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Biomedical subjects

E Alba

Publications and source records attributed to E Alba.

At least 19 recordsLinked to original sources
PubMed2003

Sequential doxorubicin and docetaxel as first-line treatment in metastatic breast cancer: a GEICAM-9801 phase II study.

PURPOSE: To evaluate the efficacy and the toxicity profile of the sequential administration of doxorubicin and docetaxel as first-line chemotherapy in metastatic breast cancer (MBC). PATIENTS AND METHODS: Eighty-one patients received a total of 436 cycles of chemotherapy: 236 of doxorubicin (75 mg/m2) and 200 of docetaxel (100 mg/m2 every 21 days). The first 35 patients received doxorubicin every 14 days with G-CSF support, and in the other 46 cases doxorubicin was administered every 21 days without G-CSF. RESULTS: After entire treatment the overall response rate was 65% (18 complete responses). With a median follow-up of 19 months (range, 1-48 months), the median time to progression was 11.3 months and the median survival time was 31 months. As expected, febrile neutropenia was the most important toxicity and it appeared in 26 cycles (6%) and 19 patients (23%). In the patients that received doxorubicin every 14 days, the febrile neutropenia incidence was higher during docetaxel treatment, especially after its first administration. CONCLUSIONS: The dose and schedule of doxorubicin and docetaxel used in this trial seems to be active in first-line treatment of patients with MBC. The toxicity profile appears to be better than observed with concomitant schedules.

Adult↗
PubMed2003

Multicenter study evaluating a dual policy of postorchiectomy surveillance and selective adjuvant single-agent carboplatin for patients with clinical stage I seminoma.

BACKGROUND: After decades of irradiation as standard therapy for clinical stage I testicular seminoma, alternative treatment approaches have emerged including postorchiectomy surveillance and adjuvant chemotherapy. This study was performed to assess a dual policy of surveillance and selective single-agent carboplatin (for high-risk cases) in a multicenter setting. PATIENTS AND METHODS: From 1994 to 1999, 203 patients with stage I seminoma were included. Sixty (29.6%) were considered poor-risk cases (i.e. with vascular invasion and/or pathological tumor stage pT2 or greater) and received two courses of adjuvant carboplatin, whereas 143 (70.4%) without risk criteria underwent close surveillance. RESULTS: Median follow-up was 52 months (range 14-92). Relapses were observed in two (3.3%) patients treated with carboplatin and in 23 patients (16.1%) on surveillance, with a median time to recurrence of 11 months (range 3.9-39.6). All relapsing patients were rendered disease-free, mainly with cisplatin-based chemotherapy. Four patients died from tumor-unrelated causes. Actuarial 5-year overall survival was 96.7% and cause-specific survival was 100%. Five-year disease-free survival was 83.5% for patients on surveillance, and 96.6% for those receiving carboplatin. CONCLUSIONS: This dual treatment policy is feasible in a multicenter setting and preserves 70% of patients from adjuvant chemotherapy. Single-agent carboplatin is effective in reducing the relapse rate in patients with high-risk stage I seminoma. A better definition of local risk features would probably improve patient selection, thus minimizing the incidence of recurrences on surveillance.

Adolescent↗
PubMed2002

Clinical pattern and therapeutic results achieved in 1490 patients with germ-cell tumours of the testis: the experience of the Spanish Germ-Cell Cancer Group (GG).

OBJECTIVE: To describe the clinical characteristics and treatment results obtained with the application of a homogeneous treatment protocol in 1490 patients with germ-cell tumours (GCT) registered in the 55 hospitals belonging to the Spanish Germ-Cell Cancer Group (GG) during the period between January 1994 and April 2001. METHODS: In general, surveillance was the common policy for stage I patients without local poor prognosis factors, whereas they received adjuvant chemotherapy in case those factor were present. Chemotherapy schedules used in advanced cases were cisplatin and etoposide (EP) for seminoma and BEP or BOMP-EPI in non-seminoma, according to whether the patient was in the good or poor prognosis IGCCCG (International Germ-Cell Cancer Collaborative Group) group. Excision of residual masses was mandatory in non-seminomatous germ-cell tumour (NSGCT). RESULTS: Initial local symptomatology was increased testis size in 90% of cases. Sonography was an excellent diagnostic tool to suggest tumour. Non-seminoma (64.2%) was more frequent than seminoma (35.8%). Approximately 10% had the antecedent of cryptorchidism. Non-seminoma patients were 7 years younger than seminoma. Right testis was involved predominantly. Pre-orchidectomy tumour markers were elevated in 21% of seminoma (betaHGC) and 79% in non-seminoma (alphaFP and/or betaHGC). Scrotum violation occurred in only 1.8%. There were significant differences among stage I and the IGCCCG prognosis groups related to a longer interval between the first symptom and orchiectomy. Eighteen percent of non-seminomatous germ-cell tumour belonged to the poor prognosis IGCCCG group. With a median follow-up to 33 months, this series has achieved a 3 year overall survival of 98% for seminoma and 94% for non-seminoma. Only 10% of excised residual masses present after chemotherapy contained malignant cells. CONCLUSION: Spanish GCT have a similar clinical pattern to that described in the other occidental countries except for a slight increased proportion of non-seminoma upon seminoma. Co-operative groups as GG are unique structures to obtain quick and wide experience on the treatment of testis tumours, contributing to achieve a high cure rate.

