Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration.

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results.

A phase I dose-escalation trial of 2-deoxy-D-glucose alone or combined with docetaxel in patients with advanced solid tumors.

Purpose: This phase I trial was initiated to evaluate the safety, pharmacokinetics (PK) and maximum tolerated dose (MTD) of the glycolytic inhibitor, 2-deoxy-D-glucose (2DG) in combination with docetaxel, in patients with advanced solid tumors.

Methods: A modified accelerated titration design was used. 2DG was administered orally once daily for 7 days every other week starting at a dose of 2 mg/kg and docetaxel was administered intravenously at 30 mg/m(2) for 3 of every 4 weeks beginning on day 1 of week 2.

Fludarabine and cytarabine in patients with acute myeloid leukemia refractory to two different courses of front-line chemotherapy.

The most effective regimen for acute myeloid leukemia (AML) patients who do not achieve complete remission (CR) after two different courses of front-line chemotherapy has not been established. We therefore evaluated the efficacy, toxicity, and prognostic factors for achieving CR following treatment with fludarabine and cytarabine in 25 newly diagnosed AML patients who did not respond to initial therapy with idarubicin and cytarabine followed by mitoxantrone and etoposide. CR was achieved in 32% of patients; in 55% of patients with intermediate-risk karyotype and in 14% with unfavorable-risk.

Mitoxantrone and etoposide in patients with newly diagnosed acute myeloid leukemia with persistent leukemia after a course of therapy with cytarabine and idarubicin.

The most effective regimen for patients with acute myeloid leukemia (AML) who do not achieve complete remission (CR) after one course of cytarabine and an anthracycline has not been extensively studied. We evaluated retrospectively the efficacy, toxicity, and prognostic factors for the achievement of CR following mitoxantrone and etoposide in 74 patients with newly diagnosed AML who did not respond to one course of therapy with cytarabine and idarubicin. CR was achieved in 39% of patients; 14% died of infectious complications; no grade 3 or 4 hepatic toxicities were observed.

Phase II study of docetaxel and gefitinib as second-line therapy in gemcitabine pretreated patients with advanced pancreatic cancer.

Background: There is no standard second-line therapy for advanced pancreatic cancer (APC). We evaluated the epidermal growth factor receptor (EGFR) inhibitor gefitinib and docetaxel in a phase II study following gemcitabine failure.

Methods: EGFR overexpression was not required.

[Strengthening the reporting of observational studies in epidemiology (STROBE): explanation and elaboration].

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results.

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration.

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalizability of its results.

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration.

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results.

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration.

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalizability of its results.

The emerging case-control study: lung cancer in relation to tobacco smoking.

Two influential case-control studies that clearly implicated cigarette smoking as a cause of lung cancer are reviewed in terms of their respective strengths and weaknesses. The findings from a U.S.

Phase II clinical trials in oncology: strengths and limitations of two-stage designs.

Two-stage designs are used widely in Phase II oncology clinical trials to reduce the number of patients placed on ineffective experimental therapies. They provide clear-cut rules for stopping early in the event that treatment is not succeeding as hoped and are relatively simple to implement. Such designs, however, can lead to situations in which patient accrual is continued in the face of a clearly inferior treatment.

Polymorphisms in the DNA methyltransferase 3b gene and prostate cancer risk.

Inactivation of tumor suppressor genes by promoter methylation is an important mechanism of tumorigenesis. Increased expression of DNA methyltransferases has been commonly observed in cancer. A C/T polymorphism in the DNA methyltransferase 3b (DNMT3b) promoter region results in increased activity and has recently been identified as a risk factor for lung cancer.

Polymorphisms in the methylenetetrahydrofolate reductase gene and prostate cancer risk.

Methylenetetrahydrofolate reductase (MTHFR) catalyzes the synthesis of 5-methyltetrahydrofolate, which is involved in the methylation of homocysteine to methionine. Genetic polymorphisms that decrease MTHFR activity result in an altered cancer risk depending on folic acid intake. In this study we examined the C677T and A1298C polymorphisms of the MTHFR gene in specimens from 81 patients with prostate cancer and 42 controls selected from patients with benign prostatic hypertrophy (BPH).

Methylation of multiple genes in prostate cancer and the relationship with clinicopathological features of disease.

