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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 ...

leukemia
issues in oncology

Reducing Infections in Patients With AML Receiving Induction and Reinduction Chemotherapy

In a report in the Journal of Oncology Practice, Morris et al described an initiative that has been successful in reducing the incidence of invasive fungal infections in patients with acute myeloid leukemia (AML) receiving induction and reinduction therapy at the University of Virginia Health...

Eicosapentaenoic Acid and Aspirin in Preventing Colorectal Adenomas

In a UK trial (seAFOod Polyp Prevention) reported in The Lancet by Hull et al, no differences in adenoma prevention were found after treatment with omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA), aspirin, both, or placebo in patients with high-risk findings on colonoscopy. On the...

Vitamin D Supplementation and Cancer Risk

In a trial reported in The New England Journal of Medicine by Manson et al, vitamin D supplementation was found to have no benefit in reducing risk of invasive cancer vs placebo over 5 years of follow-up. Study Details The trial was a randomized, placebo-controlled trial, with a two-by-two...

colorectal cancer
immunotherapy

Primary Resistance to Immune Checkpoint Inhibitors in Metastatic Colorectal Cancer and Misdiagnosis of MSI or dMMR Status

In a study reported in JAMA Oncology, Cohen et al found evidence that primary resistance to immune checkpoint inhibitor treatment in metastatic colorectal cancer (CRC) can be explained in some cases by misdiagnosis of microsatellite instability (MSI) or defective mismatch repair (dMMR) status....

breast cancer
survivorship

POEMS/SWOG Intergroup S0230 Study on Preventing Early Menopause

In the long-term follow-up of the Prevention of Early Menopause Study (POEMS)/SWOG Intergroup S0230 trial reported in the Journal of the National Cancer Institute, Moore et al found that the addition of goserelin (Zoladex) to cyclophosphamide-containing chemotherapy was associated with a higher...

leukemia

Moxetumomab Pasudotox-tdfk for Relapsed or Refractory Hairy Cell Leukemia

ON SEPTEMBER 13, 2018, moxetumomab pasudotox-tdfk (Lumoxiti), a CD22-directed cytotoxin, was approved for the treatment of adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including with a purine nucleoside analog.1,2 Supporting...

skin cancer

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...

leukemia
lymphoma

Duvelisib for Relapsed or Refractory CLL/SLL and for Relapsed or Refractory Follicular Lymphoma

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 24, 2018, duvelisib (Copiktra) was granted...

lung cancer

Pembrolizumab With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC

On August 20, 2018, pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum was granted regular approval as first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma...

breast cancer

Talazoparib for Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer

On October 16, 2018, the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib (Talzenna) was approved for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.1,2 Patients must be selected for...

hepatobiliary cancer

Lenvatinib in Unresectable Hepatocellular Carcinoma

On August 16, 2018, lenvatinib (Lenvima) was approved for the first-line treatment of patients with unresectable hepatocellular carcinoma.1,2 Supporting Efficacy Data Approval was based on the findings of a phase III open-label noninferiority trial (REFLECT), in which 954 patients with previously...

Survival With Surgery vs Radiotherapy in Gleason Score 9–10 Prostate Cancer

In a cohort study reported in JAMA Oncology, Tilki et al found that patients with Gleason score 9–10 prostate cancer treated with multimodality therapy known as MaxRP (radical prostatectomy [RP] plus adjuvant external-beam radiotherapy [EBRT] with or without androgen-deprivation therapy...

palliative care
issues in oncology

Factors Affecting Use of Outpatient Specialty Palliative Care Clinics Among Patients With Advanced Cancer

In a study reported in the Journal of Oncology Practice, Yu et al identified factors affecting use of outpatient specialty palliative care (OSPC) among patients with advanced cancer in the University of Pittsburgh Medical Center Hillman Cancer Center Network (UPMC-HCCN). Study Details The...

Marine Omega-3 Fatty Acid Supplementation and Cancer Risk

In a trial reported in The New England Journal of Medicine by Manson et al, marine n-3 (omega-3) fatty acid supplementation was found to have no benefit in reducing the risk for invasive cancer vs placebo over 5 years of follow-up. Higher intake of n-3 fatty acids has been associated with a reduced ...

