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2.
J Gastrointest Cancer ; 48(1): 58-65, 2017 Mar.
Article in English | MEDLINE | ID: mdl-28025817

ABSTRACT

BACKGROUND: ASGE and ESGE guidelines recommend endoscopic metal stent placement for pancreatic carcinoma patients with biliary obstruction, and whose estimated life expectancy is greater than 6 months. Because median overall survival (OS) of metastatic pancreatic adenocarcinoma until recently has been less than 6 months, plastic biliary stents were preferentially placed rather than metal due to the greater upfront cost of the latter. Recent advances in the treatment of metastatic pancreatic cancer have extended median OS beyond the 6-month range. Given this improvement in OS, we performed a cost-effectiveness analysis of initial metal biliary versus plastic stent placement in metastatic pancreatic cancer patients with biliary obstruction. METHODS: A Markov model was developed to predict lifetime costs, quality-adjusted life years (QALYs), and cost effectiveness of metal compared with plastic stents. Adult patients entered the model with locally advanced cancer and underwent endoscopic retrograde cholangiopancreatography (ERCP) with placement of metal or plastic stents. A targeted literature search was conducted to identify published sources, which were used to estimate clinical, cost, utility, and event rate inputs to the model. Results were estimated from the third-party payer perspective in 2012 US dollars per QALY. One-way and probabilistic sensitivity analyses were conducted to assess the impact on model outcomes resulting from uncertainty among inputs. RESULTS: Our analysis found that initial placement of metal stents was more cost effective than plastic biliary stents with lower overall costs due to lower restenting rates while at the same time associated with a better quality of life. Based on model projections, placement of metal stents could save approximately $1450 per patient over a lifetime, while simultaneously improving quality of life. These findings were robust in sensitivity analyses. CONCLUSIONS: Placement of metal biliary stents at initial onset of obstructive jaundice in adult patients with metastatic pancreatic carcinoma with an expected OS greater than 6 months was found to be a more cost-effective strategy than plastic stents. These results reinforce guidelines' suggestions for metal stent placement.


Subject(s)
Jaundice, Obstructive/surgery , Pancreatic Neoplasms/surgery , Stents/economics , Cholangiopancreatography, Endoscopic Retrograde/economics , Cholangiopancreatography, Endoscopic Retrograde/methods , Cost-Benefit Analysis , Humans , Jaundice, Obstructive/economics , Jaundice, Obstructive/physiopathology , Markov Chains , Pancreatic Neoplasms/physiopathology
3.
Ann Oncol ; 25(5): 1039-44, 2014 May.
Article in English | MEDLINE | ID: mdl-24562448

ABSTRACT

BACKGROUND: Preoperative chemoradiotherapy (CRT) improves outcomes in patients with locally advanced but resectable adenocarcinoma of the esophagus. ACOSOG Z4051 evaluated CRT with docetaxel, cisplatin, and panitumumab (DCP) in this patient group with a primary end point of a pathologic complete response (pCR) ≥35%. PATIENTS AND METHODS: From 15 January 2009 to 22 July 2011, 70 patients with locally advanced but resectable distal esophageal adenocarcinoma were enrolled. Patients received docetaxel (40 mg/m(2)), cisplatin (40 mg/m(2)), and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with RT (5040 cGy, 180 cGy/day × 28 days) beginning week 5. Resection was planned after completing CRT. PCR was defined as no viable residual tumor cells. Secondary objectives included near-pCR (≤10% viable cancer cells), toxicity, and overall and disease-free survival. Adverse events were graded using the CTCAE Version 3.0. RESULTS: Five of 70 patients were ineligible. Of 65 eligible patients (59 M; median age 61), 11 did not undergo surgery, leaving 54 assessable. PCR rate was 33.3% and near-pCR was 20.4%. Secenty-three percent of patients completed DCP (n = 70) and 92% completed RT. 48.5% had toxicity ≥grade 4. Lymphopenia (43%) was most common. Operative mortality was 3.7%. Adult respiratory distress syndrome was encountered in two patients (3.7%). At median follow-up of 26.3 months, median overall survival was 19.4 months and 3-year overall survival was 38.6% (95% confidence interval 24.5% to 60.8%). CONCLUSIONS: Neoadjuvant CRT with DCP is active (pCR + near-pCR = 53.7%) but toxicity is significant. Further evaluation of this regimen in an unselected population is not recommended. CLINICALTRIALSGOV IDENTIFIER: NCT00757172.


