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Showing 3751 - 3800Addition of Adjuvant Palbociclib to Ongoing Endocrine Therapy in HR-Positive, HER2-Negative Early Breast Cancer: PALLAS Trial
As reported in The Lancet Oncology by Erica L. Mayer, MD, and colleagues, the second interim analysis of the phase III PALLAS trial showed no improvement in invasive disease–free survival with the addition of adjuvant palbociclib to ongoing endocrine therapy in patients with hormone receptor...
Early Integration of Nutritional and Psychological Interventions for Previously Untreated Patients With Metastatic Esophagogastric Cancer
In a Chinese single-institution phase III trial reported in the Journal of Clinical Oncology, Lu et al found that early interdisciplinary supportive care with a focus on nutrition and psychological status was associated with improved overall survival vs standard care in previously untreated...
Study Identifies Four Unique Subtypes of Small Cell Lung Cancer
Researchers have developed the first comprehensive framework to classify small cell lung cancer (SCLC) into four unique subtypes based on gene expression and have identified potential therapeutic targets for each type. These findings were published by Gay et al in Cancer Cell. SCLC is known for...
Significant Survival Benefit From Chemotherapy for Older Women With Triple-Negative Breast Cancer
Women older than age 70 diagnosed with triple-negative breast cancer had significantly improved overall survival if they received adjuvant and/or neoadjuvant chemotherapy, according to an analysis of data from more than 16,000 women enrolled in the National Cancer Database. The estimated 5-year...
Chemotherapy Added to Local Therapy Improves Overall Survival in Older Women With Triple-Negative Breast Cancer
In a National Cancer Database analysis reported in The Lancet Oncology, Jennifer A. Crozier, MD, of the Division of Cancer Medicine, Baptist MD Anderson Cancer Center, Jacksonville, and colleagues found that receipt of neoadjuvant or adjuvant chemotherapy was associated with improved overall...
Duration of Adjuvant Chemotherapy Assessed in Stage III Colon Cancer
As reported in The Lancet Oncology by Thierry André, MD, of Sorbonne Université and Hôpital Saint Antoine, Paris, and colleagues, the prospective pooled analysis of six phase III trials in the IDEA collaboration has shown that noninferiority in overall survival for 3 vs 6 months of adjuvant...
A Tale of Two CDK4/6 Inhibitors in Early Breast Cancer
The primary outcome analysis of the phase III monarchE trial, an update of previous data, continued to show significant benefit for abemaciclib in the adjuvant setting, reducing the risk for invasive disease recurrence by 28.7%. Meanwhile, the first results of the phase III PENELOPE-B trial of...
Osimertinib in Adjuvant Therapy for NSCLC With EGFR Mutations
On December 18, 2020, osimertinib was approved for adjuvant therapy after tumor resection in patients with non–small cell lung cancer (NSCLC) with tumors with EGFR exon 19 deletions or exon 21 L858R mutations, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 Supporting...
Expert Point of View: Marlise Luskin, MD
Commenting on this trial, Marlise Luskin, MD, of Dana-Farber Cancer Institute, Boston, explained that the treatment of AML in older adults remains a particular challenge for leukemia clinicians. “Although many older patients eligible for intensive induction chemotherapy achieve complete remission,...
Venetoclax Added to Bortezomib Plus Dexamethasone in Relapsed or Refractory Multiple Myeloma
As reported in The Lancet Oncology by Shaji K. Kumar, MD, of the Division of Hematology, Mayo Clinic, Rochester, and colleagues, the phase III BELLINI trial has shown that the addition of venetoclax to bortezomib/dexamethasone significantly prolonged progression-free survival in patients with...
Oral Azacitidine Is Noninferior to Placebo for Health-Related Quality of Life in AML
Health-related quality of life was sustained in patients taking oral azacitidine (also known as CC-486) compared with placebo in patients with acute myeloid leukemia (AML), according to results of the phase III QUAZAR AML-001 trial reported at the 2020 American Society of Hematology (ASH) Annual...
Long-Term Follow-up of IFM 2009 Confirms Benefit of Front-Line Transplant in Myeloma
The benefit of autologous transplantation in newly diagnosed multiple myeloma has been confirmed by follow-up of the IFM 2009 trial, reported at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition by Aurore Perrot, MD, PhD, Assistant Professor of Hematology at the Cancer...
Expert Point of View: Yuan Yuan, MD, PhD
Yuan Yuan, MD, PhD, a medical oncologist at City of Hope, Duarte, California, commented on the IPATunity130 trial. “Targeting the PIK3CA/AKT/mTOR cancer driver pathway is the holy grail for breast cancer in general. About 30% to 40% of breast cancers carry an alteration. Activation of this pathway ...
