Angel Segura

Hospital Universitari i Politècnic la Fe, Valenza, Valencia, Spain

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Publications (28)49.89 Total impact

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    ABSTRACT: The combination of gemcitabine and erlotinib is a standard first-line treatment for unresectable, locally advanced or metastatic pancreatic cancer. We reviewed our single centre experience to assess its efficacy and toxicity in clinical practice. Clinical records of patients with unresectable, locally advanced or metastatic pancreatic cancer who were treated with the combination of gemcitabine and erlotinib were reviewed. Univariate survival analysis and multivariate analysis were carried out to indentify independent predictors factors of overall survival. Our series included 55 patients. Overall disease control rate was 47%: 5% of patients presented complete response, 20% partial response and 22% stable disease. Median overall survival was 8.3 months). Cox regression analysis indicated that performance status and locally advanced versus metastatic disease were independent factors of overall survival. Patients who developed acne-like rash toxicity, related to erlotinib administration, presented a higher survival than those patients who did not develop this toxicity. Gemcitabine plus erlotinib doublet is active in our series of patients with advanced pancreatic cancer. This study provides efficacy and safety results similar to those of the pivotal phase III clinical trial that tested the same combination.
    JOP: Journal of the pancreas 01/2014; 15(1):19-24.
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    ABSTRACT: Neoadjuvant 5-FU-based chemoradiotherapy in resectable rectal cancer (RC) is a standard of treatment. The use of oral fluoropyrimidines and new agents such as oxaliplatin may improve efficacy and tolerance. Between 1999 and 2009, 126 RC patients with T3-T4 and/or N+ disease were given three successive protocols: UFT (32), UFT-oxaliplatin (75) and capecitabine-oxaliplatin (19), alongside 45 Gy of radiotherapy; with surgery 4-6 weeks after. Adjuvant treatment was given in all patients. The primary objective was pathologic complete response (pCR). Preoperative therapy was well tolerated, with no toxic deaths and a 15% grade 3-4 toxicity rate. Eighty-five percent of patients received the full chemotherapy dose, 56% had an abdominoperineal resection, 6% reinterventions and 57% received the full adjuvant chemotherapy planned. The pCR rate was 13%. The downstaging rate was 80%; 8% had progression of disease. The relapse rate was 20%, with local relapse in 6%. By 5 years of followup, 92% of relapses had occurred. Median follow-up was 73 months, 5- and 10-year disease-free survival rates were 75% and 50%, and 5- and 10-year overall survival rates were 79% and 66% respectively. There was no benefit from the use of oxaliplatin regarding survival or pCR rates. Older patients had worse long-term outcomes. Neoadjuvant chemoradiotherapy with oral fluoropyrimidines and oxaliplatin is feasible and well tolerated. The risk of early progression is low. However, there was no added benefit with the use of oxaliplatin. There were no relapses in patients with pCR. The role of adjuvant chemotherapy is unclear.
    Clinical and Translational Oncology 06/2012; 14(6):471-80. · 1.28 Impact Factor
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    ABSTRACT: Neoadjuvant chemoradiotherapy before surgery is an option in the treatment of locally advanced resectable oesophageal cancer (EC). However toxicity is substantial and the improvement in overall survival (OS) with this approach is controversial. This was a prospective, single-centre study of neoadjuvant chemotherapy and concomitant chemoradiotherapy with CDDP and 5-FU and 50.4 Gy of external radiotherapy before possible radical surgery in patients with locally advanced resectable EC. If surgery was not possible, a second-phase radiotherapy boost of 10 Gy and one cycle of modified dose chemotherapy were used. Seventy-three patients included between 1998 and 2007: 96% males, median age 61, 83% squamous cell carcinomas, 23% lower third tumours, 36% stage II and 54% stage III and 47% local lymph node involvement. Eighty-six percent completed the combined protocol. Main grade 3-4 toxicities: mucositis (19%) and infections (8%); 4 toxic deaths. Clinical response rates: complete response 54%, partial response 27%, stable disease 8%. Twenty-five patients proceeded to surgery, with radical resection in 24. Pathological response rate: complete response 32%, partial response 52%, progression 16%. There were 7 postoperative deaths and 16 of 34 patients that did not have surgery received the second-phase RT boost. Survival analysis: Median follow-up of 64 months (range 6-134 months). Median OS of 10.33 months. 2-year and 5-year OS of 22 and 16%. The only significant prognostic factor in OS is the clinical complete response rate: 13.9 vs. 7.7 months (p=0.0049). Our protocol offers a high rate of clinical activity although it is relatively toxic and seems to increase the postoperative mortality, which would blunt any small improvement in survival. The achievement of a complete response is a powerful prognostic factor.
