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Biomedical subjects

R A Gams

Publications and source records attributed to R A Gams.

At least 19 recordsLinked to original sources
PubMed1992

Phase II study of intravenous idarubicin in unfavorable non-Hodgkin's lymphoma.

Idarubicin, a new analogue of daunorubicin, was administered i.v. at a dose of 15 mg/m2 to 31 previously treated patients with unfavorable non-Hodgkin's lymphoma. Clinical characteristics included median age, 69 years; performance status, 1; and prior chemotherapeutic regimens, 1. Twenty of the patients were relapsing after prior therapy and 11 were refractory; 29 had received prior anthracycline or anthracenedione. Responses were observed in 43% of patient (3 complete remission and 10 partial remission) with a median duration of 10+ months (2-29+ months). Idarubicin was well tolerated with nonhematological toxicities (nausea/vomiting, mucositis, and anorexia) seen in less than 50% of patients. Median hematological values during the first cycle for this dosage included WBC, 1,300/mm3; platelets, 129,000/mm3; and hemoglobin, 10.9 mg/dl. With dose escalation, hematological toxicity was dose limiting. Symptomatic cardiac toxicity was observed in one patient who had received maximum dose doxorubicin and radiotherapy. Median values for the cardiac ejection fraction during the full course of therapy for the entire group of patients were 0.62 (initial) and 0.60 (final). Idarubicin in i.v. form is an active drug in previously treated patients with unfavorable non-Hodgkin's lymphoma.

Adult↗
PubMed1987

Weekly mitoxantrone therapy of Hodgkin's disease, non-Hodgkin's lymphoma, and chronic lymphocytic leukemia. A Southeastern Cancer Study Group Trial.

A weekly schedule of mitoxantrone was evaluated in chronic lymphoproliferative disorders. One of 11 patients with Hodgkin's disease, 2 of 12 with favorable-histology non-Hodgkin's lymphoma, 4 of 27 with unfavorable-histology non-Hodgkin's lymphoma, and 1 of 11 with chronic lymphocytic leukemia showed a response. Since the use of a larger single dose every 3 weeks is well tolerated, simpler, and probably more effective, we do not recommend further evaluation of the weekly dose schedule.

Adolescent↗
PubMed1986

Alternating sequential combination chemotherapy in the management of advanced Hodgkin's disease. A Southeastern Cancer Study Group trial.

The Southeastern Cancer Study Group has explored the use of alternating sequential combination chemotherapy in advanced Hodgkin's disease. Two hundred twelve evaluable patients were randomly assigned to treatment with the six-drug combination, BCNU, cyclophosphamide, vinblastine, procarbazine, prednisone, and bleomycin (BCVPP-Bleo) or with the same drugs alternating in monthly cycles with doxorubicin, dacarbazine, and bleomycin. Both regimens produced complete response rates of approximately 73%. The duration of remission and survival were similar for the two treatment regimens. Although our sequence of combinations does not rigorously meet the criteria for "non-cross-resistant" our results do not lend support to the hypothesis that alternating sequential non-cross-resistant drug combinations improves the outcome in advanced Hodgkin's disease.

Adult↗
PubMed1985

A phase I trial of ametantrone acetate (NSC-287513).

Ametantrone acetate is an intensely blue anthracenedione undergoing clinical trials in man. In this Phase I study, 20 patients received 39 courses of drug as a single IV dose given daily for five days and repeated every three weeks (21 days). Dosage escalations proceeded from 15 mg/m2 to 35 mg/m2. Predictable and reversible leukopenia was the dose limiting toxicity. One previously untreated patient with renal cell carcinoma metastatic to the lungs and right arm experienced a partial response of 51 days duration. Nine patients had pharmacokinetic studies performed during the study. Ametantrone was extensively distributed (apparent volume of distribution, 26.3 l/m2) and demonstrated a short half-life (harmonic mean half-life, 0.38 hour). The maximum tolerated dose in this study was 35 mg/m2. Recommended doses for Phase II trials are 30 mg/m2 in good risk patients and 25 mg/m2 in poor risk patients. Because of the partial response seen in one patient with renal cell carcinoma, Phase II trials should include this tumor category in order to better define the activity of ametantrone in this disease. In addition, since the total amount of drug that could be given to patients receiving the five day schedule (125-150 mg/m2) was approximately the same amount that could be administered as a single dose (140 mg/m2), it would appear that the only advantage of the daily times five day dosage schedule would be in the lower incidence of bluish skin discoloration.

Adult↗
PubMed1985

Mitoxantrone in malignant lymphoma.

