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Showing 2851 - 2900EHA 2018: Obinutuzumab or Rituximab Plus Chlorambucil in CLL
Data from the final analysis of the CLL11 study evaluating obinutuzumab (Gazyva)-based treatment in previously untreated chronic lymphocytic leukemia (CLL) was presented by Goede et al during the Presidential Symposium at the 23rd Annual Congress of the European Hematology Association (EHA)...
Studies of Daratumumab in Combination With Anti–PD-L1 Agents Stopped
On May 26, Genmab A/S announced that following a planned review, the Data Monitoring Committee (DMC) has recommended that the phase Ib/II study (CALLISTO/LUC2001) of daratumumab (Darzalex) in combination with the anti–programmed cell death ligand 1 (PD-L1) antibody atezolizumab (Tecentriq) vs ...
FDA Expands Approval of Pembrolizumab to Include New Lymphoma Indication
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma or those who have relapsed after two or more prior lines of therapy. KEYNOTE-170...
Analysis of Intracranial Response to Brigatinib in ALK-Positive NSCLC With Brain Metastases
In an analysis of two clinical trials reported in the Journal of Clinical Oncology, Camidge et al found that brigatinib (Alunbrig) produced high intracranial response rates and good intracranial progression-free survival in patients with ALK-positive non–small cell lung cancer (NSCLC) and...
AUA 2018: Finasteride Reduces Risk of Prostate Cancer and Is Safe, Long-Term Results Show
Twenty-five years after it opened for enrollment, the Prostate Cancer Prevention Trial (PCPT) has delivered a final verdict: finasteride, a common hormone-blocking drug, reduces men's risk of getting prostate cancer without increasing their risk of dying from the disease. Initial study...
Study Evaluates Effect of Restrictive Opioid Protocol After Gynecologic Surgery
THE NUMBER of opioids prescribed after surgery for gynecologic cancer decreased significantly after implementation of an ultra-restrictive opioid prescription protocol, with no apparent negative effect on patient satisfaction or pain, according to research presented by Jaron Mark, MD, and...
Poorer Outcomes Reported With Minimally Invasive Surgery Than Open Approach in Early Cervical Cancer
PATIENTS UNDERGOING minimally invasive radical hysterectomy for early cervical cancer had higher rates of disease recurrence and worse disease-free, progression-free, and overall survival than did women who had the open approach, according to results from the phase III LACC trial, presented by...
Early Detection and Intervention Reduce Breast Cancer–Related Lymphedema
A NEW STUDY has found that early detection along with a simple intervention can be highly effective in preventing breast cancer–related lymphedema for at-risk women. According to data presented at the 2018 Annual Meeting of the American Society of Breast Surgeons,1 82% of women identified at an...
Geriatric Assessment Improves Communication Between Oncologists and Older Patients
A FEDERALLY FUNDED randomized study demonstrated that use of geriatric assessment in the routine care of older adults with advanced cancer significantly improved doctor-patient communication about age-related concerns as well as patient satisfaction with the communication. The study was presented...
Mobile and Sensor Technology May Lead to Reduced Symptoms of Head and Neck Cancer and Its Treatment
A RANDOMIZED clinical trial evaluating the use of mobile and sensor technology to remotely monitor symptoms in patients receiving radiation therapy for head and neck cancer found that use of this technology reduced the severity of symptoms related to cancer and its treatment compared with usual...
Immunotherapy Benefits Survival, Improves Safety, vs Platinum-Based Chemotherapy for PD-L1–Expressing NSCLC
IMMUNOTHERAPY WITH pembrolizumab (Keytruda) improved overall survival compared with investigator’s choice of platinum-based chemotherapy as first-line treatment for patients with advanced non–small cell lung cancer (NSCLC) in the KEYNOTE-042 trial. Median overall survival was improved by 4 to 8...
FDA Approves Second-Line Venetoclax for CLL or SLL With or Without 17p Deletion
On June 8, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. MURANO Approval was based ...
Following Guidelines for Healthy Eating and Physical Activity May Improve Survival in Patients Treated for Colon Cancer
Following guidelines for proper nutrition, maintaining a healthy weight, and staying physically active may improve survival among patients treated for colon cancer, according to the results of a study with nearly 1,000 patients followed for a median of 7 years.1 “The study suggests that if...
