Gemcitabine plus vinorelbine in nonsmall cell lung carcinoma patients age 70 years or older or patients who cannot receive cisplatin. Oncopaz Cooperative Group.

BACKGROUND: Although the prevalence of nonsmall cell lung carcinoma (NSCLC) is high among elderly patients, few data are available regarding the efficacy and toxicity of chemotherapy in this group of patients. Recent reports indicate that single agent therapy with vinorelbine (VNB) or gemcitabine (GEM) may obtain a response rate of 20-30% in elderly patients, with acceptable toxicity and improvement in symptoms and quality of life. In the current study the efficacy and toxicity of the combination of GEM and VNB in elderly patients with advanced NSCLC or those with some contraindication to receiving cisplatin were assessed. METHODS: Forty-nine patients with advanced NSCLC were included, 38 of whom were age >/= 70 years and 11 were age < 70 years but who had some contraindication to receiving cisplatin. All patients were evaluable for response and toxicity. Treatment was comprised of VNB, 25 mg/m(2), plus GEM, 1000 mg/m(2), both on Days 1, 8, and 15 every 28 days. Patients received a minimum of three courses unless progressive disease was detected. RESULTS: One hundred sixty-five courses were administered, with a median of 3. 6 courses per patient. The overall response rate was 26% (95% confidence interval, 15-41%). Two patients attained a complete response (4%) and 11 patients (22%) achieved a partial response. Eastern Cooperative Oncology Group performance status improved in 35% of those patients with an initial value > 0, whereas relief of at least 1 symptom without worsening of other symptoms was noted in 27 patients (55%). The median time to progression was 16 weeks and the 1-year survival rate was 33%. Toxicity was mild. Six patients (12%) had World Health Organization Grade 3-4 neutropenia, 2 patients (4%) had Grade 3-4 thrombocytopenia, and 2 patients (4%) had Grade 3 neurotoxicity. Three patients with severe neutropenia (6%) died of sepsis. The median age of those patients developing Grade 3-4 neutropenia was significantly higher than that of the remaining patients (75 years vs. 72 years; P = 0.047). CONCLUSIONS: The combination of GEM and VNB is moderately active and well tolerated except in patients age >/= 75 years. This age group had an increased risk of myelosuppression. Therefore the prophylactic use of granulocyte-colony stimulating factor should be considered with this treatment. New chemotherapy combinations with higher activity and lower toxicity are needed for elderly patients with advanced NSCLC.

Uracil and tegafur modulated with leucovorin: an effective regimen with low toxicity for the treatment of colorectal carcinoma in the elderly. Oncopaz Cooperative Group.

BACKGROUND: In spite of the high prevalence of cancer in the elderly, little information is available about the efficacy and toxicity of chemotherapy in elderly patients. In a previous study, the authors demonstrated that the combination of uracil and tegafur (UFT) with leucovorin (LV) was active and well tolerated in patients with advanced colorectal carcinoma (ACC). The objective of the current study was to determine the efficacy and toxicity of this regimen in elderly patients with ACC. METHODS: Thirty-eight unselected patients older than 70 years (median age, 74 years) with measurable ACC were included. All patients were evaluable for toxicity and response. The regimen consisted of intravenous LV 500 mg/m2 on Day 1, oral LV 15 mg every 12 hours on Days 2-14, and oral UFT 390 mg/m2 on Days 1-14. Treatment was repeated every 28 days for a minimum of 4 courses per patient. RESULTS: Two hundred eighty-eight cycles of chemotherapy were delivered (median, 7 per patient). Two patients (5%) achieved a complete response and 9 (24%) a partial response, for an overall response rate of 29%. Toxicity was mild, without dose-limiting myelosuppression. Four patients (10%) experienced Grade 3-4 diarrhea, 1 patient had Grade 3-4 nausea/vomiting, and 1 had Grade 3-4 mucositis. Grade 3-4 toxicity was more frequent among women than men (38% vs. 4%, P < 0.05). CONCLUSIONS: Treatment with oral UFT modulated with LV is effective, well tolerated, and feasible on an outpatient basis for elderly patients with ACC. However, elderly women should be followed closely for the early detection of toxicity.

