On September 30, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type, unresectable, or metastatic melanoma. The FDA is scheduled to make a decision on ...
An international team of researchers has shown that the use of the mTOR inhibitor everolimus can delay tumor growth among both gastrointestinal and lung neuroendocrine tumors. This is particularly important for patients with lung tumors, the researchers say, because there is currently no approved...
Results from a multicenter randomized international trial of an innovative treatment show a marked improvement in the length of time patients with midgut neuroendocrine tumors experience progression-free survival, researchers reported at the 2015 European Cancer Congressin Vienna, Austria, on...
First results from the largest international comparison of the treatment of elderly patients with breast cancer have shown substantial differences in the use of surgery, hormone therapy, and chemotherapy among European countries. The European Registration of Cancer Care (EURECCA) study compared the ...
In the phase III RADIANT trial reported in the Journal of Clinical Oncology, Kelly et al found no disease-free survival improvement with adjuvant erlotinib (Tarceva) vs placebo in patients with EGFR-expressing stage IB to IIIA non–small cell lung cancer (NSCLC). However, there was evidence of ...
Patients with cancers of the mid and lower throat may have higher survival rates if their initial treatment includes surgery, according to new research (Abstract 2804) presented at the 2015 European Cancer Congress in Vienna, Austria. Researchers explained that a nationwide study in Taiwan found...
The targeted drug nivolumab (Opdivo) significantly prolonged survival in patients with advanced kidney cancer whose disease had progressed after their first treatment, according to the results (Abstract 3LBA) presented at the 2015 European Cancer Congress (ECC) in Vienna, Austria, and published...
Patients with advanced kidney cancer lived for nearly twice as long without their disease progressing if they were treated with cabozantinib (Cometriq), a drug that inhibits the action of tyrosine kinases. Toni Choueiri, MD, presented the research (Abstract 4LBA) at the Presidential Session of the...
A randomized phase III study by Borghaei et al evaluating the efficacy and safety of nivolumab (Opdivo) vs docetaxel in patients with advanced nonsquamous non–small cell lung cancer (NSCLC) after failure of platinum-based chemotherapy has found that nivolumab improved overall survival, 12.2...
Overall survival data from a phase II study, reported in the Journal of Clinical Oncology by Ellis et al, suggest a benefit of first-line fulvestrant (Faslodex) vs anastrozole in postmenopausal women with estrogen receptor–positive advanced breast cancer. The study protocol was amended to...
A phase III Eastern Cooperative Oncology Group (ECOG) trial (E1A060) comparing melphalan, prednisone, and thalidomide (Thalomid) (MPT-T) with melphalan, prednisone, and lenalidomide (Revlimid) (mPR-R) in elderly patients with untreated multiple myeloma found that at the end of the induction period, ...
Patients with metastatic renal cell carcinoma treated with tyrosine kinase inhibitors in real-world clinical practice tend to be older and sicker than the patients enrolled in pivotal clinical trials of tyrosine kinase inhibitors. Conversely, patients with metastatic renal cell carcinoma treated...
In an interim analysis of the phase III PROLONG trial reported in The Lancet Oncology, van Oers et al found that maintenance therapy with ofatumumab (Arzerra) prolonged progression-free survival vs observation in patients with chronic lymphocytic leukemia in complete or partial remission after...
In a phase III trial reported in the Journal of Clinical Oncology, Demetri et al found that treatment with trabectedin significantly improved progression-free survival vs dacarbazine in patients with advanced liposarcoma or leiomyosarcoma after prior conventional chemotherapy. Interim analysis of...
In a phase III trial (Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group E4697 trial) reported in the Journal of Clinical Oncology, Lawson et al found no relapse-free or overall survival benefit with adjuvant yeast-derived granulocyte-macrophage...
In a study reported in the Journal of the National Cancer Institute, Yoon et al found that among patients with stage III colon cancer in the Alliance N0147 trial, Asians had the lowest rate of BRAF/KRAS mutations and longer disease-free survival vs whites among patients with N2 disease and that...
Among patients with clinically stage I or stage II melanoma, those treated with the immune system–boosting agent CpG-B were less likely to experience recurrence of their disease than those who received placebo, according to results from two randomized, placebo-controlled phase II clinical...
