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gynecologic cancers

Atezolizumab Plus Platinum Doublet and Maintenance Niraparib for Late-Relapsing Recurrent Ovarian Cancer

As reported in the Journal of Clinical Oncology by González-Martín et al, a phase III trial (ENGOT-OV41/GEICO 69-O/ANITA) has shown no progression-free survival benefit with the addition of atezolizumab to a carboplatin doublet and maintenance niraparib in patients with recurrent ovarian cancer...

cns cancers
issues in oncology

Radiopharmaceutical Therapy May Offer Benefit in Patients With Refractory Meningioma

A radiopharmaceutical therapy has demonstrated early efficacy in patients with difficult-to-treat meningioma, according to new findings presented by Merrell et al at the 2024 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract 2) and simultaneously published in the...

lung cancer

FDA Approves Perioperative Nivolumab for Resectable NSCLC

On October 3, 2024, the U.S. Food and Drug Administration approved nivolumab (Opdivo) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node-positive) non–small cell...

lymphoma

Autologous vs Allogeneic Stem Cell Transplantation in Younger Patients With Peripheral T-Cell Lymphoma: 7-Year Follow-up

In an analysis reported in the Journal of Clinical Oncology, Tournilhac et al identified 7-year outcomes of the phase III AATT trial evaluating autologous vs allogeneic transplantation in younger patients with peripheral T-cell lymphoma. Study Details In the trial, 103 patients (aged 18–60) from...

issues in oncology

Conversations on Cancer: Exploring Religious Literacy and Spirituality in Cancer Care

OCE Insights is an occasional department developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, the OCE’s Steven Clark Cunningham, MD, MLA, FACS, Clinical Reviewer on the Gastrointestinal Cancers Team, ...

breast cancer
issues in oncology

Duration of Postmastectomy Radiation Therapy in Patients Planning Breast Reconstruction

An accelerated course of postmastectomy radiation therapy may not increase complications in patients with breast cancer undergoing breast reconstruction, according to recent findings presented by Poppe et al at the 2024 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract 1) and ...

kidney cancer

Adjuvant Nivolumab vs Placebo in Localized Renal Cell Carcinoma at High Risk of Recurrence After Nephrectomy

As reported in the Journal of Clinical Oncology by Motzer et al, part B of the phase III CheckMate 914 trial showed no disease-free survival benefit with the adjuvant use of nivolumab vs placebo in patients with localized renal cell carcinoma at high risk of recurrence after nephrectomy. These...

legislation

Navigating Uncharted Waters in the Post-Chevron Sea Change

It is not often that the oncology community looks to the Supreme Court to forecast its future. In 2024, two decisions seemingly unrelated to health care were issued that are likely to have a monumental impact on oncology care delivery. The Court’s rulings—on June 28, Loper Bright Enterprises et ...

hepatobiliary cancer

HIMALAYA: 5-Year Analysis Confirms Survival Benefit of STRIDE Regimen in Hepatocellular Carcinoma

An updated overall survival analysis of the phase III HIMALAYA study, now at 5 years, confirms the benefit for the STRIDE regimen of the monoclonal antibodies durvalumab plus tremelimumab in unresectable hepatocellular carcinoma.1 [The STRIDE regimen consists of a single priming dose of...

breast cancer

ACS Report: Despite Overall Decreases in Breast Cancer Mortality, Incidence Rising in Key Groups

The American Cancer Society (ACS) recently released Breast Cancer Statistics, 2024, the organization’s biennial update on breast cancer occurrence and trends in the United States. The new report finds breast cancer mortality rates overall have dropped by 44% since 1989, averting approximately...

prostate cancer

LuPSMA vs Change of Androgen Receptor Pathway Inhibitor in Taxane-Naive Patients With Metastatic Castration-Resistant Prostate Cancer

As reported in The Lancet by Morris et al, the phase III PSMAfore trial has shown improved progression-free survival with lutetium-177–labeled PSMA-617 (LuPSMA) vs change in androgen receptor pathway inhibitor (ARPI) in taxane-naive patients with metastatic castration-resistant prostate cancer...

kidney cancer

Addition of Nivolumab to Tivozanib Following Immune Checkpoint Inhibitor Treatment in Metastatic Renal Cell Carcinoma

As reported in The Lancet by Choueiri et al, the phase III TiNivo-2 trial has shown that immune checkpoint inhibitor rechallenge with nivolumab plus tivozanib did not improve progression-free survival vs tivozanib alone in patients with metastatic renal cell carcinoma following immune checkpoint...

lung cancer

Immunotherapy/Chemoradiotherapy for Patients With Limited-Stage Small Cell Lung Cancer

