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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...

Gynecologic Cancers

With the Exception of Cervical Cancer, HPV-Associated Cancers Are on the Rise, Especially in Older Adults

Although the incidence of cervical cancer has decreased 1.03% a year over the past 17 years in the United States, likely due to screening or vaccination, other human papillomavirus (HPV)-associated cancers are increasing in both men and women, according to a study by Cheng-I Liao, MD, currently of...

Gynecologic Cancers

Niraparib Plus Bevacizumab Shows Clinical Benefit in Advanced Ovarian Cancer

The addition of niraparib maintenance to first-line platinum-based chemotherapy with bevacizumab demonstrated clinical benefit in patients with advanced ovarian cancer, according to data from the OVARIO study presented by Melissa M. Hardesty, MD, MPH, during the Society of Gynecologic Oncology...

Gynecologic Cancers
Immunotherapy

Expert Point of View: Mansoor Raza Mirza, MD

The invited discussant of EMPOWER-Cervical 1 was Mansoor Raza Mirza, MD, Chief Oncologist at Copenhagen University Hospital and Chairman of the European Network of Gynaecological Oncology Trials group (ENGOT). Dr. Mirza called the findings “amazing” and predicted they will “usher in a new era” in...

Gynecologic Cancers

5-Year Follow-up of SOLO-1: Sustained Benefit for Maintenance Olaparib in Ovarian Cancer

In the 5-year follow-up of the pivotal SOLO-1 trial in women with newly diagnosed advanced ovarian cancer and a BRCA1/2 mutation, maintenance treatment with olaparib led to a more than doubling in progression-free survival, according to a presentation at the Society of Gynecologic Oncology (SGO)...

Gynecologic Cancers

IMagyn050 Trial: Addition of Atezolizumab to Bevacizumab and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer

As reported in the Journal of Clinical Oncology by Kathleen N. Moore, MD, and colleagues,1 the phase III IMagyn050/GOG 3015/ENGOT-OV39 trial has shown that the addition of atezolizumab to bevacizumab and chemotherapy did not significantly improve progression-free survival in patients with newly...

Gynecologic Cancers

Overall Survival With Olaparib vs Placebo Maintenance in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and BRCA1/2 Mutation

As reported in The Lancet Oncology by Andrés Poveda, MD, and colleagues, the phase III SOLO2/ENGOT-Ov21 trial has shown a large numeric but statistically nonsignificant improvement in the secondary endpoint of overall survival with olaparib tablet maintenance therapy vs placebo in patients with...

Gynecologic Cancers

Phase III ARIEL4 Trial Evaluates Rucaparib’s Benefit in BRCA-Mutated Relapsed Ovarian Cancer

In patients with BRCA-mutated, advanced, relapsed ovarian cancer, treatment with the PARP (poly [ADP-ribose] polymerase) inhibitor rucaparib led to a significant improvement in progression-free survival compared with standard-of-care chemotherapy, according to the results of the international phase ...

Gynecologic Cancers

Fuzuloparib Maintenance Therapy Improves Progression-Free Survival in Patients With Recurrent Ovarian Cancer

A new poly (ADP-ribose) polymerase (PARP) inhibitor could soon be joining an already crowded treatment landscape in ovarian cancer, according to data presented at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer, which was held virtually.1 Results of the phase III...

Gynecologic Cancers
Immunotherapy

Immunotherapy With Cemiplimab-rwlc Yields Survival Benefit in Advanced Cervical Cancer

The PD-L1 inhibitor cemiplimab-rwlc has become the first immunotherapy to yield a statistically significant and clinically meaningful survival benefit in recurrent or metastatic cervical cancer progressing after first-line platinum-containing chemotherapy. Patients were enrolled irrespective of...

Gynecologic Cancers

Expert Point of View: Kunle Odunsi, MD, PhD, and Lilian T. Gien, MD, MSc

Comments on the OUTBACK trial were provided by invited discussant Kunle Odunsi, MD, PhD, Professor of Obstetrics and Gynecology, Dean for Oncology, and Director of the University of Chicago Medicine Comprehensive Cancer Center. Lilian T. Gien, MD, MSc, Associate Professor of Oncology at the...

