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FDA Approves Givosiran for Acute Hepatic Porphyria

On November 20, the U.S. Food and Drug Administration (FDA) approved givosiran (Givlaari) for adults with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during the production of heme. “This buildup can cause acute attacks, known...

leukemia
lymphoma

FDA Approves Acalabrutinib for CLL/SLL as Part of Project Orbis

On November 21, as part of Project Orbis—a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada—the U.S. Food and Drug Administration (FDA) granted supplemental approval to acalabrutinib (Calquence) for the treatment of adults with chronic lymphocytic leukemia...

issues in oncology

Two Societies Issue Statements on E-Cigarettes

Today, the American Cancer Society (ACS) announced an update to the organization’s position on e-cigarettes, and the American Medical Association (AMA) called for a total ban on all e-cigarette and vaping products that do not meet U.S. Food and Drug Administration (FDA) approval as cessation ...

issues in oncology

Does Testosterone Replacement Therapy Benefit Young Male Cancer Survivors?

Young male cancer survivors may significantly benefit from testosterone replacement therapy—especially after testicular cancer. Research published by Walsh et al in PLOS Medicine looked at one of the most common late-onset side effects experienced by young male survivors—reduced levels of the male...

skin cancer

Role of Voriconazole in Cutaneous Squamous Cell Carcinoma Development

For the last decade, medical experts have known that voriconazole—an antifungal medication used to prevent infections in patients with compromised immune systems—is linked to the development of particularly aggressive squamous cell carcinoma in skin exposed to ultraviolet (UV) rays. However, the...

issues in oncology

Disparities in Culturally Competent Cancer Care

Many nonwhite minority cancer survivors place importance on seeing doctors who share or understand their culture, but are less likely than non-Hispanic whites to be able to see such physicians, according to a new study. The study, which is one of the first nationally-representative studies to...

gastrointestinal cancer

Maximizing Benefit in the Treatment of Immune-Mediated Colitis

Immune-related colitis is the second most common toxicity associated with checkpoint inhibitors, affecting up to 40% of patients. The ASCO Post interviewed Yinghong Wang, MD, PhD, Director of Medication-Induced Colitis and Enteritis, Director of Fecal Microbiota Transplantation, and Associate...

lymphoma

FDA Grants Accelerated Approval to Zanubrutinib for Pretreated Mantle Cell Lymphoma

On November 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa) for adult patients with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or ...

skin cancer

Reflections on Long-Term Outcomes With BRAF/MEK Inhibition in Advanced Melanoma

For the treatment of BRAF V600-mutated advanced melanoma, we now have three BRAF/MEK inhibitor combinations that are approved by the U.S. Food and Drug Administration: dabrafenib/trametinib, vemurafenib/cobimetinib, and encorafenib/binimetinib. Although the toxicity profiles for these combinations ...

prostate cancer
breast cancer
bladder cancer
pancreatic cancer
kidney cancer
thyroid cancer
gynecologic cancers
immunotherapy

ESMO Congress 2019: Quick Takes From Key Clinical Trials

The ESMO Congress continues to grow as a pivotal platform for research in clinical oncology. At the ESMO Congress 2019, important findings were showcased in more than 2,200 studies, including 93 late-breaking abstracts. The ASCO Post summarized much of that news in separate articles over several...

lung cancer
neuroendocrine tumors
immunotherapy

Novel Therapies for Small Cell Lung Cancer and Neuroendocrine Tumors

Here is a glimpse at updated clinical trial data on newer therapies under study for the small cell lung cancer (SCLC) and advanced extrapancreatic neuroendocrine tumors. IMpower133 and ALTER: Novel Therapies for SCLC The treatment of small cell lung cancer has seen little progress in recent years, ...

gastrointestinal cancer

Pivotal Phase III Study Evaluates Investigational TKI in Fourth-Line Setting for Advanced GIST

In a late-breaking, oral presentation at the ESMO Congress 2019, Margaret von Mehren, MD, presented results from ­INVICTUS, a pivotal phase III clinical trial of ripretinib in patients with advanced gastrointestinal stromal tumor (GIST).1 Ripretinib is an investigational tyrosine kinase inhibitor...

hepatobiliary cancer

Targeted Treatment Advances in Cholangiocarcinoma

For one of the rarest and most aggressive of tumors—cholangiocarcinoma—two novel molecularly targeted agents yielded encouraging outcomes in advanced disease in studies reported at the European Society for Medical Oncology (ESMO) Congress 2019. In the phase III ClarIDHy trial, the risk of disease...

