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Showing 1951 - 2000FDA Pipeline: Updates on Treatments in NSCLC and Lymphomas, Plus New Dosimetry Software
The U.S. Food and Drug Administration (FDA) recently granted the following application, designations, and clearance: sBLA for Atezolizumab Plus Chemotherapy for First-Line Treatment of Metastatic, Nonsquamous NSCLC On January 17, the FDA accepted a supplemental biologics license application...
FDA Approves Ibrutinib in Combination With Obinutuzumab in Treatment-Naive CLL/SLL
Today, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica), a Bruton's tyrosine kinase inhibitor, in combination with obinutuzumab in treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first approval of a...
IMpassion130 Trial: Changing the Treatment Landscape in Metastatic Triple-Negative Breast Cancer
THE IMPASSION130 trial—reported in The New England Journal of Medicine by Schmid et al1 and reviewed in this issue of The ASCO Post—was an eagerly awaited study in newly diagnosed metastatic triple-negative breast cancer. To briefly review, 902 patients were randomly assigned in a 1:1 fashion to...
Challenge Moving Forward in Breast Cancer Treatment: To Show That New Approaches Change Outcomes
ADVANCES IN treating breast cancer over the past 20 years have brought us to the point where treatment can be confidently de-escalated for some patients, and immunotherapy and precision decision-making may change the way breast cancer is treated for others, William Gradishar MD, FASCO, told the...
Risk of Local Recurrence in Breast Cancer: Impact of Molecular Subtype and Surgical Approach
THE RISK of local recurrence in breast cancer “does not differ substantially based on the operation we perform, but it does differ substantially by subtype,” Tari A. King MD, FACS, stated at the 2018 Lynn Sage Breast Cancer Symposium in Chicago.1 At 10-year follow-up, Dr. King reported, local...
Primary Prophylaxis With a Direct Oral Anticoagulation Agent Reduces Venous Thromboembolism Rate in Ambulatory Patients With Cancer
LATE-BREAKING results from the large, randomized, placebo-controlled CASSINI trial showed that primary prophylaxis with the direct oral anticoagulation agent rivaroxaban reduced the incidence of venous thromboembolism (VTE) as well as VTE-related deaths in high-risk patients with cancer who were...
PACIFIC Trial of Durvalumab Sets Standard in Stage III Unresectable NSCLC
IMMUNOTHERAPY HAS revolutionized the treatment of lung cancer over the past several years. Although lung cancer is associated with immunosuppression at baseline for most patients, the addition of immune checkpoint inhibitors can overcome that suppression and lead to antitumor immune responses....
Low-Dose Tamoxifen Halves Breast Cancer Risk in Women With Preinvasive Breast Lesions
A VERY LOW DOSE of tamoxifen—5 mg/d, given for 3 years rather than 5 years—halved the risk of breast cancer recurrence or new lesions over placebo in women with breast intraepithelial neoplasia, without producing the usual toxicities seen with the standard dose, Italian researchers reported at the...
2019 GI Cancers Symposium: Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Short-Course Radiation vs Concurrent Chemoradiation
The delivery of all radiotherapy and chemotherapy neoadjuvantly—also known as total neoadjuvant therapy—has improved complete response and downstaging rates compared to treatment after surgery in patients with rectal cancer. In a study presented by Chapman et al at the 2019...
A Tribute to Arti Hurria, MD, FASCO, a Leader in Geriatric Oncology
The oncology community is deeply saddened by the untimely passing of Arti Hurria, MD, FASCO, a nationally regarded expert and advocate for elderly patients with cancer. Dr. Hurria died on November 7, 2018, in a traffic accident. At the time of her tragic death, Dr. Hurria was Director of the City...
Use of Valerian to Relieve Anxiety in Patients With Cancer
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. Eugenie Spiguel, MSN, ANP-BC, and Jyothirmai Gubili, MS, explore the use of valerian for...
2019 GI Cancers Symposium: Durvalumab, Tremelimumab, and Best Supportive Care vs Best Supportive Care Alone in Advanced, Refractory Colorectal Cancer
The phase II CCTG CO.26 trial evaluated whether the combination of durvalumab, a programmed cell death ligand 1 (PD-L1) inhibitor, and tremelimumab, an anti–cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) antibody, plus best supportive care improved survival vs best supportive care ...
