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Biomedical subjects

E Guardiola

Publications and source records attributed to E Guardiola.

At least 19 recordsLinked to original sources

Concomitant twice-a-day radiotherapy and chemotherapy in unresectable head and neck cancer patients: A long-term quality of life analysis.

BACKGROUND: The purpose of this study is to make a comparative analysis between acute toxicity with late toxicity. This study is based upon a French quality of life (QoL) questionnaire in a cohort of advanced head and neck (H&N) cancer patients treated by concomitant twice-a-day continuous radiotherapy with no acceleration and chemotherapy with cisplatin and 5-fluorouracil. METHODS: From September 1992 to November 1997, a prospective data bank of 91 patients was constituted. In November 1999, 31 patients were still alive and followed for more than 3 years. All patients had stage IV strictly unresectable squamous cell carcinoma of oropharynx or hypopharynx. A French specific H&N cancer QoL questionnaire was used at the end of radiotherapy and at the last date of follow-up of each patient (during 1999). p values reflect comparison of percentages obtained at the end of treatment with percentages at long-term follow-up. Statistical analysis was performed using chi(2) test (p <.05 considered as significant). Percentages obtained by the QoL questionnaire correspond to moderate-severe problems only. RESULTS: Twenty-nine of 31 (94%) patients participated in the QoL study. Acute treatment toxicities were severe with declines in virtually all QoL and functional domains. Globally, with an average long-term follow-up of 4.5 years (range 3-7 years after treatment), there is a statistical improvement in the following symptoms: dry mouth and sticky saliva (97% versus 55%, p <.05); tasting problems (35% versus 21%, not significant); swallowing problems (77% versus 36%, p <.05); and H&N pain (86% versus 9%, p <.05). Financial problems were not improved (21% versus 14%, not significant), and psychological problems (59% versus 5%) were statistically significant. Fourteen of 29 (48%) patients were drinking and 8 of 29 (28%) were smoking at long-term follow-up; at the diagnosis they were 86% and 90%, respectively. At long-term follow-up 22 of 29 presented good or very good QoL, and 25 of 29 said they had improved their initial QoL. CONCLUSION: The interest of twice-a-day radiotherapy with concomitant chemotherapy is to increase total radiotherapy equivalent dose without increasing late toxicity and also to improve locoregional control, survival, and long-term QoL/effectiveness ratio. Best supportive care is recommended to obtain both good QoL and cancer control in a long-term follow-up.

Adult↗

The relationship of epidermal growth factor receptor levels to the prognosis of unresectable pharyngeal cancer patients treated by chemo-radiotherapy.

The aim of this study was to analyse prognostic factors for time to treatment failure (TTF) and overall survival (OS) in patients with unresectable cancer of the pharynx. A twice daily (b.i.d.) radiotherapy with concomitant cisplatin-5-fluorouracil chemotherapy was administered to 77 consecutive patients (68 males, 9 females; median age: 56 years). The studied factors were: age, gender, tumour differentiation, tumour volume, initial hemoglobin level, karnofsky index (KI), primary tumour location, T, N, epidermal growth factor receptor (EGFR) level in the tumour (fmol/mg protein). KI and EGFR level were significant predictors in a multivariate analysis for TTF (P=0.004 and P=0.0001) and OS (P=0.004 and P=0.0001). In order to select subgroups with different outcomes, a stratification of patients was performed based on the EGFR value: patients with tumour EGFR levels <35 fmol/mg protein, between 35 and 275 fmol/mg protein and >275 fmol/mg protein had 95%, 51% and 16% 3 year OS rates, respectively (log rank test; P=0.0001). Interestingly, for patients exhibiting a complete response (CR) after concomitant b.i.d. chemo-radiotherapy, patients with EGFR levels <35 fmol/mg protein were all alive at 3 years; in contrast, there was only 70 and 13% 3 year survival rates for patients with EGFR tumour levels between 35 and 275 fmol/mg protein and above 275 fmol/mg protein, respectively. EGFR determination appears to be a powerful prognostic parameter in unresectable pharyngeal cancer patients treated by concomitant chemo-radiotherapy.