prostate cancer

Expert Point of View: Eleni Efstathiou, MD

Formal study discussant Eleni Efstathiou, MD, of MD Anderson Cancer Center, Houston, commented on results of the PROfound trial at the ESMO Congress 2019. “This is the first phase III targeted therapy trial to deliver a positive outcome in metastatic castration-resistant prostate cancer,” she...

hepatobiliary cancer

Oral Direct-Acting Antiviral Therapy May Improve Survival in Patients With Hepatitis C Virus–Related HCC

Data from a new study presented by Dang et al at The Liver Meeting (Abstract 40) found that patients with hepatitis C virus–related hepatocellular carcinoma (HCC) who achieved sustained virologic response (denoting an undetectable level of the virus) with any oral direct-acting antiviral therapy...

lung cancer
issues in oncology

Rates of Non–Guideline-Concordant Lung Cancer Treatment in the United States

Only about 6 in 10 patients with lung cancer in the United States receive the minimal lung cancer treatments recommended by National Comprehensive Cancer Network® (NCCN) Guidelines, according to new research published by Blom et al in the Annals of the American Thoracic Society. Erik F. Blom, MD,...

Expert Point of View: Sanjay Popat, FRCP, PhD

Formal discussant of the CheckMate 227 trial, Sanjay Popat, FRCP, PhD, of the Royal Marsden Hospital, London, had some reservations about endorsing nivolumab/ipilimumab as a new standard of care, mainly related to toxicity. “The landscape of treating advanced non–small cell lung cancer has changed ...

lung cancer
immunotherapy

CheckMate 227: Nivolumab Plus Ipilimumab Presents Another Option in First-Line Treatment of Advanced Non–Small Cell Lung Cancer

The combination of nivolumab and ipilimumab improved overall survival compared with chemotherapy as first-line therapy for patients with advanced non–small cell lung cancer (NSCLC) and programmed cell death ligand 1 (PD-L1) expression of at least 1%, according to the results of CheckMate 227....

Expert Point of View: Pilar Garrido, MD, PhD

At a press conference at the ESMO Congress 2019, Pilar Garrido, MD, PhD, of Ramon y Cajal University Hospital, Madrid, commented on the FLAURA trial: “These results are good news for patients with lung cancer, which is the most common cause of cancer deaths. Advances in the understanding of the...

lung cancer

Osimertinib Improves Overall Survival vs Gefitinib, Erlotinib in Advanced EGFR-Mutated Non–Small Cell Lung Cancer: FLAURA Phase III Trial

The third-generation tyrosine kinase inhibitor osimertinib extended overall survival compared with the older tyrosine kinase inhibitors gefitinib and erlotinib in patients with EGFR-mutated advanced non–small cell lung cancer (NSCLC), according to late-breaking final overall survival results of the ...

Expert Point of View: Nicoletta Colombo, MD

The invited discussant of the two trials in cervical and endometrial cancers presented at the ESMO Congress 2019 was Nicoletta Colombo, MD, of the University of Milan-Bicocca in Italy, who commented on what she called “exciting results in cancers with unmet needs.” Dr. Colombo noted: “The studies...

gynecologic cancers
immunotherapy

Checkpoint Inhibitors Benefit Women With Advanced Stages of Cervical, Endometrial Cancers

Immunotherapy studies reported at the ESMO Congress 2019 yielded encouraging outcomes in patients with advanced cervical cancer that is microsatellite-stable and patients previously treated for advanced endometrial cancer. The combination of nivolumab and ipilimumab, with two different dosing...

gynecologic cancers

Phase III Trials Suggest Paradigm Shift With PARP Inhibitors in Ovarian Cancer

At the ESMO Congress 2019, ovarian cancer was a topic of heightened interest, particularly due to findings reported in several important phase III studies of PARP inhibitors in front-line maintenance therapy for patients with newly diagnosed advanced disease—and not just those with BRCA mutations....

breast cancer
immunotherapy

Neoadjuvant Immunotherapy Plus Chemotherapy Active in Women With Early Triple-Negative Breast Cancer

Immunotherapy has changed the treatment paradigms for melanoma, lung cancer, bladder cancer, and renal cancer. Now, checkpoint inhibitor therapy is making inroads in triple-negative breast cancer—one of the most difficult-to-treat aggressive types of breast cancer. Late-breaking results of the...

breast cancer

MONALEESA-3, MONARCH 2: CDK4/6 Inhibitors Plus Fulvestrant Benefit Survival in Advanced Breast Cancer

CDK4/6 inhibitors improve overall survival in advanced breast cancer, according to results of two important phase III trials reported at the ESMO Congress 2019. Dennis J. Slamon, MD, PhD, of the University of California, Los Angeles Women’s Cancer Research Program, presented the findings from the...

