ELCC 2018: Second-Line Tyrosine Kinase Inhibitor Therapy Demonstrates Clinical Benefit in EGFR-Mutated NSCLC With Leptomeningeal Metastasis

Erlotinib (Tarceva) or high-dose erlotinib provides benefit in patients with epidermal growth factor receptor (EGFR) mutated non–small cell lung cancer (NSCLC) who develop leptomeningeal metastasis during or after treatment with a tyrosine kinase inhibitor. Findings supporting second-line...

ELCC 2018: Alectinib Provides Longer Symptom Improvement Than Crizotinib in ALK-Positive Lung Cancer

Alectinib provides longer symptom improvement than crizotinib in <em>ALK</em>-positive non–small cell lung cancer (NSCLC), according to results from the ALEX trial presented by Pérol et al at the European Lung Cancer Congress (ELCC) in Geneva, Switzerland (Abstract...

ELCC 2018: Immunotherapy Provides Long-Term Survival Benefit for Patients With Lung Cancer

Further evidence that immunotherapy provides long-term survival benefit for patients with lung cancer was presented by Mazières et al at the European Lung Cancer Congress (ELCC) in Geneva, Switzerland (Abstract 136PD_PR). Researchers presented the 3-year survival results of the randomized...

ASCO Clinical Practice Guideline: Optimizing Anticancer Therapy in Metastatic Noncastrate Prostate Cancer

As reported in the Journal of Clinical Oncology by Michael J. Morris, MD, of Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, and colleagues, ASCO has released a clinical practice guideline on optimizing anticancer therapy in men with metastatic noncastrate prostate cancer. To...

Larotrectinib in Pediatric Solid Tumors With TRK Gene Fusions

As reported in The Lancet Oncology by Laetsch et al, phase I results from an ongoing phase I/II trial have shown activity of the TRK kinase inhibitor larotrectinib in pediatric patients with solid tumors harboring TRK fusions. Study Details In the study, 24 patients in a dose-escalation cohort...

ESMO Releases Comments on Findings From the Pan-Cancer Atlas

The European Society for Medical Oncology (ESMO) welcomes the latest reports from The Cancer Genome Atlas (TCGA) as a major resource for researchers across the world and calls for increased across-the-board commitment to translate these efforts into medical advances for the benefit of patients with ...

NIH Completes In-Depth Genomic Analysis of 33 Cancer Types

Researchers funded by the National Institutes of Health (NIH) have completed a detailed genomic analysis, known as the Pan-Cancer Atlas, on a data set of molecular and clinical information from over 10,000 tumors representing 33 types of cancer. “This project is the culmination of more than...

palliative care
lung cancer

Updated ASTRO Guideline for Palliative Radiotherapy in Lung Cancer

The American Society for Radiation Oncology (ASTRO) has issued an update to its clinical guideline for the use of palliative-intent radiation therapy for patients with incurable non–small cell lung cancer (NSCLC). Reflecting new evidence from randomized clinical trials, the guideline now...

Selinexor Receives Fast Track Designation From the FDA in Pentarefractory Multiple Myeloma

On April 10, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the oral selective inhibitor of nuclear export (SINE) compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy.  The FDA’s...

cns cancers
skin cancer

Nivolumab/Ipilimumab or Nivolumab Alone in Melanoma Brain Metastases

In an Australian phase II trial reported in The Lancet Oncology, Long et al found that the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) and nivolumab alone showed intracranial activity in patients with melanoma brain metastases. Study Details In the open-label trial, 76 evaluable...

Targeted Sequencing Detection of Molecular Minimal Residual Disease and Prognosis in AML

In a study reported in The New England Journal of Medicine, Jongen-Lavrencic et al found that molecular minimal residual disease identified by next-generation sequencing during complete remission was associated with increased risk of relapse and mortality over 4 years of follow-up in patients with...

Notch Signaling and Treatment With Vismodegib in Basal Cell Carcinoma

A study by Eberl et al in Cancer Cell has pinpointed a mechanism that controls how basal cell cancers respond to treatment and offers new ideas for controlling this disease. Basal cell carcinomas are incredibly common—somewhere between 1 million to 3 million diagnosed each year—and...

