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Showing 2901 - 2950Azacitidine Tablets for Continued Treatment in Acute Myeloid Leukemia
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On September 1, 2020, azacitidine tabletswere approved...
Continuous vs Fixed-Duration Immunotherapy in Previously Treated Patients With Advanced NSCLC
In an exploratory analysis of the phase IIIb/IV CheckMate 153 trial published in the Journal of Clinical Oncology, David M. Waterhouse, MD, MPH, and colleagues found that continuing nivolumab beyond 1 year of treatment vs stopping at 1 year of treatment was associated with better outcomes in...
Use of ctDNA to Direct Therapy in Advanced Breast Cancer
In the phase IIa plasmaMATCH platform trial reported in The Lancet Oncology, Nicholas C. Turner, MD, and colleagues found that circulating tumor DNA (ctDNA) provided accurate genotyping that permitted selection of directed therapies in patients with advanced breast cancer. Study Details The...
Abbreviated Breast MRI as Supplementary Screening Method in Women With Dense Breasts
In a single-institution retrospective analysis reported in the Journal of Clinical Oncology, Weinstein et al identified the prevalent cancer detection rate associated with supplemental abbreviated breast magnetic resonance imaging (MRI) screening among average-risk women with dense breasts who had...
Association of Tumor Mutational Burden With Response to Pembrolizumab in Previously Treated Patients With Advanced Solid Tumors
A prospective biomarker analysis of the multicohort phase II KEYNOTE-158 trial reported by Marabelle et al in The Lancet Oncology found that patients with previously treated advanced solid tumors were more likely to respond to pembrolizumab monotherapy if they had high tissue tumor mutational...
Early-Phase Trial Explores Cabozantinib and Nivolumab With or Without Ipilimumab in Advanced Genitourinary Malignancies
In a phase I trial reported in the Journal of Clinical Oncology, Andrea B. Apolo, MD, and colleagues found that the combination of cabozantinib and nivolumab, as well as the combination of cabozantinib/nivolumab plus ipilimumab, produced durable responses in patients with metastatic urothelial...
Overall Survival With Apalutamide in Nonmetastatic Castration-Resistant Prostate Cancer: Analysis From the SPARTAN Trial
As reported in European Urology by Matthew R. Smith, MD, and colleagues, the final analysis of phase III SPARTAN trial has shown significant prolongation of overall survival with apalutamide vs placebo in patients with nonmetastatic castration-resistant prostate cancer and prostate-specific antigen ...
Disease-Free Survival With Adjuvant Osimertinib in Resected EGFR-Mutant NSCLC: ADAURA Trial
As reported in The New England Journal of Medicine by Wu et al, the phase III ADAURA trial has shown significantly prolonged disease-free survival with adjuvant osimertinib vs placebo in patients with resected EGFR-mutant non–small cell lung cancer (NSCLC). These findings were also presented during ...
Olanzapine for Children and Adolescents Receiving Highly Emetogenic Chemotherapy
In a single-center Indian phase III trial reported in the Journal of Clinical Oncology, Naik et al found that the addition of olanzapine to standard antiemetic treatment significantly increased the rate of complete response (CR; defined as no vomiting or use of rescue medication) among children and ...
Surgery With or Without Preoperative Radiotherapy for Primary Retroperitoneal Sarcoma
As reported in The Lancet Oncology by Bonvalot et al, the phase III EORTC-62092 (STRASS) trial showed that the addition of preoperative radiotherapy to surgery did not improve abdominal recurrence–free survival in patients with primary retroperitoneal sarcoma. Study Details In the open-label trial, ...
Overall Survival Analysis From PROfound Trial: Olaparib for Metastatic Castration-Resistant Prostate Cancer
As reported in The New England Journal of Medicine and during the ESMO Virtual Congress 2020 (Abstract 610O) by Maha Hussain, MD, FACP, FASCO, and colleagues, an overall survival analysis from the phase III PROfound trial has shown a significant benefit with olaparib vs physician’s choice of...
Role of F-18–NaF PET/CT in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide
In a phase II study reported in the Journal of Clinical Oncology, Kyriakopoulos et al found that use of quantitative total bone imaging with fluorine-18 (F-18)–sodium fluoride (NaF) positron-emission tomography/computed tomography (PET/CT) helped identify heterogeneity of response in bone lesions...
Addition of Pembrolizumab to Eribulin in HR-Positive, HER2-Negative Metastatic Breast Cancer
In a phase II trial reported in JAMA Oncology, Sara M. Tolaney, MD, MPH, and colleagues found that the addition of pembrolizumab to eribulin did not improve progression-free survival in women with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer. As stated by the...