    Clinical and Translational Oncology 12/2009; 11(12):835-41. · 1.28 Impact Factor
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    ABSTRACT: Primary meningeal lymphoma is a rare clinical entity. Central nervous system infiltration by systemic lymphoma should always be excluded. Diagnosis can be difficult, and prognosis is usually poor. Most are of B-cell origin. We present the case of a young man with a primary meningeal lymphoma of T-cell origin. He was treated with systemic chemotherapy with high-dose methotrexate and cytarabine and intraventricular chemotherapy. He had a clinical improvement and a complete remission, with a long overall survival. There is no standard treatment for this rare disease. Traditionally, treatment has been based in craniospinal radiation therapy and intrathecal chemotherapy, with poor overall results. More recently, systemic chemotherapy with high-dose methotrexate has been advocated, which could avoid the long-term toxicity of craniospinal radiation therapy, and could improve the prognosis of these patients.
    Clinical Lymphoma & Myeloma 10/2007; 7(8):546-9. · 1.13 Impact Factor
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    ABSTRACT: IntroductionLittle has been published regarding clinical predictors of severe toxicity in patients with metastatic colorectal cancer (CRC) treated with combination chemotherapy (CT) with oxaliplatin and/or irinotecan. Material and MethodsWe analyzed retrospectively 142 patients treated between 1996 and 2004 in our center with these regimes with regards to grade 3–4 toxicity and overall survival (OS) rates. Köhne's prognostic classification could be applied in all patients. ResultsKöhne classification: good (54.2%), intermediate (26.8%), and poor prognosis (19%). 50.4% received irinotecan-based CT. Median number of cycles 6 with a total response rate of 38.9%. 23.2% stopped first-line CT due to toxicity. 50.7% suffered grade 3–4 toxicity: digestive (28.2%), hematologic (19.7%), and fatigue (25.4%). 7.7% episodes of neutropenic fever with 4.9% toxic deaths. 70.9% of grade 3–4 episodes occurred in the first four cycles. Median follow-up of 33.9 mo; median OS of 15.9 mo. For Köhne classification: good (20 mo), intermediate (15.8 mo), and poor (6.8 mo). Toxicity analysis: female sex and age>70 yr predicted higher overall grade 3–4 toxicity, with no differences in CT efficacy; age>70 yr and PS>1 predicted higher grade 3–4 fatigue. No relationship could be found between baseline laboratory characteristics and higher toxicity, except baseline hemoglobin and grade 3–4 hematologic toxicity. ConclusionsFemale and elderly patients have a higher grade 3–4 toxicity rate when treated with combination CT with oxaliplatin or irinotecan. Prognostic classifications such as Köhne's can help differentiate subgroups of patients who benefit little with the use of combination CT.