In the phase III STORM trial reported in The Lancet Oncology, Bruix et al found no benefit with adjuvant sorafenib (Nexavar) treatment in patients who had undergone resection or ablation for hepatocellular carcinoma. Study Details In this double-blind trial, 1,114 patients from 202 sites in 28...
In a Japanese phase II trial reported in the Journal of Clinical Oncology, Hamanishi et al found that the anti–PD-1 (programmed cell death protein 1) antibody nivolumab (Opdivo) was active in patients with relapsed or advanced platinum-resistant ovarian cancer. Study Details In the study,...
The U.S. Food and Drug Administration (FDA) has granted Priority Review status to the New Drug Application for the investigational oral proteasome inhibitor ixazomib for the treatment of patients with relapsed or refractory multiple myeloma, Takeda Pharmaceuticals announced. The New Drug...
Analysis of a large phase III trial (S0819) suggested that adding the epidermal growth factor receptor (EGFR)-targeting monoclonal antibody cetuximab (Erbitux) to chemotherapy benefits survival in patients with squamous cell non–small cell lung cancer (NSCLC) with tumors positive...
As reported by Schmoll et al in the Journal of Clinical Oncology, the final results of the phase III NO16968 trial showed that adjuvant therapy with XELOX (capecitabine, oxaliplatin) improved overall survival vs fluorouracil (5-FU)/leucovorin in patients with resected stage III colon cancer....
Two phase III studies of anamorelin found that the medication effectively combats wasting and increases body weight and lean body mass in certain patients with lung cancer. Results (Abstract ORAL29.01) from the ROMANA 1 and ROMANA 2 phase III trials of anamorelin were presented at the 16th...
The standard of care for malignant pleural mesothelioma may be poised for change, judging by results from a study (Abstract ORAL11.01) by the French Cooperative Thoracic Intergroup. The addition of bevacizumab (Avastin) in the first-line setting to the current standard of care, pemetrexed...
Every hour lost to the cancer drug regulatory process costs 29 life-years lost in the United States and 260 life-years worldwide, according to research (Abstract ORAL12.05) presented on September 7 at the 16th World Conference on Lung Cancer hosted by the International Association of the...
In an updated analysis of the Italian phase III TRIBE trial reported in The Lancet Oncology, Cremolini et al found that FOLFOXIRI (fluorouracil [5-FU], leucovorin, oxaliplatin, irinotecan) plus bevacizumab (Avastin) significantly prolonged overall survival in patients with unresectable metastatic...
The U.S. Food and Drug Administration (FDA) approved rolapitant (Varubi) to prevent delayed-phase chemotherapy-induced nausea and vomiting. Rolapitant is approved in adults in combination with other antiemetic agents that prevent nausea and vomiting associated with initial and repeat courses of...
In a pooled analysis of trials assessing novel agent-based continuous therapy vs fixed duration of therapy reported in the Journal of Clinical Oncology, Palumbo et al found that continuous therapy prolonged progression-free survival, progression-free survival-2 (time to second progression or...
Bristol-Myers Squibb and AbbVie today announced that the U.S. Food and Drug Administration has accepted for priority review the Biologics License Application for elotuzumab, an investigational signaling lymphocyte activation molecule (SLAMF7)-directed immunostimulatory antibody, for the...
In the phase III CATCH trial reported in JAMA, Lee et al found that the low–molecular-weight heparin tinzaparin (Innohep) did not significantly reduce the risk of recurrent venous thromboembolism vs warfarin in the treatment of acute symptomatic venous thromboembolism in patients with active...
In a study reported in The Lancet Oncology, Pastore et al found that the addition of mutation status of seven genes to the Follicular Lymphoma International Prognostic Index (FLIPI) and Eastern Cooperative Oncology Group (ECOG) performance status produced a clinicogenetic model (m7-FLIPI) with high ...
The phase III NSABP B-40 (NRG Oncology) trial showed that the addition of bevacizumab (Avastin) to docetaxel-based neoadjuvant chemotherapy improved pathologic complete response rate, the primary endpoint, in patients with early HER2-negative breast cancer. In a report of secondary outcomes in The...
In a phase III trial reported in The Lancet, Pless et al in the Swiss Group for Clinical Cancer Research found that adding preoperative radiation following neoadjuvant chemotherapy did not appear to improve outcomes vs neoadjuvant chemotherapy alone in patients with stage IIIA/N2 non–small...