2018 ASCO: Lenalidomide Plus Rituximab vs Rituximab Plus Chemotherapy in Previously Untreated Follicular Lymphoma
Results from RELEVANCE, a phase III, randomized, open-label, international clinical study conducted in partnership with the Lymphoma Academic Research Organisation (LYSARC), were presented by Fowler et al at the 2018 ASCO Annual Meeting (Abstract 7005). This study evaluated the investigational...
2018 ASCO: Olaparib in Combination With Abiraterone in Metastatic Castration-Resistant Prostate Cancer
Data presented by Clarke et al at the 2018 ASCO Annual Meeting (Abstract 5003) showed clinical improvement in median radiologic progression-free survival with olaparib (Lynparza) in combination with abiraterone (Yonsa, Zytiga) compared to abiraterone monotherapy, a current standard of care, in...
Nivolumab Plus Ipilimumab in Advanced Renal Cell Carcinoma: A Shift in the Treatment Paradigm
For over a decade, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors have been the standard first-line agents in the management of patients with advanced or metastatic clear cell renal cell carcinoma.1-3 Historically, phase III trials of first-line VEGF therapies included...
2018 ASCO: Pomalidomide, Bortezomib, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma
For patients with multiple myeloma who have been treated with lenalidome (Revlimid) but have relapsed and not responded to other therapy, a three-drug combination can significantly extend the time in which the disease is held in check. The findings of the phase III OPTIMISMM trial were presented by ...
2018 ASCO: KEYNOTE-427 Trial Evaluates Immunotherapy in Advanced Clear Cell Renal Cell Carcinoma
Interim results from cohort A of KEYNOTE-427, a phase II trial evaluating pembrolizumab (Keytruda) as first-line treatment for advanced clear cell renal cell carcinoma (RCC), were presented by McDermott et al at the 2018 ASCO Annual Meeting (Abstract 4500). Interim data showed an overall response...
2018 ASCO: 2-Year Update of Pivotal JAVELIN Merkel 200 Trial Shows Continued Durable Responses With Avelumab
Updated efficacy and safety data from the international, multicenter JAVELIN Merkel 200 trial of avelumab (Bavencio) in patients with metastatic Merkel cell carcinoma were presented by Nghiem et al at the 2018 ASCO Annual Meeting (Abstract 9507). 2-Year Follow-up At the 2-year follow-up update of ...
2018 ASCO: Neoadjuvant Use of PARP Inhibitor Shows Promise in Early-Stage, BRCA-Mutated Breast Cancer
In a small phase II study of early-stage breast cancer patients with BRCA1/2 mutations, researchers at The University of Texas MD Anderson Cancer Center found that more than half of the women who took the PARP inhibitor talazoparib once daily prior to surgery had no evidence of disease at the time...
2018 ASCO: iNNOVATE Trial Evaluates Ibrutinib in Combination With Rituximab in Patients With Waldenström's Macroglobulinemia
Results from a preplanned interim analysis of the phase III iNNOVATE (PCYC-1127) study evaluating the investigational use of ibrutinib (Imbruvica) in combination with rituximab (Rituxan) in relapsed/refractory and treatment-naive patients with Waldenström’s macroglobulinemia were...
2018 ASCO: Geriatric Assessment Improves Communication Between Oncologists and Older Patients
A federally funded randomized study demonstrated that the use of geriatric assessment in routine care of older adults with advanced cancer significantly improved doctor-patient communication about age-related concerns as well as patient satisfaction with the communication. The study was featured in ...
FDA Identifies Efficacy Issue in Clinical Trials of Pembrolizumab or Atezolizumab as Monotherapy in Urothelial Cancer With Low Expression of PD-L1
On May 18, the U.S. Food and Drug Administration (FDA) alerted health-care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of pembrolizumab (Keytruda) or atezolizumab (Tecentriq) as monotherapy in clinical trials to treat patients with ...
