On November 10, 2016, nivolumab (Opdivo) was approved for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.1,2 Supporting Efficacy Data Approval was based on the finding of an overall survival advantage...
The future treatment of melanoma may rely on combinations of immunotherapy agents beyond the current checkpoint inhibitors, and they are entering clinical trials, according to Jeffrey Weber, MD, PhD, Deputy Director of the Laura and Isaac Perlmutter Cancer Center at New York University Langone...
One immune checkpoint inhibitor has now moved to the front of the line for treating advanced non–small cell lung cancer (NSCLC). Based on pivotal studies presented at the 2016 European Society for Medical Oncology (ESMO) Congress, pembrolizumab (Keytruda) became a first-line option, and it is...
Positive studies about brentuximab vedotin (Adcetris) in cutaneous T-cell lymphoma1 and rituximab (Rituxan) maintenance therapy in mantle cell lymphoma (MCL)2 were reported at the 2016 Annual Meeting of the American Society for Hematology (ASH). “These abstracts each focus on approved agents and...
In part 1 of a phase III equivalence trial reported in JAMA, Rugo et al found that treatment with trastuzumab (Herceptin) or a proposed trastuzumab biosimilar in combination with a taxane produced similar overall response rates in patients with previously untreated metastatic HER2-positive breast...
Compared with standard therapy, pacritinib significantly reduces spleen size among people with myelofibrosis who have very low levels of platelets, according to a late-breaking study presented by Mascarenhas et al during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition...
In the UK phase III ERCC1 trial reported in the Journal of Clinical Oncology, Lee et al found that presence of the excision repair cross complementing group 1 (ERCC1) biomarker did not predict better outcome with nonplatinum therapy in patients with non–small cell lung cancer (NSCLC). Study...
Jeffrey E. Lancet, MD, of the H. Lee Moffitt Cancer Center and Research Institute, discusses study findings on survival following allogeneic hematopoietic cell transplantation in older, high-risk acute myeloid leukemia patients initially treated with CPX-351 liposome injection vs standard...
Catherine Thieblemont, MD, PhD, of Hôpital Saint-Louis and INSERM, discusses in French phase III trial findings on lenalidomide maintenance in elderly patients with DLBCL treated with R-CHOP in the first-line setting (Abstract 471).
The combined use of genetic markers and minimal residual disease assessment (MRD) has made it easier to identify chronic lymphocytic leukemia (CLL) patients likely to have a poor outcome after receiving frontline chemoimmunotherapy. Interim results from the phase III German CLL M1 study presented...
Catherine Thieblemont, MD, PhD, of Hôpital Saint-Louis and INSERM, and Julie Vose, MD, MBA, of the University of Nebraska Medical Center, discuss phase III trial findings on lenalidomide maintenance in elderly patients with DLBCL treated with R-CHOP in the first-line setting (Abstract 471).
A new analysis presented by Lancet et al at the 58th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 906) found older patients with acute myeloid leukemia (AML) survived longer after receiving an allogeneic stem cell transplant if they were first treated with the...
In an analysis in the Nurses’ Health Study population reported in the Journal of Clinical Oncology, Holmes et al found modest reductions in the risk for distant recurrence of breast cancer with greater protein intake. No associations with intake of essential amino acids, branched-chain amino...
In an analysis reported in JAMA Oncology, Fumagalli et al identified genetic markers associated with pathologic complete response among women with early-stage HER2-positive breast cancer receiving neoadjuvant therapy in the phase III NeoALTTO trial. Christos Sotiriou, MD, PhD, of Institut Jules...
As reported in the Journal of Clinical Oncology, Weber et al performed a pooled analysis of the safety profile of nivolumab (Opdivo) monotherapy in advanced melanoma, including a focus on potential immune-related (select) adverse events. The analysis pooled safety data from 576 patients receiving...
Michael O’Connell, MD, received the Association of Community Cancer Centers (ACCC) 2016 Clinical Research Award in recognition of the significant and positive impact of his research on the oncology patient, family, and the community. ACCC President Jennie R. Crews, MD, MMM, FACP, accepted the...
Impaired sleep quality is a concerning problem for many patients with cancer, and pharmacologic treatments come with many negative effects. Several small studies indicate that yoga improves persistent fatigue, sleep disturbance, anxiety, and quality of life, in addition to reducing the need for ...