ESMO Congress 2019 Offers a Global Stage for Important Clinical Data

The European Society for Medical Oncology (ESMO) Congress 2019, held September 27 to October 1 in Barcelona, welcomed clinicians, researchers, journalists, and exhibitors from around the world to hear advances across the oncology spectrum, in both clinical medicine and basic research. For this...

issues in oncology
hepatobiliary cancer

Financial Burdens of Patients With Cirrhosis and Impact on Screening for HCC

Data from a new study presented by Singal et al at The Liver Meeting found that patients with cirrhosis in the United States have substantial financial burden and this is associated with underuse of surveillance for hepatocellular carcinoma (HCC) (Abstract 201). Improved intervention strategies are ...

colorectal cancer
geriatric oncology

Short-Term Survival in Patients Aged 85 Years and Older After Colorectal Cancer Surgery

Results from a preliminary research study showed the majority of patients aged 85 years and older were still alive in the short-term after undergoing segmental colectomy for stage II and III colon cancer. Kaur et al presented these findings at the American College of Surgeons Clinical Congress...

UNC Health Care Introduces New Blood Research Center

The University of North Carolina (UNC) Department of Medicine recently announced the formation of the new UNC Blood Research Center, administratively housed within the Division of Hematology and Oncology. Nigel Key, MD, the Harold R. Roberts Distinguished Professor of Medicine, Pathology and...

issues in oncology
hematologic malignancies
leukemia

How Clonal Hematopoiesis of Indeterminate Potential Increases the Risk of Heart Disease and Blood Cancers as People Age

Although stem cells throughout the body acquire genetic mutations over time, usually these alterations do not affect how the stem cells function or cause disease. However, recent research in clonal hematopoiesis and aging has found an association between clonal expansion of hematopoietic cells with ...

hematologic malignancies

Fedratinib: Back From ­Development Limbo for the Treatment of ­Myeloproliferative Neoplasms

In September 2019, Dr. Claire Harrison and colleagues, myself among them, presented two new analyses regarding the use of the JAK2 and FLT3 inhibitor fedratinib in myelofibrosis at the Society of Hematologic Oncology (SOHO) Annual Meeting, with resulting publication in Clinical Lymphoma, Myeloma...

Cleveland Clinic Names Halle Moore, MD, Director of Breast Medical Oncology, Adds New Staff Physicians

Halle Moore, MD, has been named Director of Breast Medical Oncology and Co-Director for the Comprehensive Breast Cancer Program at Cleveland Clinic. She will start her role in January 2020. Dr. Moore joined Cleveland Clinic in 1999 and specializes in the medical management of breast cancer. Her...

ASTRO and ACR Update Practice Parameters for Radiation Therapies

The American Society for Radiation Oncology (ASTRO) and the American College of Radiology (ACR) recently released seven updated practice parameters for medical providers who use radiation therapy to treat patients with cancer. The updated practice parameters synthesize the clinical best practices...

Barry Paul Sleckman, MD, PhD, to Lead O’Neal Comprehensive Cancer Center

Barry Paul Sleckman, MD, PhD, a well-known cancer researcher who focuses on understanding how DNA double-strand breaks are generated and repaired—a key topic for cancer and immune system development and function—has been named Director of the O’Neal Comprehensive Cancer Center at the University of ...

lung cancer
issues in oncology

Early Lung Cancer Detection Followed by Minimally Invasive Surgery Saves Lives

Lung cancer remains the number one cancer killer, leading to about 150,000 deaths per year in the United States and accounting for approximately 25% of all cancer deaths in the nation. Early detection has improved survival in other malignancies such as breast, colon, and cervical cancers, but...

pancreatic cancer

Management of Locally Advanced Pancreatic Cancer: A Call for Action

Advances in systemic therapy and supportive care, as well as ongoing improvements in surgical techniques, have led to improved survival for many patients with pancreatic ductal adenocarcinoma. We have observed increased survival with FOLFIRINOX (leucovorin, fluorouracil, irinotecan,...

AACR Project GENIE Begins 5-Year Collaborative Research Project With $36 Million in New Funding

The American Association for Cancer Research (AACR) initiative known as AACR Project Genomics Evidence Neoplasia Information Exchange (GENIE) is launching a 5-year, $36 million research collaboration with a coalition of nine biopharmaceutical companies. The goal of the project is to obtain clinical ...

head and neck cancer

Remembering Craig Alguire

It is with great sadness that we report Craig Alguire, MD, 42, died on October 11, 2019, at his home in Grand Rapids, Michigan. Diagnosed with grade 4 glioblastoma multiforme in 2015, Dr. Alguire chronicled the effects the cancer was having on his life in his Patient’s Corner column, published in...

