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Biomedical subjects

T F Pajak

Publications and source records attributed to T F Pajak.

At least 127 records · Page 7Linked to original sources
PubMed1981

Phase II trial of cis-dichlorodiammineplatinum (II) in advanced malignant lymphoma: a study of the cancer and acute leukemia group B.

In a cooperative study of the Cancer and Acute Leukemia Group B, 27 evaluable patients with advanced malignant lymphomas were treated with 70 mg/m2 of cisdichlorodiammineplatinum(II) (cis-platinum) once every three weeks. All patients had received extensive prior therapy. Partial remission was obtained in two of eight patients (25%) with Hodgkin's disease, for six and 40 weeks, and in five of 19 (26%) patients with non-Hodgkin's lymphoma, for a median duration of six weeks. The major toxic effects were profuse vomiting and, to a lesser degree, myelosuppression. Nephrotoxicity was easily controlled. Cis-platinum is an active agent in lymphoma and should merit incorporation into combination therapy for recently diagnosed disease.

Adult↗
PubMed1981

The superiority of CCNU in the treatment of advanced Hodgkin's disease: Cancer and Leukemia Group B Study.

In a randomized study, the effect of single agent therapy, with CCNU was compared with that of BCNU in previously treated patients with advanced Hodgkin's disease. The dosage of CCNU was 100 mg/m2 p.o. q. 6 weeks and of BCNU, 200 mg/m2, p. 6 weeks with dose modification adjusted to individual tolerance. For 60 evaluable patients the response rate (complete and partial was 60 for CCNU and 28% for BCNU (p = 0.025); median duration of response was 4.5 months and 2.0 months, respectively (P = 0.26). Median survival for responders was 11.0 months and for non-responders 5.0 months. No major difference was observed in hematologic toxicity between the two compounds. Used as single agents in equitoxic dosages, CCNU is superior to BCNU for the treatment of previously treated advanced Hodgkin's disease, and CCNU has the additional advantage of oral administration.

Adult↗
PubMed1981

MER immunotherapy and combination chemotherapy for advanced, recurrent Hodgkin's disease. Cancer and Leukemia Group B study.

The effects of chemotherapy and chemoimmunotherapy in previously treated advanced Hodgkin's disease were evaluated in a randomized study of 167 patients by CALGB. Combination chemotherapy consisted of treatment with one of three regimens with further randomization of MER (methanol extraction residue BCG) immunotherapy or no MER during chemotherapy. CVPP (CCNU, vinblastine, procarbazine, prednisone) was compared to a new combination, BAVS (bleomycin, Adriamycin, vincristine, streptozotocin), and to a third regimen consisting of alternating cycles of CVPP and BAVS. At the current analysis there is no significant difference in complete responses among the chemotherapy regimens. MER did not improve complete response frequency and was associated with significantly poorer survival for patients previously treated with chemotherapy. There was also no benefit with MER for patients with at least one pretreatment positive skin test. Because of the documented lack of therapeutic benefit and the morbidity of painful ulcers, MER treatment has been discontinued.

Adult↗
PubMed1981

Maintenance management of acute nonlymphocytic leukemia.

The necessity of intensive maintenance chemotherapy in enhancing the duration of life in patients with acute nonlymphocytic leukemia (ANLL) in remission has been evaluated. Twenty-four patients were managed with maintenance chemotherapy and 24 were not. In patients under 50, there was no evidence that maintenance prolonged survival. In patients over the age of 50, maintenance chemotherapy prolonged survival (p = 0.03). In both groups the duration of first remission appeared to be lengthened in patients on maintenance chemotherapy (p = 0.09). Since patients 50 and older were difficult to reinduce, it appears that the greatest prolongation of life for them is afforded by continuous maintenance chemotherapy which may forestall relapse. On the other hand, patients less than 50 years of age have a high likelihood of achieving a second complete remission; it is in this group that maintenance chemotherapy adds only to morbidity.

Acute Disease↗
PubMed1980

A new effective four-drug combination of CCNU (1-[2-chloroethyl]-3-cyclohexyl-1-nitrosourea) (NSC-79038), vinblastine, prednisone, and procarbazine for the treatment of advanced Hodgkin's disease.

