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Showing 5751 - 58002018 ASCO: Pembrolizumab Plus Chemotherapy as First-Line Treatment of Metastatic Squamous NSCLC: KEYNOTE-407 Study
Results from KEYNOTE-407, a randomized, double-blind, placebo-controlled, phase III study evaluating pembrolizumab (Keytruda) in combination with carboplatin/paclitaxel or carboplatin/nab-paclitaxel (Abraxane) as first-line treatment for metastatic squamous non–small cell lung cancer...
Dabrafenib Plus Trametinib for Thyroid Cancer, Melanoma With BRAF Mutations
On May 4, 2018, dabrafenib (Tafinlar) and trametinib (Mekinist) in combination was granted approval for treatment of patients with locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E mutation and no satisfactory locoregional treatment options.1-3 Dabrafenib is not indicated for ...
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...
CheckMate 214: Nivolumab Plus Ipilimumab Improves Survival vs Sunitinib in Advanced Renal Cell Cancer
As reported in The New England Journal of Medicine by Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, and colleagues, the phase III CheckMate 214 trial has shown an overall survival advantage with nivolumab (Opdivo) plus ipilimumab (Yervoy) vs sunitinib (Sutent) in patients with...
Validation of the Consensus Immunoscore for Classification of Colon Cancer
As reported in The Lancet by Pagès et al, an international collaboration has validated the consensus Immunoscore for colon cancer as a predictive tool for recurrence of disease. Study Details An international consortium of 14 centers in 13 countries, led by the Society for Immunotherapy of ...
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: Dacomitinib vs Gefitinib in Advanced NSCLC With EGFR-Activating Mutations
Overall survival (OS) data from the ARCHER 1050 trial evaluating dacomitinib as a first-line treatment for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR-activating mutations compared to gefitinib showed a median OS of 34.1 months for patients...
2018 ASCO: Erdafitinib Shows Activity in FGFR3-Mutated Urothelial Cancer
In an international phase II trial led by researchers at The University of Texas MD Anderson Cancer Center, treatment with the oral FGFR inhibitor erdafitinib was well tolerated and achieved a robust response for patients with metastatic urothelial cancers harboring mutations in the FGFR3...
2018 ASCO: Pexidartinib in Tenosynovial Giant Cell Tumor
The phase III ENLIVEN study showed a statistically significant 39% overall response rate at week 25 based on central review of magnetic resonance imaging (MRI) scans using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (the primary endpoint) for patients treated with oral...
ASCO 2018: Updated ALEX Trial Results on Alectinib in Treatment-Naive ALK Mutation–Positive NSCLC
Updated results of the global phase III ALEX trial comparing alectinib (Alecensa) with crizotinib (Xalkori) as first-line treatment against ALK-positive non–small cell lung cancer (NSCLC) show a median progression-free survival of 34.8 months in 152 patients treated with alectinib vs 10.9...
Andrew D. Seidman, MD, and Susan F. Dent, MD, on Breast Cancer: Analysis of the SANDPIPER Trial
Andrew D. Seidman, MD, of Memorial Sloan Kettering Cancer Center, and Susan F. Dent, MD, of The Ottawa Hospital Cancer Centre, analyze the phase III study findings on taselisib plus fulvestrant vs fulvestrant in patients with estrogen receptor–positive, PIK3CA-mutant, locally advanced or metastatic ...
Robert L. Coleman, MD, on Ovarian Cancer: Results From an NRG Oncology/Gynecologic Oncology Group Trial
Robert L. Coleman, MD, of The University of Texas MD Anderson Cancer Center, discusses phase III study findings on secondary surgical cytoreduction followed by platinum-based combination chemotherapy, with or without bevacizumab, in platinum-sensitive, recurrent ovarian cancer (Abstract 5501).
Martee L. Hensley, MD, on Leiomyosarcoma: Results From a GOG Treatment Trial
Martee L. Hensley, MD, of Memorial Sloan Kettering Cancer Center, discusses phase III study findings on adjuvant gemcitabine plus docetaxel followed by doxorubicin vs observation for uterus-limited, high-grade leiomyosarcoma (Abstract 5505).
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...