Two phase II trials of mitoxantrone (Novantrone; dihydroxyanthracenedione) in refractory malignant lymphoma have been conducted. In the first of these, mitoxantrone, 5 mg/m2, was given weekly for six weeks and in the second, 14 mg/m2 was administered every three weeks. The first trial was conducted by the Southeastern Cancer Study Group (SECSG) and the second was a multicenter trial sponsored by Lederle Laboratories. Of the 51 patients entered in the SECSG trial, 28 could be evaluated for response and 43 for toxicity. WBC nadirs below 4.0 X 10(9)/litre were recorded in 25 patients. Three partial responses and no complete responses were obtained. These results contrast with those of the single dose every three weeks study in which 96 patients were entered and 69 of these were evaluated for response. Responses were obtained in 30 patients (4 complete, 26 partial). Side-effects on this three-weekly dose regimen were minimal. WBC nadirs below 4.0 X 10(9)/litre occurred in 85 patients. Twenty-three patients experienced at least mild nausea and vomiting and 15 had at least mild alopecia. These preliminary data indicate that mitoxantrone has significant activity in malignant lymphoma. All of the responding patients had received extensive prior therapy, many of them with anthracyclines in combination or as single agents. The higher response rate to mitoxantrone given at 14 mg/m2 every three weeks suggests that careful consideration should be given to dose schedule when this drug is examined further in phase III trials.

Alopecia↗
PubMed1985

Phase III study of BCOP v CHOP in unfavorable categories of malignant lymphoma: a Southeastern Cancer Study Group trial.

A total of 296 evaluable patients with unfavorable categories of malignant lymphoma were randomly assigned treatment with cyclophosphamide, vincristine, and prednisone plus BCNU (BCOP) or doxorubicin (CHOP). In diffuse histiocytic (DH) lymphoma, CHOP produced superior complete (54% v 34%) and total (70% v 46%) response rates. Among the responders to either therapy, no differences were seen in duration of response or survival times. Median duration of response has not been reached with follow-up in excess of 50 months. In categories of lymphoma other than DH (including small-cell, mixed, and nodular histiocytic lymphomas), complete (27% v 29%) and total (48% v 54%) responses were similar for BCOP and CHOP, as were durations of response and survival. These data suggest that BCOP and CHOP are equivalent regimens for other categories of malignant lymphomas. CHOP appears preferable for diffuse large-cell categories, since it resulted in greater overall survival in patients with DH lymphoma; this was due to a significantly greater response rate, since patients with DH lymphoma who did respond to BCOP maintained their response and survived as long as did the CHOP responders.

Adolescent↗
PubMed1984

Mitoxantrone in malignant lymphoma.

Two phase II trials of mitoxantrone in refractory malignant lymphoma have been conducted. In the first of these, mitoxantrone (5 mg/m2) was given weekly for 6 weeks, and in the second, 14 mg/m2 was administered every 3 weeks. The first trial was conducted by the Southeastern Cancer Study Group (SECSG), and the second was a multicenter trial sponsored by Lederle Laboratories. Of the 80 patients entered in the SECSG trial, 47 could be evaluated for response and 43 for toxicity. Granulocyte nadirs below 1.9 X 10(9)/L were recorded in 18 patients. Four partial responses and no complete responses were obtained. These results contrast with those of the high dose study in which 41 patients were entered, and 28 of these were evaluated for response. Responses were obtained in 15 patients (2 complete, 13 partial). Side effects on this 3 weekly dose regimen were minimal. WBC nadirs ranged from 1 to 4.3 X 10(9) cells/L (mean 2.5 X 10(9)/L). Three patients experienced mild nausea and vomiting, and two had mild alopecia. These preliminary data indicate that mitoxantrone has significant activity in malignant lymphoma. All of the responding patients had received extensive prior therapy, many of them with anthracyclines in combination or as single agents. The higher response rate to mitoxantrone given at 14 mg/m2 every 3 weeks suggests that careful consideration should be given to dose when this drug is examined further in phase III trials.

Anthraquinones↗
PubMed1983

Acute myelogenous leukemia as a second malignant neoplasm following the successful treatment of advanced Hodgkin's disease.

Of 209 Hodgkin's disease patients treated at least 6 months with a five-drug combination of induction chemotherapy and having a complete remission, four patients developed acute myelogenous leukemia (AML) as a second malignant neoplasm. The overall relative risk for development of AML is 185.0 (P less than 0.05) and the mean time to occurrence of AML is 5.3 years (median, 5.25 years). When examining patient subgroups, the highest relative risk noted was 338.5 (P less than 0.05) for that group of patients receiving an additional 6 months of postinduction MOPP (nitrogen mustard, vincristine, procarbazine, and prednisone). Patients receiving only 6 months of induction BVCPP (BCNU, vinblastine, cyclophosphamide, procarbazine, and prednisone) had a relative risk of 166.2 (P less than 0.05). These data results are consistent with previous reports that patients treated for Hodgkin's disease are at high risk for development of AML. However, to date, no patients in this series have developed second malignancies other than AML.

Adult↗
PubMed1983

Malignant lymphoma, mixed cell type, diffuse.

