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Showing 1351 - 1400Updated Efficacy and Safety Data From CheckMate 743: First-Line Nivolumab/Ipilimumab vs Chemotherapy for Unresectable Malignant Pleural Mesothelioma
With a follow-up of at least 3 years, the results from the CheckMate 743 study represent the first long-term survival data in a phase III study evaluating first-line immune checkpoint inhibition in patients with unresectable malignant pleural mesothelioma. Overall, 23% of patients treated with...
Importing Oncology Trials From China, or Other Single Foreign Countries, for Consideration of U.S. Regulatory Approvals
In a commentary published in The Lancet Oncology, Harpreet Singh, MD, and Richard Pazdur, MD, both of the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA), warned against the increasing number of oncology drug development programs based wholly or predominantly on data...
Metformin Added to Standard Adjuvant Chemotherapy Fails to Improve Outcomes in Early Breast Cancer
The addition of metformin, a drug commonly used to treat type 2 diabetes, to standard adjuvant treatment failed to improve invasive disease–free survival or overall survival for hormone receptor–positive or –negative breast cancer, according to the results of a large landmark trial led by the...
Evidence Supports Ovarian Function Suppression Plus Aromatase Inhibitor in Premenopausal Women With Early Breast Cancer
The benefits of ovarian function suppression were sustained long term for premenopausal women with hormone receptor–positive breast cancer, according to updates from SOFT and TEXT, two randomized, controlled trials, presented at the 2021 San Antonio Breast Cancer Symposium.1 A separate large...
Expert Point of View: Hope S. Rugo, MD, FASCO
The discussant of KEYNOTE-522 at the 2021 San Antonio Breast Cancer Symposium, Hope S. Rugo, MD, FASCO, Professor of Medicine and Director of Breast Oncology and Clinical Trials Education at the University of California San Francisco Comprehensive Cancer Center, commented: “We are clearly making...
KEYNOTE-522: Sensitivity Analyses Confirm Value of Neoadjuvant Pembrolizumab in Triple-Negative Breast Cancer
Updated results from the pivotal KEYNOTE-522 trial have confirmed the benefit of neoadjuvant therapy with pembrolizumab plus chemotherapy in patients with early triple-negative breast cancer.1 The results were presented at the 2021 San Antonio Breast Cancer Symposium by Peter Schmid, MD, PhD,...
Abatacept for Prophylaxis of Acute Graft-vs-Host Disease
On December 15, 2021, abatacept, a selective T-cell costimulation modulator, was approved for prophylaxis of acute graft-vs-host disease in combination with a calcineurin inhibitor (eg, cyclosporine, tacrolimus) and methotrexate in adults and pediatric patients aged ≥ 2 years undergoing...
Fixed-Duration Venetoclax Plus Ibrutinib Achieves Deep and Durable MRD Remissions in CLL
Two different trials presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition found that fixed-duration treatment with ibrutinib and venetoclax achieved deep and sustained undetectable measurable residual disease (MRD) status when used as first-line therapy for...
HIMALAYA Trial: First-Line Tremelimumab Plus Durvalumab Improves Overall Survival in Unresectable Hepatocellular Carcinoma
Patients with advanced, unresectable hepatocellular carcinoma may be gaining another first-line treatment option. In the global phase III HIMALAYA trial, a single priming dose of tremelimumab plus regular-interval durvalumab significantly improved overall survival, according to Ghassan K....
Expert Point of View: Nilofer Azad, MD
Nilofer Azad, MD, Professor of Oncology at Johns Hopkins University School of Medicine and Co-Director of Cancer Genetics and Epigenetics at the Sidney Kimmel Comprehensive Cancer Center, Baltimore, was invited to discuss the results of the phase III TOPAZ-1 study, which found an overall survival...
TOPAZ-1: Overall Survival Prolonged With First-Line Immunotherapy Plus Chemotherapy in Biliary Tract Cancer
For the first time, a phase III study has shown an overall survival benefit for upfront treatment using immunotherapy plus chemotherapy in advanced biliary tract cancer. In the TOPAZ-1 trial, the addition of the anti–PD-L1 agent durvalumab to gemcitabine plus cisplatin significantly improved...
In All Candor, What Does CANDOR Bring to the Table in Relapsed or Refractory Multiple Myeloma?
An updated analysis of the phase III CANDOR study—recently reported by Usmani et al and summarized in this issue of The ASCO Post—confirmed a significant progression-free survival benefit for the combination of daratumumab, carfilzomib, and dexamethasone (KdD) over carfilzomib and dexamethasone...
