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solid tumors
head and neck cancer
gastroesophageal cancer

Addition of Cetuximab to Concurrent Chemoradiation in Esophageal Cancer

The phase III NRG Oncology RTOG 0436 trial has shown no survival benefit of adding cetuximab (Erbitux) to paclitaxel/cisplatin and radiation therapy in patients with esophageal cancer treated without surgery. These results were reported by Mohan Suntharalingam, MD, MBA, of the Marlene and Stewart...

skin cancer

Pooled Analysis Safety Profile of Combination Immunotherapy for Advanced Melanoma

In a retrospective study reported in the Journal of Clinical Oncology, Sznol et al have provided a pooled safety profile of combination nivolumab (Opdivo) and ipilimumab (Yervoy) treatment in patients with advanced melanoma. Study Details The study included data from 448 patients from a phase Ib...

gastrointestinal cancer

Addition of MET Inhibitor to First-Line Chemotherapy in Advanced Gastric Cancer

The phase III RILOMET-1 trial showed no survival benefit of adding the MET inhibitor rilotumumab to first-line epirubicin, cisplatin, and capecitabine in patients with advanced MET-positive gastric or gastroesophageal junction adenocarcinoma. These results were reported in The Lancet Oncology by...

solid tumors
prostate cancer

Association Between Vasectomy and Prostate Cancer

A systematic review and meta-analysis has found no association between vasectomy and high-grade, advanced, or fatal prostate cancer but a weak association with any prostate cancer. These findings were reported in JAMA Oncology by Bimal Bhindi et al. R. Jeffrey Karnes, MD, of the Mayo Clinic,...

solid tumors
skin cancer

Adjuvant 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 Jeffrey Weber and colleagues in The New England Journal of Medicine. Study Details In the ...

solid tumors
gynecologic cancers

Performance Measures for Cervical Cancer Screening

Health-care systems use performance measures for cervical cancer screening based on guidelines from such organizations as the American College of Obstetricians and Gynecologists to monitor the appropriateness of cervical cancer screening. According to the performance measure in the Healthcare...

solid tumors
hepatobiliary cancer

Adding Sorafenib to Transarterial Chemoembolization in Hepatocellular Carcinoma

As reported in The Lancet Gastroenterology & Hepatology by Tim Meyer, MBBS, of the University College London, and colleagues, the UK phase III TACE 2 trial has shown no progression-free survival benefit with the addition of sorafenib (Nexavar) to transarterial chemoembolization in patients...

solid tumors
bladder cancer

Avelumab in Locally Advanced or Metastatic Urothelial Carcinoma

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. On May 9, 2017, avelumab (Bavencio) was granted...

solid tumors
bladder cancer

Durvalumab in Advanced Urothelial Carcinoma Progressing After Platinum Therapy

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. On May 1, 2017, durvalumab (Imfinzi) was granted...

hematologic malignancies
lymphoma
leukemia

Combination of Rituximab and Hyaluronidase Human for Subcutaneous Use in Lymphoma and Leukemia

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. On June 22, 2017, the combination of rituximab (Rituxan)...

breast cancer

Preexisting Mental Illness and All-Cause and Breast Cancer Mortality in Elderly Breast Cancer Patients

A study using linked Surveillance, Epidemiology, and End Results–Medicare data has shown a significantly increased risk of all-cause mortality and a nonsignificantly increased risk of breast cancer–specific mortality in elderly breast cancer patients with preexisting severe mental...

issues in oncology

Changes in Insurance Coverage and Diagnosis Stage After Affordable Care Act Implementation

Jemal et al found decreases in the percentage of uninsured patients and trends toward earlier diagnosis among nonelderly patients with cancer after implementation of the Affordable Care Act (ACA). Their findings were reported in the Journal of Clinical Oncology. Study Details The study used...

