bluuebunny/crossref_metadata_2025_split huggingface dataset:
Analysis of Reporting Return to Work in Studies Comparing Open with Endoscopic Carpal Tunnel Release: A Review of Randomized Controlled Trials
Authors: Ayeni Olubimpe , Thoma Achilleas , Haines Ted , Sprague Sheila 
Published: February 2017

Background In studies comparing open with endoscopic carpal tunnel release, return to work (RTW) is often cited as a primary outcome. Objective The present study assessed the reporting of RTW and evaluated its usefulness in studies comparing these two methods of carpal tunnel release. Methods A computerized search was conducted to find randomized controlled trials that compared open with endoscopic carpal tunnel release, with RTW as an outcome measure. The factors that were compared across the studies included definition of RTW, units quantifying RTW, measures of hand function, patients’ type of employment, worker's compensation or insurance status, patients’ handedness, unilateral or bilateral carpal tunnel release, and use of rehabilitation. Results Fifteen studies met the inclusion criteria for the present systematic review. of the 15 studies reviewed, there were seven definitions of RTW. All studies defined whether the patients underwent unilateral or bilateral carpal tunnel release but there was variability in the calculation of RTW when bilateral releases were performed. The impact of worker's compensation or insurance, type of work, handedness and rehabilitation were inconsistently addressed as factors affecting RTW. Conclusions Although RTW ideally reflects function and recovery, it is inadequately measured and reported. The present review revealed that, in studies comparing open carpal tunnel release with endoscopic carpal tunnel release, there is lack of uniformity in reporting RTW, which may contribute to the inconclusive results for RTW. Future research needs to ensure that RTW is used in a consistent manner.
Sterile Versus Nonsterile Clean Dressings
Authors: Alqahtani Moraya , Lalonde Donald H 
Published: February 2017

Background Many patients cannot afford sterile dressings. In St John, New Brunswick, clean dressings have been used instead of sterile dressings for years, with no apparent ill effects. No previous studies have compared the sterility and cost of clean versus sterile dressing materials. Objectives The goals of the present study were to answer the following questions: how much more sterile are sterile dressings than clean dressings; and how much does this extra sterility cost? Methods Sterility and cost of sterile gauze, panty liners, sanitary napkins, diapers and Coban tape (3M, USA) were compared. Samples, 2 cm × 2 cm in size, were cut out of each material under aseptic conditions, and delivered to the microbiology laboratory in sterile urine containers. The samples were then cultured and organisms were identified using conventional means. Results The cost for one month, using one 20 cm × 5 cm wound dressing daily, was calculated and compared with panty liners ($2.43), sanitary napkins ($5.55), diapers ($9.39) and Coban tape ($0.66), which were much cheaper than sterile dressings ($16.50). How sterile were the dressings? None of the 20 sanitary napkins grew bacteria, one of the 20 panty liners grew bacteria (coagulase-negative Staphylococcus), two of 20 sterile dressings grew bacteria (one coagulase-negative Staphylococcus and one nonhemolytic Streptococcus), 15 of 20 diapers grew bacteria (all bacillus) and two of five Coban rolls grew bacteria (one bacillus and one coagulase-negative Staphylococcus). Conclusion The panty liners, sanitary napkins and Coban tape studied were cheaper than, and had a comparible sterility with, the sterile gauze examined.
Short-term vasculoprotective effects of imatinib mesylate on intimal hyperplasia of arterial anastomosis: An experimental study using a rabbit model
Authors: Sevim Kamuran Zeynep , Silistreli Ozlem , Gorgu Metin , Sevim Osman , Ergur Bekir 
Published: February 2017

