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solid tumors
gynecologic cancers

Addition of Pazopanib to Paclitaxel in Persistent or Recurrent Ovarian Cancer

In a phase II trial reported in JAMA Oncology by Debra L. Richardson, MD, of Stephenson Cancer Center, Oklahoma University Health Science Center, and colleagues, the addition of pazopanib (Votrient) to paclitaxel did not improve progression-free survival among women with persistent or recurrent...

solid tumors

2018 ASCO: Pexidartinib in Tenosynovial Giant Cell Tumor

The phase III ENLIVEN study showed a statistically significant 39% overall response rate at week 25 based on central review of magnetic resonance imaging (MRI) scans using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (the primary endpoint) for patients treated with oral...

cns cancers

Genetic Counseling and Testing for Patients With Medulloblastoma

Researchers have identified six genes that predispose carriers to develop medulloblastoma and have used the discovery to craft genetic counseling and screening guidelines. The study was published by Waszak et al in The Lancet Oncology. St. Jude Children’s Research Hospital,...

hematologic malignancies
leukemia

Nilotinib Label Updated to Provide Treatment Discontinuation Recommendations for CML With Sustained Molecular Response

On December 22, 2017, the product label for nilotinib (Tasigna) was updated to include information on nilotinib discontinuation, postdiscontinuation monitoring, and guidance for treatment reinitiation in patients with Philadelphia chromosome (Ph)-positive chronic myeloid leukemia (CML) who have...

hepatobiliary cancer

Future Looks Brighter for Treatment of Cholangiocarcinoma

THE INCIDENCE of cholangiocarcinoma is rising, and effective therapies are urgently needed. Several classes of experimental molecularly targeted agents might meet this challenge, according to Robin Kate Kelley, MD, Associate Professor of Medical Oncology and leader of the clinical trials program in ...

issues in oncology

Actively Recruiting Clinical Trials Focused on Cancer Prevention

The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on preventing cancer. These studies are investigating a multitude of methods, including educational interventions; imaging devices; dietary changes/supplements; weight management;...

colorectal cancer

Modified XELIRI vs FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer

In an Asian phase III noninferiority trial (AXEPT) reported in The Lancet Oncology, Xu et al found that modified XELIRI (mXELIRI, capecitabine plus irinotecan) was noninferior in overall survival vs standard FOLFIRI (leucovorin, fluorouracil, and irinotecan), both given with or without bevacizumab...

gynecologic cancers

Addition of Pazopanib to Paclitaxel in Persistent or Recurrent Ovarian Cancer

In a phase II trial reported in JAMA Oncology by Debra L. Richardson, MD, of Stephenson Cancer Center, Oklahoma University Health Science Center, and colleagues, the addition of pazopanib (Votrient) to paclitaxel did not improve progression-free survival among women with persistent or recurrent...

multiple myeloma
immunotherapy

Unique CAR T-Cell Construct Studied in Multiple Myeloma

CD19-DIRECTED chimeric antigen receptor (CAR) T-cell therapy has been approved by the U.S. Food and Drug Administration for the treatment of leukemia (tisagenlecleucel [Kymriah]) and lymphoma (axicabtagene ciloleucel [Yescarta]), but another type of CAR T-cell therapy is generating interest as a...

hepatobiliary cancer

Radioembolization vs Sorafenib in Asia-Pacific Patients With Hepatocellular Carcinoma

In an investigator-initiated phase III SIRveNIB trial in Asia-Pacific patients reported in the Journal of Clinical Oncology, Chow et al found no difference in overall survival with selective internal radiation therapy, or radioembolization, vs sorafenib (Nexavar) in patients with unresectable...

kidney cancer

Cabozantinib in Advanced Renal Cell Carcinoma

ON DECEMBER 19, 2017, cabozantinib (Cabometyx) was granted regular approval for the treatment of advanced renal cell carcinoma.1,2 Cabozantinib was initially granted approval in 2016 for the treatment of patients with advanced renal cell carcinoma who had received prior antiangiogenic therapy. The...

hepatobiliary cancer

In Unresectable Liver Cancer, Progression-Free Survival Doubled When Sorafenib Added to TACE

SORAFENIB (Nexavar) added to transarterial chemoembolization (TACE) doubled the median progression-free survival over TACE alone in patients with unresectable hepatocellular carcinoma, Japanese investigators reported at the 2018 Gastrointestinal Cancers Symposium.1 The results of the randomized,...

