Using a complex and innovative study design, Budd and colleagues from the Southwest Oncology Group (SWOG) addressed, in a randomized multicenter trial,1 an issue that has been under evaluation for over 40 years—namely, what are the optimal dose and schedule for adjuvant breast cancer chemotherapy?...
In a phase III trial (SWOG S0221) reported in the Journal of Clinical Oncology, George T. Budd, MD, of Taussig Cancer Center, Cleveland Clinic, and colleagues found no difference in disease-free survival among four different combinations of continuous or every-other-week...
Treatment of anaplastic lymphoma kinase (ALK)–positive lung cancer has been one of the great success stories in oncology in the past decade. First discovered in lung cancer in 2007, ALK rearrangements are found in 3% to 5% of patients and define a distinct molecular subgroup of the disease with...
In a phase III trial (PROFILE 1014) reported in The New England Journal of Medicine, Benjamin J. Solomon, MB, BS, PhD, of Peter MacCallum Cancer Centre, Melbourne, and colleagues found that the ALK inhibitor crizotinib (Xalkori) improved progression-free survival vs standard chemotherapy in...
The U.S. Food and Drug Administration (FDA) has granted approval to lenvatinib (Lenvima) to treat patients with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine therapy. Lenvatinib is a tyrosine kinase inhibitor that binds to multiple sites...
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for Genentech’s New Drug Application (NDA) for cobimetinib in combination with vemurafenib (Zelboraf) for the treatment of people with BRAF V600 mutation–positive advanced melanoma. The FDA will make a decision on...
The approval of multiple inhibitors of either the VEGF or mTOR pathway provided an incremental advance in the treatment of metastatic clear cell renal cancer. However, the agents have several important limitations: For example, the optimal clinical effect appears to be dependent on chronic...
In a randomized phase II trial reported in the Journal of Clinical Oncology, Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues found that the programmed cell death protein-1 (PD-1) immune checkpoint inhibitor antibody nivolumab (Opdivo) was associated with...
The somatostatin analog lanreotide (Somatuline) depot extended the time to disease progression in patients with pancreatic neuroendocrine tumors, in a planned subgroup analysis of the CLARINET trial, Alexandria T. Phan, MD, of The Houston Methodist Hospital in Texas, reported at the 2015...
The 2015 Gastrointestinal Cancers Symposium, held January 15–17 in San Francisco, attracted almost 4,000 attendees, who heard or viewed data from nearly 800 scientific abstracts and lectures. Here are our summaries of some of the many important developments from the meeting. Bevacizumab Plus...
Since 1990, the annual global death toll from cancer has risen about 40%, and that number is projected to increase from the current level of approximately 8 million cancer deaths per year to more than 13 million by 2030. The poorer, resource-challenged regions of the world will suffer a...
The information contained in this Clinical Trials Resource Guide includes actively recruiting observational, interventional, phase I, phase II, and phase III clinical studies for patients with newly diagnosed or recurrent esophageal cancer. All of the studies are listed on the National Institutes...
Joseph Mikhael, MD, MEd, myeloma expert at the Mayo Clinic in Arizona, Scottsdale, and Associate Dean of the Mayo School of Graduate Medical Education, considers five questions when selecting treatment for patients with multiple myeloma who relapse. “With prolonged survival, which approaches 10...
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 February 23, 2015, panobinostat (Farydak) was granted...
INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, Leah Christl, PhD, and Albert Deisseroth, MD, PhD, answer questions about biosimilar products. Dr. Christl is the Associate Director...
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 February 18, 2015, the indication for lenalidomide (Revlimid)...
In a phase III trial (SOFT) reported in The New England Journal of Medicine, Prudence A. Francis, MD, of Peter MacCallum Cancer Centre, Melbourne, Australia, Meredith M. Regan, ScD, of IBCSG Statistical Centre at Dana-Farber Cancer Institute, Boston, and colleagues found that the addition of...
The U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for trabectedin to treat patients with advanced soft-tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline. The NDA ...
