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breast cancer

Exploratory Analysis of ExteNET Trial Shows Consistency of Benefit With Neratinib

An exploratory analysis of the ­ExteNET study of neratinib in early HER2-positive breast cancer after treatment with trastuzumab (Herceptin) upheld the findings previously reported for the 2-year analysis, according to the study’s principal investigator Arlene Chan, MD, of the Breast Cancer...

breast cancer

Homologous Recombination Deficiency Score Correlated With Response to Platinum in Breast Cancer

The homologous recombination deficiency (HRD) score may be a predictive biomarker of response to neoadjuvant platinum-based therapy in patients with triple-negative breast cancer, according to studies presented at the 2015 San Antonio Breast Cancer Symposium. “We found, in our adjusted analysis,...

supportive care

Uridine Triacetate Granules for Fluorouracil or Capecitabine Overdose or Early Severe Toxicity

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 December 11, 2015, uridine triacetate (Vistogard) was approved...

Expert Point of View: Angela DeMichele, MD, and Melinda L. Telli, MD

The formal discussant for the CALGB 40603 and GeparSixto studies at the San Antonio Breast Cancer Symposium was Angela DeMichele, MD, Professor of Medicine and Miller Chair in Breast Cancer Excellence at the Perelman School of Medicine, University of Pennyslvania. “The key questions raised by these ...

breast cancer

Role of Carboplatin in Triple-Negative Breast Cancer Still Unclear

Studies presented at the 2015 San Antonio Breast Cancer Symposium built upon an increasing body of data in support of the neoadjuvant use of carboplatin in patients with triple-negative breast cancer. Overall, however, the studies fell short of establishing carboplatin’s role in this malignancy and ...

breast cancer

Immunotherapy for Breast Cancer: Early Lackluster Study Results yet Promise Remains

Immunotherapy is at the forefront of exciting new approaches to cancer, with excellent and long-lasting responses in metastatic melanoma and non–small cell lung cancer (NSCLC) and several immunotherapy agents now approved for those malignancies by the U.S. Food and Drug Administration (FDA). The...

breast cancer

Prophylactic Beta-Blocker Preserves Left-Ventricular Function in Patients Receiving Trastuzumab

The beta-blocker bisoprolol was able to prevent trastuzumab (Herceptin)-associated declines in left-ventricular ejection fraction, whereas the effect of the angiotensin-converting–enzyme (ACE) inhibitor perindopril was less robust. Use of bisoprolol reduced dose interruptions for trastuzumab due to ...

breast cancer

Surgical Margin Width Not Related to Breast Cancer Recurrence

The width of the surgical margin doesn’t matter, as long as the margin is negative, according to a large study of breast-conserving surgery in patients with invasive breast cancer. The risk of ipsilateral breast tumor recurrence was similar for wide negative margins (2–4 mm) or narrow negative...

breast cancer
issues in oncology

PI3K Inhibitor Buparlisib Extends Progression-Free Survival  in Advanced Breast Cancer

Addition of the oral investigational pan-PI3K inhibitor buparlisib to the endocrine agent fulvestrant (Faslodex) improved progression-free survival among postmenopausal women with advanced hormone receptor–positive/HER2-negative advanced breast cancer. “We are happy to announce that the phase III...

leukemia

Venetoclax May Prove to Be Strong Weapon Against Poor-Prognosis Chronic Lymphocytic Leukemia

Venetoclax, the latest entry into the field of treatment of chronic lymphocytic leukemia (CLL), is a powerful investigational therapy that promises to fill an important niche: treatment of high-risk relapsed/refractory patients with deletions of 17p. Nearly 80% of patients with relapsed/refractory...

leukemia

Severe Toxicities Seen in Younger Patients Receiving  Front-Line Idelalisib for Chronic Lymphocytic Leukemia

Hematologists and patients with chronic lymphocytic leukemia (CLL) are excited about new drugs that have dramatically improved outcomes. But all drugs have side effects, and it is important to be aware of potential consequences. Hepatotoxicity turns out to be a major concern in younger CLL patients ...

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...

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