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Showing 3551 - 3600Oral 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...
Three vs Four Courses of Chemotherapy in Younger Patients With AML
As reported in the Journal of Clinical Oncology by Burnett et al, findings from the phase III MRC AML17 trial indicated that four courses of chemotherapy, compared to three courses, reduced the cumulative incidence of relapse and improved relapse-free survival, but not overall survival, in younger...
Subcutaneous Fixed-Dose vs Intravenous Pertuzumab/Trastuzumab for HER2-Positive Early Breast Cancer
As reported in The Lancet Oncology by Tan et al, the phase III FeDeriCa trial showed comparable pharmacokinetics and pathologic complete response rates with a subcutaneous (SC) fixed-dose combination of pertuzumab and trastuzumab vs the same combination administered intravenously (IV)—both given...
Total-Body Irradiation/Etoposide vs Chemotherapy Conditioning Before Stem Cell Transplant for Pediatric Patients With ALL
As reported in the Journal of Clinical Oncology by Peters et al, the phase III FORUM trial showed superior overall survival with total-body irradiation plus etoposide vs combination chemoconditioning in pediatric patients with acute lymphoblastic leukemia (ALL) undergoing allogeneic hematopoietic...
Addition of Gemcitabine to Pazopanib for Refractory Soft-Tissue Sarcoma
In the German phase II PAPGEMO trial reported in JAMA Oncology, Hans-Joachim Schmoll, MD, PhD, and colleagues found that the combination of pazopanib and gemcitabine improved 12-week progression-free survival vs pazopanib alone in patients with anthracycline- or ifosfamide-refractory soft-tissue...
Adjuvant Gefitinib vs Vinorelbine/Cisplatin in Stage II–IIIA EGFR-Mutant NSCLC: Final Overall Survival Analysis
As reported in the Journal of Clinical Oncology by Zhong et al, the final overall survival results of the phase III CTONG1104 trial indicated no significant advantage of adjuvant gefitinib vs vinorelbine/cisplatin in patients with EGFR-mutant stage II–IIIA (N1–2) non–small cell lung cancer ...
Outcomes After Neoadjuvant Carboplatin/Paclitaxel in Women With Ovarian Cancer and Planned Delayed Surgery: ICON8 Analysis
In a post hoc analysis from the ICON8 trial reported in The Lancet Oncology, Morgan et al found evidence indicating that the evaluation of response to platinum-based neoadjuvant therapy in women with ovarian carcinoma using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, should...
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
On January 4, U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, MD, and Director of the FDA’s Center for Biologics Evaluation and Research Peter Marks, MD, PhD, issued the following statement on FDA-authorized dosing schedules for each COVID-19 vaccine. Two different mRNA...
Final Overall Survival Results of the IDEA Collaboration: 3 vs 6 Months of Adjuvant Chemotherapy for Stage III Colon Cancer
Thierry André, MD, and colleagues reported the prospective pooled analysis of six phase III trials in the IDEA collaboration in The Lancet Oncology. The analysis showed that noninferiority in overall survival for 3 vs 6 months of adjuvant chemotherapy was not established in patients with stage III...
Patient-Reported Outcomes With Triplet Therapy for Newly Diagnosed Multiple Myeloma
In an analysis from the phase III MAIA trial reported in the Journal of Clinical Oncology, Perrot et al found that the combination of daratumumab, lenalidomide, and dexamethasone (D-Rd) was associated with better health-related quality-of-life outcomes vs lenalidomide and dexamethasone (Rd) in...
Addition of First-Line Pembrolizumab to Chemotherapy in Metastatic Triple-Negative Breast Cancer: KEYNOTE-355
As reported in The Lancet by Javier Cortes, MD, and colleagues, the phase III KEYNOTE-355 trial has shown that the addition of pembrolizumab to chemotherapy improved progression-free survival among previously untreated patients with locally recurrent inoperable or metastatic triple-negative breast...
Gemogenovatucel-T Maintenance in Stage III/IV Ovarian Cancer
In the phase IIb VITAL trial reported in The Lancet Oncology, Rocconi et al found that front-line maintenance with the autologous tumor cell vaccine gemogenovatucel-T did not improve recurrence-free survival vs placebo in patients with stage III/IV ovarian cancer in clinical complete response after ...
Pembrolizumab Plus Chemotherapy for Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer
On November 13, 2020, pembrolizumab (Keytruda) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for use in combination with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer with tumors expressing PD-L1 (Combined ...
Study Reports Highly Skilled Surgeons Significantly Reduce Death From Colon Cancer
To improve long-term survival odds, individuals with early-stage colon cancer should have their surgery performed by highly skilled surgeons. In a study that used video assessment, surgeons with highly ranked skills gave their patients a 69% lower risk of dying at 5 years as compared with their...
Pembrolizumab Improves Progression-Free Survival vs Chemotherapy in First-Line Treatment of Microsatellite Instability–High Advanced Colorectal Cancer
As reported in The New England Journal of Medicine by Thierry André, MD, of Sorbonne Université and Hôpital Saint Antoine, Paris, and colleagues, the second interim analysis of the phase III KEYNOTE-177 trial has shown significantly prolonged progression-free survival with pembrolizumab vs...
Novel Combination Under Study in First-Line Treatment of Metastatic Melanoma
A first-line regimen combining the novel interleukin-2 (Il-2) agonist bempegaldesleukin (NKTR-214) with nivolumab showed encouraging clinical activity in patients with metastatic melanoma in the phase I/II PIVOT-02 trial, according to a presentation during the 2020 Annual Meeting of the Society for ...
Expert Point of View: Laura Dawson, MD
Laura Dawson, MD, Professor of Radiation Oncology at the University of Toronto and Princess Margaret Cancer Centre, viewed these initial study results as “a strong signal with high promise.” “Radiation therapy improves local control and delays local disease progression in patients with pancreatic...
Fixed-Duration First-Line Ibrutinib Plus Venetoclax Yields Treatment-Free Remission in Some Patients With CLL
The randomized phase II CAPTIVATE trial showed that a fixed-duration treatment approach with 12 cycles of ibrutinib and venetoclax as first-line therapy for chronic lymphocytic leukemia (CLL) achieved a 30-month progression-free survival of more than 95% in patients with undetectable minimal...
Ruxolitinib Improves Outcomes in Patients With Steroid-Refractory or Steroid-Dependent Graft-vs-Host Disease
Ruxolitinib was superior to best available therapy in achieving efficacy as determined by best overall response and duration of response, with acceptable safety in adolescents and adults with steroid-dependent or steroid-refractory chronic graft-vs-host disease effects. These findings were shown in ...
