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issues in oncology

Second Annual JADPRO Live Conference Attracts 400 Advanced Practitioners in Oncology From Across the Nation

The second annual JADPRO Live: Transforming Oncology Practice was held October 30 to November 2 in Orlando, Florida. The conference drew nearly 400 nurse practitioners, physician assistants, clinical nurse specialists, advanced-degree nurses, hematology/oncology nurses, pharmacists, and...

leukemia

FDA Grants Breakthrough Therapy Designation to Investigational CAR T-Cell Therapy

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to JCAR015, an investigational chimeric antigen receptor therapy developed by Juno Therapeutics. The designation applies for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia and was...

health-care policy

Policy Issues in Molecularly Targeted Therapy: The Science, the Money, the Applications

In the past decade, much new knowledge about the molecular underpinnings of cancer has accumulated, and the array of molecular aberrations in each individual tumor can be assessed through genomic sequencing and other tests. The rationale for and feasibility of developing molecularly targeted...

solid tumors

Immune-Suppressing Protein in Noncancerous Cells of Cancer Patients Offers Clue to Drug Response

A multicenter phase I study using an investigational immune therapy drug has found that the presence of the immune-suppressing protein PD-L1 in noncancerous immune cells can predict how patients with different types of advanced cancer will respond to treatment.  The study, led by a Yale Cancer...

leukemia

Racing Against Acute Lymphoblastic Leukemia: CTL019 Is a Fast CAR With Sustained Endurance

The long-term outcome for patients with relapsed or refractory acute lymphoblastic leukemia (ALL) is poor, with 5-year overall survival from first relapse being only approximately 10%.1,2 Patients with disease relapse following allogeneic transplant have the worse prognosis and are typically...

lung cancer

Moving a Mountain: Crizotinib in ROS1-Rearranged NSCLC

It was thousands of years ago in China. An elderly man was unhappy with the mountain that embraced his seaside village. He would need to walk for hours before he could reach the nearest town. So, as the old fable goes, he set his mind to move the mountain. Every day, he dug up basketfuls of rocks...

lung cancer

Crizotinib Is Highly Active in ROS1-Rearranged NSCLC

Crizotinib (Xalkori) produced a high response rate and durable responses in patients with ROS1-rearranged non–small cell lung cancer (NSCLC), according to a study reported in The New England Journal of Medicine.1 Lead authors Alice T. Shaw, MD, PhD, of Massachusetts General Hospital Cancer Center,...

survivorship

ASCO Clinical Expert Statement on Cancer Survivorship Care Planning

Efforts at implementing survivorship care plans have met with limited success in oncology practice, in part due to the time required to complete them, the lack of role clarity, and the lack of reimbursement for time to complete the documents. In response, ASCO convened a Survivorship Care Planning...

lung cancer

Lung Cancer: Next Frontier for Immunotherapy

Immune checkpoint inhibitors, particularly PD-1 (programmed cell death-1) and PD-L1 (programmed death-ligand 1) inhibitors, are being studied extensively in lung cancer. These agents, alone and in combination, appear to have the potential to change the management of non–small cell lung cancer...

skin cancer

New Serologic Assay May Help Predict Recurrences in Merkel Cell Carcinoma

A new and inexpensive serologic assay may help to predict recurrences of Merkel cell carcinoma, according to Paul Nghiem, MD, PhD, the Michael Piepkorn Endowed Chair in Dermatology Research at the University of Washington, Seattle, who helped develop the test.1 Dr. Nghiem and other experts in...

lung cancer

Revisiting Successes in Advanced NSCLC to Test Value in Earlier-Stage Disease

Some pretty good evidence suggests that chemotherapy that works in advanced disease probably works even better in early-stage disease,” said Fadlo R. Khuri, MD, Chair, Department of Hematology and Medical Oncology at Winship Cancer Institute in Atlanta, in summarizing results from ­trials of...

lung cancer

Lung Cancer Expert Offers Recommendations for Treating Toxicities Associated With Targeted Therapies

Clearly life as a thoracic oncologist has changed. Our paradigm for giving one-size-fits-all chemotherapy seems a bit dated, as we now are learning that there are multiple targets that we can treat effectively with the right drugs,” Jyoti D. Patel, MD, Associate Professor of Medicine at...

leukemia

Transplants for AML in First Remission: A Great Leap Forward, Sideways, or Backward?

