In a study of National Cancer Database data reported in the Journal of Clinical Oncology, Francis et al found that receipt of adjuvant chemotherapy before vs concurrently with radiotherapy was associated with improved survival in patients with non–small cell lung cancer (NSCLC) found to have...
As reported by Scott J. Antonia, MD, PhD, of the H. Lee Moffitt Cancer Center and Research Institute, and colleagues in The New England Journal of Medicine, an interim analysis of the phase III -PACIFIC trial showed improved progression-free survival with the programmed cell death protein 1 (PD-1) ...
As reported by Scott J. Antonia, MD, PhD, of the H. Lee Moffitt Cancer Center and Research Institute, and colleagues in The New England Journal of Medicine, an interim analysis of the phase III -PACIFIC trial showed improved progression-free survival with the programmed cell death protein 1 (PD-1)...
On November 6, 2017, alectinib (Alecensa) received regular approval for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration–approved test.1,2 Supporting Efficacy Data Approval was...
Combinations of targeted therapies (triple, quadruple, or even more) are part of the future of cancer treatment, which means that traditional clinical trials will have to be streamlined and updated to enable greater flexibility and to extract adequate safety and efficacy data. Problems inherent in...
As researchers learn more about the natural history of cancers, as more drugs are effective for more types of the disease, and as the number and complexity of combination therapies increase, the more important it is that new drugs and permutations of old ones be available to patients. The U.S. Food ...
In 1996, Jimmie C. Holland, MD, the Wayne E. Chapman Chair in Psychiatric Oncology at Memorial Sloan Kettering Cancer Center (MSK) in New York, decided to launch the cancer center’s Lung Cancer Survivorship Program after she had a startling encounter with a patient. “The woman said to me, ‘Would...
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, Jun J. Mao, MD, MSCE, and Jyothirmai Gubili, MS, explore the role of St....
ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study has expanded four cohorts for enrollment of additional participants and continues to grow, with more than 500 participants and 16 therapies now available. The TAPUR Study is designed to identify signals of activity of...
On November 16, 2017, obinutuzumab (Gazyva) was granted regular approval in combination with chemotherapy, followed by obinutuzumab monotherapy for patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular...
According to the Centers for Disease Control and Prevention (CDC), from 1999 to 2015, more than 183,000 people have died in the United States from overdoses related to prescription opioids, including methadone, oxycodone, and hydrocodone.1 To stem the epidemic in prescription opioid–related use and ...
PREMENOPAUSAL WOMEN with hormone receptor–positive, HER2-negative advanced breast cancer benefited substantially from the addition of ribociclib (Kisqali) to first-line endocrine therapy plus medical ovarian suppression, according to results from the MONALEESA-7 study.1 At the 2017 San Antonio...
POSITIVE DATA about chimeric antigen receptor (CAR) T-cell therapy in lymphoma continue to accrue. Long-term follow-up of the pivotal ZUMA-1 trial shows that patients with refractory diffuse large B-cell lymphoma (DLBCL) continue to have durable responses to the CD19-directed CAR T-cell therapy...
On December 19, the Institute for Clinical and Economic Review (ICER) released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta). The draft report, along with draft voting...
On December 18, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for the use of osimertinib (Tagrisso)—a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central...
Ulixertinib (BVD-523) is an ERK1/2 kinase inhibitor with potent preclinical activity in BRAF- and RAS-mutant cell lines. Now, a multicenter phase I study investigating its safety and efficacy in the treatment of patients with advanced solid tumors has found that ulixertinib to have an acceptable...
At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Wang et al presented results from the open-label, single-arm phase II ACE-LY-004 clinical trial, which served as the basis for the recent U.S. Food and Drug Administration (FDA) accelerated approval of acalabrutinib...
According to research by the American Cancer Society, lung cancer is the second most common cancer in men and women in the United States and is the leading cause of cancer-related death. In addition, among all populations, African Americans tend to have the highest lung cancer incidence and...
Andrew D. Zelenetz, MD, PhD, of Memorial Sloan Kettering Cancer Center, and Sattva S. Neelapu, MD, of The University of Texas MD Anderson Cancer Center, discuss long-term study findings on axicabtagene ciloleucel in patients with refractory aggressive non-Hodgkin lymphoma (Abstract 578).
Six months after receiving a single dose of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy that targets CD-19, high response rates persist among adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), according to findings reported by Schuster et al at...
Among 108 patients with fast-growing and refractory aggressive non-Hodgkin lymphoma (NHL), more than half were still alive at least a year after receiving a single infusion of a CAR T-cell therapy called axicabtagene ciloleucel that targets the CD-19 protein frequently found on cancerous lymphoma...
Phase III ASPIRE Trial of Carfilzomib in Relapsed Multiple Myeloma Overall survival results from the phase III ASPIRE trial will be detailed for the first time in an oral presentation by Stewart et al on Monday, December 11. The addition of carfilzomib to lenalidomide and...
On November 30, the U.S. Food and Drug Administration (FDA) approved CDx (F1CDx), a breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The Centers for Medicare &...
The UK IMPORT LOW phase III trial has shown noninferiority in local relapse for partial-breast and reduced-dose vs standard whole-breast radiotherapy after breast-conserving surgery in early breast cancer. These study results were reported by Charlotte E. Coles, PhD, of the University of...
The discovery of my non–small cell lung cancer (NCSLC) in 2005 was serendipitous and completely unexpected. A never smoker and physically active my whole life, the only hint something might be amiss was a slight tickle in my throat, which I’m not even sure was related to my cancer diagnosis. In...
