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Showing 4601 - 4650Adjuvant Nivolumab vs Ipilimumab in Resected Stage III or IV Melanoma
The phase III Checkmate 238 trial has shown improved recurrence-free survival with adjuvant nivolumab (Opdivo) vs ipilimumab (Yervoy) in patients with resected advanced melanoma. The findings were reported by Weber and colleagues in The New England Journal of Medicine. Study Details In the...
Durvalumab Consolidation After Chemoradiotherapy in Stage III NSCLC
As reported by Antonia et al in The New England Journal of Medicine, an interim analysis of the phase III PACIFIC trial showed improved progression-free survival with the programmed cell death protein 1 (PD-1) inhibitor durvalumab (Imfinzi) vs placebo as consolidation in patients with unresectable...
Tisagenlecleucel for B-Cell Acute Lymphoblastic Leukemia
On August 30, 2017, tisagenlecleucel (Kymriah) was granted regular approval for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.1,2 Tisagenlecleucel is the first chimeric antigen receptor (CAR)...
Inotuzumab Ozogamicin for Relapsed/Refractory B-Cell Precursor ALL
On August 17, 2017, inotuzumab ozogamicin (Besponsa) was approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1,2 Supporting Efficacy Data APPROVAL WAS BASED on complete remission rates in the open-label phase III INO-VATE ALL...
No Improvement in Melanoma-Specific Survival With Completion Dissection vs Observation for Sentinel-Node Metastasis
THE PHASE III MSLT- II TRIAL showed that completion dissection was not associated with improved melanoma-specific overall survival vs observation in patients with sentinel-node metastasis, although a benefit was observed in regional disease control. The findings were reported in The New England...
News From JCO and JOP
STAYING UP-TO-DATE in the fast-paced world of oncology literature is a daunting task at best. To assist with that task, The ASCO Post has assembled an assortment of studies recently published in the Journal of Clinical Oncology (JCO) and the Journal of Oncology Practice (JOP). Future installments...
Regorafenib in Hepatocellular Carcinoma Previously Treated With Sorafenib
On April 27, 2017, the indications for regorafenib (Stivarga) were expanded to include treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data The new approval was based on the finding of improved overall survival...
New Response Evaluation Criteria for Lymphoma Clinical Trials: RECIL 2017
New criteria for evaluating response in lymphoma clinical trials—RECIL 2017—have been developed by an International Working Group with the aim of harmonizing criteria with the RECIST criteria used for solid tumors.1 The new criteria were reported by Anas Younes, MD, of Memorial Sloan Kettering...
Surgeon-Initiated Gene-Expression Profile Testing in Early-Stage Breast Cancer and Time to Start of Chemotherapy
In a single-center study reported in the Journal of Oncology Practice, Losk et al found that an intervention including surgeon initiation of gene-expression profile testing with Oncotype DX significantly reduced the time to testing, receipt of testing results, and initiation of chemotherapy in...
Overall Survival With Nivolumab/Ipilimumab, or Nivolumab Alone, vs Ipilimumab in Advanced Melanoma
Overall survival outcomes in the phase III CheckMate 067 trial indicate improved survival with nivolumab (Opdivo)/ipilimumab (Yervoy) vs ipilimumab and with nivolumab vs ipilimumab in patients with previously untreated advanced melanoma. These findings were reported in The New England Journal of...
Final Efficacy Analysis of 9-Valent Human Papillomavirus Vaccine Trial
The final efficacy analysis of a trial of 9-valent human papillomavirus (HPV) vaccine has shown a high preventive effect against disease due to the additional HPV pathogenic strains covered compared with the quadrivalent vaccine at up to 6 years. These findings were reported by Huh et al in The...
Combination of Inotuzumab Ozogamicin and Low-Intensity Chemotherapy in Relapsed or Refractory Ph-Negative ALL
In a single-center phase II trial reported in JAMA Oncology, Jabbour et al found that the combination of inotuzumab ozogamicin (Besponsa) and low-intensity chemotherapy produced promising results in patients with relapsed or refractory Philadelphia chromosome (Ph)-negative acute lymphoblastic...
Does Reducing the Starting Dose of Sorafenib Affect Outcomes in Hepatocellular Carcinoma?
In a retrospective study reported in the Journal of Clinical Oncology, Reiss et al found that reducing the starting dose of sorafenib (Nexavar) was associated with noninferior overall survival, reduced cost, and lower risk of discontinuing treatment in patients with advanced hepatocellular...