Formal discussant of both trials, Jonathan Rosenberg, MD, of the Genitourinary Division at Memorial Sloan Kettering Cancer Center in New York, agreed that both studies move the field of antiangiogenesis in advanced bladder cancer forward. “The very high overall response rates in the pazopanib plus...
Two separate phase II studies lend support to the concept of antiangiogenesis in advanced bladder cancer. The combination of an antiangiogenic agent and chemotherapy may fulfill an unmet need in this disease, the studies suggest. Both studies were presented at the 2015 Genitourinary Cancers...
High-dose radiotherapy failed to improve overall survival at 7 years compared with standard-dose radiotherapy in men with stage II localized prostate cancer. However, the high-dose schedule had several advantages, including improved rates of local tumor control and distant metastasis, according to...
Docetaxel added to androgen-deprivation therapy did not improve overall survival over androgen-deprivation therapy alone in hormone-naive metastatic prostate cancer, according to an updated analysis of the GETUG-AFU 15 trial presented at the 2015 Genitourinary Cancers Symposium.1 In a retrospective ...
Emerging evidence suggests that immunotherapy may play an important role in treating prostate cancer. In particular, preliminary results have shown that combining a new vaccine with ipilimumab (Yervoy) boosts overall survival in men with castration-resistant prostate cancer.1 A study comparing...
I was disturbed by the article on “Radiotherapy in Good-Prognosis DLBCL” published recently in The ASCO Post.1 As a practicing radiation oncologist for 30 years, I have seen the evolution of radiation techniques (and philosophy) for non-Hodgkin lymphoma progress from regional—or even...
Patients with early-stage breast cancer still undergo imaging for distant metastases despite evidence-based local, national, and international guidelines—and a recommendation from ASCO—to avoid such imaging, according to a retrospective review of staging imaging for distant metastases in patients...
“Laparoscopic colectomy has been shown to have equivalent oncologic outcomes to open colectomy for the management of colon cancer, but its adoption nationally has been slow,” Heather Yeo, MD, of Memorial Sloan-Kettering Cancer Center in New York, and colleagues noted in reporting on a study...
In an important post hoc analysis (reviewed in this issue of The ASCO Post), Van Cutsem and colleagues have further refined our knowledge of who are the “right” patients with metastatic colorectal cancer to receive treatment with cetuximab (Erbitux).1 This refinement was accomplished through the...
The phase III CRYSTAL trial showed that the addition of cetuximab (Erbitux) to first-line FOLFIRI (fluorouracil, leucovorin, and irinotecan) significantly improved overall survival, progression-free survival, and objective response rates in patients with KRAS codon 12/13 (exon 2) wild-type...
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 March 4, 2015, the anti–programmed cell death protein 1 (PD-1) ...
The U.S. Food and Drug Administration (FDA) has approved Astellas’ New Drug Application for the use of isavuconazonium sulfate (Cresemba), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as...
Currently in myeloma, there are at least five new agents that are either approved or in the late-stage of development with impending approval. Major questions in the field relate to how we, as clinicians, will use these new agents and where they will fit in the overall treatment schema. The phase...
In a planned interim analysis of the phase III ASPIRE trial reported in The New England Journal of Medicine, A. Keith Stewart, MB, ChB, of the Mayo Clinic, Scottsdale, Arizona, and colleagues found that the addition of the proteasome inhibitor carfilzomib (Kyprolis) to lenalidomide...
The use of radiation therapy in the treatment of gastrointestinal cancer has evolved over the past several decades, in a gradual, stepwise fashion. Since most gastrointestinal cancers are diagnosed at a locally advanced stage, coupled with the inherent sensitivity of most parts of the...
Muscle-invasive bladder cancer can be a lethal disease despite curative intent local therapy, with 5-year survival that can be as low as 30% based on the extent of T status and/or lymph node involvement. The use of neoadjuvant chemotherapy with MVAC (methotrexate, vinblastine, doxorubicin, and...