Biosimilars are among the newest threads in the fabric of cancer treatment in the United States, and they are spawning numerous questions for oncologists and patients with cancer. Many of these questions were taken up by participants in a recent Washington forum on “The Future of the U.S....
In the phase III S-TRAC trial reported at the recent European Society for Medical Oncology meeting and in The New England Journal of Medicine by Alain Ravaud, MD, PhD, of Bordeaux University Hospital, and colleagues, adjuvant sunitinib (Sutent) significantly prolonged disease-free survival vs...
On October 24, 2016, pembrolizumab (Keytruda) was approved for use in patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high programmed cell death ligand 1 (PD-L1) expression (tumor proportion score ≥ 50%) as determined by a U.S. Food and Drug Administration...
The 2016 European Society for Medical Oncology (ESMO) Congress revealed many important positive findings from key trials in a number of tumor types, but many highly anticipated phase III trials in advanced disease failed to meet their primary endpoints. The ASCO Post has summarized several of these ...
Florian Lordick, MD, Professor of Oncology and Director of the University Cancer Center in Leipzig, Germany, offered some critical evaluation of the two studies. AGITG Phase II Trial For the AGITG’s phase II DOCTOR trial, he emphasized the need to show the impact on survival outcomes for...
In studies presented at the 2016 European Society for Surgical Oncology (ESMO) Congress, two different neoadjuvant treatment approaches improved the outcomes of patients with esophageal cancer. Investigators from the Australasian Gastro-Intestinal Trials Group (AGITG) reported that the addition of...
The 2016 European Society for Medical Oncology (ESMO) Congress was jam-packed with studies of the anti–programmed cell death protein 1 (PD-1) antibodies in non–small cell lung cancer and melanoma, where they have clearly changed the treatment paradigm. Here is a roundup of some of those trials,...
Most women with hormone receptor–positive breast cancer receive endocrine therapy as part of their treatment, but “the reality is that patients who receive antihormone therapy in the metastatic disease setting ultimately develop disease progression, ” William J. Gradishar, MD, stated at the 18th...
Although there are no androgen receptor antagonists currently approved for the treatment of breast cancer, clinical trials indicate that these agents benefit some patients with triple-negative breast cancer, Tiffany A. Traina, MD, told participants at the 18th Annual Lynn Sage Breast Cancer...
In the phase III MARIANNE trial reported in the Journal of Clinical Oncology, Perez et al found that ado-trastuzumab emtansine (formerly known as T-DM1; Kadcyla) was associated with noninferior progression-free survival compared with trastuzumab (Herceptin) plus taxane in patients with...
Christian U. Blank, MD, PhD, of the Netherlands Cancer Institute, discusses in German study findings on neoadjuvant ipilimumab plus nivolumab in patients with palpable stage III melanoma. (Abstract LBA39)
On November 17, the American Society for Radiation Oncology (ASTRO) issued an updated clinical practice statement for accelerated partial-breast irradiation for early-stage breast cancer. The updated guideline reflects recent evidence that greater numbers of patients can benefit from accelerated...
The current plethora of drugs in development for oncology is leading to the testing of novel agents in common as well as rare diseases. Targeted therapies have been a focus of great interest in soft-tissue sarcomas, with testing of a variety of oral tyrosine kinase inhibitors leading to the...
Commenting on ASCEND-5, Alice T. Shaw, MD, PhD, Director of Thoracic Oncology at the Massachusetts General Hospital Cancer Center, Boston, noted that it is the first randomized study to examine how a second-generation anaplastic lymphoma kinase (ALK) inhibitor compares to standard second-line...
For patients with advanced non–small cell lung cancer (NSCLC) harboring the ALK gene rearrangement, ceritinib (Zykadia) provided longer progression-free survival than chemotherapy in patients previously treated with chemotherapy and crizotinib (Xalkori), but gastrointestinal toxicity was...
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on immunotherapy as treatment for non–small cell lung cancer (NSCLC). These studies are researching programmed cell death ligand 1 (PD-L1) antibody therapy; hypofractionated...
As reviewed in this issue of The ASCO Post, Brian Rini, MD, and colleagues recently reported results from the phase III IMPRINT trial,1 which randomized HLA-A*02–positive patients with treatment-naive metastatic clear cell variant renal cell carcinoma, in favorable- and intermediate- risk...