Compression Sleeves to Reduce Risk of Arm Swelling in Women Undergoing Surgery for Breast Cancer
In an Indian single-center study reported in the Journal of Clinical Oncology, Paramanandam et al found that the prophylactic use of compression sleeves reduced the risk of arm swelling in women with breast cancer undergoing axillary lymph node dissection. Study Details In the study, 301 evaluable...
Expert Point of View: Rona Yaeger, MD
Rona Yaeger, MD, Associate Attending Physician at Memorial Sloan Kettering Cancer Center, New York, offered her thoughts on the findings of Morris et al for the combination regimen of encorafenib, cetuximab, and nivolumab in patients with microsatellite-stable BRAF V600E–mutated metastatic...
Expert Point of View: Demetris Papamichael, MB, BS
The invited discussant of the SOLSTICE trial1 was Demetris Papamichael, MB, BS, Consultant Medical Oncologist at the Bank of Cyprus Oncology Centre and Associate Professor at St. George’s Hospital and Medical School, University of London. He said that although the study concluded...
SOLSTICE Trial: Trifluridine/Tipiracil Plus Bevacizumab in Metastatic Colorectal Cancer
For the treatment of metastatic colorectal cancer in patients unfit for intensive chemotherapy, trifluridine/tipiracil plus bevacizumab as first-line therapy was no more effective than capecitabine plus bevacizumab, investigators from the phase III SOLSTICE trial reported in a European Society for...
FDA Investigating Possible Increased Risk of Death With Lymphoma Treatment Umbralisib
The U.S. Food and Drug Administration (FDA) is investigating a possible increased risk of death associated with umbralisib (Ukoniq), a kinase inhibitor including PI3K-delta and CK1-epsilon, approved to treat marginal zone and follicular lymphomas. The FDA determined that initial findings from the...
Expert Point of View: Mandana Kamgar, MD, MPH
The ASCO Post invited Mandana Kamgar, MD, MPH, Assistant Professor of Medicine at the Medical College of Wisconsin, LaBahn Pancreatic Cancer Program, Milwaukee, to comment on the KRYSTAL-1 trial. “The KRYSTAL-1 study in totality is a multiphase and multiarm ongoing study exploring the role of...
Can Weight Loss in Adulthood Reduce the Risk of Developing Colorectal Adenomas?
Weight loss for adults, particularly those who are overweight or obese, may reduce their risk of developing a type of polyp that may lead to colorectal cancer, according to a new study published by He et al in JNCI Cancer Spectrum. Losing weight from early to late adulthood (up to the mid-70s)—at...
FDA Approves Second COVID-19 Vaccine
On January 31, the U.S. Food and Drug Administration (FDA) approved a second COVID-19 vaccine, which has been known as the Moderna COVID-19 vaccine, for the prevention of COVID-19 in individuals aged 18 years and older; the approved vaccine will be marketed as Spikevax. “The FDA’s approval of [the...
MONALEESA Analyses Show Widespread Benefit for Ribociclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer
Further analyses of the MONALEESA metastatic breast cancer trials have shown that the benefit of ribociclib plus endocrine therapy in the first-line setting extends to most intrinsic molecular subtypes and is consistent across multiple subgroups. The studies were presented at the 2021 San Antonio...
Similar Efficacy—but Better Tolerability—for Ripretinib vs Sunitinib in Previously Treated Patients With Advanced GIST
In the INTRIGUE trial, the tyrosine kinase inhibitor ripretinib was not superior to sunitinib in the second-line treatment of patients with advanced gastrointestinal stromal tumors (GIST); however, the agent was better tolerated. These findings were presented by Michael C. Heinrich, MD, FACP, and...
Study Identifies Black Race as Risk Factor for Lymphedema After Axillary Dissection in Women With Breast Cancer
Black women with breast cancer had significantly higher rates of lymphedema after axillary lymph node dissection compared with Hispanic, White, and Asian women in a prospective study of breast cancer–related lymphedema presented at the 2021 San Antonio Breast Cancer Symposium (SABCS). In fact,...
Cancer Has Made Me a Risk-Taker, and That’s Good
In 2017, I was caring for my brother, who was suffering from respiratory failure due to complications from cerebral palsy, and working full-time as a registered nurse. I was feeling overwhelmed and exhausted all the time. I was also losing weight at an alarming rate—more than 70 pounds in just a...
Adjuvant Atezolizumab in IMpower010: Moving the Needle in Early-Stage NSCLC
Adjuvant platinum-based chemotherapy for early-stage non–small cell lung cancer (NSCLC) is currently almost an afterthought and is taken for granted as a standard of care for patients with stage II to IIIA NSCLC after resection. The earliest meta-analysis, published in 1995,1 gave the first hint of ...