Five hundred and sixty-six patients with either Stage III or IV Hodgkin's disease were prospectively randomized to test whether CCNU and/or vinblastine are more effective than mechlorethamine and/or vincristine with procarbazine and prednisone. The combination of CCNU, vinblastine, procarbazine, and prednisone (CVPP) was shown to be a highly effective program with a complete response frequency of 69%. The use of CCNU as part of the induction program was also shown to be the most significant determinant of prolonged remissions (P = .025). Reduced vomiting and neurotoxicity, as well as the oral administration, were the chief advantages of the CVPP as compared with MOPP. These factors resulted in improved patient and physician compliance. The MVPP regimen was also shown to be a highly effective regimen with a complete response frequency of 73% in patients without prior exposure to chemotherapy. However, the induction regimens containing vinblastine were associated with a significantly higher frequency of fatal hematopoietic toxicities than the induction regimens containing vincristine (P = .05). This higher frequency was almost exclusively seen in the elderly or in patients previously treated with both chemotherapy and radiotherapy. At this time, the remission durations maintained by vinblastine with periodic reinforcement are longer when compared with vinblastine maintenance alone (P = .06), but there is no corresponding increase in survival.

Adult↗
PubMed1980

Clinical trial of VP 16--213 (NSC 141540) I.V. twice weekly in advanced neoplastic disease: a study by the Cancer and Leukemia Group B.

The epipodophyllotoxin derivative VP 16--213 (NSC 141540) was studied by the Cancer and Leukemia Group B in a broad phase II trial at three dose levels: 60 mg/m2, 90 mg/m2, and 135 mg/m2 I.V. twice weekly. No correlation between dose of VP 16--213 and response frequency in a particular disease category could be demonstrated. Of the 382 patients, 8% obtained a complete (CR) or partial remission (PR), 8% showed improvement, and 14% had stable disease. By tumor type the best responses were obtained in lymphomas (8/31 CR + PR), uterus (2/9), prostate (1/5), rhabdomyosarcoma (2/6), neuroblastoma (2/4), colon/rectum (5/81), other gastrointestinal (4/32). In lung tumors, 4/80 patients obtained CR or PR. VP 16--213 has definite antineoplastic activity but the response frequency with the twice weekly schedule may be lower than that reported with other schedules.

Adult↗
PubMed1980

A randomized combined modality trial in small cell carcinoma of the lung: comparison of combination chemotherapy-radiation therapy versus cyclophosphamide-radiation therapy effects of maintenance chemotherapy and prophylactiv whole brain irradiation.

A randomized trial of combined modality therapy employing combination chemotherapy (cyclophosphamide (CTX) and methotrexate (MTX), CTX, MTX and Vincristine (VCR) and CTX, VCR and high-dose MTX with citrovorum rescue) and radiation therapy was compared to cyclophosphamide and radiation therapy in 258 patients with pulmonary small cell carcinoma. Patients were also rendomized: 1) to determine the effects of prophylactic whole brain irradiation; and 2) to establish the effects of maintenance chemotherapy. Survival, frequency of response and site of relapse were different in patients with limited disease (LD) (disease confined to lung, mediastinum and supraclavicular lymph nodes) when compared with disease spread beyond these sites (extensive disease) (ED). No survival advantage was seen in LD when combination chemotherapy was employed, although the frequency of complete remission was greater with three drugs than with one or two drugs (40% vs. 32%). In ED frequency of response was greater for three drugs than for one and two drugs (60% vs. 40%), but there was no survival advantage. The median survival time for complete responders was similar for limited or extensive disease (12.1 months), but 23.8% were alive at 24 months with LD compared to none with ED. Maintenance chemotherapy significantly prolonged survival by 16.8 months with 33% alive at 24 months compared to 9% who were unmaintained. Prophylactic while brain irradiation prevented brain metastases with only 4% developing this complication as compared to 18% of control subjects, but did not influence survival.

Antineoplastic Agents↗
PubMed1980

Combination chemotherapy for terminal-phase chronic granulocytic leukemia: cancer and leukemia group B studies.

A 34% response was obtained in 202 evaluable patients in the terminal phase of chronic granulocytic leukemia using combinations of hydroxyurea, 6-mercaptopurine, and corticosteroids. Twelve percent of responses were complete and 22% partial. Overall median survival was 12 wk. A 30 wk median survival for responding patients was statistically superior to the 7-wk survival for nonresponders (p less than 0.001). Response was inversely correlated with toxicity. No responses were obtained in patients sustaining both severe infectious and bleeding complications. No benefit could be demonstrated from the addition of vincristine in induction and daunorubicin for consolidation. Although the response frequency and duration of survival with this combination chemotherapy were generally superior to those previously reported by our group, the terminal phase of chronic granulocytic leukemia still remains a formidable and generally refractory disease.

Daunorubicin↗
PubMed1980

Adriamycin given as a weekly schedule without a loading course: clinically effective with reduced incidence of cardiotoxicity.

