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Showing 8551 - 8600Trabectedin in Liposarcoma/Leiomyosarcoma: The Drug Is Approved, Now the Real Drug Development Begins!
Led by George Demetri, MD, of Dana-Farber Cancer Institute, Boston, expert medical oncology investigators from leading academic sarcoma centers and Janssen Pharmaceuticals employees performed a phase III trial in order to provide evidence for the U.S. Food and Drug Administration (FDA) approval of...
Improved Progression-Free Survival With Trabectedin vs Dacarbazine After Chemotherapy Failure in Liposarcoma or Leiomyosarcoma
In a phase III trial reported in the Journal of Clinical Oncology, George D. Demetri, MD, of Harvard Medical School and Dana-Farber Cancer Institute, Boston, and colleagues found that treatment with trabectedin (Yondelis) significantly improved progression-free survival vs dacarbazine in patients...
Nivolumab Receives Two FDA Approvals in November
Nivolumab (Opdivo) is a monoclonal antibody that binds to the programmed cell death protein 1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and PD-L2, releasing PD-1 pathway–mediated inhibition of the immune response. Late last month, the U.S. Food and Drug Administration (FDA)...
The Best of SIO
The following five abstracts were chosen as the best studies presented at the 12th International Conference of the Society for Integrative Oncology (SIO) because of their quality and the impact they will have on the field of integrative medicine, according to Suzanna Zick, ND, MPH, Immediate Past...
2015 Review of Newly Approved Oncologic Therapies
Over the past year or so, a host of new agents were approved for the treatment of patients with various types of cancer (see related article on page 1). Patrick Medina, PharmD, of the University of Oklahoma College of Pharmacy, Oklahoma City, and Monique Giordana, PharmD, BCOP, of Regions...
Anamorelin Improves Cachexia Symptoms in Patients With Advanced Non–Small Cell Lung Cancer
The investigational agent anamorelin significantly increased lean body mass, body weight, total body mass, and fat mass in patients with advanced non–small cell lung cancer (NSCLC) and cachexia, according to Jennifer S. Temel, MD, who presented the results of two phase III studies at the 2015...
Olanzapine Significantly Reduces Chemotherapy-Induced Nausea and Vomiting
The addition of olanzapine to standard antiemetics significantly reduced chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy, according to Rudolph M. Navari, MD, PhD, and colleagues. “As far as I know, this is the first trial that looked at no nausea as the ...
‘Substantial Number’ of Patients Requiring Palliative Radiotherapy for Stage IV NSCLC Are Overtreated
An analysis of data from 46,803 patients with stage IV non–small cell lung cancer (NSCLC) who received palliative chest radiation therapy found that 49% received radiotherapy for longer than 15 fractions, and 28% received more than 25 fractions. This treatment pattern “is inconsistent with the...
Better Quality of Life With Melphalan and Prednisone Used With Lenalidomide Than With Thalidomide
A phase III Eastern Cooperative Oncology Group (ECOG) trial (E1A060) comparing melphalan, prednisone, and thalidomide (Thalomid) with melphalan, prednisone, and lenalidomide (Revlimid) in elderly patients with untreated multiple myeloma found that at the end of the induction period, patients...
SIOG Annual Conference Explores Global Perspectives on Geriatric Oncology and Supportive Care
The 15th Annual Conference of the International Society of Geriatric Oncology (SIOG) took place in Prague, Czech Republic, over 3 days (November 12–14, 2015). At the heart of the meeting were presentations on supportive care, comprehensive geriatric assessment and treatment—so that we fully...
Clinical Trials Actively Recruiting Patients With Pancreatic Cancer
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with pancreatic cancer. The trials are investigating preoperative rehabilitation; chimeric antigen receptors; T-cell transplants; combination chemotherapy; chemoradiotherapy; ...
Are Academic Cancer Centers a National Treasure?
The Association of American Cancer Institutes (AACI) is developing a marketing campaign to highlight the value of academic cancer centers to their communities and the nation. Called “The Academic Difference,” the 2-year campaign is the initiative of AACI President George J. Weiner, MD, Director of...
