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issues in oncology

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...

lung cancer

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...

gynecologic cancers

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...

lung cancer

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...

prostate cancer

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,...

hepatobiliary cancer

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...

solid tumors
issues in oncology

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...

breast cancer

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...

lung cancer

‘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...

gastrointestinal cancer

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...

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...

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