First-Line PD-1 Inhibitor With or Without Chemotherapy vs Chemotherapy Alone in Advanced Gastric Cancer: KEYNOTE-062
As reported in JAMA Oncology by Kohei Shitara, MD, and colleagues, the phase III KEYNOTE-062 trial showed no significant improvement in overall or progression-free survival with first-line pembrolizumab with or without chemotherapy vs chemotherapy alone in patients with PD-L1–positive advanced...
Adjuvant Chemotherapy After Pancreatic Cancer Resection and Neoadjuvant FOLFIRINOX: Improvement in Overall Survival?
In a retrospective cohort study reported in JAMA Oncology, van Roessel et al found that adjuvant chemotherapy after pancreatic cancer resection and neoadjuvant FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin) was associated with an improvement in overall survival. The benefit was...
Effect of Machine Learning–Directed Clinical Evaluations on Acute Care Visits During Outpatient Therapy
In a single-institution study reported in the Journal of Clinical Oncology, Hong et al found that mandatory twice-weekly evaluations reduced the need for unplanned acute care visits among patients undergoing outpatient radiotherapy or chemoradiation who were identified as being at high risk for...
Overall Survival With Darolutamide in Patients With Nonmetastatic, Castration-Resistant Prostate Cancer: ARAMIS Trial
As reported in The New England Journal of Medicine by Karim Fizazi, MD, and colleagues, the phase III ARAMIS trial has shown significantly prolonged overall survival with darolutamide vs placebo in men with nonmetastatic castration-resistant prostate cancer. The previously reported primary analysis ...
Meta-analysis of Duration of Adjuvant Trastuzumab in Early Breast Cancer
In individual participant data and trial-level meta-analyses reported in JAMA Network Open, Gulia et al found that disease-free survival with adjuvant trastuzumab given for less than 1 year was noninferior to 1 year of trastuzumab therapy in patients with early breast cancer. In addition, the...
Eflornithine Plus Sulindac vs Either Agent Alone in Preventing Progression of Familial Adenomatous Polyposis
In a phase III trial reported in The New England Journal of Medicine, Burke et al found that the combination of eflornithine and sulindac did not reduce the risk of disease progression vs either agent alone in patients with familial adenomatous polyposis. Study Details In the international trial,...
Association of Immunoscore With Time to Recurrence in Stage III Colon Cancer
In a study reported in the Journal of Clinical Oncology, Mlecnik et al found that high Immunoscore values were associated with reduced risk of disease recurrence and better outcomes with chemotherapy vs no chemotherapy in patients with stage III colon cancer. Study Details The international...
Racial Differences in Genomic Profiles of Primary and Metastatic Prostate Cancer
In a letter to the editor published in The New England Journal of Medicine, Brandon A. Mahal, MD, and colleagues described genomic differences in prostate cancer in Black, White, and Asian men. Study Details The study involved next-generation sequencing data from patients who had been treated for...
Addition of Debio 1143 to Cisplatin Chemoradiotherapy in Locoregionally Advanced Head and Neck Cancer
In a French Head and Neck Radiotherapy Oncology Group phase II trial reported in The Lancet Oncology, Sun et al found that the addition of Debio 1143 (a small-molecule antagonist of inhibitor of apoptosis proteins) to high-dose cisplatin chemoradiation improved locoregional disease control in...
Immune Checkpoint Inhibitor Therapy May Contribute to Arterial Inflammation
According to findings from a small study published by Calabretta et al in Circulation, treatment with immune checkpoint inhibitors may worsen inflammation in the arteries that distribute blood from the heart. The research found increased inflammation in the large arteries of 20 Austrian patients...
First-Line Pazopanib vs Doxorubicin in Patients Aged 60 or Older With Metastatic Soft-Tissue Sarcoma
In a German Intergroup phase II study reported in the Journal of Clinical Oncology, Grünwald et al found that progression-free survival with first-line pazopanib was noninferior to doxorubicin in patients aged 60 years or older with inoperable metastatic soft-tissue sarcoma. Pazopanib was also...
Phase II Trial of Capmatinib for MET Exon 14–Mutated or MET-Amplified Advanced NSCLC
As reported in The New England Journal of Medicine by Wolf et al, the phase II GEOMETRY mono-1 trial has shown durable responses with the selective MET inhibitor capmatinib in patients with advanced non–small cell lung cancer (NSCLC) and MET exon 14–skipping mutations. The trial supported the May...
Long-Term Follow-up of the COMBI-AD Trial: Adjuvant Dabrafenib/Trametinib in Patients With Stage III Melanoma and BRAF V600 Mutations
As reported in The New England Journal of Medicine by Reinhard Dummer, MD, and colleagues, 5-year follow-up of the phase III COMBI-AD trial has shown continued relapse-free survival benefit with adjuvant dabrafenib/trametinib vs placebo in patients with stage III melanoma and BRAF V600E or V600K...