In the European Organisation for Research and Treatment of Cancer (EORTC) 30994 trial, a phase III intergroup study reported in The Lancet Oncology,1 Cora N. Sternberg, MD, FACP, Chief of Medical Oncology at San Camillo and Forlanini Hospitals, Rome, and colleagues found no overall survival...
Anyone who has attended the major oncology meetings knows that research from clinical trials in breast cancer often dominates the stage, with countless abstracts featuring new and updated results. To help the readers of The ASCO Post stay up to date with the latest discoveries and findings...
Radiation Therapy Oncology Group (RTOG) 0617 was a study initially designed to address an important issue in radiation oncology regarding the treatment of stage III non–small cell lung cancer (NSCLC): Are outcomes improved with high-dose as opposed to standard-dose thoracic radiation therapy? The...
As reported in The Lancet Oncology by Jeffrey D. Bradley, MD, of Washington University, and colleagues, the phase III Radiation Therapy Oncology Group 0617 trial showed no survival benefit of high- vs standard-dose radiotherapy or addition of cetuximab (Erbitux) to concurrent...
Eric J. Small, MD, of the University of California at San Francisco, discussed what he thought went wrong for cabozantinib (Cometriq) in the COMET-1 trial, yet another example of a phase III trial that failed to deliver on the promise of phase II results. “Although this was a negative study,...
Final results of the phase III, randomized double-blind, controlled COMET-1 trial were disappointing. Although the oral tyrosine kinase inhibitor cabozantinib (Cometriq) improved several secondary endpoints compared with prednisone, including bone scan response and progression-free survival, the...
The addition of 6 months of androgen-deprivation therapy to radiation therapy as primary therapy for intermediate-risk prostate cancer improved biochemical control and disease-free survival but did not translate to an improvement in overall survival, in a phase III trial reported at the 2015...
The role of next-generation sequencing (high-throughput technologies that allow DNA and RNA to be analyzed more quickly and inexpensively than earlier techniques) in breast cancer remains unclear and at present is primarily a research tool. Therefore, clinicians should be cautious in using genetic...
The addition of trastuzumab (Herceptin) to adjuvant chemotherapy undoubtedly transformed HER2-positive breast cancer from one of the most deadly subtypes to a highly treatable disease. Randomized phase III trials established adjuvant trastuzumab as standard of care in HER2-positive breast...
Adjuvant therapy with sorafenib (Nexavar) or sunitinib (Sutent) failed to make any inroads in improving disease-free survival in patients with locally advanced kidney cancer in the randomized, placebo-controlled, multicenter, phase III Adjuvant Sorafenib and Sunitinib for Unfavorable Renal...
Nivolumab (Opdivo) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of lung cancer on March 4, 2015, before clinical data from the pivotal trials (CheckMate 017 and CheckMate 063) were presented at a major oncology conference or published in a peer-reviewed journal....
A phase II, open-label study evaluating the efficacy of brentuximab vedotin (Adcetris), an anti-CD antibody-drug conjugate, found that among 48 evaluable patients with CD30-positive diffuse large B-cell lymphoma (DLBCL), 21 (44%) had objective responses. These responses included 8 patients (17%)...
Docetaxel was being widely used by patients with metastatic prostate cancer before phase III evidence that it was more effective than the standard of care for patients with castration-resistant prostate cancer, according to an analysis of Medicare claims from before and after the trial results and...
The U.S. Food and Drug Administration (FDA) has accepted Amgen’s supplemental New Drug Application (sNDA) for carfilzomib (Kyprolis) injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is designed to support the conversion of ...
Michael E. Jung, PhD, Distinguished Professor of Chemistry and Biochemistry and Member at UCLA Jonsson Comprehensive Cancer Center; Charles Sawyers, MD, Human Oncology and Pathogenesis Program Director at Memorial Sloan Kettering Cancer Center; and Howard I. Scher, MD, Chief of the Genitourinary...
Aspirin has long proved to be a multipotent drug, with efficacy as a pain reliever, anti-inflammatory agent, antiplatelet agent, and cardioprotective agent. In the cancer world, a large literature has accumulated demonstrating its ability to prevent various epithelial malignancies, most notably...