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Showing 4401 - 4450dd-MVAC vs Gemcitabine/Cisplatin for Muscle-Invasive Bladder Cancer
The randomized phase III controlled GETUG/AFU VESPER V05 trial was designed to compare the efficacy of two perioperative treatment regimens—gemcitabine/cisplatin or dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC)—in patients with muscle-invasive bladder cancer. The...
Long-Term Outcomes in JULIET Trial of Tisagenlecleucel for Relapsed or Refractory Aggressive B-Cell Lymphomas
As reported by Stephen J. Schuster, MD, and colleagues in The Lancet Oncology, long-term outcomes of the pivotal phase II JULIET trial showed overall and complete response rates of 53% and 39% in adult patients with relapsed or refractory aggressive B-cell lymphomas treated with the T-cell...
Single-Fraction vs Multifraction SABR for Pulmonary Oligometastases: Is There a Difference in Safety or Efficacy?
In the phase II SAFRON II study reported in JAMA Oncology, Shankar Siva, PhD, MBBS, FRANZCR, and colleagues found no significant differences in safety or efficacy between single-fraction vs multifraction stereotactic ablative body radiotherapy (SABR) for the treatment of pulmonary oligometastases. ...
Naveen S. Vasudev, PhD, MBChB, on RCC: Changing the Dosing Schedule of Ipilimumab Plus Nivolumab
Naveen S. Vasudev, PhD, MBChB, of the University of Leeds, discusses phase II results from the PRISM trial, which showed that giving ipilimumab every 12 weeks instead of every 3 weeks, in combination with nivolumab, led to lower rates of grade 3 and 4 toxicities in patients with advanced renal cell ...
DESTINY-Lung01: Fam-trastuzumab Deruxtecan-nxki in Previously Treated HER2-Mutant NSCLC
In the phase II DESTINY-Lung01 trial, presented at the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract LBA45) and concurrently reported in The New England Journal of Medicine, Bob T. Li, MD, PhD, MPH, and colleagues found that fam-trastuzumab deruxtecan-nxki produced durable...
COSMIC-021: Cabozantinib Plus Atezolizumab for Advanced Renal Cell Carcinoma
In the phase Ib COSMIC-021 trial reported in the Journal of Clinical Oncology, Sumanta K. Pal, MD, FASCO, and colleagues found that the combination of cabozantinib and atezolizumab produced durable responses in patients with advanced renal cell carcinoma (RCC). Study Details One hundred and two...
Addition of Ramucirumab to Gemcitabine in Second-Line Treatment of Malignant Pleural Mesothelioma
In the Italian phase II RAMES trial reported in The Lancet Oncology, Pinto et al found that the addition of ramucirumab to gemcitabine improved overall survival in the second-line treatment of malignant pleural mesothelioma. As noted by the investigators, “There is a preclinical rationale for...
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 ...
COVID-19 Lockdown May Be Associated With Higher Tumor Burden in Newly Diagnosed Patients With Metastatic Colorectal Cancer
In a French study reported in JAMA Network Open, Thierry et al found that tumor burden (assessed as plasma circulating tumor DNA [ctDNA]) was significantly higher among patients with newly diagnosed metastatic colorectal cancer screened for a clinical trial after vs before the first COVID-19...
Adjuvant Pembrolizumab for High-Risk Stage II Melanoma: Efficacy and Safety Examined
Adjuvant pembrolizumab reduced the risk of disease recurrence in adults and children aged 12 years and older with high-risk stage II melanoma vs placebo, according to a late-breaking interim analysis of the phase III KEYNOTE-716 trial presented by Jason J. Luke, MD, and colleagues at the European...
Bispecific Antibody Epcoritamab in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
In a phase I/II study reported in The Lancet, Hutchings et al found that the novel bispecific antibody epcoritamab produced high response rates in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Epcoritamab works by targeting CD3 and CD20 and inducing T-cell–mediated cytotoxic...
DESTINY Breast03: Second-Line Fam-Trastuzumab Deruxtecan-nxki for Metastatic HER2-Positive Breast Cancer
Fam-trastuzumab deruxtecan-nxki (T-DXd) showed statistically significant improvement in progression-free survival vs trastuzumab emtansine (T-DM1) in second-line treatment for HER2-positive unresectable or metastatic breast cancer, according to results from the global phase III DESTINY-Breast03...
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...
DESTINY-Gastric02: Fam-Trastuzumab Deruxtecan-nxki Produces Responses in Patients With HER2-Positive Gastric Cancers
In the primary analysis of the phase II DESTINY-Gastric02 trial, fam-trastuzumab deruxtecan-nxki (T-DXd) produced clinically meaningful and durable responses in Western patients with advanced HER2-positive gastric or gastroesophageal junction cancers whose disease had progressed after a...
Long-Term Therapy With Bintrafusp Alfa in HPV-Associated Cancers
Bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of the TGF-βRII receptor fused to a human IgG1 monoclonal antibody blocking PD-L1, showed long-term efficacy and a manageable safety profile in patients with pretreated, immune checkpoint...
ATR Inhibitor Ceralasertib in ARID1A-Deficient and ARID1A-Intact Solid Tumors
In an ongoing phase II study, Aggarwal et al evaluated the efficacy of the ATR inhibitor ceralasertib alone and in combination with olaparib in patients with ARID1A-deficient and ARID1A-intact solid tumors. They observed antitumor activity with ceralasertib monotherapy in ARID1A-deficient solid...
