On February 28, Shire announced that the U.S. Food and Drug Administration (FDA) accepted the company’s biologics license application (BLA) for calaspargase pegol (Cal-PEG; SHP663). The investigational-stage compound is being reviewed as a component of a multiagent chemotherapeutic regimen...
As reported in The Lancet Oncology by de Boer et al, the phase III PORTEC-3 trial has shown no significant improvement in 5-year overall survival with adjuvant chemoradiotherapy vs radiotherapy alone in women with high-risk endometrial cancer. Adjuvant chemoradiotherapy, however, was associated...
As reported in the Journal of Clinical Oncology by Julie R. Brahmer, MD, of the Johns Hopkins Kimmel Cancer Center, and colleagues, ASCO has released a clinical practice guideline on management of immune-related adverse events in patients receiving immune checkpoint inhibitor therapy. To develop...
In a study reported in The New England Journal of Medicine, Drilon et al found that the oral tropomyosin receptor kinase (TRK) inhibitor larotrectinib produced a high response rate and enduring responses in patients with TRK fusion–positive cancers. These fusions have been found to lead to...
The results of a phase II trial have shown high activity of guadecitabine, a next-generation hypomethylating drug, in treatment-naive older patients with acute myeloid leukemia. The findings were reported in The Lancet Oncology by Hagop M. Kantarjian, MD, of The University of Texas MD Anderson...
As reported by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, Alexandra Hospital, and colleagues in The Lancet Oncology, a prespecified interim analysis of the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis)...
In the phase II EORTC 75111-10114 trial reported in The Lancet Oncology, Wildiers et al found that the addition of metronomic oral cyclophosphamide to pertuzumab (Perjeta) and trastuzumab (Herceptin) improved progression-free survival in elderly or frail women with HER2-positive metastatic breast...
The number of U.S. cases of Merkel cell carcinoma is rising about six times faster than most other cancers, and at nearly twice the rate of melanoma. Paulson et al reported these findings in The Journal of the American Academy of Dermatology, which are based on research conducted at the University...
It is well established that adolescents and young adults (AYAs) with cancer—defined by the National Cancer Institute as those between the ages of 15 and 39 years—have not reaped a comparable survival benefit as either younger or older adult cancer survivors over the past 4 decades, despite...
Law and Ethics in Oncology explores the legal and ethical issues oncologists must be aware of in this era of precision medicine and changing health-care policy, both to protect patients’ rights and to safeguard against potential legal jeopardy. Increasingly, across the United States, hospitals are...
A DETAILED quality-of-life analysis of the phase III EF-14 trial of tumor-treating fields (Optune) in combination with temozolomide for the treatment of newly diagnosed glioblastoma was published by Taphoorn et al in JAMA Oncology.1 This secondary endpoint analysis showed the addition of...
THE FIRST TWO randomized trials to directly compare direct oral anticoagulants vs low–molecular-weight heparin for management of venous thromboembolism (VTE) in patients with cancer suggest that direct oral anticoagulants may become the new standard of care.1,2 Direct oral anticoagulants appear to...
On February 15, updated results were made available from the phase III JAVELIN Lung 200 trial comparing avelumab (Bavencio) to docetaxel in patients with unresectable, recurrent, or metastatic non–small cell lung cancer (NSCLC) whose disease progressed after treatment with a...
“The simple questions are whether ovarian function suppression adds clinical benefit in premenopausal women, and is ovarian function suppression better with an aromatase inhibitor or tamoxifen,” said formal discussant of these trials, Ann H. Partridge, MD, MPH, FASCO, Professor of Medicine at...
“To what extent do treatments for prostate cancer impact sexual functioning? To a great extent,” Christian Nelson, PhD, Chief, Psychiatry Service, Memorial Sloan Kettering Cancer Center, New York, told participants at the 11th Annual Oncofertility Consortium Conference in Chicago.1 Most men with...
Patients with previously treated advanced hepatocellular carcinoma derived a survival benefit from cabozantinib (Cabometyx), in the phase III CELESTIAL trial.1 “Cabozantinib represents a new treatment option for patients with advanced hepatocellular carcinoma after prior systemic anticancer...
Following the publication of two landmark studies in the United States,1,2 laryngeal preservation with combined chemoradiotherapy has become standard practice as opposed to laryngectomy for patients with locally advanced laryngeal cancer. The Department of Veterans Affairs Laryngeal Cancer Study...