Adolescent↗
PubMed2002

[A new organizational model of hospitals and law].

One of the more important legislative news in Italy is the company management of the National Health Care. The Health Care System has a long time budget and a yearly time budget, which allow to achieve some objectives identified inside an organizing system, based on Departments and their Directors. Another point is the competitivity among public/public and public/private structures. The problem of the penal responsibility of the medical doctor and staff is discussed.

Hospital Administration↗
PubMed2002

[Consent to transfusion of blood and hemoderivatives].

The transfusion of blood or hemoderivatives is a medical procedure that necessarily involves the possibility of danger or damage, given that, even with maximum prudence, diligence and expertise, it is impossible to avoid severe risks of infections, transfusional reactions, alloimmunisation, undesired immunomodulating effects, etc. Article 19 of Ministerial Decree 15/01/1991 makes it obligatory to obtain informed consent , understood as the free expression of the acceptance of treatment provided after being fully informed of the nature, possibility, risks and collateral effects of the procedure. Consent to blood transfusion can only be given by a person with full mental faculties, whereas transfusion treatment can be proposed for a minor, for a prisoner or for a person who is temporarily incapacitated by their physical conditions. The authors examine a number of problems regarding the following questions: what happens if consent is withheld? What can happen if consent is not requested or if the transfusion is performed when consent has been denied? In conclusion, it is difficult to offer operating schemes that are easy to apply: much depends on the patient's conditions, his reactions, his concerns, his trust in the doctor and the latter's communication skills.

Blood Transfusion↗
PubMed2002

[Antiestrogen therapy in the treatment of breast neoplasms].

During recent years the development of hormone therapy for the treatment breast neoplasms has seen, in addition to classic aspecific antiestrogens (AE) like tamoxifen (TAM) and to a lesser extent toremifen, a major development of new molecules divided into two groups: the first is the so-called selective estrogen receptor modulators (SERMs), the most important of which is Raloxifen, which mediate estrogen-agonist effects in some tissues and estrogen-antagonist effects in others; the second group includes the aromatase inhibitors (AI), important enzymes for peripheral estrogen conversion. Some studies compare or associate classic AE with the new SERMs and AI, both in adjuvant therapy and in treatment for advanced forms. Other trials assess the anti-osteoporotic activity of some SERMs which present concomitant inhibitory activity on the breast and endometrium.

Adult↗
PubMed2001

[Clinical pattern and therapeutic results obtained in Germ-Cell testicular cancer in Spain based on a consecutive series of 1250 patients].

BACKGROUND: Even its low incidence, germ-cell testicular cancer is very relevant due to its presentation at young ages and its potential curability over 90%. Spanish Germ Cell Cancer Group (GG) joins the efforts of 51 different Spanish centres to share their experience on the diagnosis and treatment of these special tumours. PATIENTS AND METHOD: We describe the clinical characteristics and the results of treatment in the first 1,250 patients registered throughout 6 years by the GG. RESULTS: 11% had previous criptorchidism. The most frequent initial local simptomatology was increased testis size (90%). 20% lasted more than six months in receiving the first treatment. Inguinal orquidectomy was done in 95% of patients. 435 cases (35%) were seminoma and 815 (65%)non-seminoma. 19% of seminoma and 78% of non-seminoma produced tumour markers. 75% of seminoma but only 56% of non-seminoma were clinical stage I. Following the IGCCCG prognosis classification,20% of non-seminoma fitted in the poor-prognosis group. Stage I seminoma treatment was surveillance, chemotherapy and complementary radiotherapy in 60, 32 and 6%, respectively. Those features were 65, 35% and none in non-seminoma cases. Chemotherapy schedules used in advanced cases were EP for seminoma and BEP or BOMP-EPIin non-seminoma, according to whether the patient was in the good or bad prognosis IGCCCG group. With a median of follow-up in all serie of 30 months, we have obtained a three years overall survival of 98% (CI 95%, 96,4-9,6), whereas non-seminoma patients had a three years overall survival of 94% (CI 95%, 92-96). CONCLUSION: The Spanish germ cell testicular cancer clinical pattern is similar to that registered in other occidental countries. Co-operative structures like GG,are able to gather an extensive experience in a short period of time that results in achieving a very high number of cured patients.

