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BACKGROUND:Bendamustine hydrochloride is a novel alkylating agent. In this multicenter study, the authors evaluated the efficacy and toxicity of single‐agent bendamustine in patients with rituximab‐refractory, indolent B‐cell lymphoma.
METHODS:Eligible patients (N = 100, ages 31‐84 years) received bendamustine at a dose of 120 mg/m2 by intravenous infusion on Days 1 and 2 every 21 days for 6 to 8...
BACKGROUND:Tumor angiogenesis has been associated with a poor prognosis in patients with metastatic melanoma (MM). Microtubule stabilizers and cyclooxygenase 2 (COX‐2) inhibitors, alone and in combination, have produced inhibitory effects on endothelial cells and tumor angiogenesis. Angiogenesis, which is the growth of new blood vessels, is necessary for tumor growth and progression. Thus, the authors...
BACKGROUND:Axillary reverse mapping (ARM) is a novel technique to preserve upper extremity lymphatics that may reduce the incidence of lymphedema after axillary lymph node dissection. Early reports have suggested that ARM lymph nodes do not contain metastatic disease from breast cancer; however, these studies were conducted in early stage patients with low likelihood of lymph node metastasis. This...
BACKGROUND:Novel therapies are needed to improve outcomes in T‐cell lymphomas. The authors report the interim results of a prospective multicenter trial evaluating lenalidomide in T‐cell lymphomas.
METHODS:Patients with recurrent and refractory T‐cell lymphomas other than mycosis fungoides and untreated patients ineligible for combination chemotherapy were prescribed oral lenalidomide (25 mg daily)...
BACKGROUND:The treatment of patients with advanced or recurrent endometrial cancer remains problematic, because chemotherapy and hormonal therapy have yielded low response rates and limited progression‐free survival. Because the combination of gemcitabine and cisplatin demonstrated synergism in preclinical studies, the authors attempted to determine the efficacy and toxicity of this combination in...
BACKGROUND:Dysregulation of phosphatase and tensin homolog (PTEN) and the gene that encodes the p110α catalytic subunit of phosphatidylinositol‐3‐kinase (PI3K), PIK3CA, are the most common mutations in endometrial carcinoma (EC). Loss of PTEN or activation of PIK3CA results in constitutive activation of AKT, which leads to up‐regulation of mammalian target of rapamycin (mTOR). Everolimus is an oral...
BACKGROUND:Higher‐risk myelodysplastic syndromes (MDS) are similar pathobiologically to acute myeloid leukemia (AML), particularly in older adults. AML therapies thus may have activity in MDS. In the current study, phase 2 study data of arsenic trioxide (ATO) and gemtuzumab ozogamicin (GO) in CD33‐positive patients with MDS and secondary AML (sAML) were presented.
METHODS:Between June 2004 and February...
BACKGROUND:The purpose of this study was to compare 2 weekly docetaxel‐based regimens as first‐line treatments for advanced gastric cancer and to investigate the expression of secreted protein acidic and rich in cysteine (SPARC) and its abilities to predict treatment‐related clinical outcomes.
METHODS:Patients were randomly selected to receive 3 weekly cycles of docetaxel (35 mg/m2 on days 1 and...
BACKGROUND:Although it has been demonstrated that the neuronal intermediate filament alpha‐internexin (INA) is closely related to 1p19q codeletion in gliomas, its prognostic and predictive value has not yet been confirmed in a prospective trial. The authors of this report assessed the prognostic significance of INA expression and its correlation with relevant clinical and molecular characteristics...
BACKGROUND:On the basis of retrospective experience at individual centers, it appears that patients with stage IV melanoma who undergo complete resection have a favorable outcome compared with patients with disseminated stage IV disease. The Southwest Oncology Group (SWOG) performed a prospective trial in patients with metastatic melanoma who were enrolled before complete resection of their metastatic...
BACKGROUND:The phosphoinositide 3‐kinase/Akt/mammalian target of rapamycin pathway plays a critical role in the pathogenesis of hepatocellular carcinoma (HCC). We performed a single‐arm, phase 1/2 study of everolimus in patients with advanced HCC.
METHODS:Patients with histologically confirmed measurable advanced HCC, 0‐2 prior regimens, and adequate hematologic, hepatic, and renal functions received...
BACKGROUND:A subset of patients with metastatic cancer in limited organs may benefit from metastasis‐directed therapy. The authors investigated whether patients with limited metastases could be safely treated with metastasis‐directed radiotherapy.
METHODS:Patients with 1 to 5 metastatic cancer sites with a life expectancy of >3 months received escalating stereotactic body radiotherapy (SBRT) doses...
BACKGROUND:Few effective therapeutic options exist for patients with refractory diffuse large B‐cell lymphoma (DLBCL). YM155 is a survivin suppressant with activity against DLBCL in a phase I trial. This phase II study was conducted to better characterize the toxicity and efficacy of this small molecule in patients with refractory DLBCL.
METHODS:Forty‐one patients with a median age of 66 years and...
BACKGROUND:Since 1975, there has been a dramatic increase in the survival rates of pediatric and older cancer patients, but adolescent and young adult (AYA) patients ages 15 to 40 years have not had a similar improvement. Data indicate a direct correlation between increased cure rates and clinical trial enrollment.
METHODS:The authors previously published data indicating inferior clinical trial enrollment...
BACKGROUND:Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) is associated with poor survival. Platinum‐based chemotherapy is often a first‐line treatment. Pemetrexed has shown single‐agent activity in SCCHN and in combination with cisplatin for other tumors. This trial examined the efficacy of pemetrexed‐cisplatin for SCCHN.
METHODS:In a double‐blind phase 3 trial, patients...
BACKGROUND:Cilengitide is a selective integrin inhibitor that is well tolerated and has demonstrated biologic activity in patients with recurrent malignant glioma. The primary objectives of this randomized phase 2 trial were to determine the safety and efficacy of cilengitide when combined with radiation and temozolomide for patients with newly diagnosed glioblastoma multiforme and to select a dose...
The multiple symptoms arising from cancer and its treatment impose significant distress for patients. However, in clinical research, there is no agreed‐upon way of assessing and presenting the effects of treatment on multiple symptoms, as either individual scores or a composite score. The ASCPRO (Assessing the Symptoms of Cancer Using Patient‐Reported Outcomes) Multisymptom Task Force was established...
BACKGROUND:Neoadjuvant chemotherapy improves the survival of patients with high‐risk urothelial cancer. However, the lack of curative alternatives to cisplatin‐based chemotherapy is limiting for patients with neuropathy or hearing loss. Sequential chemotherapy also has not been well studied in the neoadjuvant setting. The authors explored sequential neoadjuvant ifosfamide‐based chemotherapy in a patient...
BACKGROUND:In this study, the authors evaluated the effect of denosumab versus zoledronic acid (ZA) on pain in patients with advanced breast cancer and bone metastases.
METHODS:The prevention of pain, reduction in pain interference with daily life activities, and the proportion of patients requiring strong opioid analgesics were assessed in a randomized, double‐blind, double‐dummy phase 3 study comparing...
BACKGROUND:Attrition is common among supportive care/palliative oncology clinical trials. However, to the authors' knowledge, few studies to date have documented the reasons and predictors for dropout. In the current study, the authors' objective was to determine the rate, reasons, and factors associated with attrition both before reaching the primary endpoint and at the end of the study.
METHODS:A...
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