Addition of Bortezomib to R-CHOP in Non–Germinal Center B-Cell–Like Lymphoma
A phase II trial reported in the Journal of Clinical Oncology by Leonard et al showed no significant progression-free survival benefit of adding bortezomib (Velcade) to R-CHOP (rituximab [Rituxan], cyclophosphamide, doxorubicin, vincristine, and prednisone) in previously untreated patients with...
First-Line Gemcitabine/Docetaxel vs Doxorubicin in Advanced Soft-Tissue Sarcoma
In the UK-Swiss phase III GeDDiS trial, the combination of gemcitabine and docetaxel did not significantly improve progression-free survival vs doxorubicin in first-line treatment of locally advanced or metastatic soft-tissue sarcoma. Findings were reported in The Lancet Oncology by Seddon et al....
Adjuvant Chemotherapy vs Observation After Neoadjuvant Therapy and Radical Cystectomy for Bladder Cancer
In an analysis reported in JAMA Oncology, Seisen et al found that adjuvant chemotherapy was associated with a survival benefit vs observation in patients with adverse prognostic features after neoadjuvant therapy and radical cystectomy for urothelial carcinoma of the bladder. Study Details The...
Recombinant Adenovirus Interferon-α With Syn3 in BCG-Refractory or Relapsed Non–Muscle Invasive Bladder Cancer
A phase II study has shown activity of recombinant adenovirus interferon-α with Syn3 (rAd-IFNα/Syn3), a replication-deficient recombinant adenovirus gene transfer vector, in patients with high-grade bacillus Calmette-Guerin (BCG)-refractory or -relapsed non–muscle invasive bladder ...
Osimertinib in First-Line Treatment of EGFR Mutation–Positive Advanced NSCLC
Osimertinib (Tagrisso) has shown high activity in the phase I expansion component of the AURA trial in previously untreated patients with EGFR mutation–positive advanced non–small cell lung cancer (NSCLC). These findings were reported by Ramalingam et al in the Journal of Clinical...
Hospitalization and Rehospitalization After Diagnosis of Advanced Cancer
In a study reported in the Journal of Clinical Oncology, Whitney et al found that the majority of patients diagnosed with advanced cancer were hospitalized within 1 year of diagnosis, with a sizable proportion having multiple hospitalizations. Hospitalization Rates The study involved California...
Posttransplantation Cyclophosphamide-Based Haploidentical HCT in Hodgkin Lymphoma
In a European analysis reported in the Journal of Clinical Oncology, Martínez et al found similar survival outcomes with post-transplantation cyclophosphamide-based haploidentical allogeneic hematopoietic cell transplantation (HCT) vs conventional HLA-matched sibling donor or HLA-matched...
Eribulin vs Dacarbazine in Advanced Liposarcoma Subgroup
The subgroup analysis of outcomes among patients with advanced liposarcoma from a pivotal phase III trial comparing eribulin (Halaven) vs dacarbazine in previously treated liposarcoma or leiomyosarcoma was reported in the Journal of Clinical Oncology by Demetri et al. Overall, the phase III trial...
Survey on Training in Geriatrics/Geriatric Oncology for Hematology-Oncology Fellows
Results from an ASCO-sponsored survey study indicate that despite professed interest in the area, most hematology-oncology fellows have inadequate training in geriatrics/geriatric oncology. These findings were reported in the Journal of Oncology Practice by Maggiore et al. Study Details The...
Pembrolizumab in PD-L1–Positive Nasopharyngeal Carcinoma
As reported by Hsu et al in the Journal of Clinical Oncology, pembrolizumab (Keytruda) has shown activity in programmed cell death ligand 1 (PD-L1)–positive recurrent or metastatic nasopharyngeal carcinoma, in a cohort of the phase Ib KEYNOTE-028 trial. Study Details In the study, 27...
First-in-Human Study of Tamoxifen Metabolite Z-Endoxifen in Endocrine-Refractory Metastatic Breast Cancer
A first-in-human phase I study of the oral tamoxifen metabolite Z-endoxifen showed high drug exposure, acceptable toxicity, and antitumor activity in endocrine-refractory estrogen receptor–positive metastatic breast cancer. The findings were reported in the Journal of Clinical Oncology by...