Subject(s)
Adenocarcinoma/therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Esophageal Neoplasms/therapy , Esophagogastric Junction/pathology , Adenocarcinoma/mortality , Adult , Aged , Antibodies, Monoclonal/administration & dosage , Chemoradiotherapy, Adjuvant , Cisplatin/administration & dosage , Disease-Free Survival , Docetaxel , Esophageal Neoplasms/mortality , Esophagogastric Junction/surgery , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Neoadjuvant Therapy , Panitumumab , Taxoids/administration & dosage , Treatment Outcome
4.
Breast Cancer Res Treat ; 132(1): 215-23, 2012 Feb.
Article in English | MEDLINE | ID: mdl-22138748

ABSTRACT

NOV-002 (a formulation of disodium glutathione disulfide) modulates signaling pathways involved in tumor cell proliferation and metastasis and enhances anti-tumor immune responsiveness in tumor models. The addition of NOV-002 to chemotherapy has been shown to increase anti-tumor efficacy in animal models and some early phase oncology trials. We evaluated the clinical effects of NOV-002 in primary breast cancer, whether adding NOV-002 to standard preoperative chemotherapy increased pathologic complete response rates (pCR) at surgery, and determined whether NOV-002 mitigated hematologic toxicities of chemotherapy and whether levels of myeloid derived suppressor cells (MDSC) were predictive of response. Forty-one women with newly diagnosed stages II-IIIc HER-2 negative breast cancer received doxorubicin-cyclophosphamide followed by docetaxel (AC â†’ T) every 3 weeks and concurrent daily NOV-002 injections. The trial was powered to detect a doubling of pCR rate from 16 to 32% with NOV-002 plus AC â†’ T (α = 0.05, ß = 80%). Weekly complete blood counts were obtained as well as circulating MDSC levels on day 1 of each cycle were quantified. Of 39 patients with 40 evaluable tumors, 15 achieved a pCR (38%), meeting the primary endpoint of the trial. Concurrent NOV-002 resulted in pCR rates for AC â†’ T chemotherapy higher than previously reported. Patients with lower levels of circulating MDSCs at baseline and on the last cycle of chemotherapy had significantly higher probability of a pCR (P = 0.02). Further evaluation of NOV-002 in a randomized study is warranted.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Receptor, ErbB-2/metabolism , Adolescent , Adult , Aged , Antineoplastic Agents/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/pharmacology , Breast Neoplasms/metabolism , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Cisplatin/administration & dosage , Combined Modality Therapy , Cyclophosphamide/administration & dosage , Disease-Free Survival , Docetaxel , Doxorubicin/administration & dosage , Drug Combinations , Female , Glutathione Disulfide/administration & dosage , Humans , Immunity, Cellular/drug effects , Kaplan-Meier Estimate , Mastectomy , Middle Aged , Neoadjuvant Therapy , Neoplasm Invasiveness , Neoplasm Staging , Taxoids/administration & dosage , Treatment Outcome , Young Adult
5.
Ann Oncol ; 20(10): 1682-7, 2009 Oct.
Article in English | MEDLINE | ID: mdl-19541791

ABSTRACT

BACKGROUND: To correlate serum cytokine and angiogenic factor (CAF) levels with overall survival (OS) in metastatic renal cell carcinoma (mRCC) treated with interferon-alpha (IFN-alpha). PATIENTS AND METHODS: Serum CAF levels were measured in 103 patients treated on a randomized trial with IFN-alpha 0.5 million units (MU) twice daily or 5 MU daily. Concentrations of 17 analytes were determined by multiplex bead immunoassays [vascular endothelial growth factor A (VEGF(A)) and several cytokines] or enzyme-linked immunosorbent assay (basic fibroblast growth factor). We used proportional hazards models to evaluate the effect of CAF levels and clinical factors on OS. RESULTS: Pretreatment serum interleukin (IL) 5, IL-12 p40, VEGF(A), and IL-6 levels and Memorial Sloan-Kettering Cancer Center risk grouping independently correlated with OS, with hazard ratios of 2.33, 2.00, 2.07, 1.82, and 0.39, respectively (concordance index = 0.69 for the combined model versus 0.60 for the CAF model versus 0.52 for the clinical model). Based on an index derived from these five risk factors (RFs), patients with 0-2 RF had a median OS time of 32 months versus 9 months for patients with 3-5 RF (P < 0.0001). CONCLUSIONS: Serum CAF profiling contributes to prognostic evaluation in mRCC and helps to identify a subset of patients with 20% 5-year OS.