Acute Myeloid Leukemia in the Elderly: Trial Data Stir Hope for the Transplant Option
Older patients with acute myeloid leukemia (AML) have high relapse rates after induction chemotherapy, low survival rates, and fewer treatment options compared with younger patients. One of the options for both younger and older patients is hematopoietic cell transplantation, but relatively few...
A: Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System
Question 1: Based on the rationale for the current “standard of care” for primary diffuse large B-cell lymphoma of the CNS, what is the optimal induction therapy? Correct Answer: C. A high-dose methotrexate–based regimen. Expert Perspective Untreated primary diffuse large B-cell lymphoma of the CNS ...
Necitumumab in Metastatic Squamous 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. On November 24, 2015, necitumumab (Portrazza) was approved for use ...
ASCO Endorsement of ACCP Guideline on Treating SCLC: Moving Forward to Better Outcomes in Oncology
In the current climate of rising health-care costs, particularly in the field of oncology, clinical guidelines provide a crucial tool to guide practitioners in evidence-based care and to improve the quality and consistency of care.1 The ASCO review and endorsement of the American College of Chest...
Ductal Carcinoma in Situ and Relevant Endpoints for Omission of Standard Treatments: Are We There Yet?
The optimal management strategy for ductal carcinoma in situ has become increasingly controversial with respect to potential overdiagnosis and overtreatment. Much of the controversy for ductal carcinoma in situ stems from its exceptional breast cancer–specific survival, which approaches close to...
Minimally Invasive Surgery for Rectal Cancer: An Evolving Issue
Over 10 years ago, we welcomed a new approach to cancer surgery when the 2004 COST trial demonstrated the benefits of laparoscopic compared with open surgery for colon cancer. This randomized trial of 872 patients showed improved perioperative recovery with laparoscopic colectomy without...
Phase III Trials Fail to Show Noninferiority of Surgical Outcome for Laparoscopic vs Open Resection in Rectal Cancer
Two phase III trials, reported in JAMA by James Fleshman, MD, of Baylor University Medical Center, Dallas, and colleagues1 and Andrew R. Stevenson, MBBS, FRACS, of the University of Queensland, Brisbane, Australia, and colleagues,2 failed to show noninferiority of surgical outcome for laparoscopic...
Expert Point of View: Vincent Grégoire, MD, PhD
After presentation of the study by Cheng and colleagues at the 2015 European Cancer Congress, formal discussant Vincent Grégoire, MD, PhD, Department of Radiation Oncology, UCL St-Luc University Hospital, Brussels, Belgium, was cautious in endorsing a surgical approach for stage III and IV...
Surgery for Head and Neck Cancer Improves Survival—in Taiwan
A large study presented at the 2015 European Cancer Congress in Vienna found that patients with advanced oropharyngeal or hypopharyngeal cancer had improved survival if their primary treatment included surgery.1 The caveat is that these patients were treated in Taiwan, and the results may not be...
Clinical Trial System Badly in Need of Overhaul, Say Panelists at Friends-Brookings Conference
Cancer clinical trials in three distinct phases, as they have been conducted for decades, are probably no longer the best way to bring a drug or biologic agent to market. This was the consensus of three panels at the 8th Annual Conference on Clinical Cancer Research convened by Friends of Cancer...
Partnering Therapies for Estrogen Receptor–Positive Breast Cancer Requires Close Monitoring and Patient Communication
Partnering endocrine therapy with new targeted agents for women with estrogen receptor–positive breast cancer “changes the nature of endocrine therapy from something easily tolerated, with not a lot that you have to do as physicians to monitor it,” William J. Gradishar, MD, of the Robert H. Lurie...
Nivolumab as Single-Agent Treatment for BRAF V600 Wild-Type Unresectable or Metastatic Melanoma
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 24, 2015, nivolumab (Opdivo) was approved for use as...
Pediatric Regimen Achieves Higher-Than-Expected Survival in Young Adults With Acute Lymphoblastic Leukemia
Adolescents and younger adults with acute lymphoblastic leukemia (ALL) had superior outcomes on a “pediatric” regimen compared with adult treatment protocols. A multicenter phase II study included patients aged 18–50, extending the upper limit of “younger,” since most other trials of this approach...
Expert Point of View: Nikolai Podoltsev, MD, PhD
Both the concept of an antibody-drug conjugate combined with less-intensive chemotherapy and the actual regimen used in this study are exciting, according to Nikolai Podoltsev, MD, PhD, Assistant Professor, Division of Hematology, Yale University Medical Center, New Haven, Connecticut. “This has...
