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breast cancer

Pertuzumab, Trastuzumab, Plus Aromatase Inhibitor Beneficial in Metastatic Breast Cancer

In the phase II PERTAIN study of locally advanced or metastatic hormone receptor–positive, HER2-positive breast cancer patients, the addition of pertuzumab (Perjeta) to a regimen of trastuzumab (Herceptin) and an aromatase inhibitor in the first-line setting significantly improved progression-free ...

lung cancer

Osimertinib Significantly Improves Survival for Patients With Non–Small Cell Lung Cancer

For patients with epidermal growth factor receptor (EGFR) T790M–positive non–small cell lung cancer (NSCLC), osimertinib (Tagrisso) demonstrated clinically superior efficacy over pemetrexed (Alimta) plus a platinum agent, with a 70% reduction in the risk of disease progression, according to the...

leukemia

Expert Point of View: Richard Furman, MD

“These results are interesting, important, and relevant for maintenance post chemotherapy, but if we are not using chemotherapy, they may not be relevant,” said Richard Furman, MD, of Weill Cornell Medical College, New York Presbyterian Hospital, New York. He said that newer drugs such as...

leukemia

Lenalidomide Maintenance Extends Progression-Free Survival in CLL

Lenalidomide (Revlimid), a cornerstone of therapy for multiple myeloma in the modern era, is making headway as maintenance therapy in chronic lymphocytic leukemia (CLL). Separate phase III studies presented at the 2016 American Society of Hematology (ASH) Annual Meeting & Exposition showed...

lymphoma

FDA Approves Ibrutinib in Relapsed/Refractory Marginal Zone Lymphoma

The U.S. Food and Drug Administration (FDA) today approved ibrutinib (Imbruvica) for the treatment of patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti–CD20-based therapy. Accelerated approval was granted for this indication based on...

bladder cancer

FDA Accepts sBLA and Grants Priority Review for Atezolizumab in Locally Advanced or Metastatic Urothelial Carcinoma

On January 9, the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin...

lung cancer

Is Adding Onartuzumab to Erlotinib of Benefit in Advanced Non–Small Cell Lung Cancer?

In a phase III METLung trial reported in the Journal of Clinical Oncology, Spigel et al found that adding the MET inhibitor onartuzumab to erlotinib (Tarceva) was of no benefit in patients with MET-positive advanced non–small cell lung cancer (NSCLC) who had progressed after platinum-based...

breast cancer

Buparlisib Phase III Findings: Glass Half Empty or Half Full?

The pan-phosphoinositide 3-kinase (PI3K) inhibitor buparlisib combined with fulvestrant (Faslodex) prolonged progression-free survival compared with placebo and fulvestrant in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer previously treated with an...

breast cancer

Pathologic Complete Response Not Boosted by Addition of Estrogen Deprivation to Chemotherapy and Dual HER2 Blockade

The addition of estrogen deprivation to neoadjuvant chemotherapy and HER2 blockade did not enhance the achievement of pathologic complete responses in women with early-stage breast cancer, according to the results of the NRG Oncology/NSABP B-52 trial reported at the 2016 San Antonio Breast Cancer...

breast cancer

Abemaciclib Plus Anastrozole: Promising Signals Reported in Phase II Study of Early Breast Cancer

As neoadjuvant therapy, abemaciclib alone or in combination with anastrozole achieved strong signals of anticancer activity in postmenopausal patients with hormone receptor–positive, HER2-negative breast cancer in the neoMONARCH phase II study.1 Abemaciclib alone or in combination with anastrozole...

breast cancer

Fulvestrant Plus Everolimus: New Second-Line Option for Postmenopausal Metastatic Breast Cancer

The addition of everolimus (Afinitor) to fulvestrant (Faslodex) doubled progression-free survival in postmenopausal women with hormone receptor–positive, HER2-negative metastatic breast cancer resistant to aromatase inhibitor therapy compared with fulvestrant plus placebo, according to the...

leukemia

CPX-351 Improves Survival Post Transplant in Older High-Risk Patients With Acute Myeloid Leukemia

Induction therapy with the experimental chemotherapy called CPX-351—a liposomal formulation of cytarabine and daunorubicin—outperformed standard “7+3” cytarabine plus daunorubicin by extending survival in older high-risk patients with acute myeloid leukemia (AML) who subsequently underwent...

