In the phase III NRG Oncology-RTOG 1203 study, patient-reported gastrointestinal (GI) and urinary toxicities were reduced with intensity-modulated radiation therapy (IMRT) vs standard radiotherapy (RT) in women with cervical or endometrial cancer. The findings were reported by Klopp et al in the...
EARLY IN 2018, olaparib tablets (Lynparza) were granted regular approval for treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.1,2...
EARLY IN 2018, abiraterone acetate tablets (Zytiga) in combination with prednisone were approved for the treatment of metastatic high-risk castration-sensitive prostate cancer.1,2 Supporting Efficacy Data APPROVAL WAS based on the findings of the phase III LATITUDE trial, in which 1,199 patients...
The randomized, phase III TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral ixazomib (Ninlaro) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) vs placebo. The trial evaluated the effect of ixazomib as a...
The ASCO Post presents these brief summaries of important studies in breast cancer, presented at the 2018 ASCO Annual Meeting. Ribociclib Plus Fulvestrant in Metastatic Breast Cancer The benefit of an inhibitor of cyclin-dependent kinase 4/6 (CDK4/6) added to fulvestrant has now been proven to...
It would be impossible to cover all of the important presentations from the 5,000-plus abstracts accepted for the 2018 ASCO Annual Meeting. In addition to our regular meeting coverage of the top news stories, the following highlights focus on novel investigational approaches to therapy for various...
As first-line treatment for metastatic breast cancer, the oral taxane tesetaxel produced a 45% confirmed response rate and was well tolerated, producing little alopecia or neuropathy, according to Andrew D. Seidman, MD, and colleagues from several cancer centers. Dr. Seidman, of Memorial Sloan...
As reported in The New England Journal of Medicine by Abou-Alfa and colleagues, the second interim analysis of the phase III CELESTIAL trial has shown a significant improvement in overall and progression-free survival with cabozantinib (Cabometyx) vs placebo in patients with sorafenib...
Patients with advanced squamous non–small cell lung cancer (NSCLC) had a greater benefit from first-line treatment with the combination of atezolizumab (Tecentriq) plus chemotherapy vs chemotherapy alone in the randomized, phase III, IMpower131 clinical trial.1 At the landmark of 12-month...
Two pancreatic cancer specialists commented on the PREOPANC-1 study for The ASCO Post: Colin D. Weekes, MD, PhD, of Massachusetts General Hospital and Harvard Medical School, Boston, who had discussed the abstract at the ASCO Annual Meeting, and Manish A. Shah, MD, FASCO, Chief of the Solid Tumor...
For patients with newly diagnosed, potentially resectable pancreatic cancer, neoadjuvant chemoradiotherapy led to better outcomes when compared with immediate surgery followed by chemoradiotherapy in the phase III PREOPANC-1 trial. Approximately 25% fewer deaths occurred among patients in the...
In a study reported in JAMA Oncology, Carlo et al found a high prevalence of germline mutations in cancer susceptibility genes in patients with advanced renal cell carcinoma (RCC). Study Details In this cohort study, conducted between October 2015 and July 2017, 254 of 267 patients with advanced...
Results of the phase III Trans-Tasman Radiation Oncology Group 99.03 trial reported in the Journal of Clinical Oncology by MacManus et al indicate that use of systemic therapy following involved-field radiotherapy (IFRT) increased progression-free survival in patients with stage I or II low-grade...
As reported in The New England Journal of Medicine by Hussain et al, the phase III PROSPER trial has shown a 71% reduction in risk of metastasis or death with enzalutamide (Xtandi) vs placebo in men with nonmetastatic castration-resistant prostate cancer. Study Details In the double-blind trial,...
The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) in combination with carboplatin/paclitaxel or nab-paclitaxel (Abraxane) as a first-line treatment for metastatic squamous non–small cell lung...
IN PATIENTS with advanced breast cancer harboring a PIK3CA mutation, the addition of the PI3 kinase (PI3K) inhibitor taselisib to endocrine therapy with fulvestrant (Faslodex) significantly improved progression-free survival compared with fulvestrant alone, in the international phase III SANDPIPER...
