PubMed Health⌕ Search

Biomedical subjects

Jorge Gomez

Publications and source records attributed to Jorge Gomez.

12 recordsLinked to original sources
PubMed2006

Pharmacokinetics and toxicity of weekly docetaxel in older patients.

PURPOSE: To evaluate the pharmacokinetics of weekly docetaxel in a cohort of older patients with metastatic cancer and to explore the relationship of pharmacokinetic variables, Erythromycin Breath Test results, age, geriatric assessment variables, and toxicity to therapy. EXPERIMENTAL DESIGN: Twenty patients ages > or = 65 years with metastatic breast, prostate, or lung cancer entered an Institutional Review Board-approved protocol to evaluate the pharmacokinetics of weekly docetaxel administered at 35 mg/m2 i.v. for 3 weeks followed by a 1-week break. The Erythromycin Breath Test and geriatric assessment were done before the first dose. Blood samples were collected for pharmacokinetic analysis with the first dose of docetaxel. RESULTS: Of the 20 patients who entered the study, 19 were evaluable. There were no age-related differences in the pharmacokinetics of weekly docetaxel. Fifty-eight percent (11 of 19) experienced grade > or = 3 toxicity: 16% (3 of 19) grade > or = 3 hematologic toxicity, and 53% (10 of 19) grade > or = 3 nonhematologic toxicity. There was an association between the Erythromycin Breath Test results and docetaxel pharmacokinetic variables; however, there was no association between Erythromycin Breath Test results or docetaxel pharmacokinetics with frequency of grade > or = 3 toxicity. CONCLUSIONS: Despite no statistically significant age-related differences in weekly docetaxel pharmacokinetics, over half of these older patients experienced a grade > or = 3 toxicity at the 35 mg/m2 starting dose. We advocate a starting dose of 26 mg/m2 on this weekly schedule and dose escalating if no toxicity.

Aged↗
PubMed2006

Outcome of surgical clipping of unruptured aneurysms as it compares with a 10-year nonclipping survival period.

OBJECTIVE: Recent studies on the natural history of unruptured intracranial aneurysms dictate that we reevaluate the risks and benefits of surgical intervention as it compares with the natural course. We analyzed the outcome of surgical clipping of a patient cohort with unruptured aneurysms as it compares with a 10 year nonclipping survival period on the basis of two previously published studies (International Study on Unruptured Intracranial Aneurysms and a study by Juvela et al. [36] from Helsinki). METHODS: Data on 148 unruptured aneurysms in 116 consecutive surgically treated patients were prospectively recorded and retrospectively analyzed. The overall majority were diagnosed with cerebral angiography. Data analyzed included aneurysmal properties and clinical outcomes including surgical related mortalities and morbidities. The observed outcomes were compared with the expected outcome of a 10 year nonclipping survival period if the patient cohort was included in recently reported studies on unruptured aneurysms. More than 1 year follow-up was available in 93.1% (108) of patients and follow-up cerebral angiography was performed in 80% (93) of patients. RESULTS: Mean age was 53.57 years. There were 25 (16.8%) small aneurysms (less than 7 mm), 70 (47.2%) aneurysms 7 to 12 mm in size, 41 (27.70%) large (13-24 mm), and 12 (8.10%) giant (>25 mm) aneurysms. Posterior circulation aneurysm comprised 13.51%. One hundred forty-three (96.62%) aneurysms were successfully clipped, and 3.37% were either wrapped or later coiled. Surgical-related mortality was 0.82% (1 patient because of air embolism). Surgical related permanent morbidity was 3.44% (4 patients) and transient surgical-related mild morbidities was 7.7% (9 patients). Immediate postsurgical good outcome (Glasgow Outcome Score = 4-5) was 87.93% (102 patients) and 95.68% in 3 months (111 patients). At 1 year, the modified Rankin scale scores were 0 to I = 102, II = 3, III = 2, IV = 1, and V = 0. Residual aneurysms were seen in none of the postoperative angiograms (93 patients). Using the chi method, the comparison of the expected to the observed mortality and morbidity revealed a statistically significant difference in the mortality in favor of surgical clipping (P = 0.034 when compared with the International Study on Unruptured Intracranial Aneurysms and P = 0.05 when compared with the Juvela et al. [36] study). There was no statistically significant difference in the permanent morbidity. CONCLUSION: Studies on natural history of unruptured intracranial aneurysms suggest 10 year cumulative bleeding-related mortality and severe morbidity of no less than 7.5%. In our study, surgical clipping resulted in an 0.8% rate of mortality and 3.4% permanent morbidity. This suggests that surgical clipping has the potential of a superior outcome to the natural history of patients who have an estimated life expectancy of no less than 10 years.