lymphoma

Dose-Adjusted EPOCH-R No Better Than R-CHOP in Diffuse Large B-Cell Lymphoma

Long-awaited results of the Cancer and Leukemia Group B ­(CALGB)/Alliance 50303 trial were a disappointment to many hematologists/oncologists at the 2016 American Society of Hematology (ASH) Annual Meeting & Exposition. The study failed to show that dose-adjusted EPOCH-R ­(etoposide,...

lymphoma

Obinutuzumab Prolongs Disease-Free Survival vs Rituximab in Follicular Lymphoma

Induction and maintenance therapies with obinutuzumab (Gazyva) were superior to rituximab (Rituxan) induction and maintenance in patients with untreated follicular lymphoma, according to results of the phase III GALLIUM study presented at the Plenary Session during the 58th American Society of...

breast cancer

Confirmation or Transformation? The Case of Palbociclib in Hormone Receptor–Positive Metastatic Breast Cancer

Women with hormone receptor–positive metastatic breast cancer are witnessing an unprecedented time of success in the battle against their disease. Just in the past 12 months, a number of prospective, randomized, phase III studies were reported, with positive results indicating the value of...

multiple myeloma

Single Autotransplant Not Enhanced by Additional Interventions in Multiple Myeloma

Additional interventions following upfront autologous stem cell transplant in multiple myeloma did not further improve progression-free or overall survival over transplant alone in a multicenter study presented as a late-breaking abstract at the 2016 American Society of Hematology (ASH) Annual...

leukemia

Achieving Complete Response Is Key to Improving Survival in Older Patients With AML

The importance of achieving complete response after intensive therapy in older adults with acute myeloid leukemia (AML) was confirmed in a follow-up analysis of the E2906 North American Intergroup trial.1 Patients in complete response had superior survival in this landmark analysis. This finding...

leukemia

Reduced-Intensity Chemotherapy Leads to More Relapses in Childhood ALL

Children with acute lymphoblastic leukemia (ALL) considered at standard risk for relapse should continue to receive standard-intensity regimens, according to findings from the international randomized AIEOP-BFM ALL 2000 trial.1 A reduced-intensity treatment for children with ALL considered to have ...

gynecologic cancers

FDA Approves Rucaparib and Companion Genetic Test in Advanced Deleterious BRCA-Mutated Ovarian Cancer

The U.S. Food and Drug Administration (FDA) today granted accelerated approval to rucaparib (Rubraca) to treat women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved...

lung cancer

WCLC 2016: First-Line Ceritinib Reduces Risk of Disease Progression in ALK-Positive NSCLC vs Chemotherapy

Patients who received first-line ceritinib experienced a 45% risk reduction for advanced anaplastic lymphoma kinase (ALK)­–positive on–small cell lung cancer (NSCLC) compared to a control group that received chemotherapy, according to research presented at the IASLC 17th World...

skin cancer

Investigational Immunotherapy for Advanced Melanoma

The investigational immunotherapeutic IMC-20D7S was found to be well tolerated and somewhat active in patients with advanced melanoma, including one complete response, according to the results of a phase I/Ib trial reported by Danny N. Khalil, MD, PhD, and colleagues in Clinical Cancer Research....

SABCS 2016: Women Experiencing Menopausal Symptoms Less Likely to Adhere to Medication in IBIS-1 Trial

Among women enrolled in the International Breast Cancer Intervention Study I (IBIS-I), those who had certain symptoms of menopause—nausea/vomiting and headaches—were significantly less likely to be adherent to the assigned medication 4.5 years after starting the treatment, according to...

breast cancer

SABCS 2016: BELLE-3 Trial of Buparlisib Plus Endocrine Therapy Meets Primary Endpoint of Progression-Free Survival in Breast Cancer Patients

The investigational PI3K inhibitor buparlisib, in combination with endocrine therapy, improved outcomes for patients with hormone receptor–positive advanced breast cancer that had progressed after treatment with everolimus (Afinitor) plus exemestane, according to data from the phase III...

breast cancer

SABCS 2016: Adding Veliparib to Chemotherapy Improved Response Rates Among Patients With BRCA-Mutant Breast Cancer

Adding the investigational poly ADP ribose polymerase (PARP) inhibitor veliparib to carboplatin and paclitaxel chemotherapy improved the overall response rate without increasing adverse events among patients who had locally recurrent or metastatic breast cancer with BRCA1 or BRCA2 mutations,...

breast cancer

SABCS 2016: Adding Ibandronate to Hormone Therapy Did Not Improve Outcomes for Postmenopausal Breast Cancer Patients

