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)

GEIS: una década de historia / GEIS: one decade of history

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El uso de fentanilo transdérmico por una unidad de atención domiciliaria en pacientes oncológicos en el final de la vida / Use of transdermic fentanyl by a department of home medical care of terminal oncologic patients

• Propósito: Se ha realizado un estudio observacional y retrospectivo para evaluar el modo de utilizacióny los efectos secundarios de fentanilo transdérmico (FTTS) en pacientes oncológicos en situación terminal.• Material y métodos: Se han evaluado estadísticamente pacientes incluidos en un programa de AtenciónDomiciliaria que recibieron tratamiento con FTTS.• Resultados: 112 pacientes (p) recibieron tratamiento con FTTS. Mediana de edad de 71.5 años (29-88).102p presentaban dolor y 10 disnea. Tipo de dolor: visceral 55% p, óseo 25% p, neuropático 12.5%, muscular5% p y otro 2.5% p. EVA inicial: media 5.9. La analgesia previa a la utilización de fentanilo fue: 31% p AINES,32.2% p tramadol, 5.6% p codeína y 31% p morfina. La dosis mediana inicial de fentanilo fue 50mgr/hora(25-300). La dosis mediana final fue 75 mgr/hora (25-400). EVA final media: 3,3. La mediana de la duracióndel tratamiento fue de 44 días (1-372). 35 p (31%) presentaron náuseas G2-3, somnolencia 5 p, agitacióny/o delirio 13 p. 81 p (72%) precisaron laxantes. En 10 p fue necesario rotar a otro opioide: 4 p por toxicidad y6 p por mal control del dolor.• Conclusiones: El FTTS es un analgésico bien tolerado en pacientes terminales y proporciona una analgesiaadecuada (91%), a un bajo coste en cuanto a yatrogenia intolerable (4%), tanto con paso previo conopioides como directamente desde primer escalón analgésico OMS

• Purpose: An observational and retrospective study was performed in order to evaluate the activity andtoxicity of transdermal fentanyl in patients with advanced cancer.• Material and methods: 112 patients treated by a home palliative care unit were studied. Thecharacteristics of patients, analgesic treatments, and opioid rotation were analysed from the beginning offentanyl administration to the death.• Results: The mean age of the patients (p) was 71.5 years (range, 29-88). The indication for opioidadministration was pain in 102 and dyspnea in 10 patients. The type of pain was visceral in 56 p (55%), bonyin 25 p (25%), neuropatic in 13 p (12.8%), muscular in 5 p (5%), and others in 3 p (2.1%). The baseline meanvalue of the pain analogical visual scale (AVS) was 5.9. The analgesics administered before fentanyl was givenwere tramadol (32.2%), NSAIDs (31%), morphine (31%) and codeine (5.6%). The median initial dose offentanyl was 50 µg (range, 25-300). The final mean dose at the time of death was 75 µg (25-400). The finalmean AVS was 3.3. The median treatment duration was 44 days (range, 1 to 372). It caused G2-3 nausea in 35p (31%), somnolence in 13 p, and agitation in 5 p; 81 patients received laxatives. Opioid rotation withmorphine was necessary in 10 p because of toxicity, and in 6 p because uncontrolled pain.• Conclusions: Transdermal fentanyl is a well tolerated analgesic in patients with advanced cancer,providing a good analgesia in up to 91% of the patients previously treated with opioids, as well as of thepatients proceeding directly from the first or second step of the WHO ladder