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leukemia
issues in oncology

Idelalisib Improves Progression-Free Survival Over Bendamustine Plus Rituximab in Chronic Lymphocytic Leukemia

Idelalisib (Zydelig) combined with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan) was superior to chemotherapy with bendamustine/rituximab plus placebo, reducing the risk of progressive disease and death while improving progression-free survival and overall survival in patients with...

lung cancer

ALK Rearrangements Common in Young Patients With Lung Cancer

Two investigative groups have reported interesting observations about genomic alterations in the tumors of young patients with lung cancer. Notably, ALK rearrangement was the most common driver mutation found, in studies reported at the 16th World Conference on Lung Cancer.1,2 “To our knowledge,...

issues in oncology

Patient-Centric Care: Translating Research to Results

The 2016 Genitourinary Cancers Symposium was held earlier this month in San Francisco. Abstracts and presentations included data and discussion on the latest strategies in the prevention, screening, diagnosis, and treatment of prostate, kidney, testicular, and urothelial cancers. Snapshots of data...

multiple myeloma

Elotuzumab in Previously Treated Multiple Myeloma

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 November 30, 2015, elotuzu­mab (Empliciti) was approved for...

breast cancer

Ado-Trastuzumab Emtansine Improved Overall Survival for Heavily Pretreated Patients With HER2-Positive Breast Cancer

Among patients with HER2-positive, metastatic breast cancer that had progressed despite treatment with two or more forms of HER2-targeted therapy (trastuzumab [Herceptin] and lapatinib [Tykerb]), median overall survival was increased for those treated with ado-trastuzumab emtansine (aka T-DM1...

breast cancer

Plasma-Based Test Identifies Impactful Mutations in BOLERO-2 Population

A plasma-based cell-free DNA test identified mutations in the estrogen receptor 1 gene (ESR1) in 30% of patients from the BOLERO-2 trial of everolimus (Afinitor) plus exemestane, and these mutations were correlated with survival. The results, which support the use of plasma as a source of...

breast cancer

Neoadjuvant Palbociclib Enhances Effect of Anastrozole on Complete Cell-Cycle Arrest

The cyclin-dependent kinase (CDK) 4/6  inhibitor palbociclib (Ibrance) enhanced cell-cycle control over that achieved with anastrozole alone in a study that evaluated the drugs’ ability to induce complete cell-cycle arrest in tumor cells and to produce clinical responses, as neoadjuvant therapy for ...

hematologic malignancies
lymphoma

Could CAR-T Therapy Be Moving Into Lymphoma?

The use of T cells that are genetically engineered to express chimeric antigen receptor (CAR-T) has made headway as an approach to hematologic malignancies, with the best results achieved in leukemia. At the 2015 American Society of Hematology (ASH) Annual Meeting and Exposition, a preliminary...

lung cancer

Bevacizumab Plus Chemotherapy Fails to Prolong Survival in Early-Stage Lung Cancer

Overall survival in patients with surgically resected early-stage non–small cell lung cancer (NSCLC) did not improve with the addition of bevacizumab (Avastin) to chemotherapy, according to the findings of a study researchers have called a “top abstract” from the 16th World Conference on Lung...

cost of care

The 340B Drug Pricing Program: Background, Concerns, and Solutions

The 340B Drug Pricing Program was created by Congress through the Veterans Health Care Act of 1992 to allow some health-care entities—including safety-net providers with large shares of uninsured and low-income patients and other “covered entities”—to obtain drugs at discounted prices.1,2 Congress...

multiple myeloma

Multiple Myeloma in 2015: A Year for the Record Books

Few malignancies have received as much attention, in the way of newly approved drugs, as multiple myeloma did in 2015. In November alone, 3 new agents were approved, bringing the total to 4 for the year as part of a record 7 approvals and to 16 regulatory approvals over the past 12 years. Speakers...

lung cancer

Study Finds Alectinib Highly Active in ALK-Positive, Crizotinib-Resistant NSCLC

In a North American phase II trial reported in The Lancet Oncology, Shaw et al found that alectinib (Alecensa), which is active against acquired crizotinib (Xalkori) resistance mutations and exhibits high central nervous system (CNS) penetration, was associated with considerable activity in...

sarcoma

FDA Approves Eribulin Mesylate in Unresectable or Metastatic Liposarcoma

The U.S. Food and Drug Administration today approved eribulin mesylate (Halaven), an antimicrotubular antineoplastic agent, for the treatment of unresectable or metastatic liposarcoma. This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug....

gynecologic cancers
colorectal cancer
head and neck cancer
issues in oncology
issues in oncology

100% of NCI-Designated Cancer Centers Endorse the Promotion of the HPV Vaccination for Cancer Prevention

