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Biomedical subjects

R Gelber

Publications and source records attributed to R Gelber.

At least 37 records · Page 2Linked to original sources
PubMed1986

Adjuvant treatment for early breast cancer: the Ludwig breast cancer studies.

The Ludwig Breast Cancer Study Group conducted four concomitant trials involving adjuvant chemotherapy and endocrine therapy. In Ludwig I, adjuvant combination chemotherapy was used with or without prednisone to treat premenopausal and perimenopausal women with metastases in 1-3 axillary lymph nodes. The impact of adding low-dose, continuous prednisone (7.5 mg/day) to an adjuvant, chemotherapy regimen of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) was investigated in a randomized trial of 491 premenopausal and perimenopausal patients with operable breast cancer and metastases in 1-3 axillary lymph nodes. As a consequence of lower hematologic toxicity, a significantly higher dose of CMF could be administered with added prednisone (P less than 0.0001). However, at the 4-year median follow-up, no significant improvement was observed in disease-free survival (DFS) (73% vs. 77%; P = 0.35) or overall survival (OS) (both 86%; P = 0.73). Induced amenorrhea was associated with a longer DFS for younger patients, those who received lower CMF doses, and those with tumors that were estrogen receptor (ER) positive. In Ludwig III, adjuvant therapy was administered to younger postmenopausal women in a study of chemotherapy plus endocrine therapy versus endocrine therapy alone versus mastectomy alone. In this randomized trial of 463 postmenopausal women 65 years of age or younger with axillary node metastases, treatment with the combination of CMF plus low-dose prednisone and tamoxifen (CMFp + T), was compared to endocrine therapy alone (p + T) or to no further treatment after total mastectomy and axillary clearance. At a median follow-up of 4 years, the DFS was 61% for the CMFp + T group, compared with 48% for the p + T group (P = 0.01) and 31% for the observation group (P less than 0.0001). The 4-year OS rates were not statistically different (76%, 67%, and 68%, respectively; P = 0.30). Treatment with CMFp + T reduced local, regional, and distant metastases and was equally effective in improving DFS in patients with ER-positive or ER-negative tumors. In Ludwig II, chemotherapy was given with or without oophorectomy in premenopausal and perimenopausal patients with metastases in 4 or more axillary nodes.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed1985

Prognostic significance of peritumoral vessel invasion in clinical trials of adjuvant therapy for breast cancer with axillary lymph node metastasis.

To assess the prognostic significance of peritumoral vessel invasion, data were examined for 1,510 women entered into the Ludwig Breast Cancer Group Trials I to IV evaluating adjuvant therapy for operable breast cancer with axillary nodal metastasis. Vessel invasion by tumor cells was identified by routine light microscopy in 59 per cent (889 of 1,510) of the patients and was equally distributed between premenopausal/perimenopausal (60 per cent, 468 of 778) and postmenopausal (58 per cent, 421 of 732) women. In logrank analyses stratified by nodal status (one to three or four or more positive nodes), the four-year disease-free survival (DFS) rate was significantly lower in patients with vessel invasion than in women without vessel invasion (50 per cent versus 65 per cent, P less than 0.0001). This DFS difference was seen for both premenopausal/perimenopausal (P = 0.0004) and postmenopausal (P = 0.0002) patients. The four-year overall survival rate was also lower in patients with vessel invasion (71 per cent versus 82 per cent, P = 0.0006), both for premenopausal/perimenopausal (P = 0.002) and postmenopausal (P = 0.04) women. The presence of vessel invasion was significantly associated with increasing numbers of positive axillary lymph nodes, rising tumor grade, nonstellate tumor border growth pattern, and higher steroid hormone receptor content of the primary tumor. The assessment of peritumoral vessel invasion continued to have prognostic significance for DFS (P less than 0.0001) and overall survival (P = 0.003) when evaluated in multivariate models controlling for treatment assigned, nodal status, tumor size, estrogen receptor status, menopausal status, and age. Depending on the subpopulation, patients with vessel invasion had a 41 per cent to 54 per cent greater risk of treatment failure than those without vessel invasion and a 29 per cent to 64 per cent greater risk of death. The percentage of treatment failures at distant sites was higher for women with than for those without vessel invasion (27 per cent versus 18 per cent, P = 0.003). In patients with axillary lymph node metastases, peritumoral vessel invasion may be a sign of increased systemic disease burden.

