The French phase III ALLOZITHRO trial, stopped early due to excessive hematologic relapse in the azithromycin group, showed worse airflow decline–free survival with azithromycin vs placebo after hematopoietic stem cell transplantation (HSCT) for hematologic malignancy. The study findings were...
Breast cancer specialist Stacy L. Moulder, MD, was born and reared in Brookhaven, Mississippi, a small town southwest of the state capital of Jackson. “I was always interested in math and science, and I had a wonderful biology teacher in high school. It was when the advanced placement courses...
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 December 19, 2017, bosutinib (Bosulif) was granted...
AS REPORTED in The New England Journal of Medicine by Jean-Charles Soria, MD, PhD, of Gustave Roussy Cancer Campus and University Paris-Sud, and colleagues, the phase III FLAURA trial has shown a significant progression-free survival benefit with the third-generation epidermal growth factor...
EACH YEAR, The ASCO Post asks Jame Abraham, MD, FACP, Director of the Breast Oncology Program at Taussig Cancer Institute and Co-Director of the Cleveland Clinic Comprehensive Breast Cancer Program, to give his picks for the most important research presented at the San Antonio Breast Cancer...
FOR NEWLY DIAGNOSED patients with multiple myeloma considered to be at high risk of disease progression, double autologous stem cell transplantation (ASCT) significantly prolongs progression-free and overall survival, vs single transplant, according to the phase III EMN02/HO95 study. The findings...
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Ting Bao, MD, DABMA, MS, reviews the current data on the use of acupuncture...
On January 26, 2018, the radiolabeled somatostatin analog lutetium Lu-177 dotatate (Lutathera) was approved for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors, in adults.1,2 Supporting...
In a phase III trial (BrighTNess) reported in The Lancet Oncology, Loibl et al found that the addition of the PARP inhibitor veliparib to carboplatin and paclitaxel in neoadjuvant therapy did not increase pathologic complete response rate in women with triple-negative breast cancer. Study Details ...
ADJUVANT CHEMOTHERAPY achieved robust improvements in disease-free survival and metastasis-free survival compared with surveillance in the phase III POUT study of patients with upper tract urothelial cancer.1 Further, there was an early trend toward improved overall survival with adjuvant...
IN PATIENTS WITH metastatic pancreatic adenocarcinoma, 1-year survival reached 43% following treatment with a novel immunotherapy—PEGylated human IL-10 (AM0010, pegilodecakin)—plus chemotherapy, in a small study reported at the 2018 Gastrointestinal Cancers Symposium.1 “We saw a very high disease...
LISOCABTAGENE MARALEUCEL (Liso-cel; JCAR017), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy with defined composition, has shown “potent and durable” responses in poor-prognosis patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) in a phase I trial.1 According ...
ON OCTOBER 17, 2017, Norman E. Sharpless, MD, became the 15th Director of the National Cancer Institute (NCI), succeeding Harold E. Varmus, MD, who stepped down as Director of the agency in March 2015, and replacing Douglas R. Lowy, MD, who had served as Acting Director for 2 years. The...
THE TYROSINE KINASE inhibitor sunitinib (Sutent) has been the mainstay of treatment for first-line treatment of advanced renal cell carcinoma for about a decade. The IMmotion151 study reported at the 2018 Genitourinary Cancers Symposium found that the combination of the immune checkpoint inhibitor...
FOR DECADES, the status of metastatic prostate cancer trials was not particularly exciting. With an absence of high-impact novel agents, the focus of cancer trial groups was on the improvement of standard care. Well-crafted, large trials of hormonal therapy demonstrated the utility of combined...
In a systematic review and meta-analysis reported in Leukemia & Lymphoma, Shah et al identified the risk of cardiotoxicity among patients, most with multiple myeloma, receiving carfilzomib (Kyprolis) in clinical trials. Study Details The study included data from 4,164 patients who received...
In a study reported in the Journal of Oncology Practice, Gannavarapu et al found that substantial unintentional weight loss prior to treatment is common among patients with cancer across stages of disease and is associated with poorer outcome. Study Details The retrospective cohort study included ...
In the international phase III BRIM8 trial reported in The Lancet Oncology, Maio et al found inconclusive evidence of benefit of adjuvant vemurafenib treatment in patients with BRAF V600–mutant melanoma. Study Details In the double-blind trial, 498 patients with fully resected...
An Italian phase III trial (FATA-GIM3) has shown no difference in disease-free survival with 5 years of upfront adjuvant aromatase inhibitor therapy vs 2 years of tamoxifen followed by 3 years of aromatase inhibitor therapy in women with hormone receptor–positive early breast cancer. The...
In a Japanese phase III noninferiority trial reported in the Journal of Clinical Oncology, Ito et al found that dexamethasone could be spared on days 2 and 3 in an antiemetic regimen including the neurokinin-1 (NK1) receptor antagonist aprepitant and palonosetron in patients receiving highly...
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies in melanoma. These studies focus on assessing response to checkpoint inhibitors; T-cell immunotherapy; combination therapies; adoptive cell therapy; combination therapy development; and...
On December 5, 2017, bevacizumab (Avastin) was granted regular approval for the treatment of recurrent glioblastoma in adults.1 Bevacizumab was granted accelerated approval in May 2009 for use in treating patients with glioblastoma who had disease progression on prior therapy. Supporting Efficacy...
On March 1, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the anti–connective tissue growth factor (CTGF) antibody pamrevlumab for the treatment of patients with locally advanced unresectable pancreatic cancer. This follows review of the phase II clinical...
