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Showing 5151 - 5200Adjuvant FOLFIRINOX vs Gemcitabine in Pancreatic Cancer
In a phase III Canadian and French trial reported in The New England Journal of Medicine, Conroy and colleagues in the Canadian Cancer Trials Group and the Unicancer-GI–PRODIGE Group found that adjuvant modified FOLFIRINOX (fluorouracil, leucovorin, irinotecan, oxaliplatin) produced better...
FDA Approves Ravulizumab-cwvz for Paroxysmal Nocturnal Hemoglobinuria
On December 21, 2018, the U.S. Food and Drug Administration (FDA) approved ravulizumab-cwvz (Ultomiris) for adult patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare bone marrow failure disorder that manifests with hemolytic anemia, thrombosis, and peripheral blood cytopenias....
Breakthrough Therapy Designation for Brentuximab Vedotin in Front-Line Treatment of Peripheral T-Cell Lymphomas
THE FDA recently granted Breakthrough Therapy designation to brentuximab vedotin (Adcetris) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in ...
Priority Review for Quizartinib in Relapsed or Refractory FLT3-ITD–Positive AML
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) accepted a new drug application and granted Priority Review to quizartinib, a FLT3 inhibitor, for the treatment of adult patients with relapsed or refractory FLT3-ITD–positive acute myeloid leukemia (AML). The FDA is expected to make a decision on...
Comparing Survival Outcomes With Minimally Invasive and Open Surgical Approaches to Early-Stage Cervical Cancer
MINIMALLY INVASIVE radical hysterectomy for women with early-stage cervical cancer has been associated with reduced rates of disease-free and overall survival in the phase III LACC randomized noninferiority trial comparing minimally invasive and open abdominal radical hysterectomy. The results...
Venetoclax in Combination Regimens for Older Patients With AML or Those With Comorbidities Precluding Intensive Induction
On November 21, 2018, venetoclax (Venclexta) was granted accelerated approval for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients aged ≥ 75 years or who have comorbidities that preclude the use of ...
Illustrating Genius
FOUR AND A HALF YEARS AGO, author Neil Canavan attended a scientific conference to learn what he could about the then-emerging field of immunotherapy for cancer. After a presentation by Zelig Eshhar, PhD, principal investigator in the Department of Immunology at the Weizmann Institute of Science...
New Data Reported From International Studies of Lung Cancer Treatment
At the European Society for Medical Oncology (ESMO) 2018 Congress, important studies were presented for every cancer type. Here, The ASCO Post offers some snapshots of lung cancer studies that may inform approaches to treating this common cancer, which—despite the advances in recent years—remains...
Durvalumab Improves Overall Survival After Chemoradiotherapy in Unresectable, Stage III NSCLC
AS REPORTED in The New England Journal of Medicine by Scott J. Antonia, MD, PhD, of H. Lee Moffitt Cancer Center and Research Institute, and colleagues, the phase III PACIFIC trial has shown significantly improved overall survival, a coprimary endpoint, with the programmed cell death ligand 1...
Priority Review for Atezolizumab in Combination With Chemotherapy for Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer. The...
International Trials Present New Findings in Treatment of Breast Cancer
The European Society for Medical Oncology (ESMO) 2018 Congress featured an assortment of study findings, many with far-reaching clinical implications for the treatment of patients with various cancers. Many of these trials were covered in-depth in recent issues of The ASCO Post. Here, we present...
Optimal Duration of Checkpoint Inhibition in Melanoma Is No More Than 2 Years
For patients with advanced melanoma, the concept of treating to disease progression does not always apply. With many patients responding to checkpoint inhibition for years, when can treatment be safely discontinued? This important clinical question was addressed at the European Society for Medical...
Minimally Invasive vs Open Abdominal Radical Hysterectomy in Early-Stage Cervical Cancer
TWO STUDIES recently reported in The New England Journal of Medicine indicate that minimally invasive radical hysterectomy is associated with poorer survival outcomes than open abdominal radical hysterectomy in women with early-stage cervical cancer. As reported by Pedro T. Ramirez, MD, of The...
Pembrolizumab Plus Chemoradiotherapy in HPV-Positive Head and Neck Cancer
The addition of pembrolizumab (Keytruda) to a chemoradiotherapy regimen yielded complete response rates of 85% in patients with human papillomavirus (HPV)-positive advanced squamous cell carcinoma of the head and neck. These findings from a phase Ib study were presented at the 2018 Society for...