Aged↗
PubMed1985

Elimination of malignant clonogenic cells from human bone marrow using multiple monoclonal antibodies and complement.

A clonogenic assay has been developed that utilizes Burkitt's lymphoma tumor cell lines to detect elimination of up to 5 logs of tumor cell contamination within human bone marrow. Different Burkitt's lymphoma lines bear one or more of a group of markers, including common acute lymphoblastic leukemia antigen gp26 (glycoprotein with a molecular weight of 26,000), B1, surface membrane immunoglobulin, HLA, beta 2-microglobulin, and Ia. Burkitt's tumor cells of the Namalwa line have been mixed with a 20-fold excess of irradiated human bone marrow cells. After treatment with one or more monoclonal antibodies and rabbit complement (RC), mixtures have been grown on a monolayer of irradiated human bone marrow cells and tumor cells enumerated by limiting dilution. Multiple treatments with antibody and RC were more effective than a single treatment in destroying clonogenic tumor cells which bore relevant determinants. Human serum components inhibited the lytic activity of RC in the presence of murine monoclonal antibodies. The total concentration of bone marrow cells proved critical in determining the complete elimination of tumor. Incubation of the Namalwa tumor cell line with RC and the J2 anti-gp26 eliminated more than 3 logs of malignant cells from a 20-fold excess of human bone marrow. Combinations of two monoclonal antibodies were more effective than any single antibody in eliminating Namalwa cells. A combination of three monoclonal reagents was no more effective than a combination of J2 and B1 or J2 and J5 in eliminating Namalwa cells. Treatment of human bone marrow with three antibodies and RC did not, however, produce a selective loss of nonmalignant GM-CFU-C, CFU-E, or BFU-E.

Antibodies, Monoclonal↗
PubMed1984

Interleukin 1 production by peripheral blood mononuclear cells from leprosy patients.

Quantitation of interleukin 1 production by adherent mononuclear cells from peripheral blood was performed in patients with tuberculoid and lepromatous forms of leprosy. Cells from patients with tuberculoid leprosy either secreted interleukin 1 spontaneously or produced amounts within the normal range in response to lipopolysaccharide stimulation. Conversely, stimulated cells from lepromatous patients failed to produce interleukin 1 in 5 of 13 (38.5%) cases.

Adult↗
PubMed1983

The role of radiation therapy in the palliation of metastatic genitourinary tract carcinomas. A study of the Radiation Therapy Oncology Group.

The Radiation Therapy Oncology Group has conducted several randomized clinical trials to evaluate the efficacy of various radiation therapy schedules in palliating symptomatic brain and bone metastases. Among the patients entered in these studies, there were 225 patients with primary tumors of the genitourinary tract. Of these, 68 patients had cerebral metastases and 157 patients had osseous metastases. These patients were analyzed further as to the effectiveness of radiotherapy in palliation of their symptoms, and the results were compared to those for comparable metastases in patients with other primary sites. Relief of symptoms occurred in 54% of neurologic function (NF) Class III and 28% of NF Class II patients with cerebral metastases. This result compared favorably with those for the total group of patients consisting of patients with brain and bone metastases from various primary sites. Improvement was seen in 80% of patients with headaches and 88% of patients with convulsions. Motor loss improved in 62% of the patients. Of the patients with bone metastases, 81% with prostatic carcinoma and 59% with renal primaries had lessening of pain. Complete relief of pain at eight weeks occurred in 36% of the patients, compared to 24% in the total group. The median survival for patients with solitary bone metastases from a prostatic primary was 39 weeks, compared to 30 weeks for those with multiple metastatic sites.

Bone Neoplasms↗
PubMed1983

Risk factors for thyroid abnormalities after neck irradiation for childhood cancer.