    Medical Oncology 08/2006; 23(3):347-357. · 2.15 Impact Factor
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    ABSTRACT: Little has been published regarding clinical predictors of severe toxicity in patients with metastatic colorectal cancer (CRC) treated with combination chemotherapy (CT) with oxaliplatin and/or irinotecan. We analyzed retrospectively 142 patients treated between 1996 and 2004 in our center with these regimes with regards to grade 3-4 toxicity and overall survival (OS) rates. Köhne's prognostic classification could be applied in all patients. Köhne classification: good (54.2%), intermediate (26.8%), and poor prognosis (19%). 50.4% received irinotecan-based CT. Median number of cycles 6 with a total response rate of 38.9%. 23.2% stopped first-line CT due to toxicity. 50.7% suffered grade 3-4 toxicity: digestive (28.2%), hematologic (19.7%), and fatigue (25.4%). 7.7% episodes of neutropenic fever with 4.9% toxic deaths. 70.9% of grade 3-4 episodes occurred in the first four cycles. Median follow-up of 33.9 mo; median OS of 15.9 mo. For Köhne classification: good (20 mo), intermediate (15.8 mo), and poor (6.8 mo). Toxicity analysis: female sex and age > 70 yr predicted higher overall grade 3-4 toxicity, with no differences in CT efficacy; age > 70 yr and PS > 1 predicted higher grade 3-4 fatigue. No relationship could be found between baseline laboratory characteristics and higher toxicity, except baseline hemoglobin and grade 3-4 hematologic toxicity. Female and elderly patients have a higher grade 3-4 toxicity rate when treated with combination CT with oxaliplatin or irinotecan. Prognostic classifications such as Köhne's can help differentiate subgroups of patients who benefit little with the use of combination CT.
    Medical Oncology 01/2006; 23(3):347-57. · 2.14 Impact Factor
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    ABSTRACT: Malnutrition is frequent in cancer. The objective of this study was to determine the prevalence, in Spain, of malnutrition in cancer patients with advanced disease and to assess the therapeutic focus. A total of 781 patients were evaluated to determine individual nutritional status using the Scored Patient Generated-Subjective Global Assessment (Scored PG-SGA) questionnaire. Almost 60% of the patients included were receiving cancer treatment. Patients with the highest weight loss were those with tumours of oesophagus (57%), stomach (50%) and larynx (47%). Serious eating problems were encountered by 68% of the patients; the principal problem being anorexia (42.2%). The median number of symptoms impeding food intake was 2. According to the Scored PG-SGA, 52% of the patients were moderately or severely malnourished and 97.6% required some form of nutritional intervention/recommendation. (a) the majority of patients in the study needed nutritional intervention; (b) more than 50% had moderate or severe malnutrition; (c) the Scored PG-SGA is a useful and simple tool for evaluating nutritional status and contains additional information on nutritional recommendations; (d) nutritional evaluation of the cancer patients needs to be improved so as to offer better treatment of symptoms and to improve the patient's quality of life.
    Clinical Nutrition 11/2005; 24(5):801-14. · 3.30 Impact Factor
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    ABSTRACT: The objective of this study was to analyze prognostic factors for survival and to assess the applicability of Kohne's classification in patients treated with irinotecan- or oxaliplatin-based first-line chemotherapy. One hundred forty-two consecutive cases from a single center were retrospectively reviewed. Median patient age was 62 years. Sixty percent were men. Eastern Cooperative Oncology Group (ECOG) performance status (PS) was 0/1 in 88%. Primary tumor resection (PTR) was performed in 80.6% of patients who initially had stage IV disease. Chemotherapy consisted of fluoropyrimidines or raltitrexed plus irinotecan (50.5%), oxaliplatin (38.5%), or both (11%). Univariate and multivariate analyses for survival were performed using pretreatment patient characteristics. Median follow-up was 33.9 months and median overall survival was 15.9 months. Significantly unfavorable prognostic factors were PTR not being performed, disease involvement of >1 organ, liver metastases, undifferentiated histology, EGOG PS>1, increased serum carcinoembryonic antigen and cancer antigen 19.9 levels, hypoalbuminemia, leucocytosis, and elevated alkaline phosphatase and lactate dehydrogenase (LDH) levels. Only ECOG PS, PTR, increased LDH level, no hypoalbuminemia, and number of organs involved retained prognostic value in the multivariate analysis. The incidence and median survival for Kohne's prognostic groups were as follows: good (54.2%; 20 months), intermediate (26.8%; 15.7 months), and poor (19%; 6.8 months). For patients with stage IV disease at presentation, PTR was associated with a significantly longer survival, mainly in patients with an ECOG PS of 0/1. Eastern Cooperative Oncology Group PS, PTR, serum albumin, increased LDH levels, and organ involvement were the main prognostic indicators in our series. Kohne's prognostic groups, developed in the era of 5-fluorouracil treatment, also seem to be applicable to patients treated with combination chemotherapy. Primary tumor resection should always be considered, especially in patients with an ECOG PS of 0/1. However, the benefit of PTR and multiple-agent chemotherapy is questionable in patients with an ECOG PS of >1.
