Treatment-associated musculoskeletal and vasomotor symptoms and relapse-free survival in the NCIC CTG MA.27 adjuvant breast cancer aromatase inhibitor trial.

Purpose: Treatment-emergent symptoms with adjuvant tamoxifen and aromatase inhibitors (AIs) have been associated with superior recurrence-free survival (RFS). We hypothesized that MA.27 anastrozole- or exemestane-treated patients with new or worsening vasomotor and/or joint symptoms would have improved RFS.

Effect of continuous statistically standardized measures of estrogen and progesterone receptors on disease-free survival in NCIC CTG MA.12 Trial and BC Cohort.

Introduction: We hypothesized improved inter-laboratory comparability of estrogen receptor (ER) and progesterone receptor (PgR) across different assay methodologies with adjunctive statistical standardization, akin to bone mineral density (BMD) z-scores. We examined statistical standardization in MA.12, a placebo-controlled pre-menopausal trial of adjuvant tamoxifen with locally assessed hormone receptor +/- tumours, and in a cohort of post-menopausal British Columbia (BC) tamoxifen-treated patients.

Hyperfractionated or accelerated radiotherapy for head and neck cancer.

Background: Several trials have studied the role of altered fractionation radiotherapy in head and neck squamous cell carcinoma, but the effect of such treatment on survival is not clear.

Objectives: The aim of this individual patient data (IPD) meta-analysis was to assess whether this type of radiotherapy could improve survival.

Search Strategy: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; CENTRAL (2010, Issue 3); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials.

Prognostic and predictive value of epidermal growth factor receptor tyrosine kinase domain mutation status and gene copy number for adjuvant chemotherapy in non-small cell lung cancer.

Purpose: Patients with non-small cell lung carcinoma with epidermal growth factor receptor (EGFR) mutations may have a more favorable prognosis and greater response to chemotherapy. The effect of EGFR mutation and gene copy on patients with early-stage non-small cell lung carcinoma receiving adjuvant chemotherapy has not been reported.

Patients And Methods: Tumor samples from NCIC Clinical Trials Group JBR.

Plasma transforming growth factor alpha and amphiregulin protein levels in NCIC Clinical Trials Group BR.21.

Purpose: To evaluate the prognostic and predictive significance of plasma levels of the epidermal growth factor receptor (EGFR) ligands, transforming growth factor α (TGF-α) and amphiregulin, in patients with non-small-cell lung cancer (NSCLC) enrolled in NCIC Clinical Trials Group BR.21 comparing erlotinib with placebo.

Patients And Methods: TGF-α and amphiregulin were assessed retrospectively by enzyme-linked immunosorbent assay from available prospectively collected baseline plasma samples in 565 of 731 BR.

The influence of sex on efficacy, adverse events, quality of life, and delivery of treatment in National Cancer Institute of Canada Clinical Trials Group non-small cell lung cancer chemotherapy trials.

Background: Female sex is a favorable prognostic factor in lung cancer. In small-cell lung cancer, women have been shown to experience greater toxicity from chemotherapy, but there are few studies of sex-related toxicity in non-small cell lung cancer (NSCLC).

Patients And Methods: This retrospective analysis evaluated the effect of sex on efficacy, adverse events (AEs), dose intensity (DI), and quality of life (QoL) in three phase III NSCLC trials conducted by the National Cancer Institute of Canada Clinical Trials Group; BR.

Venous thromboembolism and nonsmall cell lung cancer: a pooled analysis of National Cancer Institute of Canada Clinical Trials Group trials.

Background: Advanced nonsmall cell lung cancer (NSCLC) is associated with venous thromboembolism (VTE). However, to the authors' knowledge, the incidence of VTE in early NSCLC, predictors of VTE, and the prognostic significance of VTE in NSCLC have not been explored.

Methods: Individual patient data from 3 National Cancer Institute of Canada Clinical Trials Group trials were analyzed (n = 1987 patients).

Quality-adjusted time without symptoms or toxicity analysis of adjuvant chemotherapy in non-small-cell lung cancer: an analysis of the National Cancer Institute of Canada Clinical Trials Group JBR.10 trial.