lung cancer

Combination Therapy for Previously Untreated BRAF V600E–Mutant Metastatic NSCLC

In a phase II trial, the combination of dabrafenib (Tafinlar) plus trametinib (Mekinist) produced durable responses in a cohort of patients with previously untreated BRAF V600E–mutant metastatic non–small cell lung cancer (NSCLC). The findings were reported in The Lancet Oncology by...

kidney cancer

Adjuvant Therapy for Localized or Locally Advanced Renal Cell Carcinoma

As reported in the Journal of Clinical Oncology by Motzer et al, the phase III PROTECT trial showed no significant disease-free survival benefit for adjuvant pazopanib at 600 mg vs placebo after nephrectomy in patients with localized or locally advanced renal cell carcinoma at high risk of relapse. ...

survivorship

Cumulative Burden of Chronic Health Conditions in Childhood Cancer Survivors

In a report from the St Jude Lifetime Cohort Study published in The Lancet, Bhakta et al detailed the burden of lifetime chronic health conditions in survivors of childhood cancers. The report included retrospectively collected data on chronic health conditions in 5,522 patients treated for...

lung cancer

MicroRNA-Loaded Minicells in Recurrent Malignant Pleural Mesothelioma

An Australian phase I first-in-human trial has shown early activity of microRNA-loaded minicells in patients with malignant pleural mesothelioma. These findings were reported in The Lancet Oncology by van Zandwijk et al. The minicells (TargomiRs) are loaded with miR-16–based mimic microRNA...

lung cancer

Addition of Motesanib to Paclitaxel/Carboplatin in East Asian Patients With Advanced NSCLC

The phase III MONET-A trial has shown that the addition of the multikinase/vascular endothelial growth factor receptor inhibitor motesanib to paclitaxel and carboplatin did not significantly improve progression-free survival in East Asian patients with stage IV/recurrent nonsquamous non–small ...

skin cancer

Adjuvant Dabrafenib and Trametinib in Resected Stage III BRAF-Mutated Melanoma

The phase III COMBI-AD trial has shown a significant improvement in relapse-free survival with the combination of the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinist) vs placebo as adjuvant therapy in patients with resected stage III melanoma with BRAF V600E or V600K ...

Neurocognitive Function in Patients Treated for B-Lineage ALL

In a Children’s Oncology Group (COG) study (AALL06N1) reported in the Journal of Clinical Oncology, Hardy et al found that age < 10 years at diagnosis was associated with poorer neurocognitive function in patients with high-risk B-lineage acute lymphoblastic leukemia (ALL) regardless of...

Adding Midostaurin to Chemotherapy in AML With FLT3 Mutation

In a phase III trial (Cancer and Leukemia Group B 10603 [RATIFY]/Alliance) reported in The New England Journal of Medicine, Stone et al found that the addition of midostaurin (Rydapt) to standard chemotherapy improved overall survival in patients with newly diagnosed acute myeloid leukemia (AML)...

breast cancer

Trastuzumab-Based Regimens in Older Women With Early Breast Cancer

A comparative analysis of outcomes with two different trastuzumab (Herceptin)-based adjuvant regimens in older women with early HER2-positive breast cancer found little difference in safety and efficacy between treatments. The study was reported by Katherine E. Reeder-Hayes, MD, MBA, of the...

skin cancer

Adjuvant 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...

lung cancer

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...

lymphoma

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)...

leukemia

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...

skin cancer

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...

thyroid cancer
prostate cancer
lung cancer
survivorship
palliative care

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...

gastrointestinal cancer

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...

hematologic malignancies
lymphoma

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...

breast cancer

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...

skin cancer

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...

gynecologic cancers

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...

leukemia

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...

hepatobiliary cancer

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...

lymphoma

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...

sarcoma

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....

bladder cancer

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...

bladder cancer

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 ...

lung cancer

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...

solid tumors

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...

lymphoma

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...

sarcoma

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...

hematologic malignancies

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...

head and neck cancer

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...

breast cancer

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...

colorectal cancer

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...

prostate cancer

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...

lung cancer

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...

gastrointestinal cancer

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...

head and neck cancer

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...

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