Adolescent↗
PubMed2001

Adjuvant anthracycline therapy as a prognostic factor in metastatic breast cancer.

BACKGROUND: Prognostic factors in metastatic breast cancer continue to be identified. Previous adjuvant chemotherapy appeared to have poor prognosis in some studies but, despite this, the prior use of anthracyclines in the adjuvant setting has not been clearly established as an adverse prognostic factor once metastatic disease develops. PATIENTS AND METHODS: Patients (n = 1,436) with stages I-IIIa breast cancer were surgically treated with/without radiotherapy and/or systemic adjuvant treatment. Of these, 297 patients who relapsed with metastatic disease constitute the sample population of this retrospective study. Survival, as a function of time since diagnosis of metastatic disease, was assessed in relation to the following factors: age, size of the primary tumor, grade, number of positive axillary nodes, type of surgery, type of adjuvant treatment administered, time to relapse, number of metastatic sites, presence of visceral metastases and type of treatment employed at the time of relapse. RESULTS: In multivariable analysis three factors remained significant predictors of short survival time: more than 1 site of metastases (p = 0.00003), shorter time to relapse (p = 0.003) and the previous administration of anthracyclines as adjuvant therapy (p = 0.005). CONCLUSIONS: The prior use of adjuvant anthracyclines, with other known clinical prognostic factors, confers a poorer outcome in metastatic disease, perhaps as a result of resistant clones selection or by induction of de novo resistance.

Antibiotics, Antineoplastic↗
PubMed2001

Secondary prophylactic G-CSF (filgrastim) administration in chemotherapy of stage I and II Hodgkin's lymphoma with ABVD.

UNLABELLED: The purpose of this study was to determine the effect of granulocyte colony-stimulating factor (filgrastim, G-CSF) for maintenance of chemotherapy dose-intensity in patients with stage I or II Hodgkin's lymphoma treated with six cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). Fifty-six patients with stage I or II Hodgkin's lymphoma treated with ABVD were eligible for secondary prophylactic G-CSF administration because of neutropenia (absolute neutrophil count < 1 x 10(9) /L) causing treatment delay or febrile neutropenia. Patients received 300 microg (total dose) of G-CSF (filgrastim) subcutaneously on days 3 to 7 and 17 to 21 of each cycle in order to prevent dose reduction or delay in subsequent cycles of treatment continuing the G-CSF until completion of chemotherapy. Results showed that 30 (54%) of the patients required the use of G-CSF, 26 (47%) during the first or second cycle. After G-CSF administration delay in chemotherapy did not occur in 25 patients, whereas delays in the fifth or sixth cycle occurred in four patients. Despite treatment with G-CSF, one patient had febrile neutropenia. Dose intensity greater than 90% of that planned was delivered to more the 85% of patients. IN CONCLUSION: Secondary prophylactic G-CSF administration was necessary in more than half of patients with stage I or II Hodgkin's lymphoma during chemotherapy with ABVD. The use of G-CSF allowed maintenance of chemotherapy schedule and dose intensity in the majority of patients.

Adolescent↗
PubMed2001

[Observations on vaginal delivery in women with previous cesarean section].

BACKGROUND: The significant increase in cesarean sections both before (52.73%) and during labour (89.82%) observed in the 1990s compared to the period 1970-1980 prompted the authors to review the cases of women admitted to Department B of the Gynecology and Obstetrics Clinic at the University of Turin and to study the number of women with previous cesarean sections undergoing labour. The aim of this study was to throw light on this complex question and to reduce the incidence of surgical births wherever possible. METHODS: Two groups of pregnant women with previous cesarean sections were studied in Department B of the Gynecology and Obstetrics Clinic at the University of Turin: one group included women undergoing cesarean sections between 1990-1998, and the other included women undergoing cesarean sections between 1970-1980. The authors analysed the indications for repeat cesarean section and the percentage of vaginal births. RESULTS: The results show that during 1970-1980 the percentage of vaginal births was 24.34% (259 vaginal births out of 1593 patients), whereas between 1990-1998 the percentage of vaginal births fell to 10.18% (51 vaginal births out of 1060 patients). CONCLUSIONS: The high percentage of repeat cesarean sections found in the 1990s is not only due to strictly medical reasons, but also to ethical and political motives, and above all the maternal desire not to undergo natural labour.