Remnant Liver Ischemia and Cancer-Specific Survival After Resection of Colorectal Liver Metastases
In a single-center experience reported by Yamashita et al in JAMA Surgery, postoperative remnant liver ischemia of grade ≥ 2 was associated with worse cancer-specific survival after resection of colorectal liver metastases. Study Details The retrospective analysis included 202 patients who...
Alzheimer’s Disease Risk in Medicare Patients Receiving Androgen-Deprivation Therapy for Prostate Cancer
As reported by Baik et al in the Journal of Clinical Oncology, Medicare patients who received androgen-deprivation therapy for prostate cancer do not appear to be at increased risk for Alzheimer’s disease and may have an extremely small increased risk for dementia. Study Details The study...
Adding First-Line Ipilimumab to Paclitaxel/Carboplatin in Advanced Squamous NSCLC
In a phase III trial reported by Govindan et al in the Journal of Clinical Oncology, the addition of first-line ipilimumab (Yervoy) to paclitaxel/carboplatin did not improve overall survival in patients with advanced squamous non–small cell lung cancer (NSCLC). Study Details In the...
Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
In a single-center experience reported in JAMA Surgery, Eng et al found that an increased intraoperative fluid rate was associated with increased perioperative morbidity in patients with peritoneal cancer undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. Study...
Cabozantinib Salvage Therapy in Tyrosine Kinase Inhibitor–Refractory Differentiated Thyroid Cancer
A phase II study has shown that cabozantinib (Cometriq) produces responses in patients with tyrosine kinase inhibitor–refractory differentiated thyroid cancer. The findings were reported by Cabanillas et al in the Journal of Clinical Oncology. MET plays a role in vascular endothelial growth...
Guadecitabine in Treatment-Naive Older Patients With Acute Myeloid Leukemia
The results of a phase II trial have shown high activity of guadecitabine, a next-generation hypomethylating drug, in treatment-naive older patients with acute myeloid leukemia. The findings were reported in The Lancet Oncology by Kantarjian et al. Guadecitabine has a longer half-life and exposure...
Health-Related Quality of Life With Everolimus vs Placebo in Patients With Neuroendocrine Tumors
As reported in The Lancet Oncology by Pavel et al, no significant difference in deterioration of health-related quality of life was observed with everolimus (Afinitor) vs placebo in the phase III RADIANT-4 trial, which included patients with advanced nonfunctional well-differentiated...
Association of Supplemental Vitamin B Use and Lung Cancer in VITAL Cohort
In a study reported in the Journal of Clinical Oncology, Brasky et al found that the use of individual source supplemental vitamins B6 and B12 was associated with an increased risk of lung cancer among men in the Vitamins and Lifestyle (VITAL) cohort. Several B vitamins, including B6, B9 (folate),...
Relationship Between Molecular Subtypes of Gastric Cancer and Prognosis
In 2014, The Cancer Genome Atlas (TCGA) project discovered there are four molecular subtypes of gastric cancer: Epstein-Barr virus (EBV), microsatellite instability, genomically stable, and chromosomal instability. However, their clinical significance is unknown. Now, a study by Bo Hwa Sohn, PhD,...
First-Line Cetuximab vs Bevacizumab Plus Chemotherapy in KRAS Wild-Type Colorectal Cancer
A phase III trial has shown no significant difference in overall survival with first-line cetuximab (Erbitux) vs bevacizumab (Avastin) plus chemotherapy in patients with advanced or metastatic KRAS wild-type colorectal cancer. These study findings were reported by Alan Venook, MD, of University of ...
Dinutuximab vs Temsirolimus in Combination Therapy for Children With Resistant Neuroblastoma
A randomized phase II trial (Children’s Oncology Group [COG] ANBL1221) has resulted in the selection of dinutuximab (Unituxin) plus irinotecan/temozolomide as a regimen to be further evaluated in the treatment of pediatric patients with refractory or relapsed neuroblastoma. Study results were...
Financial Burden Among Survivors of Childhood Cancer
Findings from the Childhood Cancer Survivor Study, reported in the Journal of Clinical Oncology by Nipp et al, indicate that childhood cancer survivors are more likely than unaffected siblings to spend a higher percentage of income on out-of-pocket medical costs, potentially leading to reduced use...
Immune-Related Toxicity and Time to Treatment Failure With Nivolumab Plus Ipilimumab in Advanced Melanoma
As reported in JAMA Oncology by Shoushtari et al, a single-center experience has shown a very high rate of clinically significant immune-related adverse events with nivolumab (Opdivo) plus ipilimumab (Yervoy) for advanced melanoma. Their findings suggest that the full course of four doses of...