FDA and EMA Accept Regulatory Submissions for Dacomitinib in Metastatic NSCLC With EGFR-Activating Mutations

On April 4, Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) accepted the company’s new drug application and granted Priority Review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for the first-line treatment of...

mTOR Inhibitor Plus Endocrine Therapy in Postmenopausal Women With Advanced ER-Positive, HER2-Negative Breast Cancer

In the phase II BOLERO-4 trial reported in JAMA Oncology, Royce et al found that the combination of the mTOR inhibitor everolimus (Afinitor) and endocrine therapy was active in first-line treatment of postmenopausal women with advanced estrogen receptor (ER)-positive, human epidermal growth factor...

Adjuvant Chemotherapy Duration in Stage III Colon Cancer

In a preplanned pooled analysis of phase III trials reported in The New England Journal of Medicine, Grothey et al did not establish noninferiority of 3 vs 6 months of adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CAPOX (capecitabine and oxaliplatin) in disease-free survival in...

Updated Analysis of Obinutuzumab in Rituximab-Refractory Indolent Non-Hodgkin Lymphoma

As reported in the Journal of Clinical Oncology by Cheson et al, an updated analysis of the phase III GADOLIN trial showed an overall survival advantage with obinutuzumab (Gazyva) plus bendamustine induction followed by obinutuzumab maintenance vs bendamustine alone in patients with rituximab...

FDA Expands Rucaparib Approval to Include Maintenance Treatment of Recurrent Ovarian Cancer

Today, the U.S. Food and Drug Administration (FDA) approved rucaparib (Rubraca) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy. The FDA...

Phase III REACH-2 Study in Hepatocellular Carcinoma Meets Overall Survival Endpoint

Topline results from the phase III REACH-2 study of ramucirumab (Cyramza) as a single agent in the second-line treatment of patients with hepatocellular carcinoma (HCC) were recently announced. The trial met its primary endpoint of overall survival as well as the secondary endpoint of...

FDA Grants Fast Track Designation for TAR-200 in Muscle-Invasive Bladder Cancer

On April 3, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TAR-200, a gemcitabine-releasing intravesical system (GemRIS), for the treatment of patients with organ-confined or locally advanced muscle-invasive bladder cancer who are unfit for curative-intent therapy....

Nivolumab Plus Ipilimumab vs Sunitinib in Previously Untreated Advanced RCC

As reported in The New England Journal of Medicine by Motzer et al, the phase III CheckMate 214 trial has shown an overall survival advantage with nivolumab plus ipilimumab vs sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC). Study Details In the open-label...

Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

In a retrospective cohort study reported in JAMA Oncology, Cercek et al found evidence supporting the use of total neoadjuvant therapy as an effective option in locally advanced rectal cancer. Study Details The study involved data on 811 patients presenting with locally advanced rectal cancer (T3 ...

EMA to Review Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma

On April 3, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery....

FDA Accepts BLA for Moxetumomab Pasudotox in Hairy Cell Leukemia

On April 3, the U.S. Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukemia (HCL) who have received at ...

Cardiovascular Risk Factors, Cardiac Events, and Survival in Patients With Breast Cancer Enrolled in SWOG Clinical Trials

In a study reported in the Journal of Clinical Oncology, Hershman et al found that each additional baseline cardiovascular disease risk factor was associated with increased risk for cardiac events and death among Medicare patients who had been enrolled in SWOG trials in breast cancer. Study...

gastroesophageal cancer
gastrointestinal cancer

Anti–PD-1 Immunotherapy in Previously Treated Gastric Cancer

As reported in JAMA Oncology by Fuchs et al, pembrolizumab (Keytruda) showed activity in patients with previously treated advanced gastric and gastroesophageal junction cancer in the phase II KEYNOTE-059 trial. Study Details In the study, 259 patients from sites in 16 countries who had disease...

First-Line Avelumab in Metastatic Merkel Cell Carcinoma

In a preplanned interim analysis of a phase II trial (JAVELIN Merkel 200 part B) reported in JAMA Oncology, D’Angelo et al found that avelumab was active in the first-line treatment of metastatic Merkel cell carcinoma. Avelumab was approved in March 2017 for treatment of patients aged ≥ 12 ...