Female↗
PubMed2001

[Maternal morbidity in multiple pregnancies].

BACKGROUND: This study aimed to outline the clinical physiognomy of maternal morbidity in multiple pregnancies in order to improve maternal and feto-neonatal. METHODS: We reviewed the admissions to Department B of the Gynecology and Obstetrics Clinic at Turin University during the decade 1989-1998. Out of 17,445 pregnancies, we noted a 205 multiple pregnancies (1.17%), including 199 sets of twins, 5 triplets and 1 quadruplets. The percentages for the incidence of the various forms of maternal morbidity were compared to a control group of 1000 single births. RESULTS: Of 205 multiple pregnancies, 169 (82.43%) presented complications of varying severity and associated with statistically significant increase (always over 50%). These took the form of: premature birth (75.12%), PROM (28.29%), threat of premature birth (14.63%), phlebectasia (9.75%), anemia (8.78%), hyperemesis in the first quarter (8.29%), abortion (4.89%), polyhydramnios (4.39%), urinary tract infection (1.95%), detachment of the placenta (1.95%), liver pathology (1.46%), placenta previa (0.97%). CONCLUSIONS: The pathological picture revealed by this survey may seriously jeopardise the normal evolution of pregnancy, with severe repercussions for mother and fetus-neonate. These high-risk pregnancies should be included in a preventive programme of medical-social-outpatient and home assistance to guarantee early hospitalisation.

Adult↗
PubMed2001

[Embryo-fetal diseases in multiple pregnancies].

BACKGROUND: Embryo-fetal diseases are the consequence of prenatal (progenetic and metagenetic or environmental) and intranatal (of a traumatic, infective, toxic nature) pathological factors. In multiple pregnancies this complex etiopathogenesis also includes an altered didymous embriogenesis. This study aimed to evaluate the pathologies affecting the fetus in multiple pregnancy, a special biological situation leading to the potential onset of severe fetal and neonatal damage. METHODS: The authors studied 205 patients with multiple pregnancies, including 199 bigeminal, 5 trigeminal and 1 quadrigeminal, admitted to the Department B of the Obstetrics and Gynecological Clinic of Turin University between 1989-1999. Possible embyro-fetal damage was examined using a chronological criterion: namely following the development of the multiple fetuses from the zygotic to the neonatal phase. RESULTS: Pregnancies were biamniotic bichorionic in 54% of cases, biamniotic monochorionic in 45% and monochorionic monoamniotic in 1%. There were a total of 154 (79.38%) premature births out of 194 and neonatal birth weight was always SGA (small for gestational age). 66.84% of newborns were LBW (<2500 g) and 7.14% were VLBW (<1500 g). Fetal mortality (2.29%) was higher than early neonatal mortality (1.53%). Perinatal mortality (3.82%) was three times higher than in all neonates from the same period (1.03%). CONCLUSIONS: The severe embryo-fetal and neonatal damage found in multiple pregnancies is a clinical reality that calls for adequate diagnostic and therapeutic measures, and above all specific medical and social prevention to limit maternal pathogenic risks.

Birth Weight↗
PubMed2001

[Preventable perinatal mortality].

BACKGROUND: Using a critical systematic analysis of perinatal mortality, this study aims to examine, on the basis of current medical and scientific knowledge, whether there are still situations in which feto-neonatal death could be prevented and to define and evaluate the feasibility of realising this goal. METHODS: The concept of preventable feto-neonatal death refers to the number of individuals who could have survived with better pre-, intra and postnatal care. In other words, it indicates the number of deaths that could have been avoided in an almost perfect health organisation and therefore, by reference, the number of inevitable deaths (not preventable). In this field it is important to distinguish between clinically preventable, where there are preventable factors at the time of hospitalisation and during the clinical phase of the disease, and extra-clinically preventable when these factors, if potentially present during the preclinical phase of disease, disappear owing to the gravity of conditions at the time of hospitalisation. Using data from maternal and neonatal clinical records, death certificates and autopsy findings, the authors examined the perinatal mortality rate in Department B of the Gynecological and Obstetrics Clinic of Turin University during the period 1979-1998. The results of these two decades were compared in terms of clinical practice. RESULTS: The perinatal mortality rate fell significantly (p<0.01) during the period 1989-1998: 1.02 vs 1.77%. It is worth underlining that this was mainly the result of a marked reduction (over 50%) in late fetal mortality: 0.43 vs 0.98% (p<0.01). Early neonatal mortality also diminished, although not significantly (0.59 vs 0.79%). In order to evaluate preventable deaths, perinatal mortality was subject to a detailed critical analysis to analyse its chronological evolution: prenatal, intranatal, early neonatal. During the second period examined, the preventable nature of perinatal mortality, although slightly lower, applied to 36.35% of cases. It is important to underline that although clinically preventable deaths were unfortunately still present (approx. 10%), most cases (approx. 90%) referred to extra-clinically preventable deaths. CONCLUSIONS: On the basis of current medical and scientific knowledge, the authors outline the directives for medical and specialist obstetric and social care required in the specific fight against preventable perinatal deaths. Recent progress in basic scientific research, especially in the genetic field, may make a vital contribution to limit and reduce the coefficient of feto-neonatal pathology that is still beyond control.

