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Showing 3851 - 3900Options Shifting for First-line Treatment of Renal Cell Carcinoma
Trials with pazopanib (Votrient) have “provided significant efficacy, toxicity, and tolerability data for pazopanib to be established as a first-line standard of care” for renal cell carcinoma,” Tim Eisen, PhD, of the University of Cambridge, United Kingdom, stated at the 11th International Kidney...
Expert Point of View: Fausto Roila, MD
Thromboprophylaxis for patients with a central venous catheter is at present not recommended by the international oncologic associations. This is based on the results of four recent randomized controlled trials, three of them double-blind, in which there was no statistically significant difference...
Does Prophylaxis Prevent Catheter-related Thrombosis?
In ambulatory patients with cancer, the risk of catheter-related deep-vein thrombosis can be reduced by almost half with anticoagulation prophylaxis, according to a single-center French study presented at the 2012 European Society for Medical Oncology (ESMO) Congress in Vienna.1 Catheters implanted ...
Novel Agents for Breast Cancer and Prostate Cancer Impressive in Early Trials
Several sessions at the 2012 European Society for Medical Oncology (ESMO) Congress in Vienna focused on novel targeted therapies in various stages of development. Summarized here are data on two promising drugs for breast cancer and two for prostate cancer. E-3810 in Breast Cancer Two experimental...
Updated Results from T-DM1 and Regorafenib Trials, plus Other Highlights from ESMO 2012
The 35th European Society for Medical Oncology (ESMO) Congress in Vienna broke all records for attendance, with about 16,000 attendees from all over the world. Some sessions were standing room only, including the Presidential Symposia, the ESMO-ASCO Joint Symposium on genomics in breast cancer, and ...
Interval-compressed Chemotherapy More Effective with No Increase in Toxicity
A randomized controlled trial among patients with newly diagnosed localized Ewing sarcoma found that “chemotherapy administered every 2 weeks is more effective than chemotherapy administered every 3 weeks, with no increase in toxicity,” investigators from the Children’s Oncology Group reported in...
Small Increase in Cardiac Events for Trastuzumab plus Anthracycline in HER2-positive Disease
A 7-year follow-up of the phase III National Surgical Adjuvant Breast and Bowel Project (NSABP) protocol B-31 found that the cumulative difference in the rate of cardiac events was 3.1% between patients with HER2-positive, node-positive breast cancer who received trastuzumab (Herceptin) in addition ...
Expert Point of View: Robert Jones, MD
“The data speak for themselves,” stated Robert Jones, MD, of the Beatson West of Scotland Cancer Center, Glasgow, UK, during discussion of the MAINSAIL trial at the 2012 ESMO Congress. The study raises some important questions, he continued: What are the implications for designing future trials?...
Lenalidomide Trial Negative in Metastatic Castration-resistant Prostate Cancer
Lenalidomide (Revlimid) failed to improve survival and increased toxicity when added to docetaxel and prednisone in men with chemotherapy-naive, progressive, metastatic castration-resistant prostate cancer in the phase III MAINSAIL trial reported at the 2012 ESMO Congress in Vienna. This study...
Top 10 Most Viewed Articles on ASCOPost.com for 2012
Novel Multikinase Inhibitor Improves Survival in Metastatic Colorectal CancerBy Caroline HelwickThe novel tyrosine kinase inhibitor regorafenib, given as a single agent to patients with treatment-refractory metastatic colorectal cancer, significantly improved overall survival and delayed disease...
Expert Point of View: Nicoletta Colombo, MD
Formal discussant of the AURELIA presentation, Nicoletta Colombo, MD, University of Milan Bicocca, European Institute of Oncology, Milan, Italy, said, “This is the only positive trial in patients with platinum-resistant recurrent ovarian cancer.” Dr. Colombo was impressed with the activity of...
Androgen-deprivation Therapy plus Radiation Proven as Standard of Care for High-risk Prostate Cancer
A combined-modality approach of androgen-deprivation therapy plus radiation therapy achieves a substantial survival benefit over androgen-deprivation therapy alone in patients with locally advanced prostate cancer according to final analysis of an intergroup randomized phase III study conducted by...