Adding Genomic Factors to MSKCC Risk Model in Metastatic Renal Cell Carcinoma

In a study reported in The Lancet Oncology, Voss et al found that adding the mutation status of prognostic genes to the Memorial Sloan Kettering Cancer Center (MSKCC) risk model improved the prognostic performance of the model in patients with advanced renal cell carcinoma. The study involved...

Radiotherapy With Cisplatin or Cetuximab in Low-Risk, HPV-Positive Oropharyngeal Cancer

In the phase III De-ESCALaTE trial reported in The Lancet, Mehanna et al found no difference in severe toxicity with cisplatin vs cetuximab (Erbitux) plus radiotherapy in low-risk human papillomavirus (HPV)-positive oropharyngeal cancer. Cetuximab was associated with poorer recurrence and survival...

Bladder-Sparing Treatment Regimens for Muscle-Invasive Bladder Cancer

In a phase II trial (NRG/RTOG 0712) reported in the Journal of Clinical Oncology, Coen et al found that bladder-sparing treatment with twice-daily radiation plus fluorouracil/cisplatin (FCT) or once-daily radiation plus gemcitabine (GD) produced similar distant metastasis-free survival in patients...

issues in oncology
immunotherapy

Cardiovascular Toxicities Associated With Immune Checkpoint Inhibitor Treatment

In a pharmacovigilance study reported in The Lancet Oncology, Salem et al found that immune checkpoint inhibitors can cause “severe and disabling inflammatory cardiovascular immune-related adverse events” that need to be considered in patient care and clinical trial design. Study...

breast cancer
issues in oncology

Discontinuation of Follow-up Care Among Women With Early-Stage Breast Cancer

In a study using linked Surveillance, Epidemiology, and End Results (SEER)-Medicare data reported in the Journal of Oncology Practice, Quyyumi et al found that 21% of women with early-stage breast cancer discontinued follow-up care within 5 years after diagnosis. Study Details The study involved...

hematologic malignancies
leukemia

MRD-Guided Azacitidine Treatment in Myelodysplastic Syndrome and Acute Myeloid Leukemia

In a German phase II trial (RELAZA2) reported in The Lancet Oncology, Platzbecker et al found that minimal residual disease (MRD)–guided treatment with azacitidine was successful in preventing hematologic relapse in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia...

Multigene Classifier Test for Thyroid Nodules With Indeterminate Cytology

In a study reported in JAMA Oncology, Steward et al found that the use of a multigene genomic classifier test (ThyroSeq v3) could reduce the need for diagnostic surgery in a substantial proportion of patients with thyroid nodules with indeterminate cytology. The blinded prospective cohort...

ELOQUENT-3: Addition of Elotuzumab to Pomalidomide and Dexamethasone in Previously Treated Multiple Myeloma

As reported in The New England Journal of Medicine by Dimopoulos et al, the phase II ELOQUENT-3 trial has shown that the addition of elotuzumab (Empliciti) to pomalidomide (Pomalyst) and dexamethasone significantly prolonged progression-free survival in patients with relapsed and/or refractory...

Risk of Chronic Health Conditions in Survivors of Childhood Cancer Diagnosed From 1970 to 1999

In a report from the Childhood Cancer Survivor Study cohort published in The Lancet Oncology, Gibson et al found that more recently treated survivors of childhood cancer had reduced risk of chronic health conditions compared to those diagnosed early in the study period. The study involved data...

Ultrasonography Findings and Risk of Ovarian Cancer

In a study reported in JAMA Internal Medicine, Smith-Bindman et al found that the appearance of ovarian masses on ultrasonography was highly associated with risk of ovarian cancer in a large unselected population of women undergoing pelvic ultrasonography. Study Details The study was a nested...

cns cancers
immunotherapy

Addition of Interleukin-2 to Dinutuximab Beta in High-Risk Neuroblastoma

In an international phase III trial (HR-NBL1/SIOPEN) reported in The Lancet Oncology, Ladenstein et al found that the addition of interleukin (IL)-2 to dinutuximab beta did not improve event-free survival in children and young people with high-risk neuroblastoma. Study Details The current report...