Background Since the beginning of the ‘microvascular era’, the success rates of microvascular procedures have increased to more than 90% in most series. The main reason for failure, however, is the healing of microarterial anastomosis, which is dependent on the status of endothelial cells and affects the rate of arterial thrombosis. In 80% of arterial thrombosis cases, complications are primarily observed during the first 72 h after surgery. Healing of arterial anastomosis results in intimal hyperplasia in which myofibroblasts comprise the predominant cell type. Intimal hyperplasia has been described previously as an adaptive process that occurs in response to hemodynamic stress or injuries to the vascular bed. During wound healing, fibroblasts proliferate, migrate and differentiate into myofibroblasts – a process that takes one to three days. Imatinib mesylate (ST1571-Gleevec, Novartis, Germany) is a specific platelet-derived growth factor receptor blocker that has found use as an adjunct to sirolimus in cardiovascular surgery for restenosis. However, its potential utility in preventing arterial thrombosis in microvascular surgery has not been evaluated in routine plastic surgery practice. Methods Twenty-four randomly selected, male, white New Zealand rabbits were divided into six groups (A to F), and the femoral artery model was used for arterial anastomosis. Following anastomosis, groups A, B and C received phosphate-buffered saline orogastrically. In groups D, E and F, imatinib mesylate was administered via an orogastric tube twice per day at a dose of 10 mg/kg starting two days before arterial anastomosis. Following anastomosis, imatinib mesylate was administered for one, three and seven days, and the regression of intimal hyperplasia was recorded. Results In groups administered imatinib mesylate (ie, groups D, E and F), intimal hyperplasia decreased by up to 50%, which represented a statistically significant difference. Histological analysis confirmed smooth muscle cell migration from the tunica intima to media on days 3 and 7 in groups E and F. Conclusion The present study revealed that imatinib mesylate, which was initiated as a prophylactic, systemic pretreatment and continued for seven days, gradually decreased intimal hyperplasia at the anastomosis site.
Pathologic Stages IA and IIA Hodgkin's Disease
Authors: Hellman Samuel 
Published: February 2017

In the editorial by Samuel Hellman "Pathologic Stages IA and IIA Hodgkin's Disease: Results of Treatment With Radiotherapy Alone, 1968–1980" (Journal of Clinical Oncology 3:749–750, 1985), an error was made that altered the meaning of a sentence. The correct sentence appears below. As long as such change is the case, there is justification for exposing the patient to the morbidity and, on rare occasions, the mortality of this procedure.
Second Neoplasms in Patients With Hodgkin's Disease Following Combined Modality Therapy—The Yale Experience
Authors: Koletsky Alan J. , Bertino Joseph R. , Farber Leonard R. , Prosnitz Leonard R. , Kapp Daniel S. , Fischer Diana , Portlock Carol S. 
Published: February 2017

In the article by Koletsky et al "Second Neoplasms in Patients With Hodgkin's Disease Following Combined Modality Therapy—The Yale Experience" (Journal of Clinical Oncology 4:311–317, 1986), an error was made in the footnote on page 311 which described the composition of MVVPP. The corrected footnote appears below. *MVVPP = nitrogen mustard (0.4 mg/kg on day 1 of cycle); vinblastine (6 mg/m2 on days 22, 29, and 36); vincristine (1.4 mg/m2, 2 mg maximum dose, on days 1, 8, and 15); procarbazine (100 mg/d on days 22 through 42); prednisone (40 mg/m2 on days 1 through 15 for cycles 1, 3, and 5 only).
Levamisole Toxicity
Authors: DeLorenzo Leonard , Stewart James A. 
Published: February 2017

To the Editor: Levamisole use will no doubt increase following the recent report by Laurie et al and the National Cancer Institute (NCI) Clinical Alert both related to the use of levamisole/fluorouracil (5-FU) as adjuvant treatment for colon cancer. Toxicity of levamisole is generally described as mild with nausea, diarrhea, and leukopenia being the most significant adverse effects with fatigue, dermatitis, and stomatitis also seen. Depsite the generally mild nature of the toxicity, occasional patients experience enough side effects to cause discontinuation of therapy. We report a patient with an unusual levamisole toxicity that resulted in discontinuation of the drug. A 47-year-old woman with node-positive colon cancer agreed to randomization in a clinical trial (EST 2284, Intergroup-0035) evaluating levamisole versus levamisole with 5-FU. She received levamisole 50 mg orally three times a day every 2 weeks and 5-FU 450 mg/m2 weekly. In the fifth month of treatment, she experienced the onset of bilateral arm pain occurring late in the first day of levamisole and resolving by 24 hours after the last dose. These symptoms also occurred with the next course of levamisole. Clinical examination showed upper arm pain with aching and stiffness in the wrists and fingers. Forearm muscles were tender, but there was no joint inflammation. There was no fever, rash, mucositis, leukopenia, or eosinophilia. The erythrocyte sedimentation rate was 8 mm/hr, creatine kinase 31 U/L, and antinuclear antibodies less than 1:20. The next course of levamisole resulted in similar but more severe pain with significant disruption of the patient's work as a florist. 5-FU alone was continued with no recurrence of these symptoms. Three years later the patient is well without pain or evidence for recurrent tumor. This symptom complex is clearly related to the levamisole treatment and might be considered a variant of the "flu-like" symptoms reported in other levamisole trials. We suggest that clinicians using levamisole in randomized trials or without the NCI Group C mechanism be aware of the wide spectrum of toxicities that may be seen with this interesting drug for the purpose of pretreatment discussion with patients and for the monitoring of therapy. The last sentence of the letter-to-the-editor entitled "Levamisole Toxicity" by Drs Leonard DeLorenza and James A. Stewart, published in the February 1990 issue (J Clin Oncol 8:365, 1990) contained an error. The sentence should have read: "We suggest that clinicians using levamisole in randomized trials or within the NCI Group C mechanism be aware of the wide spectrum of toxicities that may be seen with this interesting drug for the purpose of pretreatment discussion with patients and for the monitoring of therapy."
Intravenous administration of recombinant human macrophage colony-stimulating factor to patients with metastatic cancer: a phase I study.
Authors: Sanda M G , Yang J C , Topalian S L , Groves E S , Childs A , Belfort R , de Smet M D , Schwartzentruber D J , White D E , Lotze M T 
Published: February 2017

