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Showing 751 - 800Rogaratinib/Atezolizumab in Cisplatin-Ineligible FGFR mRNA-Overexpressing Urothelial Cancer
In the phase Ib FORT-2 trial reported in JAMA Oncology, Sweis et al found that the combination of the pan-FGFR inhibitor rogaratinib and atezolizumab was active in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer overexpressing FGFR mRNA. Study Details The study...
Regorafenib in Refractory Advanced Gastric Cancer
As reported in the Journal of Clinical Oncology by Pavlakis et al, the phase III INTEGRATE IIa study showed improved overall survival with regorafenib plus best supportive care vs placebo vs best supportive care in patients with refractory advanced gastric/esophagogastric junction cancer. Study...
Three Days Was Enough
My dad agreed to receive hospice on a technicality. It happened after weeks of trying to get him home oxygen. My brother drove him to the oncologist’s office, and I helped him get into the wheelchair. He did not complain, but just asked me to hold his coffee mug, smiling because I snuck him a...
FDA Approves Novel Combination for Gastric or Gastroesophageal Junction Adenocarcinoma
On October 18, 2024, the U.S. Food and Drug Administration (FDA) approved zolbetuximab-clzb (Vyloy), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or...
Do Social Support Measures Improve Uptake of Cancer Screening?
Although improving cancer screening participation in the United States is central to the country’s national goals for reducing disability and death, currently, participation is lagging behind the Healthy People 2030 targets set by the U.S. Department of Health and Human Services. A study by the...
Addition of Thoracic Radiotherapy to First-Line Treatment of EGFR-Mutated Metastatic NSCLC
In a Chinese phase III trial (Northern Radiation Oncology Group of China-002) reported in the Journal of Clinical Oncology, Sun et al found that the addition of thoracic radiotherapy to EGFR tyrosine kinase inhibitor (TKI) treatment improved progression-free survival in first-line treatment of...
Advancing Diversity, Equity, and Inclusion Through a Challenging Policy Landscape
Among most members of the health-care and oncology workforces, the lofty goals of the organizational framework of diversity, equity, and inclusion (DEI) seem to be clear and indisputable: to promote the fair treatment and full participation of all people, particularly groups who have historically...
Tumor Treating Fields Therapy Receives FDA Approval in Metastatic NSCLC
On October 15, 2024, Novocure announced the U.S. Food and Drug Administration (FDA) approval of Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for the treatment of adults with metastatic non–small cell lung cancer (NSCLC) who have experienced disease progression on or after...
Addition of Ramucirumab to Osimertinib in TKI-Naive EGFR-Mutant Metastatic NSCLC
In an interim analysis of the phase II RAMOSE trial, reported in the Jour�nal of Clinical Oncology, Le et al found that the addition of ramucirumab to osimertinib significantly prolonged progression-free survival as initial treatment in patients with tyrosine kinase inhibitor (TKI)-naive...
Standard vs Extended Lymphadenectomy in Radical Cystectomy for Muscle-Invasive Bladder Cancer
As reported in The New England Journal of Medicine by Lerner et al, the phase III SWOG S1011 trial showed no disease-free survival benefit for extended vs standard lymphadenectomy in patients with muscle-invasive bladder cancer undergoing radical cystectomy. Study Details In the trial, 592 patients ...
ADRIATIC Trial: Durvalumab Consolidation Extends Survival in Limited-Stage Small Cell Lung Cancer
Consolidation therapy with the PD-1 immune checkpoint inhibitor durvalumab is set to become the new global standard of care for patients with limited-stage small cell lung cancer (SCLC), according to groundbreaking data presented at the European Society for Medical Oncology (ESMO) Congress 2024.1...
Cancer Clinical Trials May Continue to Be Inaccessible for Many Patients
Millions of U.S. patients with cancer may face barriers to accessing some of the most advanced treatments being tested in clinical trials for their disease, according to a recent study published by Kirkwood et al in JCO Oncology Practice. Background “We need to support bringing clinical trials to...
Patients With Multiple Sclerosis May Have an Increased Risk of Certain Types of Cancer
Some cancer types may be slightly more prevalent among patients with multiple sclerosis compared with those without the condition, according to a recent study published by Pierret et al in Neurology. Background In multiple sclerosis, the body’s immune system attacks myelin, the fatty white...
Trial Updates in Stage III Melanoma Solidify the Neoadjuvant Use of Immunotherapy as the Current Standard of Care
Neoadjuvant therapy for patients with resectable stage III melanoma has recently emerged as a better approach than resection plus adjuvant therapy. At the European Society for Medical Oncology (ESMO) Congress 2024, updates of pivotal neoadjuvant studies demonstrated the long-standing benefit of...
Capmatinib in MET Exon 14–Mutated NSCLC
As reported in The Lancet Oncology by Wolf et al, the final results of the phase II GEOMETRY mono-1 trial support the activity of the kinase inhibitor capmatinib in patients with non–small cell lung cancer (NSCLC) with MET exon 14–skipping mutation (METex14). Study Details The multicohort trial...
KEYNOTE-811: Pembrolizumab Combination in First-Line Setting Improves Overall Survival in Gastric Cancer
In the final per-protocol analysis of the phase III KEYNOTE-811 trial, an overall survival benefit was shown by adding the PD-1 inhibitor pembrolizumab to trastuzumab and chemotherapy in treatment-naive, unresectable, HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.1...
Updated Findings in Prostate Cancer Screening With Systemic Biopsy vs MRI-Targeted Biopsy
Updated results of a Swedish screening study (GOTEBORG-2), reported in The New England Journal of Medicine by Hugosson et al, indicate that omitting biopsy among individuals with negative magnetic resonance imaging (MRI) results eliminated a high proportion of diagnoses of clinically insignificant...