Phase III Trial of Minimally Invasive vs Open Abdominal Radical Hysterectomy in Early Cervical Cancer

In a phase III trial (Laparoscopic Approach to Cervical Cancer [LACC]) reported in The New England Journal of Medicine, Ramirez et al found that minimally invasive radical hysterectomy was associated with poorer disease-free and overall survival vs open abdominal radical hysterectomy in women with...

leukemia

Causes of Inferior Outcomes in AYAs With Leukemia

Despite survival gains for children diagnosed with acute lymphoblastic leukemia (ALL), adolescents and young adults (AYAs)— those between the ages of 15 and 39— diagnosed with the disease have seen only modest improvements in survival. A study by Julie A. Wolfson, MD, MSHS, Assistant Professor and ...

head and neck cancer

DNA Vaccine Leads to Immune Responses in HPV-Related Head and Neck Cancer in Small Study

A therapeutic vaccine may boost antibodies and T cells, helping them infiltrate human papillomavirus (HPV)-related head and neck cancer tumors. Researchers from the Abramson Cancer Center of the University of Pennsylvania tested the immunotherapy in two groups of patients with advanced head and...

head and neck cancer

Pazopanib Plus Cetuximab in Metastatic Head and Neck Squamous Cell Carcinoma

As reported in The Lancet Oncology by Douglas Adkins, MD, of Washington University School of Medicine, Division of Medical Oncology, and colleagues, the addition of the angiogenesis inhibitor pazopanib (Votrient) to cetuximab (Erbitux) in a phase Ib and expansion cohort study showed activity in...

lung cancer

Nivolumab for Third-Line Treatment of Metastatic Small Cell Lung Cancer

ON AUGUST 16, 2018, nivolumab (Opdivo) was granted accelerated approval for treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression after platinum-based chemotherapy and at least one other line of therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...

solid tumors

Iobenguane I-131 for Advanced Pheochromocytoma or Paraganglioma

ON JULY 30, 2018, the radiotherapeutic agent iobenguane I-131 (Azedra) was approved for the treatment of adult and pediatric patients (aged ≥ 12 years) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer...

skin cancer

Cemiplimab-rwlc for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

On September 28, 2018, cemiplimab-rwlc (Libtayo) was approved for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.1 Supporting Efficacy Data Approval...

hematologic malignancies
leukemia
lymphoma

Duvelisib vs Ofatumumab in Relapsed or Refractory CLL/SLL

As reported in Blood by Ian W. Flinn, MD, PhD, Director of the Lymphoma Research Program at Sarah Cannon Research Institute, and colleagues, the phase III DUO trial has shown significantly prolonged progression-free survival with the phosphoinositide 3-kinase (PI3K)-δ/γ inhibitor duvelisib...

lung cancer

Dacomitinib for Metastatic EGFR-Mutant NSCLC

On September 27, 2018, dacomitinib (Vizimpro) received approval for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, as detected by a test approved by the...

hematologic malignancies

Ibrutinib Plus Rituximab in Adult Patients With Waldenström’s Macroglobulinemia

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 August 27, 2018, ibrutinib (Imbruvica) was approved...

Neoadjuvant Chemotherapy vs Upfront Debulking Surgery in Advanced Tubo-Ovarian Cancer

As reported in The Lancet Oncology by Vergote et al, a pooled analysis of individual patient data in long-term follow-ups of the phase III EORTC 55971 and CHORUS trials indicated that overall survival is similar with neoadjuvant therapy vs upfront debulking surgery in advanced tubo-ovarian cancer....

Multimodality Therapy and Lateral Local Recurrence in Rectal Cancer

In a study reported in the Journal of Clinical Oncology, Ogura et al found that lateral lymph node dissection (LLND) reduced the risk of lateral local recurrence in patients with lateral nodes ≥ 7 mm undergoing neoadjuvant chemoradiation or radiation and total mesorectal excision in clinical...