First-Line Durvalumab Plus Cisplatin/Pemetrexed in Malignant Pleural Mesothelioma
As reported in The Lancet Oncology by Nowak et al, the Australian phase II DREAM trial showed activity with the triplet of durvalumab plus cisplatin/pemetrexed in previously untreated patients with advanced malignant mesothelioma. Study Details In the multicenter trial, 54 evaluable patients with...
Second-Line Carboplatin/Etoposide vs Topotecan in Relapsed Small Cell Lung Cancer
As reported in The Lancet Oncology by Baize et al, a French phase III trial has shown significant improvement in progression-free survival with second-line carboplatin plus etoposide vs topotecan in patients with chemotherapy-sensitive relapsed small cell lung cancer. As noted by the investigators, ...
Lisocabtagene Maraleucel for Relapsed or Refractory Large B-Cell Lymphomas
In the TRANSCEND NHL 001 study reported in The Lancet, Jeremy S. Abramson, MD, and colleagues found that the autologous CD19-directed chimeric antigen receptor (CAR) T-cell agent lisocabtagene maraleucel (liso-cel) produced a high response rate in patients with relapsed or refractory large B-cell...
Addition of ATR Inhibitor Berzosertib to Gemcitabine Improves Progression-Free Survival in Recurrent Platinum-Resistant High-Grade Serous Ovarian Cancer
As reported in The Lancet Oncology by Panagiotis A. Konstantinopoulos, MD, Dana-Farber Cancer Institute, and colleagues, a U.S. Experimental Therapeutics Clinical Trials Network phase II trial has shown significantly prolonged progression-free survival with the addition of the ATR (ataxia...
Belantamab Mafodotin-blmf for Relapsed or Refractory Multiple Myeloma
On August 5, 2020, the antibody-drug conjugate belantamab mafodotin-blmf was granted accelerated approval for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, ...
Oral Combination of Decitabine and Cedazuridine for Myelodysplastic Syndromes
On July 7, 2020, an oral combination of the nucleoside metabolic inhibitor decitabine and the cytidine deaminase inhibitor cedazuridine was approved for treatment of adult patients with myelodysplastic syndromes (MDS), including: Previously treated and untreated, de novo, and secondary MDS with the ...
Atezolizumab Plus Cobimetinib/Vemurafenib in BRAF V600–Positive Unresectable or Metastatic Melanoma
On July 30, 2020, atezolizumab was granted approval for use in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation–positive unresectable or metastatic melanoma.1,2 Supporting Efficacy Data Approval was based on findings from the phase III, double-blind IMspire150 trial ...
Avelumab in Maintenance Treatment of Urothelial Carcinoma
On June 30, 2020, avelumab was approved for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.1,2 Supporting Efficacy Data Approval was based on findings in the randomized, multicenter, ...
PROfound Trial Evaluates Olaparib in Homologous Recombination Repair Gene–Mutant Prostate Cancer
In a phase III trial (PROfound) reported in The New England Journal of Medicine, Johann de Bono, MB, ChB, PhD, of the Institute of Cancer Research and Royal Marsden Hospital, London, and colleagues found that olaparib significantly improved progression-free survival vs hormonal therapy in patients...
Carfilzomib vs Bortezomib, Each Combined With Lenalidomide/Dexamethasone, in Newly Diagnosed Patients With Multiple Myeloma
As reported in The Lancet Oncology by Shaji K. Kumar, MD, and colleagues, the phase III ENDURANCE trial has shown no improvement in progression-free survival with carfilzomib plus lenalidomide/dexamethasone (KRd) vs bortezomib plus lenalidomide/dexamethasone (VRd) in patients with newly diagnosed...
Local Recurrence With Radiation Boost in HER2-Positive Breast Cancer: HERA Trial Analysis
In a retrospective analysis reported in the International Journal of Radiation Oncology • Biology • Physics, Jaoude et al found that a radiation boost did not reduce the risk of local recurrence among women with HER2-positive breast cancer receiving breast-conserving surgery, whole-breast...
Quality-Adjusted Progression-Free Survival and Time Without Symptoms or Toxicity in the ARIEL3 Trial of Rucaparib Maintenance Therapy for Recurrent Ovarian Cancer
In an exploratory post hoc analysis reported in the Journal of Clinical Oncology, Amit M. Oza, MD, and colleagues found superior quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST) in patients with platinum-sensitive, recurrent...