Purpose: National Cancer Institute of Canada Clinical Trials Group JBR.10 demonstrated that adjuvant vinorelbine and cisplatin after resection of stage IB-II non-small-cell lung cancer (NSCLC) improved relapse-free and overall survival. However, many patients either are not referred for chemotherapy or decline treatment.

Presentation of nonfinal results of randomized controlled trials at major oncology meetings.

Purpose: To assess the frequency, implications, and factors associated with reporting nonfinal analyses (NFAs) of randomized controlled trials (RCTs) as abstract publications.

Methods: We identified 138 consecutive reports of RCTs testing systemic therapy for lymphoma, breast, colorectal, or non-small-cell lung cancer published in six major journals between 2000 and 2004. We then searched proceedings of seven major cancer meetings, 1990 to 2004, for abstracts related to these publications which presented efficacy results.

Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients.

Background: Our previous individual patient data (IPD) meta-analysis showed that chemotherapy improved survival in patients curatively treated for non-metastatic head and neck squamous cell carcinoma (HNSCC), with a higher benefit with concomitant chemotherapy. However the heterogeneity of the results limited the conclusions and prompted us to confirm the results on a more complete database by adding the randomised trials conducted between 1994 and 2000.

Methods: The updated IPD meta-analysis included trials comparing loco-regional treatment to loco-regional treatment+chemotherapy in HNSCC patients and conducted between 1965 and 2000.

Anticoagulation and bleeding: a pooled analysis of lung cancer trials of the NCIC Clinical Trials Group.

Background: Patients with cancer, including lung cancer are at an increased risk for venous thromboembolism and frequently are anticoagulated. Due to concerns of bleeding and drug-drug interactions, many clinical trials suggest the use of low-molecular-weight heparin (LMWH) rather than warfarin (coumadin) for patients requiring anticoagulation. We sought to evaluate, in a retrospective analysis, whether these recommendations were appropriate.

Surrogate endpoints for overall survival in locally advanced head and neck cancer: meta-analyses of individual patient data.

Background: The gold standard endpoint in randomised trials of locally advanced head and neck squamous-cell carcinoma (HNSCC) is overall survival. Our objective was to study whether duration of locoregional control or event-free survival (EFS) could be considered as surrogate endpoints to estimate the effect of radiotherapy and chemotherapy on overall survival. This would allow a reduction in the duration and cost of the development of new treatments.

Addition of estramustine to chemotherapy and survival of patients with castration-refractory prostate cancer: a meta-analysis of individual patient data.

Background: Estramustine phosphate is a mustard-oestradiol conjugate, and has hormonal and non-hormonal effects. In phase II trials of patients with cancer, response to microtubule inhibitors increases when these drugs are combined with estramustine. We aimed to assess whether combining estramustine with chemotherapy increases survival in patients with castration-refractory prostate cancer.

Individual patients' data meta-analyses in head and neck cancer.

Purpose Of Review: This is a review of the experience obtained at the Institute Gustave Roussy, evaluating the role of chemotherapy and of altered fractionated radiotherapy in locally advanced head and neck cancer. The database included nearly 120 randomized trials, and about 25,000 patients, with a median follow-up of 6 years.

Recent Findings: In the chemotherapy database (Meta-Analysis of Chemotherapy in Head, Neck Cancer and Meta-Analysis of Chemotherapy in Nasopharynx Carcinoma), concomitant cisplatin-based radiotherapy-chemotherapy provided the most significant benefit on locoregional control and survival, both in head and neck squamous cell carcinomas and nasopharyngeal carcinomas.

Hyperfractionated or accelerated radiotherapy in head and neck cancer: a meta-analysis.

Background: Several trials have studied the role of unconventional fractionated radiotherapy in head and neck squamous cell carcinoma, but the effect of such treatment on survival is not clear. The aim of this meta-analysis was to assess whether this type of radiotherapy could improve survival.

Methods: Randomised trials comparing conventional radiotherapy with hyperfractionated or accelerated radiotherapy, or both, in patients with non-metastatic HNSCC were identified and updated individual patient data were obtained.