ATEZOLIZUMAB (TECENTRIQ) plus bevacizumab (Avastin) plus a platinum doublet (ABCP) improved overall survival by 22% compared with bevacizumab plus a platinum doublet (BCP) in patients with advanced wild-type (without an identified mutation) nonsquamous non–small cell lung cancer (NSCLC), according...
IN PATIENTS with previously untreated advanced follicular lymphoma, the chemotherapy-free combination of rituximab (Rituxan) plus lenalidomide (Revlimid), the so-called R-squared (R2) regimen, yielded outcomes as good as those in patients who received standard rituximab-chemotherapy, in the interim ...
THE ADDITION OF 6 months of maintenance chemotherapy in the treatment of rhabdomyosarcoma improved 5-year survival by 13%, in the European RMS2005 Maintenance study reported at the 2018 ASCO Annual Meeting.1 “At the end of this long, not-easy study, we concluded that maintenance is an effective and ...
A REGIMEN COMBINING ibrutinib (Imbruvica) and venetoclax (Venclexta) in previously untreated patients with chronic lymphocytic leukemia (CLL) greatly reduced the risk of venetoclax-associated tumor-lysis syndrome and led to promising rates of undetectable minimal residual disease (MRD) in the phase ...
RESEARCH TO DATE has not been able to identify a subgroup of patients with estrogen receptor–positive HER2-negative metastatic breast cancer who do not derive benefit from the addition of inhibitors of cyclin-dependent kinases 4/6 (CDK4/6) to endocrine therapy, according to a study by the U.S. Food ...
THE COMBINATION of pembrolizumab (Keytruda) plus platinum-based chemotherapy improved overall survival, response rates, and duration of response in patients with advanced squamous cell non–small cell lung cancer (NSCLC) compared with chemotherapy alone irrespective of programmed cell death ligand 1 ...
In a Japanese phase III noninferiority trial (JCOG0504) reported in the Journal of Clinical Oncology, Kayama et al found that salvage stereotactic radiosurgery (SRS) was noninferior to whole brain radiation therapy (WBRT) for survival in patients with 1 to 4 resected brain metastases. In the...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Earlier this year, apalutamide (Erleada) was approved for ...
The U.S. Food and Drug Administration (FDA) recently accepted a new drug application and granted Priority Review designation for glasdegib, an investigational oral smoothened inhibitor being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in...
As reported by Bisogno et al in The Lancet Oncology, a phase III trial (EpSSG RMS 2005) has shown no benefit of adding doxorubicin to standard IVA (ifosfamide, vincristine, dactinomycin) in 3-year event-free survival among patients with high-risk rhabdomyosarcoma. Study Details In the open-label...
GUEST EDITOR Integrative Oncology is guest edited by Jun J. Mao, MD, MSCE, Laurance S. Rockefeller Chair in Integrative Medicine and Chief, Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York. “Mindfulness” has gained significant popularity in the lay press in recent...
The phase III IMpassion130 study has met its co-primary endpoint of progression-free survival (PFS). Results demonstrated that the combination of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) as first-line treatment significantly reduced the risk of disease worsening or death in patients...
The U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma. The Prescription Drug User Fee Act, or...
As reported in the Journal of Clinical Oncology by Tao et al, the phase III GORTEC (Groupe Oncologie Radiothèrapie Tête et Cou) 2007-01 trial has shown improved progression-free survival with the addition of concurrent chemotherapy to cetuximab (Erbitux) and radiotherapy (RT) in...
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental new drug application (sNDA) for ibrutinib (Imbruvica) in combination with rituximab (Rituxan) as a new treatment option for Waldenström's macroglobulinemia. If approved, the sNDA would expand the...
The phase III IMpower133 study recently met its coprimary endpoints of overall survival (OS) and progression-free survival (PFS) at its first interim analysis. The study demonstrated that first-line treatment with the combination of atezolizumab (Tecentriq) plus chemotherapy (carboplatin and...
