-Reported Outcomes With Addition of Combination Treatment to ADT in Newly Diagnosed Metastatic Castration-Naive Prostate Cancer

As reported by Chi et al in The Lancet Oncology, the addition of abiraterone and prednisone to androgen-deprivation therapy (ADT) in the phase III LATITUDE trial was associated with improved patient-reported outcomes in patients with newly diagnosed metastatic castration-naive prostate cancer. The...

immunotherapy

CAR T-Cell Immunotherapy Named Advance of the Year in ASCO’s Clinical Cancer Advances 2018

A new and unique new way to treat cancer—chimeric antigen receptor (CAR) T-cell therapy—is poised to transform the outlook for children and adults with certain otherwise incurable cancers. ASCO named this type of adoptive-cell immunotherapy the Advance of the Year in its annual...

breast cancer
colorectal cancer

Two Genetic Mutations Implicated in Breast Cancer Emerge From Study of Lynch Syndrome

Researchers at Columbia University Irving Medical Center (CUIMC) and GeneDx, a genetic testing company, have identified two new genetic mutations associated with breast cancer: MSH6 and PMS2. The researchers’ study—published by Roberts et al in Genetics in Medicine—suggests that...

breast cancer
colorectal cancer
gynecologic cancers
hepatobiliary cancer
lung cancer
pancreatic cancer
gastroesophageal cancer

Detecting and Localizing Eight Cancer Types With One Multianalyte Blood Test

Johns Hopkins Kimmel Cancer Center researchers developed a single blood test that screens for eight common cancer types and also helps identify the location of the cancer. The test, called CancerSEEK, is a unique noninvasive, multianalyte test that simultaneously evaluates levels of eight cancer...

gynecologic cancers

Addition of Hyperthermic Intraperitoneal Chemotherapy to Cytoreductive Surgery in Advanced Ovarian Cancer

In a Dutch/Belgian phase III trial reported in The New England Journal of Medicine by van Driel et al, the addition of hyperthermic intraperitoneal chemotherapy to interval cytoreductive surgery following neoadjuvant chemotherapy was associated with significantly improved recurrence-free and...

multiple myeloma

Role of Bone-Modifying Agents in Multiple Myeloma: ASCO Clinical Practice Guideline Update

As reported in the Journal of Clinical Oncology by Kenneth Anderson, MD, of Dana-Farber Cancer Institute, and colleagues, ASCO has issued a clinical practice guideline update on the role of bone-modifying agents in multiple myeloma. The update was informed by an expert panel systematic literature...

multiple myeloma

Cardiovascular Adverse Events and Multiple Myeloma Treatment

In a systematic review and meta-analysis reported in JAMA Oncology, Waxman et al found that any-grade and grade ≥ 3 cardiovascular adverse events occurred in 18.1% and 8.2% of patients receiving carfilzomib (Kyprolis) for multiple myeloma in clinical trials. Study Details The study involved...

kidney cancer

Risk Prediction Model for Acute Kidney Injury After First Course of Cisplatin

As reported in the Journal of Clinical Oncology, Motwani et al have developed a predictive model for acute kidney injury following a first course of cisplatin that includes patient age, cisplatin dose, hypertension, and serum albumin level. Study Details The study involved data from 2,118...

multiple myeloma
immunotherapy

FDA Grants Priority Review for Daratumumab in Front-Line Multiple Myeloma Setting

On January 19, the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone for the treatment of patients with newly diagnosed...

Former President and Director of Fred Hutchinson Cancer Research Center, Robert W. Day, MD, Dies at 87

ROBERT W. DAY, MD, the longest-serving President and Director of Fred Hutchinson Cancer Research Center and the leader who brought into being its campus overlooking Seattle’s South Lake Union, died in his Seattle home on January 6, 2018 of lung cancer. He was 87.  “It is a tragic loss for all of...

cns cancers

Adjuvant Temozolomide in 1p/19q Non-codeleted Anaplastic Glioma

Interim results of the phase III CATNON trial (EORTC study 26053-22054) indicate a survival benefit of adjuvant temozolomide in 1p/19q non-codeleted anaplastic glioma. These findings were reported in The Lancet by Martin J. van den Bent, MD, of the Brain Tumour Centre at Erasmus MC Cancer...

head and neck cancer

Plasma Epstein-Barr Virus DNA Screening for Nasopharyngeal Cancer

In a Hong Kong study reported in The New England Journal of Medicine, K.C. Allen Chan, MBBS, PhD, MRCP, FRCPA, FHKCPath, FHMAM, of The Chinese University of Hong Kong, Department of Chemical Pathology, and colleagues found that screening for circulating cell-free Epstein-Barr virus (EBV) DNA is...

