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cns cancers

Alisertib Shows Activity With Irinotecan/Temozolomide in Relapsed or Refractory Neuroblastoma

The oral Aurora A kinase inhibitor alisertib was active in combination with irinotecan/temozolomide in patients with relapsed or refractory neuroblastoma, in a phase I dose-escalation trial reported in the Journal of Clinical Oncology by DuBois et al. The maximum tolerated dose of alisertib was 60...

bladder cancer

Atezolizumab Active in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma

The anti–PD-L1 (programmed cell death ligand 1) antibody atezolizumab produced durable responses in a marked proportion of patients with previously treated locally advanced or metastatic urothelial carcinoma, according to a phase II trial reported in The Lancet by Rosenberg et al. The...

gynecologic cancers

Frequent Copy Number Gain of Genes for PD-1 Ligands in Squamous Cell Carcinoma of the Cervix or Vulva

In a study reported in JAMA Oncology, Howitt et al identified copy number gain of genes encoding programmed cell death protein 1 (PD-1) ligands in a sizable proportion of patients with squamous cell carcinoma of the cervix or vulva. Study Details The study involved fluorescence in situ...

colorectal cancer

High Expression of Epiregulin or Amphiregulin Predicts Benefit of Panitumumab in RAS Wild-Type Advanced Colorectal Cancer

In the UK phase III PICCOLO trial reported in JAMA Oncology, Seligmann et al found that high expression of either of the epidermal growth factor receptor (EGFR) ligands epiregulin or amphiregulin was associated with a progression-free survival benefit with panitumumab (Vectibix)/irinotecan vs...

hematologic malignancies

Adding Ibrutinib to Bendamustine/Rituximab Improves Outcome in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

In the phase III HELIOS trial reported in The Lancet Oncology, Asher Chanan-Khan, MD, of the Mayo Clinic Cancer Center, Jacksonville, Florida, and colleagues found that addition of the Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib (Imbruvica) to bendamustine (Treanda)/rituximab (Rituxan)...

sarcoma

Eribulin Mesylate in Advanced Liposarcoma Previously Treated With an Anthracycline

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 January 28, 2016, eribulin mesylate (Halaven) was approved for...

head and neck cancer

Loss of Skeletal Muscle Before or After Radiotherapy Linked to Poorer Survival in Head and Neck Squamous Cell Carcinoma

In a single-center retrospective study reported in JAMA Oncology, Grossberg et al found that skeletal muscle loss before or after radiotherapy was associated with poorer overall survival in patients with head and neck squamous cell carcinoma. Study Details The study included 2,840 patients...

breast cancer

Adjuvant Endocrine Therapy for Primary Breast Cancer Treatment Associated With Increased Symptom Burden Over 12 Months

Patients in the observational Mind-Body Study receiving adjuvant endocrine therapy for primary breast cancer treatment reported a greater symptom burden than did patients not receiving endocrine therapy over 12 months, as reported by Ganz et al in the Journal of Clinical Oncology. No differences in ...

hematologic malignancies
multiple myeloma

Carfilzomib Plus Dexamethasone in Previously Treated Multiple Myeloma

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 January 21, 2016, carfilzomib (Kyprolis) was approved for use in ...

breast cancer

Genomic Alterations in Primary Invasive Lobular Breast Cancer

In a study reported in the Journal of Clinical Oncology, Desmedt et al identified genomic alterations in invasive lobular breast cancer, including several that may serve as targets for current treatment and for treatment research. Invasive lobular breast cancer cells are characterized by...

lung cancer

Anamorelin Increases Lean Body Mass in NSCLC Patients With Cachexia

Anamorelin (a ghrelin-receptor agonist) increased lean body mass but had no beneficial effect on handgrip strength vs placebo in patients with advanced non–small cell lung cancer (NSCLC) and cachexia, according to two international phase III trials (ROMANA 1 and 2) reported in The Lancet...

colorectal cancer

Selective Internal Radiotherapy Does Not Improve Any-Site but Prolongs Liver-Specific Progression-Free Survival in Metastatic Colorectal Cancer

In the phase III SIRFLOX trial reported in the Journal of Clinical Oncology, van Hazel et al found that adding selective internal radiation therapy with yttrium-90 resin microspheres to FOLFOX (fluorouracil, leucovorin, oxaliplatin) with or without bevacizumab (Avastin) did not improve any-site...

breast cancer

Neratinib Shows Some Activity in Previously Treated HER2-Positive Breast Cancer Brain Metastases

In the phase II Translational Breast Cancer Research Consortium (TBCRC) 022 study, reported by Freedman et al in the Journal of Clinical Oncology, the erbB1, HER2, erbB4 inhibitor neratinib showed some activity in patients with HER2-positive breast cancer brain metastases. Study Details In the...

