This Clinical Trials Resource Guide includes a selection of actively recruiting clinical trials of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, including palbociclib, ribociclib, and abemaciclib in multiple tumor types. All of the studies here and many others are listed on the National...
Geoffrey I. Shapiro, MD, PhD, Director of the Early Drug Development Center at the Dana-Farber Cancer Institute, Boston, explained the current research initiatives involving cyclin D–dependent kinase (CDK) 4/6 inhibitors. Mechanism of Action How do CDK4/6 inhibitors work at the cellular level in...
The novel mechanism of action of drugs that inhibit the cyclin D–dependent kinases CDK4 and CDK6 has prompted effective new treatment strategies. Although the bulk of the data supporting the use of selective CDK4/6 inhibitors is currently in breast cancer, patients with other tumor types are...
On April 28, the European Commission approved nivolumab (Opdivo) as monotherapy for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in adults with disease progression on or after platinum-based therapy. Nivolumab is the first and only immuno-oncology treatment that has...
As reported in the Journal of Clinical Oncology, Renfro et al have derived a nomogram for predicting early mortality in metastatic colorectal cancer using data from more than 20,000 patients in the ARCAD (Aide et Recherche en Cancérologie Digestive) database. Study Details The analysis...
In the international phase III REMARC trial reported by Thieblemont et al in the Journal of Clinical Oncology, lenalidomide (Revlimid) maintenance was found to prolong progression-free survival vs placebo in older patients with diffuse large B-cell lymphoma responding to first-line R-CHOP...
A randomized trial, reported by Maly et al in the Journal of Clinical Oncology, has shown that having an individualized survivorship care plan in place was associated with increased physician implementation of recommended breast cancer survivorship care among low-income, predominantly Latina breast ...
On April 27, the investigational next-generation ALK/ROS1 tyrosine kinase inhibitor lorlatinib was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell...
The U.S. Food and Drug Administration (FDA) has expanded the approved use of regorafinib (Stivarga) to include treatment of patients with hepatocellular carcinoma who have been previously treated with the drug sorafenib (Nexavar). This is the first new FDA-approved treatment for liver cancer in...
Results of the SARAH trial presented at the 2017 International Liver Congress (ILC) demonstrated that selective internal radiation therapy (SIRT) resulted in a median overall survival of 8.0 months compared to 9.9 months with sorafenib (Nexavar; P = .179) in patients with locally advanced ...
A phase II trial conducted at the University of California at Davis and at Los Angeles showed good outcomes with reduced-dose radiotherapy in patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. These findings were reported in The Lancet Oncology by Chen et al....
A Japanese phase III trial has shown no survival benefit of prophylactic cranial irradiation vs observation in patients with extensive-disease small cell lung cancer who had any response to platinum-based doublet chemotherapy and no brain metastases at baseline. These findings were reported in The...
A pathologic complete response to presurgical therapy occurs in between 40% and 50% of patients with HER2-positive and triple-negative breast cancer, raising the question of the need for surgery for all patients after neoadjuvant chemotherapy indicates a pathologic complete response in...
As reported by Blum et al in the Journal of Clinical Oncology, the efficacy analysis of the combined adjuvant Anthracyclines in Early Breast Cancer (ABC) Trials showed better invasive disease-free survival with taxane plus doxorubicin/cyclophosphamide (TaxAC) regimens vs six cycles of...
Casali et al have reported 10-year progression-free and overall survival rates among patients with locally advanced unresectable or metastatic gastrointestinal stromal tumors (GISTs) receiving imatinib at 400 or 800 mg/d in the phase III European Organisation for Research and Treatment of Cancer,...
An ASCO clinical practice guideline update, reported by Khorana et al in the Journal of Clinical Oncology, includes the recommendation of gemcitabine-capecitabine doublet therapy as an adjuvant therapy option in potentially curable pancreatic cancer. The updated recommendation (4.1) modifies the...
An article that appeared in the April 10 issue of The ASCO Post (“Olaparib Maintenance Prolongs Progression-Free Survival in Ovarian Cancer”) suggests unwarranted conclusions from the phase III SOLO2 trial of olaparib (Lynparza) in patients with platinum-sensitive relapsed ovarian cancer and...
