Molecular Landscape and Actionable Alterations in a Genomically Guided Cancer Clinical Trial: National Cancer Institute Molecular Analysis for Therapy Choice (NCI-MATCH).

Purpose: Therapeutically actionable molecular alterations are widely distributed across cancer types. The National Cancer Institute Molecular Analysis for Therapy Choice (NCI-MATCH) trial was designed to evaluate targeted therapy antitumor activity in underexplored cancer types. Tumor biopsy specimens were analyzed centrally with next-generation sequencing (NGS) in a master screening protocol.

The Molecular Analysis for Therapy Choice (NCI-MATCH) Trial: Lessons for Genomic Trial Design.

Background: The proportion of tumors of various histologies that may respond to drugs targeted to molecular alterations is unknown. NCI-MATCH, a collaboration between ECOG-ACRIN Cancer Research Group and the National Cancer Institute, was initiated to find efficacy signals by matching patients with refractory malignancies to treatment targeted to potential tumor molecular drivers regardless of cancer histology.

Methods: Trial development required assumptions about molecular target prevalence, accrual rates, treatment eligibility, and enrollment rates as well as consideration of logistical requirements.

Improving Breast Ultrasound Interpretation in Uganda Using a Condensed Breast Imaging Reporting and Data System.

Rationale And Objectives: This study aimed to determine whether a 2-day educational course using a condensed Breast Imaging Reporting and Data System (condensed BI-RADS) improved the accuracy of Ugandan healthcare workers interpreting breast ultrasound.

Materials And Methods: The target audience of this intervention was Ugandan healthcare workers involved in performing, interpreting, or acting on the results of breast ultrasound. The educational course consisted of a pretest knowledge assessment, a series of lectures on breast imaging interpretation and standardized reporting using a condensed BI-RADS, and a posttest knowledge assessment.

The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations.

Introduction: Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions.

Methods: The National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts.

Q&A: Robert Comis and Mitchell Schnall on trials. Interview by Eric Bender.

The co-chairs of ECOG-ACRIN talk about combining forces to advance clinical studies.

Outcomes of a cancer clinical trial matching service.

The American Cancer Society (ACS) and Coalition of Cancer Cooperative Groups (CCCG) provide a clinical trial (CT) information/matching/eligibility service (Clinical Trials Matching Service [CTMS]). Patients' demographic and clinical data, enrollment status, and self-reported barriers to CT participation were analyzed to assess enrollment rates and determinants of enrollment. During 3 years beginning October 1, 2007, the CTMS served 6,903 patients via the ACS call center.

Measuring cancer clinical trial understanding.

Researchers, practitioners, and participants in cancer clinical trials must have a clear understanding of clinical trials if participation in them is to be solicited ethically and effectively. A valid and reliable measure of cancer clinical trial understanding did not exist prior to a 2005 study conducted for the Coalition of Cooperative Cancer Groups. This report outlines a measure derived from that study, discusses the rationale for its component items, examines its psychometric properties, and demonstrates the relationship of this measure to the enrollment decision.

A Comparison of white and African American outcomes from a three-arm, randomized, phase III multicenter trial of advanced or metastatic non-small cell lung cancer.

Purpose: To investigate the effect of race on the efficacy and safety of standard chemotherapy doublet regimens in African American patients, we conducted a subgroup analysis of a phase III randomized trial.

Patients And Methods: Chemonaïve patients with a performance status of 0 or 1 and stage IIIB or IV non-small cell lung cancer were randomized to arm A: gemcitabine 1000 mg/m2 on days 1 and 8 plus carboplatin area under the curve 5.5 on day 1; arm B: the same schedule of gemcitabine plus paclitaxel 200 mg/m2 on day 1; or arm C: paclitaxel 225 mg/m2 on day 1 plus carboplatin area under the curve 6.

A retrospective analysis of outcomes by age in a three-arm phase III trial of gemcitabine in combination with carboplatin or paclitaxel vs. paclitaxel plus carboplatin for advanced non-small cell lung cancer.

Purpose: Sufficient data are currently unavailable to assist in defining suitable regimens for patients ≥ 70 years with advanced non-small cell lung cancer (NSCLC).

Methods: Chemonaïve patients with a performance status (PS) of 0 or 1 and stage IIIB or IV NSCLC were randomized to gemcitabine 1000mg/m(2) on days 1 and 8 plus carboplatin area under the curve (AUC) 5.5 on day 1; the same schedule of gemcitabine plus paclitaxel 200mg/m(2) on day 1; or paclitaxel 225mg/m(2) on day 1 plus carboplatin AUC 6.

Recommendations for research priorities in breast cancer by the coalition of cancer cooperative groups scientific leadership council: imaging and local therapy.

Imaging and local therapy are important modalities for detection and management of localized breast cancer. Improvements in screening and local therapy have contributed to reduced breast cancer-associated morbidity and mortality. The Coalition of Cancer Cooperative Groups (CCCG) convened the Scientific Leadership Council (SLC) in breast cancer, an expert panel, to identify priorities for future research and current trials with greatest practice-changing potential.

A randomized, phase III multicenter trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic non-small-cell lung cancer.

Background: Paclitaxel-carboplatin is used as the standard regimen for patients with advanced or metastatic non-small-cell lung cancer (NSCLC). This trial was designed to compare gemcitabine + carboplatin or gemcitabine + paclitaxel to the standard regimen.

Patients And Methods: A total of 1135 chemonaive patients with stage IIIB or IV NSCLC were randomly allocated to receive gemcitabine 1000 mg/m(2) on days 1 and 8 plus carboplatin area under the concentration-time curve (AUC) 5.