2019 GI Cancers Symposium: Pembrolizumab in Second-Line Therapy for Advanced Esophageal Cancer
Pembrolizumab significantly improved overall survival in the second-line setting of advanced esophageal cancer in patients whose tumors tested positive for programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) of 10 or greater. This was compared to investigator’s choice...
FDA Approves Cabozantinib in Previously Treated Hepatocellular Carcinoma
On January 14, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib. The FDA’s approval of this oral tyrosine kinase inhibitor was based on the results of the phase III...
2019 GI Cancers Symposium: Neoadjuvant Chemotherapy vs Upfront Surgery in Resectable Pancreatic Cancer
A phase II/III trial presented by Unno et al at the 2019 Gastrointestinal Cancers Symposium (Abstract 189) sought to compare neoadjuvant chemotherapy (using gemcitabine and the oral fluoropyrimidine combination of tegafur/gimeracil/oteracil [S-1]) to upfront surgery in patients with histologic ...
New Regulations Require Better Communication With Patients Who Have Disabilities and Limited English Proficiency
Ever since President Barack Obama signed the Patient Protection and Affordable Care Act (ACA) into law on March 23, 2010, the nondiscrimination provision of the law, Section 1557, which prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health ...
2019 GI Cancers Symposium: Addition of Andecaliximab to mFOLFOX6 in Treatment-Naive Advanced Gastric or GEJ Adenocarcinoma
A phase I/Ib study found that the addition of andecaliximab, a monoclonal antibody that inhibits matrix metalloproteinase 9, to modified fluorouracil (5-FU), leucovorin, and oxaliplatin (mFOLFOX6) showed activity in gastric and or gastroesophageal junction (GEJ) carcinoma. Based on these...
Impact of Survival Predictions on Aggressive End-of-Life Care Among Patients With Metastatic Cancer
In a single-institution study reported in the Journal of Oncology Practice, Sborov et al found that inaccurate prediction of life expectancy can be associated with greater likelihood of aggressive end-of-life care among patients with metastatic cancer receiving palliative radiation therapy. Study...
Germline DNA Repair Mutations and Outcomes in Metastatic Castration-Resistant Prostate Cancer
A subset of patients with aggressive prostate cancer are carriers of germline BRCA2 mutations, which are also linked to hereditary breast cancer, ovarian cancer, and pancreatic cancer. Study findings also showed family members of patients with prostate cancer who carry BRCA2 and DNA-repair...
FDA Approves Cabozantinib for Previously Treated Hepatocellular Carcinoma
On January 14, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib. The FDA’s approval of cabozantinib was based on results from the phase III CELESTIAL trial....
Higher Incidence of Brain and CNS Tumors Among People Living in Appalachia
A recent study published by Ostrom et al in the Journal of Neuro-Oncology showed that compared to the rest of the United States, the Appalachian region has a 5% higher incidence of malignant primary brain tumors and other central nervous system (CNS) tumors, a higher mortality rate due to ...
Study Assesses Impact of Digital Mammography on Breast Cancer Detection and Recall Rates
The shift from film to digital mammography increased the detection of breast cancer overall in the United Kingdom—without increasing the recall rate—according to a study published by Blanks et al in Radiology. “Image quality with digital mammography is improved over that of...
Breakthrough Therapy Designation for Brentuximab Vedotin in Front-Line Treatment of Peripheral T-Cell Lymphomas
THE FDA recently granted Breakthrough Therapy designation to brentuximab vedotin (Adcetris) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in ...
Illustrating Genius
FOUR AND A HALF YEARS AGO, author Neil Canavan attended a scientific conference to learn what he could about the then-emerging field of immunotherapy for cancer. After a presentation by Zelig Eshhar, PhD, principal investigator in the Department of Immunology at the Weizmann Institute of Science...