Postmenopausal women with hormone receptor–positive early-stage breast cancer who received the bisphosphonate ibandronate (Boniva) in addition to adjuvant hormone therapy did not have improved disease-free survival outcomes, according to data from the phase III clinical trial TEAM IIB...

breast cancer

SABCS 2016: No Added Benefit With Aromatase Inhibitor as Part of Presurgical Therapy for Hormone Receptor–Positive, HER2-Positive Breast Cancer

Adding an aromatase inhibitor to presurgical treatment with docetaxel, carboplatin, trastuzumab (Herceptin), and pertuzumab (Perjeta) did not significantly increase or decrease the percentage of patients with hormone receptor­–positive, HER2-positive breast cancer who had a pathologic...

cns cancers

Approval of Dinutuximab for High-Risk Neuroblastoma: Lessons Learned in Expediting the Development of Pediatric Cancer Drugs

On March 10, 2015, the U.S. Food and Drug Administration (FDA) granted regular approval to dinutuximab (formerly known as chimeric 14.18 antibody; Unituxin) for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid...

Christine Laronga, MD, FACS, Elected President of the Association of Women Surgeons

Christine Laronga, MD, FACS, a surgical oncologist specializing in breast cancer at Moffitt Cancer Center, has been named President of the Association of Women Surgeons. The international organization has more than 1,800 members and represents 21 countries. “I am thrilled to be in this new...

breast cancer

Treatment of Early HER2-Positive Breast Cancer: One Size Does Not Fit All

Despite the routine use of HER2 blockade in early HER2-positive breast cancer, clinicians can always benefit from a refresher on key treatment considerations. Clinical pearls and controversial issues were the topic of a presentation at the 14th Annual School of Breast Oncology at Emory University, ...

lung cancer

New Treatments for Lung Cancer in 2016

With drug approvals for immunotherapy in the first- and second-line settings, breakthroughs in targeting epidermal growth factor receptor (EGFR) mutations, and the rapid evolution of therapies that target anaplastic lymphoma kinase (ALK) rearrangements, 2016 has been an extraordinary year for lung...

multiple myeloma

FDA Approves Daratumumab in Combination Therapy for Patients With Multiple Myeloma Receiving at Least One Prior Treatment

On November 21, 2016, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior...

lung cancer

Experts Consider the New Immunotherapy Paradigm in Advanced Lung Cancer

One immune checkpoint inhibitor has now moved to the front of the line for treating advanced non–small cell lung cancer (NSCLC). Based on pivotal studies presented at the 2016 European Society for Medical Oncology (ESMO) Congress, pembrolizumab (Keytruda) became a first-line option, and it is...

lymphoma

‘Clinically Useful’ Findings for Brentuximab Vedotin in CTCL, Rituximab Maintenance in MCL

Positive studies about brentuximab vedotin ­(Adcetris) in cutaneous T-cell lymphoma1 and rituximab (Rituxan) maintenance therapy in mantle cell lymphoma (MCL)2 were reported at the 2016 Annual Meeting of the American Society for Hematology (ASH). “These abstracts each focus on approved agents and...

hematologic malignancies
symptom management

ASH 2016: New Data Shed Light on Potential Advantages of Pacritinib for Patients With Myelofibrosis

Compared with standard therapy, pacritinib significantly reduces spleen size among people with myelofibrosis who have very low levels of platelets, according to a late-breaking study presented by Mascarenhas et al during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition...

leukemia

ASH 2016: Interim Analysis Shows Adding Lenalidomide Maintenance Therapy to Chemoimmunotherapy Prolongs Progression-Free Survival in High-Risk CLL

The combined use of genetic markers and minimal residual disease assessment (MRD) has made it easier to identify chronic lymphocytic leukemia (CLL) patients likely to have a poor outcome after receiving frontline chemoimmunotherapy. Interim results from the phase III German CLL M1 study presented...

breast cancer

Genetic Markers Associated With Pathologic Complete Response Identified in HER2-Positive Breast Cancer

In an analysis reported in JAMA Oncology, Fumagalli et al identified genetic markers associated with pathologic complete response among women with early-stage HER2-positive breast cancer receiving neoadjuvant therapy in the phase III NeoALTTO trial. Christos Sotiriou, MD, PhD, of Institut Jules...