    Clinical Colorectal Cancer 09/2005; 5(3):197-202. · 1.80 Impact Factor
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    ABSTRACT: Neoadjuvant chemotherapy (CT), prior to radical radiotherapy (RT), in the treatment of high-grade gliomas may offer several advantages over standard adjuvant CT. The addition of tamoxifen, which can circumvent P-glycoprotein (P-gp)-mediated chemo-resistance, also merits attention. We have evaluated the neoadjuvant regimen of cisplatin and etoposide after surgery of grade III-IV gliomas and prior to radical RT, with regard to response rates (RRs), overall survival (OS) and time to progression (TTP). The synergistic activity between etoposide and tamoxifen was also studied. Forty-four patients were included. CT regime: cisplatin 100 mg/m2 on day +1 and etoposide 100 mg/m2 on days +1 to +3 every 3 weeks for 3 cycles. The initial 24 were also treated with high-dose tamoxifen, 275 mg/m2 on days -3 to +3. An immunohistochemical analysis of P-gp, p53, vascular endothelial growth factor, Ki67 and bcl-2 was also performed. Median follow-up was 11.57 months. In the 16 patients with measurable disease after surgery, a RR of 12.5% was seen, with 37.5% of disease stabilizations and 31.25% of progressions. The median OS and TTP were 11.3 and 5.7 months. Excluding the three deaths possibly related to tamoxifen, grade 3-4 was low, mainly emesis. Favorable prognostic factors were age less than 60 years, extent of surgery, absence of measurable disease, and the absence of radiological necrosis and ring enhancement. Only high p53 expression was associated with better OS. We conclude that neoadjuvant cisplatin and etoposide is a feasible regime, although any real advantage over standard adjuvant CT is dubious. Short-course high-dose tamoxifen should not be used alongside primary CT.
    Anti-Cancer Drugs 04/2005; 16(3):323-9. · 2.23 Impact Factor
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    ABSTRACT: 5-fluorouracil (5-FU) is a chemotherapeutic agent widely used in the treatment of solid malignancies, especially in colorectal cancer. A characteristic note seen with its use is the considerable interindividual variation in the incidence and severity of the toxicities seen among patients. We report the case of a 55-year old woman who presented with severe, lethal toxicity to standard doses of 5-fluorouracil (5-FU) and folinic acid. We discuss the known clinical determinants of toxicity. We also discuss the possible molecular factors implicated in the variable toxicity seen to 5-FU, especially in regards to dihiyropyrimidine dehydrogenase, a pivotal enzyme in the metabolism of 5-FU.
    Journal of chemotherapy (Florence, Italy) 01/2005; 16(6):599-603. · 0.83 Impact Factor
  • Leukemia and Lymphoma 05/2004; 45(4):853-5. · 2.61 Impact Factor
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    ABSTRACT: The case of a 55-yr-old male with a right pleural effusion and multiple bilateral nodules is reported. A diagnostic thoracothomy was necessary to obtain a definitive histological diagnosis. During the postoperative course, the subject's neurological condition deteriorated and multiple cerebral mass lesions were discovered. The pathological analysis of both lung and cerebral tumours revealed an atypical endothelial cell proliferation; vascular immunohistochemical markers, such as factor VIII and CD34, were strongly positive. His general condition remained poor and the patient died 18 months after the initial diagnosis. The final diagnosis was pulmonary epitheloid haemangioendothelioma with synchronous central nervous system dissemination, the first time the authors believe that association has been reported. Little is known of the prognosis and treatment of these tumours, due to their rarity. Negative prognostic factors appear to be the presence of symptoms, pleural effusion or multifocal presentations. Treatment should include surgical resection if possible; chemotherapy appears to have little effect. Watchful waiting is an acceptable option, especially in asymptomatic patients.