Independent review of E2100: a phase III trial of bevacizumab plus paclitaxel versus paclitaxel in women with metastatic breast cancer.

Purpose: E2100, an open-label, randomized, phase III trial conducted by the Eastern Cooperative Oncology Group (ECOG), demonstrated a significant improvement in progression-free survival (PFS) and overall response rate (ORR) with paclitaxel plus bevacizumab compared with paclitaxel alone as initial chemotherapy for patients with HER2-negative metastatic breast cancer.

Methods: An independent, blinded review of radiologic and clinical data was performed, assessing progression and response according to Response Evaluation Criteria in Solid Tumors. In addition, ECOG's investigator assessments were reanalyzed using the same methods applied to the independent review.

Recommendations for research priorities in breast cancer by the Coalition of Cancer Cooperative Groups Scientific Leadership Council: systemic therapy and therapeutic individualization.

Over 9,000 women with breast cancer are enrolled annually on clinical trials sponsored by the National Cancer Institute (NCI), accounting for about one-third of all patients enrolled on NCI-sponsored trials. Thousands are also enrolled on pharmaceutical-sponsored studies. Although breast cancer mortality rates have recently declined for the first time in part due to systemic therapeutic advances, coordinated efforts will be necessary to maintain this trend.

Physician-related factors involved in patient decisions to enroll onto cancer clinical trials.

The development of new cancer therapies requires additional, and more complex, clinical trials. But only approximately 3% to 5% of adult cancer patients participate in cancer clinical trials. This study seeks to identify and understand the attitudes of the public and cancer survivors toward health-related decisions and cancer clinical trials to identify the key factors that must be addressed to increase that percentage.

The role of the Eastern Cooperative Oncology Group in establishing standards of cancer care: over 50 years of progress through clinical research.

Since its start as the Eastern Cooperative Cancer Chemotherapy Group in 1955, the Eastern Cooperative Oncology Group (ECOG) has been at the vanguard of adult cancer clinical research in the United States, and for more than 50 years its research findings have influenced cancer care worldwide. While the cancer clinical research milieu has changed considerably since its inception, the ECOG, through sound leadership and a committed membership, has maintained its pioneering roles in scientific discovery and defining standards of cancer care for all adult cancers.

Addressing the current challenges of non-small-cell lung cancer clinical trial accrual.

Conducting research in patients with non-small-cell lung cancer (NSCLC) is challenging, primarily because of low patient accrual rates resulting from patient-, physician-, protocol-, and healthcare system-related barriers. The Coalition of Cancer Cooperative Groups convened a 1-day program entitled Addressing the Current Challenges of NSCLC Clinical Trial Accrual to develop specific strategies for enhancing accrual into NSCLC clinical trials and to increase and sustain the level of discussion with and among cooperative group and community-based researchers. Some of the important areas that were highlighted at the meeting included predictors of successful and unsuccessful trial accrual based on 6 NSCLC trials, of which 4 were considered high-priority NSCLC trials; issues surrounding the process of clinical trial activation; and the role of patient advocates in enhancing trial accrual.

Development of clinical trials in a cooperative group setting: the eastern cooperative oncology group.

Purpose: We examine the processes and document the calendar time required to activate phase II and III clinical trials by an oncology group: the Eastern Cooperative Oncology Group (ECOG).

Methods: Setup steps were documented by (a) interviewing ECOG headquarters and statistical center staff, and committee chairs, (b) reviewing standard operating procedure manuals, and (c) inspecting study records, documents, and e-mails to identify additional steps. Calendar time was collected for each major process for each study in this set.

Priorities in colorectal cancer research: recommendations from the Gastrointestinal Scientific Leadership Council of the Coalition of Cancer Cooperative Groups.

Emerging technologies have greatly expanded our ability to detect, characterize, and treat colorectal cancer. The Coalition of Cancer Cooperative Groups convened a multidisciplinary panel, the Scientific Leadership Council in GI cancer, to discuss and advise on the priorities and opportunities to advance current and future approaches into the clinical arena to impact most rapidly the morbidity and mortality from this disease. The Council's recommendations for research priorities are the result of engagement of community and academic oncologists, patient advocacy groups, and other stakeholders including the pharmaceutical industry and governmental agencies.

Evaluating antiangiogenesis agents in the clinic: the Eastern Cooperative Oncology Group Portfolio of Clinical Trials.

Recent evidence indicates that treatment with a humanized monoclonal antibody (bevacizumab) directed at vascular endothelial growth factor improves response and survival in metastatic colorectal cancer when added to standard chemotherapy, validating angiogenesis as a therapeutic target. Investigators from the Eastern Cooperative Oncology Group (ECOG) have initiated a number of Phase III studies that will help further define the role of antiangiogenic agents for the treatment of breast, colon, lung, renal, and head and neck cancer, as well as melanoma and myeloma. The agents being evaluated target various biological functions involved in angiogenesis, including vascular endothelial growth factor (bevacizumab), endothelial cell proliferation (thalidomide, IFN-alpha), and matrix metalloproteinases (marimastat).

A brief history of the research and treatment of lung cancer from 1970 to 2003.

Lung cancer accounts for one-third of all cancer deaths worldwide. Once considered untreatable, lung cancer patients now have several different treatment options, and the potential for more effective therapies is promising. Clinical trials conducted during the past 25 to 30 years in the United States Cooperative Group System and throughout the world have defined the standard of care and made several initial treatment therapies possible.