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Gynecologic Cancers
Immunotherapy

Cemiplimab-rwlc vs Single-Agent Chemotherapy in Recurrent Cervical Cancer After First-Line Platinum-Based Chemotherapy

As reported in The New England Journal of Medicine by Krishnansu S. Tewari, MD, and colleagues, the phase III EMPOWER-Cervical1/GOG-3016/ENGOT-cx9 trial has shown improved overall survival with cemiplimab-rwlc vs investigator’s choice of single-agent chemotherapy in patients with cervical cancer...

Gynecologic Cancers

Efficacy of Trametinib in Recurrent Low-Grade Serous Ovarian Carcinoma

A study published by David Gershenson, MD, and colleagues in The Lancet reported that the MEK inhibitor trametinib reduced the risk of disease progression or death by 52% compared to standard-of-care therapies in low-grade serous ovarian carcinoma. The international, multicenter phase II/III trial...

Gynecologic Cancers

Invasive Cervical Cancer Prognosis According to High-Risk HPV Status

In a Swedish study reported in the Journal of Clinical Oncology, Lei et al found that patients with invasive cervical cancer and undetectable human papillomavirus (HPV) or infection with low-risk HPV types alone have poorer survival vs those with disease associated with high-risk HPV types. Study...

Gynecologic Cancers
Immunotherapy

Lenvatinib/Pembrolizumab vs Chemotherapy in Previously Treated Patients With Advanced Endometrial Cancer

As reported in The New England Journal of Medicine by Vicky Makker, MD, and colleagues, the phase III Study 309-KEYNOTE-775 trial has shown prolonged progression-free and overall survival with lenvatinib plus pembrolizumab vs physician’s choice of chemotherapy among previously treated patients with ...

Gynecologic Cancers
Immunotherapy

Pembrolizumab in Previously Treated Patients With MSI-H/dMMR Endometrial Cancer

As reported in the Journal of Clinical Oncology by David M. O’Malley, MD, and colleagues, pembrolizumab showed durable activity in a cohort of patients with microsatellite instability–high or mismatch repair–deficient (MSI-H/dMMR) advanced endometrial cancer enrolled in the multicohort KEYNOTE-158...

Breast Cancer
Gynecologic Cancers

Expert Point of View: Steven J. Isakoff, MD, PhD

Steven J. Isakoff, MD, PhD, Director of Breast Cancer Clinical Research at Massachusetts General Hospital, Boston, found the TAMARISK study “interesting.” “Looking at genomic profiles of uterine cancer in both tamoxifen-associated uterine cancer, the researchers found a lower frequency of PIK3...

Breast Cancer
Gynecologic Cancers

PI3K Pathway Activation May Underlie Tamoxifen-Associated Uterine Cancer

Even though it is infrequent, uterine cancer can develop in patients treated with tamoxifen. A study presented at the 2021 San Antonio Breast Cancer Symposium (SABCS) suggests that the mechanism by which uterine cancers develop is tamoxifen-induced PI3K pathway activation.1 Patients treated with...

Gynecologic Cancers

Study Finds Guideline-Concordant Cervical Cancer Screening Dropped From 2005 to 2019 Among Women in the United States

Rates of cervical cancer screening have dropped recently in the United States, with screening rates lowest among Asian and Hispanic women, as well as women who live in rural areas, are uninsured, or are sexual minorities, according to findings published by Ryan Suk, PhD, and colleagues in JAMA...

Gynecologic Cancers

Paclitaxel/Carboplatin vs Paclitaxel/Ifosfamide in Chemotherapy-Naive Patients With Uterine Carcinosarcoma

As reported in the Journal of Clinical Oncology by Powell et al, the phase III NRG Oncology GOG-0261 trial has shown that paclitaxel/carboplatin is noninferior to paclitaxel/ifosfamide in terms of overall survival among chemotherapy-naive patients with uterine carcinosarcoma. Study Details The...

Gynecologic Cancers
Immunotherapy

Balstilimab Plus Zalifrelimab for the Second-Line Treatment of Advanced Cervical Cancer

In a phase II trial reported in the Journal of Clinical Oncology, David M. O’Malley, MD, and colleagues found that the PD-1 inhibitor balstilimab and the CTLA-4 inhibitor zalifrelimab—both investigational agents—produced durable responses as second-line treatment for patients with recurrent or...