Thyroid evaluations were performed in 95 patients who received radiotherapy to the neck region for childhood cancer five to 34 years earlier. Fifty-six patients (61 percent) had at least one abnormality of serum free thyroxine index, serum thyroid-stimulating hormone (thyrotropin), or thyroid palpation. Seven had subnormal free thyroxine index and 40 had elevated thyrotropin concentrations. Thyroidal radiation doses of 3,000 or more rads and lymphangiography independently increased the risk (p less than or equal to 0.01) of an elevated serum thyrotropin concentration (present in 11 percent of patients with neither risk factor, 50 percent of those who underwent lymphangiography and received less than 3,000 rads, 46 percent of those who had 3,000 or more rads and no lymphangiography, and 76 percent of those with both), but duration of follow-up did not. Twenty-six patients had thyroid nodules and six others had diffuse thyroid enlargement. The frequency of palpable abnormalities increased with the follow-up time after radiation (30 percent of patients followed up less than 10 years had abnormalities versus 43 percent of those followed up 10 or more years, p = 0.03), but was not related to the serum thyrotropin level, radiation dose, or lymphangiography. Among 10 patients who had surgery for nodules, three had localized papillary thyroid carcinomas.

Adolescent↗
PubMed1983

Influence of intensive asparaginase in the treatment of childhood non-T-cell acute lymphoblastic leukemia.

Between June 1977 and December 1979, 72 evaluable patients with childhood non-T-cell acute lymphoblastic leukemia were induced into complete remission using vincristine, prednisone, and doxorubicin. All received asparaginase consolidation and central nervous system prophylaxis with cranial irradiation and intrathecal methotrexate. All patients then received prolonged intensification with vincristine, prednisone, and doxorubicin, and half of them were randomized to receive weekly high-dose asparaginase. Continuation therapy was with vincristine, prednisone, methotrexate, and 6-mercaptopurine. After a median follow-up of 57 months, there were four remission deaths and 25 relapses. Central nervous system relapse was the first event in 4% of patients. There were fewer treatment failures in the asparaginase-treated group [2-sided, p = 0.04 (0.07 controlling for standard and high-risk groups)]. Asparaginase toxicity occurred in six patients (8%) and was self-limited, but it precluded further use of the drug in those patients. The major toxicity of this treatment program was drug-induced cardiomyopathy which occurred in 10 patients (14%) and was fatal in three of them. In summary, we conclude that the intensive use of high-dose asparaginase has an important role in the treatment of children with acute lymphoblastic leukemia. The morbidity of multiple doses of doxorubicin outweighed its antileukemic advantage in standard-risk patients.

Adolescent↗
PubMed1982

Does preoperative irradiation increase the rate of surgical complications in carcinoma of the head and neck? A Radiation Therapy Oncology Group Report.

This is a comparison of the rate of surgical complications in a group of patients with advanced but operable carcinoma of the head and neck who underwent surgery after preoperative radiotherapy (5000 rad in five weeks, 200 rad fractions, directed to the primary tumor area and neck) versus another group operated without prior irradiation. Both groups of patients formed part of a randomized prospective multiinstitutional trial of the Radiation Therapy Oncology Group (73-03). Of 229 patients who had planned operations, 88 (38%) developed some degree of surgical complications, and in 28 (12%) the complications were rated as severe. The most frequently reported complications were delayed healing and fistula formation each occurring in approximately one-fourth of each of the two treatment groups. Carotid blow-out occurred in 5% or less of the cases. No significant statistical difference between treatment groups was noted for the overall complication rate or specific type of surgical complications. A trend was noted towards more complications in the preoperative group for patients with lesions in the oropharynx and supraglottic larynx. However, an opposite trend towards more complications in the no prior irradiation group was observed among patients with lesions in the oral cavity and hypopharynx. Surgical mortality and postoperative hospital stay were not significantly different between treatment groups. We conclude that preoperative irradiation for carcinoma of the head and neck, with the stated dose, followed by surgery in 4-6 weeks, does not substantially increase the rate of overall or specific type of surgical complications, surgical mortality or hospital stay versus those patients operated without prior irradiation.

Aged↗
PubMed1980

Chemotherapy of advanced esophageal carcinoma: Eastern Cooperative Oncology Group experience.

In a Phase II study, patients with measurable metastatic or recurrent esophageal carcinoma randomly received after Adriamycin (ADR), 60 mg/M2 I.V. q three weeks, or methotrexate (MTX), 40 mg/M2 I.V. q one week, or 5-fluorouracil (5-FU), 500 mg/m2 I.V. x 5 days q five weeks. Objective partial response rates for 72 patients were 5% for ADR (one of 20), 12% for MTX (three of 26), and 15% for 5-FU (four of 26). There were no complete responses. Median duration of response was 13 weeks. Median survival was 14 weeks (eight weeks for ADR, 14 weeks for MTX, and 15 weeks for 5-FU). Factors of liver metastasis, adjacent anatomic involvement, time from initial diagnosis to study entry, and prior radiation were found to be significant determinants of survival. Adriamycin did not appear to benefit patients with advanced measurable squamous cell carcinoma of the esophagus. Methotrexate and 5-fluorouracil showed comparable activity and survival, although methotrexate was slightly more toxic.