Elizabeth A. Mittendorf, MD, PhD, and Lisa A. Carey, MD, on Breast Cancer: Commentary on the TAILORx Trial
Elizabeth A. Mittendorf, MD, PhD, of Dana-Farber/Brigham and Women’s Cancer Center, and Lisa A. Carey, MD, of the University of North Carolina, discuss the impact of new phase III findings on chemoendocrine treatment vs endocrine treatment alone in hormone receptor–positive, HER2-negative,...
Toni K. Choueiri, MD, and Lauren C. Harshman, MD on RCC: Results From the PROSPER Trial
Toni K. Choueiri, MD, and Lauren C. Harshman, MD, both of Dana-Farber Cancer Institute, discuss phase III study findings on perioperative nivolumab vs observation in patients with localized renal cell carcinoma undergoing nephrectomy (Abstract TPS4597).
Thierry Conroy, MD, on Pancreatic Cancer: Results From the PRODIGE 24 Trial
Thierry Conroy, MD, of the Institut de Cancérologie de Lorraine, discusses phase III study findings on adjuvant mFOLFIRINOX vs gemcitabine in patients with resected pancreatic ductal adenocarcinomas (Abstract LBA4001).
Michael J. Overman, MD, and François Quenet, MD, on Colorectal Cancer: Results From the PRODIGE 7 Trial
Michael J. Overman, MD, of The University of Texas MD Anderson Cancer Center, and François Quenet, MD, of the Institut Régional du Cancer de Montpellier, discuss phase III study findings on hyperthermic intraperitoneal chemotherapy for colorectal peritoneal carcinomatosis (Abstract LBA3503).
Paolo A. Ascierto, MD, on Melanoma: Results From the COLUMBUS Trial
Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori–Fondazione Pascale, discusses phase III study findings on encorafenib plus binimetinib vs vemurafenib or encorafenib in BRAF-mutant melanoma (Abstract 9504).
Pirkko-Liisa Irmeli Kellokumpu-Lehtinen, MD, PhD, on Prostate Cancer: Results of the SPCG-13 Trial
Pirkko-Liisa Irmeli Kellokumpu-Lehtinen, MD, PhD, of Tampere University Hospital, discusses phase III findings on adjuvant docetaxel and surveillance after radical radiotherapy for intermediate- and high-risk prostate cancer (Abstract 5000).
Geertjan van Tienhoven, MD, PhD, on Pancreatic Cancer: Results From the PREOPANC-1 Trial
Geertjan Van Tienhoven, MD, PhD, of the Dutch Pancreatic Cancer Group, discusses phase III study findings on preoperative chemoradiotherapy vs immediate surgery for resectable and borderline resectable pancreatic cancer (Abstract LBA4002).
Helena Margaret Earl, MBBS, PhD, on Early Breast Cancer: Results From the Persephone Trial
Helena Margaret Earl, MBBS, PhD, of the University of Cambridge, discusses phase III study findings on 6 vs 12 months of adjuvant trastuzumab in patients with HER2-positive early breast cancer (Abstract 506).
Naoki Furuya, MD, PhD, on NSCLC: Results From the NEJ026 Study
Naoki Furuya, MD, PhD, of the St. Marianna University School of Medicine, discusses phase III study findings on a comparison of bevacizumab plus erlotinib to erlotinib in patients with untreated non–small cell lung cancer with activating EGFR mutations (Abstract 9006).
2018 ASCO: Esomeprazole With Aspirin Offers Moderate Benefits in Patients With Barrett’s Esophagus
An updated analysis of a randomized phase III trial showed that taking a high dose of the acid-reducing medicine esomeprazole with low-dose aspirin for at least 7 years can moderately reduce the risk of developing high-grade dysplasia or esophageal cancer and delay death from any cause in people...
2018 ASCO: PREOPANC-1 Trial Compares Preoperative Chemoradiotherapy vs Immediate Surgery for Pancreatic Cancer
A randomized, phase III trial found that patients who received chemoradiotherapy before pancreatic cancer surgery had better disease-free survival than those who started their treatment with surgery, which is the current standard of care. In addition, the 2-year survival rate was higher for those...
2018 ASCO: Adjuvant mFOLFIRINOX vs Gemcitabine in Resected Pancreatic Cancer
In a randomized phase III trial, patients with surgically removed pancreatic cancer who received mFOLFIRINOX (a modified regimen containing oxaliplatin, leucovorin, irinotecan, and fluorouracil) lived a median of 20 months longer and were cancer-free 9 months longer than those who received the...