Adult↗

Combination of cisplatin-doxorubicin-cyclophosphamide in adenocarcinoma of unknown primary site: a phase II trial.

The purpose of this report is to evaluate toxicity, response, and survival of the cyclophosphamide-doxorubicin-cisplatin (CAP) chemotherapy regimen in patients with adenocarcinoma of unknown primary site (ACUP). Twenty-two patients with ACUP were eligible for this study between June 1992 and April 1999. There were 13 men (59%) and 9 women (41%) with a median age of 53.5 years (range: 29--78 years). Lung (seven), liver (six), vertebral bone site (six), and abdominal nodes (six) were the most common metastatic sites. Treatment consisted of doxorubicin 50 mg/m(2), cyclophosphamide 1,000 mg/m(2), and cisplatin 100 mg/m(2) (CAP), administered every 3 weeks; a total of six courses were planned. Twenty-two patients were assessable for toxicity and 20 patients were assessable for response. Grade III to IV neutropenia was observed in 14 patients (64%); febrile neutropenia occurred in 6 patients (27%) and in 10 cycles (12.5%). Grade III to IV anemia and thrombocytopenia were found in 12 (54.5%) and 9 patients (41%), respectively. Grade III to IV nausea and vomiting was observed in 9 patients (41%). Ten patients, 50% of the assessable population, obtained an objective response, including 3 complete (15%) and 7 partial (35%) responses. The median response duration was 3.9 months (range: 0.5--13.3 months). One patient (5%) had stable disease and 5 patients (25%) had progressive disease. The median overall survival and the median time to progression were 10.7 months (range: 0.4--56.9 months) and 8.8 months (range: 6.6--16.5 months), respectively. The CAP regimen in patients with ACUP had significant activity. This chemotherapy regimen induced a high level of grade III to IV toxicities and could not be considered as a treatment of reference. However, the emergence of long-term survivors among responder patients highlighted the need to search for an active treatment for patients with ACUP.

Adenocarcinoma↗

Phase II trial of a paclitaxel-carboplatin combination in recurrent squamous cell carcinoma of the head and neck.

OBJECTIVE: Twenty-seven patients with recurrent squamous cell carcinoma of the head and neck were entered in a multicenter study to determine the efficacy of the paclitaxel-carboplatin association. METHODS: Standard eligibility criteria applied, i.e. measurable disease, and chemotherapy given as induction treatment or concomitant chemoradiotherapy was allowed if completed more than 6 months prior to the study. Every 21 days, paclitaxel 175 mg/m(2) and carboplatin AUC 6 were administered. The patient group included 3 females and 24 males with a median age of 61 years (range 39-75 years). RESULTS: All patients were assessable for toxicity and 24 for responses. Main grade 3-4 toxicities were: neutropenia (62.9%), febrile neutropenia (18.5%), anemia (11.1%), thrombocytopenia (14.8%), mucositis (7.4%) and vomiting (7.4%). Among the intent-to-treat population, 29.6% of patients had an objective response, with a median response duration of 4.2 months (range 1-5.7 months). Stable and progressive disease were observed in 11.1 and 48.1% of patients, respectively. The median overall survival was 7.2 months (range 0.5-10.9 months). CONCLUSION: From these data, paclitaxel-carboplatin seems to have an activity in recurrent squamous cell carcinoma of the head and neck, but the high level of toxicity highlights the need to search for a safer chemotherapy combination.

Adult↗

Clinical prognostic factors for patients with recurrent head and neck cancer: implications for randomized trials.

The purpose of our study was to determine the clinical prognostic factors for the duration of the overall survival from recurrence (OSR) in patients with recurrent head and neck squamous-cell carcinoma. We performed a retrospective analysis on 496 patients treated between 1982 and 1993 at the Antoine Lacassagne Center. The significant favorable prognostic factors for the OSR were: initial T(1-2) (p = 0.008), no initial nodal involvement (p = 0.002), no initial chemotherapy exposure (p = 0.002), induction chemotherapy response (p = 0.001), duration of disease-free interval (DFI; p = 0.0001), performance status (PS) 0-1 (p = 0.004) and local-regional recurrence (p = 0.001). In the multivariate analysis, the apparent nonsignificance of all factors apart from the DFI suggested that relevant prognostic factors could be embedded in the DFI. Multivariate analysis was performed after excluding the DFI. The results indicated that local-regional recurrence, PS 0-1 and no initial chemotherapy exposure remained significant favorable prognostic factors for the OSR. The advantages of taking into account such prognostic factors are to eliminate the patient selection bias and to ensure a fairer comparative evaluation of new or already existing agents in recurrent head and neck cancer.

