More than two-thirds of patients diagnosed with esophageal cancer will have unresectable disease. The objective of this article is to review the clinical trials utilizing cytotoxic chemotherapy in patients with recurrent and metastatic esophageal cancer. A computerized (MEDLINE) search was performed to identify papers published on this topic between 1966 and 2007. A total of 96 trials were subsequently identified. Two randomized trials compared palliative chemotherapy with best supportive care in 180 patients with advanced esophageal cancer. Effectiveness and side-effects were evaluated in 49 phase II studies and 3 randomized phase III trials. Combination chemotherapy as compared to monochemotherapy is associated with significantly higher response rates but nevertheless results in similar survival. CF (cisplatin and 5-fluorouracil) currently represents one of the most effective regimens for advanced esophageal cancer, while among the newer combinations, irinotecan or taxane-based regimens have also given promising results. Prognosis for the majority of patients, however, remains poor as increases in survival were moderate at best.

To compare the effects of pegylated interferon-alpha2b (P-IFN) and interferon-alpha2b (IFN) on quality of life (QoL) and toxicity in patients with multiple myeloma maintained on a steady dose of IFN.

To evaluate if raising baseline and maintaining hemoglobin (Hb) levels with red blood cell (RBC) transfusion could improve the outcomes of chemotherapy for advanced gastric cancer (AGC).

Initial analysis of the Assessment of Proteasome Inhibition for Extending Remissions (APEX) trial of relapsed multiple myeloma patients showed significantly longer time to progression, higher response rate, and improved survival with single-agent bortezomib versus high-dose dexamethasone. In this updated analysis (median follow-up: 22 months), survival was assessed in both arms, and efficacy updated for the bortezomib arm. Median survival was 29.8 months for bortezomib versus 23.7 months for dexamethasone, a 6-month benefit, despite substantial crossover from dexamethasone to bortezomib. Overall and complete response rates with bortezomib were 43% and 9%, respectively; among responding patients, 56% improved response with longer therapy beyond initial response, leading to continued improvement in overall quality of response. Higher response quality (100% M-protein reduction) was associated with longer response duration; response duration was not associated with time to response. These data confirm the activity of bortezomib and support extended treatment in relapsed multiple myeloma patients tolerating therapy.

The combination of docetaxel/gemcitabine is an acceptable chemotherapy regimen for the treatment of non-small cell lung cancer. An economic evaluation is undertaken alongside a multi-centre randomized phase III trial, which compares docetaxel/gemcitabine combination with docetaxel monotherapy, in untreated patients with advanced/metastatic non-small cell lung cancer.

Tumor necrosis factor-alpha (TNF-alpha) is a putative mediator of the cancer anorexia/weight loss syndrome. The current study was designed to determine whether etanercept (a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75-kilodalton TNF receptor linked to the Fc portion of human immunoglobulin [Ig] G1) could palliate this syndrome.

The goal of this study is to identify novel genes frequently silenced by promoter hypermethylation in lung cancer.

It has been shown that nonpharmacologic interventions are effective management techniques for cancer-related fatigue (CRF) in cancer survivors. However, few studies have investigated their effectiveness in patients who are receiving chemotherapy. In this study, the authors tested the effectiveness of a brief behaviorally oriented intervention in reducing CRF and improving physical function and associated distress in individuals who were receiving chemotherapy.

To investigate the effect of topical imiquimod in patients with vulvar intraepithelial neoplasia (VIN).

The purpose of this analysis was to investigate trastuzumab-associated cardiac adverse effects in breast cancer patients after completion of (neo)adjuvant chemotherapy with or without radiotherapy.

The purpose of this study was to investigate the effects of familiar live music on the anxiety levels of patients undergoing chemotherapy treatment. Randomly selected patients were assigned to experimental (n = 25) and control (n = 25) conditions. Pre and posttests consisted of questionnaires and the recording of the patient's heart rate and blood pressures. Subjects in the experimental group received 20 minutes of familiar live music during their chemotherapy treatment. Subjects in the control group received standard chemotherapy. It was assumed that those patients receiving music intervention would: (a) lower their anxiety levels; (b) experience a decrease in heart rate and blood pressure; (c) improve their levels of negative reactions including fatigue, worry, and fear; and (d) improve their levels of positive reactions including comfort and relaxation. Results of the study showed statistically significant improvement for the experimental group on the measures of anxiety, fear, fatigue, relaxation, and diastolic blood pressure. No significant differences between groups were found for heart rate and systolic blood pressure. Descriptive values indicated that, on average, the experimental group was influenced positively by the music intervention, and participants improved their quality of life while undergoing chemotherapy treatment.

