The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies of children and young adult cancer survivors. The studies include phase I, I/II, III, observational, and interventional trials investigating genomic profiling to personalize treatment;...
The following five abstracts, which include four clinical studies and one basic research study, were named the top abstracts at the 2014 International Conference of the Society for Integrative Oncology. Therapeutic Effects of Lyophilized Leech Saliva Extract Hassona MDH, Ammar AE, Gao TY, et al: In ...
Venetoclax, formerly known as ABT-199, is moving forward into phase III development in acute myelogenous leukemia (AML) and chronic lymphocytic leukemia (CLL), based on encouraging data from separate phase Ib and II trials presented at the 56th Annual Meeting and Exposition of the American Society...
The interactions between the estrogen receptor (ER) and HER2 pathways in breast cancers are clearly complex and remain incompletely understood. Historically, cancers that express both ER and HER2 were thought to be intrinsically resistant to endocrine therapy, likely due to HER2 being the dominant...
In a phase III trial (Cancer and Leukemia Group B [CALGB] 40302/Alliance) reported in the Journal of Clinical Oncology, Harold J. Burstein, MD, PhD, of Dana-Farber Cancer Institute, Boston, and colleagues found that the addition of the dual EGFR-HER2 inhibitor lapatinib (Tykerb) to endocrine...
As reported in this issue of The ASCO Post, Robert and colleagues recently published a phase III study comparing the anti–programmed death 1 (PD-1) antibody nivolumab with the standard melanoma chemotherapy dacarbazine in the front-line treatment of patients with advanced BRAF wild-type melanoma.1...
In a phase III trial reported in The New England Journal of Medicine, Robert and colleagues found that the programmed cell death protein-1 (PD-1) immune-checkpoint–inhibitor antibody nivolumab (Opdivo) significantly increased overall survival, progression-free survival, and objective response rate...
Nab-paclitaxel (Abraxane) achieved superior results compared with conventional solvent-based paclitaxel in patients with early-stage high-risk breast cancer in the large phase III GeparSepto trial from the German Breast Group (GBG).1 The study, presented at the 2014 San Antonio Breast Cancer...
Adjuvant therapy with capecitabine plus ibandronate failed to improve outcomes vs ibandronate alone in elderly patients with moderate-to-high-risk early-stage breast cancer in the ICE study—the largest study to date conducted in elderly women with breast cancer.1 “Capecitabine is frequently used in ...
The final survival analysis of the landmark Women’s Intervention Nutrition Study (WINS) confirmed that a low-fat diet can reduce the risk of dying for a subset of breast cancer patients.1 At the San Antonio Breast Cancer Symposium, Rowan T. Chlebowski, MD, PhD, of the Los Angeles Biomedical...
Clinical trials are the key to driving advances in the prevention, diagnosis, and treatment of cancer, yet, it is estimated that only about 5% of patients with cancer participate in clinical trials. That is why Cancer.Net, ASCO’s patient-facing educational website, has teamed up with Neal Meropol,...
In the treatment of advanced/metastatic melanoma, recent debate has focused on the choice of initial therapy: ipilimumab (Yervoy) or, for patients with BRAF-mutant cancer, a BRAF/MEK inhibitor. This issue is now taking a back seat to the emerging conversation about the positioning of antibodies...
Adding veliparib to carboplatin and paclitaxel resulted in “clinically meaningful improvements” in progression-free survival and overall survival among patients with previously untreated metastatic or advanced non–small cell lung cancer (NSCLC), particularly those with squamous histology. The...
Progression-free survival was significantly improved among patients with advanced non–small cell lung cancer (NSCLC) receiving sunitinib (Sutent) as switch maintenance compared to placebo, according to results of an Alliance phase III trial (Cancer and Leukemia Group B [CALGB] 3067). The effect of...
Fulvestrant (Faslodex) at a 500-mg dose was superior to anastrozole as first-line therapy for advanced hormone receptor–positive breast cancer in the phase II FIRST study.1 Overall survival and time to disease progression were significantly better with fulvestrant than with the current standard of...
The addition of everolimus (Afinitor) to weekly trastuzumab (Herceptin) plus paclitaxel in the first-line metastatic breast cancer setting did not improve outcomes in the phase III BOLERO-1/TRIO-019 but did provide a “signal” in the hormone receptor–negative subset. The study was reported at the...