Breast Cancer
Gynecologic Cancers
Survivorship

Effect of Bupropion vs Placebo on Sexual Desire in Postmenopausal Female Cancer Survivors

In a phase II trial (NRG-CC004) reported in the Journal of Clinical Oncology, Barton et al found that bupropion, a dopaminergic agent, did not improve sexual desire vs placebo as measured by the Female Sexual Function Index (FSFI) desire subscale among postmenopausal women with low desire scores...

Gynecologic Cancers

Study Examines Socioeconomic Status and Cervical Cancer Incidence in New York City

In a study reported in a research letter in JAMA Oncology, Cham et al found that cervical cancer incidence increased with decreasing socioeconomic status index scores across neighborhoods in New York City (NYC). Study Details The population-based, cross-sectional study included data on women...

Gynecologic Cancers

Addition of Cytoreductive Surgery to Platinum-Based Chemotherapy in Relapsed Ovarian Cancer

In a European Network of Gynecologic Oncology Trialists–Gynecologic Cancer Intergroup trial (DESKTOP III) reported in The New England Journal of Medicine, Philipp Harter, MD, PhD, and colleagues found that the addition of cytoreductive surgery to platinum-based chemotherapy improved overall...

Gynecologic Cancers
Immunotherapy

Study Examines Safety and Efficacy of Retifanlimab in Recurrent MSI-H/dMMR Endometrial Cancer

The novel PD-1 inhibitor retifanlimab appears to be safe and effective in patients with pretreated, recurrent microsatellite instability–high (MSI-H) or deficient mismatch repair (dMMR) endometrial cancer, according to according to data presented by Berton-Rigaud et al at the Society for...

Gynecologic Cancers

FDA Approves Pafolacianine to Help Identify Ovarian Cancer Lesions

On November 29, the U.S. Food and Drug Administration (FDA) approved pafolacianine (Cytalux), a targeted fluorescent imaging agent intended to assist surgeons in identifying ovarian cancer lesions. The drug, which is indicated for use in adult patients with ovarian cancer and is administered in the ...

Gynecologic Cancers

Pembrolizumab Plus Chemotherapy With or Without Bevacizumab in First-Line Treatment of Advanced Cervical Cancer

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 13, 2021, pembrolizumab in combination with...

Gynecologic Cancers

Effect of National HPV Vaccination Program on the Incidence of Cervical Cancer and Intraepithelial Neoplasia in Young Women in England

As reported in The Lancet by Falcaro et al, a register-based observational study has shown that the England national human papillomavirus (HPV) vaccine program, initiated in 2008 using a bivalent vaccine (Cervarix; HPV16/18), has been successful in reducing the rates of cervical cancer and grade 3...

Lymphoma
Head and Neck Cancer
Solid Tumors
Genomics/Genetics
Gynecologic Cancers
Skin Cancer
Immunotherapy

FDA Pipeline: Novel Treatments in Lymphoma, Nasopharyngeal Cancer, Solid Tumors, and More

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents for several kinds of lymphoma, as well as nasopharyngeal cancer; a Breakthrough Therapy designation for a treatment for patients with NTRK-positive advanced solid tumors; and Fast Track designation for...

Gynecologic Cancers
Genomics/Genetics

Five-Year Follow-up of Olaparib Maintenance for Newly Diagnosed Patients With Advanced BRCA-Mutant Ovarian Cancer

As reported in The Lancet Oncology by Susana Banerjee, MBBS, PhD, and colleagues, 5-year follow-up of the pivotal phase III SOLO-1/GOG 3004 trial has shown a median progression-free survival of 56 months with maintenance olaparib following response to platinum-based chemotherapy in newly diagnosed...

Gynecologic Cancers

Tisotumab Vedotin-tftv in Recurrent or Metastatic Cervical Cancer

On September 20, 2021, tisotumab vedotin-tftv, a tissue factor-directed antibody and microtubule inhibitor conjugate, was granted accelerated approval for the treatment of adults with recurrent or metastatic cervical cancer who have had disease progression on or after chemotherapy.1 Supporting...