    European Respiratory Journal 04/2004; 23(3):483-6. · 6.36 Impact Factor
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    ABSTRACT: IntroductionSurgery and radiotherapy show an improvement in overall survival rates in the treatment of newly diagnosed malignant gliomas. The role of chemotherapy is uncertain. The aim of the present study was to evaluate toxicity and outcomes in patients with high-grade gliomas treated with carmustine (BCNU) concurrent with radiotherapy. Material and methodsA descriptive single-arm study was conducted in patients with newly diagnosed high grade glioma who, post-surgery and concurrent with radiotherapy, had BCNU (200 mg/m2) administered on day 1 every 42 days. ResultsThere were 43 patients (26 men and 17 women), median age of 54.5 years in the trial. Histology indicated glioblastoma in 36 patients (84%) and anaplastic astrocytoma in 7 patients (16%). Surgery was radical in 30 patients (70%) and non-radical in 13 (30%). Complete response (CR) was achieved in 13 patients (30%) by the conclusion of the treatment with 2 patients (5%) in partial response (PR). Progressive disease (PD) was recorded in 26 patients (60%). With a median follow-up 11 months, 8 patients (19%) are alive and disease free, 5 (12%) are alive with disease and 30 (70%) have expired. With a median time to progression of 7 months, median survival is 12 months and at 6 months the disease free survival is 53%. With 36 months of follow-up, the potential rate of long-term survival is 15% (10% in patients with glioblastoma). Toxicity grades 3–4 observed were: 16% leukopenia, 12% thrombopenia, 5% emesis and anaemia. ConclusionsBCNU concurrent with radiotherapy is a well-tolerated and feasible regimen. Patients with radical surgery remain progression-free at the end of treatment in a 50% of cases. In cases in which surgery was non-radical, 2 partial responses were achieved (15%). We also obtained a satisfactory time-to-progression and overall survival. IntroducciónEl tratamiento con cirugía radical y radioterapia postoperatoria ha demostrado un incremento de la supervivencia en los pacientes afectos de gliomas de alto grado. La quimioterapia tiene un papel limitado. El propósito de este estudio es analizar la toxicidad y supervivencia en pacientes de alto grado tratados con carmustina (BCNU) concomitante con radioterapia. Material y métodosEstudio descriptivo no aleatorizado que incluye de forma prospectiva a los pacientes afectos de gliomas de alto grado. Tras la cirugía los pacientes recibieron: BCNU 200 mg/m2 día 1 cada 42 días concomitante con radioterapia. ResultadosCuarenta y tres pacientes (26 hombres, 17 mujeres), con una media de edad de 54,5 años, con glioblastoma multiforme en 36 pacientes (84%) y astrocitoma anaplásico en 7 pacientes (16%). Se realizó cirugía radical en 30 (70%) y no radical en 13 (30%). Trece pacientes se mantenían en remisión completa (RC) al finalizar el tratamiento, 2 alcanzaron remisión parcial (RP) (5%) y 26 pacientes progresaron (60%). Tras una mediana de seguimiento de 11 meses, 8 pacientes están vivos y sin enfermedad (19%), 5 viven con enfermedad (12%) y 30 (70%) han fallecido. La mediana de tiempo hasta la progresión fue de 7 meses y la mediana de supervivencia de 12 meses. La supervivencia libre de enfermedad a los 6 meses es del 53%. Tras 36 meses de seguimiento potencial exite un 15% de supervivientes (10% con glioblastoma multiforme). La toxicidad grado 3–4 ha sido escasa: 16% leucopenia, 12% trombopenia, 5% emesis y anemia. ConclusionesBCNU concomitante con radioterapia es un régimen de tratamiento bien tolerado y factible. En los pacientes con cirugía radical, el 50% permanecen sin progresión al final del tratamiento. En aquéllos en los que la cirugía no fue radical se obtuvieron dos respuestas parciales (15%). Los pacientes tienen un tiempo prolongado de supervivencia y supervivencia libre de progresión.