Findings of a multi-institutional phase III trial indicated that people with limited-stage small cell lung cancer may benefit from the addition of immunotherapy to chemoradiotherapy, but not if both treatments are given simultaneously, new research finds. The results suggest that the timing of when ...

lung cancer

KEYNOTE-671: Overall Survival With Perioperative Pembrolizumab in Resectable NSCLC

As reported in The Lancet by Spicer et al, overall survival results of the phase III KEYNOTE-671 trial indicate benefit of the addition of neoadjuvant pembrolizumab to chemotherapy followed by adjuvant pembrolizumab in patients with early-stage non–small cell lung cancer (NSCLC). At the first...

breast cancer

Adding Durvalumab to Neoadjuvant Regimen Improves Pathologic Complete Response Rate in High-Risk Breast Cancer

Adding the immune checkpoint inhibitor durvalumab, with or without the monoclonal antibody oleclumab, to neoadjuvant chemotherapy and stereotactic body radiation therapy (SBRT) significantly improved pathologic complete response rates in patients with high-risk hormone receptor (HR)-positive breast ...

breast cancer

EMBER: Imlunestrant in Estrogen Receptor–Positive, HER2-Negative Advanced Breast Cancer

In the the phase IA/B dose-escalation and -expansion EMBER study reported in the Journal of Clinical Oncology by Jhaveri et al, the next-generation oral selective estrogen receptor degrader imlunestrant (alone and in combination with other targeted therapies) demonstrated a manageable safety...

lung cancer

Amivantamab-vmjw Plus Lazertinib Improves Long-Term Outcomes in First-Line Setting of EGFR-Mutant Advanced NSCLC

The combination of the EGFR-MET bispecific antibody amivantamab-vmjw and the EGFR tyrosine kinase inhibitor lazertinib continues to demonstrate superior efficacy compared with the kinase inhibitor osimertinib alone in the first-line treatment of EGFR-mutant advanced non–small cell lung cancer...

Updated Findings With Belzutifan in von Hippel-Lindau Disease–Associated CNS Hemangioblastomas

As reported in The Lancet Oncology by Iliopoulos et al, updated findings from the phase II LITESPARK-004 trial support the efficacy of belzutifan in patients with von Hippel-Lindau (VHL) disease–associated CNS hemangioblastomas. Study Details In the study, 50 patients with CNS hemangioblastomas...

lung cancer
issues in oncology

Quality Improvements in Lung Cancer Surgery and Tumor Pathology May Extend Survival Postsurgery

Advancing surgical and pathologic techniques may improve overall survival rates in high-risk patients with lung cancer, according to new findings presented by Akinbobola et al at the 2024 ASCO Quality Care Symposium (Abstract 278). Background “Over the past 15 years, a quality improvement...

thyroid cancer
head and neck cancer

FDA Approves Selpercatinib for RET Fusion–Positive Medullary Thyroid Cancer

On September 27, 2024, the U.S. Food and Drug Administration granted traditional approval to selpercatinib (Retevmo) for adult and pediatric patients aged 2 years and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require...

solid tumors

CABINET Trial Supports Multitargeted Tyrosine Kinase Inhibitor for Advanced Neuroendocrine Tumors

As reported in The New England Journal of Medicine by Chan et al, the multicenter phase III CABINET trial has shown significantly improved progression-free survival with the multitargeted tyrosine kinase inhibitor cabozantinib vs a placebo in previously treated patients with progressive, advanced...

solid tumors
symptom management
supportive care
issues in oncology

Olanzapine May Reduce Chemotherapy-Induced Nausea and Improve Quality of Life Among Patients With Cancer

Researchers have found that olanzapine may be more effective in controlling severe nausea and improving the quality of life in patients with cancer who are undergoing treatment with chemotherapy, according to new findings presented by Peppone et al at the 2024 ASCO Quality Care Symposium (Abstract...

lung cancer
immunotherapy

Datopotamab Deruxtecan vs Docetaxel in Previously Treated Advanced or Metastatic NSCLC

As reported in the Journal of Clinical Oncology by Ahn et al, the phase III TROPION-Lung01 trial showed significantly improved progression-free survival—but not overall survival—with the TROP2-directed antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) vs docetaxel in patients with...

gynecologic cancers
immunotherapy

Overall Survival Results With Pembrolizumab and Chemoradiotherapy in Newly Diagnosed, High-Risk, Locally Advanced Cervical Cancer

As reported in The Lancet by Lorusso et al, overall survival results from the phase III ENGOT-cx11/GOG-3047/KEYNOTE-A18 trial indicated a significant benefit of pembrolizumab vs placebo with concurrent chemoradiotherapy followed by pembrolizumab vs placebo in patients with newly diagnosed,...

breast cancer
issues in oncology

Quality-of-Life Outcomes: Whole-Breast Irradiation vs Accelerated Partial-Breast Irradiation Following Breast-Conserving Surgery