Gynecologic Cancers
Genomics/Genetics

Relationship Between Preexisting TP53 CHIP Variants and Risk of Secondary Myeloid Neoplasms in High-Grade Ovarian Cancer

In a study reported in JAMA Oncology, Kwan et al found that preexisting TP53 clonal hematopoiesis of indeterminate potential (CHIP) variants were associated with increased risk of secondary myeloid neoplasms in patients receiving poly (ADP-ribose) polymerase (PARP) inhibitor therapy with rucaparib...

Gynecologic Cancers
Global Cancer Care

Efficacy of Quadrivalent HPV Vaccine in Girls in India Against Persistent HPV-16/18 Infection: 10-Year Protection Analysis

In a prospective cohort study reported in The Lancet Oncology, Partha Basu, MD, and colleagues found that a single dose of quadrivalent human papillomavirus (HPV) vaccine given to girls in India provided 10-year protection equal to two or three doses against persistent infection with HPV types 16...

gynecologic cancers

Susana N. Banerjee, MBBS, PhD, on Ovarian Cancer: Novel Combination Therapy Under Study

Susana N. Banerjee, MBBS, PhD, of The Royal Marsden NHS Foundation Trust, discusses phase I results that have generated interest in the combination of the RAF/MEK inhibitor VS-6766 and the FAK inhibitor defactinib for patients with recurrent low-grade serous ovarian cancer, a disease that typically has limited response to conventional chemotherapy and hormonal therapy. The data support ongoing investigation (Abstract 725MO).

gynecologic cancers
immunotherapy

Susana N. Banerjee, MBBS, PhD, on Ovarian, Fallopian Tube, or Primary Peritoneal Adenocarcinoma: Treatment Findings From the EORTC-1508 Trial

Susana N. Banerjee, MBBS, PhD, of The Royal Marsden NHS Foundation Trust, discusses phase II results of the EORTC-1508 trial, the first study to combine an anti–PD-L1 antibody, atezolizumab, with bevacizumab and the COX1/2 inhibitor acetylsalicylic acid as treatment for patients with ovarian, fallopian tube, or primary peritoneal adenocarcinoma (Abstract LBA32).

Gynecologic Cancers

Expert Point of View: Clare L. Scott, MBBS, PhD

Invited discussant Clare L. Scott, MBBS, PhD, Chair of Gynaecological Cancer at the University of Melbourne and medical oncologist at Peter MacCallum Cancer Centre, Melbourne, Australia, said: “We now know that PARP [poly (ADP-ribose) polymerase] inhibitors are active post PARP therapy. We also...

Gynecologic Cancers

PARP Rechallenge Slows Ovarian Cancer Progression in Platinum-Sensitive Disease

Rechallenge with the poly (ADP-­ribose) polymerase (PARP) inhibitor olaparib in patients with platinum-sensitive ovarian cancer led to significant improvement in progression-free survival, in patients with either BRCA1/2-mutated or nonmutated (ie, wild-type) disease compared with placebo, according ...

Gynecologic Cancers
Immunotherapy

FDA Approves Pembrolizumab Combination for the First-Line Treatment of Cervical Cancer

On October 13, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score [CPS] ≥ 1), as...

Gynecologic Cancers
Immunotherapy

Camrelizumab/Apatinib for High-Risk Chemorefractory or Relapsed Gestational Trophoblastic Neoplasia

In a Chinese single-institution phase II trial (CAP 01) reported in The Lancet Oncology, Cheng et al found that the PD-1 inhibitor camrelizumab in combination with the antiangiogenic agent apatinib produced a high rate of complete responses in women with high-risk chemorefractory or relapsed...

Gynecologic Cancers
Immunotherapy

Expert Point of View: Mansoor Raza Mirza, MD

“The standard of care [in advanced cervical cancer] has been the addition of bevacizumab to platinum-based chemotherapy since 2014. Even with the addition of bevacizumab, we still need to do better. There is a substantial unmet need for new therapies,” said invited discussant Mansoor Raza Mirza,...

Gynecologic Cancers
Immunotherapy

Study Shows Pembrolizumab Plus Chemotherapy Improves Survival in Advanced Cervical Cancer

The addition of pembrolizumab to chemotherapy prolonged survival in recurrent, persistent, or metastatic cervical cancer, according to the results of the first interim analysis of the ­KEYNOTE-826 trial, presented at a Presidential Symposium during the European Society for Medical Oncology (ESMO)...