Adult↗

An analysis of potential factors allowing an individual prediction of cisplatin-induced anaemia.

Severe cisplatin (CP)-induced anaemia significantly impairs the patient's quality of life. Prevention based on erythropoietin (EPO) administration would be cost-effective providing that individual predictive factors of anaemia are identified. The aim of the present study was to identify parameters able to predict the occurrence of CP-related anaemia. This prospective study was conducted on 40 head and neck cancer patients receiving a CP (100 mg/m(2), intravenous (i. v.) on day 1) - 5-fluorouracil (5-FU, 1 g/m(2)/dx5 days by continuous infusion) induction chemotherapy. Three cycles were given at 3-weekly intervals. Platinum pharmacokinetics (total and ultrafilterable plasma platinum concentration measured 16 h after CP administration) and 5-FU pharmacokinetics (full-cycle plasma area under the curve, (AUC(0-105h)30 g/l) occurred in 15 patients (38%) and 3 of them also received a blood transfusion. Patient age, 5-FU AUC(0-105h) and total platinum concentration were unrelated to Hb loss. In contrast, ultrafilterable (UF) platinum concentration was significantly correlated to Hb loss: the higher the UF platinum concentration, the greater the Hb loss (P=0.015). A discriminant analysis allowed a cut-off value for UF platinum to be proposed to identify patients developing significant loss of Hb: 91% of patients exhibiting a UF platinum concentration above 50 ng/ml developed significant loss of Hb in contrast to 18% in the group of patients with a UF platinum concentration below 50 ng/ml (odds ratio (95% confidence interval, CI) of 46 (4.7-446)). In conclusion, the present platinum pharmacokinetic survey may be proposed as a valuable approach to identify patients at risk for developing severe anaemia.

Adult↗

[Books on anesthesiology and resuscitation published in Spain. An approach to their study].

INTRODUCTION: Few authors have examined the publication of medical books. Our aim was to analyze the nature of books published in Spain on anesthesiology and recovery. MATERIAL AND METHODS: Books listed by the Spanish ISBN agency were selected if they included anestesi* or reanima* in any field. Duplicates were removed. Multiple editions or references were considered single books, with data for the oldest edition entered into analysis. Multiple volume collections were grouped as complete works. Data analyzed for each book were year of publication, language (of publication and the original), subject (according to ISBN classification) and place of publication. Nine subject classifications were applied: general, recovery, anesthetic techniques, pharmacology, obstetrics/gynecology, pediatrics, veterinary anesthesia, dental anesthesia and miscellaneous. RESULTS: We analyzed 216 books. Years that saw publication of the greatest number of books were 1988 (17), 1993 (16) and 1979 (15), and the five-year period in which the most books were published was 1985 to 1989 (48 books, 22.2%). Most books (114, 52.8%) were originally written in English, Spanish being the second most common original language (58, 26.8%). All books were published in Spanish. The Spanish ISBN classification system identified 11 categories: general diseases/clinical medicine/therapy (161, 74.5%); drugs/pharmacology/physical therapy/toxicology (20, 9.3%); gynecology/obstetrics (9, 4.2%), veterinary medicine (9, 4.2%) and medicine (8, 3.7%). Classification by specific subjects showed a predominance of monographs or treatises on general aspects (42, 19.4%) followed by books on recovery (37, 17.1%), anesthetic techniques (25, 11.6%) and pharmacology (17, 7.9%). Most books were published in Barcelona (142, 65.7%), Madrid (36, 16.7%) or Saragossa (10, 4.6%). CONCLUSIONS: Spanish publication of books on anesthesiology and recovery has increased in recent years. Most books are translations usually from English. Spanish ISBN agency data, although it has limitations, can be useful for locating books published in Spain on anesthesiology and recovery. It would be useful to introduce keywords into the ISBN data base so that books on specific subjects could be classified and retrieved.