Tibolone is a selective tissue estrogenic activity regulator, approved for the treatment of vasomotor symptoms in postmenopausal women. We have done an exploratory, double-blind, randomized, placebo-controlled pilot trial to investigate the tissue-specific effects of 2.5 mg tibolone on breast cancer in postmenopausal women, in particular on tissue proliferation (STEM, Study of Tibolone Effects on Mamma carcinoma tissue).

The present study established the psychometric properties of the Functional Assessment of Cancer Therapy-Neutropenia (FACT-N), a self-report instrument to assess neutropenia-specific concerns and health-related quality of life (HRQL), in a sample of adults 65 years of age and older.

The results of a randomized controlled trial that tested the effects of eight-week, six-contact multidimensional interactive interventions for symptom management are presented. Four hundred and thirty-five cancer patients with solid tumors undergoing chemotherapy were randomized to receive either nurse-assisted symptom management (NASM) or automated telephone symptom management (ATSM). A prior trial established the effectiveness of NASM compared with conventional care. Seventeen symptoms commonly experienced by patients undergoing chemotherapy were rated on a scale from 0 to 10 and were evaluated at baseline, at each of the six intervention contacts, and postintervention observation at 10 weeks. Both groups achieved significant reduction in symptom severity over baseline, and there was no difference between groups on symptom severity at 10 weeks. Randomization accounted for possible reductions in severity due to response shifts. Severity of symptoms reported by patients at each of the six intervention contacts was measured using a Rasch model. Symptom pattern was different for lung and non-lung cancer patients, and they were analyzed separately. Longitudinal analyses revealed that lung cancer patients with greater symptom severity withdrew from later intervention contacts of the ATSM. The results suggest that both NASM and ATSM achieved a clinically significant reduction in symptom severity. The NASM may be more effective than ATSM in retaining lung cancer patients in the intervention. Further testing of ATSM supplemented by NASM for patients with severe symptoms is warranted.

The optimal trastuzumab-based chemotherapy regimen for HER2-overexpressing, metastatic breast cancer is not known. The trastuzumab and vinorelbine or taxane (TRAVIOTA) study was a prospective, multicenter, randomized trial that was designed to compare these regimens.

To observe the change of nephron damaged by chemotherapy and to evaluate the effect of Baoshen Mixture (, BSM) in protecting and treating damaged nephrons.

Ixabepilone is the first in a new class of antineoplastic agents, the epothilones and their analogs. This international, randomized, phase II trial assessed two administration schedules of ixabepilone as second-line therapy in patients with non-small-cell lung cancer (NSCLC).

Although current treatment options for metastatic non-small-cell lung cancer (NSCLC) rely on cisplatin-based chemotherapy, individualized approaches to therapy may improve response or reduce unnecessary toxicity. Excision repair cross-complementing 1 (ERCC1) has been associated with cisplatin resistance. We hypothesized that assigning cisplatin based on pretreatment ERCC1 mRNA levels would improve response.

Dexamethasone induces the hepatic cytochrome P450 3A and, therefore, is predicted to change the pharmacokinetics, activities, and side effects of drugs metabolized by cytochrome P450 3A. The aim of this study was to determine whether the pharmacokinetics of the cytochrome P450 3A-dependent oxazaphosphorine cytostatic drug ifosfamide is influenced by short-term antiemetic use of dexamethasone in patients. The peak concentration and area under the curve (AUC) were determined for the parent compound and the metabolites 4-hydroxyifosfamide and chloracetaldehyde in eight patients who received two cycles of ICE chemotherapy (ifosfamide 5 g/m(2) day 1, carboplatin 300 mg/m(2) day 1, etoposide 100 mg/m(2) days 1-3). One cycle included concomitant administration of dexamethasone (40 mg over 30 min, 16 h and 1 h before chemotherapy), whereas the other did not. The half-lives of ifosfamide, 4-hydroxyifosfamide, and chloracetaldehyde were shorter with concomitant administration of dexamethasone, but the differences were not statistically significant. In addition, there were no significant differences in the ifosfamide and active 4-hydroxyifosfamide peak concentrations and AUCs when dexamethasone was included. After dexamethasone administration, the chloracetaldehyde peak concentration was slightly increased by 1.5-fold and the AUC by 1.3-fold; however, these increases were not statistically significant. In conclusion, dexamethasone comedication in ICE chemotherapy did not change the ifosfamide pharmacokinetics. Thus, dexamethasone can be used safely as an antiemetic drug in ifosfamide chemotherapy.

Many molecularly targeted anticancer agents entering the definitive stage of clinical development benefit only a subset of treated patients. This may lead to missing effective agents by the traditional broad-eligibility randomized trials due to the dilution of the overall treatment effect. We propose a statistically rigorous biomarker-adaptive threshold phase III design for settings in which a putative biomarker to identify patients who are sensitive to the new agent is measured on a continuous or graded scale.