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gastroesophageal cancer
immunotherapy

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...

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...

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...

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...

solid tumors
issues in oncology

Spiritual Themes, Distrust May Factor Into Black Patients’ Reluctance to Participate in Cancer Clinical Trials

Spiritual beliefs and a historically based distrust of clinical research may influence Black patients’ decisions about whether to participate in cancer trials, according to new findings presented by Gomez et al at the 2024 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract...

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...

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, ...

lung cancer

Distinguished Service Awards Presented at the IASLC World Conference on Lung Cancer

Distinguished Service Awards were presented to Kwun Fong, MBBS, PhD, FRACP; Claudia Henschke, MD, PhD; Erik Thunnissen, MD, PhD; and Julie Brahmer, MD, MSc, FASCO, during the 2024 International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer. Adi F. Gazdar IASLC...

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

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 ...

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...

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...

issues in oncology
cost of care

More Than Half of AYA Cancer Survivors Experience Financial Toxicity and Are Unable to Afford Food and Housing

A study conducted by Kaitlyn Lapen, MD, a radiation oncologist resident at Memorial Sloan Kettering Cancer Center, and colleagues evaluated the financial challenges adolescent and young adults (AYA) survivors experience during and after treatment. They found that more than half (54%) of these...

lung cancer

FDA Approves Osimertinib in Stage III NSCLC After Chemoradiotherapy

On September 25, the U.S. Food and Drug Administration approved osimertinib (Tagrisso) for adults with locally advanced, unresectable (stage III) non–small cell lung cancer (NSCLC) whose disease has not progressed during or after concurrent or sequential platinum-based chemoradiation therapy. These ...

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...

colorectal cancer
issues in oncology
health-care policy
legislation

ACA May Increase Access to Colorectal Cancer Care Among Underserved Groups

The Affordable Care Act (ACA) has increased guideline-concordant care for colorectal cancer among non-White patients, those from rural areas, and those from the most deprived neighborhoods in Pennsylvania, according to new findings presented by Kudaravalli et al at the 2024 American Association for ...

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...

lung cancer

FDA Approves Amivantamab-vmjw With Carboplatin and Pemetrexed for Non–Small Cell Lung Cancer With EGFR Exon 19 Deletions or L858R Mutations

On September 19, the U.S. Food and Drug Administration (FDA) approved amivantamab-vmjw (Rybrevant) with carboplatin and pemetrexed for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R...

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...

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...

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...

gynecologic cancers

Immunotherapy and Novel Targeted Drug Appear Beneficial in Women With Early-Stage Gynecologic Disease

Studies reported at the European Society for Medical Oncology (ESMO) Congress 2024 reveal new groups of women with early-stage cervical1 and endometrial cancers2 who gain clinically meaningful benefit from adding immunotherapy to current standard treatments, and a first-in-human study found...

solid tumors

FDA Approves Atezolizumab and Hyaluronidase-tqjs for Subcutaneous Injection

The U.S. Food and Drug Administration (FDA) approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq), including non–small cell lung cancer (NSCLC), small cell lung cancer...

lung cancer

Taletrectinib in ROS1-Positive NSCLC: Focus on Prior Tyrosine Kinase Inhibitor Exposure Status

Updated data from the global, multicenter, single-arm phase II TRUST-II trial, which were reported by Liu et al during the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC; Abstract MA06.03), continued to demonstrate robust overall and...

lung cancer
issues in oncology

NeoCOAST-2 Trial: Durvalumab Plus Novel Agents May Increase Pathologic Responses in Resectable NSCLC

Researchers have demonstrated that the combination of durvalumab with the TROP2-directed antibody-drug conjugate datopotamab deruxtecan may yield high pathologic complete response rates in patients with resectable non–small cell lung cancer (NSCLC), according to findings presented by Cascone et al...

lung cancer
issues in oncology

Using TROP2 Expression to Predict Outcomes in Advanced NSCLC

Researchers have uncovered that TROP2 expression as measured by quantitative continuous scoring may be a predictor of clinical outcomes in patients with advanced or metastatic non–small cell lung cancer (NSCLC) treated with the TROP2-directed antibody-drug conjugate datopotamab deruxtecan,...

lung cancer
issues in oncology

Perioperative Nivolumab May Improve Event-Free Survival Compared With Neoadjuvant Nivolumab Plus Chemotherapy Alone in Patients With Resectable NSCLC

