Gini Fleming, MD, had a peripatetic path to her destination as a gynecologic and breast cancer expert. As a child, she moved around a lot, living in about 10 or 12 different places, so she had no real sense of being born and reared in any particular place. “My parents married young, when my father ...
Early in 2018, abemaciclib (Verzenio) in combination with an aromatase inhibitor was approved as initial endocrine-based therapy for postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.1,2 Supporting Efficacy Data Approval was based on findings in ...
Two phase III studies—KX-AK-003 and KX-AK-004—achieved their primary endpoint of 100% clearance of actinic keratosis lesions at day 57 within the face or scalp treatment areas, with each study achieving statistical significance (P < .0001). Statistical significance (P < .001) ...
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of adult patients with stage III melanoma...
The phase III KEYNOTE-048 trial, which is investigating pembrolizumab (Keytruda) for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), met a primary endpoint of overall survival (OS) as monotherapy in patients whose tumors expressed programmed cell death ...
In a prospective cohort study reported in The Lancet Oncology, Merritt et al found evidence that recent use of aspirin or nonaspirin nonsteroidal anti-inflammatory drugs (NSAIDs) after diagnosis appears to improve ovarian cancer–specific survival. Study Details The study involved...
The global, randomized, phase III ALTA-1L (ALK in Lung Cancer Trial of AP26113 in 1st Line) trial met its primary endpoint at the first prespecified interim analysis, with brigatinib (Alunbrig) demonstrating a statistically significant improvement in progression-free...
In a pivotal phase III trial reported in the Journal of Clinical Oncology, Lancet et al found that cytarabine and daunorubicin liposome (CPX-351, Vyxeos) significantly improved overall survival vs standard cytarabine plus daunorubicin (7+3 regimen) in older patients with newly diagnosed secondary...
Patients with colorectal cancer tumors on the right side may have poorer 5-year survival rates than those whose tumors are located on the left side. However, a new large-scale retrospective study is the first to demonstrate a potential improvement of these outcomes. Study results show that nearly...
A joint analysis of parallel phase III trials reported in the Journal of Clinical Oncology by Gridelli et al found no overall survival benefit of adding cisplatin to first-line treatment of elderly patients with advanced non–small cell lung cancer (NSCLC) without an EGFR mutation. Study...
In a study reported in The Lancet Oncology, Oza et al found that quality of life (QOL) based on patient-reported outcomes (PROs) was not worsened with niraparib (Zejula) maintenance vs placebo in the phase III ENGOT-OV16/NOVA trial in women with recurrent ovarian cancer who were in response to...
In an Australian phase III trial reported in The Lancet Oncology, Coughlin et al found similar functional outcomes at 2 years with robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy in men with newly diagnosed clinically localized prostate cancer. Study Details In ...
The phase III IMpower132 study met its co-primary endpoint of progression-free survival and demonstrated that the combination of atezolizumab (Tecentriq) plus chemotherapy (cisplatin or carboplatin plus pemetrexed [Alimta]) reduced the risk of disease worsening or death compared to chemotherapy...
In the phase III SOLO2 trial reported in The Lancet Oncology, Friedlander et al found that olaparib maintenance therapy did not worsen health-related quality of life vs placebo in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1 or BRCA2 mutation. In the study, maintenance...
In a study reported in JAMA Oncology by Chelain R. Goodman, MD, PhD, of the Department of Radiation Oncology at Northwestern University Feinberg School of Medicine, and colleagues, adjuvant radiotherapy was associated with better outcome in patients with early breast cancer who had detectable...
ON JUNE 13, 2018, bevacizumab (Avastin) was granted approval for treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection1,2. The...
ASCO’s Conquer Cancer Foundation presented more than $7.3 million in grants and awards to exceptional oncology researchers at the 2018 ASCO Annual Meeting. ASCO and Conquer Cancer congratulate the recipients and offer their profound thanks to those who generously supported these awards. Visit...
As reported in The Lancet by Thomas Powles, MD, of Barts Cancer Institute, Queen Mary University of London, and colleagues, the phase III IMvigor211 trial showed no survival benefit for atezolizumab vs physician’s choice of chemotherapy in platinum-treated locally advanced or metastatic urothelial...
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) as a first-line treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver...
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...