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Biomedical subjects

A Ribas

Publications and source records attributed to A Ribas.

At least 55 records · Page 3Linked to original sources

Frequent dose delays and growth factor requirements with the sequential doxorubicin-CMF schedule.

Doxorubicin for four cycles plus cyclophosphamide, methotrexate and 5-fluorouracil (CMF) for eight cycles is an effective adjuvant regimen for breast cancer patients with more than three involved axillary lymph nodes. We reviewed the incidence of dose delays and growth factor requirements when this regimen is administered to patients receiving concurrent irradiation. Thirty-six patients with more than three involved axillary lymph nodes were treated with the sequential regimen doxorubicin-CMF and irradiation. Patients with two or more dose delays received G-CSF treatment. Seventy-five percent of the patients required dose delays for day-22 neutropenia, and growth factors were needed for half of the patients in order to maintain a received dose intensity of 0.940. The first delayed cycle occurred in 74% of the patients while receiving concomitant chemoradiotherapy. Frequent dose delays were required when the sequential regimen doxorubicin-CMF was administered along with radiotherapy. Growth factors are needed to maintain dose intensity similar to that achieved in the original trial.

Adult↗

M-CAVI, a neoadjuvant carboplatin-based regimen for the treatment of T2-4N0M0 carcinoma of the bladder.

Carboplatin, methotrexate, and vinblastine (M-CAVI) is an active and well-tolerated regimen for bladder cancer patients ineligible for cisplatin-based regimens. We treated 47 T2-4 N0 M0 bladder cancer patients with M-CAVI in a neoadjuvant phase II trial. These 47 patients are evaluable for clinical response and toxicity. Clinical overall response rate was 34%, for a 95% confidence interval (CI95%) of 21-49%. Pathological response was seen in 40% of the patients (CI95%, 26-56%) with a 26.5% rate of pathological complete response (CI95%, 15-42%). Factors associated with the achievement of a response to therapy were the initial TNM stage (pT3a or lower, greater than pT3a, p = 0.001) and a Karnofsky score greater or equal than 90%, which was marginally significant (p = 0.08). With a median follow-up of 14 months, the disease-specific actuarial survival at 2 years is 42%. No patient has relapsed beyond 21 months of follow-up in a disease-free status. Toxic effects have been moderate. In conclusion, M-CAVI is an active and well-tolerated regimen that should be compared in terms of response rate and survival with a cisplatin-based regimen for invasive bladder cancer.

Actuarial Analysis↗

Five-day course of granulocyte colony-stimulating factor in patients with prolonged neutropenia after adjuvant chemotherapy for breast cancer is a safe and cost-effective schedule to maintain dose-intensity.

PURPOSE: To analyze the safety and efficacy of a short course of granulocyte colony-stimulating factor (G-CSF) to maintain dose-intensity of subsequent cycles of chemotherapy after a prior episode of prolonged neutropenia, without febrile complications, in patients receiving adjuvant treatment for breast cancer. PATIENTS AND METHODS: Thirty-two patients undergoing adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin-CMF for stages I to II breast cancer were included after having chemotherapy delays due to neutropenia (absolute neutrophil count [ANC] < 1.5 x 10(9)/L) on day 22. G-CSF was administered subcutaneously on days 15 to 19 of each subsequent cycle. RESULTS: None of the patients included in this study had to be admitted to the hospital for fever and neutropenia. The median percentage of the projected dose-intensity for CMF or doxorubicin-CMF on an intent-to-treat basis was 0.994, which was significantly higher than the delivered dose-intensity before the start of G-CSF treatment (P < .0001). Patients who received concomitant G-CSF and radiotherapy achieved a similar dose-intensity as patients who did not undergo radiotherapy. Seven patients discontinued G-CSF treatment due to musculoskeletal pain. These patients had more subsequent cycle delays because of day 22 neutropenia than the 25 patients who followed the G-CSF schedule (P = .0028). CONCLUSION: A 5-day course of G-CSF in patients with prior chemotherapy delays due to prolonged neutropenia seems to be a safe and cost-effective schedule to maintain CMF or doxorubicin-CMF dose-intensity in the adjuvant treatment of breast cancer.

