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Biomedical subjects

M L García de Paredes

Publications and source records attributed to M L García de Paredes.

At least 19 recordsLinked to original sources

Idarubicin and intermediate dose ARA-C followed by consolidation chemotherapy or bone marrow transplantation in relapsed or refractory acute myeloid leukemia.

Sixty-one adult patients with relapsed or refractory acute myelogenous leukemia (AML) were treated in a cooperative study with Idarubicin 12 mg/m2/day on days 1 to 3 and AraC 1 g/m2/12h on days 1 to 4. Responding patients were scheduled for consolidation with Ida-IDAraC and bone marrow transplantation (BMT) when feasible. Twelve of 23 refractory patients (52%) and 21 of 38 relapsed patients (55%) achieved complete remission (CR). Refractory patients treated very early with Ida-IDAraC (CR 63%) and relapsed patients with initial CR > 6 months (CR 68%) were the subgroups with better CR rate. The only factor influencing the disease free survival (DFS) was the intensity of postremission therapy: Nine patients had severe toxicity with the salvage regimen and were excluded for consolidation, fourteen patients received Ida-IDAraC and ten patients proceeded to myelo-ablative therapy supported with autologous or allogeneic BMT. The three groups had different median DFS of 6 months, 9 months and 15 months respectively (P = 0.017). In summary, Ida-AraC is an efficient salvage regimen for AML. The CR rate seems to be improved in refractory patients if used promptly, but the long term outcome appears to depend on the intensity of treatment given once remission is achieved and on the ability to perform BMT.

Acute Disease↗

Phase II study with iododoxorubicin in measurable advanced colorectal adenocarcinoma. Effective rescue using weekly high-dose 5-fluorouracil (WFU). Spanish Cooperative Group for Gastrointestinal Tumor Therapy (TTD), Work Group of SEOM (Spanish Medical Oncology Society).

AIMS AND BACKGROUND: To evaluate a new anthracycline 4'-iodo-4'-deoxydoxorubicin (I-DOX) in patients with measurable advanced colorectal adenocarcinoma in a phase II study. METHODS: We investigated therapeutic activity and toxicities associated with repeated courses of I-DOX 80 mg/m2 administered every 3 weeks. Eighteen patients entered the trial, all of them evaluable for response and toxicity. RESULTS: A total of 47 courses were administered. The median cumulative I-DOX dose was 238 mg/m2 (80-320). Myelosuppression, particularly leukopenia, was the most frequent and serious side effect associated with I-DOX treatment; World Health Organization (WHO) grade 3-4 leukopenia occurred in 4 patients (22%). No thrombocytopenia was observed except in 1 patient who presented WHO grade 4. Only 1 patient developed febrile neutropenia but recovered uneventfully. Overall, the I-DOX treatment was well tolerated. Grade 3-4 nausea/vomiting was observed in 2% of the cycles and no other severe toxicities were recorded. Echocardiography or multiple gated scan was performed before treatment and during follow-up in 14 patients to measure left ventricular ejection fraction (LVEF), and a decrease > 15% was detected in 3, including 1 whose LVEF fell below normal values (48%) (normal range > 49%). There were no cases of congestive heart failure or treatment-related deaths. No complete or partial response (PR) was observed. Twelve patients received weekly high-dose 5-fluorouracil (WFU) as rescue. Four patients had PR, 5 no change and 3 progressive disease (PD). The median time to PD of the whole group from study entry to failure after WFU was 30 weeks and the overall median survival was 11 months. CONCLUSIONS: As reported for other anthracyclines, I-DOX showed no activity in colorectal adenocarcinoma; however, the use of an investigational agent as front-line chemotherapy for colorectal adenocarcinoma does not compromise further response to 5-FU.

Adenocarcinoma↗

Soft tissue sarcomas: thirteen years experience in the service of medical oncology of a general hospital.

Thirty-seven patients with soft tissue sarcomas were treated between 1981 and 1990. All of them were operated. Thirteen patients with marginal resection received adjuvant radiotherapy. Radiotherapy decreased the rate of local relapses. Sixteen patients received adjuvant chemotherapy with ifosfamide-epirubicin and four of them had a recurrence. Twenty-one patients did not receive chemotherapy and 13 of them relapsed. Adjuvant chemotherapy improved the disease-free survival during the first year, but not benefit appeared in long-term disease-free survival and overall survival.

Adult↗

Usefulness of megestrol acetate in cancer cachexia and anorexia. A placebo-controlled study.