ESMO Immuno-Oncology 2018: Second-Line Nivolumab vs Chemotherapy in SCLC
Treatment with nivolumab (Opdivo) did not improve response rates or survival over standard chemotherapy in patients with metastatic small cell lung cancer (SCLC) who relapsed following first-line treatment, according to findings presented by Reck et al at the European Society for Medical...
ESMO Immuno-Oncology 2018: OpACIN Trial: Neoadjuvant Ipilimumab Plus Nivolumab in Stage III Melanoma
Updated data of the OpACIN study, which studied combined ipilimumab (Yervoy) plus nivolumab (Opdivo) administered as neoadjuvant or adjuvant therapy in patients with high-risk stage III melanoma, demonstrated high response rates upon neoadjuvant therapy and promising long-term clinical outcome,...
ESMO Immuno-Oncology 2018: OAK Trial: Fast Progression in Patients With NSCLC Treated With Atezolizumab vs Chemotherapy
Overall survival (OS) was improved across all subgroups of patients with non–small cell lung cancer (NSCLC) who received atezolizumab (Tecentriq) compared with chemotherapy, including poor prognostic factors that were evaluated in an analysis of data from the OAK trial. Additionally, this...
Front-Line Daratumumab Combination Regimen Improves Outcomes in Multiple Myeloma
In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract...
Adjuvant Trastuzumab Emtansine vs Trastuzumab in Patients With HER2-Positive Breast Cancer With Residual Disease After Neoadjuvant Therapy
As reported at the recent San Antonio Breast Cancer Symposium and in The New England Journal of Medicine by von Minckwitz et al, an interim analysis of the phase III KATHERINE trial has shown that adjuvant trastuzumab emtansine (T-DM1; Kadcyla) improved invasive disease–free survival vs...
Disease-Free Survival With Letrozole vs Placebo After Aromatase Inhibitor–Based Therapy in Postmenopausal Breast Cancer
As reported by Mamounas et al in The Lancet Oncology, the phase III NRG Oncology/NSABP B-42 trial has shown no disease-free survival benefit with 5 years of letrozole (Femara) vs placebo after 5 years of aromatase inhibitor–based therapy in women with hormone receptor–positive...
First-Line Ibrutinib With or Without Rituximab vs Rituximab/Bendamustine in Older Patients With CLL
In a phase III trial reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine by Woyach et al, ibrutinib (Imbruvica) and ibrutinib/rituximab (Rituxan) were associated with superior progression-free survival vs...
Expert Point of View: Aaron T. Gerds, MD, MS
At a press conference where the ECOG-ACRIN E1912 presentation and related issues were discussed, session moderator Aaron T. Gerds, MD, MS, of the Cleveland Clinic Taussig Cancer Center, was quite enthusiastic about these results. “I believe these results should change clinical practice....
First-Line Ibrutinib/Rituximab Combination Shows Benefit for Younger Patients With CLL
First-line therapy with the combination of ibrutinib (Imbruvica) and rituximab (Rituxan) reduced disease progression by two-thirds compared with standard chemotherapy using fludarabine, cyclophosphamide, and rituximab (FCR) in younger patients with chronic lymphocytic leukemia (CLL), according to...
KATHERINE Trial: Adjuvant T-DM1 Reduces Invasive Disease Risk by 50% vs Trastuzumab in HER2-Positive Early Breast Cancer
In patients with HER2-positive early breast cancer and residual disease after neoadjuvant chemotherapy, adjuvant treatment with trastuzumab emtansine (T-DM1; Kadcyla) reduced the risk of invasive disease by 50% over trastuzumab (Herceptin).1 The phase III KATHERINE study was presented at the 2018...
MURANO Trial Follow-up: MRD and Prognosis With Fixed Duration of Venetoclax/Rituximab in Relapsed or Refractory CLL
As reported in the Journal of Clinical Oncology by Kater et al, high undetectable minimal residual disease (MRD) rates persisted after the end of venetoclax (Venclexta)/rituximab (Rituxan) treatment in the phase III MURANO trial in relapsed or refractory chronic lymphocytic leukemia (CLL), and were ...