Adult↗
PubMed2005

Randomized phase II study of weekly docetaxel plus trastuzumab versus weekly paclitaxel plus trastuzumab in patients with previously untreated advanced nonsmall cell lung carcinoma.

BACKGROUND: Trastuzumab is a monoclonal antibody directed against the human epidermal growth factor receptor-2 (HER-2). Nonsmall cell lung carcinoma (NSCLC) overexpresses HER-2 protein in approximately 20% of cases. In the current study, the authors combined trastuzumab with weekly taxanes in an attempt to improve outcomes over standard chemotherapy in patients with advanced NSCLC. METHODS: The primary objective was to determine whether docetaxel plus trastuzumab or paclitaxel plus trastuzumab was the superior regimen based on response and toxicity, and to determine whether either regimen was appropriate for further testing in a randomized Phase III trial. After stratification based on the results of HER-2 immunohistochemistry, chemotherapy-naive patients were randomized to receive trastuzumab plus docetaxel or trastuzumab plus paclitaxel. The study was designed so patients with or without HER-2 overexpression would be distributed equally between the study arms. RESULTS: Immunohistochemistry for HER-2 protein expression was attempted for 182 pathologic samples from 169 patients. Twenty-eight of the 179 evaluable samples (16%) revealed 2+ or 3+ staining. The objective response rate was 23% (7 of 30 patients) in the patients treated with docetaxel plus trastuzumab and 32% (11 of 34 patients) in the patients treated with paclitaxel plus trastuzumab (P=0.76, Wilcoxon test). No difference was noted in the median survival (16 mos vs. 14 mos) or 1-year survival (57% vs. 55%) (P=0.998). Toxicities were mild in both treatment arms. No difference with regard to response rates or survival was noted between HER-2-positive (2+ or 3+) and HER-2-negative (0-1+) patients. CONCLUSIONS: The expression of HER-2 protein in patients with advanced NSCLC in this study was found to be similar to that reported in previous series. The response rates and toxicities for patients treated with docetaxel and trasuzumab or paclitaxel and trasuzumab were not significantly different, though survival in both arms was better than expected. HER-2 expression status did not appear to affect outcomes for this uniform group of patients who were treated in a comparable fashion. Because of the infrequency of HER-2 overexpression, and the absence of improved outcomes in patients with NSCLC who were treated with trastuzumab plus chemotherapy in other studies, neither regimen tested will be advanced to a Phase III trial.

Antibodies, Monoclonal↗
PubMed2005

Developing a cancer-specific geriatric assessment: a feasibility study.

BACKGROUND: As the U.S. population ages, there is an emerging need to characterize the "functional age" of older patients with cancer to tailor treatment decisions and stratify outcomes based on factors other than chronologic age. The goals of the current study were to develop a brief, but comprehensive, primarily self-administered cancer-specific geriatric assessment measure and to determine its feasibility as measured by 1) the percentage of patients able to complete the measure on their own, 2) the length of time to complete, and 3) patient satisfaction with the measure. METHODS: The geriatric and oncology literature was reviewed to choose validated measures of geriatric assessment across the following domains: functional status, comorbidity, cognition, psychological status, social functioning and support, and nutritional status. Criteria applied to geriatric assessment measurements included reliability, validity, brevity, and ability to self-administer. The measure was administered to patients with breast carcinoma, lung carcinoma, colorectal carcinoma, or lymphoma who were fluent in English and receiving chemotherapy at Memorial Sloan-Kettering Cancer Center (New York, NY) or the University of Chicago (Chicago, IL). RESULTS: The instrument was completed by 43 patients (mean age, 74 yrs; range, 65-87 yrs). The majority had AJCC Stage IV disease (68%). The mean time to completion of the assessment was 27 minutes (range, 8-45 mins). Most patients were able to complete the self-administered portion of the assessment without assistance (78%) and were satisfied with the questionnaire length (90%). There was no association noted between age (P = 0.56) or educational level (P = 0.99) and the ability to complete the assessment without assistance. CONCLUSIONS: In this cohort, this brief but comprehensive geriatric assessment could be completed by the majority of patients without assistance. Prospective trials of its generalizability, reliability, and validity are justified.

Activities of Daily Living↗
PubMed2005

Imatinib mesylate lacks activity in small cell lung carcinoma expressing c-kit protein: a phase II clinical trial.