Promoter methylation plays an important role in the inactivation of tumor suppressor genes during tumorigenesis. We examined the methylation status of glutathione s-transferase Pi1 (GSTP1), retinoic acid receptor beta (RARB), CD44, E-cadherin (ECAD), RAS association domain family protein 1A (RASSF1A) and endothelin B receptor (EDNRB) genes in 81 prostate cancer and 42 benign prostatic hyperpasia specimens. Genomic DNA was isolated from archived formaldehyde-fixed and paraffin-embedded tissue blocks.

Allogeneic vaccination with a B7.1 HLA-A gene-modified adenocarcinoma cell line in patients with advanced non-small-cell lung cancer.

Purpose: To determine the safety, immunogenicity, and clinical response to an allogeneic tumor vaccine for non-small-cell lung cancer, we conducted a phase I trial in patients with advanced metastatic disease.

Patients And Methods: We treated 19 patients with a vaccine based on an adenocarcinoma line (AD100) transfected with B7.1 (CD80) and HLA A1 or A2.

Safety concerns and health benefits associated with oral contraception.

Since the introduction of hormonal contraceptives in the 1960s, there have been a variety of both health benefits and safety concerns attributed to their use. In most instances, the noncontraceptive benefits of oral contraceptives (OCs) outweigh the potential cardiovascular risks. In fact, the probability of a patient experiencing a cardiovascular event while taking a low-dose OC is very low.

Induction of CD8 T-cell-Ifn-gamma response and positive clinical outcome after immunization with gene-modified allogeneic tumor cells in advanced non-small-cell lung carcinoma.

Large tumor burdens in advanced non-small-cell lung carcinoma (NSCLC) are thought to be immunosuppressive. To determine whether CD8-mediated immune responses could be elicited in stage IIIB/IV NSCLC patients, 14 subjects were immunized several times with allogeneic NSCLC cells transfected with CD80 (B7.1) and HLA-A1 or A2.

Evaluating systematic reviews and meta-analyses.

Systematic review and meta-analysis procedures make use of explicit methods to methodically search and critically appraise and synthesize the medical care research literature. The methods involve refining a clinical question, designing a search procedure to find eligible studies, and determining the validity of the eligible studies. Independent data extraction by two or more reviewers is preferred.

Perimenopausal use of reproductive hormones effects on breast and endometrial cancer.

The effect of reproductive hormone use in the form of oral contraception or HRT on endometrial cancer incidence is not caused by simply bias: the epidemiologic studies are consistent; the effect of ERT is large; the biologic rationale cited is a plausible mechanism; and the response to progestin in oral contraception or combined HRT tends to confirm the biologic mechanism. In contrast, it remains unclear whether changes in breast cancer incidence following use of oral contraception and HRT are caused by hormone exposure or to other factors: the results of epidemiologic studies are not entirely consistent, and the smaller relative effect on risk of breast cancer is susceptible to bias and other sources of error. Although the exact nature of the association between repro ductive hormone use and breast cancer incidence is not yet clear, breast cancer is a common neoplasm in older women.

Risk of positive margins and biochemical recurrence in relation to nerve-sparing radical prostatectomy.

Purpose: To assess the effect of nerve-sparing (NS) radical retropubic prostatectomy (RRP) on surgical margins and biochemical recurrence.

Patients And Methods: Location and incidence of positive surgical margins, recurrence, and time to recurrence were assessed in a consecutive series of 734 men who underwent RRP for localized prostate cancer from 1992 through February 2000. NS procedures were used in 33% (n = 240) of 734 patients studied.

Family history of cancer, oral contraceptive use, and ovarian cancer risk.

Objective: The purpose of this study was to determine whether women with a family history of ovarian cancer are at reduced risk of ovarian cancer from the use of oral contraceptives and to compare their risk with that of women with no family history of ovarian cancer.

Study Design: A population-based case-controlled study was conducted from May 1994 through July 1998 in which 767 women aged 20 to 69 years with a diagnosis of epithelial ovarian cancer were ascertained from 39 hospitals in 3 northeastern states. Personal interviews with the women and 1367 control subjects provided data that allowed us to estimate the relative risk of ovarian cancer in relation to a family history of cancer and total duration of oral contraception.