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Biomedical subjects

H Bleiberg

Publications and source records attributed to H Bleiberg.

At least 91 records · Page 5Linked to original sources
PubMed1991

Sequential high-dose methotrexate and fluorouracil combined with doxorubicin--a step ahead in the treatment of advanced gastric cancer: a trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group.

In a prospective phase III multicenter trial, 213 patients with advanced measurable or nonmeasurable gastric cancer were randomized to receive methotrexate (MTX), fluorouracil (5-FU), and Adriamycin (doxorubicin; Farmitalia Carlo Erba, Milan, Italy) (FAMTX) or 5-FU, Adriamycin, and mitomycin (FAM). The results show a significantly superior response rate (41% v 9% [P less than .0001]), and survival (median, 42 weeks v 29 weeks [P = .004]) for FAMTX. There was a cumulative thrombocytopenia in FAM and not in FAMTX. The FAMTX protocol should be the reference treatment in future clinical trials that seek to improve the therapeutic outcome in advanced gastric cancer.

Adult↗
PubMed1991

Management of esophageal, gastric, pancreatic, and hepatobiliary neoplasms.

Data published during the latter part of 1980s have shown that the natural history of gastrointestinal cancers can be influenced by treatment. This was further confirmed in esophageal cancers, for which many phase II studies have shown that chemotherapy with and without radiotherapy can induce major responses before surgery. Trials demonstrating a survival benefit are needed. Gastric cancers were confirmed to be sensitive to chemotherapy. Treatment based on combinations of fluorouracil, methotrexate, doxorubicin, etoposide, and cisplatin have shown high response rates (FAMTX [fluorouracil, doxorubicin, and methotrexate], EAP [etoposide, doxorubicin, and cisplatin], ELF [etoposide, leucovorin, and fluorouracil]) and a survival benefit (FAMTX). Adjuvant treatment after surgery using the FAM (fluorouracil, epirubicin, methotrexate) regimen has failed to improve survival. The prognosis for other cancers remains dismal. When all types of gastrointestinal cancers except colon cancers are reviewed, current data indicate that chemotherapy should not be recommended outside the confines of prospective studies.

Adenocarcinoma↗
PubMed1991

Hepatic artery ligation with and without portal infusion of 5-FU. A randomized study in patients with unresectable liver metastases from colorectal carcinoma. The E.O.R.T.C. Gastrointestinal Cancer Cooperative Group (G.I. Group).

The aim of this multicentric prospective randomized clinical trial was to study the efficacy of hepatic artery ligation (HAL) with and without portal infusion (PI) of 5-FU in patients with liver metastasis of colorectal origin. Seventy-four patients were randomized. Sixty-seven were fully evaluable. Thirty-five patients were eligible in the HAL + PI of 5-FU group and 32 in the HAL alone group. The 5-FU infusion had to be discontinued for technical reasons in 13 patients. Complications of HAL were relatively high, including four hepatic failures (WHO grading greater than 2). Side effects of chemotherapy were limited. Five patients out of 30 had a partial response (WHO criteria) and one patient had a complete response in the group treated by HAL and PI of 5-FU. Only one patient had a partial response in the HAL alone group. Median survival for both groups was 12 months. Median time to progression for both groups was 6 months. This study did not show any advantage of delivery using the portal route in addition to hepatic artery ligation in terms of progression nor in survival of patients.

Adenocarcinoma↗
PubMed1990

Randomized phase II study of a combination of cisplatin (DDP), 5-fluorouracil (5-FU), and allopurinol (HPP) versus 5-FU in advanced colorectal carcinoma. An EORTC Gastrointestinal Tract Cancer Cooperative Group study.

In order to improve the therapeutic index of fluorouracil (5-FU), it has been combined with cisplatin (DDP) as synergistic agent and with allopurinol (HPP) as toxicity modulator. Patients with measurable colorectal carcinoma, previously untreated by chemotherapy, were randomized to receive either 5-FU alone 500 mg/m2 push iv days 1-5 or HPP 3 x 300 mg po, days 1-5, 5-FU 800 mg/m2 push iv, days 3-5 and DDP 50 mg/m2 d6. Treatment was repeated every 4 weeks. Of 104 patients randomized, 82 were evaluable for response and survival. Six partial responses were seen in each treatment group (15%) and the median survival time was 7 months. Hematologic toxicities were comparable in both treatment groups, with a mean nadir white blood cell count of 3500/ vs. 3800/mm3 and a mean nadir platelet count of 148,000/ vs, 203,000/mm3 for HPP-5-FU-DDP and 5-FU, respectively. This study suggests that the addition of both HPP and DDP does not improve the activity of 5-FU.

Adult↗
PubMed1990

The future of adjuvant treatment in gastrointestinal cancer.

Adjuvant treatment is based on the concept that surgery is only potentially curative and that apparently localized disease has extended beyond surgical resection or is already disseminated. Although death might be related to local recurrence as well as to disease dissemination, most of the trials have tested only one adjuvant modality. Among many negative and non-contributory studies, very few positive results were obtained: in rectal cancer it seems that pre-operative and perhaps postoperative radiotherapy may reduce the incidence of local recurrences, and in colon cancer patients treated with Methyl-CCNU, vincristine and 5-fluorouracil (5-FU) had a significant increase in survival. In colon cancer, the lack of active drug might at least partly explain negative studies, but in gastric cancer the most active combination in advanced disease has failed to demonstrate an improvement of survival in the adjuvant setting. Future trials should take account of this succession of negative trials.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1989

An EORTC gastrointestinal (GI) group randomized evaluation of the toxicity of sequential high dose methotrexate and 5-fluorouracil combined with adriamycin (FAMTX) vs 5-fluorouracil, adriamycin and mitomycin (FAM) in advanced gastric cancer.