Comprehensive Genomic-Profiling Assay FoundationOne CDx Is Commercially Available

On March 30, Foundation Medicine announced that FoundationOne CDx, the first U.S. Food and Drug Administration (FDA)-approved comprehensive genomic-profiling assay for all solid tumors incorporating multiple companion diagnostics, is now available in the United States. FoundationOne CDx is a...

EBCC-11: Mastectomy and Axillary Dissection and Neoadjuvant Targeted Treatment in HER2-Positive Breast Cancer

Extensive surgery involving mastectomy and removal of several lymph nodes may be safely avoided for more women with some types of breast cancer if they receive targeted drugs before surgery, according to research presented at the 11th European Breast Cancer Conference (EBCC-11) (Abstract 19). The...

Immunotherapy in Recurrent and Metastatic Nasopharyngeal Carcinoma

In an international phase II trial (Mayo Clinic Phase 2 Consortium–NCI-9742) reported in the Journal of Clinical Oncology, Ma et al found that nivolumab (Opdivo) was active in previously treated recurrent or metastatic nasopharyngeal carcinoma. Study Details In the study, 44 evaluable...

Extended Follow-up of Nivolumab Treatment in Relapsed/Refractory Classical Hodgkin Lymphoma After Failure of Autologous HCT

As reported by Armand and colleagues in the Journal of Clinical Oncology, extended follow-up of the phase II CheckMate 205 trial continues to show benefits and good tolerability of nivolumab (Opdivo) treatment in relapsed or refractory classical Hodgkin lymphoma after failure of autologous ...

MRI-Targeted vs Standard Biopsy in Prostate Cancer Diagnosis

In the international PRECISION trial reported in The New England Journal of Medicine, Kasivisvanathan et al found that magnetic resonance imaging (MRI)-targeted biopsy resulted in a significantly higher rate of diagnosis of clinically significant prostate cancer and a lower rate of diagnosis of...

SGO 2018: Participation in Clinical Trials May Overcome Health Disparities in Ovarian Cancer

Participation in clinical trials may overcome health disparities in the treatment of advanced or recurrent ovarian cancer, according to a study presented at the Society of Gynecologic Oncology’s (SGO) 2018 Annual Meeting on Women’s Cancer (Abstract 6). The study evaluated the effect of ...

IMpower150: Increased OS With Atezolizumab/Bevacizumab Plus Chemotherapy in Advanced Nonsquamous NSCLC

The phase III IMpower150 study met its coprimary endpoint of overall survival (OS) at interim analysis and showed that first-line treatment with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) plus carboplatin and paclitaxel (chemotherapy) helped patients with advanced...

EBCC-11: Women Report Fewer Side Effects With Partial or Reduced Breast Radiotherapy vs Standard WBRT

The average number of moderate or marked side effects reported by patients with breast cancer is lower if they are treated with radiotherapy to part of the breast or a reduced dose to the whole breast, rather than with standard whole breast radiotherapy (WBRT), according to new findings presented...

5-Year Follow-up of Patients Receiving Immunotherapy for Previously Treated Advanced NSCLC

As reported in the Journal of Clinical Oncology by Gettinger et al, 5-year follow-up of patients receiving nivolumab (Opdivo) in a phase I study (CA209-003) in previously treated advanced non­–small cell lung cancer (NSCLC) has shown prolonged survival and durable responses in a subgroup...

Addition of Trastuzumab to Carboplatin/Paclitaxel in HER2-Positive Uterine Serous Carcinoma

In a phase II trial reported in the Journal of Clinical Oncology, Fader et al found that the addition of trastuzumab (Herceptin) to carboplatin/paclitaxel improved progression-free survival among women with HER2-overexpressing uterine serous carcinoma. HER2 has been found to be overexpressed in...

Antibiotic Therapy for Helicobacter pylori Infection and Prevention of Metachronous Gastric Cancer

In a Korean study reported in The New England Journal of Medicine, Choi et al found that antibiotic treatment for Helicobacter pylori was associated with a significant reduction in metachronous gastric cancer in patients who had undergone endoscopic resection of early gastric cancer or high-grade...