Adjuvant nivolumab following neoadjuvant nivolumab plus chemotherapy and surgery may be effective at reducing the risk of disease recurrence or mortality in patients with resectable non–small cell lung cancer (NSCLC) compared with neoadjuvant nivolumab plus chemotherapy alone, according to new...

lung cancer
issues in oncology
immunotherapy

Pathway to Developing Predictive Biomarkers for Immune Checkpoint Inhibitors in NSCLC

Researchers may have uncovered a metabolic pathway that could lead to the development of predictive biomarkers for immune checkpoint inhibitors, according to new findings presented by Kulasinghe et al at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on...

lung cancer

HARMONi-2: Ivonescimab Outperforms Pembrolizumab as First-Line Treatment in NSCLC

In a phase III study conducted in China, the bispecific antibody ivonescimab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with the PD-1 inhibitor pembrolizumab as a first-line treatment of PD-L1–positive advanced non–small...

lung cancer

Addition of Pembrolizumab to Chemotherapy in EGFR TKI-Resistant, EGFR-Mutant, Metastatic Nonsquamous NSCLC

As reported in the Journal of Clinical Oncology by Yang et al, the phase III KEYNOTE-789 trial has shown no significant improvement in progression-free or overall survival with the addition of pembrolizumab to pemetrexed/platinum in EGFR tyrosine kinase inhibitor (TKI)-resistant, EGFR-mutant...

head and neck cancer

Chinese Study Finds Radiation Alone May Be as Effective as Chemoradiation in Patients With Low-Risk Nasopharyngeal Cancer

Nasopharyngeal carcinoma is an aggressive malignant head and neck cancer that is highly prevalent in the southern and southwestern provinces of China. Although the incidence of the cancer is less than 1 per 100,000 in Europe, the United States, and the Pacific,1 data from the International Agency...

genomics/genetics
solid tumors

FDA Approves Cancer Biomarker Test, Companion Diagnostic Indications

The U.S. Food and Drug Administration (FDA) has approved the in vitro diagnostic TruSight Oncology (TSO) Comprehensive test and its first two companion diagnostic indications. This targeted sequencing panel interrogates over 500 genes to profile a patient's solid tumor, helping to increase the...

lung cancer
immunotherapy

ICI-Based Strategies in Advanced, Progressing EGFR-Mutated NSCLC

As reported in The Lancet Oncology by Zhao et al, meta-analyses of trials of immune checkpoint inhibitors (ICIs) in patients with advanced EGFR-mutated non–small cell lung cancer (NSCLC) progressing on EGFR tyrosine kinase inhibitor (TKI) treatment indicate that the optimal treatment strategy is...

kidney cancer

Adjuvant Everolimus in Localized Papillary and Chromophobe Non–Clear Cell Renal Cell Carcinoma

In a subgroup analysis of the EVEREST trial reported in JAMA Network Open, Gulati et al found that adjuvant everolimus did not improve recurrence-free survival vs placebo in patients with localized papillary or chromophobe non–clear cell renal cell carcinoma (RCC). Study Details In the trial,...

gastrointestinal cancer

The Evolving Epidemiology of Gastrointestinal Stromal Tumors in Major Organ Sites

Based on a descriptive, U.S. population–based cohort study reported in JAMA Network Open by Alvarez et al, over the past 2 decades, the incidence of gastrointestinal stromal tumors in major organ sites has increased among several patient populations. The findings may assist in directing future...

lung cancer

Inoperable Stage III NSCLC: Adaptive Radiotherapy Based on FDG-PET Tumor Residual Uptake

In a French phase II study (RTEP7–IFCT-1402) reported in The Lancet Oncology, Vera et al found that adaptive radiotherapy based on fluorine F-18–labeled fluorodeoxyglucose (FDG)–positron-emission tomography (PET) residual uptake appeared to improve local disease control compared with standard...

hematologic malignancies

BTK Degraders and CELMoDs: Novel Mechanisms Overcoming Resistance in Hematologic Malignancies

Despite advances in targeted therapies for hematologic malignancies, drug resistance and persistent side effects continue to challenge clinicians and limit patient outcomes, underscoring the urgent need for novel therapeutic approaches. At the 2024 Pan Pacific Lymphoma Conference, Marc S. Hoffmann, ...