In an Italian phase III trial reported in the Journal of Clinical Oncology, Marcello Tiseo, MD, of Azienda Ospedaliero-Universitaria, Parma, Italy, and colleagues found that adding first-line bevacizumab (Avastin) to cisplatin/etoposide did not prolong overall survival in patients with...
Long-term survivors of melanoma are more likely than those who have not been diagnosed with the disease to use sunscreen, protective clothing, and other means to limit exposure to the sun, according to a survey of melanoma survivors and controls about ultraviolet radiation exposure and protective...
Better vision function seems to be related to better quality of life after treatment for head and neck cancer, particularly among patients who have had surgery, according to Hsiao-Lan Wang, PhD, RN, Assistant Professor in the College of Nursing at the University of South Florida. Head and neck...
The human epidermal growth factor receptor (HER) family consists of four members—epidermal growth factor receptor (EGFR), HER2, HER3, and HER4—all transmembrane receptor tyrosine kinases, which regulate cell growth and survival, differentiation, and migration, as well as other cellular responses.1 ...
In part 1 of the Heritage study, a phase III equivalence trial reported in JAMA, Hope S. Rugo, MD, of the University of California Helen Diller Family Comprehensive Cancer Center, San Francisco, and colleagues found that treatment with trastuzumab (Herceptin) or a proposed trastuzumab biosimilar...
The advent of successful monoclonal antibody therapy in the treatment of relapsed/refractory myeloma has dramatically improved the prognosis of patients for whom currently approved novel therapies have failed. In 2015, the approval of the combination of elotuzumab (Empliciti) with lenalidomide...
As reported in The New England Journal of Medicine by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, and colleagues, the phase III POLLUX trial has shown that the addition of the CD38-targeted antibody daratumumab (Darzalex) to lenalidomide...
Long-term follow-up of treatment with ibrutinib (Imbruvica) in patients with previously untreated and treated chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) has shown high response rates that are durable. At 5 years, 89% of patients with treatment-naive and relapsed or...
Although the prognosis of patients with diffuse large B-cell lymphoma (DLBCL) has improved with R-CHOP—the addition of rituximab (Rituxan) to the cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy regimen—one-third of patients still relapse after therapy, and patients with the ...
Eric Jonasch, MD, Professor in the Department of Genitourinary Cancer at MD Anderson Cancer Center in Houston, commented on this phase II study. “This is an important study, since we have, for the first time, randomized, prospective data comparing the combination of a checkpoint antibody with an...
The combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) appears to be promising in the first-line treatment of patients with metastatic renal cell carcinoma, according to results of a phase II trial presented at the 2017 Genitourinary Cancers Symposium.1 Despite the failure of the...
Read more in the Journal of Oncology Practice (JOP). Visit ASCOPubs.org/journal/jop Patients with stage I lung cancer are achieving excellent local tumor control, thanks to an evolution in radiotherapy and surgical approaches. Jeffrey A. Bogart, MD, Professor and Chair of the Department of...
The approach to treatment of high-risk, clinical stage I, nonseminomatous or combined germ cell tumors of the testis is not written in stone. Orchiectomy followed by surveillance or chemotherapy with two cycles of bleomycin, etoposide, and cisplatin (BEP) is a favored approach by most experts. A...
Early-phase studies suggest that venetoclax (Venclexta) holds promise as a treatment for myeloma. At the 2016 American Society of Hematology (ASH) Annual Meeting & Exposition, investigators reported strong activity in heavily pretreated patients, especially those with the t(11;14)...
Invited discussant Jonathan Ledermann, MD, of UCL Cancer Institute, University College London, said the ARIEL2 results for rucaparib (Rubraca) add to the evidence base for PARP (poly ADP-ribose polymerase) inhibition in ovarian cancer established by olaparib (Lynparza). It’s been about 2 years...
A Web-based decision aid that allows women with early breast cancer to easily compare surgical treatment options helps them make more informed decisions, suggests a randomized trial reported at the 2017 Society of Surgical Oncology (SSO) Annual Cancer Symposium.1 “Having knowledge of surgical...
