Open-label trial on efficacy and security of treatment with gemcitabine and oral modulation with tegafur and levofolinic acid (GEMTG) in patients with advanced pancreatic cancer

AIM: Advanced pancreatic cancer has a bad prognosis, with a median overall survival (OS) no longer than 4-6 months. Since the end of last century, monotherapy with gemcitabine has remained the elective therapy, but new schedules are needed in order to improve these results. We aim to evaluate the efficacy of tegafur and levofolinic acid (LV) associated with gemcitabine, as well as its toxicity, progression-free survival and OS in advanced pancreatic cancer. PATIENTS AND METHODS: An open-label, multicentric, prospective, non-controlled trial was carried out on patients with advanced or disseminated pancreatic cancer. Gemcitabine 1250 mg/m² was administered on the 1st and 8th days of the cycle, tegafur 750 mg/m²/day for 21 consecutive days and LV 25 mg/day continuously, every 28 days, with a maximum of six cycles. The primary variable was tumour overall response rate (ORR). Secondarily, time to progression (TTP), OS and scheme toxicity were determined. RESULTS: Forty patients were recruited; the male/female ratio was 30:10, with a mean age of 61 years. Forty percent had a Karnofsky index of 90% or 100%. Only 11 patients (27%) completed the six cycles of treatment, but more than 50% received three or more cycles. Dose intensity was 89.56% for gemcitabine and 87.36% for tegafur. Efficacy ORR was 22.5% (CI 95%, 6-37%). TTP was 3.87 months (CI 95%, 2.1-5.6), time to treatment failure was 2.97 months (CI 95%, 2.43-4.67) and OS 6.3 months (CI 95%, 4-7). The chemotherapeutic combination was well accepted; most haematologic and non-haematologic toxicities were grade 1 or 2. The most prevalent grade 3/4 toxicities were asthenia (30%), liver biochemistry disorders (25%), diarrhoea (15%) and stomatitis (12%). CONCLUSIONS: The administration of gemcitabine, associated with oral tegafur and leucovorin, has activity against advanced pancreatic cancer, with an adequate toxicity profile (AU)

Investigación en cuidados paliativos en España. Una revisión de las comunicaciones presentadas en los congresos de la Sociedad Española de Cuidados Paliativos (2000-2006) / No disponible

Objetivo: analizar la producción científica en el ámbito de los cuidados paliativos basándose en las comunicaciones presentadas en los III, IV,V y VI congresos de la SECPAL. Material y método: se han presentado un total de 1.069 comunicaciones orales o póster. Para cada comunicación se han analizado los siguientes parámetros: comunidad de origen, número de autores, principales centros investigadores, lugar de trabajo, áreas temáticas y tipo de estudio. Las comunicaciones presentadas en los V y VI Congresos se han puntuado en función de 6 parámetros: importancia, interés, relación entre título y contenido, adecuación del diseño y metodología, solidez y relevancia de los resultados y solidez de las conclusiones. Resultados: las comunidades autónomas más activas han sido Cataluña,Valencia, Canarias y Andalucía. El equipo más productivo ha sido el Hospital Dr. Negrín de Las Palmas de Gran Canaria (90 comunicaciones). La mayoría de comunicaciones corresponden a trabajos realizados en unidades de cuidados paliativos (434), seguidas por las efectuadas en equipos de soporte domiciliarios (175). Los temas de organización, otros síntomas excepto dolor, tratamiento complementario y farmacología son las áreas temáticas preponderantes. El 21% son estudios prospectivos. Sobre un máximo de 18 puntos por comunicación, la media ha sido de 7,66 para el V Congreso y de 7,36 para el VI. Conclusiones: el mayor número de aportaciones a los congresos de la SECPAL corresponde a las unidades de cuidados paliativos. El nivel científico es mejorable y es necesario un esfuerzo para la mejora de la calidad de los trabajos presentados (AU)

Objective: to describe the scientific activity in palliative care research in Spain, as measured by the abstracts submitted to four national congresses of the Spanish Society of Palliative Care (SECPAL) (3th-6th, from 2000 to 2006). Material and method: 1,069 abstracts accepted in the four congresses were analyzed. Data collected: autonomic administration source, number of authors, work center, issues, study design. The quality of the abstracts presented to the 5th and 6th congresses was evaluated. Assessments included six items: study importance, interest, connection between title and contents, study design, result and conclusion significance. Results: the most productive autonomic administrations were Catalonia, Valencia, Canary Islands and Andalusia. Mean authors: 5.4 (1-19). Setting: 175 (16%) Home Palliative Care Team, 434 (41%) Palliative CareUnit, 129 (12%) Medical Oncology Department, 154 (14%) other hospital departments, and 179 (17%) others. Topic areas: 234 (22%) organization, 69 (6%) pain, 186 (17%) other symptoms, 106 (10%) complementary therapies/treatment, 101 (9%) pharmacology, 51 (5%) family, 322 (31%) others. Study design: 452 (42%) descriptive, 224 (21%) retrospective, 224 (21%) prospective, 22 (2%) others. Mean total score obtained was 7.66 (5th congress) and 7.36 (6th congress) (range: 0-18). Conclusions: Palliative Care Units presented most of the abstracts. Organization and health system issues were common topics. The mean total score obtained was low. Prospective and multicenter studies should be encouraged to improve research in palliative care, and more stringent criteria for abstract acceptance should be implemented (AU)

A phase II trial of the combination of gemcitabine, ifosfamide and cisplatin in the treatment of advanced non-small cell lung cancer.