As reported in the Journal of Clinical Oncology by Overman et al, findings in the nivolumab (Opdivo) plus ipilimumab (Yervoy) cohort of the CheckMate-142 study indicate a high response rate and durable responses with the combination in previously treated patients with DNA mismatch...
ASCO has released its review of leading oncology pathway vendors in the United States. “Oncology Clinical Pathways: Charting the Landscape of Pathway Providers,” published in the Journal of Oncology Practice (JOP), examines the clinical pathways offered by six commercial vendors using...
Cancer care guidelines recommend that cancer survivors who experience sexual dysfunction after cancer treatment use therapeutic aids to help improve their sexual health. However, a new study of 25 leading cancer centers found that 87% of the centers reported having no sexual aids available on site...
Combining the antiangiogenic agent axitinib (Inlyta) with the immunotherapy pembrolizumab (Keytruda) was found to have promising antitumor activity and no unexpected side effects in an early-phase clinical trial in patients with advanced kidney cancer who had not been previously treated. The full...
AS REPORTED in The Lancet Oncology by Manish R. Patel, MD, of Florida Cancer Specialists/Sarah Cannon Research Institute, and colleagues, the anti–programmed cell death ligand 1 (PD-L1) antibody avelumab (Bavencio) produced durable responses in patients with locally advanced or metastatic...
In a single-center phase II study reported in The Lancet Oncology, Giaccone et al found that pembrolizumab (Keytruda) produced durable responses in patients with recurrent thymic carcinoma. Study Details In the study, 40 evaluable patients with advanced disease progressing after at least one line ...
TWO IMPORTANT STUDIES, both updates of earlier findings and presented at the 2017 San Antonio Breast Cancer Symposium, provided different findings as to the relative benefit of nanoparticle albumin-bound (nab)-paclitaxel (Abraxane), vs solvent-based paclitaxel in breast cancer. “The two studies...
NEIL P. SHAH, MD, PhD, Leader of the Hematopoietic Malignancies Program at the University of California, San Francisco, Helen Diller Family Cancer Comprehensive Cancer Center, noted that BLU- 285 could fill an “unmet medical need” for a KIT inhibitor that is “both potent and selective.” He pointed ...
IN PREVIOUSLY treated patients with amyloid light-chain (AL) amyloidosis, the chimeric fibril-reactive monoclonal antibody 11-1F4 (CAEL-101) produced organ responses in about two-thirds of patients in a phase Ia/b trial reported at the 2017 American Society of Hematology (ASH) Annual Meeting &...
DARATUMUMAB (DARZALEX) may be an effective treatment for systemic amyloid light-chain (AL) amyloidosis, according to phase II studies reported at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition.1,2 While the cohorts were small and the arms uncontrolled, the findings...
A detailed quality-of-life analysis of the phase III EF-14 trial of tumor-treating fields (Optune) in combination with temozolomide for the treatment of newly diagnosed glioblastoma was published by Taphoorn et al in JAMA Oncology. This secondary endpoint analysis demonstrated that the...
Esophageal cancer is the eighth most common cancer worldwide, with an estimated 456,000 new cases in 2012, and the sixth most common cause of death from cancer with an estimated 400,000 deaths, according to data from GLOBOCAN, which provides statistics on the incidence and mortality of cancer...
A new analysis of the ongoing STAMPEDE clinical trial found that adding docetaxel to hormone therapy for advanced prostate cancer improves quality of life and lowers the need for subsequent therapy. Docetaxel was also found to be cost-effective. These findings will be presented by James et al at...
In a phase III clinical trial of patients with previously untreated metastatic renal cell cancer combining the immunotherapy atezolizumab (Tecentriq) with the targeted therapy bevacizumab (Avastin) delayed cancer growth by about 3 months longer than sunitinib, another targeted therapy. The benefit...
Findings from the phase III placebo-controlled SPARTAN trial suggest that apalutamide is an effective treatment for men with nonmetastatic castration-resistant prostate cancer who are at high risk for developing metastatic disease and for whom no approved treatments exist. Men who received...
The phase III ACT IV study has shown no survival benefit of adding rindopepimut, a vaccine targeting the epidermal growth factor receptor (EGFR) deletion mutation EGFRvIII, to temozolomide in patients with newly diagnosed EGFRvIII-positive glioblastoma. These findings were reported in The Lancet...