Ipatasertib Plus Paclitaxel Falters in Advanced Triple-Negative Breast Cancer Phase III Trial
The combination of ipatasertib plus paclitaxel failed to improve progression-free survival in PIK3CA/AKT1/PTEN-altered locally advanced, unresectable or metastatic triple-negative breast cancer, according to results from cohort A of the phase III IPATunity130 trial, presented at the 2020 San...
Expert Point of View: Yuan Yuan, MD, PhD
Yuan Yuan, MD, PhD, a medical oncologist at City of Hope, Duarte, California, said that this was yet another failed phase III trial following promising phase II data. “Entinostat was granted Fast Track designation by the U.S. Food and Drug Administration several years back based on preclinical and...
Adding Entinostat to Exemestane Fails to Overcome Aromatase Inhibitor Resistance in Advanced Breast Cancer
The histone deacetylase inhibitor (HDAC) entinostat, added to exemestane, failed to overcome endocrine therapy resistance in advanced breast cancer, according to the E2112 phase III trial conducted by the ECOG-ACRIN Cancer Research Group. Results showed that overall survival was not improved by the ...
KEYNOTE-355: Pembrolizumab Plus Chemotherapy Improves Progression-Free Survival in PD-L1–Enriched Advanced Triple-Negative Breast Cancer
Pembrolizumab plus chemotherapy improved progression-free survival vs chemotherapy alone as first-line treatment of advanced or metastatic triple-negative breast cancer, according to the results of KEYNOTE-355.1 Progression-free survival was significantly improved with pembrolizumab plus...
Expert Point of View: William Gradishar, MD
Thoughts on oral taxanes—and in particular, tesetaxel—were provided by William Gradishar, MD, the Betsy Bramsen Professor of Breast Oncology at Northwestern University Feinberg School of Medicine and Deputy Director for the Clinical Network of the Lurie Cancer Center. Dr. Gradishar commented that...
Oral Taxanes Moving Forward in Metastatic Breast Cancer
Positive results have now been reported in phase III trials of two oral taxanes in the treatment of metastatic breast cancer. At the 2020 San Antonio Breast Cancer Symposium, treatment with tesetaxel and reduced-dose capecitabine resulted in an improvement in progression-free survival of about 3...
Relugolix for Advanced Prostate Cancer
On December 18, 2020, relugolix was approved for the treatment of adult patients with advanced prostate cancer. Relugolix is the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist to be approved in this setting.1,2 Supporting Efficacy Data Approval was based on findings in the...
Selinexor in Relapsed or Refractory Multiple Myeloma
On December 18, 2020, selinexor was approved for use in combination with bortezomib and dexamethasone for treatment of adult patients with multiple myeloma who have received at least one prior therapy.1,2 Selinexor received accelerated approval in 2019 for use in combination with dexamethasone for...
Margetuximab-cmkb for Previously Treated Metastatic HER2-Positive Breast Cancer
On December 16, 2020, margetuximab-cmkb (margetuximab) was approved for use in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.1,2...
IMpower133 Update: Atezolizumab Plus Carboplatin/Etoposide for Extensive-Stage Small Cell Lung Cancer
As reported in the Journal of Clinical Oncology by Stephen V. Liu, MD, and colleagues, an updated overall survival analysis in the phase I/III IMpower133 trial showed continued benefit with the addition of atezolizumab to carboplatin/etoposide as first-line treatment in patients with...
Allogeneic Hematopoietic Cell Transplantation in Acute Leukemias and Myelodysplastic Syndromes
To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on the use of allogeneic hematopoietic cell transplantation (allo-HCT) in the...
Rocio Garcia-Carbonero, MD, on Treating Neuroendocrine Tumors of Nonpancreatic Origin With Octreotide Acetate and Axitinib
Rocio Garcia-Carbonero, MD, of Hospital Universitario 12 De Octubre, discusses results of the phase II/III AXINET trial, which showed that axitinib plus long-acting release octreotide improved overall response compared with placebo and octreotide in patients with advanced grade 1 or 2...
Evolving Landscape of First-Line Therapy for Metastatic Renal Cell Carcinoma
In the past 3 years, we have seen a dramatic shift in the treatment paradigm for first-line therapy for metastatic clear cell renal cell carcinoma. Multiple phase III clinical trials have demonstrated improved efficacy with combinations compared with sunitinib, leading to the regulatory approval of ...
