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issues in oncology
health-care policy

Friends of Cancer Research Releases White Paper on Patient-Reported Outcomes

On November 17, Friends of Cancer Research (FOCR) released a white paper report, Enhancing Use of Patient-Centered Data in Regulatory Decision Making.1 The contents of that paper are summarized below. Improving Patient Input Many stakeholders agree that to ensure truly transformational therapies,...

health-care policy
issues in oncology

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...

breast cancer
survivorship

Breast Cancer Survivors May Expect More Extensive or Frequent Follow-up Testing Than Recommended

Patients who have been treated for breast cancer may overestimate the value of follow-up testing and may expect—or even ask for—more testing than recommended, Harold J. ­Burstein, MD, PhD, of the Dana-Farber Cancer Institute and Harvard Medical School, Boston, told participants at the Lynn Sage...

breast 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...

hematologic malignancies

Optimizing the Treatment of HIV-Associated Lymphoma

Non-Hodgkin lymphoma (NHL) associated with human immunodeficiency virus (HIV) infection generally can be treated the same as lymphoma in non–HIV-infected patients, with a few caveats, according to Lawrence D. Kaplan, MD, of the Helen Diller Family Comprehensive Cancer Center of the University of...

skin cancer

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...

leukemia

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...

leukemia

Promising Upfront Combination in Older Patients With Acute Lymphoblastic Leukemia

Frontline treatment with the antibody-drug conjugate inotuzumab ozogamicin plus deintensified chemotherapy is a promising option for older patients with Philadelphia chromosome–negative acute lymphoblastic leukemia (ALL). Phase II results suggest that this combination has the ability to improve...

kidney cancer

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...

hematologic malignancies

ASH Announces Top Trainee Abstracts of 2015 Annual Meeting

The American Society of Hematology (ASH) recognized investigators with the highest-scoring abstracts in the categories of undergraduate student, medical student, graduate student, resident physician, and postdoctoral fellow at the 57th ASH Annual Meeting and Exhibition, December 5–8 in Orlando,...

leukemia

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...

hematologic malignancies
leukemia
issues in oncology

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...

Expert Point of View: Virginia Kaklamani, MD

Press conference moderator Virginia Kaklamani, MD, commented on these results from the ABCSG-18 trial: “It’s pretty clear that 3 years of adjuvant denosumab not only reduced fracture risk but improved disease-free survival. It’s also pretty clear that adjuvant bisphosphonates improve disease-free...

breast cancer

Adjuvant Denosumab Improves Disease-Free Survival in Estrogen Receptor–Positive Postmenopausal Breast Cancer

There is good news about denosumab (Prolia). The primary analysis of the ABCSG-18 trial showed that adjuvant denosumab (given at low doses) reduces the risk of clinical fracture by 50% in postmenopausal women with early breast cancer who are taking an aromatase inhibitor.1 More good news is that...

breast cancer

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...

gynecologic cancers
issues in oncology

A Shot to End Cancer: HPV Vaccination

As health-care providers, we have an obligation and a responsibility not only to care for our patients, but also to educate them—and the general public—about their cancer risk and ways to reduce or prevent it. We are living in the golden era of cancer prevention and treatment, made possible by...

multiple myeloma

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%...

American Psychosocial Oncology Society Endorses Psychosocial Standards of Care for Children With Cancer and Their Families

The American Psychosocial Oncology Society (APOS) has endorsed the “Psychosocial Standards of Care for Children with Cancer and Their Families” published in a December 2015 special supplement to Pediatric Blood and Cancer. The scientific, evidence-based psychosocial standards...

survivorship

Study Finds Cardiovascular Disease Is Prevalent and Often Asymptomatic in Childhood Cancer Survivors

Although historically the leading cause of death among survivors of childhood cancer has been cancer recurrence, adverse late effects of cancer therapy have become the leading cause of death 30 years after diagnosis, and those deaths are frequently attributed to premature cardiovascular disease,...

colorectal cancer
issues in oncology

Gene Thought to Suppress Cancer May Actually Promote Spread of Colorectal Cancer

A gene that is known to suppress the growth and spread of many types of cancer has the opposite effect in some forms of colorectal cancer, University of Missouri (MU) School of Medicine researchers have found. It is a finding that may lay the foundation for new colorectal cancer treatments. Results ...

leukemia
lymphoma

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 ...

solid tumors

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...

hepatobiliary cancer

Stereotactic Body Radiotherapy vs Radiofrequency Ablation in Inoperable Nonmetastatic Hepatocellular Carcinoma