Subject(s)
Angiogenesis Inducing Agents/therapeutic use , Carcinoma, Renal Cell/drug therapy , Carcinoma, Renal Cell/secondary , Cytokines/therapeutic use , Interferon-alpha/therapeutic use , Angiogenesis Inducing Agents/blood , Carcinoma, Renal Cell/pathology , Chi-Square Distribution , Cytokines/blood , Dose-Response Relationship, Drug , Enzyme-Linked Immunosorbent Assay , Female , Fibroblast Growth Factor 2/blood , Follow-Up Studies , Humans , Immunoassay , Interleukin-12 Subunit p40/blood , Interleukin-12 Subunit p40/therapeutic use , Interleukin-5/blood , Interleukin-5/therapeutic use , Interleukin-6/blood , Interleukin-6/therapeutic use , Kaplan-Meier Estimate , Male , Proportional Hazards Models , Randomized Controlled Trials as Topic , Risk Factors , Survival Analysis , Time Factors , Treatment Outcome , Vascular Endothelial Growth Factor A/blood , Vascular Endothelial Growth Factor A/therapeutic use
6.
Int J Gynecol Cancer ; 13(3): 381-8, 2003.
Article in English | MEDLINE | ID: mdl-12801274

ABSTRACT

Langerhans cell histiocytosis (LCH) is a rare malignant disease involving the accumulation of a monoclonal proliferation of cells in various organs, that phenotypically resemble Langerhans cells (LC). LCH is not merely a hyperplasia of LC, as it typically affects organs that are outside of their normal physiologic distribution. Normal Langerhans cells are bone marrow-derived dendritic cells that populate the epidermis and are distinguished by the presence of Birbeck granules and cell surface protein CD1a. LC act as sentinels; they recognize, internalize, and process antigens encountered in the skin. Upon encountering an antigen, LC become activated with subsequent maturation and induction of their migratory capacity. Langerhans cells in patients with LCH are aberrant and profoundly differ from normal LC. The clinical spectrum of LCH is quite diverse; multiple organs can be affected. "Pure" genital Langerhans cell histiocytosis is a rare presentation, with only 12 previously reported cases. Due to the rarity of this disease, treatment of genital LCH is still very diverse. No modality is proven to be superior in improving patient outcome, and relapses frequently occur after surgery. Dramatic responses of cutaneous and ano-genital lesions to thalidomide and interferons have been reported. We advocate the use of immuno-modulating agents in LCH of the female genital tract first, rather than surgery.


Subject(s)
Genital Diseases, Female/physiopathology , Genital Diseases, Female/therapy , Histiocytosis, Langerhans-Cell/physiopathology , Histiocytosis, Langerhans-Cell/therapy , Langerhans Cells/immunology , Adjuvants, Immunologic/therapeutic use , Combined Modality Therapy , Female , Genital Diseases, Female/diagnosis , Genital Diseases, Female/immunology , Gynecologic Surgical Procedures/methods , Histiocytosis, Langerhans-Cell/diagnosis , Histiocytosis, Langerhans-Cell/immunology , Humans
7.
Arch Fam Med ; 6(3): 273-8, 1997.
Article in English | MEDLINE | ID: mdl-9161355

ABSTRACT

As groups of physicians continue to provide more of their activities in sites remote from the central office, communication among providers and staff and the provision of common educational activities are important priorities. An analysis of a 12-month period of the use of full-motion interactive video technology to accomplish these goals in a decentralized academic department shows this method to be acceptable and cost-effective. Careful attention to room environment and staff support were found to be important. Practical recommendations are provided for those considering the use of this technology.


Subject(s)
Academic Medical Centers/organization & administration , Family Practice/organization & administration , Remote Consultation , Academic Medical Centers/economics , Cost-Benefit Analysis , Faculty, Medical , Family Practice/economics , Humans , Remote Consultation/economics , Remote Consultation/instrumentation , Video Recording
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