All National Cancer Institute (NCI)-designated cancer centers have united to support human papillomavirus (HPV) vaccination. A team of HPV experts drafted a consensus statement that advises widespread use of HPV vaccines to prevent cancer. HPV causes cancer of the cervix, anus, and throat. The HPV ...

prostate cancer

DNA Damage and Repair Pathway Signature May Be Associated With Prognosis After Prostatectomy in High-Risk Prostate Cancer

In a study reported in JAMA Oncology, Evans et al identified a DNA damage and repair pathway gene signature that was significantly associated with outcomes after prostatectomy for high-risk prostate cancer independent of standard clinicopathologic factors. Study Details The study involved 1,090...

breast cancer
issues in oncology

UK Study Suggests Association Between Screen-Detected Ductal Carcinoma in Situ and Reduced Invasive Interval Breast Cancers

In a UK retrospective population-based study reported in The Lancet Oncology, Duffy et al found a significant inverse association between the detection of ductal carcinoma in situ in breast cancer screening and the incidence of invasive interval cancers diagnosed within 3 years after screening....

skin cancer

Nivolumab Plus Ipilimumab Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status

Bristol-Myers Squibb announced on January 23 that the U.S. Food and Drug Administration (FDA) has approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation–positive unresectable or metastatic...

multiple myeloma

FDA Approves Carfilzomib as Single Agent or in Combination in Relapsed/Refractory Multiple Myeloma

Amgen announced on January 21 that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application of carfilzomib (Kyprolis) for injection in combination with dexamethasone or with lenalidomide (Revlimid) plus dexamethasone for the treatment of patients with relapsed or...

palliative care
pancreatic cancer

2016 GI Symposium: Irinotecan Liposome Injection in Metastatic Pancreatic Cancer: Updated Results of the Phase III NAPOLI-1 Study

Merrimack Pharmaceuticals, Inc, announced that an updated overall survival analysis of the phase III NAPOLI-1 study of irinotecan liposome injection (Onivyde) in combination with fluorouracil (5-FU) and leucovorin achieved a substantial improvement in 12-month overall survival compared to 5-FU and...

palliative care
solid tumors

2016 GI Symposium: New Regimen for Locally Advanced Rectal Cancer as Effective as, but Less Toxic Than, Chemoradiation

Findings from a Polish phase III study point to an additional treatment option for patients with advanced rectal cancer. Patients who received short-course (5-day) radiation followed by consolidation chemotherapy before surgery achieved  outcomes similar to those of patients treated with...

breast cancer

Study Finds Adjuvant Anastrozole Reduces Recurrence Risk vs Tamoxifen in Postmenopausal Women With Ductal Carcinoma in Situ

In a phase III trial (National Surgical Adjuvant Breast and Bowel Project [NSABP] B-35) reported in The Lancet, Margolese et al found that adjuvant anastrozole significantly improved the breast cancer–free interval vs tamoxifen in postmenopausal women with hormone receptor–positive...

New Precision Medicine Guidelines Aimed at Improving Personalized Cancer Treatment Plans for Patients

A committee of national experts, led by a Cleveland Clinic researcher, has established first-of-its-kind guidelines to promote more accurate and individualized cancer predictions, guiding more precise treatment and leading to improved patient survival rates and outcomes. These guidelines were...

breast cancer
supportive care

No Association Seen Between New or Worsening Aromatase Inhibitor–Related Musculoskeletal or Vasomotor Symptoms and Relapse-Free Survival

Retrospective analyses of the ATAC, TEAM, and BIG 1-98 adjuvant endocrine therapy trials in breast cancer have suggested that treatment-emergent endocrine symptoms may be associated with superior survival outcomes. However, in a study reported in the Journal of Clinical Oncology, Stearns et al...

leukemia

Increased Response Rate With Higher Dose of Obinutuzumab Monotherapy for Patients With Chronic Lymphocytic Leukemia

A randomized phase II study in symptomatic, untreated patients with chronic lymphocytic leukemia (CLL) found an increased overall response rate with obinutuzumab (Gazyva) at a dose of 2,000 mg vs 1,000. In addition, the “data demonstrate that obinutuzumab produces a higher response rate in...

gynecologic cancers
issues in oncology

UK Study Suggests Potential Mortality Benefit of Ovarian Cancer Screening in Postmenopausal Women

As reported in The Lancet by Jacobs et al, the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) suggests there may be a mortality benefit of ovarian cancer screening in postmenopausal women. Study Details In the trial, 202,546 postmenopausal women aged 50 to 74 years from 13 centers...

breast cancer

High Risk on Breast Cancer Risk Prediction Tools Associated With More Favorable Disease Characteristics

In a Swedish study reported in the Journal of Clinical Oncology, Holm et al found that high risk on the Tyrer–Cuzick predicted 10-year breast cancer risk score (TCRS) and a 77-single nucleotide polymorphism polygenic risk score (PRS) tended to be associated with favorable prognostic features...