Until now advanced gastric cancer has been generally treated with the FAM chemotherapy protocol. Due to the relatively low response rates with this protocol we decided to start a randomized prospective phase II trial comparing the FAM with the FAMTX protocol. The primary aim of our trial was to compare the toxicity in both protocols. The FAMTX protocol has been demonstrated to be fully comparable with the toxicity of the FAM protocol. The trial has been extended to a phase III study. With respect to response rates and survival times it is too early for evaluation.

Adult↗
PubMed1989

Current status of chemotherapy for gastric cancer.

High response rates to combination chemotherapy reported by the end of the seventies led many oncologists to recommend standard treatment for gastric cancer. In randomized trials conducted by different groups, the response rate with fluorouracil (F), adriamycin (A), mitomycin C (M) ranged between 17 and 39% and was advocated for adjuvant treatment. However, further studies indicate that combination chemotherapy has no beneficial effect on survival compared with 5-FU alone. Several studies assessing the FAM regimen versus control in the adjuvant setting show, so far, no difference between the treatment arms. Other agents and combinations have recently been investigated. Cisplatin (P) is active in gastric cancer. In six studies using a combination with FA (FAP), the response rate ranged between 29 and 55% with a median survival of 4-12 months. Other combinations using P with F or etoposide and A have also been promising. Recently, the EORTC Gastrointestinal Group, using a combination of sequence of high dose methotrexate and F with A (FAMTX) reported 22 positive responses out of 66 eligible patients, including nine complete responders. These new treatments are currently being tested by different groups in a randomized trial. For the time being, apart from 5-FU alone, chemotherapy in advanced gastric cancer should not be administered on a routine basis outside clinical trials.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1989

Measurements of response to chemotherapy using ultrasound in metastatic liver involvement.

The liver is a frequent site of metastases and in several cases the only available target for assessing the activity of chemotherapeutic agents. A standard procedure for liver measurements by ultrasound was investigated. One hundred and twenty-three chemotherapy cycles were evaluated. This study shows that metastatic involvement of the liver can be measured by several ultrasound parameters which represent different features of the same process: the number and the surface of the nodules, the volume of the organ. Ultrasound parameters were correlated with liver function tests, CEA, hepatomegaly and measurements of other metastatic sites. The surface of metastases still appeared to be the most reliable criterion of response. Our results suggest that several liver ultrasound parameters may help to definitely assess the type of response to chemotherapy.

Antineoplastic Agents↗
PubMed1989

Palliative therapy of inoperable oesophageal carcinoma with radiotherapy and methotrexate: final results of a controlled clinical trial.

Between May 1976 and January 1982, 170 patients were entered in a randomized study comparing a combined treatment consisting of methotrexate followed by irradiation versus radiotherapy alone in patients with non metastatic inoperable oesophageal cancer. Methotrexate was administered subcutaneously in 4 days to a total dose of 24 mg/m2. Radiotherapy was performed, in both groups, at a dose of 56.25 Gy in 25 fractions (5 weeks). The administration of methotrexate did not lead to an increased intolerance to radiotherapy but severe hematological toxicities were observed in 7.8% of the cases. No difference in the duration of survival was detected. Initial performance status of the patients and their weight loss prior to entry on trial were the factors that were most predictive of the patient's prognosis.

Adult↗
PubMed1989

Adjuvant radiotherapy and chemotherapy in resectable gastric cancer. A randomized trial of the gastro-intestinal tract cancer cooperative group of the EORTC.

One hundred and fifteen patients with curative and palliative surgery for gastric cancer were randomized to receive radiotherapy alone (1) or in combination with short-term (ST) 5-FU (2), long-term (LT) 5-FU (3), ST and LT 5-FU (4). The ST 5-FU was given at a daily dose of 575 mg/m2, every 4-6 h during the first 4 days of treatment before starting irradiation. The LT 5-FU was given at a dosage of 750 mg/m2 every 2 weeks for 18 months or until progression. The median survival times for treatment 1 to 4 was respectively 12, 10, 15 and 18 months. There was a statistically significant overall difference between the four treatments (P = 0.041). However, when the comparisons were adjusted for the most significant prognostic factors, the difference in survival disappeared. Moreover, no difference was found between treatments in terms of time progression. Nevertheless, among 22 patients with residual tumour, the three who were still alive without disease progression (with survivals of 19+, 49+ and 90+ months at the time of this analysis) had been treated with radiotherapy combined with ST and LT 5-FU.

Adenocarcinoma↗
PubMed1989

Controversies in the management of gastrointestinal non-Hodgkin's lymphomas.

Although more than a thousand GI non-Hodgkin's lymphomas have been reported, the literature does not indicate a clear optimal therapeutic approach. This is primarily due to histological confusion and to the absence of uniform staging procedures and therapeutic modalities. This overview attempts to summarize controversies in the multidisciplinary approach to GI non-Hodgkin's lymphomas and to introduce a European multicentric prospective randomized study for the treatment of this rare disease.

Combined Modality Therapy↗
PubMed1989

Hepatic candidosis in a patient with acute leukemia.

Isolated hepatic candidosis has been described more frequently in patients with leukemia and consists in a particular clinical entity which remains difficult to control. We report here the case of a patient treated for acute nonlymphoblastic who developed hepatic candidosis two months after the end of intensive consolidation therapy.

Candidiasis↗