A study by Ganz et al assessed quality-of-life outcomes following whole- or partial-breast radiation in patients with breast cancer who underwent lumpectomy. The researchers published their findings in the Journal of the National Cancer Institute. Study Methods and Results In the NRG Oncology...

bladder cancer
immunotherapy
issues in oncology

Adjuvant Pembrolizumab Following Surgery May Improve Cancer-Free Survival in Patients With High-Risk Urothelial Carcinoma

Treatment with the immunotherapy agent pembrolizumab may nearly double the length that patients with high-risk, muscle-invasive urothelial carcinoma are cancer free following surgical removal of the bladder, according to a recent study published by Apolo et al in The New England Journal of...

sarcoma
solid tumors

Survival Outcomes With Addition of Trabectedin to Docetaxel in Leiomyosarcoma

As reported in The New England Journal of Medicine by Pautier et al, the French Sarcoma Group phase III LMS04 trial showed that the addition of trabectedin to doxorubicin significantly improved progression-free and overall survival in the first-line treatment of unresectable or metastatic uterine...

gynecologic cancers

KEYNOTE-A18: Overall Survival in Cervical Cancer Improved by Pembrolizumab Plus Chemoradiotherapy

  In the phase III ENGOT-cx11/GOG-3047/KEYNOTE-A18 trial presented at the European Society for Medical Oncology (ESMO) Congress 2024, the PD-1 inhibitor pembrolizumab plus chemoradiotherapy, with pembrolizumab continued as monotherapy, improved overall survival in previously untreated, high-risk...

prostate cancer

Addition of Lu-177–PSMA-617 to Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

In an Australian phase II trial (UpFrontPSMA) reported in The Lancet Oncology, Azad et al found that sequential lutetium (Lu)-177–prostate-specific membrane antigen (PSM)-617 (Lu-177–PSMA-617) and docetaxel was superior to docetaxel alone in achieving undetectable prostate-specific antigen (PSA)...

kidney cancer

Detecting Clear Cell Renal Cell Carcinoma: Use of Zr-89 Girentuximab PET-CT Imaging

In a phase III trial reported in The Lancet Oncology, Shuch et al found that zirconium Zr-89–labeled girentuximab (Zr-89 girentuximab) positron-emission tomography/computed tomography (PET-CT) imaging was accurate in detecting clear cell renal cell carcinoma (RCC) in patients with renal masses....

multiple myeloma

Isatuximab Plus VRd Approved by FDA for Newly Diagnosed, Transplant-Ineligible Multiple Myeloma

On September 20, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody isatuximab-irfc (Sarclisa) in combination with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)....

skin cancer

A Clinical Trial Has Halted Progression of Merkel Cell Carcinoma and Allowed Me to Pursue My Love of Music

At the age of 75, I’m just happy to still be here and be able to continue to contribute to my musical community. When I was diagnosed with Merkel cell carcinoma in 2021, I had never heard of the cancer and didn’t realize how aggressive and deadly it is. It was especially surprising to get such a...

gynecologic cancers

Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer

On April 29, 2024, tisotumab vedotin-tftv (Tivdak) was granted regular approval for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.1 Tisotumab vedotin is a tissue factor–directed antibody and microtubule inhibitor conjugate. The agent was granted...

lymphoma

Combination Targeted Therapy Produces Durable Remissions in Some Patients With Relapsed Diffuse Large B-Cell Lymphoma

The results from a phase Ib/II study of a five-drug targeted therapy regimen—venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR)—in the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) showed the treatment produced durable remissions and potential...

breast cancer

Long-Term Outcomes With Adjuvant Trastuzumab for 9 Weeks or 1 Year in HER2-Positive Breast Cancer: Analysis From SOLD Trial

As reported by Joensuu et al in JAMA Network Open, long-term follow-up of the European SOLD trial indicates the addition of adjuvant trastuzumab to chemotherapy for 9 weeks vs 1 year continued to show poorer disease-free survival in patients with HER2-positive breast cancer, with no difference in...

neuroendocrine tumors
issues in oncology

Phase III CABINET Trial: Cabozantinib in Advanced Neuroendocrine Tumors

Cabozantinib may be effective at improving progression-free survival in patients with previously treated neuroendocrine tumors, according to recent findings presented by Chan et al at the European Society for Medical Oncology (ESMO) Congress 2024 (Abstract 1141O) and simultaneously published in The ...

skin cancer
immunotherapy

Immunotherapy Combination May Improve Long-Term Survival in Patients With Metastatic Melanoma

Researchers have found that about 50% of patients with metastatic melanoma treated with a combination of nivolumab and ipilimumab experienced cancer-free survival of 10 years or longer, according to a recent study published by Wolchok et al in The New England Journal of Medicine. Background In...

