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...
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,...
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...
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 ...
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 ...
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...
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 ...
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...
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...
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...
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 ...
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...
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,...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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....
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 ...
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...
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....
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
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...
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, ...
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...