hematologic malignancies
leukemia

Use of Antilymphocyte Globulin Appears to Reduce Chronic Graft-vs-Host Disease After Allogeneic Stem Cell Transplantation in Acute Leukemia

In a European phase III study reported in The New England Journal of Medicine, Kröger et al found that inclusion of antihuman T-lymphocyte immune globulin (ATG) in the myeloablative conditioning regimen in patients with acute myeloid or lymphoid leukemia resulted in a significant reduction in...

breast cancer

Japanese Study Shows Oral Fluoropyrimidine S-1 Is Noninferior to Taxanes as First-Line Treatment of HER2-Negative Metastatic Breast Cancer

In a Japanese phase III trial (SELECT BC) reported in The Lancet Oncology, Takashima et al found that first-line treatment with the oral fluoropyrimidine S-1 was associated with noninferior overall survival vs taxane regimens in women with HER2-negative metastatic breast cancer resistant to...

breast cancer

Nonsignificant Improvement in Disease-Free Survival With Adjuvant Lapatinib/Trastuzumab vs Trastuzumab in Early HER2-Positive Breast Cancer

Results of a phase III trial, reported in the Journal of Clinical Oncology by Piccart-Gebhart et al, showed a modest and statistically nonsignificant increase in disease-free survival with concurrent adjuvant lapatinib (Tykerb) and trastuzumab (Herceptin) vs trastuzumab alone in patients with...

palliative care
skin cancer
issues in oncology

Blood Test That Monitors ctDNA Better Than the Standard in Tracking Metastatic Melanoma

Physicians treating patients with metastatic melanoma may soon have a superior tool in their efforts to closely track the disease. A new study shows that a blood test that monitors blood levels of DNA fragments from dead cancer cells does a better job than the current standard test at tracking the...

lung cancer

Pembrolizumab Improves Survival vs Docetaxel in Previously Treated PD-L1–Positive Advanced NSCLC

As reported in The Lancet by Herbst et al, the phase II/III KEYNOTE-010 trial showed that pembrolizumab (Keytruda) significantly improved overall survival vs docetaxel in patients with previously treated programmed death ligand 1 (PD-L1)–positive advanced non–small cell lung cancer...

health-care policy
issues in oncology

ASCO Calls for Improvements to Clinical Pathway Programs in Oncology

ASCO released a new policy statement with recommendations to ensure that clinical pathways in oncology promote—not hinder—the care of patients with cancer. Published by Zon et al in the Journal of Oncology Practice, the statement asserts that the way in which these treatment management...

breast cancer

AACR, Triple Negative Breast Cancer Foundation, and Carol’s Crusade for a Cure Foundation Partner to Offer Grant Opportunity

The American Association for Cancer Research (AACR), Triple Negative Breast Cancer Foundation, and Carol’s Crusade for a Cure Foundation have announced a new partnership and grant opportunity in metastatic triple-negative breast cancer research. The AACR–Triple Negative Breast Cancer...

skin cancer

LETTER TO THE EDITOR: Adjuvant Therapy in Cutaneous Melanoma: The Need for a New Approach

Melanoma of the skin remains a fatal disease, and its incidence continues to rise, mostly in young adults during their prime. Surgery remains the most effective therapeutic modality, but patients’ survival depends on the stage of the disease at the time of diagnosis. Various therapeutic agents have ...

kidney cancer

Sunitinib-induced Hypertension May Be Efficacy Biomarker in Patients with Metastatic Renal Cell Carcinoma

A retrospective exploratory analysis of pooled efficacy data from more than 500 patients with metastatic renal cell carcinoma treated with sunitinib (Sutent) “support the hypothesis that hypertension may be a viable biomarker of antitumor efficacy in this patient population,” according to a report...

gynecologic cancers

Adding Gemcitabine to Chemoradiation Improves Survival Outcomes for Locally Advanced Cervical Cancer

A phase III, open-label, randomized trial found that adding gemcitabine to concurrent cisplatin chemoradiotherapy and using gemcitabine as adjuvant chemotherapy with cisplatin improved survival outcomes in women with locally advanced cervical cancer. Toxicity was increased compared to standard...

multiple myeloma

Subcutaneous Bortezomib Offers Improved Safety Profile for Treating Patients with Relapsed Multiple Myeloma

Subcutaneous administration of bortezomib (Velcade) was comparably efficacious to intravenous administration in a phase III trial in patients with relapsed multiple myeloma, but the SC route “seemed to have an improved systemic safety profile compared with intravenous delivery,’’ investigators...