2018 ASCO: Hyperthermic Intraperitoneal Chemotherapy Does Not Add Benefit in Patients With Advanced Colorectal Cancer
A randomized phase III clinical trial showed that people with advanced colorectal cancer may not need a frequently considered component of treatment—heated chemotherapy delivered to the abdomen during surgery. There was no difference in survival between patients with metastases in the abdomen ...
Peter Hillmen, MB, ChB, on CLL: Results From the MURANO Trial
Peter Hillmen, MB, ChB, of St James’s University Hospital, discusses phase III study findings on minimal residual disease negativity with venetoclax plus rituximab in relapsed or refractory chronic lymphocytic leukemia (Abstract 7508).
Sumanta K. Pal, MD, and Neeraj Agarwal, MD, on Prostate Cancer: The Talapro-2 Trial
Sumanta K. Pal, MD, of the City of Hope, and Neeraj Agarwal, MD, of the Huntsman Cancer Institute, University of Utah, discuss the ongoing phase III Talapro-2 study of talazoparib with background enzalutamide in metastatic castration-resistant prostate cancer with DNA damage–repair deficiencies...
Nathan Hale Fowler, MD, and Julie M. Vose, MD, MBA, on Follicular Lymphoma: Results From the RELEVANCE Trial
Julie M. Vose, MD, MBA, of the University of Nebraska Medical Center, and Nathan Hale Fowler, MD, of The University of Texas MD Anderson Cancer Center, discuss phase III study findings on lenalidomide plus rituximab vs chemotherapy plus rituximab, followed by rituximab maintenance, in patients with ...
Joseph A. Sparano, MD, on Breast Cancer: Results of the TAILORx Trial
Joseph A. Sparano, MD, of Montefiore Medical Center, discusses phase III study results on chemoendocrine treatment vs endocrine treatment alone in hormone receptor–positive, HER2-negative, node-negative breast cancer and an intermediate prognosis 21-gene recurrence score (Abstract LBA1).
Gilberto Lopes, MD, MBA, on NSCLC: Results From the KEYNOTE-042 Trial
Gilberto Lopes, MD, MBA, of the Sylvester Comprehensive Cancer Center at the University of Miami, discusses phase III findings on pembrolizumab vs platinum-based chemotherapy as first-line treatment for advanced/metastatic non–small cell lung cancer with a PD-L1 tumor proportion score ≥ to 1%...
2018 ASCO: Carmena Trial Compares Nephrectomy Plus Adjuvant Sunitinib vs Sunitinib Alone in Metastatic RCC
The randomized phase III Carmena trial showed that many people with advanced kidney cancer can avoid nephrectomy without compromising survival. The median overall survival for people who received the targeted therapy sunitinib (Sutent) alone was 18.4 months, compared with 13.9 months for those who...
2018 ASCO: TAILORx: Most Women With Early-Stage Breast Cancer Can Forgo Chemotherapy When Guided by a Diagnostic Test
The federally funded, phase III TAILORx clinical trial showed that most women with hormone receptor (HR)–positive, HER2-negative, axillary node–negative early-stage breast cancer and a mid-range score on a 21-tumor gene expression assay (Oncotype DX® Breast Recurrence Score) do not...
2018 ASCO: Low-Dose Maintenance Chemotherapy in Rhabdomyosarcoma
A new chemotherapy strategy seems to improve cure rates for children with rhabdomyosarcoma who are at high risk for cancer recurrence. In a randomized phase III clinical trial, adding 6 months of low-dose maintenance chemotherapy after initial treatment increased the 5-year overall survival rate...
2018 ASCO: KEYNOTE-042 Trial Compares Pembrolizumab With Chemotherapy as First-Line Treatment of NSCLC With PD-L1 Expression of 1% or More
A large, randomized phase III trial shows that the immunotherapy pembrolizumab (Keytruda) is a more effective initial treatment than chemotherapy (the current standard of care) for the majority of patients with the most common type of lung cancer. People with advanced non–small cell lung...
Robert M. Jotte, MD, PhD, on NSCLC: Results From the IMpower131 Trial
Robert M. Jotte, MD, PhD, of Rocky Mountain Cancer Centers, discusses phase III study findings on atezolizumab plus carboplatin plus paclitaxel or nab-paclitaxel vs carboplatin plus nab-paclitaxel, as first-line therapy in advanced squamous non–small cell lung cancer (Abstract LBA9000).
