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The data monitoring regulatory procedures, and administrative tasks associated with protocol management have become increasingly complex. Relational database technology and Internet-based connectivity offer resources to improve the quality and efficiency of protocol operations. At Fox Chase Cancer Center, we have developed a suite of database applications for protocol management and tracking of patient accrual. All data transactions and reporting occur through a graphical web browser interface using standard Internet technology. Security and confidentiality have been addressed through encryption, user authentication, address restriction, and database authority. Database management has been tightly integrated with protocol operations to avoid duplication of resources and effort. Data query functions also extend to other institutional resources, such as tumor registry and the hospital clinical laboratory, to further reduce the need for redundant data storage. Newer components, such as chemotherapy orders and toxicity reporting, have been incorporated in a modular fashion. Although custom software development can be expensive and time-consuming, it offers the best opportunity for successful integration with existing resources, staff, and procedures, as well as collaboration with other institutions.
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PMID:Web-based resources for clinical protocol management. 1002 16

The purpose of this study was to present patterns and risk of biochemical failure following external beam irradiation of prostate cancer and to make comparisons to a published modern radical prostatectomy series. Between January 1987 and December 1994, 328 men were treated definitively at Fox Chase Cancer Center for localized prostate cancer using conventional or three-dimensional conformal radiotherapy. The median biochemical follow-up was 6.4 years, with all patients having at least 5 years follow-up. Two prognostic patient groups were established on the basis of proportional hazards modeling that considered treatment and presenting tumor characteristics. For each of the two prognostic groups, biochemical failure and hazard functions were estimated using the ASTRO consensus definition of failure and life table methodology. Failure risk comparisons were made to modern published radical prostatectomy series. Multivariate analysis demonstrated the independent predictive power of pretreatment PSA level, palpation stage, Gleason score, and dose. Thus, the favorable prognosis group, Group I, consisted of 83 patients who were treated with a dose level > or = 74 Gy and who presented with PSA levels < 20 ng/ml, T1/T2A tumors, and Gleason score 2-6. Group II consisted of 245 patients with at least one of the following: pretreatment PSA level > or = 20 ng/ml, T2B/T3 tumor, Gleason score 7-10, dose < 74 Gy. The 5- and 8-year bNED estimates were 76% and 76% for Group I, and 51% and 49% for Group II. Only three failures occurred after 5 years, all from Group II, representing 2% of the total failures observed. Hazard function estimates indicate maximum risk of failure at 24 to 36 months, tapering to a low rate at 4 years with no failures observed after 6 years. Differences in patterns of failure by prognostic group show maximum risk of failure at 24 months (median, 31 months) for Group I, and 12 to 36 months (median, 22 months) for Group II. Group II reaches low levels of risk at 6 years, in contrast to 4 years for the patients with a more favorable prognosis. We concluded that patients treated with external beam radiation alone show little risk of failure after 4 to 6 years. This result suggests that the 5-year bNED control rate approximates the eventual cure rate of prostate cancer.
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PMID:Failure pattern implications following external beam irradiation of prostate cancer: long-term follow-up and indications of cure. 1080 36

This work examined the role of constitutional genetic variation at the glutathione S-transferase M1 (GSTM1) and NAD(P)H:quinone oxidoreductase 1 (NQO1) detoxification loci in breast cancer development. Methods included contrasting patterns of genetic variations at these loci between cases with breast cancer and healthy controls and assessing the association of genotypes with tumor characteristics. Participants were Caucasian women living in the Greater Philadelphia region, recruited from 1988 to 1994, with recently diagnosed women attending breast cancer clinics at Fox Chase Cancer Center (FCCC) and network affiliated hospitals as cases, and FCCC employees or women attending noncancer clinics as controls. The GSTM1 locus was determined for 402 cases and 238 controls, NQO1 for 346 cases and 235 controls. Results show that neither locus was associated with breast cancer occurrence, with the GSTM1 null genotype occurring at frequencies of 0.560 and 0.563 in cases and controls, respectively [odds ratio (OR) 0.98, 0.95 confidence interval (CI) 0.70-1.38] and the NQO1 wild-type allele at frequencies of 0.808 and 0.845, respectively (OR 0.77, 0.95 CI 0.55-1.06). The GSTM1 null genotype, however, was significantly overrepresented among larger (T3 and T4) primary tumors (OR 7.61, 0.95 CI 1.05-333) and with the occurrence of axillary lymph node metastases (OR 1.62, 0.95 CI 0.98-2.69). NQO1 results revealed that homozygotes for the wild type allele were more likely to have ductal carcinoma and poor histologic grade when compared with individuals carrying one or two mutated alleles (OR 3.50, 0.95 CI 1.41-9.0, and OR 2.26, 0.95 CI 1.18-4.35 for histology type and grade, respectively). We conclude that while these loci are not associated with breast cancer occurrence, the GSTM1 locus is likely associated with tumor progression. NQO1 results suggest that different quinones (possibly estrogenic quinone metabolites) might affect the histological development of breast tumors.
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PMID:Significance of genetic variation at the glutathione S-transferase M1 and NAD(P)H:quinone oxidoreductase 1 detoxification genes in breast cancer development. 1181 42