PURPOSE Recombinant human macrophage colony-stimulating factor (M-CSF) has been shown to stimulate specifically macrophage lineage differentiation in vitro and to induce cells capable of antitumor activity alone or in combination with an antibody. The administration of M-CSF to mice has demonstrated antitumor therapeutic effects in vivo. Therefore, a phase I trial of M-CSF administration to patients with metastatic cancer was undertaken. PATIENTS AND METHODS M-CSF was given by intermittent intravenous bolus infusion every 8 hours for 7 days; the treatment cycle was repeated once after a week of rest. Cohorts of three patients underwent dose escalation from 10 to 100,000 micrograms/m2/d; 23 patients received 27 courses of M-CSF administration. All patients had metastatic solid tumors refractory to conventional therapy, including renal cell carcinoma (RCC) (nine), melanoma (seven), and colorectal carcinoma (seven). RESULTS Treatment-related toxicity was minimal; five patients developed transient signs of ocular or periorbital inflammation, with iridocyclitis as the most severe manifestation. At the highest doses, platelet counts decreased with therapy (but remained > 100,000/mm3) and the absolute monocyte count increased during the course of therapy. Only at 30,000 and 100,000 micrograms/m2/d was treatment limited because of toxicity (iritis and malaise). Pharmacokinetic studies demonstrated up to a 1,000-fold increase in circulating serum M-CSF after bolus infusion; half-life varied from 1 to 6 hours. Complete regression of mediastinal adenopathy and multiple pulmonary metastases were observed in one patient with RCC. CONCLUSION Recombinant M-CSF can be administered safely to patients with metastatic cancer at doses that demonstrate biologic activity.
Autologous versus allogeneic bone marrow transplantation for non-Hodgkin's lymphoma: a case-controlled analysis of the European Bone Marrow Transplant Group Registry data.
Authors: Chopra R , Goldstone A H , Pearce R , Philip T , Petersen F , Appelbaum F , De Vol E , Ernst P 
Published: February 2017

PURPOSE A case-controlled study of patients who reported to the European Bone Marrow Transplant Group (EBMTG) was performed to investigate the relative roles and efficacy of allogeneic (alloBMT) and autologous bone marrow transplantation (ABMT) in non-Hodgkin's lymphoma. PATIENTS AND METHODS Of 1,060 patients who reported to the lymphoma registry, 938 patients underwent ABMT and 122 patients underwent alloBMT. A case-controlled study was performed by matching 101 alloBMT patients with 101 ABMT patients. The case matching was performed after the selection of the main prognostic factors for progression-free survival by a multivariate analysis. RESULTS The progression-free survival was similar in both types of transplants (49% alloBMT v 46% ABMT). The overall relapse and progression rate for the alloBMT patients was 23% compared with 38% in the ABMT patients. This difference was not significant statistically. In the lymphoblastic lymphoma subgroup, alloBMT was associated with a lower relapse rate than ABMT (24% alloBMT v 48% ABMT; P = .035). The progression-free survival, however, was not significantly different because patients with lymphoblastic lymphoma who underwent alloBMT had a higher procedure-related mortality (24% alloBMT v 10% ABMT; P = .06). A significantly lower relapse/progression rate was also observed in patients with chronic graft-versus-host disease (cGVHD) compared with those patients without (0% cGVHD v 35% no cGVHD; P = .02). Fourteen of 18 patients who had cGVHD also had lymphoblastic lymphoma. CONCLUSION This study suggests that ABMT and alloBMT for non-Hodgkin's lymphoma are comparable, with the exception of lymphoblastic lymphoma in which a graft-versus-lymphoma effect may account for the lower relapse rate for patients who underwent alloBMT.
High-dose consolidation therapy with autologous stem-cell rescue in stage IV breast cancer: follow-up report.
Authors: Williams S F , Gilewski T , Mick R , Bitran J D 
Published: February 2017

