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...
In a study reported in the Journal of Clinical Oncology, Cella et al found little difference in quality-of-life (QOL) outcomes between the cabozantinib (Cabometyx) and everolimus (Afinitor) groups in the phase III METEOR trial. The study investigated these treatments in patients with metastatic...
New findings from a clinical trial of women with breast cancer suggest that guided exercise with a physical therapist after lymph node dissection helps women regain their range of arm motion more quickly. These findings will be presented by Paskett et al at the upcoming 2018 Cancer Survivorship...
A follow-up study to a randomized clinical trial reveals that exercising during adjuvant chemotherapy helps people engage in more physical activity years later. Four years later, people with breast or colon cancer who had participated in an 18-week exercise program while receiving chemotherapy...
Eric J. Small, MD, of the University of California, San Francisco, discusses phase III findings on apalutamide vs placebo in patients with nonmetastatic castration-resistant prostate cancer (Abstract 161).
Sumanta K. Pal, MD, of the City of Hope Comprehensive Cancer Center, discusses phase III study findings from IMmotion151, which looked at atezolizumab plus bevacizumab vs sunitinib in untreated metastatic renal cell carcinoma (RCC), and results from a safety and efficacy trial of axitinib in...
Maha Hussain, MD, of Northwestern University, discusses phase III findings on enzalutamide in men with nonmetastatic castration-resistant prostate cancer (Abstract 3).
Daniel J. George, MD, of Duke University Medical Center, discusses phase III findings on adjuvant sunitinib in patients with high-risk renal cell carcinoma, in an exploratory pharmacogenomic analysis (Abstract 576).
Thomas Powles, MD, of Barts Cancer Institute, discusses phase III study findings on atezolizumab vs chemotherapy in platinum-treated locally advanced or metastatic urothelial carcinoma, with an emphasis on immune biomarkers, tumor mutational burden, and clinical outcomes (Abstract 409).
Joaquim Bellmunt, MD, PhD, of the Dana-Farber Cancer Institute, discusses phase III 2-year follow-up findings on pembrolizumab vs investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (Abstract 410).
In a study of National Cancer Database data reported in the Journal of Clinical Oncology, Neuman et al found that synchronous distant recurrence was identified in 27% of women with stage II or III breast cancer experiencing locoregional recurrence. Study Details The study—an American...
Results from the phase III PROSPER trial in patients with nonmetastatic castration-resistant prostate cancer were presented by Hussain et al at the 2018 Genitourinary Cancers Symposium (Abstract 3). The results show that the use of enzalutamide (Xtandi) plus androgen-deprivation therapy (ADT)...
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 BY Catherine Van Poznak, MD, FASCO, of the University of Michigan, Ann Arbor, and colleagues in the Journal of Clinical Oncology, ASCO and Cancer Care Ontario (CCO) have collaborated in providing a focused update for the ASCO clinical practice guideline on the role of bone-modifying...
AS REVIEWED in this issue of The ASCO Post, Patel and colleagues have presented data from the phase I JAVELIN study evaluating avelumab (Bavencio) in platinum-refractory patients with advanced urothelial carcinoma.1 The drug is active with durable responses when compared with historical...
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...
THE PHASE III SUCCESS A trial, presented at the 2017 San Antonio Breast Cancer Symposium, found no benefit for extending the use of intravenous zoledronic acid from 2 years to 5 years.1 “At this time point, our study showed no difference in disease-free survival or overall survival between 5 years ...
ANOTHER TRIAL has validated that 1 year of adjuvant trastuzumab (Herceptin) remains the standard in HER2-positive breast cancer, but the margin of difference, compared with just 9 weeks of the drug, was slim, based on the findings of the phase III SOLD trial reported at the 2017 San Antonio Breast...
ALTHOUGH PRECISION medicine may be a recent discovery in some fields, it is an old story in the field of breast cancer, and one that has been exceptionally important in terms of managing the disease, according to George Sledge, MD, FASCO, Professor of Medicine and Medical Oncologist at the...
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...
As reported in the Journal of Clinical Oncology by Shadman et al, long-term follow-up of patients with previously untreated advanced-stage follicular lymphoma in the phase III SWOG-S0016 trial has shown continued good outcomes with both R-CHOP (rituximab [Rituxan] plus cyclophosphamide,...
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...
The ongoing phase III CheckMate-227 study met its coprimary endpoint of progression-free survival with a combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) vs chemotherapy in patients with first-line advanced non–small cell lung cancer (NSCLC) whose tumors have a high (≥ 10...
IN PATIENTS undergoing treatment of multiple myeloma, the prophylactic use of levofloxacin significantly reduced febrile episodes and deaths, without increasing healthcare-associated infections or carriage of key nosocomial pathogens, in a large multicenter study from the United Kingdom.1 The...
In a European phase III trial (ETNA) reported in JAMA Oncology, Gianni et al found no significant difference in pathologic complete response rate with nab-paclitaxel (Abraxane) vs paclitaxel followed by an anthracycline regimen in neoadjuvant treatment for HER2-negative breast cancer. Study...
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...
STEPHEN LEONG, MD, of the University of Colorado Comprehensive Cancer Center, Aurora, discussed the RAINFALL findings at the symposium, commenting, “The study did meet its primary endpoint of progression-free survival; however, it was disappointing not to see a benefit in overall survival or...
BASED ON EFFICACY seen in the second-line setting for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma, ramucirumab (Cyramza) was evaluated as first-line therapy in the international phase III RAINFALL trial. Although the study met its primary endpoint, with a 25%...
AS REVIEWED in this issue of The ASCO Post, ASCO and Cancer Care Ontario (CCO) have issued an updated guideline on the role of bone-modifying agents in metastatic breast cancer.1 The updated guideline supports a change in clinical practice for our patients with breast cancer and bone metastasis....
CLINICAL TRIALS are an essential research tool to advance medical knowledge and patient care. Traditionally, the majority of pharmaceutical-sponsored clinical trials have been implemented in Western Europe and North America. More recently, however, large pharmaceutical companies have increased...
As reported in The Lancet Oncology by Pavel and colleagues, no significant difference in deterioration of health-related quality of life was observed with everolimus (Afinitor) vs placebo in the phase III RADIANT-4 trial, which included patients with advanced nonfunctional well-differentiated...