“All great truths begin as blasphemies.” —George Bernard Shaw (Annajanksa, 1918)   Until about 15 years ago, persons with acute myelogenous leukemia (AML) were considered candidates to receive a blood cell or bone marrow allotransplant in first remission only if they had had an HLA-identical...

breast cancer
gynecologic cancers

Study Finds Whole-Genome Sequencing Is Successful in Identifying Patients’ Risk for Inherited Cancers

A study by researchers at The University of Texas Southwestern Medical Center in Dallas and The Ohio State University in Columbus of whole-genome sequencing on patients found to have BRCA1 or BRCA2 mutations as well as on those who were not carriers of a BRCA1/2 mutation has found cancer risk of...

hematologic malignancies

Will Checkpoint Inhibitors Be Winners in Hematologic Cancers, Too?

A  “Featured Topic” session during the 56th American Society of Hematology (ASH) Annual Meeting and Exposition drew a standing-room-only crowd to hear two experts weigh in on checkpoint blockade in hematologic malignancies. While new to hematology, these drugs—the cytotoxic T-lymphocyte–associated...

leukemia

Blinatumomab Achieves Complete Molecular Responses in Majority of B-Cell Leukemia Patients

Results from the international phase II BLAST study show that one cycle of blinatumomab (Blincyto) immunotherapy achieved complete minimal residual disease response in 78% of patients with acute lymphoblastic leukemia.1 Complete minimal residual disease response was achieved in 80% of patients...

leukemia

Venetoclax Gaining Ground in Two Types of Leukemia

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...

lung cancer

Crizotinib in ROS1-Positive NSCLC: A Next Step Forward

Advances in the molecular characterization of non–small cell lung cancer (NSCLC) have led to the identification of molecularly defined distinct subsets of patients who derive benefit from targeted therapies. Currently, two such groups of agents have moved widely into clinical practice: epidermal...

issues in oncology

Top 10 Myths About FDA’s Office of Hematology and Oncology Products

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, FDA oncologists Gideon Blumenthal, MD, and Tatiana Prowell, MD, discuss 10 common myths about FDA’s Office of Hematology and Oncology ...

solid tumors
hematologic malignancies

FDA Drug Approvals 2014

Nivolumab (Opdivo), a monoclonal antibody, was approved for treatment of metastatic melanoma.  Approved December 22, 2014. Olaparib (Lynparza), a poly (ADP-ribose) polymerase (PARP) inhibitor, was approved for treatment of BRCA-mutated advanced ovarian cancer. Approved December 19, 2014....

lung cancer

Top 10 Lessons Learned So Far About Treating Lung Cancer With Immunotherapy

Immunotherapy agents “really work” in treating lung cancer, but they have unique toxicities, are challenging to combine with other therapies, and questions remain about dose and duration, Roy S. Herbst, MD, PhD, stated at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology. “There are ...

lung cancer

‘Clinically Meaningful Improvements’ in Survival for Patients With NSCLC When Veliparib Is Added to Carboplatin and Paclitaxel

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...

lung cancer

Significant Improvement in Progression-Free Survival Using Sunitinib as Switch Maintenance in Advanced NSCLC

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...

breast cancer

Fulvestrant Surpasses Anastrozole in First-Line Treatment of Metastatic Breast Cancer

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...

lung cancer

FDA Approves Ramucirumab Combination for Non–Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) for use in combination with docetaxel for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK mutations ...

breast cancer

Neoadjuvant Therapy in Triple-Negative Breast Cancer: Impact of Subtype

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...

Friends of Cancer Research Holds Annual Conference on Clinical Cancer Research

Friends of Cancer Research, in conjunction with the Engelberg Center for Health Care Reform at Brookings, recently held the seventh annual Conference on Clinical Cancer Research in Washington, DC. The panels that comprised the daylong meeting discussed a future that has already begun. The most...

lung cancer

Ramucirumab in Metastatic Non–Small Cell Lung Cancer

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 ...

lymphoma

FDA Expands Approved Use of Ibrutinib for Waldenström’s Macroglobulinemia

The U.S. Food and Drug Administration (FDA) today expanded the approved use of ibrutinib (Imbruvica) for patients with Waldenström’s macroglobulinemia, a rare, indolent type of B-cell lymphoma. Ibrutinib is the first therapy indicated specifically for Waldenström’s macroglobulinemia and previously...

leukemia

CAR T Cells Impressive in Acute Lymphocytic Leukemia

As more experience is gained with the use of genetically engineered chimeric antigen receptor (CAR) T cells in patients with leukemia, the data continue to be highly encouraging. Three different groups using slightly different modifications of CAR T cells reported positive experiences in treating...

lung cancer

First-Line Crizotinib Superior to Pemetrexed‑Plus‑Platinum Chemotherapy in Patients With ALK‑Positive NSCLC

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...

