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gynecologic cancers

Two-Year Interim Analysis of Conservatively Managed Ovarian Tumors

In an interim analysis of a prospective cohort study (IOTA5) reported in The Lancet Oncology, Froyman et al found that the risk of malignancy and acute complications is low when adnexal masses with benign ultrasound findings are managed conservatively. In the study, patients with at least 1...

gynecologic cancers

'Deep Learning'–Based Visual Evaluation for Cervical Cancer Screening

In an observational study reported in the Journal of the National Cancer Institute, Hu et al found that an automated 'deep learning'–based visual evaluation algorithm permitted identification of cervical precancer/cancer cases with greater accuracy than other screening methods. Study Details ...

gynecologic cancers
immunotherapy

Avelumab in Recurrent or Refractory Ovarian Cancer

In phase Ib results from the JAVELIN Solid Tumor Trial reported in JAMA Oncology, Disis et al found that avelumab produced durable responses in some patients with recurrent or refractory ovarian cancer. In the study, an expansion cohort of 125 women with advanced disease who had received...

gynecologic cancers

HPV Testing Using Self-Collected vs Clinician-Collected Samples for the Detection of Cervical Intraepithelial Neoplasia

In a Dutch study (IMPROVE) reported in The Lancet Oncology, Polman et al found that human papillomavirus (HPV) testing with a clinically validated polymerase chain reaction (PCR)–based assay had similar accuracy using self-collected vs clinician-collected samples in detecting cervical...

gynecologic cancers

Al Identifies Features of Tumor Cells in High-Risk Ovarian Cancer  

Scientists have developed a new test that scans the shapes of tumor cells to select women with especially aggressive ovarian cancer. A team at The Institute of Cancer Research (ICR), London, created an artificial intelligence (AI) tool that looks for clusters of cells within tumors with misshapen...

breast cancer
gynecologic cancers
issues in oncology

BRCA Exchange: Resource Aggregates Data on BRCA Variants

A global resource that includes data on thousands of inherited variants in the BRCA1 and BRCA2 genes is available to the public. The BRCA Exchange was created through the BRCA Challenge, a long-term demonstration project initiated by the Global Alliance for Genomics and...

gynecologic cancers

Maintenance Olaparib in Newly Diagnosed Advanced Ovarian Cancer

As reported in The New England Journal of Medicine by Moore et al, the phase III SOLO-1 trial has shown that maintenance with olaparib, following complete or partial response to platinum-based chemotherapy, significantly prolonged progression-free survival vs placebo in...

gynecologic cancers

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...

colorectal cancer
gynecologic cancers

CIMRA Assay for Detection of Gene Variants in Lynch Syndrome

An international team of researchers has developed, calibrated, and validated a novel tool for identifying the genetic changes in Lynch syndrome genes that are likely to be responsible for causing symptoms of the disease. The results were published by Drost et al in Genetics in Medicine. ...

gynecologic cancers

Ultrasonography Findings and Risk of Ovarian Cancer

In a study reported in JAMA Internal Medicine, Smith-Bindman et al found that the appearance of ovarian masses on ultrasonography was highly associated with risk of ovarian cancer in a large unselected population of women undergoing pelvic ultrasonography. Study Details The study was a nested...

gynecologic cancers

Phase III Trial of Minimally Invasive vs Open Abdominal Radical Hysterectomy in Early Cervical Cancer

In a phase III trial (Laparoscopic Approach to Cervical Cancer [LACC]) reported in The New England Journal of Medicine, Ramirez et al found that minimally invasive radical hysterectomy was associated with poorer disease-free and overall survival vs open abdominal radical hysterectomy in women with...

gynecologic cancers

Neoadjuvant Chemotherapy vs Upfront Debulking Surgery in Advanced Tubo-Ovarian Cancer

As reported in The Lancet Oncology by Vergote et al, a pooled analysis of individual patient data in long-term follow-ups of the phase III EORTC 55971 and CHORUS trials indicated that overall survival is similar with neoadjuvant therapy vs upfront debulking surgery in advanced tubo-ovarian cancer....

breast cancer
gynecologic cancers
lymphoma
pancreatic cancer
gastroesophageal cancer
bladder cancer
symptom management
gastrointestinal cancer

FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More

The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv (Udenyca). The biosimilar has been approved to decrease the incidence...