lung cancer

Tarlatamab in Previously Treated Small Cell Lung Cancer

As reported in the Journal of Clinical Oncology by Dowlati et al, extended follow-up of the phase I DeLLphi-300 trial has shown sustained benefit with tarlatamab, a bispecific T-cell engager immunotherapy targeting delta-like ligand 3, in patients with previously treated small cell lung cancer....

lymphoma

Atezolizumab, Venetoclax, and Obinutuzumab in Richter Transformation Diffuse Large B-Cell Lymphoma

In a phase II trial (MOLTO) reported in the The Lancet Oncology, Tedeschi et al found that the combination of the PD-L1 blocker atezolizumab, the BCL2 inhibitor venetoclax, and the anti-CD20 antibody obinutuzumab was active in Richter transformation diffuse large B-cell lymphoma (DLBCL-RT). Study...

genomics/genetics
issues in oncology

Optimizing the Use of Multicancer Early Detection Tests

Multicancer early detection (MCED) tests are beginning to enter clinical practice, but how useful will they be? “This is an exciting field, with many competing technologies. MCED assays will be coming across your desk in the near future if they haven’t already. But they are not a panacea. They are ...

breast cancer

Use of Immune Checkpoint Inhibitors Under Study in High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer

Clinical trials are now demonstrating the value of immune checkpoint inhibitors as neoadjuvant therapy in certain subsets of patients with hormone receptor–positive, HER2-negative breast cancer. Hope S. Rugo, MD, FASCO, described this newer approach—specifically, which subsets of patients may...

solid tumors
issues in oncology
hematologic malignancies

The Formative Years of Medical Oncology in the United States: A Rough and Tumble Road, Part 2

Medical oncology had a turbulent beginning, as we explained in part 1 of this commentary published in the September 25, 2024, issue of The ASCO Post. And although no other specialty we know of struggled as much, with perseverance and time, it had become a stable specialty of internal medicine by...

issues in oncology
solid tumors
hematologic malignancies

The Formative Years of Medical Oncology in the United States: A Rough and Tumble Road, Part 1

Medical oncology had a turbulent beginning. No other specialty we know of struggled as much. But by 1980, it had become a stable specialty of internal medicine and was off and running—with the major problem of how to marshal available resources to freely test the myriad opportunities presented by ...

lung cancer

AEGEAN Update Confirms Benefit of Perioperative Durvalumab in Resectable NSCLC

The second planned interim analysis of the global phase III AEGEAN trial—reported by John V. Heymach, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer...

hepatobiliary cancer

Addition of Palliative Radiotherapy to Best Supportive Care in Painful Hepatic Cancer

As reported in The Lancet Oncology by Laura A. Dawson, MD, of the University Health Network–Princess Margaret Cancer Centre, University of Toronto, and colleagues, the Canadian phase III CCRG HE1 trial showed that the addition of a single fraction of palliative radiotherapy to best supportive care...

solid tumors
immunotherapy

FDA Approves Pembrolizumab With Chemotherapy for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

On September 17, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma. Efficacy and Safety Efficacy was investigated in KEYNOTE-483...

bladder cancer

NURE-Combo: First Results for a Perioperative Chemoimmunotherapy Approach in Muscle-Invasive Bladder Cancer

Based on the first results of the single-center phase II NURE-Combo trial, which were reported in the Journal of Clinical Oncology (JCO) by Mercinelli et al, the combination of neoadjuvant nivolumab plus nab-paclitaxel followed by postsurgical adjuvant nivolumab appeared to be safe and active in...

skin cancer

Retifanlimab Plus Chemotherapy May Extend Progression-Free Survival in Patients With Squamous Cell Anal Carcinoma

Retifanlimab plus platinum-based chemotherapy may benefit patients with squamous cell anal carcinoma, according to new findings presented by Rao et al at a presidential symposium at the European Society for Medical Oncology (ESMO) Congress 2024 (Abstract LBA2). Background The incidence of squamous...

solid tumors
gynecologic cancers
breast cancer

Novel Antibody-Drug Conjugate Puxitatug Samrotecan May Demonstrate Manageable Safety Profile and Preliminary Efficacy in First-in-Human Trial

The novel antibody-drug conjugate puxitatug samrotecan may have a manageable safety profile consistent with similar antibody-drug conjugates and demonstrated initial efficacy in patients with heavily pretreated advanced or metastatic solid tumors, according to new findings presented by...

bladder cancer

NIAGARA Trial: Perioperative Durvalumab Reduced Risk of Recurrence or Death vs Neoadjuvant Chemotherapy Alone in Muscle-Invasive Bladder Cancer

Positive results from the phase III NIAGARA trial showed perioperative treatment with the PD-L1 blocker durvalumab in combination with neoadjuvant chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and the key...

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