New Data Reported From International Studies of Lung Cancer Treatment
At the European Society for Medical Oncology (ESMO) 2018 Congress, important studies were presented for every cancer type. Here, The ASCO Post offers some snapshots of lung cancer studies that may inform approaches to treating this common cancer, which—despite the advances in recent years—remains...
International Trials Present New Findings in Treatment of Breast Cancer
The European Society for Medical Oncology (ESMO) 2018 Congress featured an assortment of study findings, many with far-reaching clinical implications for the treatment of patients with various cancers. Many of these trials were covered in-depth in recent issues of The ASCO Post. Here, we present...
Optimal Duration of Checkpoint Inhibition in Melanoma Is No More Than 2 Years
For patients with advanced melanoma, the concept of treating to disease progression does not always apply. With many patients responding to checkpoint inhibition for years, when can treatment be safely discontinued? This important clinical question was addressed at the European Society for Medical...
Front-Line Daratumumab Combination Regimen Improves Outcomes in Multiple Myeloma
In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract...
Frederick National Laboratory Names Leonard P. Freedman, PhD, Chief Science Officer
Leonard P. Freedman, PhD, has been named Chief Science Officer at the Frederick National Laboratory for Cancer Research. He joins the Frederick National Laboratory after 6 years as Founding President of the Global Biological Standards Institute, a nonprofit organization dedicated to advancing life ...
FDA Approves Olaparib for Maintenance Treatment of BRCA-Mutated, Advanced Ovarian Cancer
On December 19, 2018, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer...
Nuclear Excision Repair as a Possible Predictor of Early Relapse in Pediatric ALL
Researchers recently discovered that by testing the level of nucleotide excision repair (NER) gene expression, pediatric oncologists may be able to determine the likelihood of early relapse (less than 3 years) in patients with acute lymphoblastic leukemia (ALL). These findings were published by...
Jonathan Chernoff, MD, PhD, Receives Grant to Investigate RAC1-Mutant Melanoma
Jonathan Chernoff, MD, PhD, Chief Scientific Officer and Stanley P. Reimann Chair in Oncology Research at the Fox Chase Cancer Center, has received a grant from the Melanoma Research Foundation to support research on RAC1-mutant melanoma. The grant will provide $200,000 over 2 years. With this...
Will the Trump Administration’s Plan to Reduce Cancer Drug Prices Work?
High drug prices are the number one health-care concern of many Americans. The average price of a cancer drug rose from less than $10,000/yr before 2000 to more than $170,000/yr in 2017.1-3 Between 1995 and 2013, the launch price of cancer drugs increased by 10% to 12% every year, and the average...
KATHERINE Trial: Adjuvant T-DM1 Reduces Invasive Disease Risk by 50% vs Trastuzumab in HER2-Positive Early Breast Cancer
In patients with HER2-positive early breast cancer and residual disease after neoadjuvant chemotherapy, adjuvant treatment with trastuzumab emtansine (T-DM1; Kadcyla) reduced the risk of invasive disease by 50% over trastuzumab (Herceptin).1 The phase III KATHERINE study was presented at the 2018...
ESMO Immuno-Oncology 2018: KEYNOTE-010: Long-Term Treatment With Pembrolizumab in Previously Treated NSCLC
Patients with previously treated, advanced non–small cell lung cancer (NSCLC) who received pembrolizumab (Keytruda) showed significantly longer overall survival (OS) compared to those treated with docetaxel, Herbst et al reported at the ESMO Immuno-Oncology Congress 2018 in Geneva,...
FDA Approves Romiplostim for Pediatric Patients With Immune Thrombocytopenia
On December 14, 2018, the U.S. Food and Drug Administration (FDA) approved romiplostim (Nplate) for pediatric patients at least 1 year old with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Approval was based ...
Genetic Assay May Help Predict Disease Relapse in Patients With Gastroesophageal Cancer
A seven-gene assay could improve care for patients with gastroesophageal cancer by predicting their likelihood of relapse after chemotherapy and surgery. These findings were published by Smyth et al in Annals of Oncology. A team at The Institute of Cancer Research (ICR), London, and The Royal...
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
Management of HER2-Positive Breast Cancer: Business as Usual?