Two recent reports reveal new roles for FoxO proteins in cell proliferation and tumorigenesis. Seoane and colleagues show that FoxO proteins play key roles in the TGFbeta-dependent activation of p21Cip1 by partnering with Smad3 and Smad4. FoxG1, a protein from a distinct Fox subfamily, binds FoxO/Smad complexes and blocks p21Cip1 expression. These interactions establish a relationship between the PI3K pathway, FoxG1, and the TGFbeta/Smad pathways. The second report identifies IkappaB kinase as a negative regulator of FoxO proteins, suggesting a mechanism for relieving negative regulation of cell cycle and promoting tumor cell proliferation.
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PMID:FoxO: linking new signaling pathways. 1514 89

We applied MRI to the in vivo detection of spontaneous colorectal tumors in a unique mouse model, the Fox Chase Cancer Center (FCCC) ApcMIN mouse. Unlike other Min (multiple intestinal neoplasia) strains, FCCC ApcMIN animals develop an appreciable number of tumors in the large intestine, which makes them an appropriate mouse model for colon cancer in humans. We describe a method for marking the colon on MRI data sets that involves a bowel-cleansing procedure and the insertion of a polyurethane tube (filled with an MRI contrast agent) fully into the colon. We found that tumors as small as 1.5 mm in diameter can be consistently identified from MRI datasets with a voxel size of 0.1 mm x 0.133 mm x 0.133 mm. Tumor volumes were determined from the MRM data sets with the use of a novel approach to planimetry in 3D data sets. We observed a correlation between tumor volume (as measured from the MRI datasets) and tumor weight of 0.942, and a P-value of 0.008, based on Spearman's test. These data show that MRI can be used to accurately monitor tumor growth in mouse models of colorectal carcinogenesis.
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PMID:Detection and volume determination of colonic tumors in Min mice by magnetic resonance micro-imaging. 1533 70

Zoledronic acid is a potent bisphosphonate licensed for the treatment of myeloma and bone metastases from solid tumors. Renal deterioration is the most significant toxicity associated with zoledronic acid. We attempted to define the incidence and clinical significance of renal deterioration in patients receiving zoledronic acid and to develop a risk-factor profile for this treatment sequela. This study is a retrospective analysis of all patients who received zoledronic acid at Fox Chase Cancer Center, Philadelphia, Pa, between 1/10/02 and 1/30/04. Data recorded included patient demographics, tumor characteristics, comorbid illnesses, concomitant medications, cancer therapy, number of zoledronic acid doses administered, and serial creatinine measurements. In total, 3,115 evaluable doses of zoledronic acid were administered to 446 patients (median, 4 doses; mean, 6.98 doses; range, 1-28 doses) at a dose of 4 mg over 15 minutes every 3-4 weeks. Of these 446 patients, 42 experienced renal deterioration (median rise in creatinine level, 1.0 mg/dL; range, 0.5-4.4 mg/dL), requiring discontinuation of zoledronic acid therapy in 8 cases. No patient required dialysis and no patient died as a result of zoledronic acid-induced renal dysfunction. On multivariable analysis, predictive factors for the development of renal deterioration were patient age, a diagnosis of myeloma or renal cell cancer, cumulative number of doses, concomitant therapy with a nonsteroidal anti-inflammatory drug, and current or prior therapy with cisplatin. Using these factors, we constructed a predictive model with an area under the receiver operating characteristic curve of 0.75. The incidence of clinically significant renal deterioration in patients treated with zoledronic acid is low.We present a predictive model for decision support when estimating this risk.
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PMID:Impact of zoledronic acid on renal function in patients with cancer: Clinical significance and development of a predictive model. 1713 70

