No evidence for changes in skeletal muscle mass or weight during first-line chemotherapy for metastatic colorectal cancer.

Background: Studies over the past 10 years strongly support an association between skeletal muscle mass (SMM) depletion and outcome in metastatic colorectal cancer (mCRC). Factors influencing SMM changes over time are, however, poorly studied. We analyzed the impact of SMM on overall survival and chemotherapy toxicities in mCRC patients treated with first-line chemotherapy.

CRM2DIM: A SAS macro for implementing the dual-agent Bayesian continual reassessment method.

Background And Objective: The continual reassessment method (CRM) is a model-based dose-finding design for single-agent phase I oncology trials. With the advance of targeted therapies in oncology, more and more phase I trials investigate drug combinations rather than a single agent in order to find one or more maximum tolerated dose combinations. Several designs have been proposed for such dose-finding trials but only a few software packages are available to implement them.

Cyclin E1 Expression and Palbociclib Efficacy in Previously Treated Hormone Receptor-Positive Metastatic Breast Cancer.

Purpose: A large-panel gene expression analysis was conducted to identify biomarkers associated with the effectiveness of adding palbociclib to fulvestrant.

Methods: The PALOMA-3 ( ClinicalTrials.gov identifier: NCT01942135) trial randomly assigned 521 endocrine-pretreated patients with metastatic breast cancer to receive palbociclib plus fulvestrant or placebo plus fulvestrant.

A new prognostic model for survival in second line for metastatic renal cell carcinoma: development and external validation.

Background: In patients with metastatic renal cell carcinoma (mRCC), the oncologic benefit of second-line treatment for high volume tumors or presence of more than five risk factors remain to be defined. Our aim was to develop and externally validate a new model most likely to correctly predict overall survival (OS) categories in second line.

Method: mRCC patients treated within clinical trials at Gustave Roussy Cancer Campus (GRCC) formed the discovery set.

Daily Versus Weekly Prostate Cancer Image Guided Radiation Therapy: Phase 3 Multicenter Randomized Trial.

Purpose: The optimal frequency of prostate cancer image guided radiation therapy (IGRT) has not yet been clearly identified. This study sought to compare the safety and efficacy of daily versus weekly IGRT.

Materials And Methods: This phase 3 randomized trial recruited patients with N0 localized prostate cancer.

ER Breast Cancers Resistant to Prolonged Neoadjuvant Letrozole Exhibit an E2F4 Transcriptional Program Sensitive to CDK4/6 Inhibitors.

This study aimed to identify biomarkers of resistance to endocrine therapy in estrogen receptor-positive (ER) breast cancers treated with prolonged neoadjuvant letrozole. We performed targeted DNA and RNA sequencing in 68 ER breast cancers from patients treated with preoperative letrozole (median, 7 months). Twenty-four tumors (35%) exhibited a PEPI score ≥4 and/or recurred after a median of 58 months and were considered endocrine resistant.

Integrating Tenascin-C protein expression and 1q25 copy number status in pediatric intracranial ependymoma prognostication: A new model for risk stratification.

Purpose: Despite multimodal therapy, prognosis of pediatric intracranial ependymomas remains poor with a 5-year survival rate below 70% and frequent late deaths.

Experimental Design: This multicentric European study evaluated putative prognostic biomarkers. Tenascin-C (TNC) immunohistochemical expression and copy number status of 1q25 were retained for a pooled analysis of 5 independent cohorts.

Factors which modulate the rates of skeletal muscle mass loss in non-small cell lung cancer patients: a pilot study.

Purpose: Advanced non-small cell lung cancer (NSCLC) is associated with weight loss which may reflect skeletal muscle mass (SMM) and/or total adipose tissue (TAT) depletion. This study aimed to describe changes in body composition (BC) parameters and to identify the factors unrelated to the tumor which modulate them.

Methods: SMM, TAT, and the proportion of SMM to SMM + TAT were assessed with computed tomography.

Statistical approaches for evaluating body composition markers in clinical cancer research.

The term 'morphomics' stands for the markers of body composition in muscle and adipose tissues. in recent years, as part of clinical cancer research, several associations between morphomics and outcome or toxicity were found in different treatment settings leading to a growing interest. we aim to review statistical approaches used to evaluate these markers and suggest practical statistical recommendations.

Sarcopenia is Associated with Chemotherapy Toxicity in Patients Undergoing Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis from Colorectal Cancer.

Background: Despite the positive survival results of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC), criticisms have been put forward regarding the safety of this treatment as a result of a high morbidity rate. Muscle depletion (sarcopenia) is associated with the occurrence of postoperative complications. The purpose of this study was to determine the association between sarcopenia and postoperative morbidity after CRS-HIPEC for peritoneal carcinomatosis from colorectal cancer by distinguishing the complications linked to CRS itself and those associated with chemotherapy (HIPEC) toxicities.

New insights into the evaluation of randomized controlled trials for rare diseases over a long-term research horizon: a simulation study.

Large sample sizes are required in randomized clinical trials designed to meet typical one-sided 2.5% α-level and 80% power. This may not be achievable when the disease is rare.

Phase I trial evaluating the antiviral agent Cidofovir in combination with chemoradiation in cervical cancer patients.

Purpose: This phase I trial aimed to assess the safety and determine the recommended Phase II dose (RP2D) of Cidofovir combined with chemoradiotherapy in patients with stage IB2-IVA cervical cancer.

Experimental Design: Incremental doses (1, 2.5, 5 and 6.