Nivolumab in Advanced Renal Cell Carcinoma After Antiangiogenic Therapy
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 23, 2015, nivolumab (Opdivo) was approved for use in...
Expert Point of View: Mark J. Levis, MD
Putting this trial into context, Mark J. Levis, MD, of the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore, said: “Six different FLT3 inhibitors have advanced into phase III trials. Midostaurin in the only one that has made it to the ‘station.’” “The fact that midostaurin is...
Midostaurin: A New Standard of Care in Acute Myeloid Leukemia?
Upfront treatment with midostaurin added to standard chemotherapy improved survival compared with placebo plus chemotherapy in high-risk patients with acute myeloid leukemia (AML) characterized by FLT3 mutations. No new drugs have been approved for AML since 1990, and midostaurin is the first...
Ibrutinib Bests Standard of Care for Elderly Patients With CLL
First-line treatment with the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) significantly reduced the risk of dying or disease progression compared with chlorambucil (Leukeran) in older treatment-naive patients with chronic lymphocytic leukemia (CLL) in the RESONATE-2 trial. At the time...
Patients With Incomplete Response to Neoadjuvant Chemotherapy Benefit From Capecitabine
Treatment with capecitabine increased disease-free and overall survival in breast cancer patients with residual disease after neoadjuvant chemotherapy, according to a study reported by researchers from Japan and Korea at the 2015 San Antonio Breast Cancer Symposium.1 “It has been unclear whether...
Impressive Results With Daratumumab Plus Lenalidomide/Dexamethasone in Multiple Myeloma
The anti-CD38 monoclonal antibody daratumumab (Darzalex) took center stage among multiple myeloma studies presented at the 57th American Society of Hematology Annual Meeting and Exposition. In relapsed/refractory patients, daratumumab plus lenalidomide (Revlimid)/dexamethasone yielded an 81%...
National Cancer Database Study Indicates Racial Differences in Neoadjuvant Chemotherapy Use in Women With Breast Cancer
In a study reported in the Journal of Clinical Oncology, Killelea et al found that chemotherapy, particularly neoadjuvant chemotherapy, was more frequently given to black, Hispanic, and Asian women vs white women with stage I to III breast cancer, with the difference largely attributable to more...
Adding Ibrutinib to Bendamustine/Rituximab May Increase Progression-Free Survival in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
In the phase III HELIOS trial reported in The Lancet Oncology, Chanan-Khan et al found that the addition of the Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib (Imbruvica) to bendamustine (Treanda)/rituximab (Rituxan) increased progression-free survival in patients with chronic lymphocytic ...
Study Reports Improved Survival With Lapatinib and CapeOx in Asian and Younger Patients With HER2-Positive Advanced Gastroesophageal Adenocarcinoma
In a phase III trial (TRIO-013/LOGiC) reported in the Journal of Clinical Oncology, Hecht et al found that the addition of lapatinib (Tykerb) to capecitabine-oxaliplatin (CapeOx) in patients with previously untreated HER2-amplified advanced gastroesophageal adenocarcinoma did not improve overall...
Patient-Reported Outcomes With Adjuvant Anastrozole vs Tamoxifen in Postmenopausal Women With Ductal Carcinoma in Situ
As reported in The Lancet and at the recent San Antonio Breast Cancer Symposium, Ganz et al found differences in patient-reported outcomes with anastrozole vs tamoxifen in the phase III National Surgical Adjuvant Breast and Bowel Project (NSABP) B-35 trial in postmenopausal women with hormone...
Jack Cuzick, PhD, FMedSci, on DCIS Recurrence Rates: Anastrozole vs Tamoxifen
Jack Cuzick, PhD, FMedSci, of Queen Mary, University of London, discusses his phase III study on postmenopausal women with DCIS who had similar outcomes whether they took tamoxifen or anastrozole for 5 years after surgery. (Abstract S6-03)
Hans Wildiers, MD, PhD on the TH3RESA Study: Final OS Results
Hans Wildiers, MD, PhD, of the University Hospitals, Leuven, discusses this phase III study on the use of ado-trastuzumab emtansine vs treatment of physician’s choice in previously treated HER2-positive metastatic breast cancer (Abstract S5-05).