head and neck cancer

New Staging System for Human Papillomavirus–Related Oropharyngeal Cancer

As reported in The Lancet Oncology by O’Sullivan et al, a new staging system for human papillomavirus–related oropharyngeal cancer has been developed based on findings from the International Collaboration on Oropharyngeal Cancer Network for Staging (ICON-S) study. Study Details The...

lung cancer

Racial/Ethnic Variations in Lung Cancer Incidence and Mortality in the Women’s Health Initiative Study Cohort

As reported by Patel et al in the Journal of Clinical Oncology, analysis of lung cancer incidence and mortality in the Women’s Health Initiative Study cohort of postmenopausal women showed a marginally significant lower risk of cancer in Hispanic women vs white women and no difference in...

gynecologic cancers

Study Finds No Progression-Free Survival Benefit for Weekly Dose-Dense vs Every-3-Week Paclitaxel Plus Carboplatin in Ovarian Cancer

Weekly dose-dense paclitaxel did not provide a progression-free survival benefit over every-3-week paclitaxel in combination with carboplatin and with or without elective bevacizumab (Avastin) in patients with previously untreated ovarian cancer, according to the results of the phase III GOG-0262...

gastrointestinal cancer

Asian Trial Finds No Survival Benefit of Adding Gastrectomy to Chemotherapy in Incurable Advanced Gastric Cancer

In the Asian phase III REGATTA trial reported in The Lancet Oncology, Fujitani et al found that the addition of gastrectomy to chemotherapy did not improve overall survival in patients with advanced gastric cancer with a single noncurable factor. Study Details In this open-label trial conducted...

colorectal cancer

Factors Associated With Early Mortality in Patients Receiving Adjuvant Therapy for Colon Cancer

In an analysis of the ACCENT (Adjuvant Colon Cancer Endpoints) database reported in the Journal of Clinical Oncology, Cheung et al found that factors associated with early mortality in patients in trials of adjuvant systemic therapy included age, performance status, tumor grade, stage, and ratio of ...

lung cancer

Improved Outcomes Reported With Adjuvant Therapy in Patients With Early-Stage SCLC Undergoing Complete Resection

Adjuvant chemotherapy and chemotherapy plus prophylactic cranial irradiation were associated with significantly improved survival vs surgery alone in patients with early-stage small cell lung cancer (SCLC) undergoing complete resection, according to an analysis of National Cancer Data Base data...

cns cancers

Single-Center Study Evaluates Proton Radiotherapy for Pediatric Medulloblastoma

In a phase II study reported in The Lancet Oncology by Yock et al, use of proton radiotherapy for pediatric medulloblastoma was associated with acceptable long-term toxic effects and good survival outcomes. Study Details In the study, 59 patients aged 3 to 21 years were treated at...

gynecologic cancers

Study Finds No Adverse Impact of Minimally Invasive Hysterectomy on Long-Term Survival in Endometrial Cancer

Use of minimally invasive hysterectomy did not seem to have an adverse impact on long-term survival in women with endometrial cancer, according to an analysis reported in the Journal of Clinical Oncology by Wright et al. Study Details The study involved Surveillance, Epidemiology, and End Result...

breast cancer

Phase III Trial Shows No Benefit of Afatinib vs Trastuzumab Plus Vinorelbine in HER2-Positive Metastatic Breast Cancer

In the phase III LUX-Breast 1 trial reported in The Lancet Oncology, Harbeck et al found no benefit of afatinib (Gilotrif)/vinorelbine vs trastuzumab (Herceptin)/vinorelbine after previous trastuzumab treatment in patients with HER2-positive metastatic breast cancer. Broader inhibition of ErbB...

hepatobiliary cancer

Single-Center Trial Indicates No Benefit of Hepatic Artery Chemoembolization vs Embolization in Hepatocellular Carcinoma

In a phase II study reported in the Journal of Clinical Oncology, Brown et al found no apparent benefit of hepatic artery chemoembolization using doxorubicin-eluting microspheres vs embolization with microspheres alone in patients with hepatocellular carcinoma. Study Details In the trial, 101...

skin cancer

Improved Melanoma-Specific Survival Reported With Wider Excision Margin in High-Risk Primary Melanoma

Wider excision margins in high-risk primary cutaneous melanoma were associated with improved melanoma-specific survival, according to long-term follow-up in a UK-led trial reported by Hayes et al in The Lancet Oncology. No significant improvement in overall survival was observed. The initial report ...

lung cancer

UK Trial Shows No Survival Benefit of Low–Molecular-Weight Heparin in Patients With Lung Cancer

In the UK phase III FRAGMATIC trial reported in the Journal of Clinical Oncology, Macbeth et al found no survival benefit of adding low–molecular-weight heparin to standard treatment in patients with lung cancer. Previous evidence suggested that low–molecular-weight heparin might...

