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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 ...
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...
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...
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...
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...
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...
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...
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...
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).
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).
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...
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 ...
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...
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...
“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,...
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)...
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...
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...
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...
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, ...
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...
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...
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 ...
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 ...
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 ...
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).
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...
“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....
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...
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 ...
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 ...
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...
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)...
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...
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...
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...
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...
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...
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...
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)...
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...
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...
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 ...
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...
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...
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...
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 ...
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,...
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...
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 ...