Adjuvant Atezolizumab Improves Disease-Free Survival Following Adjuvant Chemotherapy in PD-L1–Positive Resected Stage II–IIIA NSCLC
As reported in The Lancet by Enriqueta Felip, MD, of Vall d’Hebron University Hospital, Barcelona, and colleagues, the phase III IMpower010 trial has shown improved disease-free survival with adjuvant atezolizumab vs best supportive care in the predefined population of patients with resected stage ...
Promise and Need for More Progress in Treatment of Squamous Cell NSCLC
A greater understanding of the mutational landscape in non–small cell lung cancer (NSCLC) has identified key oncogenes, such as EGFR, ALK, ROS, RET, and BRAF, among others. These discoveries, coupled with the availability of specific targeted small-molecule inhibitors, have transformed the...
BELINDA Trial: CAR T-Cell Therapy Fails to Improve Outcomes in Aggressive Non-Hodgkin Lymphoma
The autologous chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel failed to improve event-free survival vs standard-of-care treatment strategies in patients with aggressive, relapsed or refractory non-Hodgkin lymphoma (NHL), according to results of the phase III BELINDA trial,...
Isatuximab-Containing Induction Therapy for Multiple Myeloma Increases Measurable Residual Disease Negativity
For the first-line treatment of newly diagnosed multiple myeloma, the percentage of patients achieving measurable residual disease (MRD, previously called minimal residual disease) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to a standard...
Expert Point of View: Laurie H. Sehn, MD, MPH
Press conference moderator, Laurie H. Sehn, MD, MPH, of the University of British Columbia, Vancouver, Canada, noted, that her center participated in the single-arm trial of mosunetuzumab. “We witnessed first-hand the tremendous capacity bispecific antibodies have to make a real difference in...
Mosunetuzumab Meets Primary Endpoint of Phase II Trial in Relapsed or Refractory Follicular Lymphoma
The bispecific antibody mosunetuzumab achieved deep and durable remissions as monotherapy in patients with relapsed or refractory follicular lymphoma, according to the results of a pivotal phase II trial presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition.1 In ...
POLARIX: Addition of Polatuzumab Vedotin-piiq to Standard of Care Significantly Reduces Progression of Diffuse Large B-Cell Lymphoma
As a first-line treatment of inter-mediate- or high-risk diffuse large B-cell lymphoma, the addition of the antibody-drug conjugate polatuzumab vedotin-piiq to standard-of-care therapy resulted in a 27% reduction in the relative risk of disease progression, relapse, or death, with a similar safety...
Expert Point of View: Amy Tiersten, MD and Carlos L. Arteaga, MD
Amy Tiersten, MD, Professor of Medicine, Hematology, and Medical Oncology, Icahn School of Medicine at Mount Sinai, and Carlos L. Arteaga, MD, Director of the Simmons Comprehensive Cancer Center and Associate Dean of Oncology at The University of Texas Southwestern Medical Center, Dallas,...
PADA-1 Trial: With Early Identification of ESR1 Mutation, Switch to Fulvestrant in Metastatic Breast Cancer
Switching from an aromatase inhibitor to fulvestrant upon early identification of the ESR1 mutation in plasma—before disease progression—doubled progression-free survival in the phase III PADA-1 trial, presented at the 2021 San Antonio Breast Cancer Symposium.1 “PADA-1 is the first trial to...
ZUMA-7: Axicabtagene Ciloleucel Quadruples Event-Free Survival in Large B-Cell Lymphoma
In the primary analysis of the phase III ZUMA-7 trial, examining second-line therapy for relapsed or refractory large B-cell lymphoma, the CAR T-cell therapy axicabtagene ciloleucel led to a fourfold increase in event-free survival over the standard of care. These findings were presented at the...
Studies Evaluate Screening for Early Multiple Myeloma
Precursors to multiple myeloma were identified by population screening in two studies reported at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition. The prevalence of monoclonal gammopathies was determined in the PROMISE trial using cutting-edge technology in a high-risk ...
PANTHER: No Significant Benefit for Pevonedistat Plus Azacitidine in Higher-Risk Myelodysplastic Syndrome
The phase III PANTHER trial, which evaluated pevonedistat plus azacitidine vs azacitidine alone in higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia, and low–blast count acute myeloid leukemia (AML), failed to meet its primary endpoint of event-free survival, though lessons...
Does Early Locoregional Therapy for the Primary Site Improve Survival in Newly Diagnosed Metastatic Breast Cancer?
In the phase III ECOG-ACRIN E2108 trial reported in the Journal of Clinical Oncology, Seema A. Khan, MD, MPH, and colleagues found no difference in overall survival with early locoregional therapy vs continued systemic therapy among women with newly diagnosed stage IV breast cancer and an intact...