In the phase III IMPRINT trial reported in The Lancet Oncology, Brian I. Rini, MD, of the Cleveland Clinic Taussig Cancer Institute, and colleagues found no overall survival benefit of adding the multipeptide cancer vaccine IMA901 to sunitinib (Sutent) in the first-line treatment of locally...
A landmark study showed that the investigational PARP (poly ADP-ribose polymerase) 1/2 inhibitor niraparib, when used as maintenance therapy, significantly improves the outcome of platinum-sensitive recurrent ovarian cancer. Specifically, niraparib significantly prolonged progression-free survival ...
November is National Pancreatic Cancer Awareness Month, the impetus for this article. Pancreatic cancer is a huge health challenge. It's the eighth most common cancer in the United States and the fourth most common cause of cancer deaths but is expected to become the second most common cause of...
We are in the midst of a paradigm shift in lung cancer. In the past 2 years, the anti–programmed cell death protein 1 (anti–PD-1) inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda) were found to improve overall survival in the second-line setting compared with docetaxel for patients with...
In the phase III KEYNOTE-024 trial reported in The New England Journal of Medicine by Martin Reck, MD, PhD, of the German Center of Lung Research, Grosshansdorf, and colleagues, pembrolizumab (Keytruda) significantly improved progression-free and overall survival vs platinum-based chemotherapy in...
Here is a brief look at the study findings and clinical implications of several recent and important clinical trials in neoplastic hematology. Attention is focused on myelodysplastic syndromes, multiple myeloma, and chronic lymphocytic leukemia. Myelodysplastic Syndromes Clinical Trial:...
In the phase III PALOMA-2 trial reported in The New England Journal of Medicine, Finn et al found that the addition of palbociclib (Ibrance) to letrozole significantly improved progression-free survival in postmenopausal women with previously untreated advanced estrogen receptor–positive,...
In the phase III TELESTAR trial reported in the Journal of Clinical Oncology by Kulke et al, telotristat ethyl, a tryptophan hydroxylase inhibitor, significantly reduced the frequency of bowel movements in patients with metastatic neuroendocrine tumors and carcinoid syndrome. Telotristat ethyl...
As reported in the Journal of Clinical Oncology by Platzbecker et al, the final results of the Italian-German phase III APL0406 trial indicate that the combination of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO [Trisenox]) is associated with better outcomes than standard ATRA plus...
In the phase III PICASSO III trial reported in the Journal of Clinical Oncology, Ryan et al found that adding palifosfamide to doxorubicin did not prolong progression-free survival among patients with metastatic soft-tissue sarcoma. Palifosfamide is the active metabolite of ifosfamide. In the...
I’ve always had fibrocystic breasts and was steadfast in performing monthly breast self-exams, so I could become familiar with the terrain of my breasts and spot any subtle changes. So, in November 2002, when I felt something in my left breast that seemed different from my usual lumps, I made a...
In an analysis of National Cancer Data Base data reported in the Journal of the National Cancer Institute, Shailender Bhatia, MD, of the University of Washington/Fred Hutchinson Cancer Research Center, and colleagues found that adjuvant radiotherapy was associated with a survival benefit in...
In a pooled analysis reported in the Journal of Clinical Oncology, Michel Meignan, MD, PhD, of the Université Paris-Est Créteil, and colleagues found that higher baseline total metabolic tumor volume measured by 18F-fluorodeoxyglucose (18F-FDG) positron-emission tomography–computed tomography (FDG...
Seattle Genetics, Inc, and Takeda Pharmaceutical Company Limited have announced completion of patient enrollment in the ECHELON-2 clinical trial. ECHELON-2 is a global phase III randomized trial evaluating brentuximab vedotin (Adcetris) as part of a front-line combination chemotherapy regimen in...
Nonrhabdomyosarcoma soft-tissue sarcomas account for about 5% of all childhood malignancies and are also diagnosed in adolescents and young adults, as well as in older adults, and can require different approaches to treatment based on a patient’s age and stage of disease. These sarcomas comprise...
The ASCO Research Community Forum held its 2016 Annual Meeting from September 25–26, at ASCO headquarters in Alexandria, Virginia. Nearly 100 physician investigators and research staff from all types of research sites across the United States attended the meeting. Each year, the ASCO Research...