Andrew X. Zhu, MD, PhD, on IDH1-Mutant Cholangiocarcinoma: Ivosidenib vs Placebo
Andrew X. Zhu, MD, PhD, of Massachusetts General Hospital, discusses final results from the phase III ClarIDHy study, which showed that ivosidenib may improve overall and progression-free survival compared with placebo in patients with previously treated cholangiocarcinoma and an isocitrate...
Talia Golan, MD, on Pancreatic Cancer: Olaparib for BRCA-Mutated Disease
Talia Golan, MD, of the Oncology Institute, Sheba Medical Center, discusses phase III results from the POLO trial, which explored the question of whether maintenance olaparib could improve overall and progression-free survival for patients with germline BRCA-mutated metastatic pancreatic cancer...
Richard S. Finn, MD, on HCC: Atezolizumab Plus Bevacizumab vs Sorafenib
Richard S. Finn, MD, of the UCLA Medical Center, discusses updated results from the IMbrave 150 study, which showed atezolizumab plus bevacizumab provides the longest overall survival seen in a front-line phase III study in advanced hepatocellular carcinoma, confirming this combination as the...
Risk Categories for Pediatric Patients With Medulloblastoma
In an analysis from the international phase III SJMB03 trial reported in the Journal of Clinical Oncology, Gajjar et al identified lower- and higher-risk groups of pediatric patients with medulloblastoma based on molecular and clinical risk factors. Study Details SJMB03 is a phase III trial of...
Lenalidomide Plus Epoetin Alfa vs Lenalidomide Alone in Refractory Non-del(5q) MDS
In a phase III U.S. Intergroup trial reported in the Journal of Clinical Oncology, Alan F. List, MD, and colleagues found that treatment with lenalidomide plus epoetin alfa increased the rate of major erythroid response vs lenalidomide alone in patients with lower-risk, non-del(5q) myelodysplastic...
Novel Risk Tool for Predicting Severe Toxicity in Older Patients Receiving Chemotherapy for Early-Stage Breast Cancer
As reported in the Journal of Clinical Oncology, Allison Magnuson, DO, and colleagues have developed a risk tool for predicting severe toxicity in patients aged 65 and older receiving chemotherapy for early-stage breast cancer. Study Details The prospective cohort study included 473 patients...
Empowering the FDA to Require Dose Optimization of All New Oncology Drugs
The vast majority of drugs used outside of oncology are evaluated in randomized dose-ranging trials to optimize the therapeutic index prior to the pivotal phase III trial. No one would think of dosing a statin or an antibiotic at the highest dose patients could tolerate, especially if that dose...
Reduced Frequency of Vincristine/Dexamethasone Pulses in Maintenance Therapy for Pediatric Patients With Average-Risk B-Cell ALL
As reported in the Journal of Clinical Oncology by Angiolillo et al, findings from the phase III Children’s Oncology Group (COG) AALL0932 trial indicated that “outstanding outcomes” can be achieved with maintenance therapy with a reduced frequency of vincristine/dexamethasone pulses in pediatric...
Bemarituzumab Plus Chemotherapy Improves Outcomes in Advanced Gastric/Gastroesophageal Junction Cancer
Gastric cancer has a new target: fibroblast growth factor receptor 2b (FGFR2b). Targeting FGFR2b with bemarituzumab plus chemotherapy led to clinically meaningful and statistically significant improvements in progression-free survival, overall survival, and response rates in the randomized phase II ...
Addition of Sitagliptin to Tacrolimus/Sirolimus Prophylaxis for Acute Graft-vs-Host Disease
In a phase II trial reported in The New England Journal of Medicine, Farag et al found that the addition of the dipeptidyl peptidase 4 (DPP-4; CD26) inhibitor sitagliptin to tacrolimus and sirolimus prophylaxis resulted in a low rate of acute graft-vs-host disease among patients with hematologic...
Electronic Patient Self-Reporting of Adverse Events During Cancer Chemotherapy: eRAPID System
In a single-institution phase III trial reported in the Journal of Clinical Oncology, Absolom et al found that use of the electronic patient self-reporting of adverse events: patient information and advice (eRAPID) system was associated with improvements in patient-reported outcomes vs usual care...
Kai-Keen Shiu, MD, PhD, on Colorectal Cancer: Pembrolizumab vs Chemotherapy for Microsatellite Instability–High Disease
Kai-Keen Shiu, MD, PhD, of the University College Hospital NHS Foundation Trust - London, discusses an interim analysis of PFS 2 results (defined as time from random assignment to progression on the next line of therapy or death) from the phase III KEYNOTE-177 trial. This study has already shown...