Antineoplastic Agents↗
PubMed1980

Value of radiation therapy in the management of patients with cerebral metastases from malignant melanoma: Radiation Therapy Oncology Group Brain Metastases Study I and II.

Sixty patients from two Radiation Therapy Oncology Group (RTOG) studies with cerebral metastases from malignant melanoma were analyzed to determine the response to whole brain irradiation. General performance status, neurologic function, and specific neurologic symptoms were evaluated for rate and duration of improvement. Also analyzed was the influence of chemotherapy and steroids, although neither was a controlled factor. Results indicate a significant benefit from radiation therapy in terms of symptomatic and neurologic function improvement. Symptomatic improvement was observed in 76%, with 31% completely improved. Of the four most frequent symptoms, complete or partial improvement was observed as follows: headache--27 of 37 patients (73%); motor loss--14 of 23 patients (61%); impaired mentation--13 of 24 patients (62%); and convulsions--10 of 12 patients (83%). Improvement in neurologic function class was observed in 18 of 44 patients (41%). Median survival for Study 1 patients was 10 weeks (range 1-200) and that of Study II patients 14 weeks (range 1-76). These results are comparable to those found in radiation therapy of brain metastases from all other primary tumors.

Adrenal Cortex Hormones↗
PubMed1980

Cell surface antigens: prognostic implications in childhood acute lymphoblastic leukemia.

Lymphoblasts from 93 children with acute lymphoblastic leukemia (ALL) were characterized by immunologic cell surface markers. These patients were treated on a single protocol, featuring adriamycin therapy during remission, and have been followed from 2 to 6.5 yr (median 4 yr). Three classes of patients were defined serologically: HTA+ Ia- CALLA-, Ia+ CALLA+ HTA-, and Ia+ CALLA- HTA-. Disease-free survival and sites of relapse were assessed within immunologic subsets. Similar to the findings of others, T-cell (HTA+ Ia-) patients fared poorly as compared to non-T-cell (Ia+ HTA-) patients (median disease-free survival was 12 and 47 mo. respectively; p = 0.0004). The majority of relapses in the HTA+ patients occurred at extramedullary sites. Late testicular relapse was rare among Ia+ patients. In addition, the "common ALL antigen" (CALLA) may identify a relatively favorable subset within the Ia+ population. The prognostic value of the immunologic markers was compared with traditional clinical factors. There was much overlap between HTA+, older age, and elevated WBC. However, neither age nor WBC alone were of prognostic significance among the Ia+ patients. We conclude that surface markers define both biologic and prognostic characteristics. The course of childhood ALL must be viewed in the context of homogeneous subsets and within particular therapeutic programs.

Antigens, Neoplasm↗
PubMed1979

Disseminated granulomatous acanthamoeba infection presenting as an unusual skin lesion.

A fatal case of disseminated granulomatous infection with a skin lesion and focal encephalitis due to Acanthamoeba astronyxis is reported. Indirect fluorescent antibody tests of both tissue and serum from the patient established the diagnosis. The administration of amphotericin B is ineffective in vitro and has not been effective in vivo. It is recommended that corticosteroid therapy be avoided because it may aggravate the disease. Physicians caring for diseases caused by free-living ameba may call the CDC Parasitic Drug Service.

Adult↗
PubMed1978

The Radiation Therapy Oncology Group: a progress report.

The Radiation Therapy Oncology Group (RTOG), founded in 1971, comprises 35 university hospitals which are participating in 21 active protocols, four registries and eight pilot studies, including Phase I/II studies. Case accession has grown to over 1000 in 1977 with 19,801 patients being entered in the RTOG initial registration. Goals of the RTOG include: advancing knowledge of the role of radiation therapy in disease management; improving control of primary and regional disease; reducing morbidity and complications from treatment; and collaborating with other oncology disciplines to obtain data on multimodality therapy.

Clinical Trials as Topic↗