Phase III Trial Investigates Extended Adjuvant Endocrine Therapy for Postmenopausal Patients With Breast Cancer
For patients with early-stage hormone receptor–positive breast cancer, extending the duration of letrozole after tamoxifen—for up to 8 years of total endocrine therapy—significantly improved invasive disease–free survival and overall survival over the standard treatment of approximately 5 years of...
FDA Approves Cabozantinib for Patients With Previously Treated Radioactive Iodine–Refractory Differentiated Thyroid Cancer
On September 17, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth...
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....
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...
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 ...
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 ...
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...
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)...
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...
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...
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...
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...
Expert Point of View: Deborah Armstrong, MD
The invited discussant of the SOLO-1 trial, Deborah Armstrong, MD, Professor of Oncology and Director of the Breast and Ovarian Surveillance Service at Johns Hopkins Medicine, said the update provides “important information for us.” It shows that 2 years of maintenance olaparib conveys “a really...
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...
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...
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...
Expert Point of View: Thomas Herzog, MD
The discussant of the fuzuloparib abstract at the Society of Gynecologic Oncology meeting was Thomas Herzog, MD, Deputy Director of the University of Cincinnati (UC) Cancer Center and Professor of Obstetrics and Gynecology at the UC College of Medicine. He said that these data have already led to...
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...
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...
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...
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 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,...
Sotorasib: Subgroup Analysis of Phase II Trial Shows Activity With KRAS Inhibitor in Lung Cancer
The KRAS-specific inhibitor sotorasib achieved responses in patients with KRAS G12C–mutated non–small lung cancer (NSCLC) who had experienced disease progression on platinum-based chemotherapy, immunotherapy, or both treatments. The objective response rate was 37.1%, and responses extended to all...
Atezolizumab Reduces Risk of Disease Progression in Patients With PD-L1–Expressing Early-Stage NSCLC
Atezolizumab given after chemotherapy to patients with resected stage II to IIIA non–small cell lung cancer (NSCLC) significantly improved disease-free survival compared with best supportive care alone in patients whose tumors expressed PD-L1.1 These results of the global phase III IMpower010 trial ...
Extended Follow-up of PALOMA-3 Supports Survival Benefit of Palbociclib Plus Fulvestrant in Advanced Breast Cancer
An updated analysis of the PALOMA-3 randomized, placebo-controlled trial demonstrated continued superiority for the combination of palbociclib (CDK4/6 inhibitor) plus fulvestrant over fulvestrant plus placebo in women with hormone receptor–positive, HER2-negative advanced breast cancer whose...
ADAPT Trial: ‘Excellent’ Outcomes Reported With Neoadjuvant Dual HER2 Therapy in Breast Cancer
The first overall survival analysis of the WGS-ADAPT HER2+/HR– study, which evaluated neoadjuvant therapy in patients with hormone receptor–negative, HER2-positive disease, showed that treatment with pertuzumab and trastuzumab plus paclitaxel—or with the chemotherapy-free regimen of...
Roundup of Notable Abstracts in Hematologic Malignancies
In addition to covering the biggest news from the meeting in other articles, The ASCO Post brings you these brief news summaries of notable abstracts in multiple myeloma, lymphoma, and leukemia. Maintenance Daratumumab in Multiple Myeloma Part 2 of the CASSIOPEIA trial in 866 patients with newly...
Expert Point of View: Melinda Telli, MD
EA1131 study discussant, Melinda Telli, MD, Associate Professor of Medicine at Stanford University, Director of the Breast Cancer Program at the Stanford Cancer Institute, and Associate Director of the Stanford Women’s Cancer Center, commented: “At this point, capecitabine remains preferred as...
EA1131 Trial: Platinum Not Equal to Capecitabine for Residual Disease in Triple-Negative Breast Cancer
In patients with triple-negative breast cancer who have residual disease after neoadjuvant chemotherapy, adjuvant capecitabine remains the standard of care. In the multicenter randomized noninferiority EA1131 trial, which included primarily basal tumors, noninferiority of adjuvant platinum over...
Fixed-Dose, First-Line Ibrutinib/Venetoclax Combination Achieves Durable Remissions in CLL
The combination of fixed-duration, first-line treatment with ibrutinib plus venetoclax achieved complete responses in more than half of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL), based on the primary analysis of the fixed-dose cohort of the phase II CAPTIVATE ...
Expert Point of View: Nadine M. Tung, MD
Formal discussant of the OlympiA trial, Nadine M. Tung, MD, Director of Breast Medical Oncology and the Cancer Genetics and Prevention Program at Beth Israel Deaconess Medical Center and Harvard Medical School, was enthusiastic about the ability of olaparib to improve invasive disease–free survival ...
ELEVATE-RR Trial: Acalabrutinib as Effective as Ibrutinib, With Fewer Cardiac Effects, in Resistant CLL
Acalabrutinib was equally efficacious with less toxicity when compared directly with ibrutinib in patients with previously treated relapsed or refractory chronic lymphocytic leukemia (CLL), according to the results of an open-label, randomized, noninferiority phase III trial presented at the 2021...
OlympiA Trial: Adjuvant Olaparib Extends Disease-Free Survival in BRCA-Mutated Early Breast Cancer
Adjuvant therapy with the PARP inhibitor olaparib for 1 year extended disease-free survival in patients with high-risk early-stage HER2-negative breast cancer with BRCA1/2 germline (inherited) mutations, according to a prespecified interim analysis of the phase III OlympiA trial presented at the...
Expert Point of View: Surbhi Sidana, MD
The session’s invited discussant Surbhi Sidana, MD, Assistant Professor of Medicine, Stanford University, said chimeric antigen receptor (CAR) T-cell therapy and bispecific antibodies targeting myeloma are emerging as potentially effective options for patients with highly refractory disease. For...