prostate cancer

ASCO Endorses Cancer Care Ontario Guideline on Active Surveillance for Management of Localized Prostate Cancer

As reported by Ronald C. Chen, MD, MPH, of the University of North Carolina at Chapel Hill, and colleagues in the Journal of Clinical Oncology, ASCO has endorsed, with qualifications, the 2015 Cancer Care Ontario (CCO) guideline on active surveillance for management of localized prostate cancer....

leukemia

Minimal Residual Disease Identified by NPM1 Mutation May Be Prognostic Marker for Poorer Outcome in Standard-Risk AML

In a study reported in The New England Journal of Medicine, Ivey et al found that a leukemia-specific marker consisting of a mutation in the gene encoding nucleophosmin (NPM1) can be used to identify minimal residual disease in peripheral blood in standard-risk acute myeloid leukemia (AML), with...

breast cancer
issues in oncology

ASCO Clinical Practice Guideline Update on Ovarian Suppression/Adjuvant Endocrine Therapy in Hormone Receptor–Positive Breast Cancer

As reported in the Journal of Clinical Oncology by Burstein et al, ASCO has released a clinical practice guideline update on ovarian suppression as part of the extant guideline on adjuvant endocrine therapy in hormone receptor–positive breast cancer. The update is based on an update panel...

lung cancer

No Survival Benefit of Pemetrexed/Cisplatin Chemoradiation vs Standard Treatment in Nonresectable Stage III NSCLC

As reported by Senan et al in the Journal of Clinical Oncology, the phase III PROCLAIM trial showed no significant improvement in overall survival for chemoradiation with pemetrexed (Alimta)/cisplatin vs etoposide/cisplatin followed by consolidation pemetrexed vs a platinum-based doublet in...

skin cancer

Nivolumab Plus Ipilimumab in Unresectable or Metastatic Melanoma Regardless of BRAF Mutation Status

On January 23, 2016, the indication for nivolumab (Opdivo) plus ipilimumab (Yervoy) in unresectable or metastatic melanoma was expanded through accelerated approval to include patients regardless of BRAF V600 mutation status.1 The combination was previously approved for treatment of patients with...

supportive care

Rolapitant Reduces Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately and Highly Emetogenic Chemotherapy

In three phase III studies reported in The Lancet Oncology, the addition of the neurokinin-1 (NK-1) receptor antagonist rolapitant to serotonin (5-HT3) receptor antagonist and dexamethasone treatment significantly improved complete response rates in the prevention of chemotherapy-induced nausea and ...

leukemia

Ofatumumab for Extended Treatment of Patients With Recurrent or Progressive Chronic Lymphocytic Leukemia

On January 19, 2016, ofatumumab (Arzerra) was approved for extended treatment of patients in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL).1,2 Ofatumumab was previously approved for treatment of untreated patients...

hematologic malignancies

Antithymocyte Globulin Reduces Need for Immunosuppressants After Hematopoietic Cell Transplantation From Unrelated Donors

In a phase III trial reported in The Lancet Oncology, Walker et al found that treatment with antithymocyte globulin reduced the need for immunosuppressive therapy in patients with hematologic malignancies receiving hematopoietic cell transplantation from unrelated donors. Study Details In this...

survivorship
cns cancers
issues in oncology

Increased Risk of Severe Neurocognitive Impairment in Adult Survivors of Pediatric CNS Tumors

As reported in the Journal of Clinical Oncology by Brinkman et al, a study in the St. Jude Lifetime Cohort showed that adult survivors of pediatric central nervous system (CNS) tumors are at increased risk of severe neurocognitive impairment. Study Details The study involved 224 survivors of CNS...

sarcoma

Eribulin Improves Overall Survival vs Dacarbazine in Advanced Liposarcoma or Leiomyosarcoma

In a phase III trial reported in The Lancet, Schöffski et al found that eribulin improved overall survival vs dacarbazine in patients with advanced or metastatic soft-tissue sarcoma who had received at least two prior systemic treatments for advanced disease. Outcome in the subgroup with...

lung cancer

Intense Tumor Lymphocytic Infiltration Prognostic of Better Outcome in Resectable NSCLC

Intense tumor lymphocytic infiltration was associated with improved outcomes in patients with resectable non–small cell lung cancer, according to a study reported in the Journal of Clinical Oncology by Brambilla et al. Study Details The LACE-Bio (Lung Adjuvant Cisplatin Evaluation...

solid tumors
solid tumors

High Conditional Survival for Patients With Metastatic Testicular Germ Cell Tumors Receiving First-Line Curative Therapy

Two-year conditional overall and disease-free survival were substantially increased in patients surviving and surviving without recurrence for 2 years after first-line curative therapy for metastatic testicular germ cell tumors, according to a study reported by Ko et al in the Journal of Clinical...