gynecologic cancers

Overall Survival After Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer

In a cohort study reported in The New England Journal of Medicine, Melamed et al found that minimally invasive radical hysterectomy was associated with poorer overall survival compared with open radical hysterectomy in women with early-stage cervical cancer. Study Details The study involved...

gynecologic cancers

Five-Year Risk of Cervical Precancer With p16/Ki67 Dual-Stain or Cytology Triage in HPV-Positive Women

In a study reported in JAMA Oncology, Clarke et al found that triage with p16/Ki-67 dual-stain testing (DS) was associated with better risk stratification for cervical precancer than Papanicolaou cytology testing over 5 years among human papilloma virus (HPV)–positive women. Study Details...

gynecologic cancers

Analgesic Use and Risk of Ovarian Cancer

In an analysis of data from two Nurses’ Health Study cohorts reported in JAMA Oncology by Barnard et al, use of low-dose but not standard-dose aspirin was associated with reduced risk of epithelial ovarian cancer, whereas use of nonaspirin nonsteroidal anti-inflammatory drugs (NSAIDs)...

gynecologic cancers

ESMO 2018: SOLO-1: Olaparib Maintenance Extends Progression-Free Survival in BRCA1/2-Mutated Advanced Ovarian Cancer

Two-year maintenance therapy with olaparib (Lynparza), a poly ADP-ribose polymerase (PARP) inhibitor, led to a substantial improvement in progression-free survival (PFS) in newly diagnosed patients with advanced ovarian cancer and a BRCA1/2 mutation, results from the phase III SOLO-1 trial...

gynecologic cancers

Adjuvant Chemotherapy in High-Grade Uterine Leiomyosarcoma

As reported in the Journal of Clinical Oncology by Hensley et al, a phase III NRG Oncology/Gynecologic Oncology Group study assessing adjuvant chemotherapy vs observation in disease-free patients with uterus-confined high-grade leiomyosarcoma was stopped due to accrual futility; available data...

gynecologic cancers

FDA Approves Expanded Use of Gardasil 9 to Include Individuals Aged 27 to 45

The U.S. Food and Drug Administration (FDA) has approved a supplemental application for recombinant human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and...

gynecologic cancers
immunotherapy

Addition of a CTLA-4–Targeted Therapy to a Checkpoint Inhibitor in Ovarian Cancer

An analysis of the NRG Oncology clinical trial NRG-GY003 suggests that adding ipilimumab (Yervoy), a monoclonal antibody that targets the protein receptor cytotoxic T-lymphocyte–associated protein 4 (CTLA-4), to a regimen with the checkpoint inhibitor nivolumab (Opdivo) could improve response ...

colorectal cancer
gynecologic cancers

PMS2-Associated Lynch Syndrome and Cancer Risks

In a study reported in the Journal of Clinical Oncology, ten Broeke et al found that patients with Lynch syndrome associated with PMS2 mutation are at increased risk of colorectal and endometrial cancers but not other cancers associated with the syndrome. As noted by the investigators, Lynch...

gynecologic cancers

Near-Infrared Fluorescence With Indocyanine Green Dye vs Isosulfan Blue Dye for Detecting Sentinel Nodes in Gynecologic Cancers

In the phase III FILM study reported in The Lancet Oncology, Frumovitz et al found that near-infrared fluorescence imaging with indocyanine green dye identified more sentinel nodes vs isosulfan blue dye in women with clinical stage I endometrial or cervical cancer undergoing curative surgery. There ...

gynecologic cancers

U.S. Preventive Services Task Force Recommendation Statement on Screening for Cervical Cancer

As reported in JAMA, the U.S. Preventive Services Task Force (USPSTF) has updated its 2012 recommendations on screening for cervical cancer. Key Recommendations The key USPSTF recommendations on screening are as follows: The USPSTF recommends screening for cervical cancer every 3 years with...

gynecologic cancers
head and neck cancer
issues in oncology

HPV Vaccine Completion Up 5% From 2016 to 2017

The number of adolescents who are up to date on human papillomavirus (HPV) vaccination—meaning they started and completed the HPV vaccine series—increased 5 percentage points from 2016 to 2017, according to results from a national survey published by Walker et al in Morbidity and...

gynecologic cancers

FDA Grants Fast Track Designation to AVB-S6-500 for Platinum-Resistant Ovarian Cancer

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AVB-S6-500 as a potential treatment for platinum-resistant recurrent ovarian cancer. About AVB-S6-500 AVB-S6-500 is a novel high-affinity, soluble Fc-fusion protein designed to block the activation of the GAS6-AXL...