Adrian Lee, PhD, Named Director of the Institute for Precision Medicine at Pitt

Breast cancer researcher Adrian Lee, PhD, has been named Director of the Institute for Precision Medicine (IPM), a joint effort by the University of Pittsburgh Medical Center (UPMC) and the University of Pittsburgh to move biomedical research into personalized well-being and clinical care.  Dr....

head and neck cancer

FDA Approves Nivolumab for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

On November 10, 2016, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. Approval was based on data from an...

multiple myeloma

FDA Approves Daratumumab in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Multiple Myeloma

On November 21, 2016, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior...

integrative oncology

Sleep Disruption in Cancer Survivors: Yoga Offers a Low-Risk Intervention With High Potential for Benefit

Impaired sleep quality is a concerning problem for many patients with cancer, and pharmacologic treatments come with many negative effects. Several small studies indicate that yoga improves persistent fatigue, sleep disturbance, anxiety, and quality of life, in addition to reducing the need for ...

palliative care

How Video Support Tools Help Patients Make Informed Decisions About End-of-Life Care

A relatively recent study by Areej El-Jawahri, MD, and her colleagues is showing how the use of visual media can empower patients with advanced cancer, as well as other life-threatening illnesses, to make more informed decisions about their end-of-life care.1 The aim of Dr. El-Jawahri’s study was ...

kidney cancer

Adjuvant Sunitinib for Renal Cell Carcinoma: Not Ready for Prime Time

In renal cell carcinoma and other cancer types, a consistent paradigm in drug development exists: Observe efficacy of a drug in the metastatic setting and move quickly to explore the agent in the adjuvant setting. In the cytokine era, there were multiple efforts to characterize whether adjuvant...

issues in oncology
lung cancer
gastrointestinal cancer
prostate cancer
colorectal cancer

At ESMO 2016, Many Phase III Trials Fail to Meet Primary Endpoints

The 2016 European Society for Medical Oncology (ESMO) Congress revealed many important positive findings from key trials in a number of tumor types, but many highly anticipated phase III trials in advanced disease failed to meet their primary endpoints. The ASCO Post has summarized several of these ...

Expert Point of View: Florian Lordick, MD

Florian Lordick, MD, Professor of Oncology and Director of the University Cancer Center in Leipzig, Germany, offered some critical evaluation of the two studies. AGITG Phase II Trial For the AGITG’s phase II DOCTOR trial, he emphasized the need to show the impact on survival outcomes for...

gastroesophageal cancer

Locally Advanced Esophageal Cancer Outcomes Improved With Neoadjuvant Therapy

In studies presented at the 2016 European Society for Surgical Oncology (ESMO) Congress, two different neoadjuvant treatment approaches improved the outcomes of patients with esophageal cancer. Investigators from the Australasian Gastro-Intestinal Trials Group (AGITG) reported that the addition of...

lung cancer
skin cancer

Numerous ESMO Presentations Focused on Anti–PD-1 Therapy in Lung Cancer and Melanoma

The 2016 European Society for Medical Oncology (ESMO) Congress was jam-packed with studies of the anti–programmed cell death protein 1 (PD-1) antibodies in non–small cell lung cancer and melanoma, where they have clearly changed the treatment paradigm. Here is a roundup of some of those trials,...

ASCO Quality Improvement Grant Spotlight: The Ralph Lauren Center for Cancer Care

In 2016 and 2017, a team from The Ralph Lauren Center for Cancer Care (RLCCC) is participating in an ASCO Quality Improvement Grant program, which is supported by the Stavros Niarchos Foundation. The grant program aims to improve the delivery of cancer care in medically underserved communities by...

sarcoma

Cautious Optimism About Olaratumab in Soft-Tissue Sarcoma

The current plethora of drugs in development for oncology is leading to the testing of novel agents in common as well as rare diseases. Targeted therapies have been a focus of great interest in soft-tissue sarcomas, with testing of a variety of oral tyrosine kinase inhibitors leading to the...

lung cancer

Cabozantinib Shows Activity in Advanced RET-Rearranged NSCLC

In a phase II trial reported in The Lancet Oncology, Drilon et al found that cabozantinib (Cabometyx) produced responses in some patients with advanced RET-rearranged non–small cell lung cancer (NSCLC). RET rearrangements are found in 1% to 2% of NSCLCs. In the single-arm study, 25 evaluable ...

Expert Point of View: Alice T. Shaw, MD, PhD

Commenting on ASCEND-5, Alice T. Shaw, MD, PhD, Director of Thoracic Oncology at the Massachusetts General Hospital Cancer Center, Boston, noted that it is the first randomized study to examine how a second-generation anaplastic lymphoma kinase (ALK) inhibitor compares to standard second-line...

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