Chimeric antigen receptor (CAR) T-cell therapy burst upon the scene as an innovative approach to the treatment of hematologic malignancies, mainly for patients who have exhausted all other treatment options. Recently two CAR T-cell products were approved by the U.S. Food and Drug Administration...
On August 17, 2017, olaparib -(Lynparza) in tablet form was granted regular approval for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.1,2 Olaparib...
Cisplatin-based combination chemotherapy is the preferred first-line therapy for metastatic urothelial cancer and the only treatment shown to improve survival in patients with previously untreated disease for many years. This chemotherapy also has proven to be beneficial in the neoadjuvant and...
Ipilimumab (Yervoy) is a fully human monoclonal antibody that inhibits cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) and was the first checkpoint inhibitor approved after showing survival benefit in metastatic melanoma.1 Indeed, in the first-line setting for metastatic melanoma, ipilimumab ...
The roadside along the path to curing follicular lymphoma is riddled with the debris of failed cytotoxic regimens. For decades, clinical trials unsuccessfully pitted various chemotherapy combinations against each other. It took but a single, noncytotoxic molecule, rituximab (Rituxan), to forever...
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 November 6, 2017, vemurafenib (Zelboraf) was granted...
Obesity has been established as a strong risk factor for the development of cancer. African Americans and Hispanics are particularly at risk, and their access to health care is often poor. How do racial and ethnic disparities in the development of obesity as well as access to care intersect to...
Cancer may be a disease of aging, but data suggest that older patients with cancer are undertreated, especially with respect to chemotherapy. One analysis showed that approximately 40% of patients in their 70s—and 60% of patients in their 80s—do not receive adjuvant therapy after surgery for colon...
Formal discussant of this trial, Michael Boyer, MBBS, PhD, a medical oncologist at Sydney Cancer Centre, Royal Prince Alfred Hospital, Camperdown, Australia, was enthusiastic about these results, with the caveat that overall survival data are needed. “Unresectable stage III non–small cell lung...
The PACIFIC study showed that the addition of the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) following chemoradiotherapy for patients with unresectable stage III non–small cell lung cancer (NSCLC) dramatically improved progression-free survival compared with placebo....
With the recent U.S. Food and Drug Administration (FDA) approvals of two chimeric antigen receptor (CAR) T-cell products, this novel approach seems to be moving into the mainstream. The approvals were tisagenlecleucel (also known as CTL019; Kymriah) for the treatment of pediatric B-cell acute...
Over the past 15 years, multiple myeloma has garnered among the highest number of regulatory approvals by the U.S. Food and Drug Administration (FDA) for the management of all phases of the disease. This fast-expanding repertoire of treatment options has pushed the median survival of multiple...
Increasing the dose intensity of chemotherapy—by either shortening the intervals between the cycles or by sequential administration instead of concurrent administration of the drugs—reduced the risk of early-stage breast cancer recurrence and death compared with standard chemotherapy...
Patients with human immunodeficiency virus (HIV) who are treated with combination antiretroviral therapy (cART) can safely undergo chemotherapy to treat associated lymphomas at the same time, researchers from the AIDS Malignancy Consortium have found. These findings were published by Tan et al in...
As reported in The Lancet Oncology by Herbst et al, the phase III SWOG S0819 trial showed no overall benefit of adding cetuximab (Erbitux) to carboplatin/paclitaxel both with and without bevacizumab (Avastin) in patients with previously untreated stage IV non–small cell lung cancer (NSCLC). A ...
On November 30, the U.S. Food and Drug Administration (FDA) approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The ...
Compared with the non-Hispanic white (NHW) population, the urban American Indian and Alaskan Native (AIAN) community was more likely to have lower survival rates following invasive prostate and breast cancer, according to a new study by Emerson et al in Cancer Research. “It’s been...
As reported in The New England Journal of Medicine by Soria et al, the phase III FLAURA trial has shown a significant progression-free survival benefit with the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) osimertinib (Tagrisso) vs standard EGFR TKIs in...
The phase III E1505 trial has shown no benefit of adding bevacizumab (Avastin) to adjuvant therapy in early-stage resected non–small cell lung cancer (NSCLC). These results were reported by Wakelee et al in The Lancet Oncology. Study Details In the open-label trial, 1,501 patients from...
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) approved a number of novel drugs and new indications in November 2017. Several of them are listed here. Fulvestrant/Abemaciclib Combination in Breast Cancer ON NOVEMBER 15 , the FDA approved fulvestrant (Faslodex) in combination with abemaciclib...
ON SEPTEMBER 22, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of hepatocellular carcinoma in patients previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS based on findings in a 154-patient subgroup of the CheckMate 040 trial consisting...
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 clonal myeloid disorders, acute lymphoblastic leukemia, lymphoma, and plasma cell dyscrasias. Clonal Myeloid Disorders STUDY:...
Even with equivalent access to care, black patients with breast cancer may fare worse than white patients with breast cancer, according to Lawrence H. Kushi, ScD, Director of Scientific Policy at the Kaiser Permanente Northern California Division of Research in Oakland. “Accounting for...
Staying up-to-date with peer-reviewed oncology literature is a daunting task. To assist readers, The ASCO Post has summarized a number of studies recently published in the Journal of Oncology Practice (JOP) and the Journal of Clinical Oncology (JCO). Survival as Quality Metric in Cancer Care In a...
As reviewed in this issue of The ASCO Post, Losk and colleagues from Dana-Farber/Brigham and Women’s Cancer Center report their institution’s implementation of a protocol of surgeon-initiated genomic profiling of estrogen receptor–positive tumors in women with early breast cancer that resulted in ...