In a single-institution retrospective study reported in the Journal of Clinical Oncology, Wahl et al found that stereotactic body radiotherapy may provide better freedom from local tumor progression vs radiofrequency ablation in patients with inoperable nonmetastatic larger hepatocellular...

breast cancer

Andrew Seidman, MD, and Erica Mayer, MD, MPH, on Results of the PALLAS Clinical Trial

Andrew Seidman, MD, of Memorial Sloan Kettering Cancer Center, and Erica L. Mayer, MD, MPH, of the Dana-Farber Cancer Institute, discuss this phase 3 trial of palbociclib with adjuvant endocrine therapy vs endocrine therapy alone for HR-positive/HER2-negative early breast cancer. (Abstract...

breast cancer

Andrew Seidman, MD, and Hope Rugo, MD: Less is More: Scaling Back Breast Cancer Treatment

Andrew Seidman, MD, of Memorial Sloan Kettering Cancer Center, and Hope S. Rugo, MD, of the University of California, San Francisco, discuss findings on de-escalating systemic therapy for breast cancer (Abstract ES6-3).

issues in oncology
lung cancer

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...

head and neck cancer

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...

skin cancer

FDA Expands Pembrolizumab Label to Include Approval in Initial Treatment of Unresectable or Metastatic Melanoma

On December 18, 2015, the U.S. Food and Drug Administration (FDA) expanded the pembrolizumab (Keytruda) label to include approval of the drug for the treatment of patients with unresectable or metastatic melanoma. This expansion now includes the initial treatment of patients with unresectable or...

prostate cancer
issues in oncology

Swedish Screening Model Improves Performance of Prostate Cancer Screening vs PSA Alone in Men Aged 50–69 Years

In a Swedish study reported in The Lancet Oncology (Stockholm 3 study), Grönberg et al found that a screening model including prostate-specific antigen (PSA) and other plasma protein markers, genetic polymorphisms, and clinical variables improved the accuracy of detecting prostate cancer with...

Bruce E. Johnson, MD, FASCO, Elected ASCO President for 2017–2018 Term

Bruce E. Johnson, MD, FASCO, has been elected President of ASCO for the term beginning in June 2017. He will take office as President-Elect during the ASCO Annual Meeting in Chicago in June 2016. Additionally, four new members were elected to the ASCO Board of Directors, as well as three new...

prostate cancer
issues in oncology

New ‘Condensed’ Grading System Shown to Be Accurate for Predicting Prostate Cancer Outcomes

Using information gleaned from more than 20,000 men, researchers at Johns Hopkins have affirmed the value of their alternative system for assessing the likelihood of growth and spread of prostate cancer. The new grading system, they said, is not only easier to use and understand, but also more...

hematologic malignancies
leukemia
lymphoma

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...

gynecologic cancers

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 ...

breast cancer

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...

issues in oncology
breast cancer
issues in oncology

Homologous Recombination Deficiency Diagnostic Test Helps Identify Patients With Breast Cancer Likely to Respond to Platinum-Based Therapy

Two studies evaluating the ability of myChoice HRD, a homologous recombination deficiency (HRD) test, to identify patients with breast cancer who are likely to respond to platinum-containing therapies have found that the test is effective in optimizing therapy selection for patients. The diagnostic ...

breast cancer

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...

lung cancer

Alectinib Highly Active in Crizotinib-Refractory ALK-Rearranged NSCLC

In a phase II trial reported in the Journal of Clinical Oncology, Ou et al found that the investigational ALK inhibitor alectinib, which is active against acquired crizotinib (Xalkori) resistance mutations and exhibits high CNS penetration, was associated with considerable activity in patients with ...

prostate cancer
issues in oncology

Repeating Abnormal PSA Tests Reduces Number of Unnecessary Biopsies

For more than 20 years, the prostate-specific antigen (PSA) test has been used to help screen for prostate cancer. However, in recent years, some task forces have called for this blood test to be abandoned because it leads to many unnecessary biopsies. Now, a new study from The Ottawa Hospital and...

breast cancer

SABCS 2015: Pathologic Complete Response to Presurgery Chemotherapy Improves Survival for Patients With Triple-Negative Breast Cancer

Patients with stage II or stage III triple-negative breast cancer who had a pathologic complete response (pCR) after presurgery chemotherapy had increased event-free and overall survival compared with those who had more than minimal residual invasive disease at surgery following presurgery...

pancreatic cancer

Improved Overall Survival With Addition of Nanoliposomal Irinotecan to Fluorouracil/Leucovorin in Metastatic Pancreatic Cancer