Feasibility Studies↗
PubMed2000

Gemcitabine in combination with doxorubicin in advanced breast cancer: final results of a phase II pharmacokinetic trial.

PURPOSE: Gemcitabine has promising single-agent activity in advanced breast disease. The aim of this phase II study was to determine the efficacy, toxicity, and pharmacokinetic profile of gemcitabine administered with doxorubicin as first-line treatment in patients with metastatic breast cancer. PATIENTS AND METHODS: Of the 42 women with metastatic breast cancer (age 33 to 74 years; mean age, 55 years), 13 were chemotherapy-naive and 29 had received adjuvant chemotherapy. Gemcitabine (800 or 1,000 mg/m(2)) and doxorubicin (25 mg/m(2)) were administered intravenously on days 1, 8, and 15 of each 28-day cycle. Blood samples were drawn on day 8 of cycles 1, 2, and 3 and of subsequent odd cycles for gemcitabine pharmacokinetic determinations and before and after the first dose of cycle 1 or 2 for doxorubicin determinations. RESULTS: There were three complete and 20 partial responses, for an overall response rate of 55% (95% confidence interval [CI], 40% to 70%) and a complete response rate of 7%. The median survival time for all 42 patients was 27 months (95% CI, 13.4 to 30.0 months) and the 1-year survival rate was 80%. Toxicity was mainly hematologic. The disposition of both drugs was unchanged when they were administered on the same day compared with when they were given singly. CONCLUSION: The combination of gemcitabine (800 mg/m(2)) and doxorubicin (25 mg/m(2)) can be safely administered using a weekly schedule. The disposition of both drugs is unchanged when they are administered on the same day. This combination shows promising activity with acceptable toxicity compared with other combination therapies.

Adult↗
PubMed1999

BOMP/EPI intensive alternating chemotherapy for IGCCC poor-prognosis germ-cell tumors: the Spanish Germ-Cell Cancer Group experience (GG)

BACKGROUND: Patients with poor-prognosis germ-cell tumors according to the IGCCC have a poor long-term survival. This study evaluates the efficacy and toxicity of the intensive alternating chemotherapy regimen BOMP/EPI in these patients. PATIENTS AND METHODS: Patients with IGCCC poor-prognosis germ-cell tumors treated at 13 centres were studied. Treatment consisted of bleomycin 30 mg, vincristine 2 mg, methotrexate 300 mg/m2 and cisplatin 100 mg/m2 (BOMP), alternating after a 14-day interval with etoposide 120 mg/m2 day 1-4, ifosfamide 1.3 g/m2 day 1-4 and cisplatin 25 mg/m2 day 1-4 (EPI). BOMP was administered 21 days after the EPI. Bleomycin was administered weekly per 12 weeks. RESULTS: Thirty-eight patients were treated. The median number of cycles administered was 7 (1-10 cycles). Eighteen patients achieved complete responses with chemotherapy alone (12 had necrosis and 2 mature teratoma at postchemotherapy resection), and four achieved complete responses with chemotherapy and surgical resection of viable cancer. Thus, an overall favorable response was achieved in 22 patients (60%). Four additional patients had marker-negative non-resected residual masses. Eleven patients were considered treatment failures, including one who died early and another who succumbed to granulocytopenic sepsis and renal failure. Hematologic toxicity was the most common, with 26 patients (70%) having grade 4 granulocytopenia. After a median follow-up of 41 months, the actuarial two-year overall survival and progression-free survival were 64% and 58%, respectively. CONCLUSION: BOMP/EPI is active in poor-prognosis germ-cell tumors according to the IGCCC criteria. The results obtained compare favorably with those expected with conventional chemotherapy, and justify further studies.

Adolescent↗