Oral Rinse Doxepin Relieves Painful Mucositis in Head and Neck Cancer
Doxepin oral rinse significantly improved oral mucositis in patients treated with radiation therapy for head and neck cancer according to results of a phase III trial presented at the 54th Annual Meeting of the American Society for Radiation Oncology (ASTRO) in Boston. However, the improvement was...
Revised Everolimus Dosing and New Safety/Efficacy Data for Approval in Subependymal Giant Cell Astrocytoma
On August 29, 2012, everolimus in a tablet for oral suspension form (Afinitor Disperz) was given accelerated approval for the treatment of pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but...
Liposomal Vincristine for Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia
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. Indication In August 2012, vinCRIStine sulfate LIPOSOME injection...
Supplemental New Drug Application Submitted for Erlotinib as a First-line Therapy in Genetically Distinct NSCLC
Astellas Pharma US, Inc, announced it has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval for erlotinib (Tarceva) tablets for first-line treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth...
Combination Therapy Not Better than Single-agent Bevacizumab for Advanced Renal Cell Carcinoma in BeST Trial
None of three combination therapies tested among patients with advanced renal cell carcinoma in the BeST trial came close to achieving the primary objective of a 67% improvement in median progression-free survival compared to single-agent bevacizumab (Avastin), Keith T. Flaherty, MD, reported at...
Bevacizumab Added to Radiation and Chemotherapy Improved Progression-free Survival in Newly Diagnosed Glioblastoma
Recently announced results of the phase III AVAglio study showed that bevacizumab (Avastin) in combination with radiation and temozolomide chemotherapy increased progression-free survival (a co-primary endpoint) by 36% compared to radiation and temozolomide chemotherapy plus placebo (hazard ratio...
Radiation Therapy Extends Survival in Elderly Women with Early Breast Cancer
Chronologic age alone should not preclude use of radiation in elderly women with early breast cancer, suggest two studies presented at the 54th Annual Meeting of the American Society for Radiation Oncology (ASTRO). Both studies showed a survival improvement in elderly women with early breast cancer ...
Expert Point of View: Vinai Gondi, MD
This memantine study is a critical first step in understanding and delaying cognitive deterioration in brain metastasis patients, noted formal discussant Vinai Gondi, MD, Associate Director of Research at the CDH Proton Center in Warrenville, Illinois, and Clinical Associate Professor at the...
Cabozantinib Approved for Treatment of Progressive Metastatic Medullary Thyroid Cancer
The FDA recently approved cabozantinib (Cometriq), for the treatment of patients with progressive metastatic medullary thyroid cancer. Cabozantinib is a small molecule that inhibits the activity of multiple tyrosine kinases, including RET, MET, and VEGF receptor 2. The approval was based on the...
Persistent Survival Benefit in Patients with Untreated Disease Treated with Bortezomib Added to Melphalan and Prednisone
A final analysis of the phase III VISTA trial (Velcade as Initial Standard Therapy in Multiple Myeloma: Assessment with Melphalan and Prednisone) found a persistent significant benefit in overall survival with VMP (bortezomib, melphalan, prednisone) vs MP (melphalan, prednisone) in patients with...
Expert Point of View: Ian Smith, MD
Invited discussant Ian Smith, MD, of The Royal Marsden Hospital and Institute of Cancer Research in London, commented at the ESMO meeting that while all three arms of NeoALLTO, especially the arm with dual HER2 blockade, achieved good pathologic complete response rates, “the breast-conserving...
FDA Expands Abiraterone’s Use for Late-stage Prostate Cancer
In December, the FDA approved an expanded indication for abiraterone acetate (Zytiga) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. Trial Design The approval was based on a trial randomly assigning patients with metastatic...
Faster Rituximab Infusion for Previously Untreated Follicular Non-Hodgkin and Diffuse Large B-cell Lymphomas
On October 19, 2012, FDA approved a 90-minute infusion for rituximab (Rituxan) starting at cycle 2 for patients with previously untreated follicular non-Hodgkin or diffuse large B-cell lymphoma who do not experience a grade 3 or 4 infusion-related reaction during cycle 1.1 Patients with clinically...