First Interim Analysis of Phase III SEQUOIA Trial in Pancreatic Cancer

ARMO BioSciences, Inc, recently announced the completion of the first interim analysis in its phase III SEQUOIA trial in patients with pancreatic cancer. The Data Monitoring Committee (DMC) for SEQUOIA, a clinical trial studying pegilodecakin (AM0010) plus FOLFOX (leucovorin,...

EBCC-11: MINDACT Trial: Patients With Early Breast Cancer and Risk of Locoregional Recurrence

Women with small, low-grade, well-defined breast tumors and a genetic profile that shows they are at low risk of the cancer metastasizing have only a 1.4% risk of locoregional recurrence within 5 years, according to new results from a large randomized trial of nearly 7,000 patients. This low risk...

AAD Issues Guidelines for Treatment of Nonmelanoma Skin Cancer

Skin cancer is the most common cancer in the United States, and nonmelanoma skin cancer is the most common type of skin cancer, affecting more than 3 million Americans every year. Moreover, nonmelanoma skin cancer incidence is growing at an exponential rate—between 1976–1984 and...

Long-Term Outcomes With Standard vs Dose-Escalated Radiation Therapy in Intermediate-Risk Prostate Cancer

As reported in JAMA Oncology by Michalski et al, long-term follow-up in the NRG Oncology/RTOG 0126 trial showed no significant difference in overall survival with dose-escalated vs standard-dose radiotherapy in patients with intermediate-risk prostate cancer. High-dose radiotherapy was associated...

Modified XELIRI vs FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer

In an Asian phase III noninferiority trial (AXEPT) reported in The Lancet Oncology, Xu et al found that modified XELIRI (mXELIRI, capecitabine plus irinotecan) was noninferior in overall survival vs standard FOLFIRI (leucovorin, fluorouracil, and irinotecan), both given with or without bevacizumab...

Venetoclax Plus Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia

In the phase III MURANO trial reported in The New England Journal of Medicine by Seymour et al, the combination of the BCL2 inhibitor venetoclax (Venclexta) with rituximab (Rituxan) markedly improved progression-free survival vs bendamustine plus rituximab in patients with relapsed or refractory...

SGO 2018: Immunotherapy/PARP Inhibitor Combination Produces Remissions in Ovarian Cancer

A combination of the immunotherapy pembrolizumab (Keytruda) and the DNA repair–blocking agent niraparib (Zejula) can be significantly more effective than either drug alone in women with hard-to-treat ovarian cancer, a phase I/II clinical trial led by Dana-Farber Cancer Institute researchers...

EBCC-11: Sentinel Lymph Node Biopsy in Triple-Negative and HER2-Positive Breast Cancers

Sentinel lymph node biopsies may be safely avoided for some women, according to research presented at the 11th European Breast Cancer Conference (EBCC-11). Two new studies show that women with either triple-negative or HER2-positive types of breast cancer, whose cancers respond well to chemotherapy ...

FDA Accepts sBLA for Nivolumab Plus Ipilimumab in Previously Treated MSI-H or dMMR Metastatic Colorectal Cancer

On March 27, the U.S. Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of adults with microsatellite instability–high (MSI-H) or mismatch repair deficient...

FDA Expands Approval of Blinatumomab for Certain Patients With B-Cell Precursor ALL

The U.S. Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). In patients who have achieved remission after...

Study Cites Geographic Disparities in Lung Cancer Mortality Rates Among Women

According to the American Cancer Society, lung cancer is the leading cause of death among men and women, killing about 84,000 men and 71,000 women each year. Although lung cancer–related death rates in the United States have declined steadily since 1990 in men, they did not start to decline...

Linda D. Bosserman, MD, FACP, FASCO, Named Editor-in-Chief of Journal of Oncology Practice

Linda D. Bosserman, MD, FACP, FASCO, has been named Editor-in-Chief of the Journal of Oncology Practice (JOP), an ASCO publication. Dr. Bosserman is a recognized leader in cancer care delivery with a deep understanding of the issues impacting all types of oncology practices. "We are delighted ...

Quality of Life With Chemohormonal Treatment in Prostate Cancer

In the E3805 trial reported in the Journal of Clinical Oncology, Morgans et al found that chemohormonal therapy with docetaxel and androgen-deprivation therapy (ADT) was associated with poorer quality of life (QOL) at 3 months but better QOL at 12 months vs ADT alone in metastatic hormone-sensitive ...

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