hematologic malignancies

Novel PI3Kδ Inhibitor in Relapsed or Refractory Hematologic Malignancies

In a phase I trial reported in The Lancet Oncology, Burris et al determined the phase II dose of the next-generation PI3Kδ inhibitor umbralisib and found evidence of the agent’s activity in relapsed or refractory hematologic malignancies. Umbralisib exhibits improved PI3K isoform...

issues in oncology

Genomic Analyses Highlight Need for Precision Therapies That Target Pediatric Cancers

Researchers have determined that children and adults with cancer often have different mutated genes driving their disease, which suggests they would likely benefit from different therapies. The finding, from a collaborative study led by St. Jude Children’s Research Hospital and published by...

CancerCare Raises Nearly $665,000 to Support Patients With Cancer Affected by Hurricanes

SINCE SEPTEMBER 2017, the national nonprofit organization CancerCare has raised nearly $665,000 to provide direct financial assistance for people with cancer who have been impacted by hurricanes. The majority of this support has been allocated to people with cancer in Puerto Rico, many of whom are...

breast cancer
immunotherapy

Neoadjuvant Trastuzumab Biosimilar vs Trastuzumab in HER2-Positive Early Breast Cancer

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...

kidney cancer
immunotherapy

2018 GU CANCERS SYMPOSIUM: Early-Phase Trial of Glutaminase Inhibitor CB-839 in Combination With Cabozantinib or Everolimus in Renal Cell Carcinoma

Data on CB-839, a first-in-class glutaminase inhibitor, will be presented by Tannir et al at the 2018 Genitourinary Cancers Symposium in San Francisco (Abstract 603). The data are from the CX-839-001 study, which includes cohorts evaluating the safety, efficacy and recommended phase II dose of ...

symptom management

Safety Information on Rolapitant Injectable Emulsion

The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) is informing health-care providers about new safety information for rolapitant (Varubi) injectable emulsion, a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and...

gynecologic cancers

Addition of Pazopanib to Paclitaxel in Persistent or Recurrent Ovarian Cancer

In a phase II trial reported in JAMA Oncology, Richardson et al found that the addition of pazopanib to paclitaxel did not improve progression-free survival among women with persistent or recurrent ovarian cancer. Study Details In the double-blind study, 106 women from 26 U.S. study sites with...

kidney cancer

Activity of Hypoxia-Inducible Factor-2α Antagonist in Advanced Renal Cell Carcinoma

In a phase I trial reported in the Journal of Clinical Oncology, Courtney et al found that a first-in-class hypoxia-inducible factor-2α (HIF-2α) antagonist (PT2385) was active in patients with previously treated advanced clear cell renal cell carcinoma (RCC). Study Details In the...

solid tumors
gynecologic cancers

Olaparib Tablets for Maintenance Treatment in Ovarian Cancer

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...

issues in oncology

Informed Consent and the Oncologist: Legal Duties to Discuss Costs of Treatment

For 50 years, clinicians in the United States have had a legal duty to disclose to patients with cancer the risks, benefits, and alternatives to a proposed cancer treatment. Until recently, however, it has been unclear whether clinicians have a similar duty to discuss the costs of that treatment....

Journal of Clinical Oncology Literature Update

STAYING UP-TO-DATE in the fast-paced world of oncology literature is a daunting task at best. To assist with that task, The ASCO Post has assembled an assortment of studies recently published in the Journal of Clinical Oncology.  Sorafenib Dosing and Outcomes in Hepatocellular Cancer  IN A...

breast cancer

ASTRO 2017: Accelerated Breast Radiation Therapy Following Mastectomy Can Shorten Treatment Time While Maintaining Tumor Control

Radiation therapy following mastectomy for intermediate-stage, high-risk breast cancer can be shortened from 5 to 3 weeks while maintaining tumor control rates in the breast and surrounding region that are equivalent to conventional treatment, according to research presented by Sun et al at the...

kidney cancer

Adjuvant Therapy for Localized or Locally Advanced Renal Cell Carcinoma

As reported in the Journal of Clinical Oncology by Motzer et al, the phase III PROTECT trial showed no significant disease-free survival benefit for adjuvant pazopanib at 600 mg vs placebo after nephrectomy in patients with localized or locally advanced renal cell carcinoma at high risk of relapse. ...

hepatobiliary cancer

Does Reducing the Starting Dose of Sorafenib Affect Outcomes in Hepatocellular Carcinoma?

