The monoclonal antibody gemtuzumab ozogamicin (Mylotarg) improved event-free survival and reduced the risk of relapse in children with acute myeloid leukemia (AML) in a study from the Children’s Oncology Group, presented at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition ...
Idelalisib plus rituximab (Rituxan) improved progression-free survival, overall response rates, and overall survival compared with rituximab alone in heavily pretreated patients with relapsed chronic lymphocytic leukemia (CLL). Moreover, the combination provided effective, durable disease control...
The addition of bevacizumab (Avastin) to adjuvant chemotherapy did not improve invasive disease-free survival or overall survival in patients with high-risk HER2-positive breast cancer in the large randomized phase III BETH trial. Although not specifically designed to answer this question, BETH...
Multiple studies reported at the 2014 Gastrointestinal Cancers Symposium add further support for widening the genetic analysis of colorectal cancer tumors. In fact, experts predict that more extensive genetic testing for RAS gene mutations (in KRAS and NRAS) beyond the routine analysis of KRAS exon ...
Organ preservation is a hallmark of progress in the world of cancer management. For patients with muscle-invasive bladder cancer, the bladder-sparing approach is a well-established alternative to radical cystectomy. Patients undergo cystoscopic evaluation between the induction and consolidation...
The 10th Genitourinary Cancers Symposium, sponsored by ASCO, the American Society for Radiation Oncology, and the Society of Urologic Oncology, was held January 29–February 1, 2014, in San Francisco. The more than 630 abstracts presented addressed essential research in genitourinary malignancies,...
Ipilimumab (Yervoy) failed to meet the primary endpoint of improving overall survival in the randomized, phase III CA184-043 trial. However, the immunotherapy did improve progression-free survival and prostate-specific antigen (PSA) response compared with placebo in postdocetaxel metastatic...
For decades, dedicated members of the oncology community have fought to increase the nation’s focus on lung cancer prevention and treatment. Although smoking cessation initiatives have reduced cigarette consumption, lung cancer 5-year survival has remained stagnant at 15%, lagging far below most...
Colorectal cancer is a common malignancy that will impact 1.4 million individuals globally each year.1 Approximately 70% to 75% of patients will present with locally advanced disease. For patients with stage III colon cancer, adjuvant chemotherapy is commonly offered, whereas chemotherapy for those ...
If a randomized, controlled trial of therapy for breast cancer was submitted for publication in which 1. The drug being tested was old and ineffective, and 2. prior to randomization, the women underwent a clinical breast examination and the study coordinators knew who had the largest cancers, and...
The recent report from the Canadian National Breast Screening Study (CNBSS)—published in BMJ and reviewed in this issue of The ASCO Post—concluded that annual mammography in women aged 40 to 59 does not result in a reduction in mortality from breast cancer beyond that of physical examination alone...
As reported in BMJ by Anthony B. Miller, MD, Professor Emeritus at the Dalla Lana School of Public Health, University of Toronto, and colleagues, the 25-year follow-up of the Canadian National Breast Screening Study has shown no mortality benefit of annual mammography screening for breast cancer...
More data have emerged that discount the potential for benefit with epidermal growth factor receptor (EGFR) inhibitors in esophageal cancer. The latest comes from the RTOG 0436 randomized phase III trial in patients with nonoperable esophageal cancer, the results of which were presented at the 2014 ...
Cancer Immunotherapy What is the role of immunotherapy in the treatment of metastatic renal cell carcinoma? The harnessing of the immune system as an effective treatment for cancer was recently selected by the journal Science as the top scientific Breakthrough of the Year for 2013.1 With this...
Detailed quality-of-life data from the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) Mammary Prevention 3 (MAP.3) trial showed that exemestane given for the prevention of breast cancer “has limited negative impact on menopause-specific and health-related [quality of life] in...
In an editorial accompanying publication of the AURELIA study results, Joyce F. Liu, MD, MPH, of Dana-Farber Cancer Institute, and Stephen A. Cannistra, MD, of Beth Israel Deaconess Medical Center, Boston, considered the implications of the benefits observed in the trial and limitations in...