PURPOSE Fifty-nine patients with newly diagnosed metastatic breast cancer were treated with induction chemotherapy followed by high-dose intensification and autologous stem-cell rescue (ASCR) to determine therapeutic efficacy. PATIENTS AND METHODS Induction consisted of cyclophosphamide, doxorubicin, vincristine, and methotrexate with leucovorin rescue (LOMAC) in 27 patients, or fluorouracil, cisplatin, doxorubicin, and cyclophosphamide (FCAP) in 32 patients. Intensification after LOMAC was cyclophosphamide and thiotepa (CyTepa) with ASCR, and after FCAP it was cyclophosphamide, thiotepa, and carmustine (BCNU) in all but eight patients who received CyTepa. RESULTS Median survival from study entry for the entire group was 13.3 months. Median time to progression from reinfusion for the 45 patients who underwent intensification was 7.5 months. After LOMAC and intensification, there were 12 complete responses (CR) (nine partial responses [PRs] after induction converted to CRs). Responses after FCAP and intensification were eight CRs (two PRs after induction converted to CRs). Median time to treatment failure from reinfusion was 5.4 months for LOMAC and intensification, and was 10.5 months for FCAP and intensification. Median survival from study entry was 15.1 months for all 27 LOMAC patients and 9.3 months for all 32 FCAP patients. Median time to treatment failure from reinfusion for 11 patients who were CRs at intensification has not been reached and is more than 13 months compared with a median of 5.5 months for the 23 patients in partial remission at intensification. CONCLUSIONS High-dose intensification therapy has led to increased CR rates in metastatic breast cancer. The role of such therapy in the treatment of stage IV breast cancer requires further refinement.
Patterns of Treatment Failure and Prognostic Factors Associated With the Treatment of Esophageal Carcinoma With Chemotherapy and Radiotherapy Either as Sole Treatment or Followed by Surgery
Authors: Gill Peter G. , Denham Jim W. , Jamieson Glyn G. , Devitt Peter G. , Yeoh Eric , Olweny Charles 
Published: February 2017

The dosage of fluorouracil printed in the abstract of the report by Gill et al, "Patterns and Treatment Failure and Prognostic Factors Associated With the Treatment of Esophageal Carcinoma With Chemotherapy and Radiotherapy Either as Sole Treatment or Followed by Surgery" (J Clin Oncol 10:1037–1043, 1992), should have been 800 mg/m2 as stated elsewhere in the report. The unit of measure for interleukin-2 and Interferon alfa-2a in the report by Ilson et al, "A Phase II Trial of Interleukin-2 and Interferon Alfa-2a in Patients With Advanced Renal Cell Carcinoma" (J Clin Oncol 10:1124–1130, 1992), should have been "U/m2d," not "µ/m2/d."
Gemcitabine in leukemia: a phase I clinical, plasma, and cellular pharmacology study.
Authors: Grunewald R , Kantarjian H , Du M , Faucher K , Tarassoff P , Plunkett W 
Published: February 2017