OBJECTIVE: This phase II trial was designed to assess the efficacy and toxicity profile of the combination of gemcitabine, ifosfamide and cisplatin (GIP) in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients included in the study were those with surgically unresectable or metastatic NSCLC, with bidimensionally measurable disease, a Karnofsky performance status > 60, and who had not received previous chemotherapy. Treatment consisted of 1000 mg/m(2) gemcitabine on days 1 and 8, 3 g/m(2) ifosfamide on day 1, and 50 mg/m(2) cisplatin on day 1, administered in 21-day cycles. A maximum of six cycles were administered. RESULTS: Between March 1996 and December 1997, 60 patients were included in the study (37 stage III and 23 stage IV), of which 59 were evaluated for response. An objective response was obtained in 43% of patients (3% complete and 40% partial responses), whereas 22% had stable disease. The median survival time for the whole group was 52 weeks (65 weeks in patients with stage III, and 35 weeks in stage IV). The most frequent toxicity was haematological, 56% of patients presented grade 3 or 4 myelotoxicity in one of the cycles, although only seven episodes of febrile neutropenia were recorded in the 255 cycles administered. CONCLUSIONS: The GIP regimen attains response rates similar to those obtained with the gemcitabine plus cisplatin combination used in advanced NSCLC, and had an acceptable toxicity profile.

[The initial symptom attributable to cancer in digestive tube tumors. A study of agreement between the patient and the physician]. / El síntoma inicial atribuible al cáncer en los tumores del tubo digestivo. Un análisis de la concordancia entre el paciente y el médico.

BACKGROUND: Clinical practice shows that certain patients may underestimate and others overestimate some initial symptoms of their disease. In studies on the interval between first symptoms and treatment onset, estimating the date in which symptoms first appeared is crucial. The study analyzed patient-physician agreement in assessing first symptom attributable to cancer. METHODS: During two years, two physicians personally interviewed, through a structured questionnaire, all symptomatic patients with a neoplasm of the digestive tract admitted to Hospital del Mar (Barcelona, Spain). Patients had a mid-low sociocultural profile and most had been admitted through the Emergency Department. RESULTS: Absolute agreement (symptom and date) occurred in 85% of the 183 subjects. In most discordant cases, patients had overlooked some component of the "toxic syndrome", and the date of symptom onset was, based on physician's assessment, chronologically prior to the date elicited from the patient. Disagreement was directly related to the patient's health status (p < 0.05) and to the number of reported symptoms until hospital admittance (p = 0.002), but not to tumour stage. Agreement increased with the importance attributed by the patient to the first symptom (p < 0.05). CONCLUSIONS: In spite of difficulties inherent to measuring symptomatic onset of diseases, structured patient interviews appear to be a reasonably valid method and deserve further development in this and other areas of research.

[Hodgkin's disease and infection with human immunodeficiency virus]. / Enfermedad de Hodgkin e infección por el virus de la inmunodeficiencia humana.

Three patients with Hodgkin's disease, mixed cellularity subtype, plus infection by human immunodeficiency virus are presented. Two of them were intravenous drug abusers, and one had promiscuous heterosexual behaviour; they all presented B-type symptoms. One patient died because of infection, whereas the other two persisted in complete remission after treatment at 4 and 5 years of follow-up, respectively. None of the patients still alive has developed AIDS. The criteria for considering Hodgkin's disease as an AIDS-related lymphoproliferative disorder are discussed.

[A descriptive study of 105 patients with cerebral metastasis]. / Estudio descriptivo de 105 pacientes con metástasis cerebrales.

BACKGROUND: To investigate the hospital frequency and natural history of patients with cerebral metastases (CM). METHODS: A retrospective study of patients seen because of CM from 1984 to 1989. They were identified from the discharge reports and the cancer registry (CR). Data of interest were taken from the clinical record and the CR. RESULTS: 105 patients were identified. Mean age was 60 years. There were 77 males. In 44 patients cancer past history was present, in 33 lung cancer was simultaneously diagnosed and in 28 there was no past cancer history and the primary neoplasm was not identified. CM were multiple in 49 patients. In 18 patients CM was single, with no extracerebral neoplasia. Craniotomy was carried out in 22 patients and 11 received postoperative radiotherapy. The probability of one-year survival in the operated and nonoperated group was 27% and 1.5%, respectively (27 +/- 20% and 1.5% +/- 1.5%; 95% confidence intervals). CONCLUSIONS: The frequency of the diagnosis of CM is not negligible and its occurrence virtually always represents a fatal prognosis. About one half are caused by a lung cancer that may have clinically presented with CM. Poor general condition, multiple CM or extracerebral neoplastic disease prevent radical therapeutic intervention in nearly 80% of these patients. Survival with palliative therapy is shorter than that with surgical treatment.