How a Recent Study Heats up the Debate Over Intraperitoneal Chemotherapy in Newly Diagnosed Advanced Ovarian Cancer
Based on pharmacokinetic and preclinical data, there appears to be a biologic advantage to the use of intraperitoneal chemotherapy in treating some malignancies confined to the abdomen. Since most ovarian, fallopian tube, and peritoneal cancers present and recur in the peritoneal cavity, this...
Role of MRI in Detection of Clinically Significant Prostate Cancer: ‘Practice-Affirming’ Results From The PRECISION Trial
Simultaneously presented at the 2018 European Association of Urology meeting and published in The New England Journal of Medicine, the PRECISION trial will go down as a landmark study for solidifying the role of magnetic resonance imaging (MRI) in prostate cancer diagnosis.1 This trial provides...
Tisagenlecleucel for Adults With Relapsed or Refractory Large B-Cell Lymphoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 1, 2018, tisagenlecleucel (Kymriah), a...
FDA Approves Daratumumab/VMP Combination for Newly Diagnosed Multiple Myeloma
On May 7, the U.S. Food and Drug Administration(FDA) approved daratumumab (Darzalex) in combination with bortezomib (Velcade), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone—VMP—for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for...
FDA Expands Tisagenlecleucel Approval to Include Relapsed or Refractory Large B-Cell Lymphoma
On May 1, 2018, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade...
Upfront Use of Nelarabine Plus Chemotherapy Improves Disease-Free Survival in T-Cell Malignancies
Upfront use of nelarabine plus standard Children’s Oncology Group–augmented Berlin-Frankfurt-Münster (aBFM) chemotherapy boosted survival rates in children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic leukemia (T-LL), according to the...
For Adjuvant Trastuzumab, 6 Months Is Noninferior to 12 Months
The noninferiority phase III Persephone trial could shake up the standard of care for adjuvant trastuzumab (Herceptin), showing that patients with early-stage HER2-positive breast cancer derived as much benefit from 6 months of trastuzumab as 12 months, according to research from the United Kingdom ...
2018 ASCO: Mobile and Sensor Technology May Lead to Reduced Symptom Severity in Patients With Head and Neck Cancer
A randomized clinical trial evaluating the use of mobile and sensor technology to remotely monitor symptoms in patients receiving radiation therapy for head and neck cancer found that use of this technology reduced severe symptoms related to cancer and its treatment compared with usual care....
2018 ASCO: Shortening Adjuvant Trastuzumab to 6 Months in Patients With HER2-Positive Early Breast Cancer Is Effective and Reduces Cardiac Toxicities
Persephone, a large phase III randomized noninferiority study conducted in the United Kingdom comparing 6 months to 12 months of trastuzumab (Herceptin) in patients with HER2-positive early breast cancer has found 6 months of trastuzumab to be noninferior to 12 months of the therapy. In addition,...
2018 ASCO: Adding Nelarabine to Standard Chemotherapy Improves Survival in Children and Young Adults With T-Cell Cancers
A large randomized phase III clinical trial by the Children’s Oncology Group (COG) investigating the safety and efficacy of adding nelarabine (Arranon) to COG-augmented Berlin-Frankfurt-Munster chemotherapy (aBFM) to treat newly diagnosed patients with T-cell acute lymphoblastic...
Updated ASCO/SSO Guideline on Sentinel Lymph Node Biopsy in Melanoma: Addressing Fundamental Clinical Questions
Dr. Thompson is Professor of Melanoma and Surgical Oncology, Sydney Medical School, The University of Sydney, and Senior Surgeon, Melanoma Institute Australia, Sydney. IN THE MID-1990s, the surgical management of patients presenting with primary cutaneous melanomas changed forever when the...
Actively Recruiting Clinical Trials Focused on Nonmelanoma Skin Cancers
THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on nonmelanoma skin cancers—basal cell carcinoma; merkel cell carcinoma; cutaneous lymphoma; and squamous cell carcinoma. These studies are investigating brachytherapy; topical...
Adjuvant Pembrolizumab Improves Relapse-Free Survival in High-Risk Stage III Melanoma
ADJUVANT THERAPY with pembrolizumab (Keytruda) significantly prolonged recurrence-free survival compared with placebo for patients with resected high-risk stage III melanoma, according to the results of the EORTC 1325/KEYNOTE-054 trial.1 Patients who received pembrolizumab had a 43% reduction in...