Umbilical Cord Blood Transplant: Two Units are No Better Than One in Children with Hematologic Malignancies
Use of two partially HLA-matched units of umbilical cord blood were not superior to a single unit if it contained an adequate number of hematopoietic stem cells, according to a randomized study by the Blood and Marrow Clinical Trials Network. Results were reported at the 54th Annual Meeting of the...
Radiation Therapy for Patients with Invasive Breast Cancer: 3 Weeks Proves as Effective as 5 Weeks
Ten-year follow-up of the two-part UK Standardisation of Breast Radiotherapy Trials (START) supported the 5-year findings, demonstrating that a 3-week course of adjuvant radiation therapy is equivalent to a 5-week course of radiation for women with invasive breast cancer. The update was presented...
Overall Survival Benefit Achieved with Pomalidomide in Advanced Myeloma
Support for the oral immunomodulatory agent pomalidomide for multiple myeloma took a step forward when the phase III MM-003 trial showed a survival advantage in patients with advanced disease, in addition to a doubling in progression-free survival, when pomalidomide was given with low-dose...
FDA Approves Ponatinib to Treat CML and Philadelphia Chromosome–positive ALL
In December, the FDA granted accelerated approval to ponatinib (Iclusig) for the treatment of adult patients with chronic-, accelerated-, or blast-phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome–positive...
Adding Temsirolimus to Letrozole Did Not Improve Survival but Might Benefit Patients under 65
Adding temsirolimus (Torisel) to letrozole did not improve progression-free survival in patients with aromatase inhibitor–naive, estrogen receptor (ER)-positive advanced breast cancer, but exploratory analysis indicated the combination could benefit postmenopausal patients ≤ 65. In their Journal of ...
Cisplatin Linked to Significantly Increased Risk of Venous Thromboembolism
Patients with advanced solid tumors treated with cisplatin-based chemotherapy had a significantly increased risk of venous thromboembolic events, according to a meta-analysis of 38 randomized phase II and III trials evaluating cisplatin-based vs non–cisplatin-based chemotherapy. The trials involved ...
Postoperative Radiation Therapy Extends Progression-free Survival in Men with High-risk Prostate Cancer
Postoperative irradiation significantly improves biochemical progression-free survival and local control compared with a “wait-and-see” approach in men with high-risk prostate cancer, according to more than a decade of long-term follow-up in the European Organisation for Research and Treatment of...
PET-negative Scan after Short-course Chemotherapy Identifies Early Hodgkin Lymphoma Patients Who Can Forgo Radiation
Positron-emission tomography (PET)-directed therapy is promising for early-stage Hodgkin lymphoma, according to results of the UK NCRI RAPID trial presented at the 54th Annual Meeting of the American Society of Hematology (ASH).1 The use of PET scan enabled the identification of a population of...
Dune Medical Devices Receives FDA Approval for the MarginProbe System
Dune Medical Devices, Inc, announced that the FDA has granted Premarket Approval to the MarginProbe System, the company’s breakthrough intraoperative tissue assessment tool for early-stage breast cancer surgery. The technology significantly improves surgeons’ ability to intraoperatively identify...
SIDEBAR: Treating Earlier with Eribulin
Eribulin is also being evaluated for use earlier in patients with breast cancer, in both the metastatic and adjuvant settings, in three studies described at the San Antonio meeting. In a phase II study of eribulin as first-line treatment for locally recurrent or metastatic HER2-negative breast...
Primary Endpoint Not Met for Eribulin vs Capecitabine in Breast Cancer
While a global phase III trial failed to meet its primary endpoint in showing an overall or progression-free survival benefit for eribulin (Halavan) in metastatic breast cancer, a trend toward greater efficacy than capecitabine (Xeloda) was observed, researchers reported at the 2012 San Antonio...
Inotuzumab Moves Forward in Relapsed/Refractory ALL
Single-agent inotuzumab ozogamicin achieved an encouraging overall response rate of 57% in the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL) in a phase II trial reported at the 54th Annual Meeting of the American Society of Hematology (ASH). Response was independent of monthly ...
Survival Benefit Achieved with Four Drugs plus Maintenance in Myeloma
An overall survival benefit in newly diagnosed multiple myeloma was attained with a four-drug induction regimen followed by a duet for maintenance in a study from the Italian GIMEMA network. Antonio Palumbo, MD, Chief of the Myeloma Unit at the University of Torino in Italy, reported the findings...