Pericardial tamponade as the first manifestation of adenocarcinoma.

We hereby report on 13 cases of pericardial tamponade as the first manifestation of an adenocarcinoma. The primary tumor was detected in 10 cases: 7 lung, 1 stomach, 1 breast and 1 thyroid. A first cytologic examination of the pericardial fluid yielded the diagnosis of adenocarcinoma in 10 cases, whereas a second cytology was needed in another two cases. The pericardial biopsy was positive in 7 out of 7 patients. The therapeutic procedures included pericardiocentesis in 9 patients (6 of whom had recurrent tamponade), a pericardial window in 4 and pericardiotomy in 4 (without recurrences). The mean survival was 4 months.

Cisplatin and UFT modulated with leucovorin for the treatment of Advanced non-small-cell lung cancer.

We performed a phase II study to assess the efficacy and toxicity of the cisplatin-UFT-leucovorin (LV) combination in patients with advanced non-small-cell lung cancer (NSCLC). Twenty-five patients with measurable disease who had not received prior chemotherapy were entered into the trial. The therapeutic regimen consisted of cisplatin 90 mg/m(2) and i.v. LV 500 mg/m(2) on day 1, followed by oral UFT 390 mg/m(2)/day (in two doses on days 1 through 14. Patients also received oral LV 15 mg/12 h on days 2 through 14. Seventeen patients required reduced doses of UFT (200 mg/m(2) due to toxicity. Courses were repeated every 28 days for a minimum of three per patient. Three of 25 patients (12%) achieved a partial response (95% CI: 2.6 to 32.2%), two with 390 mg/m(2)/day and one with 200 mg/m(2)/day of UFT. The main side effects were hematological and gastrointestinal. In the courses including 390 mg/m(2)/day of UFT, grade 3-4 toxicity was leucopenia in 18% of the courses, nausea/vomiting in 27%, and diarrhea and epigastralgia in 13% each. Grade 3-4 toxicities for 200 mg/m(2)/day of UFT were leucopenia 2%, nausea/vomiting 9% and diarrhea 7%. In conclusion, this regimen cannot be recommend for the treatment of advanced NSCLC due to its low response rate and high toxicity.

Efficacy of oral tegafur modulation by uracil and leucovorin in advanced colorectal cancer. A phase II study.

A phase II study was performed to assess the efficacy and toxicity of UFT (tegafur-uracil in the molar ratio 1:4) modulated with leucovorin (LV) in previously untreated patients with advanced colorectal carcinoma (CRC). 79 patients with measurable advanced colorectal cancer (CRC) and no prior chemotherapy were included. 75 patients were evaluable for toxicity and response. The regimen consisted of LV 500 mg/m2 administered intravenously on day 1, followed by oral UFT 390 mg/m2 on days 1-14. Patients received oral LV 15 mg every 12 h on days 2-14. Treatment was repeated every 28 days for a minimum of four courses per patient. Three hundred and ninety-eight cycles of chemotherapy were delivered (median five per patient). 7 patients (9%) had a complete response, and 22 a partial response for an overall response rate of 39%. Mild gastrointestinal toxicity was dose limiting: grade 3-4 diarrhoea appeared in 9% of patients. Other grade 3-4 toxicities were nausea/vomiting and mucositis in 4% of patients, gastric pain and leucopenia in 3%. Oral UFT modulated by oral LV is active in advanced CRC and can be administered on an outpatient basis with no significant toxicity requiring hospitalisation. Given its excellent tolerance profile and low toxicity, the regimen should be thoroughly studied and compared with 5-fluorouracil modulated by LV.

Comparison of two chemotherapeutic regimens--mitomycin + vindesine + cisplatin (MVP) vs. mitomycin + ifosfamide + cisplatin (MIP)--in advanced non-small-cell lung cancer. ONCOPAZ Cooperative Group.

