Eastern Cooperative Oncology Group

About: Eastern Cooperative Oncology Group is a facility organization based out in Philadelphia, Pennsylvania, United States. It is known for research contribution in the topics: Cancer & Breast cancer. The organization has 249 authors who have published 170 publications receiving 26514 citations. The organization is also known as: ECOG.

Delineation of the minimal commonly deleted segment and identification of candidate tumor-suppressor genes in del(9q) acute myeloid leukemia.

Abstract: Deletion of the long arm of chromosome 9, del(9q), is a recurring chromosomal aberration in acute myeloid leukemia (AML) that is frequently associated with t(8;21). The critical gene products affected by del(9q) are unknown but likely cooperate with the AML1/ETO fusion gene created by t(8;21) in leukemogenesis. In 43 AML samples with del(9q), we used high-density microsatellite markers to define the commonly deleted region (CDR) to less than 2.4 Mb. We found no homozygous loss at any locus tested. The CDR contains 7 known genes, FRMD3, UBQLN1, GKAP42, KIF27, HNRPK, SLC28A3, and NTRK2, and 4 novel genes, RASEF, C9orf103, C9orf64, and C9orf76. In addition, TLE1 and TLE4 are adjacent to the CDR. We performed a comprehensive mutational analysis of the coding regions of all these genes. No sequence variations absent in normal controls were seen in more than a single del(9q) AML sample. Expression of 7 of the 10 genes examined was significantly down-regulated in del(19q)AML as compared with the CD34-purified progenitors from normal individuals, a pattern distinct from that seen in AML samples with a normal karyotype. The results of our studies are consistent with a model of tumor suppression mediated by haploinsufficiency of critical genes in del(9q) AML. © 2005 Wiley-Liss, Inc.

Analysis of age, estimated creatinine clearance and pretreatment hematologic parameters as predictors of fludarabine toxicity in patients treated for chronic lymphocytic leukemia: a CALGB (9011) coordinated intergroup study.

Abstract: Purpose. Fludarabine is a renally excreted agent that is an effective treatment for chronic lymphocytic leukemia (CLL), a disease predominantly of the elderly. We sought to determine whether age, renal function or pretreatment hematologic status predicted toxicity of fludarabine treatment for CLL. Methods. We evaluated 192 patients with previously untreated B-cell CLL who were entered onto the fludarabine treatment arm (25 mg/m2 daily for 5 days every 28 days) of CALGB study 9011, an intergroup study with participation from SWOG, CTG/NCI-C and ECOG. Patients were required to have serum creatinine within 1.5 times normal. Hematologic indices and infections were recorded during the first 28-day cycle of treatment. A time-to-toxicity endpoint was evaluated over the entire course of fludarabine treatment. Creatinine clearance (CrClest) was estimated using serum creatinine, age and body mass index. Results. The median age was 64 years (range 37–87 years) and median CrClest was 62 ml/min (range 27–162 ml/min, interquartile range 52–79 ml/min). We found no association between age and incidence of hematologic toxicity or infection during the first cycle of treatment. There was a strong association between CrClest and the time-to-toxicity endpoint. Patients with CrClest below 80 ml/min had increased incidence of toxicity during their treatment course (P<0.0001). Pretreatment anemia, thrombocytopenia and Rai stage were highly associated with the incidence of neutrophil toxicity and grade III/IV hematologic toxicities during the first cycle of treatment (P<0.0001). Conclusions. Patient age was not an independent risk factor for fludarabine-related toxicity, but CrClest was associated with time to toxicity.

Estrogen Replacement Therapy in Breast Cancer Survivors-Reply

Abstract: In Reply. —We thank the many authors of letters written in response to our work. Meta-analyses, which overcome type II error, have not demonstrated an association between ERT and risk of breast cancer. In general, prospective studies are preferable to case-control studies. However, there are problems with all studies, including prospective ones. For example, the Nurses' Health Study found an increase in breast cancer risk only in those who were drinking alcohol. 1 The Swedish study wasn't a true prospective cohort trial. 2 Files from a prescription database were merged with files from a cancer registry. It is not known whether "hormone users" were actually taking hormones. We need to weigh the entire body of evidence. We should not discount the results of 25 case-control studies because we think two prospective ones are better. Most studies of adjuvant tamoxifen in postmenopausal women evaluated tamoxifen vs no treatment, whereas those in

Development of Clinical Trials in a Cooperative Group Setting: The Eastern Cooperative Oncology Group

Abstract: 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. Results: Twenty-eight phase III studies were activated by ECOG during the January 2000 to July 2006 study period. We examined a sample from 16 of those studies in detail. More than 481 distinct processes were required for study activation: 420 working steps, 61 major decision points, 26 processing loops, and 13 stopping points. Median calendar days to activate a trial in the phase III subset was 783 days (range, 285-1,542 days) from executive approval and 808 days (range, 435-1,604 days) from initial conception of the study. Data were collected for all phase II and phase III trials activated and completed during this time period ( n = 52) for which development time represented 43.9% and 54.1% of the total trial time, respectively. Conclusion: The steps required to develop and activate a clinical trial may require as much or more time than the actual completion of a trial. The data shows that to improve the activation process, research should to be directed toward streamlining both internal and external groups and processes.