    Clinical and Translational Oncology 01/2004; 6(4):207-211. · 1.28 Impact Factor
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    ABSTRACT: The aim of this study is to assess the clinical impact of gallium-67 scintigraphy, before and after treatment, in patients with Hodgkin's disease, and to compare the overall survival between the patients whose gallium studies after treatment were negative and those whose studies remained positive. We have studied 75 patients (40 women, 35 men) with Hodgkin's disease. All the patients underwent (67)Ga scintigraphy at the moment of the diagnosis (basal study) and in the case that basal study was positive (abnormal hyper-uptake focus) we performed follow-up studies after the treatment. We have calculated the overall survival among patients whose studies after treatment were negative (1(st) group) and those whose studies remained positive (2(nd) group) and between patients whose studies were negative at diagnosis (3(rd) group). Gallium scintigraphy was positive at diagnosis in 47 patients (62.6%). In 39 of them we were able to perform the follow-up study after treatment. The follow-up study was negative in 31 patients while in 8 patients the gallium scintigraphy remained positive. The overall survival was significantly higher (p<0.001) in the 1(st) group compared with the 2(nd) group. The overall survival was higher in the 1(st) group compared with the 3(rd) but statistic significance level was not reached. Our data suggest that: 1) in Hodgkin's disease (67)Ga scintigraphy is useful to establish the diagnosis of complete remission; 2) if the gallium scan remains positive after treatment, the prognosis of patients is worse than the prognosis of patients with a negative scan.
    The quarterly journal of nuclear medicine: official publication of the Italian Association of Nuclear Medicine (AIMN) [and] the International Association of Radiopharmacology (IAR) 06/2003; 47(2):101-8.
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    ABSTRACT: Colorectal cancer (CRC) is one of the most common malignant tumors in adults. Twenty-five percent of patients are not amenable to surgical resection because they have locally advanced or metastatic disease. For these patients, median survival time is between 4 and 13 months, and chemotherapy is used mainly with palliative intent. We conducted this study to evaluate potential prognostic factors for time to progression and survival. A retrospective review of 91 patients with metastatic CRC treated with bolus 5-fluorouracil-based chemotherapy (Mayo Clinic schedule) was performed. Univariate and multivariate analyses of clinical prognostic factors were carried out. Median follow-up time was 53 months (range, 17-107 months). Median time to disease progression was 9.6 months, and median survival time was 15.4 months. Actuarial 5-year survival was 17%. In the univariate analyses, factors predictive of time to progression were visceral metastases, elevated alkaline phosphatase (AP) levels, performance status (PS), and elevated carcinoembryonic antigen (CEA) and CA 19-9 levels. Multivariate analyses confirmed the independent prognostic value of PS and AP levels. In the univariate analyses for survival, significant prognostic factors were visceral metastases, hypoalbuminemia, elevated lactate dehydrogenase levels, elevated AP levels, PS, and elevated CEA and CA 19-9 levels. In the multivariate analyses, only PS, elevated CEA and CA 19-9 levels, and liver involvement retained prognostic significance. This study confirms the prognostic value of PS for both time to progression and survival. AP levels are significantly related to time to progression. Additional factors influencing survival time are elevated tumor marker levels and the existence of liver metastases.
    Clinical Colorectal Cancer 03/2003; 2(4):231-4. · 1.80 Impact Factor
  • Lung Cancer. 01/2003; 41.
  • Clinical Nutrition - CLIN NUTR. 01/2003; 22.
  • Medical and Pediatric Oncology 03/2002; 38(2):145.