In a retrospective study reported in the Journal of Clinical Oncology, Reiss et al found that reducing the starting dose of sorafenib (Nexavar) was associated with noninferior overall survival, reduced cost, and lower risk of discontinuing treatment in patients with advanced hepatocellular...

prostate cancer

Clinical Trials Actively Recruiting Patients With Prostate Cancer

THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on patients with prostate cancer. These studies highlight noninvasive imaging, gene therapy, allogeneic bone marrow transplant, selective androgen receptor modulators, Vitamin D3...

ASCO Publishes Resources for Cancer Care Providers and Patients Affected by Hurricane Harvey

In the aftermath of the devastation caused by Hurricane Harvey throughout the state of Texas, which has resulted in more than 30,000 people being displaced from their homes, ASCO has published a list of resources and information for oncology providers and patients with cancer affected by the...

genomics/genetics

Identifying Genetic Basis for Extraordinary Clinical Responses May Accelerate Development of New Therapies

Accelerating the discovery of targeted cancer therapies requires defining the targets present in individual tumors, and there are two main ways to do this, David B. Solit, MD, told participants at the inaugural OncoSET Symposium: Emerging Approaches to Precision Medicine in Chicago.1 The...

National Cancer Institute Awards Fred Hutch $24 Million for Contact Center

THE NATIONAL CANCER INSTITUTE (NCI) has awarded $24 million to Fred Hutchinson Cancer Research Center (Fred Hutch) to continue operating the NCI’s primary public access point for cancer information in both English and Spanish. With the new contract, the Contact Center will emphasize clinical trial ...

leukemia
lymphoma

ICML 2017: Triplet Combination of Umbralisib, Ublituximab, and Ibrutinib in CLL/SLL/NHL

Data from the chemotherapy-free triple combination of umbralisib, an oral, next generation PI3K delta inhibitor; ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody; and ibrutinib (Imbruvica) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and...

gastroesophageal cancer

High-Dose First-Line Trastuzumab Maintenance in Metastatic HER2-Positive Gastric Cancer

As reported in the Journal of Clinical Oncology by Shah et al, the phase IIIB HELOISE trial has shown no survival benefit of high-dose vs standard trastuzumab (Herceptin) maintenance plus chemotherapy in the first-line treatment of metastatic gastric or gastroesophageal junction adenocarcinoma....

skin cancer

New Immunotherapy Combinations Gain Ground in Advanced Melanoma, but Results Preliminary

Attention is focused among the cancer community on identifying the optimal immunotherapy combinations, with more than 800 ongoing trials of combination therapy. Two studies presented at the 2017 Annual Meeting of the American Association for Cancer Research (AACR) reported promising preliminary...

solid tumors

Selected Clinical Trials of CDK4/6 Inhibitors

This Clinical Trials Resource Guide includes a selection of actively recruiting clinical trials of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, including palbociclib, ribociclib, and abemaciclib in multiple tumor types. All of the studies here and many others are listed on the National...

bladder cancer

Second-Line Pazopanib vs Weekly Paclitaxel in Relapsed or Progressive Urothelial Cancer

A UK phase II trial comparing pazopanib (Votrient) with paclitaxel after failure of platinum-based therapy in patients with locally advanced or metastatic urothelial carcinoma was stopped early due to futility. These results were reported by Jones et al in the Journal of Clinical Oncology. Two...

gastrointestinal cancer

10-Year Outcomes With Two Dose Levels of Imatinib in Unresectable or Metastatic GIST

Casali et al have reported 10-year progression-free and overall survival rates among patients with locally advanced unresectable or metastatic gastrointestinal stromal tumors (GISTs) receiving imatinib at 400 or 800 mg/d in the phase III European Organisation for Research and Treatment of Cancer,...

kidney cancer

Analysis of High-Risk Subgroup in ASSURE Trial of Sunitinib or Sorafenib in Renal Cell Carcinoma

In an analysis of the phase III ASSURE trial reported in JAMA Oncology, Haas et al found no disease-free or overall survival benefit of adjuvant sunitinib (Sutent) or sorafenib (Nexavar) vs placebo in a high-risk subset of patients with clear cell renal cell carcinoma histology and pT3, pT4, or...

prostate cancer

Antisense Oligonucleotide Custirsen Combined With Docetaxel and Prednisone in Metastatic Prostate Cancer

In the phase III SYNERGY trial reported in The Lancet Oncology, Chi et al found that the addition of the second-generation antisense oligonucleotide custirsen to docetaxel and prednisone did not improve overall survival in patients with metastatic castration-resistant prostate cancer. Custirsen...