Romain Cohen, MD, PhD, on Colon Cancer: Prognostic Value of Tumor Deposits
Romain Cohen, MD, PhD, of the Mayo Clinic and Sorbonne University, discusses a post-hoc analysis of phase III results from the CALGB/SWOG 80702 study, which showed that adding the number of tumor deposits, a negative prognostic factor, to the count of lymph node metastases may improve the accuracy...
Rutika Mehta, MD, MPH, on Gastric Cancer: Adjuvant Chemotherapy With S-1 and Docetaxel
Rutika Mehta, MD, MPH, of the H. Lee Moffitt Cancer Center and Research Institute, discusses the 3-year regression-free and overall survival results from the JACCRO study, which compared the efficacy of S-1, an oral prodrug of fluorouracil, vs S-1 plus docetaxel after curative resection of stage...
Wasat Mansoor, MBChB, PhD, on Esophageal Cancer: Quality of Life With Pembrolizumab and Chemotherapy
Wasat Mansoor, MBChB, PhD, of The Christie NHS Foundation Trust, discusses phase III results from the KEYNOTE-590 trial, which showed no deterioration in health-related quality of life when pembrolizumab was added to chemotherapy in patients with metastatic and unresectable esophageal cancers...
Postsurgical Disease Recurrence in Stage I to III Colorectal Cancer May Be Predicted by ctDNA
Patients with stage I to III colorectal cancer and a high risk for disease recurrence may be identified by serial testing of circulating tumor DNA (ctDNA) after resection, according to a study in which ctDNA was more reliable than carcinoembryonic antigen (CEA) surveillance or standard radiologic...
IDH Inhibitor Ivosidenib Improves Overall Survival in Previously Treated Patients With Cholangiocarcinoma: ClarIDHy Trial
Ivosidenib, an inhibitor of isocitrate dehydrogenase 1 (IDH1), improved overall survival by almost 3 months compared with placebo in previously treated patients with advanced IDH1-mutated cholangiocarcinoma. Researchers presented results from the global phase III ClarIDHy trial at the 2021...
Palbociclib Plus Endocrine Therapy vs Capecitabine for Patients With HR-Positive, HER2-Negative Breast Cancer: The PEARL Trial
Although patients with hormone receptor (HR)-positive, HER2-negative, aromatase inhibitor–resistant metastatic breast cancer maintained quality of life for a longer time following treatment with palbociclib plus either exemestane or fulvestrant than capecitabine, those receiving chemotherapy...
Adding Oxaliplatin to Fluoropyrimidine for Patients With Stage III Colon Cancer and Microsatellite Instability
In a pooled analysis reported in the Journal of Clinical Oncology, Cohen et al found that the addition of oxaliplatin to fluoropyrimidine was associated with improved overall and disease-free survival in patients with stage III colon cancer with microsatellite instability (MSI). They also found the ...
Stereotactic Ablative Body Radiotherapy in Extracranial Oligometastatic Cancers
In a registry-based observational study reported in The Lancet Oncology, Chalkidou et al found that stereotactic ablative body radiotherapy (SABR) was associated with high overall survival and low rates of toxicity in patients with extracranial oligometastatic cancers. Study Details The prospective ...
Subcutaneous Daratumumab Meets Primary Endpoint in APOLLO Trial in Myeloma
The first phase III study to evaluate the subcutaneous form of daratumumab has met its primary endpoint, investigators of the APOLLO trial reported at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition.1 The triplet of daratumumab, pomalidomide, and low-dose dexamethasone ...
Ann H. Partridge, MD, MPH, on ER+, HER2– Breast Cancer: More Effective Treatments Needed
Ann H. Partridge, MD, MPH, of Dana-Farber Cancer Institute, discusses results from the ALTERNATE trial on response to neoadjuvant chemotherapy in postmenopausal women with clinical stage II or III estrogen receptor–positive and HER2-negative breast cancer that is resistant to endocrine therapy. The ...
Maintenance Oral Azacitidine for Patients With AML in First Remission: QUAZAR AML-001 Trial
As reported in The New England Journal of Medicine by Andrew H. Wei, MBBS, PhD, and colleagues, the phase III QUAZAR AML-001 trial has shown prolonged overall survival with oral azacitidine maintenance therapy vs placebo in patients with acute myeloid leukemia (AML) in first remission. The oral...
FDA Pipeline: Two Reviews in NSCLC, Plus Prescribing Information Update for Darolutamide
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to lorlatinib in ALK-positive non–small cell lung cancer (NSCLC) and Breakthrough Therapy designation to the combination of tiragolumab plus atezolizumab in NSCLC with high PD-L1 expression. The FDA also updated the...