The alpha-melanocyte-stimulating hormone (alpha-MSH) receptor (melanocortin type 1 receptor, or MC1R) plays an important role in the development and growth of melanoma cells. It was found that MC1R was overexpressed on most murine and human melanoma, making it a promising molecular target for melanoma imaging and therapy. Radiolabeled alpha-MSH peptide and its analogs that can specifically bind with MC1R have been extensively explored for developing novel agents for melanoma detection and radionuclide therapy. The goal of this study was to evaluate a 64Cu-labeled alpha-MSH analog, Ac-Nle-Asp-His-D-Phe-Arg-Trp-Gly-Lys(DOTA)-NH2 (DOTA-NAPamide), as a potential molecular probe for microPET imaging of melanoma and MC1R expression in melanoma xenografted mouse models. 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA) conjugated NAPamide was synthesized and radiolabeled with 64Cu (t1/2=12 h) in NH4OAc (0.1 M; pH 5.5) buffered solution for 60 min at 50 degrees C. Cell culture studies reveal rapid and high uptake and internalization of 64Cu-DOTA-NAPamide in B16F10 cells. Over 90% of receptor-bound tracer is internalized at 3 h incubation. A cellular retention study demonstrates that the receptor-bound 64Cu-DOTA-NAPamide is slowly released from the B16F10 cells into the medium; 66% of the radioactivity is still associated with the cells even after 3 h incubation. The biodistribution of 64Cu-DOTA-NAPamide was then investigated in C57BL/6 mice bearing subcutaneous murine B16F10 melanoma tumors with high capacity of MC1R and Fox Chase Scid mice bearing human A375M melanoma with a relatively low number of MC1R receptors. Tumor uptake values of 64Cu-DOTA-NAPamide are found to be 4.63 +/- 0.45% and 2.49 +/- 0.31% ID/g in B16F10 and A375M xenografted melanoma at 2 h postinjection (pi), respectively. The B16F10 tumor uptake at 2 h pi is further inhibited to 2.29 +/- 0.24% ID/g, while A375M tumor uptake at 2 h pi remains 2.20 +/- 0.41% ID/g with a coinjection of excess alpha-MSH peptide. MicroPET imaging of 64Cu-DOTA-NAPamide in B16F10 tumor mice clearly shows good tumor localization. However, low A375M tumor uptake and poor tumor to normal tissue contrast were observed. This study demonstrates that 64Cu-DOTA-NAPamide is a promising molecular probe for alpha-MSH receptor positive melanoma PET imaging as well as MC1R expression imaging in living mice.
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PMID:64Cu-labeled alpha-melanocyte-stimulating hormone analog for microPET imaging of melanocortin 1 receptor expression. 1734

Fox, M. W., The Jackson Laboratory, Bar Harbor, Maine. Developmental Abnormalities of the Canine Skull. Prognathism of the upper jaw and partial agnathia of the lower jaw and related disorders including dental anomalies, palatitis, and otocephaly are described. Similarly, secondary or concurrent anomalies associated with brachygnathism are discussed where an excess of soft tissue in proportion to the size of the upper jaw and facial (brachyfacial) area may cause a variety of clinical conditions. The higher incidence of neoplasia of the CNS in brachycephalic dogs may be related to reduction in cranial capacity in proportion to brain volume and pressure changes are less easily compensated in the brachygnathic breeds.
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PMID:Developmental Abnormalities of the Canine Skull. 1764 61

Fox Chase Cancer Center Partners (FCCCP) is a community hospital/academic partnership consisting of 25 hospitals in the Delaware Valley. Originally created in 1986, FCCCP promotes quality community cancer care through education, quality assurance, and access to clinical trial research. An important aspect of quality assurance is a yearly medical oncology audit that benchmarks quality indicators and guidelines and provides a roadmap for quality improvement initiatives in the community oncology clinical office setting. Each year, the FCCCP team and the Partner Medical Oncologists build disease site- and stage-specific indicators based on National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Concordance with multiple indicators is assessed on 20 charts from each community practice. A report for each FCCCP medical oncology practice summarizes documentation, screening recommendations, new drug use, and research trends in a particular disease site. Descriptive statistics reflect indicators met, number of new cases seen per year, number of disease site cases from tumor registry information, and clinical trial accrual total. Education and documentation tools are provided to physicians and oncology office nursing staff. The FCCCP Clinical Operations Team, consisting of medical oncologists and oncology-certified nurses, has conducted quality audits in medical oncology offices for 7 years using NCCN-derived indicators. Successful audits comprising gastric, colorectal, and breast cancer have been the focus of recent evaluations. For the 2005 stage II/III breast cancer evaluation, mean compliance per parameter was 88%, with 15 of 16 practices achieving mean compliance greater than 80%. A large-scale quality assurance audit in a community cancer partner network is feasible. Recent evaluation of localized breast cancer shows high compliance with guidelines and identifies areas for focused education. Partnership between academic and community oncologists produces a quality review process that is broadly applicable and adaptable to changing medical knowledge.
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PMID:Development and implementation of a medical oncology quality improvement tool for a regional community oncology network: the Fox Chase Cancer Center Partners initiative. 1797

Primary pulmonary tumors are less common in dogs than secondary (metastatic) tumors. Most primary tumors are malignant and of epithelial origin. Pulmonary large-cell carcinoma is considered extremely rare in domestic animals, and some of the few reported cases actually may have been cases of malignant pulmonary histiocytosis. An 8-year-old female Wire Fox Terrier with diffuse alveolar pattern radiographically was euthanatized when it failed to respond to antibiotic therapy. Histologically, pulmonary alveolar spaces contained clusters of large round anaplastic cells with ample eosinophilic cytoplasm and large irregularly shaped nuclei with prominent nucleoli. Immunohistochemistry was used to distinguish large-cell carcinoma from malignant pulmonary histiocytosis. Tumor cells had strong immunoreactivity for cytokeratin, consistent with epithelial origin. However, a substantial percentage of the neoplastic cells co-expressed vimentin and MHC-II. The type II alveolar epithelial cell was considered the cell of origin of the neoplasm based on the presence of lamellar bodies in some neoplastic cells and immunoreactivity for surfactant protein A and thyroid transcription factor-1.
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PMID:Immunohistochemical characterization of a pulmonary large-cell carcinoma in a dog. 1858 94


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