The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra) injection in combination with chlorambucil (Leukeran) for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate. The...
In 2012, three randomized placebo-controlled trials reported a significant prolongation of progression-free survival with lenalidomide (Revlimid) as maintenance therapy for multiple myeloma.1-3 Two of these trials tested lenalidomide maintenance after stem cell transplantation, and one investigated ...
The neurosurgeon is often the gateway provider when patients present with what on magnetic resonance imaging (MRI) appears to be a new glioblastoma. Because histology-based diagnosis is a prerequisite for initiating standard therapy with radiation and chemotherapy, the first question that the...
Project Data Sphere, which launched on April 8, is a “giant digital laboratory, an enormous library containing data about tens of thousands of patients and hundreds of clinical trials, all of which will be in the public domain,” said Martin J. Murphy, Jr, DMedSc, PhD, FASCO, Chief Executive Officer ...
Data from trials conducted mostly in the 1970s and 1980s established the paradigm that optimal treatment of rectal cancer requires a combination of radiation therapy, chemotherapy, and surgery.1 Virtually all of these trials, however, demonstrated that radiotherapy added only to the local control...
Pharmacyclics, Inc, and Janssen Biotech, Inc, have announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA), based on data from the randomized, multicenter, open-label phase III RESONATE study, a head-to-head comparison of single-agent ibrutinib ...
The U.S. Food and Drug Administration (FDA) has approved siltuximab (Sylvant injection) for the treatment of patients with multicentric Castleman’s disease who are human immunodeficiency virus (HIV)-negative and human herpes virus-8 (HHV-8)-negative. Multicentric Castleman’s disease is a rare...
In women with breast cancer who had between one and three positive lymph nodes, radiotherapy reduced the recurrence rate by 32% and the breast cancer death rate by 20%. Giving radiotherapy to these women led to nearly 12 fewer recurrences of breast cancer per 100 women after 10 years, and eight...
In the targeted-therapy era, it is important to identify subsets of patients who can benefit from novel agents and combinations as quickly as possible. The I-SPY 2 trial is designed to expedite this goal and to change the way that targeted agents are studied and approved. This innovative adaptive...
Patients with early-stage breast cancer who underwent sentinel lymph node dissection experienced lymphedema with increasing incidence over time, according to a presentation at the 2014 Society of Surgical Oncology (SSO) Cancer Symposium in Phoenix.1 In women who took part in the American College of ...
The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) to treat patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy....
Contralateral prophylactic mastectomy improved breast cancer patients’ odds of overall survival by 23% compared with single mastectomy alone, according to a retrospective analysis of nearly 170,000 patients in a U.S. database, but surgical breast cancer specialists warned that the data needed to be ...
The Clinical Trials and Translational Research Advisory Committee (CTAC) of the National Cancer Institute (NCI) met for the 22nd time on March 12, 2014, in their ongoing effort to improve efficiency and effectiveness of cancer clinical trials. A significant portion of the meeting addressed lagging...
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 April 29, 2014, ceritinib (Zykadia) was granted accelerated...
Over the past several decades, the convergence of scientific discovery, technology, and therapeutic developments has created an unparalleled opportunity to integrate our growing knowledge of genomics into the clinical practice of oncology. To shed light on the current state and future of...
Radiation therapy is associated with significantly fewer postoperative complications than axillary lymph node dissection, according to a detailed analysis of morbidity from the AMAROS (After Mapping of the Axilla: Radiotherapy or Surgery?) trial presented at a press briefing prior to the American...
The highly anticipated results from the phase III ALTTO trial show no additional benefit for adding lapatinib (Tykerb) to trastuzumab (Herceptin) in the adjuvant treatment of HER2-positive breast cancer.1 The results were presented at the 2014 ASCO Annual Meeting’s Plenary Session by Martine J....
Adding docetaxel to standard androgen ablation therapy (ie, testosterone suppression) extended survival by more than 1 year in men with newly diagnosed metastatic hormone-sensitive prostate cancer in the phase III E3805 trial, funded by the National Institutes of Health. As reported at the ASCO...
