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,...
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...
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...
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...
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...
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...
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...
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...
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...
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,...
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...
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...
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...
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...
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...
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...
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%...
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...
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,...
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 ...
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 ...
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...
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...
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...
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).
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...
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...
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...
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, 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...
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...
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...
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 ...
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...
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 ...
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...
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 ...
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...
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...
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...
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). ...
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...
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...
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...
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...
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...
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 ...
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...
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...
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...