A machine learning model that uses a set or ensemble of algorithms has good accuracy for predicting colorectal cancer recurrence, investigators reported during a plenary session at the 2017 Society of Surgical Oncology (SSO) Annual Cancer Symposium.1 Persistent key questions in managing early...
On April 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. Atezolizumab was previously approved for people...
“The status quo for HPV [human papillomavirus]-associated oropharyngeal squamous cell carcinoma is not sufficient.… Our treatment is effective, but the toxicity associated with it is not tolerable.” And HPV-associated oropharyngeal cancer “is a cancer of relatively younger patients,” said Nishant...
The American Society for Radiation Oncology (ASTRO) has issued a new clinical guideline for the management of oropharyngeal cancer. The guideline, “Radiation therapy for oropharyngeal squamous cell carcinoma: An ASTRO Evidence-based Clinical Practice Guideline,” was published by Sher et ...
In an Australian study reported in the Journal of Clinical Oncology, Haydu et al found that conditional melanoma-specific survival was worse within the first 2 years of diagnosis of stage III disease for men, increasing age, and increasing American Joint Committee on Cancer (AJCC) stage. The...
The final results of the European phase III International Extranodal Lymphoma Study Group (IELSG)-19 trial, reported in the Journal of Clinical Oncology by Zucca et al, showed that event-free and progression-free survival were better with rituximab (Rituxan) plus chlorambucil vs either agent alone...
The programmed cell death ligand 1 (PD-L1)–inhibitor avelumab (Bavencio) has shown activity in patients with refractory metastatic urothelial cancer, according to findings in a phase Ib study reported by Apolo et al in the Journal of Clinical Oncology. This patient cohort is part of the...
A French phase III trial (IFM 2009), reported by Attal et al in The New England Journal of Medicine, has shown that consolidation treatment with lenalidomide (Revlimid), bortezomib (Velcade), and dexamethasone (RVD) was associated with poorer progression-free survival vs high-dose chemotherapy and...
An analysis of patients from 4 prospective radiotherapy trials for locally advanced non–small cell lung cancer (NSCLC) conducted at 2 centers in Michigan showed that grade ≥ 3 cardiac events occurred in more than 10% of patients. The study was reported by Dess et al in the Journal of...
On March 13, the cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali) was approved for use in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast ...
Overall survival in recurrent, metastatic cervical cancer was substantially extended with a Listeria-based immunotherapy approach that targets the human papillomavirus (HPV), investigators reported at the Society of Gynecologic Oncology Annual Meeting.1 Of 50 evaluable patients, 19 were alive at...
Final results of the phase III EORTC/LYSA/FIL H10 trial confirm the benefits of early positron-emission tomography (PET)-adapted treatment in patients with stage I or II Hodgkin lymphoma. The results were reported by André et al in the Journal of Clinical Oncology. Study Details The...
In a study reported in the Journal of Oncology Practice, Adelson et al found that using standardized criteria for palliative care consultation on a solid tumor oncology service resulted in increased hospice referral and reduced rates of hospital readmission and chemotherapy use after discharge....
Adding the investigational immunotherapy indoximod to the immunotherapy pembrolizumab (Keytruda) increased the proportion of patients with advanced melanoma who responded to treatment compared with previously reported response rates for pembrolizumab monotherapy, according to interim results from a ...
The adaptive phase II/III GATSBY trial has shown no survival difference between ado-trastuzumab emtansine (Kadcyla) vs taxane treatment in patients with previously treated locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. Results were reported by Thuss-Patience et...
Eloise Chapman-Davis, MD, a gynecologic oncologist at New York-Presbyterian and Weill Cornell Medicine, commented on the SOLO2 trial results for The ASCO Post. “SOLO2 is the third randomized trial to evaluate the use of maintenance therapy in a selected subgroup of ovarian cancer patients with...
Maintenance therapy with the tablet formulation of olaparib (Lynparza) significantly prolonged progression-free survival in patients with platinum-sensitive relapsed ovarian cancer and mutations in BRCA1/2 in the phase III SOLO2 trial, presented at the 2017 Society of Gynecologic Oncology (SGO)...