Addition of EGFR-Targeting Vaccine to Temozolomide in EGFRvIII-Expressing Glioblastoma
The phase III ACT IV study has shown no survival benefit of adding rindopepimut, a vaccine targeting the epidermal growth factor receptor (EGFR) deletion mutation EGFRvIII, to temozolomide in patients with newly diagnosed EGFRvIII-positive glioblastoma. These findings were reported by Weller et al...
Accelerated vs Standard Epirubicin and Capecitabine vs CMF in Breast Cancer
The phase III UK TACT2 trial has shown no efficacy benefit of accelerated vs standard epirubicin and a potential quality-of-life benefit of capecitabine vs CMF (cyclophosphamide, methotrexate, fluorouracil) as adjuvant therapy for breast cancer. The findings were reported in The Lancet Oncology by ...
Midostaurin in FLT3 Mutation–Positive Acute Myeloid Leukemia and Systemic Mastocytosis
ON APRIL 28, 2017, midostaurin (Rydapt) was approved for treatment of adults with newly diagnosed acute myeloid leukemia (AML) who have FLT3 mutation–positive disease, as detected by a U.S. Food and Drug Administration (FDA)-approved test, in combination with standard cytarabine and daunorubicin...
Pembrolizumab in Classical Hodgkin Lymphoma
On March 14, 2017, pembrolizumab (Keytruda) was granted accelerated approval for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma or those who have relapsed after three or more prior lines of therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...
Atezolizumab in Patients With Advanced Urothelial Carcinoma Who Are Ineligible for Cisplatin
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 17, 2017, the programmed cell death ligand 1 (PD-L1)...
Journal of Clinical Oncology Literature Update
Staying up-to-date in the fast-paced world of oncology literature is a daunting task at best. To assist with that task, The ASCO Post has assembled an assortment of studies recently published in the Journal of Clinical Oncology. The topics range from therapy for stage IV non–small cell lung cancer...
Long-Term Follow-up in PIVOT Trial Shows No Significant Benefit of Surgery vs Observation for Overall or Prostate Cancer Mortality
After 19.5 years of follow-up in the PIVOT trial, radical prostatectomy was not associated with significantly improved all-cause or prostate cancer mortality vs observation among men with localized prostate cancer.1 The long-term follow-up was reported in The New England Journal of Medicine by...
Assessment of Embedding Palliative Care Nurse Practitioners in Oncology Clinics
In a study reported by Walling et al in the Journal of Oncology Practice, the embedding of a palliative care nurse practitioner in an oncology clinic resulted in improved hospice referral, advance care planning documentation, and referral for psychosocial support. Study Details The study compared ...
Overall Survival With Carfilzomib vs Bortezomib in Relapsed or Refractory Multiple Myeloma
As reported by Dimopoulos et al in The Lancet Oncology, a prespecified interim analysis of the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis) vs bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma. Carfilzomib was...
Labetuzumab Govitecan in Heavily Pretreated Patients With Metastatic Colorectal Cancer
As reported by Dotan et al in the Journal of Clinical Oncology, the antibody-drug conjugate labetuzumab govitecan showed antitumor activity in a phase I/II trial in patients with heavily pretreated metastatic colorectal cancer who had received prior irinotecan therapy. The agent comprises...
Adding Adjuvant Erlotinib to Gemcitabine After R0 Resection of Pancreatic Cancer
The German phase III CONKO-005 trial has shown no significant benefit of adding adjuvant erlotinib (Tarceva) to gemcitabine after R0 resection in patients with pancreatic ductal adenocarcinoma. The findings were reported in the Journal of Clinical Oncology by Sinn et al. Study Details In the...
Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma
Updated results of a phase I/II study of durvalumab (Imfinzi) in locally advanced or metastatic urothelial carcinoma were reported by Powles et al in JAMA Oncology. Data from the ongoing study supported the recent approval of durvalumab as second-line treatment in this setting on the basis of...
Postdiagnosis Statin Use and Mortality in Prostate Cancer
As reported by Larsen et al in the Journal of Clinical Oncology, a Danish retrospective study has shown reduced cancer-specific and all-cause mortality with postdiagnosis statin use in patients with prostate cancer. Study Details The study involved nationwide Danish registry data from 31,790...