Robert Winn, MD, Named Director of VCU Massey Cancer Center

Robert Winn, MD, has been named Director of Virginia Commonwealth University Massey Cancer Center (VCU). An expert in lung cancer and community-based health care, Dr. Winn will start at VCU in December. Dr. Winn comes to VCU from the University of Illinois at Chicago, where he has served as...

Kazuaki Takabe, MD, PhD, FACS, Delivered Keynote on Immunotherapy for Breast Cancer at JSCO Meeting

Roswell Park Comprehensive Cancer Center’s Chief of Breast Surgery, Kazuaki Takabe, MD, PhD, FACS, delivered the keynote address on immunotherapy for breast cancer at the 57th Annual Meeting of the Japan Society of Clinical Oncology (JSCO) in Fukuoka. During the meeting, Dr. Takabe also led a...

FDA Awards Research Grants for the Study of Rare Cancers

The U.S. Food and Drug Administration (FDA) recently awarded 12 new clinical trial research grants totaling more than $15 million over the next 4 years, many of them focusing on cancer. Also, the FDA awarded two new research grants for natural history studies in rare diseases, totaling more than...

ASCO Presidents Through the Years: Past, Present, and Future

2020–2021: Lori J. Pierce, MD, FASTRO 2019–2020: Howard “Skip” Burris, III, MD, FACP 2018–2019: Monica M. Bertagnolli, MD 2017–2018: Bruce E. Johnson, MD 2016–2017: Daniel F. Hayes, MD 2015–2016: Julie Vose, MD, MBA 2014–2015: Peter P. Yu, MD 2013–2014: Clifford A. Hudis, MD 2012–2013: Sandra M....

FDA Approves Luspatercept-aamt for Anemia in Patients With Beta Thalassemia

On November 8, the U.S. Food and Drug Administration (FDA) approved luspatercept-aamt (Reblozyl) for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. Beta thalassemia is a blood disorder that reduces the production of hemoglobin. In...

prostate cancer

2019 NCRI: Higher IGF-1 and Free Testosterone Levels May be Risk Factors for Prostate Cancer

Men with higher levels of free (biologically active) testosterone and insulin-like growth factor-1 (IGF-1) in their blood are more likely to be diagnosed with prostate cancer, according to research presented by Travis et al at the 2019 National Cancer Research Institute (NCRI) Cancer Conference....

gynecologic cancers

2019 NCRI: CA125 Testing May Help General Practitioners to Detect Ovarian Cancer

Testing for levels of the serum biomarker cancer antigen 125 (CA125) in the blood may be a useful tool for the detection of ovarian cancer, and could help detect other types of cancer among patients in primary care, according to research presented by Funston et al at the 2019 National Cancer...

hepatobiliary cancer

2019 NCRI: Hepatocellular Carcinoma Incidence and Mortality Rates in England Have Tripled Over the Past 20 Years

From 1997 to 2016, incidence and deaths from hepatocellular carcinoma have tripled in England, according to research presented by Burton et al at the 2019 National Cancer Research Institute (NCRI) Cancer Conference. Anya Burton, PhD, a cancer epidemiologist at Public Health England, said in a press ...

colorectal cancer

2019 NCRI: Use of Mendelian Randomization to Determine Role of Human Gut Microbiome in Colorectal Cancer Development

A study using a technique called Mendelian randomization to investigate the causal role played by bacteria in the development of colorectal cancer was presented at the 2019 National Cancer Research Institute (NCRI) Cancer Conference. First study author Kaitlin Wade, PhD, of the University of...

How Patients Add Life to Their Days

The ASCO Post is pleased to reproduce installments of the Art of Oncology as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...

Thomas J. Smith, MD, Honored With ASCO’s Palliative and Supportive Care in Oncology Endowed Award and Lecture

ASCO recognized Thomas J. Smith, MD, FACP, FASCO, FAAHPM, a leader in the field of oncology palliative care, with its Walther Cancer Foundation Palliative and Supportive Care in Oncology Endowed Award and Lecture. Dr. Smith accepted his award and delivered a keynote address at the 2019 Supportive...

multiple myeloma

Daratumumab Combination Therapy for Patients With Multiple Myeloma Who Are Eligible for Transplantation

On September 26, 2019, daratumu-mab (Darzalex) was approved in combination with bortezomib, thalidomide, and dexamethasone for the treatment of multiple myeloma in newly diagnosed adult patients eligible for autologous stem cell transplantation (ASCT).1,2 Supporting Efficacy Data Approval was based ...

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