Anesthesiology↗

[Books published in Spain on smoking].

Tobacco dependence, considered for a long time as a habit and, more recently, as an addiction, has many bad effects in health. The objective of this study was to analyse books published in this field in Spain. Books indexed in the ISBN Spanish database in CD-ROM (updated to 1993) dealing with addiction to tobacco, that included one of the following words: tabac*, tabak*, tabaq*, fuma*, fumad*, nicotine*, alquitran*, antitabac*, antitabaq*, cigarro*, cigarri*, exfumad*, pipa*, puro*, picadura* or filtro, were included in the study. Authors, ISBN classification, year of publication, language (of publication and original) and publishers were descriptively analysed. One hundred and four books were analysed. The highest number was published during the period 1990-1993 (42%); being 1993 (n = 15) and 1991 (n = 14) the most productive years. A big increase was observed from 1985. A great number (76% of books, n = 79) was written by personal authors and the 14% (n = 14) by public organizations. Most of the books (n = 88; 85%); were published in Spanish, followed by Catalan (n = 13; 13%); 21 books (20%) were translations: most of them from English (n = 12; 60%) or from French (n = 3; 14%). Forty six per cent of books was published by trade publishers and 31% by public organizations. According to the ISBN classification, these books were grouped in 20 different topics; but, most of them (70%) were included in three of these topics: hygiene (n = 42, 40%), pharmacology-toxicology-drugs (n = 18, 17%) and pathology-diseases and medical/therapeutical clinical practice (n = 14; 13%). The number of books published in Spain dealing with tobacco dependence has increased very much from 1985; it suggests that interest in this area in SPain has also increased. Most of the books are published in Spanish, and the most frequently translated language is English. These books are basically published by trade publishers and public organizations. These results have to be considered taking into account that fighting against consumption of tobacco and tobacco dependence is a relatively new area of research and study.

Bibliographies as Topic↗

[Published books on pain and its treatment in Spain. Analysis with the ISBN database].

INTRODUCTION: Although analyses have been done on the publishing of scientific articles on pain in Spanish, book publications in the field have not been studied. This article fills that gap. MATERIAL AND METHODS: A bibliography of books with pain approached from a medical standpoint was compiled from ISBN CD-ROM database (updated for 1993). Books going into more than one edition were considered single titles. Multi-volume collections were considered single books. We analyzed type of book, subject, ISBN classification, year, language (of publication and original), publisher and place of publication. RESULTS: Two hundred books were studied. Over 60% had been published within the previous 10 years. The year that showed the most books published was 1990 (19) followed by 1989 (16) and 1988 (16). Output has been rising steadily. One hundred ninety-eight books were published in Spanish and 2 in Catalan. The original language was Spanish in 114 cases, English in 51 cases, French in 21 and German in 7. By ISBN classification, most (146) covered pathology, disease and medical/therapeutic clinical practice. By topic, 51 books were general, 41 treated lumbalgia, sciatica or back pain and 35 covered headaches in general or migraine. Most of the books were issued by trade publishers. The cities most often involved were Barcelona and Madrid. CONCLUSIONS: An increased number of books about pain are being published in Spain, coinciding with a rise in the publication of scientific articles on the subject.

Databases, Bibliographic↗

[International diffusion of clinical trials carried out in Spain. An analysis based on their publication in scientific journals].

