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Clinical Cancer Researcher Gini Fleming, MD, Firmly Believes in the Power of Ideas

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 ...

breast cancer

Abemaciclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer

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 ...

skin cancer

Two Phase III Trials of KX2-391 in Actinic Keratosis Achieve Primary Endpoints

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) ...

skin cancer

Dabrafenib/Trametinib Combination Receives CHMP Recommendation for the Adjuvant Treatment of BRAF V600 Mutation–Positive Melanoma

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...

head and neck cancer
immunotherapy

KEYNOTE-048: Pembrolizumab Monotherapy in Head and Neck Squamous Cell Carcinoma

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 ...

gynecologic cancers

Use of Analgesics and Ovarian Cancer–Specific Survival

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...

lung cancer

ALTA-1L Trial of Brigatinib vs Crizotinib in ALK-Positive Advanced NSCLC Meets Primary Endpoint

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...

leukemia

CPX-351 Liposome in Older Patients With Newly Diagnosed Secondary Acute Myeloid Leukemia

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...

colorectal cancer

Study Examines Right-Sided vs Left-Sided Colon Cancer Survival Rates

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...

lung cancer

Adding Cisplatin to First-Line Treatment of Elderly Patients With Advanced NSCLC

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...

gynecologic cancers

Quality of Life With Niraparib Maintenance vs Placebo in Patients With Recurrent Ovarian Cancer

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...

prostate cancer

Robot-Assisted Laparoscopic Prostatectomy vs Open Radical Retropubic Prostatectomy in Newly Diagnosed Prostate Cancer

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 ...

lung cancer
immunotherapy

IMpower 132: Atezolizumab in Combination With Pemetrexed and Platinum-Based Chemotherapy in Advanced Nonsquamous NSCLC

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...

gynecologic cancers

Quality-of-Life and Patient-Centered Outcomes With Olaparib Maintenance in Relapsed Ovarian Cancer

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...

breast cancer

Circulating Tumor Cells and Adjuvant Radiotherapy in Early Breast Cancer

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...

gynecologic cancers
immunotherapy

Bevacizumab Plus Chemotherapy in Advanced Ovarian Cancer

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, Conquer Cancer Congratulate 2018 Grant and Award Recipients

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...

bladder cancer
immunotherapy

No Survival Benefit for Atezolizumab inPD-L1–Positive Urothelial Cancer

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...

hepatobiliary cancer
immunotherapy

FDA Grants Breakthrough Therapy Designation for Atezolizumab/Bevacizumab Combination as First-Line Treatment for Advanced or Metastatic HCC

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...

gynecologic cancers

Less Toxicity With Pelvic IMRT vs Standard RT in Cervical and Endometrial Cancers

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...

breast cancer

Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer

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...

prostate cancer

Abiraterone Plus Prednisone in High-Risk Metastatic Castration-Sensitive Prostate Cancer

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...

multiple myeloma

Phase III TOURMALINE-MM3 Trial of Ixazomib as Maintenance Therapy in Patients With Multiple Myeloma Posttransplant

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...

issues in oncology

In Case You Missed It: Update on Breast Cancer Research

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...

issues in oncology

In Case You Missed It: Short Takes on Current Cancer Research

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...

solid tumors
breast cancer

Oral Taxane Shows Strong Activity and Good Tolerability in Metastatic Breast Cancer

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...

hepatobiliary cancer

Cabozantinib vs Placebo in Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib

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...

lung cancer
immunotherapy

Atezolizumab Plus Chemotherapy Extends Survival in Squamous NSCLC Regardless of PD-L1 Level

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...

Expert Point of View: Colin D. Weekes, MD, PhD and Manish A. Shah, MD, FASCO

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...

solid tumors
pancreatic cancer

Preliminary Data Suggest Neoadjuvant Chemoradiotherapy May Improve Outcomes in Patients With Early Stages of Pancreatic Cancer

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...

kidney cancer

Germline Mutations in Cancer Susceptibility Genes in Patients With Advanced Renal Cell Carcinoma

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...

lymphoma

Addition of Systemic Therapy to Involved-Field Radiotherapy in Early-Stage Follicular Lymphoma

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...

prostate cancer

PROSPER: Enzalutamide Prolongs Metastasis-Free Survival in Nonmetastatic Castration-Resistant Prostate Cancer

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,...

lung cancer
immunotherapy

FDA Accepts sBLA for Pembrolizumab in Combination With Chemotherapy as First-Line Treatment for Metastatic Squamous NSCLC

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...

breast cancer

Study of PI3K Inhibitor Added to Fulvestrant in Advanced Breast Cancer Affirms Proof-of-Principle

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...

lung cancer
immunotherapy

More Evidence of Benefit With Immunotherapy and Chemotherapy in Nonsquamous Non–Small Cell Lung Cancer

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...

lymphoma

Chemotherapy-Free Regimen Comparable to Rituximab-Chemotherapy as Front-Line Therapy for Follicular Lymphoma

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 ...

sarcoma

With European Protocol, Maintenance Therapy Improved 5-Year Survival in Rhabdomyosarcoma

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 ...

leukemia

Ibrutinib Plus Venetoclax in CLL: High MRD-Negativity Rates, Reduced Risk for Tumor-Lysis Syndrome

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 ...

breast cancer

Pooled Study Analysis Explores the Use of CDK4/6 Inhibitors in Metastatic Breast Cancer

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 ...

lung cancer
immunotherapy

KEYNOTE-407: Pembrolizumab Plus Chemotherapy Benefits Response, Survival in Squamous NSCLC

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 ...

cns cancers

Surgery Followed by Salvage Stereotactic Radiosurgery vs Whole-Brain Radiotherapy for Four or Fewer Brain Metastases

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...

prostate cancer
immunotherapy

Apalutamide in Nonmetastatic Castration-Resistant Prostate Cancer

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 ...

leukemia

FDA Grants Priority Review for Glasdegib in Patients With Previously Untreated AML

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...

sarcoma

Addition of Dose-Intensified Doxorubicin to Standard Chemotherapy in Rhabdomyosarcoma

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...

integrative oncology
supportive care

Mindfulness in Cancer Care: Hype or Help?

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...

breast cancer
immunotherapy

IMpassion130: Atezolizumab Plus Nab-Paclitaxel in Metastatic or Locally Advanced Triple-Negative Breast Cancer

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...

skin cancer
immunotherapy

FDA Accepts sBLA for Pembrolizumab as Adjuvant Therapy in Advanced Melanoma

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...

head and neck cancer

Addition of Concurrent Chemotherapy to EGFR Inhibitor and Radiotherapy in Locally Advanced Head and Neck Carcinoma

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...

hematologic malignancies

FDA Accepts sNDA for Ibrutinib Plus Rituximab in Waldenström’s Macroglobulinemia

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...

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