lung cancer
cardio-oncology

AI May Help Uncover Relationship Between Radiation Therapy for NSCLC and Cardiac Arrhythmia

Artificial intelligence (AI) tools may be used to better understand the risk of specific cardiac arrhythmias when various parts of the heart are exposed to different thresholds of radiation as part of a treatment plan for non–small cell lung cancer (NSCLC), according to a recent study published by...

lung cancer

FDA Approves Lazertinib With Amivantamab-vmjw for EGFR-Mutated NSCLC

The U.S. Food and Drug Administration (FDA) has approved the EGFR inhibitor lazertinib (Lazcluze) in combination with the EGFR/MET-targeting bispecific antibody amivantamab-vmjw (Rybrevant) for the first-line treatment of patients with locally advanced or metastatic non–small cell lung cancer...

lymphoma

Acalabrutinib Plus Chemoimmunotherapy Improves Progression-Free Survival in Older Patients With Mantle Cell Lymphoma

Combining Bruton’s tyrosine kinase (BTK) inhibition with chemoimmunotherapy induction significantly extended progression-free survival for older patients with mantle cell lymphoma, and there was also a trend toward improvement on the overall survival benefit, according to data presented during the...

palliative care

ASCO Guideline Update Highlights the Importance of Early Integration of Palliative Care for Patients With Cancer

Growing awareness of the benefits of palliative care in patients with cancer has prompted ASCO to update its recommendations for clinicians, patients, caregivers, and health-care organizations on integrating palliative care in oncology.1 The updated guideline reinforces prior recommendations in the ...

lung cancer

LIBRETTO-431 Trial Shows Selpercatinib Is Effective in East Asian Patients With RET Fusion–Positive Non–Small Cell Lung Cancer

A subgroup analysis of data from the LIBRETTO-431 trial (ClinicalTrials.gov identifier NCT04194944) showed that the selective RET inhibitor selpercatinib safely improved progression-free survival compared to chemotherapy plus pembrolizumab in East Asian patients diagnosed with RET fusion–positive...

gynecologic cancers
geriatric oncology

Age Is Just a Number: Treatment Considerations for Endometrial Cancer in Older Women

Endometrial cancer is most frequently diagnosed among women aged 55 to 65, with a median age at diagnosis of 64 years.1 In epidemiologic studies, women diagnosed with endometrial cancer at an older age are more likely to have high-grade disease, aggressive histology, deep myometrial invasion, lower ...

lung cancer

FDA Approves Neoadjuvant/Adjuvant Durvalumab for Resectable NSCLC

The U.S. Food and Drug Administration (FDA) has approved the PD-L1 inhibitor durvalumab (Imfinzi) with platinum-containing chemotherapy as neoadjuvant treatment followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive)...

solid tumors
immunotherapy

Corticosteroids for Immune-Related Adverse Events and Clinical Outcomes With ICIs for Solid Tumors

In an analysis reported in the Journal of Clinical Oncology, Verheijden et al found that higher peak corticosteroid doses for patients with immune-related adverse events were associated with poorer outcomes in patients receiving immune checkpoint inhibitors (ICIs) for solid tumors.   Study Details...

head and neck cancer

Cannabis Use and Risk of Head and Neck Cancer

In a study reported in JAMA Otolaryngology–Head & Neck Surgery, Gallagher et al found that individuals with cannabis-related disorder were at an increased risk of head and neck cancer vs those without cannabis-related disorder. Cannabis-related disorders are defined by the excessive use of...

lung cancer

Can Neoadjuvant Atezolizumab Set a New Standard for Unresectable Stage III NSCLC?

Immune checkpoint inhibitors, including atezolizumab, have been evaluated in several phase II trials for neoadjuvant therapy in resectable lung cancer, both with and without chemotherapy, such as the LCMC3 trial and CheckMate 816. Ongoing studies, including the IMpower030 trial, are further...

lung cancer

Visceral Pleural Invasion and Recurrence Risk in Patients Undergoing Surgery for NSCLC

In an analysis from the CALGB 140503 trial reported in JAMA Oncology, Nasser Altorki, MD, and colleagues found that pathologically identified visceral pleural invasion was associated with poorer outcomes in patients undergoing surgery for non–small cell lung cancer (NSCLC). Study Details The trial ...

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