CLL14 Trial Follow-up: Venetoclax Plus Obinutuzumab in Previously Untreated Patients With Chronic Lymphocytic Leukemia
As reported in The Lancet Oncology by Al-Sawaf et al, 3-year follow-up of the phase III CLL14 trial showed maintained significant improvement in progression-free survival with the fixed-duration regimen of venetoclax/obinutuzumab vs chlorambucil/obinutuzumab in previously untreated patients with...
Selective MET Inhibitor Tepotinib in Patients With Advanced NSCLC and MET Exon 14–Skipping Mutation
As reported in The New England Journal of Medicine by Paul K. Paik, MD, and colleagues, the phase II VISION trial has shown durable responses with the highly selective MET inhibitor tepotinib in patients with non–small cell lung cancer (NSCLC) and MET exon 14–skipping mutation. As noted by the...
COVID-19 Prevalence and Mortality in Patients With Cancer in the UK
In a UK study reported in The Lancet Oncology, Lee et al in the UK Coronavirus Cancer Monitoring Project (UKCCMP) found an increased prevalence of COVID-19 infection among patients with hematologic malignancies and increased risk of death from COVID-19 in patients with leukemia and those with...
Long-Term Outcomes With Accelerated Partial-Breast vs Whole-Breast Irradiation in Patients With Early Breast Cancer
As reported in the Journal of Clinical Oncology by Icro Meattini, MD, and colleagues, 10-year follow-up of the Italian single-center APBI-IMRT-Florence trial showed no differences in ipsilateral recurrence or survival with accelerated partial-breast irradiation vs whole-breast irradiation after...
Updated Results of the ALTERNATIVE Trial of Lapatinib/Trastuzumab Plus AI in HER2-Positive, HR-Positive Metastatic Breast Cancer
Updated results of the phase III ALTERNATIVE trial of dual HER2 inhibition with lapatinib/trastuzumab plus aromatase inhibitor (AI) therapy in HER2-positive, hormone receptor (HR)-positive metastatic breast cancer were reported in the Journal of Clinical Oncology by Johnston et al. The previously...
Adjuvant Nivolumab Plus Ipilimumab vs Nivolumab Alone in Resected Stage IV Melanoma With No Evidence of Disease
In an interim analysis of the German phase II IMMUNED trial reported in The Lancet, Lisa Zimmer, MD, of University Hospital Essen, and colleagues found that adjuvant nivolumab plus ipilimumab and nivolumab alone significantly prolonged recurrence-free survival vs placebo in patients with resected...
Does Binimetinib Improve Progression-Free Survival in Recurrent or Persistent Low-Grade Serous Ovarian Carcinomas?
As reported in the Journal of Clinical Oncology by Bradley J. Monk, MD, and colleagues, the phase III MEK Inhibitor in Low-Grade Serous Ovarian Cancer (MILO)/ARRAY-162-311/ENGOT-ov11 trial showed that the MEK1/2 inhibitor binimetinib did not improve progression-free survival vs physician’s choice...
Addition of Veliparib to Carboplatin/Paclitaxel in Previously Treated Patients With BRCA-Mutated Advanced Breast Cancer: BROCADE3 Trial
As reported in The Lancet Oncology by Véronique Diéras, MD, and colleagues, the phase III BROCADE3 trial showed a significant improvement in progression-free survival with the addition of the poly (ADP-ribose) polymerase (PARP) inhibitor veliparib to carboplatin and paclitaxel in patients with...
Association of Adjuvant Endocrine Therapy With Overall Survival in Small HR-Positive, HER2-Negative Breast Cancer
In a National Cancer Database cohort study reported in a research letter in JAMA Network Open, Ma et al found that receipt vs no receipt of adjuvant endocrine therapy was associated with improved overall survival in women with small hormone receptor (HR)-positive, HER2-negative breast cancers. As...
Changes in Reoperation Rates After Publication of SSO/ASTRO Guideline on Margins for Breast-Conserving Surgery
In a meta-analysis reported in JAMA Surgery, Marinovich et al found that reoperation rates after breast-conserving surgery in women with breast cancer declined after the publication of the Society of Surgical Oncology/American Society for Radiation Oncology (SSO/ASTRO) Consensus Guideline on...
Geriatric Comanagement After Cancer Surgery in Patients Aged 75 and Older
In a single-institution study reported in JAMA Network Open, Shahrokni et al found that postoperative care comanaged by the geriatrics service and surgical service was associated with reduced 90-day postoperative mortality vs care managed by the surgical service alone among patients aged 75 and...
Assessment of Potential Abscopal Effect of SBRT Added to Nivolumab in Metastatic Head and Neck Cancer
In a single-center phase II trial reported in the Journal of Clinical Oncology, McBride et al found that use of stereotactic body radiotherapy (SBRT) for a potential abscopal effect together with nivolumab did not improve objective response rate vs nivolumab alone in patients with metastatic head...