BACKGROUND: Few studies have evaluated the clinical trials carried out in Spain and published in international journals. The present study has analyzed this situation over the period from 1981 to 1990. METHODS: Spanish studies including "clinical trial" as a key word present in Excerpta Medica CD (Drugs and Pharmacology) or MEDLINE in the CD-ROM version were evaluated. RESULTS: Two hundred forty-one original articles were obtained. The number of clinical trials was relatively stable from 1981 to 1986 (n = 8.15) increasing to a maximum from 1986 to 1988 (n = 64) with a posterior decrease. The languages of publication were English (51%) and Spanish (49%). A significant increase was observed in the number of articles published in English (p < 0.01) in the last five years. Phase III and IV clinical trials were the most frequent (89%) followed by those of phase II (9%) and phase I (2%). The open design predominated in the phase III-IV trials (58%) over the double blind trials (37%) and the single blind trials (5%). Among the former 70% were comparative and 57% followed randomized treatments. The clinical trials were published in 112 journals, Medicina Clínica (n = 32) and Current Therapeutic Research Clinical and Experimental (n = 6) were the most frequently used in Spanish and English, respectively. Two hundred sixty-three drugs were studied in the clinical trials, cisplatin was the most frequently studied (n = 10). The most commonly studied pharmacologic groups were antiinfectious (n = 40) and cytostatic (n = 35). The number of randomized clinical trials increased significantly after 1986 (p < 0.01). CONCLUSIONS: An increase in the number of clinical trials published in international journals was observed with preference for publication in English. The growing presence of randomized double blind clinical trials suggests an improvement in the quality of the clinical trials performed in Spain, particularly after 1986.

Clinical Trials as Topic↗

[Spanish scientific production on drug dependence].

BACKGROUND: The investigation of drug dependency has been strengthened in the last few years in Spain. One indicator of the scientific production in one area is constituted by the analysis of the studies included in data bases. METHODS: The Spanish publications in the field of drug dependency from 1985-1990 were reviewed. The references of studies published by Spanish authors collected in MEDLINE with Medical Subject Headings (MeSH) corresponding to Substance abuse or Substance dependence were selected. The following studies were collected a) those in which Spain was reported as the country of the author; b) published in Spanish journals; c) those in which Spain was indicated as the MeSH; b) and c) were not included if the publications did not correspond to Spanish authors. RESULTS: Three hundred thirty-one references were collected; 273 corresponded to Substance dependence and 58 to Substance abuse. The two themes most frequently studied were dependent on heroin (n = 99) and alcoholism (n = 94). Most studies were done in universities, mainly in schools of Medicine. Forty-three percent of the papers were signed by three or four authors. There were 1,044 authors; 844 (81%) authors published one article and 9 published seven or more. Twenty-three percent of the articles were published in 1988 and 20% in 1989. Three hundred thirty-one studies were published in 78 journals. Sixty percent of the journals published one article and 17% two. The journal which published the most articles were Medicina Clínica (n = 112), and Revista Clínica Española (n = 40). The foreign journal which published the most articles was Drug and Alcohol Dependence (n = 11). Twenty-nine articles were published in 7 of the journals with greatest impact factor in this area. CONCLUSIONS: These results confirm the tendency observed in other studies and indicate the increase in the quantity and quality of the Spanish publications on drug dependence.

Humans↗

[Clinical efficacy and tolerance to acarbose in the treatment of non-insulin-dependent diabetic patients].

BACKGROUND: Acarbose is a pseudotetrasacaride which reversibly and competitively inhibits the intestinal alpha-glycosidases leading to a decrease in the increase of postprandial glycemia. METHODS: A multicentric double-blind clinical trial (8 centers), controlled versus placebo, crossover and randomized was carried out in 90 non insulin dependent diabetic patients under treatment with diet or with diet and sulphonilureas. During the first three months of the trial the patients received placebo or acarbose randomly. Following one months of wash-out with placebo the patients received the inverse medication for 3 more months. During the first month of each phase the patients received 3 x 50 mg/day of acarbose or placebo and the following 2 months 3 x 100 mg/day. RESULTS: Upon comparison of the two treatments significant statistical differences were observed in HbA1 (p = 0.0115) and in postprandial glycemia (p = 0.0001). There were differences, although not significant, in the levels of triglycerides, cholesterol, fasting glycemia, and postprandial insulinemia. Episodes of hypoglycemia appeared in 12 patients and 57 patients referred undesirable gastrointestinal effects. CONCLUSIONS: The results of this trial indicate that acarbose may be useful in the treatment of non insulindependent diabetic patients since it significantly reduces the amount of postprandial glycemia and HbA1.

Acarbose↗