gynecologic cancers

Adding Sorafenib to Topotecan in Platinum-Resistant Ovarian Cancer

In a German phase II trial reported in The Lancet Oncology, Chekerov et al found that the addition of sorafenib (Nexavar) to topotecan improved progression-free survival in women with platinum-resistant ovarian cancer. Study Details In the multicenter investigator-initiated double-blind trial,...

breast cancer
gynecologic cancers
issues in oncology

BRCA Testing in Medically Underserved Women in Southeastern United States

Medically underserved women in the Southeast region of the United States diagnosed with breast cancer or ovarian cancer may have not received genetic testing that could have helped them and their relatives make important decisions about their health, according to new research from Vanderbilt-Ingram ...

gynecologic cancers

Definitive Pelvic Radiation Therapy Plus Chemotherapy and Survival in Newly Diagnosed Metastatic Cervical Cancer

In a study using National Cancer Database data reported in JAMA Oncology, Wang et al found that definitive pelvic radiation therapy plus chemotherapy was associated with improved survival vs chemotherapy alone in newly diagnosed metastatic cervical cancer. The study included data from 3,169...

gynecologic cancers
pancreatic cancer

FDA Grants Breakthrough Device Designation for Cancer Detection Liquid Biopsy

PapGene, Inc, has announced their cancer detection test has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The PapGene test is a multianalyte test that uses a combination of circulating tumor DNA...

gynecologic cancers

Apatinib and Oral Etoposide in Platinum-Resistant/Refractory Ovarian Cancer

In a Chinese single-center phase II study reported in The Lancet Oncology, Lan et al found a high response rate with oral apatinib plus oral etoposide in patients with platinum-resistant or refractory ovarian cancer. Study Details The study included 35 patients with progression within 6 months...

gynecologic cancers

careHPV Test Receives WHO Prequalification Status for Cervical Cancer Screening

The careHPV Test, a molecular diagnostic for high-risk human papillomavirus (HPV) designed to screen women in low-resource settings, has been added to the World Health Organization (WHO) list of prequalified in vitro diagnostics (IVDs). HPV is the primary cause of cervical cancer, so ...

gynecologic cancers
immunotherapy

FDA Grants Breakthrough Therapy Designation to Lenvatinib Plus Pembrolizumab in Endometrial Carcinoma

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lenvatinib (Lenvima) in combination with pembrolizumab (Keytruda) for the potential treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient...

gynecologic cancers

Use of Analgesics and Ovarian Cancer–Specific Survival

In a prospective cohort study reported in The Lancet Oncology, Merritt et al found evidence that recent use of aspirin or nonaspirin nonsteroidal anti-inflammatory drugs (NSAIDs) after diagnosis appears to improve ovarian cancer–specific survival.   Study Details The study involved...

gynecologic cancers

Quality of Life With Niraparib Maintenance vs Placebo in Patients With Recurrent Ovarian Cancer

In a study reported in The Lancet Oncology, Oza et al found that quality of life (QOL) based on patient-reported outcomes (PROs) was not worsened with niraparib (Zejula) maintenance vs placebo in the phase III ENGOT-OV16/NOVA trial in women with recurrent ovarian cancer who were in response to...

gynecologic cancers

Quality-of-Life and Patient-Centered Outcomes With Olaparib Maintenance in Relapsed Ovarian Cancer

In the phase III SOLO2 trial reported in The Lancet Oncology, Friedlander et al found that olaparib maintenance therapy did not worsen health-related quality of life vs placebo in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1 or BRCA2 mutation. In the study, maintenance...

gynecologic cancers

Less Toxicity With Pelvic IMRT vs Standard RT in Cervical and Endometrial Cancers

In the phase III NRG Oncology-RTOG 1203 study, patient-reported gastrointestinal (GI) and urinary toxicities were reduced with intensity-modulated radiation therapy (IMRT) vs standard radiotherapy (RT) in women with cervical or endometrial cancer. The findings were reported by Klopp et al in the...

gynecologic cancers
health-care policy

Study Evaluates Effects of Affordable Care Act on Young Women With Gynecologic Cancer

The gains in insurance coverage with the Patient Protection and Affordable Care Act (ACA) have already translated into improved health for young women with gynecologic cancers, who are getting diagnosed at earlier stages of their disease because of ACA benefits. That’s the conclusion of a new ...