In a phase III International Liver Tumor Strategy Group trial (SIOPEL 6) reported in The New England Journal of Medicine, Brock et al found that sodium thiosulfate reduced cisplatin-induced hearing loss in pediatric patients with standard-risk hepatoblastoma. Study Details The trial enrolled a...
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the first-line treatment of advanced non–small cell lung cancer (NSCLC) in patients with a tumor mutational burden...
In the phase III DERMA trial reported in The Lancet Oncology, Dreno et al found that an adjuvant MAGE-A3 immunotherapeutic provided no benefit vs placebo in patients with resected MAGE-A3–positive stage IIIB or IIIC melanoma. Development of the agent for use in melanoma has been stopped. The ...
In the phase III LILAC equivalence trial reported in The Lancet Oncology, von Minckwitz et al found similar efficacy and safety with the trastuzumab biosimilar ABP 980 vs reference trastuzumab (Herceptin) in HER2-positive early breast cancer. On local review, the risk difference and risk ratio (RR) ...
As reported in The Lancet by Shitara et al, the phase III KEYNOTE-061 trial showed no significant overall survival benefit with pembrolizumab vs paclitaxel in patients with advanced gastric or gastroesophageal junction cancer progressing on platinum-fluoropyrimidine treatment with programmed cell...
New research led by Dana-Farber Cancer Institute investigators suggests that patients treated for nonmetastatic colon cancer may sharply reduce the risk that the disease will return by following a diet low in carbohydrates and other foods that raise insulin levels. In a study published by...
As reported by Slamon and colleagues in the Journal of Clinical Oncology, the phase III MONALEESA-3 trial has shown significant improvement in progression-free survival with the addition of the CDK4/6 inhibitor ribociclib (Kisqali) to fulvestrant (Faslodex) in hormone receptor (HR)-positive,...
As reported at the 2018 ASCO Annual Meeting and in The New England Journal of Medicine by Socinski et al, the phase III IMpower150 trial has shown that the addition of atezolizumab (Tecentriq) to bevacizumab (Avastin) plus chemotherapy significantly improved progression-free and overall survival in ...
The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to the immune checkpoint inhibitor pembrolizumab (Keytruda) for use in combination with chemotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC). KEYNOTE-021 This...
In a phase II trial reported in The Lancet Oncology, Cortes et al found that the next-generation FLT3 inhibitor quizartinib had good activity in patients with relapsed or refractory acute myeloid leukemia (AML), with greater activity in patients with FLT3-ITD mutations. Study Details The study...
ON JUNE 13, 2018, the U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) for the treatment of patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV...
The final results of a phase III trial reported by Roger Stupp, MD, of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, and colleagues in JAMA indicate that adding antimitotic treatment with tumor-treating fields to maintenance temozolomide is associated with improved...
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. Gary Deng, MD, PhD, and Jyothirmai Gubili, MS, present information on the potential health benefits ...
This year’s ASCO Research Community Forum (RCF) 2018 Annual Meeting will not be one to miss! Though still a few months away, I am thrilled to share the work that is already underway to bring the research community together for 2 days of learning and collaboration. During my term as Chair of the...
After about 70 years with no significant progress, the landscape for men with de novo metastatic prostate cancer has changed dramatically in the past 4 years, with statistically significant and highly clinically meaningful survival improvement reported from multiple phase III trials when...
As reported in the Journal of Clinical Oncology by Michael J. Morris, MD, of Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, and colleagues, ASCO has released a clinical practice guideline on optimizing anticancer therapy in men with metastatic non-castrate prostate cancer.1 To ...
The combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) improved progression-free survival compared with chemotherapy as first-line treatment for patients with advanced non–small cell lung cancer (NSCLC) and a high tumor mutational burden irrespective of programmed cell death ligand 1...
Biologics are credited with increasing median overall survival in colorectal cancer to approximately 30 months. Their optimal use was discussed by Axel Grothey, MD, Professor of Oncology at the Mayo Clinic, Rochester, Minnesota, in an article he coauthored for the Journal of Oncology Practice 1...