ESMO Immuno-Oncology 2018: KEYNOTE-010: Long-Term Treatment With Pembrolizumab in Previously Treated NSCLC
Patients with previously treated, advanced non–small cell lung cancer (NSCLC) who received pembrolizumab (Keytruda) showed significantly longer overall survival (OS) compared to those treated with docetaxel, Herbst et al reported at the ESMO Immuno-Oncology Congress 2018 in Geneva,...
Radiotherapy Plus Cetuximab or Cisplatin in HPV-Positive Oropharyngeal Carcinoma
In a noninferiority phase III trial (NRG Oncology RTOG 1016) reported in The Lancet, Gillison et al found that radiotherapy plus cetuximab (Erbitux) was associated with poorer overall survival vs radiotherapy plus cisplatin in patients with human papillomavirus (HPV)-positive oropharyngeal...
Pembrolizumab vs Standard of Care in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
In the phase III KEYNOTE-040 trial reported in The Lancet, Cohen et al found that pembrolizumab (Keytruda) was associated with a “clinically meaningful prolongation of overall survival” vs investigator’s choice of standard therapies in patients with previously treated recurrent or ...
Genetic Assay May Help Predict Disease Relapse in Patients With Gastroesophageal Cancer
A seven-gene assay could improve care for patients with gastroesophageal cancer by predicting their likelihood of relapse after chemotherapy and surgery. These findings were published by Smyth et al in Annals of Oncology. A team at The Institute of Cancer Research (ICR), London, and The Royal...
Apixaban Thromboprophylaxis in Patients With Cancer
In the Canadian phase III AVERT trial reported in The New England Journal of Medicine, Carrier et al found that the oral factor Xa inhibitor apixaban reduced the risk of venous thromboembolism vs placebo among intermediate- to high-risk ambulatory patients with cancer starting chemotherapy but was...
Palbociclib Plus Fulvestrant in Advanced Breast Cancer: Overall Survival Analysis of PALOMA-3
An overall survival analysis of the PALOMA-3 trial reported by Turner et al in The New England Journal of Medicine found that the addition of the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib (Ibrance) to fulvestrant (Faslodex) improved survival among patients with hormone...
ECHELON-2: Brentuximab Vedotin Plus Chemotherapy in CD30-Positive Peripheral T-Cell Lymphoma
As reported by Horwitz et al in The Lancet, the phase III ECHELON-2 trial showed that brentuximab vedotin (Adcetris) plus cyclophosphamide, doxorubicin, and prednisone (CHP) improved progression-free and overall survival vs cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in...
SELECT Trial: Adjuvant Erlotinib in Resected EGFR-Mutant NSCLC
In a phase II trial reported in the Journal of Clinical Oncology, Pennell et al found that adjuvant erlotinib (Tarceva) improved disease-free survival over historical controls in patients with resected EGFR-mutant non–small cell lung cancer (NSCLC). In the study, 100 patients with ...
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
Encorafenib and Binimetinib: A New Benchmark in Metastatic Melanoma Therapy?
IN JULY 2018, the U.S. Food and Drug Administration (FDA) approved the combination of the oral BRAF inhibitor encorafenib (Braftovi) and the oral MEK inhibitor binimetinib (Mektovi) for BRAF V600E– or V600K– positive metastatic melanoma. The FDA approval was based on the results of the COLUMBUS...
Encorafenib Plus Binimetinib vs Vemurafenib in Advanced BRAF-Mutant Melanoma
AS REPORTED in The Lancet Oncology by Reinhard Dummer, MD, of the University Hospital Zurich Skin Cancer Center, and colleagues, the phase III COLUMBUS trial has shown a significant improvement in overall survival with the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK...
Bladder Cancer: Strategies to Address Checkpoint Inhibitor Failure
CHECKPOINT INHIBITORS have rapidly become the standard of care as second-line treatment, and in some patients first-line treatment, of advanced bladder cancer. However, the majority of patients do not respond and eventually experience disease progression; these patients will need subsequent...
Management of HER2-Positive Breast Cancer: Business as Usual?
MANAGEMENT OF HER2-positive breast cancer changed after the introduction of trastuzumab (Herceptin), the first anti-HER2 therapy to be approved by the U.S. Food and Drug Administration (FDA) for this type of cancer. Recent studies have more clearly defined the role of pertuzumab (Perjeta) and...
Expert Point of View: Rebecca Dent, MD, and Suzette Delaloge, MD, MSc
FORMAL DISCUSSANT of the ACE trial, Rebecca Dent, MD, of the National Cancer Center in Singapore, commented that the phase II ENCORE 301 study provided proof of concept that a histone deacetylase (HDAC) inhibitor can reprogram epigenetic changes.1 In that randomized, double-blind,...