In the phase III NAPOLI-1 trial reported in The Lancet, Wang-Gillam et al found that the addition of nanoliposomal irinotecan (Onivyde) to fluorouracil (5-FU) and folinic acid (leucovorin) resulted in improved overall survival in patients with metastatic pancreatic ductal cancer who had received...

multiple myeloma

ASH 2015: Updated Results of the Phase I/II GEN503 Study of Daratumumab in Multiple Myeloma

In a study update presented by Plesner et al at the 57th American Society of Hematology (ASH) Annual Meeting, daratumumab (Darzalex) was shown to be safe and effective in combination with lenalidomide (Revlimid) and dexamethasone in patients with relapsed/refractory multiple myeloma (Abstract 507). ...

leukemia

ASH 2015: Young Adults With Acute Lymphoblastic Leukemia Have Encouraging Survival With Pediatric Chemotherapy Regimen

Using a pediatric chemotherapy regimen to treat young adults with acute lymphoblastic leukemia (ALL) significantly improved their outcomes compared to what has historically been achieved with “adult” treatment protocols, report Dana-Farber Cancer Institute scientists. Overall survival...

hematologic malignancies
leukemia
lymphoma
lymphoma

ASH 2015: High Response Rates, Long-Term Remissions in Relapsed/Refractory Pediatric ALL, Lymphomas After CTL019 Immunotherapy

Ninety-three percent of pediatric patients (55 of 59) with relapsed/refractory acute lymphoblastic leukemia (ALL) went into remission after receiving an investigational therapy made from their own immune cells, with continuous remissions of over 1 year in 18 patients and over 2 years in nine...

gynecologic cancers
gynecologic cancers

European Trial Shows Front-Line Addition of Nintedanib to Standard Chemotherapy Improves Progression-Free Survival in Advanced Ovarian Cancer

In a European phase III trial (AGO-OVAR 12) reported in The Lancet Oncology, du Bois et al found that adding the antiangiogenic multikinase inhibitor nintedanib (Ofev) to carboplatin/paclitaxel improved progression-free survival in patients with newly diagnosed ovarian cancer. Gastrointestinal...

breast cancer

Better Invasive Disease–Free Survival With Epirubicin/Cyclophosphamide and Docetaxel vs Epirubicin/Docetaxel and Capecitabine in Breast Cancer

In a Spanish phase III trial (GEICAM/2003-10) reported in the Journal of Clinical Oncology, Martín et al found that invasive disease–free survival was improved with adjuvant epirubicin/cyclophosphamide (EC) followed by docetaxel (EC-T) vs epirubicin/docetaxel followed by capecitabine...

leukemia
issues in oncology

ASH 2015: Midostaurin Improves Survival in Patients With FLT3-Mutated Acute Myeloid Leukemia Aged 18–60

A study presented by Stone et al at the 57th American Society of Hematology (ASH) Annual Meeting described a phase III trial of the first targeted therapy for genetically defined subset of patients with acute myeloid leukemia and its improvement of their survival (Abstract 6). Acute myeloid...

supportive care

ASH 2015: Two Studies Focus on Treatment for Cancer-Associated Thrombosis

Two studies presented at the 57th American Society of Hematology (ASH) Annual Meeting examine the common problem of cancer-associated thrombosis. One looked to validate dosing guidelines for avoiding chemotherapy-induced thrombocytopenia, a common autoimmune response to therapy; the second compared ...

leukemia
issues in oncology

ASH 2015: Genetic Variants Discovered in Acute Lymphocytic Leukemia That Indicate Higher Risk for Osteonecrosis, Avascular Necrosis

Two new studies to be reported at the 57th American Society of Hematology (ASH) Annual Meeting highlighted new insights on genetic mutations in children with acute lymphocytic leukemia (ALL) that indicate a higher risk for debilitating chemotherapy-associated bone damage. The study findings were...

hematologic malignancies

Reduced Nonrelapse Mortality With Busulfan/Fludarabine vs Busulfan/Cyclophosphamide for Stem Cell Transplantation in Acute Myeloid Leukemia

In a phase III trial reported in The Lancet Oncology, Rambaldi et al found that a myeloablative conditioning regimen of busulfan/fludarabine was associated with reduced nonrelapse mortality vs busulfan/cyclophosphamide in patients with acute myeloid leukemia (AML) undergoing allogeneic...

breast cancer
issues in oncology

Systematic Review Informing ACS Updated Guideline for Breast Cancer Screening in Women at Average Risk

Findings of a systematic review of the benefits and harms of breast cancer screening commissioned by the American Cancer Society (ACS) to inform its updated guideline on screening in average-risk women were reported in JAMA by Myers et al of the Duke Evidence Synthesis Group. Their findings were...

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