BACKGROUND: A prospectively randomized trial was performed to compare the efficacy and toxicity of two chemotherapeutic regimens widely used in advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: From January 1989 to March 1992, 196 patients with measurable disease were included in the trial. Ninety-three patients received mitomycin-vindesine-cisplatin (MVP) and 94 mitomycin-ifosfamide-cisplatin (MIP). RESULTS: The objective response rate (complete plus partial remissions) was 28% (26/93 patients, 95% confidence interval 20%-40%) in the MVP arm and 30% (28/94 patients, 95% confidence interval 20.5%-40%) in the MIP arm. The median survival was 8.5 and 9 months, respectively. Neither the response rates nor the median survivals were significantly different. Grade III-IV leukopenia was more frequent with MVP (13% vs. 2% of the courses, p < 0.001), as well as grade I-II neurologic toxicity (30% vs. 6%, p < 0.001). In contrast, grade I-II anemia and grade I-II urologic toxicity were more frequent with MIP (7% vs. 25%, p < 0.001 and 1% vs. 11%, respectively). CONCLUSION: Given the low efficacy of both schemes in the treatment of advanced NSCLC, their use cannot be recommended outside of clinical trials.

Phase I study of UFT plus leucovorin in advanced colorectal cancer: a double modulation proposal.

Twenty-six patients with advanced colorectal cancer were treated with UFT and leucovorin (LV). On day 1, patients received LV 500 mg/m2 in IV infusion, followed by 15 mg/12 h for 13 days. On days 1 to 14, patients took oral UFT twice daily. Three cycles were given every 28 days, unless grade III-IV toxicity appeared. The initial dose of UFT (200 mg/day) was increased until 800 mg/day. Dose limiting toxicities were stomatitis, diarrhea and epigastralgia. The maximum tolerated dose of UFT was 390 +/- 10 mg/m2. Three out of 24 evaluable patients achieved a partial response and 1 a complete response with UFT doses of 260 to 390 mg/m2. These results warrant confirmation in phase II studies.

[Bearable truth as the crux of information for the cancer patient]. / La verdad soportable como eje de la información al paciente con cáncer.

The communication with the patient suffering cancer is attracting an increasing attention. The change of attitudes towards death in our society, the poor training of physicians in this field and other factors have raised this new problem. In addition to the patient and the physician, the relatives and the nursing staff are also involved in the communication process. From the studies already performed, it can be derived that the "bearable truth" has to be supplied to the patient. The application of this concept needs time and dedication to the patient.

[Descriptive study of the care of oncologic patients at the emergency service of a general hospital]. / Estudio descriptivo de la asistencia a enfermos oncológicos en el Servicio de Urgencias de un hospital general.

Clinical records of 352 patients seen in the Emergency Room of Hospital La Paz between January and April 89 and previously diagnosed of a malignancy were retrospectively reviewed. From the present study we concluded: 85.5% of them had not been seen by a physician before admission; most common tumors were lung, breast and gastrointestinal; anxiety and respiratory diseases were the most frequent diagnoses. This group of patients rarely need sophisticated complementary tests or therapy, but they spend more time at the hospital than other patients.

[Primary multicentric cerebral lymphoma in a previously healthy patient]. / Linfoma cerebral primario multicéntrico en paciente previamente sano.

Primary cerebral non-Hodgkin's lymphoma (PCL) is not very frequent, especially in the immunologically normal patient. Its radiological features and the response to steroid and radiotherapy treatment force the physician to consider it amongst the differential brain tumor diagnoses; particularly when an extraordinary remission is observed after steroid treatment, even in an immunologically normal patient.

Bone metastases as the first manifestation of a tumour.

We have reviewed 29 patients whose first sign of a tumour was a bone metastasis. Two primaries were identified, lung adenocarcinoma and uterine adenocarcinoma and in 2 cases a presumptive diagnosis of tumours of the breast and prostate was made. The mean survival time was 3 months. When bone metastases are found in the absence of a primary tumour, investigation must include a clinical history, physical examination, routine laboratory tests and chest radiographs. Mammography should be done in women, particularly when there are palpable axillary nodes. Abdominal CT scanning and bronchoscopy should only be undertaken when there is a clinical indication.