Skin Cancer
Gynecologic Cancers
Prostate Cancer
Breast Cancer
Solid Tumors
Hepatobiliary Cancer
Gastroesophageal Cancer
Immunotherapy

FDA Pipeline: Recent Reviews, Designations, Applications, and Authorizations in the Oncology Space

Over the past month, the U.S. Food and Drug Administration (FDA) issued several regulatory decisions for novel treatments for patients with cancer. Priority Review for Relatlimab and Nivolumab Fixed-Dose Combination in Unresectable or Metastatic Melanoma The FDA accepted for Priority Review the...

Gynecologic Cancers
Issues in Oncology

Study Examines Benefits of Cervical Cancer Screening Program Tailored to Transgender Men and Nonbinary People

Worldwide, cervical cancer is the fifth most commonly occurring cancer in women, mostly due to human papillomavirus (HPV) infection. In 2020, globally, an estimated 604,237 women were diagnosed with cervical cancer and about 341,843 died from the disease. In the United States, in 2021, it is...

Gynecologic Cancers

Trends in Use of Neoadjuvant Chemotherapy and Association With Overall Survival in Patients With Advanced Ovarian Cancer

In a study reported in JAMA Oncology, Alexander Melamed, MD, MPH, and colleagues found that improvements in median overall survival have been similar in patients from U.S. cancer programs that did vs did not increase their use of neoadjuvant chemotherapy for women with advanced ovarian cancer in...

Issues in Oncology
Cost of Care
Lung Cancer
Gynecologic Cancers

Two Studies Show Health-Care Costs May Impact Follow-up Care After Cancer Screening

Eleven years ago this month, the scans and exams that hold the most power to spot the early signs of cancer became available for free to many American adults through the passing of the Affordable Care Act. Now, two new studies show that when those screening tests reveal potentially troubling signs, ...

Gynecologic Cancers

Biomarker May Help to Predict Response to Gemcitabine for Patients With High-Grade Serous Ovarian Cancer

For more than 2 decades, the chemotherapy agent gemcitabine has been a mainstay treatment for several types of cancer. Now, scientists have uncovered genetic evidence of which patients with high-grade serous ovarian cancer are likely to benefit from the drug. In a study published by Panagiotis...

Gynecologic Cancers
Immunotherapy

Pembrolizumab and Lenvatinib in Advanced Endometrial Carcinoma

On July 21, 2021, pembrolizumab in combination with lenvatinib was granted regular approval for treatment of patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair–deficient who have disease progression following prior systemic therapy in any...

Gynecologic Cancers

Does Adjuvant Image-Guided Intensity-Modulated Radiotherapy for Cervical Cancer Lead to Increased Rates of Late Toxicity?

In the Indian single-center phase III PARCER trial reported in the Journal of Clinical Oncology, Supriya Chopra, MD, DNB, and colleagues found that adjuvant image-guided intensity-modulated radiotherapy (IG-IMRT) was associated with less late grade ≥ 2 gastrointestinal toxicity vs three-dimensional ...

Gynecologic Cancers

Relacorilant Plus Nab-paclitaxel May Improve Progression-Free Survival in Recurrent Platinum-Resistant Ovarian Cancer

In the first randomized, controlled study to explore the efficacy and safety of relacorilant—a selective glucocorticoid receptor modulator—in combination with nab-paclitaxel compared to nab-paclitaxel alone, the combination improved progression-free survival and showed a favorable safety profile in ...

Gynecologic Cancers
Immunotherapy

FDA Grants Accelerated Approval to Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer

On September 20, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv (Tivdak), a tissue factor–directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer who experienced disease progression on ...

gynecologic cancers
immunotherapy

Nicoletta Colombo, MD, on Cervical Cancer: KEYNOTE-826 Trial of Pembrolizumab Plus Chemotherapy

Nicoletta Colombo, MD, of the Istituto Europeo Oncologico, discusses phase III results that showed improvements in progression-free and overall survival with a combination of pembrolizumab plus chemotherapy, compared with placebo and chemotherapy, for patients with persistent, recurrent, or metastatic cervical cancer. These benefits were seen regardless of PD-L1 expression and concomitant bevacizumab use, suggesting that pembrolizumab plus chemotherapy, with or without bevacizumab, may be a new standard of care for this population (Abstract LBA2).