MANAGEMENT OF HER2-positive breast cancer changed after the introduction of trastuzumab (Herceptin), the first anti-HER2 therapy to be approved by the U.S. Food and Drug Administration (FDA) for this type of cancer. Recent studies have more clearly defined the role of pertuzumab (Perjeta) and...
SABCS 2018: Oxybutynin for the Management of Hot Flashes in Women Unable to Receive Hormone Replacement Treatment
Treatment with oxybutynin helped reduce the frequency and intensity of hot flashes for women who could not take hormone replacement therapy, including breast cancer survivors, according to the results of a trial presented at the 2018 San Antonio Breast Cancer Symposium by Leon-Ferre et al (Abstract ...
FDA Approves Atezolizumab in Combination With Bevacizumab and Chemotherapy for First-Line Treatment of Metastatic, Nonsquamous NSCLC
On December 6, 2018, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or...
ASH 2018: Ibrutinib Plus Rituximab vs Standard Chemoimmunotherapy in Younger Patients With Treatment-Naive CLL
A 6-month course of chemotherapy-based treatment with FCR (intravenous fludarabine and cyclophosphamide plus rituximab [Rituxan]) has historically been the most effective treatment for chronic lymphocytic leukemia (CLL), especially in patients 70 years of age and younger. However, results from a...
SABCS 2018: Does Adjuvant Capecitabine Improve Outcomes in Early-Stage Triple-Negative Breast Cancer?
Treating patients with early-stage triple-negative breast cancer with capecitabine after surgery and standard chemotherapy did not significantly improve disease-free or overall survival compared with observation, according to data from the randomized, phase III GEICAM/CIBOMA clinical trial...
ASH 2018: CASSINI Trial: Rivaroxaban Thromboprophylaxis for VTE Prevention in Patients With Cancer
A new study suggests taking a direct oral anticoagulant (DOAC) can reduce the risk of harmful blood clots in patients undergoing cancer treatments, without substantially increasing the risk of bleeding problems. Findings from the CASSINI trial were presented by Khorana et al at the 2018 American...
ASH 2018: CAR.CD30 T-Cell Therapy in Relapsed or Refractory CD30-Positive Lymphomas
At the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, Grover et al presented preliminary results from a clinical study of an investigational cellular immunotherapy for Hodgkin lymphoma and non-Hodgkin lymphoma expressing the CD30 protein marker (Abstract 681). Data...
ASH 2018: Apixaban for the Treatment of Cancer-Associated VTE
According to findings from the ADAM VTE trial, an oral drug, apixaban (Eliquis), is safe and effective in treating blood clots in patients undergoing cancer therapy. The drug was associated with fewer major bleeding events and fewer recurrent blood clots compared to low–molecular-weight. ...
John P. Leonard, MD, on NHL: Results From the AUGMENT Trial
John P. Leonard, MD, of Weill Cornell Medicine/Cornell University, discusses phase III findings on lenalidomide plus rituximab vs rituximab plus placebo for people with relapsed or refractory indolent non-Hodgkin lymphoma (Abstract 445).
ASH 2018: Four vs Six Cycles of Chemotherapy in Diffuse Large B-Cell Lymphoma
A new study suggests that it may be safet to reduce the standard course of treatment for younger patients with low-risk diffuse large B-cell lymphoma (DLBCL) by two cycles of chemotherapy. The trial, which tracked patients for a median of more than 5 years and up to 11 years, showed 4 cycles of...
Discontinuation of Follow-up Care Among Women With Early-Stage Breast Cancer
In a study using linked Surveillance, Epidemiology, and End Results (SEER)-Medicare data reported in the Journal of Oncology Practice, Quyyumi et al found that 21% of women with early-stage breast cancer discontinued follow-up care within 5 years after diagnosis. Study Details The study involved...
ADVISE PATIENTS ABOUT THE IMPLICATIONS OF RACIAL DISPARITIES FOR BREAST CANCER SCREENING
“BLACK WOMEN are more likely to develop breast cancer at a younger age, compared with white American women, and at all ages, younger and older individuals are more likely to develop triple-negative breast cancers,” Lisa A. Newman, MD, MPH, told The ASCO Post. “So, I think it is very clear that if...