Community Oncology Alliance Elects Officers and New Board Members for 2018

THE COMMUNITY ONCOLOGY ALLIANCE (COA) is pleased to announce the election of new members to the Board of Directors and Executive Committee. Additionally, the COA Board has launched and nominated participants for a dedicated standing committee on Government Affairs and Policy as well as Payment...

solid tumors
issues in oncology
global cancer care

Second Global AYA Cancer Congress Highlights Research Advances and the Global Burden of Cancer Among Young Adults

This past December, nearly 400 medical professionals from a variety of fields—including medical oncology, palliative care, science, nursing, social work, and psychology—and 23 countries traveled to Atlanta, to attend the 2nd Global Adolescent & Young Adult (AYA) Cancer Congress. The 3-day...

colorectal cancer
immunotherapy

2018 GI CANCERS SYMPOSIUM: Nivolumab Plus Ipilimumab Yields Survival Benefit in Metastatic Colorectal Cancer

Nivolumab (Opdivo) plus ipilimumab (Yervoy) led to a 1-year overall survival rate of 85% in previously treated metastatic colorectal cancer patients with DNA mismatch repair–deficient (dMMR) or microsatellite instability–high (MSI-H) tumors. These data were presented in the first report ...

prostate cancer

Pomegranates and Other Polyphenols: New Evidence to Share With Prostate Cancer Patients

The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Channing Paller, MD, explores the role of pomegranate- and grape-based...

breast cancer
kidney cancer

Reports From the Journal of Clinical Oncology

BREAST CANCER  Survival in Metastatic Triple-Negative Breast Cancer Explored in Retrospective Study  In a study reported in the Journal of Clinical Oncology, Stover et al found that cell-free (cf) DNA tumor fraction ≥ 10% was associated with worse survival in metastatic triple-negative breast...

solid tumors
lung cancer

FDA Approves Afatinib for Previously Untreated, Metastatic NSCLC With Other Nonresistant EGFR Mutations

On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted approval to afatinib (Gilotrif) for a broadened indication in first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have nonresistant epidermal growth factor receptor (EGFR) mutations ...

solid tumors
lung cancer
immunotherapy

Durvalumab Takes a Giant Leap Into Stage III NSCLC

Immune checkpoint inhibitors have had a dramatic impact on survival for patients with stage IV non–small cell lung cancer (NSCLC), with whispers that a cure might be achieved in a subset of patients. In typical fashion, active new agents are evaluated in earlier stages of disease. Stage III NSCLC...

pancreatic cancer

2018 GI CANCERS SYMPOSIUM: Nab-Paclitaxel Plus Gemcitabine in Locally Advanced Pancreatic Cancer

Primary endpoint findings and updated results of secondary endpoints from the phase II LAPACT trial of nanoparticle albumin–bound (nab)-paclitaxel (Abraxane) plus gemcitabine in patients with locally advanced pancreatic cancer were presented by Hammel et al at the 2018 Gastrointestinal (GI)...

colorectal cancer

2018 GI CANCERS SYMPOSIUM: Novel Triplet Combination Improves Progression-Free Survival in Patients With BRAF-Mutant Colorectal Cancer

Updated results were recently reported from the 30 patient safety lead-in of the phase III BEACON CRC trial evaluating the triplet combination of encorafenib (a BRAF inhibitor), binimetinib (an MEK inhibitor), and cetuximab (Erbitux, an anti–EGFR antibody) in patients with BRAF-mutant...

solid tumors
lung cancer

ASCO Endorsement of ASTRO Guideline on Stereotactic Body Radiotherapy for NSCLC Highlights Shared Patient Decision-Making

As reviewed in this issue of The ASCO Post, a recent ASCO panel, chaired by Bryan Schneider, MD, and Brendon Stiles, MD, has provided an endorsement of a recently published guideline on the use of stereotactic body radiotherapy for non–small cell lung cancer.1 The original guideline,2 developed and ...

solid tumors
lung cancer

ASCO Endorses ASTRO Guideline on Stereotactic Body Radiotherapy for Early-Stage NSCLC

As reported in the Journal of Clinical Oncology by Bryan J. Schneider, MD, of the University of Michigan, Ann Arbor, and colleagues, ASCO has endorsed the recently released American Society for Radiation Oncology (ASTRO) evidence-based guideline on stereotactic body radiotherapy (SBRT) in early...

Diary of a Storm

FOR DAYS BEFORE HURRICANE HARVEY was expected to move toward Houston, Texas, on Sunday, August 27, 2017, after pummeling other cities in Texas and Louisiana, the leadership team at The University of Texas MD Anderson Cancer Center (MD Anderson) in Houston strategized on how to ensure the...

bladder cancer
immunotherapy

Pembrolizumab in Advanced Urothelial Carcinoma

On May 18, 2017, pembrolizumab (Keytruda) was granted regular approval for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...

lung cancer

Ceritinib in ALK-Positive Metastatic Non–Small Cell Lung Cancer

 On May 26, 2017, ceritinib (Zykadia) was granted regular approval for treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by a U.S. Food and Drug Administration–approved test.1,2 In 2014, the drug received ...