BACKGROUND: Imatinib inhibits the c-kit tyrosine kinase, which, accounts for its activity in gastrointestinal stromal tumors. The presence of c-kit protein expression in small cell lung carcinoma (SCLC) tumor specimens, as well as in vitro data supporting the role of c-kit in autocrine and paracrine growth stimulation specifically in SCLC, provided a rationale for studying imatinib in this disease. The authors conducted a Phase II single-institution study of imatinib in patients with recurrent SCLC whose tumor specimens expressed c-kit protein. METHODS: Patients with progressive SCLC after one or two previous chemotherapy regimens consented to have their tumor specimens screened by immunoperoxidase stain (CD117, Dako Corporation, Carpinteria, CA) for c-kit protein expression. If present, individuals were then eligible for treatment with an imatinib dose of 400 mg orally twice daily (total, 800 mg per day). RESULTS: The presence of c-kit protein was assessable in 36 of 39 (92%) tumor samples. Twenty-eight (78%) tumor samples had immunohistochemical staining for c-kit protein. Twelve patients were enrolled in the treatment portion of the current study. No responses were observed, and all patients had disease progression by Week 4. Edema, fatigue, nausea, and electrolyte abnormalities were the primary toxicities. CONCLUSIONS: Imatinib did not have antitumor activity against SCLC, even with c-kit protein present in tumor specimens. The dismal prognosis for these patients with progressive SCLC emphasized the urgent need for continued studies of new therapies in this population.

Antineoplastic Agents↗
PubMed2005

Use of performance-enhancing substances.

Performance-enhancing substances include dietary supplements, prescription medications, and illicit drugs. Virtually no data are available on the efficacy and safety in children and adolescents of widely used performance-enhancing substances. This statement is intended to provide a generalized but functional definition of performance-enhancing substances. The American Academy of Pediatrics strongly condemns the use of performance-enhancing substances and vigorously endorses efforts to eliminate their use among children and adolescents.

Adolescent↗
PubMed2004

Vaccination of patients with small-cell lung cancer with synthetic fucosyl GM-1 conjugated to keyhole limpet hemocyanin.

PURPOSE: Immunotherapy directed toward cell surface antigens may provide a novel approach to the eradication of chemoresistant micrometastatic disease in patients with small-cell lung cancer (SCLC). Studies in SCLC cell lines and human tissues suggest that the ganglioside fucosyl GM1 is an abundant yet specific target. A prior clinical study demonstrated the potent immunogenicity of fucosyl GM-1 derived from bovine thyroid gland, conjugated to keyhole limpet hemocyanin (KLH) and administered with QS-21 adjuvant. EXPERIMENTAL DESIGN: We tested the immunogenicity of three different doses of a synthetic version of fucosyl-GM1 in patients with SCLC after a major response to initial therapy. The primary end point was to establish the lowest effective dose capable of inducing antibody production. RESULTS: Five of six patients at the 30-microg dose and three of five patients at the 10-microg dose mounted IgM responses of 1:80 or greater. These antibodies were confirmed by flow cytometry in seven of eight cases. None of the patients at the 3-microg dose had titers above 1:80. One patient at the 30-microg dose had an IgG response with a titer of 1:80. The sera from six of the eight responders induced potent complement-mediated cytotoxicity of tumor cells. CONCLUSIONS: Vaccination with the synthetic fucosyl GM1-KLH conjugate induces an IgM antibody response against fucosyl GM1 and tumor cells expressing fucosyl GM1, comparable with the response induced by the bovine derivative. We plan to combine synthetic fucosyl GM1 vaccine at a dose of 30 microg with vaccines against three other antigens-GM2, Globo H, and polysialic acid-to test in patients with SCLC after initial chemotherapy.

Adult↗
PubMed2004

Bronchioloalveolar pathologic subtype and smoking history predict sensitivity to gefitinib in advanced non-small-cell lung cancer.