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    ABSTRACT: Currently, monotherapy is considered a valid alternative to the combination antibiotic treatments used for initial, empirical management of febrile neutropenia. The advent of new cephalosporins warrants assessment. The aim of this study was to prospectively evaluate the effectiveness of cefepime monotherapy in the treatment of cancer patients with febrile granulocytopenia (< 1000 leukocytes/muL and/or < 500 neutrophils/muL). A prospective, multicenter, nonrandomized trial was conducted. Initial treatment consisted of iv cefepime, 2 g every 8 h. If the patient was still febrile after 72 h, amikacin, vancomycin/teicoplanin, and amphotericin B were added sequentially. Response was evaluated according to EORTC criteria. One hundred twenty episodes were analyzed in 81 males and 39 females (median age, 52 yr; range, 15-83). The median leukocyte count at the time of diagnosis was 781 microL(-1) (range, 100-2600) and the median neutrophil count was 173 microL(-1) (range 0-500). The median duration of neutropenia (< 1000 neutrophils/microL) was 4.8 d (range, 3-20). Fifty-two episodes (44%) were confirmed microbiologically (42 presented as bacteremia), 31 with Gram-positive bacteria and 21 with Gram-negative bacteria, 47 (39.3%) were confirmed clinically, 16 (13.3%) were considered as probable infections, and 5 (4.2%) as doubtful infections. Protocol success was achieved in 110 episodes (91.7%), 8 (6.6%) were treatment failures, and 2 (1.7%) were not evaluable. Ninety-nine episodes (83.3%) were controlled with cefepime monotherapy, with 19 other episodes requiring additional antibiotics: amikacin in 7 (5.8%), amikacin + vancomycin/teicoplanin in 12 (10.1%). Three patients (2,5%) died during an episode of neutropenic fever. Cefepime is effective as an initial, empirical treatment of febrile neutropenia. The early addition of amikacin and/or vancomycin resolves most of the monotherapy failures, which seem somewhat lower than with other monotherapies.
    Medical Oncology 01/2002; 19(3):161-6. · 2.15 Impact Factor
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    ABSTRACT: To assess, in a multicenter setting, the effectiveness of a combination of vinorelbine, ifosfamide and cisplatin in the treatment of non-small cell lung cancer, 123 patients (males=116) with a mean age of 60 years (range 27-75) with stage IIIb/IV non-small cell lung cancer (NSCLC) and performance status <or=2 were treated with vinorelbine (VNR; 25 mg/m(2)) on days 1 and 8; ifosfamide (IFO; 3 g/m(2)) on day 1; and cisplatin (CDDP; 80 mg/m(2)) on day 1, in repeated cycles of 21 days. Response rates, overall patient survival and toxicity profiles of the three-drug combination were assessed. The number of evaluable patients was 112, with a total of 441 cycles administered (mean=3.6 cycles/patient). Dose intensities (mg/m(2)/week; calculated in patients who concluded the proposed treatment and expressed as mean, median, and standard deviation) were: VNR 13.65, 13.32, 4.7; IFO 918.88, 868.97, 258.1; CDDP 23, 24.68, 6.98. Response rates were: complete response=3 (2.4%); partial response=58 (47.2%%); stable disease=20 (16.3%). The most frequent toxic events were nausea and vomiting (G1=33%, G2=31%, G3=8%). Neutropenia was the dose limiting toxicity (G1=6%, G2=11%, G3=10%, G4=7%). Alopecia G3 was a common undesirable effect in all the patients. Time to progression was 296 days (95% confidence interval 261-332) and the mean survival time was 338 days (95% CI 301-374). We conclude that the described therapeutic schedule is effective with good survival rates and response ratios together with a good tolerance and an acceptable toxicity level.
    Lung Cancer 12/2001; 34(2):305-11. · 3.39 Impact Factor

Publication Stats

204 Citations
49.89 Total Impact Points

Institutions

  • 2000–2006
    • Hospital Universitari i Politècnic la Fe
      • • Medical Oncology Unit
      • • Department of Medical Oncology
      Valenza, Valencia, Spain