Anthracycline Plus Taxane Reduces Risk of Breast Cancer Recurrence at 10 Years
In a large patient-level meta-analysis of 16 trials, presented at the 2021 San Antonio Breast Cancer Symposium (SABCS),1 the combination of an anthracycline plus a taxane achieved a substantial 15% reduction in breast cancer recurrence at 10 years vs taxane chemotherapy alone, representing an...
Durvalumab/Tremelimumab Improves Overall Survival vs Sorafenib in Patients With Advanced Hepatocellular Carcinoma: HIMALAYA
Results from the randomized international phase III HIMALAYA trial showed that a combination of the anti–PD-L1 immunotherapy durvalumab plus the anti–CTLA-4 immunotherapy tremelimumab reduced the risk of death by 22% in patients with stage III or IV unresectable hepatocellular carcinoma compared to ...
Expert Point of View: Anne Blaes, MD, MS, and Virginia Kaklamani, MD
Commenting on the update of RxPONDER presented at the 2021 San Antonio Breast Cancer Symposium were Anne Blaes, MD, MS, Associate Professor of Hematology/Oncology at the University of Minnesota and Co-Director of the Screening, Prevention, Etiology and Cancer Survivorship Program at the Masonic...
RxPONDER Update Explores Benefit of Chemotherapy in Subgroups
Updated results of the SWOG S1007 RxPONDER trial confirmed the key takeaway from the previous analysis: adjuvant chemotherapy benefits premenopausal women but not postmenopausal women with hormone receptor–positive, HER2-negative disease, one to three positive lymph nodes, and a 21-gene Oncotype DX ...
AGILE Study: Addition of Ivosidenib to Azacitidine Triples Median Overall Survival in Difficult-to-Treat AML Population
In patients with newly diagnosed acute myeloid leukemia (AML) with an IDH1 mutation who were ineligible for intensive chemotherapy, the addition of the IDH1 inhibitor ivosidenib to azacitidine significantly improved survival vs azacitidine alone, according to data presented at the 2021 American...
Second-Line T-DXd Improves Progression-Free Survival Across HER2-Positive Metastatic Breast Cancer Subgroups
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) lengthened progression-free survival and improved objective response rate compared to the antibody-drug conjugate ado-trastuzumab emtansine (T-DM1) after trastuzumab and taxane therapy in women with HER2-positive metastatic breast...
EMERALD Trial: Oral Selective Estrogen Receptor Degrader as Second- or Third-Line Therapy for Advanced Breast Cancer
Use of the first investigational oral selective estrogen receptor degrader (SERD) elacestrant significantly reduced the risk of death or disease progression and lengthened progression-free survival compared with standard-of-care endocrine therapy with fulvestrant or an aromatase inhibitor in...
COSMIC-312: Cabozantinib Plus Atezolizumab Improves Progression-Free Survival in Advanced Hepatocellular Carcinoma
The phase III COSMIC-312 study has met its primary endpoint, showing a significant improvement in progression-free survival with cabozantinib plus atezolizumab compared with sorafenib in treatment-naive hepatocellular carcinoma (HCC), investigators reported at a European Society for Medical...
ORIENT-31: Novel Four-Drug Regimen Evaluated in EGFR-Mutated NSCLC
A four-drug combination of the anti–PD-1 antibody sintilimab, the bevacizumab biosimilar IBI305, plus pemetrexed and cisplatin chemotherapy significantly improved progression-free survival compared with chemotherapy alone in patients with advanced nonsquamous non–small cell lung cancer (NSCLC) with ...
Expert Point of View: Matthew J. Ellis, MB, BChir, PhD, FACP
The final results of the phase III PALLAS trial1 are “deeply disappointing,” said session moderator Matthew J. Ellis, MB, BChir, PhD, FACP, Professor of Medicine and Director of the Lester and Sue Smith Breast Center at Baylor College of Medicine. The results of the final primary analysis of PALLAS ...
Final Analysis of PALLAS Trial: No Benefit of Adjuvant Palbociclib Plus Endocrine Therapy in Early Breast Cancer
The final protocol-defined analysis of the phase III PALLAS trial confirmed the negative results of the second interim analysis, showing no benefit of palbociclib plus endocrine therapy in the adjuvant breast cancer setting. Michael Gnant, MD, of the Medical University of Vienna, reported these...
Measurable Residual Disease Kinetics: A Potential New Tool in CLL
Achieving undetectable measurable residual disease (MRD) is an important milestone in the treatment of patients with chronic lymphocytic leukemia (CLL) as well as those with other hematologic malignancies undergoing treatment. Now a small phase II study, presented at the 2021 American Society of...