hematologic malignancies
lymphoma
survivorship

Dutch Study Shows Increased Risk of Second Cancer for Survivors of Hodgkin Lymphoma During Long-Term Follow-up

In a Dutch study reported in The New England Journal of Medicine, Schaapveld et al found that survivors of Hodgkin lymphoma treated between 1965 and 2000 were at a 4.6-fold greater risk of second cancer vs the general population during long-term follow-up. There was no significant difference in the ...

prostate cancer

Study Finds Enzalutamide Increases Progression-Free Survival vs Bicalutamide in Metastatic Prostate Cancer

Use of the androgen receptor–inhibitor enzalutamide (Xtandi) more than doubled progression-free survival vs the nonsteroidal antiandrogen bicalutamide in patients with metastatic prostate cancer progressing on androgen-deprivation therapy, according to the randomized phase II TERRAIN trial...

breast cancer
survivorship

ACS/ASCO Breast Cancer Survivorship Care Guideline

The American Cancer Society (ACS) and ASCO have issued a Breast Cancer Survivorship Care guideline, published jointly in the Journal of Clinical Oncology and CA: A Cancer Journal for Clinicians. The guideline recommendations were formulated by a multidisciplinary expert work group and are based on...

leukemia
lymphoma
survivorship

Reduction in Late Mortality in Childhood Cancer Survivors in the Childhood Cancer Survivor Study Cohort

In a study reported in The New England Journal of Medicine, Armstrong et al found that late mortality decreased over time among 5-year survivors of childhood cancer in the Childhood Cancer Survivor Study cohort. The reduction is consistent with efforts during recent decades to modify treatment with ...

lung cancer

Addition of TG4010 Vaccine to First-Line Chemotherapy Appears to Improve Progression-Free Survival in Advanced NSCLC

As reported in The Lancet Oncology by Quoix et al, the addition of immunotherapy with TG4010—the modified vaccinia Ankara expressing MUC1 and interleukin 2—to first-line chemotherapy improved progression-free survival in patients with advanced non–small cell lung cancer (NSCLC) in ...

lung cancer

Alectinib in ALK-Positive Metastatic NSCLC After Crizotinib

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 December 11, 2015, alectinib (Alecensa) was granted...

head and neck cancer

No Benefit of Adding Adjuvant and Maintenance Lapatinib to Chemoradiation in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck

In a phase III trial reported in the Journal of Clinical Oncology, Harrington et al found that the addition of concurrent adjuvant lapatinib (Tykerb) to chemoradiation therapy and the use of maintenance lapatinib did not improve disease-free or overall survival in high-risk patients with resected...

prostate cancer

Similar Low Incidence of Bowel Symptoms With Hypofractionated vs Conventionally Fractionated Radiotherapy in Localized Prostate Cancer

As reported by Wilkins et al in The Lancet Oncology, 2-year patient-reported outcomes in a UK phase III trial (CHHiP) substudy have shown a similar low incidence of bowel problems among patients with intermediate-risk localized prostate cancer receiving hypofractionated vs conventionally...

skin cancer

Expanded Approval of Pembrolizumab in Unresectable or Metastatic Melanoma

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 December 18, 2015, approval of the programmed cell death...

skin cancer

Increased Incidence of in Situ and Invasive Melanoma in Denmark

In a study reported in JAMA Dermatology,1 Neel Maria Helvind, MD, of the University Hospital Rigshospitalet, Copenhagen, Denmark, and colleagues analyzed the increases in melanoma incidence seen in Denmark between 1985 and 2012. Over that time, the incidence of malignant melanoma doubled to rates...

hematologic malignancies

Reduced-Intensity Conditioning Hematopoietic Stem Cell Transplantation in Older Patients With AML in First Remission

In a phase II study (CALGB 100103/Alliance/Blood and Marrow Transplant Clinical Trial Network 0502) reported in the Journal of Clinical Oncology,1 Steven M. Devine, MD, of The Ohio State University, Columbus, et al found that reduced-intensity conditioning allogeneic hematopoietic stem cell...

colorectal cancer

Transcription Factor CDX2 May Be Prognostic Biomarker in Stage II and III Colon Cancer

In a study reported in The New England Journal of Medicine, Dalerba et al found that absence of the transcription factor CDX2, although prognostic for poor outcome in stage II and III colon cancer vs cancers with CDX2 expression, identified a subgroup of high-risk patients who appeared to benefit...

solid tumors
prostate cancer

Increased Survival and Toxicity With Docetaxel, No Apparent Benefit of Zoledronic Acid in Prostate Cancer

As reported in The Lancet by James et al, results of the STAMPEDE trial, which used a multiarm, multistage seamless phase II/III design, showed increased survival and toxicity with docetaxel and little benefit of zoledronic acid when added to first-line long-term hormone therapy in patients with...

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