Tremelimumab Not Better Than Standard-of-care Chemotherapy in Patients with Advanced Melanoma
Tremelimumab did not produce a statistically significant advantage in overall survival compared to first-line standard-of-care chemotherapy in a phase III randomized trial reported in the Journal of Clinical Oncology. At final analysis, median overall survival by intent to treat was 12.6 months...
Ponatinib in Chronic Myeloid Leukemia and Philadelphia Chromosome–positive Acute Lymphoblastic Leukemia
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. Indication On December 14, 2012, ponatinib (Iclusig) was granted...
Subcutaneous Trastuzumab a Potential Alternative to Intravenous Administration in Breast Cancer
Subcutaneous administration of trastuzumab might offer improvements in patient convenience and resource use compared with conventional intravenous administration (Herceptin). A new subcutaneous trastuzumab formulation containing a fixed dose of 600 mg and recombinant human hyaluronidase PH-20...
Treatment of HER2-positive Disease in 2013
From the initial discovery of the HER2 family of receptors in the mid-1980s to the present, a “wealth of riches” has been uncovered in terms of agents that can target pathways relevant to this aggressive breast cancer type, notes Hope S. Rugo, MD, Director of Breast Oncology and Clinical Trials...
Research Roundup from San Antonio: New Data on Triple-negative, HER2-positive, Local, and Advanced Breast Cancer
The 2012 San Antonio Breast Cancer Symposium featured more than 2,500 abstracts and lectures, including timely research in the field and discussions for scientists and clinicians alike. In addition to nearly two dozen in-depth reports from the meeting, The ASCO Post brings readers the following...
ASH Highlights Included New Data in Myeloma, Lymphoma, and Leukemia, plus Studies of Mucositis and Graft-vs-Host Disease
The 54th Annual Meeting of the American Society of Hematology (ASH) featured about 5,000 abstracts, including oral sessions and posters, as well as named lectures and symposia. In addition to our regular news coverage from the meeting, below are capsule summaries of a few news highlights that we...
Expert Point of View: Michel Ducreux, MD, PhD
Michel Ducreux, MD, PhD, of the Institut Gustave Roussy in Villejuif, France, discussed the findings at the ESMO meeting. He said that TH-302 represents a “new drug and new concept, the microenvironment.” He noted, “Pancreatic cancers are frequently hypovascularized, at least the primary tumor, and ...
TH-302 plus Gemcitabine Delays Progression in Untreated Advanced Pancreatic Adenocarcinoma
A novel drug that is activated under conditions of hypoxia significantly delayed progression in locally advanced or metastatic pancreatic adenocarcinoma when combined with gemcitabine in untreated patients. The findings of the randomized phase II TH-CR-04 trial were presented at the 2012 ESMO...
Chemotherapy-free Regimen Successful in Acute Promyelocytic Leukemia
For the first time, a chemotherapy-free regimen was superior to conventional cytotoxic chemotherapy for the treatment of acute promyelocytic leukemia (APL). The combination of all-trans retinoic acid (ATRA) plus arsenic trioxide (Trisenox) achieved significantly superior overall survival compared...
Expert Point of View: Philip Agop Philip, MD and Alan P. Venook, MD
Philip Agop Philip, MD, Head of the Multidisciplinary Team for Gastrointestinal and Neuroendocrine Oncology and Neuroendocrine at Karmanos Cancer Institute at Wayne State University, Detroit, was the formal discussant of the paper at the Gastrointestinal Cancers Symposium. He said the positive...
Nab-paclitaxel/Gemcitabine Combination Improves Overall Survival in Pancreatic Cancer
In patients with treatment-naive metastatic pancreatic cancer, the addition of nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) to gemcitabine improved overall survival vs gemcitabine alone, in an international study presented at the 2013 Gastrointestinal Cancers Symposium.1 New Standard “We...
No Rationale for Eliminating Prophylactic Platelet Transfusions in Patients with Hematologic Malignancies
Prophylactic platelet transfusions should remain the standard of care for many patients with hematologic malignancies who are thrombocytopenic during intensive treatment or stem cell transplant, investigators of the TOPPS trial (noninferiority Trial Of Prophylactic Platelet transfusionS)...