Roswell Park Cancer Institute Appoints New Leaders for 2018

AT THE START OF 2018, seven senior employees assumed new roles at Roswell Park Cancer Institute in Buffalo, New York. Five of these program leaders were promoted or reappointed, and two have newly joined the Institute from other centers around the United States.  Meet the Appointees  Charles...

survivorship

Cancer Statistics, 2018: U.S. Cancer Mortality Continues Decades-Long Drop

THE CANCER death rate dropped 1.7% from 2014 to 2015, continuing a drop that began in 1991 and has reached 26%, resulting in nearly 2.4 million fewer cancer deaths during that time.  The data are reported in “Cancer Statistics, 2018,” the American Cancer Society’s comprehensive annual report on...

Howard A. ‘Skip’ Burris III, MD, FACP, FASCO, Elected ASCO President for 2019–2020 Term

Howard A. “Skip” Burris III, MD, FACP, FASCO, a long-time member and volunteer, has been elected to serve as the President of ASCO for the term beginning in June 2019. He will take office as President-Elect during the ASCO Annual Meeting in Chicago in June 2018. Additionally, five members were...

gastroesophageal cancer

Abraham J. Wu, MD, on Esophageal Cancer: Impact of Lung and Heart Dose on Survival After Radiotherapy

Abraham J. Wu, MD, of Memorial Sloan Kettering Cancer Center, discusses his findings that suggest efforts to reduce lung dose, such as shrinking the treatment volumes or using proton therapy, may improve outcomes in esophageal cancer (Abstract 3).

gastrointestinal cancer

2018 GI CANCERS SYMPOSIUM: Cabozantinib Demonstrates Significant Overall Survival Benefit in Patients With Previously Treated Advanced HCC

Detailed results of the phase III CELESTIAL trial in patients with previously treated advanced hepatocellular carcinoma (HCC) were presented in a late-breaking oral session by Abou-Alfa et al at the 2018 ASCO Gastrointestinal (GI) Cancers Symposium (Abstract 207). Study Findings In CELESTIAL,...

gastrointestinal cancer
immunotherapy

2018 GI CANCERS SYMPOSIUM: KEYNOTE-224 Trial: Pembrolizumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib

Findings from the phase II KEYNOTE-224 trial investigating the use of pembrolizumab (Keytruda) in patients with advanced hepatocellular carcinoma who were previously treated with sorafenib (Nexavar) were presented by Zhu et al at the 2018 Gastrointestinal (GI) Cancers Symposium in San Francisco...

issues in oncology
survivorship

Preserving Sexual Function in Women Treated for Cancer

“There is huge potential to positively influence a patient’s experience and outcomes” by addressing concerns about sexual function after cancer treatment early in the course of treatment planning, Stacy Tessler Lindau, MD, MA, stated in her keynote address at the 11th Annual Oncofertility...

hematologic malignancies
leukemia
immunotherapy

Venetoclax Plus Rituximab Outperforms Standard Bendamustine Plus Rituximab in CLL

  Venetoclax (Venclexta) plus rituximab (Rituxan)—a non–chemotherapy-containing regimen—was superior to standard-of-care bendamustine plus rituximab for patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to a final analysis of the phase III MURANO study reported at...

hematologic malignancies
lymphoma
immunotherapy

Update on CAR T-Cell ‘Breakthrough’ Therapy in Lymphoma

Primary analysis of the JULIET trial adds to mounting evidence that chimeric antigen receptor (CAR) T-cell therapy is effective for the treatment of lymphoma in patients with no other good treatment options. A single infusion of CAR T cells (CTL019) achieved durable remissions in almost 40% of...

hematologic malignancies
lymphoma

Best Outcomes to Date in Older Patients With Hodgkin Lymphoma

  Older patients with Hodgkin lymphoma typically do not fare as well as younger patients on standard regimens. A phase II study reported the best outcomes to date in older patients with Hodgkin lymphoma who were treated with sequential brentuximab vedotin (Adcetris) before and after a regimen of...

hematologic malignancies

Carfilzomib-Based Treatment and Transplant in Smoldering Myeloma

Can aggressive treatment of high-risk smoldering multiple myeloma patients prevent disease worsening? A carfilzomib (Kyprolis)-based regimen and autologous stem cell transplant (ASCT) plus maintenance produced encouraging outcomes in the phase II GEM-CESAR study by the Spanish Myeloma Group. The...

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