Gynecologic Cancers

OUTBACK: No Benefit for Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

In women with locally advanced cervical cancer, adjuvant chemotherapy adds no benefit to standard cisplatin-based chemoradiation, results of the international phase III OUTBACK study have shown,1 as reported at the 2021 ASCO Annual Meeting by Linda R. Mileshkin, MD, Professor of Medical Oncology at ...

Gynecologic Cancers
Immunotherapy

Gynecologic Cancers 2020–2021 Almanac

The past year has been a remarkable and noteworthy time with much exciting progress made in gynecologic cancers, despite the underlying presence of the COVID-19 pandemic. Several key studies were presented in 2020–2021 that detailed the results of novel therapies for our patients with cervical,...

Gynecologic Cancers

Adavosertib Effective in PARP-Resistant Ovarian Cancer

The Wee1 inhibitor adavosertib, given alone or in combination with olaparib, was effective in patients with poly (ADP-ribose) polymerase (PARP)-resistant ovarian cancer in the phase II EFFORT trial presented by Shannon Neville Westin, MD, of The University of Texas MD Anderson Cancer Center.1...

Gynecologic Cancers

OUTBACK: No Benefit for Adjuvant Chemotherapy in Cervical Cancer

In women with locally advanced cervical cancer, adjuvant chemotherapy adds no benefit to standard cisplatin-based chemoradiation, results of the international phase III OUTBACK study have shown,1 as reported at the 2021 ASCO Annual Meeting by Linda R. Mileshkin, MD, Professor of Medical Oncology at ...

Gynecologic Cancers
Immunotherapy

Nivolumab vs Gemcitabine or Pegylated Liposomal Doxorubicin: What Regimen Improves Survival in Platinum-Resistant Ovarian Cancer?

In a Japanese phase III trial (NINJA) reported in the Journal of Clinical Oncology, Hamanishi et al found that nivolumab did not improve overall survival vs chemotherapy with either gemcitabine or pegylated liposomal doxorubicin in platinum-resistant epithelial ovarian cancer. Study Details In the...

Gynecologic Cancers
Genomics/Genetics

Prevalence of Germline BRCA Mutations in Indian Women With Ovarian Cancer

Ovarian cancer is one of the most common gynecologic cancers, with 313,959 new cases and 207,252 deaths reported worldwide in 2020.1 Since there is no effective screening method, ovarian cancer in general is diagnosed in its late stage. The 5-year survival rate in women with ovarian cancer is less...

Gynecologic Cancers
Genomics/Genetics

High Prevalence of Germline BRCA Mutations in Indian Women With Ovarian Cancer

In a prospective cross-sectional study reported in JCO Global Oncology, Sudeep Gupta, MBBS, MD, DM, of Tata Memorial Centre, and colleagues found that Indian women with ovarian cancer not selected for study based on clinical factors had a high prevalence of germline pathogenic or likely pathogenic...

Gynecologic Cancers
Issues in Oncology

Study Finds Low-Poverty U.S. Counties May Eliminate Cervical Cancer 14 Years Earlier Than High-Poverty Counties

About 14,500 new cases of invasive cervical cancer are diagnosed each year in the United States and nearly 4,300 women die from the disease. Studies show that those living in higher-poverty areas experience higher rates of morbidity and mortality from many preventable cancers, including cervical...

Gynecologic Cancers

Inguinofemoral Radiotherapy vs Inguinofemoral Lymphadenectomy for Patients With Vulvar Cancer and Sentinel Node Metastasis

In the phase II GROINSS-V II study reported in the Journal of Clinical Oncology, Oonk et al found that inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy in women with early-stage vulvar cancer and sentinel node micrometastasis but was associated with a higher...

Hematologic Malignancies
Head and Neck Cancer
Gynecologic Cancers
Immunotherapy
Symptom Management

FDA Pipeline: Reviews for Agents in Acute Graft-vs-Host Disease, Nasopharyngeal and Ovarian Cancers

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to an agent for the prevention of acute graft-vs-host disease; Breakthrough Therapy designation to an anti–PD-1 monoclonal antibody for the treatment of metastatic nasopharyngeal carcinoma; and Fast Track designation to a ...

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