gynecologic cancers
issues in oncology

ESHRE 2018: Large Population Study Does Not Find Causal Link Between Assisted Reproduction and Ovarian Cancer Risk

Following concerns over many years that hormonal stimulation of the ovaries necessary for in vitro fertilization (IVF) may increase the risk of ovarian cancer, a nationwide cohort study from Denmark has now concluded that any perceived increase in risk is actually a statistical bias resulting from...

gynecologic cancers

Analgesic Use and Risk of Ovarian Cancer

In a study of Ovarian Cancer Cohort Consortium data reported in the Journal of the National Cancer Institute, Trabert et al found that daily aspirin use was associated with a modest reduction in the risk of ovarian cancer. The study included prospective individual-level data from 13 studies in the ...

gynecologic cancers

FDA Grants Priority Review to Expanded Use of Gardasil 9 in Women and Men Aged 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases

On June 13, the U.S. Food and Drug Administration (FDA) accepted for review a new supplemental biologics license application (sBLA) for recombinant human papillomavirus (HPV) 9-valent vaccine (Gardasil  9). The application is seeking approval for an expanded age...

gynecologic cancers
immunotherapy

FDA Approves Bevacizumab Plus Chemotherapy in Advanced Ovarian Cancer Following Initial Surgery

Today, the U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) in combination with chemotherapy (carboplatin and paclitaxel) followed by bevacizumab as a single agent for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection....

gynecologic cancers
immunotherapy

FDA Approves Pembrolizumab for Previously Treated Recurrent or Metastatic PD-L1–Expressing Cervical Cancer

On June 12, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with recurrent or metastatic cervical cancer and disease progression on or after chemotherapy whose tumors express programmed cell death ligand 1 (PD-L1) [Combined Positive Score...

colorectal cancer
solid tumors
gynecologic cancers

2018 ASCO: Genomic Study Finds Lynch Syndrome Is Common Among Patients With MSI-High Tumors

A genomic study of more than 15,000 tumor samples showed that people who have tumors with high microsatellite instability (MSI-H)—a genomic marker associated with a large number of genetic mutations in the tumor—are more likely to have Lynch syndrome, a hereditary condition that...

gynecologic cancers

Long-Term Follow-up of Women With Vaginal and Cervical Clear Cell Adenocarcinoma Associated With DES Exposure

In a letter to the editor of The New England Journal of Medicine, Huo et al described long-term outcomes of women with vaginal and cervical clear cell adenocarcinoma associated with prenatal exposure to the synthetic nonsteroidal estrogen diethylstilbestrol (DES). As noted by the authors, women...

gynecologic cancers
survivorship

Survivors of Uterine Cancer Have Increased Risk of Heart Disease Years After Treatment Has Ended

A large population-based study by Soisson et al examining the long-term cardiovascular outcomes among survivors of endometrial cancer has found that women were at higher risk for a number of cardiovascular risks, including hypertension; diseases of the arteries, arterioles, and capillaries;...

gynecologic cancers

Proportion of Cancer Cell Nuclei With High Chromatin Entropy and Outcome in Gynecologic Cancers

In a study reported in the Journal of the National Cancer Institute, Nielsen et al found significant associations between higher proportions of cancer cell nuclei with high chromatin entropy (associated with genomic instability) and poorer outcomes in gynecologic cancers. Study Details In the...

gynecologic cancers

Positive Results From QUADRA Trial of Niraparib in Ovarian Cancer

Tesaro recently announced results from the QUADRA study, which was designed to assess the clinical benefit of niraparib (Zejula) treatment in heavily pretreated patients with ovarian cancer. Results successfully achieved the prespecified primary endpoint and demonstrated niraparib monotherapy...

gynecologic cancers

ESTRO 37: Brachytherapy for Patients With Cervical Cancer Does Not Increase Risk of Ureteral Stricture

A rare but potentially serious complication following radiation treatment for cervical cancer is a narrowing of the tube that takes urine from the kidneys to the bladder (the ureter), which can lead to kidney damage and sometimes life-threatening infections. This is called ureteral stricture and,...

gynecologic cancers
immunotherapy

Personalized Tumor Vaccine Shows Promise in Advanced Ovarian Cancer

A new type of cancer vaccine has yielded promising results in an initial clinical trial conducted at the Perelman School of Medicine at the University of Pennsylvania and the Abramson Cancer Center of the University of Pennsylvania. The personalized vaccine is made from a patient’s own immune ...

gynecologic cancers

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...

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