The U.S. Food and Drug Administration approved eltrombopag (Promacta) for the treatment of thrombocytopenia in pediatric patients aged 1 year and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The approval was...
In two phase III trials reported in The Lancet Oncology, Rapoport et al found that the addition of rolapitant to serotonin (5-HT3) receptor antagonist and dexamethasone treatment significantly improved complete response rates in prevention of chemotherapy-induced nausea and vomiting in patients...
In a phase III study reported in The Lancet Oncology, Schwartzberg et al found that the addition of rolapitant to serotonin (5-HT3) receptor antagonist and dexamethasone treatment significantly improved complete response rates in prevention of chemotherapy-induced nausea and vomiting in patients...
In an analysis from the NRG Oncology/Gynecologic Oncology Group 210 trial reported in the Journal of the National Cancer Institute, Felix et al found that tubal ligation, which should impede transtubal passage of cells, was associated with lower stage of endometrial cancer at presentation and...
The U.S. Food and Drug Administration has approved brentuximab vedotin (Adcetris) as post–autologous hematopoietic stem cell transplantation consolidation treatment for patients with classical Hodgkin lymphoma at high risk of relapse or progression, Seattle Genetics has announced. The...
Initial results of the Dutch phase III CROSS trial showed a significant 5-year overall survival benefit with the addition of neoadjuvant chemoradiotherapy to surgery after a median 45-month follow-up in patients with squamous cell carcinoma or adenocarcinoma of the esophagus or esophagogastric...
Using whole-exome sequencing on newly diagnosed patients with multiple myeloma, British researchers identified 15 genes that were significantly mutated in a subset of patients and mapped how these mutations related to long-term survival. They found 90% of patients with very aggressive disease who...
A large observational study investigating the effect of coffee consumption on advanced-stage colon cancer and survival has found that patients who drank four or more cups of coffee a day were 42% less likely to experience a recurrence than non-coffee drinkers and were 33% less likely to die from...
Final results of the German phase III CAO/ARO/AIO-04 trial reported in The Lancet Oncology by Rödel et al showed that adding oxaliplatin to fluorouracil (5-FU)–based neoadjuvant chemoradiation and postoperative chemotherapy improved disease-free survival in patients with locally advanced ...
A novel combination therapy appears to be effective in treating patients with melanoma skin metastases, according to new research from the University of California (UC) Davis. Led by Emanual Maverakis, MD, of the UC Davis Department of Dermatology, the research found that interleukin-2...
Chemotherapy prolongs life for older adults with most types of cancer, but for women with breast cancer over age 80, the chances of survival with chemotherapy alone are significantly lower than in younger patients, according to a study led by researchers from the University of Texas...
As reported in the Journal of Clinical Oncology by Palumbo et al, the International Myeloma Working Group recommends the use of a revised international staging system (R-ISS) for newly diagnosed multiple myeloma that incorporates chromosomal abnormalities detected by interphase fluorescent in situ...
In the phase III E3805 trial reported in The New England Journal of Medicine, Sweeney et al found that chemohormonal therapy with docetaxel plus androgen-deprivation therapy produced a significant 13.6-month increase in median overall survival vs androgen-deprivation therapy alone in men with...
In a phase III VALOR trial reported in The Lancet Oncology, Ravandi et al found that the addition of the quinolone derivative vosaroxin to cytarabine did not significantly improve overall survival in patients with relapsed or refractory acute myeloid leukemia (AML). However, differences favoring...
An observational study investigating the use and effectiveness of a combination regimen of intraperitoneal and intravenous chemotherapy in the treatment of advanced-stage ovarian cancer has found that although the dual approach substantially improved survival—81% of those treated with the...
Cancer therapy has evolved to a personalized approach, and important aspects of this method are pharmacogenomic studies that analyze associations between genetic variations and patient drug responses. Moffitt Cancer Center researchers published a study by Dressler et al in the Journal of the...
In a phase III trial (National Cancer Institute of Canada [NCIC] Clinical Trials Group MA.20) reported in The New England Journal of Medicine, Whelan et al found that the addition of regional nodal irradiation to whole-breast irradiation did not improve overall survival in women with node-positive...