Funding Promising Women Researchers: Women Who Conquer Cancer

Tomorrow’s cancer breakthroughs depend on making sure that talented young researchers have the chance to succeed today. Providing early funding for women in clinical oncology research is the singular goal of Women Who Conquer Cancer, a meaningful program of the ASCO-affiliated Conquer Cancer...

Conquer Cancer Foundation Researchers Lead Six Key Studies Featured in Clinical Cancer Advances 2015

Six of the studies featured in the recently released Clinical Cancer Advances 2015: ASCO’s Annual Report on Progress Against Cancer were led by researchers that whom Conquer Cancer Foundation (CCF) funded early in their careers through its signature Young Investigator Award (YIA) and Career...

New Product May Help to Reduce Non-Compliance

A novel product created to help reduce medication non-adherence was recently recognized by the 2014 Pharma Choice Awards as the top innovative branded technology. The product, called “remind-a-cap” is a customizable and patented pill bottle cap with an ergonomic dial to set for next dosing. The cap ...

Expert Point of View: George Sledge, MD

Discussion of the TNT trial was brisk at the 2014 San Antonio Breast Cancer Symposium. George Sledge, MD, Professor of Medicine and Chief of Oncology at Stanford University School of Medicine, Palo Alto, California, called the study “intriguing” and commented: “The platinum results, I believe, are...

breast cancer

TNT Trial Supports Platinums in BRCA-Mutated Breast Cancer

The TNT trial, presented at the 2014 San Antonio Breast Cancer Symposium, provided no evidence that unselected advanced triple-negative breast cancer patients are more likely to respond to carboplatin than to docetaxel.1 However, patients with BRCA1/2 mutations do have a greater response and a...

lymphoma

Tailoring Therapy for Diffuse Large B-Cell Lymphoma by Interim PET May Be Problematic

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...

lymphoma

Radiotherapy in Good-Prognosis DLBCL

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)...

pancreatic cancer

Pancreatic Cancer: Latest Drug Development Hits and Misses

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...

Statement from the NBPAS

The National Board of Physicians and Surgeons (NBPAS) President Paul Teirstein, MD, released his own statement shortly after Dr. Baron’s letter was released: “ABIM’s recent press release is clearly a step in the right direction. Suspending the practice assessment and patient safety requirements of...

colorectal cancer

Ramucirumab Added to FOLFIRI Yields Results Similar to Bevacizumab or Aflibercept in Second‑Line Colorectal Cancer

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...

gynecologic cancers
survivorship

High-Quality Diet Before Ovarian Cancer Diagnosis May Lengthen Survival

An overall high-quality diet at least 12 months before a diagnosis of ovarian cancer “was associated with a statistically significant 27% lower risk of death after ovarian cancer,” an analysis of dietary data from the Women’s Health Initiative showed. The protective effect was strongest among women ...

hematologic malignancies

The Current State of Hematologic Malignancies

Due in part to the refinement of bone marrow transplantation and its many innovations, some leukemias that once were death sentences now have cure rates of up to 90%. As research in transplantation and other promising areas accelerates, we are on the verge of breaking new clinical boundaries in...

lung cancer

Crizotinib Crosses Another Finish Line in Lung Cancer

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...

lung cancer

First-Line Crizotinib Improves Progression-Free Survival vs Chemotherapy in ALK-Positive NSCLC

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...

lung cancer

FDA Grants Breakthrough Therapy Designation to MPDL3280A for Non–Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Genentech’s investigational cancer immunotherapy MPDL3280A for the treatment of PD-L1–positive non–small cell lung cancer (NSCLC) that has progressed during or after platinum-based chemotherapy (and an...

kidney cancer

Nivolumab in Previously Treated Metastatic Renal Cell Cancer

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...

lymphoma

HIV-Related Lymphoma Can Be Safely Treated With Transplant

Human immunodeficiency virus (HIV)-positive patients with relapsed/refractory lymphoma can safely undergo autologous hematopoietic cell transplantation, according to results of a phase II multicenter trial presented at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition in...

colorectal cancer
pancreatic cancer
gastrointestinal cancer

New Data Reported in Colorectal, Gastric, and Pancreatic Cancers

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...

gastroesophageal cancer

Clinical Trials Actively Recruiting Patients With Esophageal Cancer

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...

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