Adult↗

[Preliminary results of a phase II randomized controlled trial comparing M-VAC and M-CAVI in patients with bladder cancer (T2-4 N0-1 M0)].

OBJECTIVES: The combination of carboplatin, methotrexate and vinblastine (M-CAVI) is an active and well-tolerated regimen for patients with bladder cancer who are ineligible for cisplatin-based regimens. We have prospectively randomized patients with locally advanced (T2-4 N0 M0) or locoregional (Tx N1 M0) bladder cancer suitable for subsequent surgical treatment to M-VAC or M-CAVI chemotherapy. METHODS: M-CAVI consisted of carboplatin (300 mg/m2 on day 1 and later adjusted to 4.5 mg/dl/min according to Calvert's formula), methotrexate (30 mg/m2 on days 1, 15 and 22) and vinblastine (3 mg/m2 on days 1, 15 and 22). After 3-4 cycles, the patients were assessed for surgical resection. RESULTS: To date, 60 patients have been included. There were 58 completely evaluable patients, 27 were randomized to M-VAC and 31 to M-CAVI. The overall response rates were similar for M-VAC (48%; confidence interval 95%, 26%-67%) and M-CAVI (45%; confidence interval 95%, 28%-62%). The pathological complete responses were similar for the M-VAC and M-CAVI regimens for both the group with locally advanced (27% vs 39%, p = NS) and locoregional (14% vs 14%, p = NS) bladder cancer. The median actuarial survival for the M-VAC treated group was 23 months and 18 months for the M-CAVI. M-VAC therapy was statistically significantly associated with more events of granulocytopenic fever, grade 2-3 nausea and vomiting, grade 2 alopecia and grade 3-4 mucositis. CONCLUSIONS: The results achieved in the 60 patients included in the study indicate that M-CAVI is better tolerated than M-VAC, although both treatment regimens have similar overall response rates, pathological response rates and survival in patients with locally advanced and locoregional bladder cancer.

Adolescent↗

Phase II trial of an all-oral regimen of tegafur and folinic acid in patients with previously treated metastatic breast cancer.

BACKGROUND: Tegafur is an antimetabolite slowly metabolized to 5-fluorouracil in vivo. Protracted administration of oral tegafur is active in metastatic breast cancer, with reported response rates ranging from 29 to 44%. The addition of folinic acid could improve the efficacy of tegafur by means of biochemical modulation. METHODS: A prospective Phase II trial in patients with pretreated metastatic breast cancer was performed. The regimen consisted of oral tegafur (750 mg/m2/day) and oral folinic acid (45 mg/day) for 21 days, recycling at day 28. RESULTS: Twenty-five patients were included. Eight partial responses were observed for an objective response rate of 32% (95% confidence intervals for response, 23-41%). The median duration of response was 7 months. According to WHO criteria, 24% of patients experienced grade 3 mucositis and 12% grade 3 diarrhea, but no other significant toxicities were observed. Twenty-eight percent of patients required dose reductions for toxicity. CONCLUSIONS: A significant response rate with oral tegafur and folinic acid in patients with heavily pretreated breast cancer was found. This all-oral regimen, which could be safely administered on an outpatient basis, deserves further evaluation to define the role of folinic acid on the activity of tegafur in metastatic breast cancer.

Administration, Oral↗

Malignant lymphoproliferative diseases in HIV-seropositive patients. A study of 40 cases at a single institution in Spain.

We identified 40 patients with malignant lymphoproliferative diseases (MLD) and HIV infection (seropositive) at a single Spanish university hospital. Thirty-two patients had non-Hodgkin's lymphoma (NHL), 6 primary central nervous system lymphoma (PCL) and 8 patients Hodgkin's disease (HD). Median age at presentation was 32 years. Four histopathological groups had distinct presenting clinical features: in 93% of the Burkitt-type lymphomas, the lymphoma itself was the AIDS defining criterion, while high and intermediate grade NHL other than Burkitt-like tended to have a more advanced HIV infection, demonstrated by antecedent AIDS criteria in 58% of these patients and a median CD4 positive cell count of 291 mm3; HD occurred in some patients without previous opportunistic infections (7/8 patients) but with median CD4 cells of 105 mm3; PCL occurred in a terminal stage of HIV infection, in patients with a low performance status, and frequent antecedent AIDS criteria. Objective response to chemotherapy could be seen in 62% of NHL patients and 100% of HD. Survival was adversely related to an antecedent diagnosis of AIDS, low performance status, and a primary localization in the central nervous system. Overall median survival was 5 months, but patients without the mentioned three adverse prognostic factors had a median survival of 10 months.