Gynecologic Cancers
Immunotherapy

KEYNOTE-826: Pembrolizumab Plus Chemotherapy in Advanced Cervical Cancer

The addition of pembrolizumab to chemotherapy prolonged survival in recurrent, persistent, or metastatic cervical cancer, according to results of the KEYNOTE-826 study presented at the European Society for Medical Oncology (ESMO) Congress 2021 by Nicoletta Colombo, MD, and colleagues (Abstract...

Gynecologic Cancers
Immunotherapy

Expert Point of View: Carol Aghajanian, MD

“The phase III ENGOT/GCIG study1 proved to be negative, with no advantage seen with the extension of bevacizumab treatment,” said the abstract’s invited discussant, Carol Aghajanian, MD, Chief of the Medical Gynecologic Oncology Service at Memorial Sloan Kettering Cancer Center, New York. Dr....

Gynecologic Cancers
Immunotherapy

Bevacizumab in Advanced Ovarian Cancer: Phase III Trial Finds More Is Not Better

In advanced ovarian cancer, the duration of maintenance bevacizumab should remain 15 months, according to the European multicenter phase III ENGOT/GCIG trial. These results were presented during the 2021 ASCO Annual Meeting by Jacobus Pfisterer, MD, PhD, of the AGO Study Group and Gynecologic...

Gynecologic Cancers

Study Shows Sentinel Lymph Node Biopsy to Be ‘Viable Option’ for Surgical Staging of Endometrial Cancer

Sentinel lymph node biopsy “had similar diagnostic accuracy and prognostic ability as lymphadenectomy in patients with high-grade endometrial cancer at greatest risk for nodal metastases,” according to the SENTOR trial, a prospective cohort study of 156 patients with clinical stage I disease. Using ...

Gynecologic Cancers

Lenvatinib/Pembrolizumab Improves Survival in Advanced Endometrial Cancer in a Phase III Trial

In the first report from the pivotal phase III KEYNOTE-775/Study 309 trial, the combination of lenvatinib, a multikinase inhibitor of VEGFR1, VEGFR2, and VEGFR3 kinases, and the PD-1 inhibitor pembrolizumab significantly improved multiple outcomes compared with standard single-agent chemotherapy in ...

Gynecologic Cancers
Immunotherapy

Expert Point of View: Ana Oaknin, MD, PhD

The innovaTV 204 trial’s invited discussant, Ana Oaknin, MD, PhD, Head of the Gynecologic Cancer Program at Vall d’Hebron Institute of Oncology in Barcelona, was encouraged by the study’s findings. “Of note, the response rate was 24%, the time to response was short, and the median duration of...

Gynecologic Cancers

Hormonal Intrauterine Device Under Study for Managing Early Endometrial Cancer

Disease regression was observed in 82% of women with endometrial hyperplasia with atypia and 43% of women with endometrial cancer after treatment for 6 months with a hormonal intrauterine device, in a phase II study reported during the virtual edition of the Society of Gynecologic Oncology (SGO)...

Gynecologic Cancers
Immunotherapy

Novel Treatments Show Activity in Advanced Cervical Cancer

The treatment of recurrent or metastatic cervical cancer has not changed much in recent years, but according to preliminary trials presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, checkpoint inhibitors and antibody-drug conjugates may become new options. In the...

Gynecologic Cancers

Recent FDA Approvals in Endometrial Cancer

In recent months, the U.S. Food and Drug Administration approved two treatment options for patients with endometrial cancer, which are summarized herein. Dostarlimab-gxly for dMMR Endometrial Cancer On April 22, 2021, the FDA granted accelerated approval to dostarlimab-gxly (Jemperli) for adult...

Gynecologic Cancers

Benefit of Niraparib Maintenance Therapy Extends Beyond First Disease Progression in Recurrent Ovarian Cancer

The PARP (poly [adp-ribose] polymerase) inhibitor niraparib is safe for long-term use and effective as maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer, according to data presented by Ursula A. Matulonis, MD, at the Society of Gynecologic Oncology (SGO) 2021...

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