The use of chemotherapy to treat women with early-stage breast cancer “declined markedly over time,” according to analysis of data from 2,926 women between the ages of 20 and 79. The trends documented “are remarkable for their steepness of decline, independent of clinical factors and despite no...
On August 1, 2017, the IDH2 inhibitor enasidenib (Idhifa) was granted regular approval for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by a U.S. Food and Drug Administration (FDA)-approved...
On July 11, 2017, blinatumomab (Blincyto) was approved for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.1,2 Blinatumomab received accelerated approval in December 2014 for the treatment of Philadelphia chromosome (Ph)-negative...
In the POSH study in the UK population reported in The Lancet Oncology, Copson et al found women with young-onset breast cancer who carry a germline BRCA mutation have survival similar to noncarriers, and BRCA-mutation carriers vs noncarriers with triple-negative breast cancer may have an early...
Immune checkpoint inhibitors have had a dramatic impact on survival for patients with stage IV non–small cell lung cancer (NSCLC), with whispers that a cure might be achieved in a subset of patients. In typical fashion, active new agents are evaluated in earlier stages of disease. Stage III NSCLC...
Updated results were recently reported from the 30 patient safety lead-in of the phase III BEACON CRC trial evaluating the triplet combination of encorafenib (a BRAF inhibitor), binimetinib (an MEK inhibitor), and cetuximab (Erbitux, an anti–EGFR antibody) in patients with BRAF-mutant...
As reviewed in this issue of The ASCO Post, a recent ASCO panel, chaired by Bryan Schneider, MD, and Brendon Stiles, MD, has provided an endorsement of a recently published guideline on the use of stereotactic body radiotherapy for non–small cell lung cancer.1 The original guideline,2 developed and ...
As reported in the Journal of Clinical Oncology by Bryan J. Schneider, MD, of the University of Michigan, Ann Arbor, and colleagues, ASCO has endorsed the recently released American Society for Radiation Oncology (ASTRO) evidence-based guideline on stereotactic body radiotherapy (SBRT) in early...
On May 18, 2017, pembrolizumab (Keytruda) was granted regular approval for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...
On May 26, 2017, ceritinib (Zykadia) was granted regular approval for treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by a U.S. Food and Drug Administration–approved test.1,2 In 2014, the drug received ...
THE CANCER death rate dropped 1.7% from 2014 to 2015, continuing a drop that began in 1991 and has reached 26%, resulting in nearly 2.4 million fewer cancer deaths during that time. The data are reported in “Cancer Statistics, 2018,” the American Cancer Society’s comprehensive annual report on...
Detailed results of the phase III CELESTIAL trial in patients with previously treated advanced hepatocellular carcinoma (HCC) were presented in a late-breaking oral session by Abou-Alfa et al at the 2018 ASCO Gastrointestinal (GI) Cancers Symposium (Abstract 207). Study Findings In CELESTIAL,...
Findings from the phase II KEYNOTE-224 trial investigating the use of pembrolizumab (Keytruda) in patients with advanced hepatocellular carcinoma who were previously treated with sorafenib (Nexavar) were presented by Zhu et al at the 2018 Gastrointestinal (GI) Cancers Symposium in San Francisco...
“There is huge potential to positively influence a patient’s experience and outcomes” by addressing concerns about sexual function after cancer treatment early in the course of treatment planning, Stacy Tessler Lindau, MD, MA, stated in her keynote address at the 11th Annual Oncofertility...
Primary analysis of the JULIET trial adds to mounting evidence that chimeric antigen receptor (CAR) T-cell therapy is effective for the treatment of lymphoma in patients with no other good treatment options. A single infusion of CAR T cells (CTL019) achieved durable remissions in almost 40% of...
Older patients with Hodgkin lymphoma typically do not fare as well as younger patients on standard regimens. A phase II study reported the best outcomes to date in older patients with Hodgkin lymphoma who were treated with sequential brentuximab vedotin (Adcetris) before and after a regimen of...
Can aggressive treatment of high-risk smoldering multiple myeloma patients prevent disease worsening? A carfilzomib (Kyprolis)-based regimen and autologous stem cell transplant (ASCT) plus maintenance produced encouraging outcomes in the phase II GEM-CESAR study by the Spanish Myeloma Group. The...