Actuarial Analysis↗

[Initial clinicopathological manifestations of malignant lymphoproliferative processes in patients with human immunodeficiency virus seropositivity. Study of 40 cases].

We analyzed the series of 40 malignant lymphoproliferative diseases (MLD) in HIV positive patients, diagnosed between 1986 and 1993 in a University Hospital in Spain. Median age was 32 years. 52% of the patients belonged to the intravenous drug users risk group, and 30% were homosexual. 26 patients were diagnosed of a non-Hodgkin's lymphoma (NHL), 8 of Hodgkin's disease (HD) and 6 of a primary central nervous system lymphoma (PCL). The 6 patients with a PCL (median CD4 of 20 cells/mm3, 80% antecedent AIDS criteria) and 13 NHL with histology of immunoblastic, large cell, plasmablastic, and high grade lymphoma non-otherwise specified (median CD4 of 291, 58% with AIDS criteria) tended to appear in patients with a deteriorated clinical and immunological status due to the underlying HIV infection. However, the 14 small non-cleaved cell NHLs appeared in patients without a previous AIDS-defining condition (93% of the cases, p = 0.065 compared with other NHL histologies). Finally, 8 patients with HD had a low CD4 cell count (median 103 cells/mm3, p = 0.049 compared with median CD4 in NHL patients) without other previous AIDS criteria. In conclusion, The presenting characteristics of HIV positive patients with MLD allows to define four subgroups of patients with a high clinicopathological correlation.

Adolescent↗

Carboplatin, methotrexate, and vinblastine in patients with bladder cancer who were ineligible for cisplatin-based chemotherapy.

BACKGROUND: A Phase II trial with a new regimen of methotrexate, carboplatin, and vinblastine (M-CAVI) was conducted for patients with bladder cancer who could not receive cisplatin-based chemotherapy. METHODS: Treatment consisted of methotrexate (30 mg/m2) on days 1, 15, and 22; carboplatin (300 mg/m2) on day 2; and vinblastine (3 mg/m2) on days 2, 15, and 22, scheduled at 28-day intervals. The dosage of carboplatin was adjusted for creatinine clearance. Twenty-five patients with metastatic (n = 9) or locally advanced or locoregional bladder cancer with a poor prognosis (n = 16) were treated with M-CAVI. Fifteen patients had abnormal serum creatinine levels, 4 had a low performance status, 3 had cardiac disease, and 3 were older than 70 years old. RESULTS: Among 23 patients assessable for clinical response, the response rate was 48%. The median duration of response for metastatic disease was 7 months. Among nine patients assessable for pathologic response, there were two complete responses and three partial responses. The toxic effects have been moderate. CONCLUSIONS: M-CAVI is an active and well-tolerated regimen that can be used in patients with bladder cancer who are ineligible to receive cisplatin-based chemotherapy.

Adult↗

What is the role of recombinant colony stimulating factors in bone marrow transplantation?

Colony stimulating factors (CSFs) regulate production of myeloid cells. Use of CSFs post bone marrow transplant accelerates granulocyte recovery by shortening the interval of relative but not absolute granulocytopenia. Data from non-randomized trials suggest that CSFs decrease documented infections by about one-third; there is no apparent increase in survival. Adverse effects of CSFs are modest; there are no indications of increased graft failure, graft-versus-host disease or cancer recurrence after their use. Future studies of CSFs should be in the context of randomized trials where their therapeutic efficacy is best evaluated. CSFs may also be useful in other transplant settings such as treating graft failure or increasing the efficiency of harvesting myeloid progenitor cells from the blood for subsequent transplantation. Controlled trials are needed to evaluate these uses. Future directions will probably include combinations of CSFs and, possibly, in vitro treatment of the graft.

Animals↗