In an Indian single-center phase III trial reported in the Journal of Clinical Oncology, Gupta et al found that cisplatin-based chemoradiotherapy improved disease-free survival vs neoadjuvant chemotherapy and radical surgery in women with locally advanced squamous cervical cancer. Study Details...
In a phase III trial reported in The Lancet Oncology, Raje et al found that denosumab was noninferior to zoledronic acid in preventing skeletal-related events (SREs) in newly diagnosed multiple myeloma patients with bone disease. Study Details In the double-blind trial, 1,718 patients with at...
As reported in the Journal of Clinical Oncology by Wapnir et al, the final analysis of the phase III CALOR trial showed benefit of adjuvant chemotherapy in estrogen receptor (ER)–negative but not ER-positive isolated locoregional recurrence of breast cancer. Study Details In this open-label ...
People with stage III colon cancer who regularly eat nuts are at significantly lower risk of cancer recurrence and mortality than those who don’t, according to findings published by Fadelu et al in the Journal of Clinical Oncology. Findings The study followed 826 participants in the CALGB...
As reported in JAMA Oncology by Issels et al, long-term follow-up of the phase III EORTC 62961-ESHO 95 trial has shown improved outcomes with the addition of regional hyperthermia to neoadjuvant chemotherapy in patients with high-risk soft-tissue sarcoma. Study Details In the open-label trial,...
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...
In the phase III Hokusai VTE Cancer trial reported by Raskob et al in The New England Journal of Medicine, the direct-acting oral factor Xa inhibitor edoxaban proved noninferior to the low–molecular-weight heparin dalteparin in the composite outcome of recurrent venous thromboembolism or...
As reported by Smith et al in The New England Journal of Medicine, the phase III SPARTAN trial has shown that the androgen receptor inhibitor apalutamide (Erleada) produces significant improvement in metastasis-free survival and time to symptomatic progression vs placebo among men with...
The use of maintenance therapy in older patients with acute myeloid leukemia (AML) is theoretically sensible, but its clinical value remains uncertain. The phase III HOVON97 randomized study demonstrated that maintenance therapy with the hypomethylating agent azacitidine may improve disease-free...
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 a study reported in the Journal of the National Cancer Institute, Brown et al found that the serum bone biomarkers P1NP, CTX, and 1-CTP showed good prognostic ability for bone metastasis in patients in the phase III AZURE (BIG01/04) trial of adjuvant zoledronic acid in early breast cancer....
Kathleen M. Schmeler, MD, Associate Professor in the Department of Gynecologic Oncology at The University of Texas MD Anderson Cancer Center and the Lyndon B. Johnson Hospital, was given the “Heroes in Medicine” award from Physician’s Weekly in May 2016. Her primary work is in cervical cancer...
TOPLINE RESULTS of the phase III ARROW trial (ClinicalTrials.gov identifier NCT02412878) were recently announced by Amgen. The study showed carfilzomib (Kyprolis) administered once weekly at 70 mg/m2 with dexamethasone allowed patients with relapsed or refractory multiple myeloma to live 3.6 months ...
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...
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...
On February 16, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) for the treatment of patients with stage III unresectable non–small cell lung cancer (NSCLC) whose cancer has not progressed after treatment with chemoradiation. “This is the first treatment...
Matthew J. Ellis, MB, PhD, Director of the Lester and Sue Smith Breast Center at Baylor College of Medicine in Houston, commented on the POETIC trial for The ASCO Post. “This is a wonderful study that validates a point that our research team has also made over the years—that Ki67 is much more...
Updated analysis from the United Kingdom’s POETIC trial found no evidence that perioperative aromatase inhibitor therapy slows or prevents time to recurrence of breast cancer. However, the study did show that tumor Ki67 levels after 2 weeks of perioperative aromatase inhibitor therapy are...
We have covered many of the important presentations from the 2017 San Antonio Breast Cancer Symposium in the pages of The ASCO Post and in our online Evening News. Here are summaries of additional noteworthy studies presented at the meeting. We hope you will find them of interest. Predicting...
In a phase III noninferiority trial reported in The Lancet, Kudo et al found that first-line lenvatinib was noninferior to sorafenib in overall survival of patients with unresectable hepatocellular carcinoma. Study Details In the open-label trial, 954 patients from 154 sites in 20 countries in...
Patients newly diagnosed with locally advanced pancreatic cancer who received induction therapy with nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) and gemcitabine achieved a time to treatment failure and median progression-free survival that exceeded the protocol-specified target by more...
Discussant Jordi Bruix, MD, PhD, Head of the Barcelona Clinic Liver Cancer Group at the University of Barcelona in Spain, said the results of the CELESTIAL trial show that cabozantinib (Cabometyx) provides a clinically meaningful survival benefit to patients with advanced hepatocellular carcinoma ...
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...
Analysis of long-term survival outcomes in the phase III CHAARTED trial showed a survival advantage with the addition of docetaxel to androgen-deprivation therapy (ADT) in patients with hormone-sensitive metastatic prostate cancer, although no advantage was observed among patients with low-volume...
Preliminary results from the phase II portion of the TiNivo study, a phase Ib/II multicenter trial of oral tivozanib in combination with intravenous (IV) nivolumab (Opdivo) for the treatment of metastatic renal cell carcinoma (RCC) were presented by Escudier et al at the 2018 Genitourinary Cancers...
In a phase III trial reported in the Journal of Clinical Oncology, Pivot et al found equivalence of the trastuzumab biosimilar SB3 and the reference trastuzumab (Herceptin) in producing breast pathologic complete response in the neoadjuvant treatment of patients with HER2-positive early breast...