PURPOSE: Gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, induces radiographic regressions and symptomatic improvement in patients with non-small-cell lung cancer (NSCLC). Phase II trials suggested female sex and adenocarcinoma were associated with response. We undertook this analysis to identify additional clinical and pathologic features associated with sensitivity to gefitinib. PATIENTS AND METHODS: We reviewed medical records, pathologic material, and imaging studies of all 139 NSCLC patients treated on one of three consecutive studies of gefitinib monotherapy performed at our institution. We identified patients experiencing a major objective response and compared their clinical and pathologic features with the others. Univariate and multivariable analyses were performed on potential predictive features associated with sensitivity to gefitinib. RESULTS: Of 139 patients, 21 (15%; 95% CI, 9% to 21%), experienced a partial radiographic response. Variables identified as significant in univariate analysis included adenocarcinoma versus other NSCLC (19% v 0%; P=.004), adenocarcinoma with bronchioloalveolar features versus other adenocarcinomas (38% v 14%; P<.001), never smoker status versus former/current (36% v 8%; P<.001), and Karnofsky performance status > or =80% versus < or =70% (22% v 8%; P=.03). Multivariable analysis revealed the presence of adenocarcinoma with any bronchioloalveolar features (P=.004) and being a never smoker (P=.006) were independent predictors of response. CONCLUSION: Our data suggest that individuals in whom gefitinib is efficacious are more likely to have adenocarcinomas of the bronchioloalveolar subtype and to be never smokers. These observations may provide clues to mechanisms determining sensitivity to this agent and suggest that NSCLC has a different biology in patients who never smoked and those with bronchioloalveolar carcinoma.

Adult↗
PubMed2003

A 13-month multicenter clinical experience of a low-dose monophasic oral contraceptive containing 20 microg ethinylestradiol and 75 microg gestodene in Latin American women.

This prospective, multicenter study was conducted to evaluate the contraceptive reliability, cycle control and tolerability of a 21-day oral contraceptive regimen containing 20 microg ethinylestradiol and 75 microg gestodene in four Latin American countries (Mexico, Argentina, Brazil and Colombia). Participants took trial medication daily for 21 days. Contraceptive efficacy, cycle control and tolerability were evaluated over a period of 13 cycles. Efficacy data gathered from 5,109 treatment cycles were obtained from 393 participants. The trial medication proved to be an effective contraceptive and provided good cycle control. One pregnancy because of poor compliance was recorded. This resulted in a study Pearl index of 0.25. Forty-six percent of Latin American women reported one intracyclic spotting bleeding episode and 37.6% reported one intracyclic breakthrough bleeding (medium/excessive bleeding) episode during cycles 2-4 (primary target). Overall, intracyclic bleeding was reported in 41%. Overall, there was a trend towards a lower incidence of spotting in all the countries and this difference had statistical significance between Argentina and the others three countries (p < 0.05) during cycles 2-4. This trend was also apparent with respect to breakthrough bleeding, but again the difference did not achieve statistical significance. The discontinuation rate because of adverse events was low (3%); no serious adverse events were reported. More than 78% of the women in the four countries maintained constant body weight or lost weight (2 kg) during the study. The treatment effect on blood pressure was negligible. There were no appreciable changes in mean laboratory values over the course of the study.

Adolescent↗
PubMed2003

Targeting lethal minimal residual disease in small cell lung cancer.

In the last three decades, treatment for small cell lung cancer has improved with advances in chemotherapy and radiotherapy. Almost all patients respond initially to standard chemotherapy, and some patients with limited stage disease are cured with the combination of chemotherapy and thoracic irradiation. Nonetheless, the majority of patients will experience lethal relapse from chemotherapy-resistant micrometastatic disease, and this has resulted in poor long-term survival for most patients. Addressing the problem of relapse requires unique approaches to eliminating minimal residual disease. This review will focus on the detection of minimal residual disease as well as strategies with which to treat it, including matrix metalloproteinase inhibitors, tyrosine kinase inhibitors, and vaccine therapy.

Antineoplastic Agents↗
PubMedDate not supplied

Simultaneous biological removal of nitrogen, carbon and sulfur by denitrification.

Refinery wastewaters may contain aromatic compounds and high concentrations of sulfide and ammonium which must be removed before discharging into water bodies. In this work, biological denitrification was used to eliminate carbon, nitrogen and sulfur in an anaerobic continuous stirred tank reactor of 1.3 L and a hydraulic retention time of 2 d. Acetate and nitrate at a C/N ratio of 1.45 were fed at loading rates of 0.29 kg C/m3 d and 0.2 kg N/m3 d, respectively. Under steady-state denitrifying conditions, the carbon and nitrogen removal efficiencies were higher than 90%. Also, under these conditions, sulfide (S(2-)) was fed to the reactor at several sulfide loading rates (0.042-0.294 kg S(2-)/m3 d). The high nitrate removal efficiency of the denitrification process was maintained along the whole process, whereas the carbon removal was 65% even at sulfide loading rates of 0.294 kg S(2-)/m3 d. The sulfide removal increased up to approximately 99% via partial oxidation to insoluble elemental sulfur (S0) that accumulated inside the reactor. These results indicated that denitrification is a feasible process for the simultaneous removal of nitrogen, carbon and sulfur from effluents of the petroleum industry.

Acetates↗