This retrospective study of diffuse mixed (DM) cell lymphoma was undertaken as a collaborative study between the Repository Center for Lymphoma Clinical Studies and four cooperative oncology groups (CALGB, ECOG, SECSG, SWOG), and was based on 62 patients from the files of the Repository Center. We wanted to ascertain whether there were any significant clinical differences among the various morphological subtypes of this lymphoma. All patients were treated according to different protocols of the Cooperative Oncology Groups sponsored by the National Cancer Institute. In 16 patients (26%), the malignant lymphoma (ML) had morphological features consistent with follicular center cell origin (FCC); in 34 patients (55%), the ML did not have features of follicular center cell type (non-FCC), but had morphology described for peripheral T-cell-derived ML. In 8 of the patients (13%), no agreement could be reached by the 7 histopathologists who participated in the study, and these were classified as unresolved; the remaining 4 (6%) were unclassifiable. We compared the survival times of the 16 patients having the morphological features of the FCC subtype with the survival times of the 34 patients with the non-FCC subtype and found that patients with FCC lived longer (p = 0.07 Cox's regression). In the FCC group, all patients who had complete remissions (CR) were alive; however, their survival times were similar to those who had a partial or no response (p = 0.32). In contrast, in the non-FCC group, the median survival was 20 mo, and patients with a CR had a significantly longer survival than did incomplete responders (p = 0.003). According to these results the non-FCC diffuse mixed cell lymphoma appears to be a high-grade malignant lymphoma, whereas the FCC type is not.

B-Lymphocytes↗
PubMed1982

Chemotherapy for advanced Hodgkin's disease: conclusions from the Southeastern Cancer Study Group.

The Southeastern Cancer Study Group has explored a variety of approaches to the management of advanced Hodgkin's disease. These have largely involved the use of nitrosoureas, especially BCNU (carmustine), alone or in combination with other agents. Initial phase II trials of BCNU as a single agent in patients refractory to mechlorethamine demonstrated considerable antitumor activity. Exploratory experiments with BCNU in combination with alkylating agents, vinca alkaloids, and corticosteroids resulted in the development of the combination BVCPP (BCNU, vinblastine, cyclophosphamide, procarbazine, and prednisone). BVCPP, given only once monthly, produces at least a 65% complete response rate with minimal to moderate toxicity, making it an effective alternative to other regimens such as MOPP. Alternating BVCPP with a non-cross-resistant combination (doxorubicin, DTIc [dacarbazine], and bleomycin) offered no advantage in response rate or survival. Continued research with new agents and/or combined modality approaches is necessary in view of continued primary and secondary treatment failure with all regimens used for the management of advanced Hodgkin's disease.

Antineoplastic Agents↗
PubMed1981

Lymphoblastic lymphoma: a clinicopathologic study of 95 patients.

A retrospective clinicopathologic study of lymphoblastic lymphoma was based on 95 patients from the files of the Repository Center for Lymphoma Clinical Studies. All patients were treated according to different protocols of Cooperative Oncology groups sponsored by the National Cancer Institute. The patients ranged in age from 4 to 84 years, with a median of 30 years. Sixty-eight patients were male and 27 female, with respective median ages of 27 and 50 years. The male-to-female ratio was 2.5:1. Forty patients had mediastinal masses; 30 (75%) of whom were male. The median survival of all patients was 17 months (range 1-100 months). To ascertain the influence of various clinical and morphologic parameters of survival, univariate and multivariate statistical analyses were performed. Patients older than 30 years of age had significantly lower incidences of mediastinal involvement (P = 0.01), number of mitotic figures (P = 0.04), and development of leukemia (P = 0.02) than patients younger than 30. Whereas lymphoblastic lymphoma is generally considered to be a disease of children and young adults, this study indicates that lymphoblastic lymphoma occurs in all age groups. These findings further suggest that lymphoblastic lymphoma may have a different biologic behavior in older patients.

Adolescent↗
PubMed1981

Subcategories of histiocytic lymphoma: associations with survival and reproducibility of classification. The Southeastern Cancer Study Group experience.

Five pathologists reviewed histologic slides from 134 cases of histiocytic lymphoma and subclassified these cases using Lukes-Collins classification system. Of 98 morphologically subclassifiable cases, 85 were distributed among three categories, each presumed to represent a lymphoma of follicular center cell origin. The remaining 12 cases were classified among three additional categories. The cases within the three follicular center cell categories, considered collectively, had a significantly better survival than did the cases within the other three categories considered as a whole. The pathologists classified cases generally as being of a follicular center cell type with a high degree of reproducibility, but their individual classifications varied significantly with respect to more specific morphologic categories. Suboptimal quality of histologic sections was a significant factor contributing to problems in morphologic classification. Ancillary immunologic techniques may be required for definitive subclassification of large cell lymphomas.

Adolescent↗