Expert Point of View: Daniel Heinrich, MD, and Silke Gillessen, MD

Formal discussant of the ERA 223 trial, Daniel Heinrich, MD, of Akershus University Hospital, Lørenskog, Norway, reminded listeners at the European Society for Medical Oncology (ESMO) 2018 Congress that radium-223 was developed in Norway. “When the ALSYMPCA results came out, we were celebrating....

prostate cancer

Treatment With Radium-223 Plus Abiraterone Not Advisable in Metastatic Prostate Cancer

The combination of radium-223 plus AAP (abiraterone acetate [Zytiga] and prednisone) was not superior to placebo plus AAP in the phase III ERA 223 trial, which enrolled men with asymptomatic bone-predominant metastatic castration-resistant prostate cancer.1 Patients treated with the combination had ...

breast cancer
issues in oncology
survivorship

Adverse Mental Health Outcomes in Breast Cancer Survivors

In a systematic review of the literature reported in the Journal of the National Cancer Institute, Carreira et al found that most evidence strongly supports increased risk of anxiety, depression, neurocognitive dysfunction, and other forms of psychological issues in survivors of breast...

Lorlatinib Shows Overall and Intracranial Activity in ALK-Positive NSCLC

In a global phase II study reported in The Lancet Oncology, Solomon et al found that lorlatinib (Lorbrena) showed high overall and intracranial activity in patients with advanced ALK-positive non–small cell lung cancer (NSCLC) who were treatment-naive or who had received crizotinib (Xalkori)...

Sequential vs Combination Fluoropyrimidine, Irinotecan, and Bevacizumab in Metastatic Colorectal Cancer

In a German phase III noninferiority trial (XELAVIRI) reported by Modest et al in the Journal of Clinical Oncology, noninferiority of first-line sequential vs combination fluoropyrimidine, irinotecan, and bevacizumab (Avastin) was not demonstrated in metastatic colorectal cancer (CRC). Benefit of...

issues in oncology
cost of care

Financial Toxicity Experienced by Adults With Cancer

In a study reported in the Journal of Oncology Practice, Knight et al found that 26% of patients with cancer acknowledged ‘financial toxicity’—treatment-related financial harm—with respect to cancer care, and that this toxicity was associated with consequences such as...

Effect of Donor Clonal Hematopoiesis of Indeterminate Potential in Allogeneic Hematopoietic Stem Cell Transplantation

In a study reported in the Journal of Clinical Oncology, Frick et al found that allogeneic hematopoietic stem cell transplantation (HSCT) from donors with clonal hematopoiesis of indeterminate potential (CHIP) appears safe and not associated with poorer survival when donors are older, related...

Neoadjuvant Chemotherapy With vs Without Anthracyclines Plus Dual HER2 Inhibitors in HER2-Positive Breast Cancer

In the Dutch Breast Cancer Research Group’s phase III TRAIN-2 trial reported in The Lancet Oncology, van Ramshorst et al found no difference in pathologic complete response rate with neoadjuvant chemotherapy with vs without an anthracycline plus dual HER2 blockade in women with HER2-positive...

Risk Factors for Late Recurrence After Resection for Hepatocellular Carcinoma

In a Chinese retrospective study reported in JAMA Surgery, Xu et al found that risk of late recurrence (> 2 years) of hepatocellular carcinoma (HCC) after curative liver resection was associated with male sex, presence of cirrhosis, and aggressive characteristics of the initial HCC. The study...

skin cancer
immunotherapy

Outcomes in Melanoma With Active Brain Metastases After Treatment With Pembrolizumab

As reported in the Journal of Clinical Oncology by Kluger et al, pembrolizumab (Keytruda) showed activity in brain metastases in patients with melanoma enrolled in a phase II study. The study included 23 patients with melanoma with one or more asymptomatic untreated 5- to 20-mm brain metastasis...

Cost of Cancer Care in Community vs Hospital Settings

In a study reported in the Journal of Oncology Practice, Gordan et al found that costs of care for patients with breast, colorectal, and lung cancers were significantly higher at hospital-based vs community-based clinics, largely reflecting higher costs of chemotherapy and provider visits. Study...

Dysregulation of Immune Pathways in AML Relapse After Allogeneic HSCT

In a study reported in The New England Journal of Medicine, Christopher et al found that acute myeloid leukemia (AML) relapse after allogeneic hematopoietic stem cell transplantation (HSCT) was accompanied by dysregulation of immune pathways, including downregulation of major histocompatibility...

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