Meletios A. Dimopoulos, MD, on Waldenström’s Macroglobulinemia
Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, discusses phase III findings on ibrutinib/rituximab vs placebo/rituximab in Waldenström’s macroglobulinemia (Abstract 8003).
Martee L. Hensley, MD, on Leiomyosarcoma: Results From a GOG Treatment Trial
Martee L. Hensley, MD, of Memorial Sloan Kettering Cancer Center, discusses phase III study findings on adjuvant gemcitabine plus docetaxel followed by doxorubicin vs observation for uterus-limited, high-grade leiomyosarcoma (Abstract 5005).
2018 ASCO: Phase III SANDPIPER Trial Evaluates Taselisib Plus Fulvestrant in Advanced Breast Cancer
In a phase III clinical trial, the investigational PI3K inhibitor taselisib combined with standard hormone therapy fulvestrant (Faslodex) halted the growth of advanced breast cancer growth by 2 months longer than hormone therapy alone. In addition, the novel combination decreased the chance of...
2018 ASCO: Blood Test Shows Potential as a Detection Tool for Early-Stage Lung Cancer
An initial report from the large, ongoing Circulating Cell-Free Genome Atlas (CCGA) study provides preliminary evidence that a blood test may be able to detect early-stage lung cancer. This is one of the first studies to explore blood tests analyzing free-floating or cell-free DNA as a tool for the ...
2018 ASCO: IMpower 131 Studies Addition of Atezolizumab to Chemotherapy in Advanced Squamous NSCLC
Initial findings from a randomized phase III clinical trial showed that patients with advanced squamous non–small cell lung cancer (NSCLC) benefit more from initial treatment with the programmed cell death ligand 1 (PD-L1)-targeted immunotherapy atezolizumab (Tecentriq) and chemotherapy than...
2018 ASCO: Black Men With Advanced Prostate Cancer Treated With Chemotherapy May Have Equal or Better Survival Than White Men
An analysis of pooled data from 9 randomized phase III trials of more than 8,000 men with advanced prostate cancer who received chemotherapy shows chances of survival are as good for black men as white men. The median survival was the same in black men and white men overall (21 months), but black...
FDA Accepts Supplemental New Drug Application for Cabozantinib in Previously Treated Advanced Hepatocellular Carcinoma
On May 29, the U.S. Food and Drug Administration (FDA) accepted for filing the supplemental new drug application (sNDA) for cabozantinib (Cabometyx) tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma (HCC). The filing has been assigned a Prescription Drug...
FDA Grants Priority Review to Gilteritinib for the Treatment of Relapsed or Refractory FLT3 Mutation–Positive AML
The U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, a new drug application (NDA) for gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) and a mutation in the FLT3 gene, as detected by an FDA-approved test....
FDA Oncology Drug Approvals Granted Between June 2017 and May 16, 2018
Over the past year (June 2017–May 2018), the U.S. Food and Drug Administration (FDA) granted approval to a number of new oncology drug products, including several biosimilar products. Here we provide the labeling approved for these novel drugs and new indications. EPOETIN ALFA-EPBX (RETACRIT)...
AUA 2018: Apalutamide Significantly Reduced Risk of PSA Progression in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
A post-hoc analysis from the phase III SPARTAN study that showed treatment with apalutamide (Erleada) significantly reduced the risk of prostate-specific antigen (PSA) progression in patients with nonmetastatic castration-resistant prostate cancer (CRPC) who had a rapidly rising PSA while receiving ...
Risk of Recurrence in Stage III Colon Cancer According to RAS- and BRAF-Mutation Status
In a study in the PETACC-8 trial population reported in JAMA Oncology, Julien Taieb, MD, PhD, of the Université Paris Descartes, and colleagues found that the risk of recurrence in patients with stage III colon cancer differed for the primary tumor location according to RAS- and BRAF-mutation...
PET-Guided Therapy for Aggressive Non-Hodgkin Lymphomas
In a German phase III trial (PETAL) reported in the Journal of Clinical Oncology, Dührsen et al found that interim 18F-FDG positron emission tomography (PET) findings were associated with survival in patients with aggressive non-Hodgkin lymphomas receiving R-CHOP (rituximab [Rituxan]...