Among women with triple-negative breast cancer, overall, basal-like and non–basal-like tumors were equally likely to demonstrate a pathologic complete response to neoadjuvant chemotherapy, but they responded differently to the addition of carboplatin and bevacizumab (Avastin) to a standard...
In patients with Hodgkin lymphoma who are at risk for disease progression following autologous stem cell transplantation, early consolidation with brentuximab vedotin (Adcetris) post-transplant significantly improved progression-free survival compared with placebo in the phase III AETHERA trial.1...
Several studies presented at the 2014 ASH Annual Meeting supported the use of brentuximab vedotin (Adcetris) in Hodgkin lymphoma. The Reed-Sternberg cells of classical Hodgkin lymphoma typically express CD30, which is targeted by brentuximab vedotin, an anti-CD30 monoclonal antibody conjugated by a ...
The phase III global ASPIRE trial documented an “unprecedented” duration of remission in relapsed multiple myeloma patients receiving carfilzomib (Kyprolis) plus a standard-of-care doublet, according to Keith Stewart, MB, ChB, Professor of Medicine at the Mayo Clinic in Scottsdale, Arizona, who...
Patients with unresectable stage III or IV melanoma treated with ipilimumab (Yervoy) plus sargramostim (Leukine) had longer overall survival and less toxicity than did those treated with ipilimumab alone, according to a phase II randomized clinical trial conducted by the Eastern Cooperative...
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with newly diagnosed or recurrent glioblastoma multiforme. The studies include pilot, phase I, I/II, III, and observational trials investigating chemoradiation therapy;...
Amgen and its subsidiary Onyx Pharmaceuticals, Inc, announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) carfilzomib (Kyprolis) to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least...
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Celator Pharmaceuticals’ investigational agent CPX-351, a liposomal formulation of cytarabine:daunorubicin, for the treatment of elderly patients with secondary acute myeloid leukemia. The FDA established the Fast...
Nearly 5,000 scientific abstracts were presented at the 2014 American Society of Hematology (ASH) Annual Meeting and Exhibition in San Francisco. Along with our targeted coverage of the meeting’s key newsmakers, The ASCO Post provides you with these brief reports of other interesting...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. In December 12, 2014, ramucirumab (Cyramza) was approved for use in ...
Treatment of advanced bladder cancer continues to prove challenging, and therapies that offer long-term survival remain elusive. The ASCO Post recently spoke with Derek Raghavan, MD, PhD, FACP, FRACP, FASCO, President of the Levine Cancer Center, Charlotte, North Carolina, about the current state...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 4, 2014, ruxolitinib (Jakafi) was approved for the...
An investigational class of agents in multiple myeloma, the anti-CD38 monoclonal antibodies, could be the next blockbusters in this malignancy, myeloma experts predicted at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition. Anti-CD38 antibodies target multiple myeloma...
Highlighted here are summaries of four abstracts presented at the 2014 San Antonio Breast Cancer Symposium: They focus on the EPO-ANE-3010 clinical trial of epoetin alfa (Epogen, Procrit) in anemic patients with metastatic breast cancer, a New York Cancer Consortium trial of fulvestrant (Faslodex)...
An update of clinical trial E1199 showed that weekly paclitaxel and every-3-week docetaxel were both more effective than every-3-week paclitaxel in preventing deaths and tumor recurrences, according to Joseph Sparano, MD, Professor of Medicine and Women’s Health at the Albert Einstein College of...
A less intensive regimen of nab-paclitaxel (Abraxane) plus gemcitabine appears to be as efficacious as the standard regimen in first-line treatment for metastatic pancreatic cancer, but less toxic and far less expensive, according to a study that earned a Merit Award at the 2015 Gastrointestinal...
Some patients with rectal cancer who achieve a complete response to neoadjuvant chemoradiation therapy can be monitored for tumor recurrence and may never need surgery, according to a retrospective review from patients at Memorial Sloan Kettering Cancer Center, New York, presented at the 2015...
I am writing in regard to the report and commentary in this issue on the RAISE Trial. To begin, a discussion of this phase III clinical trial presented at the 2015 Gastrointestinal Cancers Symposium (RAISE study) may not be the most appropriate forum to air legitimate views on finances and...