HDAC Inhibitor May Overcome Endocrine Resistance in Advanced Breast Cancer
EPIGENETIC CHANGES are associated with the development of cancer, and epigenetic therapy is an attractive strategy for targeting the tumor microenvironment. One approach targeted to epigenetic changes is using histone deacetylase (HDAC) inhibition, which has antitumorigenic effects including growth ...
Pembrolizumab Triplet Shows Activity in BRAF-Mutant Melanoma
AS FIRST-LINE treatment of advanced BRAF-mutant melanoma, pembrolizumab (Keytruda) added to dabrafenib (Tafinlar) and trametinib (Mekinist) produced a nonsignificant improvement in progression-free survival. It also increased the rate of grade 3 to 5 treatment-related adverse events in the phase II ...
Expert Point of View: Joaquin Mateo, MD, PhD
FORMAL DISCUSSANT Joaquin Mateo, MD, PhD, of the Prostate Cancer Translational Research Group, Vall d’Hebron Institute of Oncology, Barcelona, said that the TRITON2 findings were encouraging, although still preliminary. “We should interpret these results with caution, because this interim analysis ...
Progress Made in Identifying Gene-Signature Biomarkers in Renal Cell Carcinoma
A NEW ANALYSIS of the phase III IMmotion151 trial identified gene signatures in renal cell carcinoma that correlate with improved progression-free survival in patients treated with atezolizumab (Tecentriq) plus bevacizumab (Avastin) vs sunitinib (Sutent). These findings were presented at the...
Hippocampus-Sparing Whole-Brain Radiotherapy and Neurocognitive Function in Patients With Brain Metastases
ANALYSIS OF a phase III trial has confirmed that conformal avoidance of the hippocampal dentate gyrus using intensity-modulated radiotherapy during whole-brain radiotherapy for brain metastases preserves neurocognitive function and improves patient-reported symptom burden while achieving similar...
Stereotactic Ablative Radiotherapy May Improve Outcomes in Some Patients With Oligometastatic Tumors
IN PATIENTS with a controlled primary tumor and up to 5 oligometastatic lesions, delivering stereotactic ablative radiotherapy was associated with a 13-month improvement in overall survival when compared with palliative standard-of-care treatments alone (41 months vs 28 months; P = .09).1...
De-escalation of Chemotherapy in Favorable-Risk Diffuse Large B-Cell Lymphoma
THE REGIMEN of four cycles of rituximab (Rituxan)/cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) plus two cycles of rituximab was noninferior to that of six cycles of R-CHOP in younger patients with favorable-risk diffuse large B-cell lymphoma (DLBCL), according to the results of...
Beyond Checkpoint Inhibitors: Novel Immunotherapy Combinations With Antitumor Activity
THE 2018 Society for Immunotherapy of Cancer (SITC) Annual Meeting hosted a meeting of the minds of the world’s premier cancer immunologists. In addition to the cutting-edge laboratory science explored and presented at the meeting, numerous phase I clinical trials and a few phase II studies offered ...
Ibrutinib vs Standard of Care in Front-Line Treatment of Older Patients With Chronic Lymphocytic Leukemia
IBRUTINIB (IMBRUVICA) as a front-line agent proved superior to standard-of-care chemoimmunotherapy for chronic lymphocytic leukemia (CLL) in older patients in A041202, an Alliance-led National Clinical Trials Network study.1 At a follow-up of 38 months, the median progression-free survival was not ...
Dejan Juric, MD, on Advanced Breast Cancer: Results From the SOLAR-1 Trial
Dejan Juric, MD, of Massachusetts General Hospital, discusses phase III study findings on liquid biopsy–based assessment of PIK3CA mutational status and the combination of the selective PI3K-alpha inhibitor alpelisib plus fulvestrant in the treatment of advanced breast cancer (Abstract GS3-08).
SABCS 2018: SOLAR-1: Liquid Biopsies in Predicting Benefit of Alpelisib in PIK3CA-Mutant Breast Cancer
Liquid biopsy–based assessment of PIK3CA mutational status served as a better indicator of progression-free survival compared with analysis of tissue biopsy in patients with breast cancer enrolled in the phase III SOLAR-1 clinical trial, according to data presented by Juric et al at the 2018...