Olivier Casasnovas, MD, on Advanced-Stage Hodgkin Lymphoma: Interim Analysis of the Lysa Study (French Language Version) 
Olivier Casasnovas, MD, of Hôpital Le Bocage, discusses in French a phase III study comparing an early PET-driven treatment de-escalation to a not PET-monitored strategy in patients with advanced Hodgkin lymphoma (Abstract 577).
Olivier Casasnovas, MD, on Advanced-Stage Hodgkin Lymphoma: Interim Analysis of the Lysa Study
Olivier Casasnovas, MD, of Hôpital Le Bocage, discusses a phase III study comparing an early PET-driven treatment de-escalation to a not PET-monitored strategy in patients with advanced Hodgkin lymphoma (Abstract 577). To see the French language version of this video, please click here.
ESMO Asia 2015: Results From the KEYNOTE-010 Trial Show Pembrolizumab Benefit in Patients With NSCLC
More patients with advanced non–small cell lung cancer (NSCLC) could benefit from pembrolizumab (Keytruda), said Roy Herbst, MD, PhD, Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven. Dr. Herbst presented promising results from the pivotal phase...
ESMO Asia 2015: Immunotherapy and Targeted Therapy Provide New Options for Difficult-to-Treat Head and Neck Cancer
Novel strategies are being explored for difficult-to-treat and advanced head and neck cancer—the most heterogeneous group of malignancies that are generally associated with poor survival—and encouraging results have been presented in two trials at the first European Society for Medical...
ESMO Asia 2015: Afatinib a Better Choice for EGFR-Mutated Lung Cancer in First-Line Treatment
Patients with epidermal growth factor receptor (EGFR)-activating mutations in advanced lung cancer seem to benefit more from afatinib (Gilotrif) than gefitinib (Iressa) as first-line treatment, Park et al reported in a study (Abstract LBA2) presented at the European Society for Medical Oncology...
Adding Ibrutinib to Bendamustine/Rituximab Increases Progression-Free Survival in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
In the phase III HELIOS trial, reported in The Lancet Oncology, Chanan-Khan et al found that adding the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) to bendamustine (Treanda)/rituximab (Rituxan) increased progression-free survival in patients with chronic lymphocytic leukemia or...
Similar Outcomes Reported With Surgery vs Definitive Concurrent Chemoradiotherapy in Resectable Stage III NSCLC
Findings in an early-terminated German phase III trial (ESPATUE), reported in the Journal of Clinical Oncology by Eberhardt et al, indicate similar outcomes with surgery vs definitive concurrent chemoradiotherapy after induction chemotherapy and chemoradiotherapy in patients with resectable stage...
Treatment Trends in Stage II and III Colorectal Cancer in the United States
As reported by Murphy et al in the Journal of the National Cancer Institute, an analysis of Surveillance, Epidemiology, and End Results (SEER) data from patients with stage II or III colorectal cancer indicated that the use of adjuvant chemotherapy in colon cancer declined slightly between 2005 and ...
Moore Scoring System Helps Identify Women With Advanced Cervical Cancer Who May Not Benefit From Bevacizumab
Previously published reports from the randomized phase III Gynecologic Oncology Group (GOG) protocol 240 clinical trial showed that adding bevacizumab (Avastin) to a chemotherapy regimen of paclitaxel plus cisplatin or topotecan significantly increased overall survival and progression-free survival ...
FDA Allows Marketing of Cooling Cap to Reduce Hair Loss During Chemotherapy
The U.S. Food and Drug Administration has cleared the first cooling cap to reduce hair loss in female breast cancer patients undergoing chemotherapy for marketing in the United States. Hair loss is a common side effect of certain types of chemotherapy, commonly associated with the treatment of...
SABCS 2015: Phase III BELLE-2 Trial Meets Primary Endpoint of Progression-Free Survival
Among women with locally advanced or metastatic hormone receptor–positive breast cancer that was resistant to hormone therapy, those who had mutated PIK3CA detected in their blood benefited from a combination of the investigational PI3K inhibitor buparlisib and fulvestrant (Faslodex),...
SABCS 2015: 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...