Bucking national trends toward preserving the larynx in patients with advanced laryngeal cancer, treatment of patients for stage IV disease at Louisiana State University (LSU) Health-Shreveport were more likely to involve primary surgical therapy, including total laryngectomy, and more likely to...
Crizotinib (Xalkori) treatment “was superior to pemetrexed-plus-platinum chemotherapy with respect to progression-free survival, objective response rate, reduction in lung-cancer symptoms, and improvement in quality of life” in patients with previously untreated advanced anaplastic lymphoma kinase...
Scientific name: 8-methyl-N-vanillyl-6-nonenamide Brand names: Zostrix cream 0.025% or 0.075%, Salonpas Gel-Patch Hot, Sinus Buster (homeopathic intranasal spray). The use of dietary supplements by patients with cancer has increased significantly over the past 20 years despite insufficient evidence ...
The first poly ADP ribose polymerase (PARP) inhibitor was developed in the early 1990s. Since then, the activity of PARP inhibitors has been explored in a variety of settings, including and perhaps most enthusiastically in the treatment of cancer. The greater dependence of several cancers on PARP,...
In a phase III trial reported in Journal of Clinical Oncology, Joyce O’Shaughnessy, MD, of Baylor Charles A. Sammons Cancer Center, Dallas, and colleagues found that the addition of iniparib to gemcitabine and carboplatin did not improve overall survival or progression-free survival in patients...
In a study that reflected clinical practice, treatment of diffuse large B-cell lymphoma based on the results of interim positron-emission tomography (PET) was feasible; however, switching PET-positive patients to an alternative treatment still resulted in inferior treatment outcomes, and the...
Two orally administered proteasome inhibitors—oprozomib and ixazomib—looked encouraging in multiple myeloma studies presented at the 2014 ASH Annual Meeting and Exposition. Study Details for Oprozomib Oprozomib, given as a single agent in a dose-escalation study of heavily pretreated patients,...
Limited-stage nonbulky diffuse large B-cell lymphoma (DLBCL) carries an excellent prognosis, and radiotherapy provides no value in patients who obtain a complete response, according to the phase III 02-03 trial from the Lysa/Goelams group, presented at the 56th American Society of Hematology (ASH)...
David Ilson, MD, of Memorial Sloan Kettering Cancer Center in New York, criticized the trial presented by Dr. Penniment at the 2015 Gastrointestinal Cancers Symposium for lacking a chemotherapy-alone arm. “Chemotherapy alone, in phase III trials, has achieved dysphagia relief in 70% of patients,”...
Palliation of dysphagia associated with advanced esophageal cancer can be effectively accomplished with radiotherapy alone, without the addition of chemotherapy, according to a multinational phase III study presented at the 2015 Gastrointestinal Cancers Symposium.1 “There was no significant...
Targeting one of the deadliest cancers and seeking to fill an unmet need, drug development in pancreatic cancer is an area of high interest. This was certainly the case at the 2015 Gastrointestinal Cancers Symposium, where results were impressive for some novel agents but disappointing for several...
The phase III international RAISE trial found that ramucirumab (Cyramza) extends survival when given with chemotherapy to metastatic colorectal cancer patients who progress on treatment,1 but some experts commented that “financial toxicity” might be an issue, given the modest benefit. “The RAISE...
Tyrosine kinase inhibitors “are associated with numerous adverse effects, many of which are cutaneous and can affect patients’ quality of life and impede their adherence to long-term treatment,” National Cancer Institute (NCI) investigators concluded after studying the adverse effects of the...
I come from strong physical stock and inherited a sort of “tough it out mentality” when it comes to coping with the usual aches and pains that creep up as you age. So by the time I realized that my legs had become so swollen and my breathing so labored it was difficult for me to walk, I could...
The U.S. Food and Drug Administration (FDA) has expanded the existing indication for lenalidomide (Revlimid) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. Lenalidomide plus dexamethasone was previously approved in June 2006 for use in multiple myeloma...
Each year in the United States, about 55,000 people will be diagnosed with head and neck cancer, and of them, about 12,000 will die of the disease. Although advances have been made in the treatment of head and neck cancer, this disease remains persistently problematic, due, in part, to the complex...