IASLC Statement Regarding Philip Morris’ Smoke-Free Future

On February 1, 2017, the International Association for the Study of Lung Cancer (IASLC) issued the following statement: According to its own public reports, in 2016 Phillip Morris manufactured 800 billion cigarettes. Thus, [IASLC] views with some skepticism Philip Morris’ recent statement...

solid tumors

Can Histone Deacetylase Inhibitors Reverse Resistance to Angiogenesis Inhibitors?

In a phase I study reported in the Journal of Clinical Oncology, Aggarwal et al found evidence that the histone deacetylase (HDAC) inhibitor abexinostat may act to reverse resistance to the vascular endothelial growth factor (VEGF) inhibitor pazopanib (Votrient) via epigenetic modulation of VEGF in ...

pain management

Clinical Trials Actively Recruiting Patients With Cancer-Related Pain

Phase I Study Title: Qigong Mind-Body Exercise for Persistent Post-Surgical Pain in Breast Cancer Survivors: A Pilot Study Study Type: Phase I/interventional/single-group assignment Study Sponsor and Collaborators: Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Spaulding...

lung cancer

IASLC Statement on Philip Morris’ New Manifesto Highlights the Importance of Tobacco Control

On February 1, 2017, the International Association for the Study of Lung Cancer (IASLC) issued the following statement: “According to its own public reports, in 2016 Phillip Morris manufactured 800 billion cigarettes. Thus, [IASLC] views with some skepticism Philip Morris’ recent...

lymphoma

Venetoclax Studied in Relapsed or Refractory Non-Hodgkin Lymphoma

The BCL-2 inhibitor venetoclax (Venclexta) was found to be active in patients with relapsed or refractory non-Hodgkin lymphoma (NHL), according to a phase I study reported by Davids et al in the Journal of Clinical Oncology. Further study of this agent, including in combination therapy to augment...

geriatric oncology

Falls in Older Patients With Cancer: Recognizing and Reducing the Risk

In older patients, a current or previous cancer diagnosis confers a 15% to 20% greater risk of suffering a fall.1 Defined as an “unexpected event in which the participant comes to rest on the ground, floor, or lower level,” a fall occurs in 30% to 50% of cancer patients 65 years of age or...

cns cancers

Approval of Dinutuximab for High-Risk Neuroblastoma: Lessons Learned in Expediting the Development of Pediatric Cancer Drugs

On March 10, 2015, the U.S. Food and Drug Administration (FDA) granted regular approval to dinutuximab (formerly known as chimeric 14.18 antibody; Unituxin) for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid...

breast cancer

Treatment of Early HER2-Positive Breast Cancer: One Size Does Not Fit All

Despite the routine use of HER2 blockade in early HER2-positive breast cancer, clinicians can always benefit from a refresher on key treatment considerations. Clinical pearls and controversial issues were the topic of a presentation at the 14th Annual School of Breast Oncology at Emory University, ...

MD Anderson Cancer Center Marks 75 Years of Research to End Cancer

In November, The University of Texas MD Anderson Cancer Center celebrated its 75th anniversary with a week-long series of events that raised nearly $15 million to support its efforts in patient care and in the investigation and treatment of cancer. Housed on 16 million square feet in the city of...

leukemia
lymphoma

ASH 2016: Ibrutinib and TGR-1202 Combination Yields Encouraging Results in Patients With Relapsed Forms of Leukemia or Lymphoma

A combination of two targeted agents has demonstrated safety as well as encouraging signs of effectiveness in a phase I clinical trial in patients with relapsed or hard-to-treat chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL). Davids et al reported the findings at the 58th American ...

issues in oncology

Study Finds EXITS Gene Mutations May Contribute to Cancer Sex Bias

According to Surveillance, Epidemiology, and end Results (SEER) data from 2008 to 2012, American males have an excess risk of 20.4% of developing any cancer compared with females, and there is a ≥ 2:1 male predominance for some individual cancers. This excess risk results in approximately...

leukemia

Venetoclax Monotherapy Safe and Clinically Active in Acute Myelogenous Leukemia

A phase II study has found venetoclax (Venclexta) to be clinically active in patients with high-risk relapsed/refractory acute myelogenous leukemia (AML) or those unfit for intensive chemotherapy, with an overall response rate of 19% and a tolerable safety profile. The study results, which were...

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