Pembrolizumab Plus Standard Chemotherapy Improves Survival in Newly Diagnosed Metastatic Non–Small Cell Lung Cancer
ADDING THE IMMUNE checkpoint inhibitor pembrolizumab (Keytruda) to standard chemotherapy with pemetrexed (Alimta) and a platinum as first-line therapy was superior to chemotherapy alone in the KEYNOTE-189 trial.1 Induction and maintenance therapies with the new triplet therapy improved overall...
FDA Accepts sBLA, Grants Priority Review to Atezolizumab for Initial Treatment of Metastatic Nonsquamous NSCLC
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the first-line treatment of metastatic nonsquamous...
FDA Approves Daratumumab in Combination With VMP for Newly Diagnosed Patients With Multiple Myeloma Who Are Transplant-Ineligible
On May 7, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with bortezomib (Velcade), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone—VMP—for the treatment of patients with newly diagnosed multiple myeloma who are...
ASBrS 2018: Early Detection and Intervention Effective for Preventing Breast Cancer–Related Lymphedema
Early, ongoing screening of lymphatic function and immediate patient-administered therapies as needed are highly effective in improving outcomes for women at high risk for breast cancer–related lymphedema (BCRL). These were the findings of a new study presented at the American Society of ...
ASBrS 2018: Regular Mammograms May Mean Earlier Breast Cancer Diagnosis and Less Aggressive Treatment
Women with breast cancer who underwent regular mammographic screening were diagnosed with earlier-stage disease and treated with significantly less aggressive therapies than those who delayed or never underwent screening, according to new research presented at the American Society of Breast...
FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
On April 30, the U.S. Food and Drug Administration (FDA) accepted for priority review the biologics license application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma or patients with locally advanced cutaneous squamous cell carcinoma who...
FDA Approves Drug Combination for Adjuvant Treatment of BRAF V600–Mutant Melanoma
On April 30, 2018, the U.S. Food and Drug Administration (FDA) approved dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and lymph node involvement following...
Long-Term Quality-of-Life Results Compared for Two Radiotherapy Strategies After Breast-Conserving Surgery
As reported in The Lancet Oncology by Schäfer et al, little difference in quality of life was observed over long-term follow-up between women receiving accelerated partial-breast irradiation (APBI) with interstitial brachytherapy vs whole-breast irradiation (WBI) after breast-conserving...
Nilotinib Label Updated to Provide Treatment Discontinuation Recommendations for CML With Sustained Molecular Response
On December 22, 2017, the product label for nilotinib (Tasigna) was updated to include information on nilotinib discontinuation, postdiscontinuation monitoring, and guidance for treatment reinitiation in patients with Philadelphia chromosome (Ph)-positive chronic myeloid leukemia (CML) who have...
Positive Results From QUADRA Trial of Niraparib in Ovarian Cancer
Tesaro recently announced results from the QUADRA study, which was designed to assess the clinical benefit of niraparib (Zejula) treatment in heavily pretreated patients with ovarian cancer. Results successfully achieved the prespecified primary endpoint and demonstrated niraparib monotherapy...
FDA Approves Dabrafenib Plus Trametinib for Adjuvant Treatment of Melanoma With BRAF V600E or V600K Mutations
On April 30, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to dabrafenib (Tafinlar) and trametinib (Mekinist) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations (as detected by an FDA-approved test) and involvement of...
Long-Term Outcomes of Adjuvant Treatment in High-Risk Prostate Cancer
As reported by Hussain et al in the Journal of Clinical Oncology, long-term follow-up of the phase III SWOG S9921 trial showed that the addition of adjuvant mitoxantrone and prednisone (MP) to androgen-deprivation therapy (ADT) did not improve survival and increased death from other malignancies in ...
FDA Approves Osimertinib for First-Line Treatment of Metastatic NSCLC With Most Common EGFR Mutations
On April 18, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as...
Fine-Tuning Treatment in Myeloma and Leukemia
It is a difficult task to include every notable presentation from the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition. In addition to our more comprehensive coverage of the news from that meeting over the past several issues, below are summaries of additional key...