At a median follow-up of 8 years, patients receiving trastuzumab (Herceptin) sequentially after chemotherapy and radiotherapy in the Herceptin Adjuvant (HERA) trial had a low incidence of cardiac events and these were reversible in the vast majority of patients. This long-term assessment confirms...
One of the most reported studies emanating from the 2014 ASCO Annual Meeting involves the use of the luteinizing hormone–releasing hormone (LHRH) agonist goserelin (Zoladex) to reduce the risk of ovarian failure among women being treated with chemotherapy for early-stage breast cancer, and to...
For the past 40 years the story of breast cancer surgery in general, and for the past 20 years the management of the axilla in particular, has been one of increasing conservatism. To give our readers insight into the current and future direction of axillary management, The ASCO Post spoke with...
Approximately 20% of all breast cancers are human epidermal growth factor receptor 2 (HER2)-positive. Prior to the era of HER2-targeted therapy, HER2-positive breast cancer was characterized by a poor prognosis.1,2 The development of the first HER2-targeted therapy, trastuzumab (Herceptin), led to...
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, FDA hematologist/oncologist Albert Deisseroth, MD, PhD, discusses the recent approval of siltuximab for patients with multicentric Castleman’s disease who are human...
A public-private collaboration among the National Cancer Institute (NCI), SWOG Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D...
Ramucirumab (Cyramza) added to docetaxel improved overall survival compared to chemotherapy alone in patients with stage IV non–small cell lung cancer (NSCLC) that has progressed on one prior therapy, according to results of a phase III trial presented at the 50th ASCO Annual Meeting.1 The...
Improved relapse-free survival following treatment with adjuvant trastuzumab (Herceptin) appears to be associated with a heightened state of immunologic function, according to genomic analysis that resulted in a 14-gene profile predictive of outcomes in the landmark NCCTG (Alliance) N9831 trial.1...
The good news for younger women with hormone receptor–negative early breast cancer is that adding goserelin (Zoladex), a luteinizing hormone–releasing hormone (LHRH) agonist, to chemotherapy can prevent sudden menopause, better preserve ovarian function and fertility, and lead to successful...
Separate studies in early-stage non–small cell lung cancer (NSCLC) found that the addition of consolidation chemotherapy to concurrent chemoradiotherapy did not improve survival and that adjuvant erlotinib (Tarceva) did not improve survival. There was a suggestion of benefit for adjuvant erlotinib...
Ibrutinib (Imbruvica) significantly improved progression-free survival, overall survival, and response when compared with ofatumumab (Arzerra) as second-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in the phase III RESONATE study. The study results were...
Three separate studies of treatments for prostate cancer reported at the 2014 ASCO Annual Meeting in Chicago showed excellent, intermediate, and disappointing results. An update of the previously reported PREVAIL trial (see March 1 issue of The ASCO Post, page 1) was overwhelmingly positive for the ...
Josep Tabernero, MD, PhD, Head of Medical Oncology and the Institute of Oncology at Vall d’Hebron University Hospital in Barcelona, Spain, discussed the results of CALGB/SWOG 80405 at the ASCO Plenary Session. “CALGB/SWOG 80405 did not meet the primary endpoint of superiority [for cetuximab] in a...
Call it a draw: Cetuximab (Erbitux), an EGFR inhibitor, and bevacizumab (Avastin), a VEGF inhibitor, confer comparable benefits as first-line treatment with chemotherapy for metastatic colorectal cancer, according to the phase III Cancer and Leukemia Group B (CALGB)/Southwest Oncology Group (SWOG) ...
This study provides key insights into the longstanding and vexing debate about optimal systemic therapy for these young women. We wonder about the role of tamoxifen, aromatase inhibitors, chemotherapy, and ancillary therapies like bisphosphonates,” said Nancy E. Davidson, MD, Director of the...
A joint analysis of two important phase III clinical trials—TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial)—showed that exemestane plus ovarian function suppression was superior to tamoxifen plus ovarian suppression in preventing recurrence in premenopausal...