Radiation-Associated Secondary Cancers in Breast Cancer Harboring TP53 Germline Pathogenic Variants
In a study published as a research letter in JAMA Oncology, Cederquist et al found that patients with breast cancer who received adjuvant radiation therapy and harbored likely pathogenic TP53 germline variants were at increased risk of developing secondary in-field sarcoma during follow-up. Study...
New Directions in ALL, CML, and CLL Treatment
The Society of Hematologic Oncology (SOHO) 2024 Annual Meeting showcased several groundbreaking studies in the field of hematologic oncology, including key findings in childhood acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), and chronic lymphocytic leukemia (CLL). The ASCO...
Overall Survival Analysis Confirms Pembrolizumab Regimen as Standard of Care for Triple-Negative Breast Cancer
For women with early-stage triple-negative breast cancer, KEYNOTE-522 changed the treatment paradigm several years ago. Support for neoadjuvant use of the PD-1 inhibitor pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, was bolstered by the positive overall survival analysis...
Sintilimab/Bevacizumab in Relapsed or Persistent Ovarian Clear Cell Carcinoma
In a Chinese phase II trial (INOVA) reported in The Lancet Oncology, Peng et al found that the combination of sintilimab and bevacizumab showed activity in patients with relapsed or persistent ovarian clear cell carcinoma. Study Details In the multicenter trial, 37 evaluable patients with exposure...
Bridging the Gap in Cancer Clinical Trial Funding
In a Journal of Clinical Oncology editorial, Yara Abdou, MD, and Norman E. Sharpless, MD, responded to a recent study by the Fred Hutchinson Cancer Center in Seattle that found enrollment in industry-sponsored cancer clinical trials doubled between 2008 and 2022, whereas federally supported trial...
Stereotactic vs Hypofractionated Radiotherapy for Inoperable Stage I NSCLC
As reported in JAMA Oncology by Swaminath et al, the Canadian phase III LUSTRE trial has shown no significant benefit in local tumor control with stereotactic body radiotherapy (SBRT) vs hypofractionated conventional radiotherapy (CRT) in patients with inoperable stage I non–small cell lung cancer...
Sexual Health and Quality of Life With Simple vs Radical Hysterectomy in Low-Risk, Early-Stage Cervical Cancer
In an analysis from the phase III SHAPE trial reported in the Journal of Clinical Oncology, Ferguson et al found that simple hysterectomy was associated with a reduced risk of sexual dysfunction vs radical hysterectomy in patients with low-risk, early-stage cervical cancer. The trial showed...
ASCO Updates Stage III NSCLC Guideline to Include Osimertinib in Wake of LAURA Trial Data
ASCO has issued a rapid update to its guideline on the management of stage III non–small cell lung cancer (NSCLC), based on the results of the phase III LAURA trial, which was presented at the 2024 ASCO Annual Meeting and published simultaneously in The New England Journal of Medicine.1,2 The...
PEACE-3: Enzalutamide Plus Radium-223 Significantly Improves Survival in Metastatic Castration-Resistant Prostate Cancer
Initial analysis from the PEACE-3 trial suggests that the addition of radium-223 dichloride to enzalutamide could offer a promising new first-line treatment option for patients with metastatic castration-resistant prostate cancer, according to data presented by lead study author, Silke Gillessen,...
LEAP-012: Combination of Therapies Extends Progression-Free Survival in Intermediate-Stage Hepatocellular Carcinoma
The combination of the VEGF tyrosine kinase inhibitor lenvatinib, the PD-1 inhibitor pembrolizumab, and transarterial chemoembolization (TACE) significantly improved progression-free survival in patients with intermediate-stage hepatocellular carcinoma (HCC) compared with TACE alone, according to...
AI Language Models May Generate Effective Physician's Letters
An artificial intelligence (AI) algorithm may be effective at writing physician’s letters, according to a recent study published by Heilmeyer et al in JMIR Medical Informatics. Background According to recent surveys, physicians may spend almost 3 hours per day on documentation activities. “The...
DESTINY-Breast12: T-DXd of Benefit in Patients With Breast Cancer and Brain Metastases
Late-breaking findings from the phase IIIb/IV, open-label DESTINY-Breast12 trial support the use of the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) in patients with HER2-positive metastatic breast cancer and brain metastases who have experienced disease progression on at least...
‘Encouraging’ Pathologic Responses Achieved With Novel Combination Regimen in Early-Stage NSCLC
In the multiarm phase II NeoCOAST-2 trial, neoadjuvant treatment with datopotamab deruxtecan (Dato-DXd) plus the monoclonal antibody durvalumab and single-agent platinum chemotherapy led to promising rates of pathologic complete and major pathologic responses in patients with early-stage non–small...
NO-CUT Trial: Nonoperative Management of Benefit for Many Patients With Rectal Cancer
Total neoadjuvant therapy (TNT) followed by rectal surgery is the standard of care in proficient mismatch repair (pMMR) locally advanced rectal cancer, but studies are finding that patients with clinical complete response may often avoid surgery and be followed “nonoperatively.” In the first...
Novel Radioconjugate or Conventional Care Prior to Allogeneic Hematopoietic Cell Transplantation in Relapsed/Refractory AML
As reported in Journal of Clinical Oncology by Gyurkocza et al, the phase III SIERRA trial has shown higher rates of durable complete remissions with the anti-CD45 radioconjugate iodine-131–apamistamab vs conventional care followed by allogeneic hematopoietic cell transplantation (allo-HCT) in...
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...
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...
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...
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...
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, ...
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 ...
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...
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 ...
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...
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...
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...
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...
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 ...
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...
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 ...
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...
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...