To assess the effect of megestrol acetate (MA) on the appetite and weight of cancer patients with nonhormone-dependent tumors, a double-blind, placebo-controlled trial was designed. One hundred fifty patients were included: 76 were given MA (240 mg/day orally) for at least 2 months, and 74 were given placebo (P). Body weight, subjective sense of appetite (SSA) evaluated by an analogic linear visual scale scored from 1 to 10, and performance status (PS) were measured before therapy and monthly thereafter. No differences in body weight before and after treatment could be found in any group. However, 32% of the patients in the MA group (95% confidence interval: 20.1-44.6%) gained 2 or more kilograms (P less than 0.001). This group also showed an improvement in SSA (P less than 0.01): an increase greater than or equal to 2 points appeared in 57.5% of patients (95% confidence interval 44.6-69.4%). There was no significant difference in PS for the treatment groups before or after therapy. The percentage of reported adverse events did not differ significantly from one treatment group to the next. We conclude that therapy with MA at a dose of 240 mg/day improved SSA and was associated with moderate weight gain in patients with hormone-insensitive malignancies.

Adult↗

Comparison of two antibiotic regimens (piperacillin plus amikacin versus ceftazidime plus amikacin) as empiric therapy for febrile neutropenic patients with cancer.

A total of 170 febrile episodes in neutropenic patients with cancer were randomly assigned to be treated with piperacillin-amikacin or ceftazidime-amikacin. The overall response rates were similar in both groups (68 and 65%, respectively). Response rates for clinically or microbiologically documented episodes were 54.5% for piperacillin-amikacin and 58.8% for ceftazidime-amikacin. Response rates for gram-negative bacillary infections were 65 and 73%, respectively. There was also no difference for gram-positive infections (31 and 50%, respectively). The toxicities were also comparable and consisted of skin rashes, hypokalemia, and diarrhea. Vancomycin was added if the fever persisted 72 h after the beginning of therapy; it increased the response rates to 94% when used with piperacillin-amikacin and 92% when used with ceftazidime plus amikacin. Our results suggest that the combinations show similar global efficacies in the treatment of febrile episodes in cancer patients.

Adult↗

Antiemetic regimens in outpatients receiving cisplatin and non-cisplatin chemotherapy. A randomized trial comparing high-dose metoclopramide plus methylprednisolone with and without lorazepam.

Results of a randomized trial on antiemesis for cisplatin (CDDP) and non-CDDP chemotherapy-induced vomiting are reported. One hundred and sixty-three outpatients received 282 chemotherapy courses (141 with CDDP and 141 without CDDP). Patients were randomly assigned to receive either high-dose metoclopramide plus methylprednisolone (arm A) or the same drugs plus lorazepam (arm B). In both arms a high protection rate for vomiting was obtained, on the whole without statistically significant differences. Patients who received lorazepam had, however, significantly fewer nausea episodes during first day post-chemotherapy (p less than 0.05). Arm B was also superior in anxiety control during the first day of chemotherapy (p less than 0.01). Both regimens were significantly more effective in patients who had not been given chemotherapy previously (p less than 0.01). No differences in antiemetic protection were found between CDDP and non-CDDP courses. No significant differences were found in premonitory vomiting control between the two arms of the trial. Toxicity was very mild with both regimens, although sedation was significantly higher in arm B (p less than 0.001). We conclude that high-dose metoclopramide plus methylprednisolone is a highly effective combination for chemotherapy-induced nausea and vomiting, and that it is quite suitable for outpatient use. Lorazepam did not significantly increase the antiemetic potency of the combination, nor did it improve premonitory vomiting control, although it gave a better control of acute nausea and anxiety.

Antineoplastic Agents↗

[Second neoplasms in Hodgkin's disease].

Today, excellent therapeutic results are obtained in Hodgkin's disease however, they may be obscured by the development of long term complications due to the treatment given including second neoplasias. Out of the total of 250 cases of Hodgkin's disease reviewed during 19 years we found 13 secondary neoplasias. All the patients received alkylating drugs and in 10, both chemo and radiotherapy were associated. The average interval of time was 48 months. Bronchopulmonary carcinomas and acute leukemias were the malignancies most often encountered.

Adolescent↗

Ewing's tumor in brothers. An unusual observation.

Ewing's sarcoma in two brothers is described. This has not been previously reported in the literature. Hypotheses which might explain this association are discussed. Genetic factors predisposing to the development of neoplasia are a very attractive possibility, although viral factors and chance association cannot be excluded.

Adolescent↗