PURPOSE Phase I clinical and in vitro studies of gemcitabine (2',2'-difluorodeoxycytidine; dFdC) have demonstrated that the accumulation rate of dFdC 5'-triphosphate (dFdCTP) in mononuclear and leukemia cells is saturated when plasma or extracellular dFdC levels exceed 15 to 20 mumol/L. Thus, we designed a phase I study to maximize the accumulation of dFdCTP by leukemia cells by administering dFdC at 10 mg/m2/min, a dose rate calculated to produce steady-state plasma dFdC levels that exceed 15 to 20 mumol/L. PATIENTS AND METHODS The treatment intensity was increased in patients (n = 22) with relapsed or refractory acute leukemia or chronic myelogenous leukemia (CML) in blast crisis by prolonging the infusion duration but maintaining the same rate. Doses of dFdC between 1,200 mg/m2 and 6,400 mg/m2 were administered weekly for 3 weeks. RESULTS The maximum-tolerated dose was 4,800 mg/m2 infused over 480 minutes. The mean steady-state dFdC level in plasma of all infusions was 26.5 +/- 9 mumol/L (n = 19). The accumulation rates of dFdCTP in circulating leukemia cells varied greatly among patients but remained linear in eight patients infused for 120 to 240 minutes, and up to or beyond 360 minutes in five of eight additional patients. Elimination of dFdCTP was significantly related to its cellular concentration: blasts with greater than 450 mumol/L dFdCTP exhibited biphasic elimination, whereas blasts with lower dFdCTP concentrations exhibited linear kinetics. Biphasic elimination was associated with higher dFdCTP areas under the concentration-times-time curve (AUCs) and greater inhibition of DNA synthesis. CONCLUSION Studies of the cellular pharmacology and pharmacodynamics of dFdC may be useful in optimizing protocol designs for leukemia.
High-dose carboplatin and etoposide with autologous bone marrow transplantation in refractory germ cell cancer: an Eastern Cooperative Oncology Group protocol.
Authors: Nichols C R , Andersen J , Lazarus H M , Fisher H , Greer J , Stadtmauer E A , Loehrer P J , Trump D L 
Published: February 2017

PURPOSE A phase II trial was undertaken to assess the feasibility, toxicity, and efficacy of high-dose carboplatin and etoposide with autologous bone marrow transplantation in patients with relapsed or refractory germ cell tumors. PATIENTS AND METHODS Forty patients with recurrent germ cell cancer received carboplatin 500 mg/m2 and etoposide 400 mg/m2 given at 7, 5, and 3 days before marrow infusion. Autologous marrow infusion (day 0) was accomplished using one half of the bone marrow harvested before chemotherapy. Patients who achieved a complete or partial response with the first cycle of treatment received a second identical cycle of chemotherapy followed by infusion of the remaining cryopreserved bone marrow. RESULTS Objective responses were obtained in 17 of the 38 patients (45%) assessable for response, including eight partial and nine complete remissions. Five of these patients remain in continuous complete remission with minimal follow-up of 1 year. Toxicity encountered was primarily hematologic, and five patients (13%) died of treatment-related complications. Significant toxicities often seen with high-dose cisplatin (ototoxicity, neurotoxicity, and renal toxicity) were manageable in this regimen of high-dose carboplatin. CONCLUSIONS This trial confirms the curative potential of high-dose carboplatin and etoposide in highly refractory germ cell cancer.
Elevated circulating levels of tumor necrosis factor predict unresponsiveness to treatment with interferon alfa-2b in chronic myelogenous leukemia.
Authors: Herrmann F , Helfrich S G , Lindemann A , Schleiermacher E , Huber C , Mertelsmann R 
Published: February 2017

PURPOSE The study was undertaken to analyze circulating tumor necrosis factor (TNF) levels in patients with chronic-phase chronic myelogenous leukemia (CML) undergoing interferon (IFN) alfa-2b therapy, and to correlate pretreatment serum levels of TNF with response to IFN alfa-2b therapy. PATIENTS AND METHODS Fourteen patients with CML in chronic phase were treated with recombinant human IFN alfa-2b for 7 to 39 months. RESULTS In eight patients IFN alfa-2b treatment failed due to lack of hematologic response. A complete or partial hematologic remission was achieved in the remaining six patients, of whom two patients experienced a complete cytogenetic response. Retrospective analysis of serum samples obtained from all patients before the onset of IFN alfa-2b administration revealed that levels (mean +/- SEM) of circulating TNF were higher (P less than .001) in the group of patients who did not respond to IFN alfa-2b treatment (157 +/- 15 U/mL) than in the responders (10.3 +/- 4 U/mL) or healthy control subjects (9.1 +/- 3 U/mL). However, there was no correlation between TNF serum levels and other patient characteristics at study enrollment including age, sex, duration of disease, performance status, splenomegaly, WBC count, platelet count, hemoglobin value, prior therapy, and prognostic category. CONCLUSION These findings indicate that circulating levels of TNF are increased in a subset of patients with chronic-phase CML and that this elevation is associated with poor response to IFN alfa-2b therapy.