Expert Point of View: More Evidence Links Vitamin D Deficiency to Breast Cancer

Julie R. Gralow, MD, Professor of Oncology at the University of Washington, Seattle, said the data reported by Rickles et al at the American Society of Breast Surgeons Annual Meeting support the Goodwin study presented at the 2008 ASCO Annual Meeeting.1 In that earlier Canadian cohort of 512 women, ...

breast cancer

Radiotherapy in DCIS: Recurrence Patterns Are Different

For women with ductal carcinoma in situ (DCIS), radiation therapy after excision is not a slam-dunk in terms of benefits, according to a study presented at the American Society of Breast Surgeons 12th Annual Meeting.1 In a study that focused on the pattern of breast cancer recurrence in women with...

breast cancer

‘Paradoxical’ Result Tying Estrogen to Reduced Risk of Breast Cancer Is Consistent with Laboratory Data

Results from the Women’s Health Initiative1 showing a decreased incidence of breast cancer among postmenopausal hysterectomized women who took estrogen replacement therapy (ERT) may seem paradoxical, but “comply exactly” with laboratory research, according to V. Craig Jordan, OBE, PhD, DSc,...

gynecologic cancers

Important Briefs from the ACOG 59th Annual Clinical Meeting

Several presentations at the 59th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG), held April 30–May 4 in Washington, DC, focused on cancers associated with the reproductive tract and issues important to women’s health. Four noteworthy studies presented at...

health-care policy

Opinion: The FDA–Pharmaceutical Industry Complex

On January 17, 1961, President Dwight D. Eisenhower, in his farewell address to the nation, coined the term “the military-industrial complex.” His purpose was to warn of the inefficiencies that could result from such a relationship, which would imperil the strength of our military and the safety of ...

Expert Point of View: 3-Year Screening Interval Safe for Women with HPV-negative and Normal Pap Tests, Data Show

This is a wonderful population-based study… that makes us comfortable with the current recommendations. The issue of how frequently one or the other test should be used is an evolving area,” said George W. Sledge, Jr, MD. Dr. Sledge is ASCO Immediate Past President. Dr. Sledge pointed out that...

gynecologic cancers

2011 ASCO Annual Meeting: 3-Year Screening Interval Safe for Women with HPV-negative and Normal Pap Tests, Data Show

A large, “real-world” study has validated current recommendations from the American Congress of Obstetricians and Gynecologists (ACOG), American Cancer Society (ACS), and American Society for Colposcopy and Cervical Pathology (ASCCP) endorsing a 3-year cervical cancer screening interval for women...

lymphoma
survivorship

Survivorship Symposium 2016: Study Finds That Less Than Half of Survivors of Hodgkin Lymphoma Received All Recommended Follow-up Care

According to the American Cancer Society’s 2014 Cancer Facts & Figures, Hodgkin lymphoma is diagnosed in about 800 adolescents and young adults each year. And while standard treatments for the cancer, including chemotherapy and radiation, are very effective in improving survival,...

gynecologic cancers

Cancer Diagnosis Can Spark Worry over Numerous Health Concerns

The early discovery of my endometrial cancer is a prime example of the health rewards you can reap if you are lucky enough to have good medical care and a dogged physician. Long past menopause, I wasn’t experiencing any of the typical warning signs of the disease—vaginal bleeding or pelvic...

colorectal cancer

Capecitabine Noninferior to 5-FU with Improved Toxicity Profile in Rectal Cancer, Two Studies Demonstrate

Two separate trials presented during an oral session at the 2011 ASCO Annual Meeting suggest that capecitabine (Xeloda) can replace fluorouracil (5-FU) as part of chemoradiotherapy for rectal cancer. Patients randomly assigned to either treatment had comparable outcomes but with less toxicity from...

prostate cancer

Sunitinib/Prednisone Improves Progression-free Survival but not Overall Survival in Metastatic Castrate-resistant Prostate Cancer

According to M. Dror Michaelson, MD, PhD, second-line therapy with sunitinib (Sutent) and prednisone improves progression-free survival but not overall survival in men with metastatic castrate-resistant prostate cancer previously treated with docetaxel-based chemotherapy. Dr. Michaelson, of the...

lung cancer

Understanding Crizotinib, 1 Year after High-profile Presentation

The findings from a phase I study of crizotinib in non–small cell lung cancer (NSCLC) were presented in a Plenary Session at the 2010 ASCO Annual Meeting—an unusual event, since such early-phase data are not generally the topic of plenary sessions. The study showed that a majority of mostly...

symptom management

Vanderbilt Oncologists Partner with Cardiologists to Research Chemotherapy-related Cardiac Toxicity

Cardiac toxicity related to chemotherapy is not a new topic but it is an increasingly important one, as concerns are no longer limited to the anthracyclines. Targeted agents unfortunately “target” the cardiovascular system as well, especially bevacizumab (Avastin), trastuzumab (Herceptin) when...

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