Three hundred and thirty-six patients with a variety of tumors were treated with Adriamycin given weekly as an iv bolus of 1 mg/kg with subsequent doses adjusted for hematologic toxicity. This weekly schedule, not utilizing a loading course, resulted in only a 20% incidence of stomatitis. The number of evaluable patients and the percent with objective responses (respectively) according to tumor type were: lung (57 patients, 14%); sarcoma (62, 24%); breast (31, 35%); transitional cell carcinoma (17, 29%); non-Hodgkin's lymphoma (17, 29%); head and neck (16, 13%); colorectal (13, 0); ovarian (eight, 25%); and other (53, 11%). These response frequencies are comparable to those reported for every-3-week regimens using 60-75 mg/m2 of Adriamycin. Sixteen patients were given 450-550 mg/m2 of Adriamycin, five were given 550-600 mg/m2, and ten were given greater than 600 mg/m2. None of the study patients developed definite evidence of drug-induced congestive heart failure. Therefore, Adriamycin given as a weekly schedule provides a clinically effective alternative to the every-3-week schedule of administration. The weekly schedule is associated with tolerable toxicity and a decreased risk of developing drug-induced congestive heart failure.

Doxorubicin↗
PubMed1979

A comparative study of a BCNU containing 4-drug program versus MOPP versus 3-drug combinations in advanced Hodgkin's disease: a cooperative study by the Cancer and Leukemia Group B.

A prospective randomized trial by CALGB examined the relative value of four chemotherapy regimens in 537 patients with stage III B and IV Hodgkin's disease. A new combination BOPP, derived by substitution of BCNU for nitrogen mustard in the MOPP regimen, was compared to MOPP and to two 3-drug regimens, derived by removing the procarbazine in BOPP (BOP) or removing the alkylating agent (OPP). The 4-drug programs gave significantly higher frequency of complete remissions (BOPP 67%, MOPP 63%) than the 3-drug regimens (BOP 40%, OPP 42%), and significantly longer duration of remission and survival. BOPP had a therapeutic activity equal to MOPP, and was accompanied by less toxicity. After 6 cycles of induction chemotherapy, responding patients, both CR and PR, were continued on maintenance chemotherapy for 3 years. No significant difference in relapse rate was demonstrated following maintenance treatment with either vinblastine, chlorambucil, or chlorambucil plus monthly vincristine + prednisone doses. Nor could a reinforcement phase late in the maintenance program be shown to influence the relapse rate. The median survival for all patients entered on the 4-drug programs was 5 years, while the median has not yet been reached at 6 years for those patients, who obtained CR.

Adult↗
PubMed1979

Combination chemotherapy for non-Hodgkin lymphomas: a ten year follow-up study.

In 1968 the Cancer and Acute Leukemia Group B (CALGB) demonstrated optimal control of disseminated non-Hodgkin lymphomas (NHL) with vincristine-prednisone induction followed by cyclophosphamide maintenance. A study was then begun to determine whether four drugs in combination or sequence could achieve greater control. NHL patients at each participating CALGB institution were randomly assigned to one of three regimens:I) Cyclic vincristine-streptonigrin alternating every 2 weeks with cyclophosphamide-prednisone up to 155 days; II) Sequential treatment with the same 4 drugs taken singly up to 182 days; and III) Vincristine-prednisone induction for 6 weeks followed by cyclophosphamide maintenance. Results are now reported after a 10 year follow-up period. The 203 evaluable patients are those on whom Rappaport histopathologic classification was available. Frequency of complete-response did not differ significantly among the three regimens: I) 38%; II) 30%; and III) 45%. Remission durations were significantly longer among patients receiving maintenance therapy. After ten years, two patients from Regimen I, one from Regimen II, and five from Regimen III remain alive and well. It was concluded that neither of the four-drug regimens conferred a significant advantage in terms of response rate or survival time over the standard treatment.

Antineoplastic Agents↗
PubMed1979

Response to therapy in IgG myeloma patients excreting lambda or kappa light chains: CALGB experience.

Sixty-eight previously untreated patients with IgG myeloma who were entered into five protocols of Cancer and Leukemia Group B (CALGB) were studied in order to determine the possible influence of excretion of kappa versus lambda urinary light chains on responses to treatment and survival. All patients in these protocols were included if the serum and urine protein abnormalities were confirmed by one of the two group reference laboratories. Pretreatment characteristics of the two groups of patients did not differ significantly. Of 44 patients with kappa Bence Jones proteinuria, 19 patients (43%) had good responses to treatment, whereas only 3 of 24 patients (13%) with lambda Bence Jones proteinuria had good responses (p = 0.02). Survival for the patients excreting kappa light chains was significantly better than survival for patients excreting lambda chains (median survival 31 versus 12 mo, p = 0.02).

Humans↗
PubMed1979

Procarbazine, vinblastine, and actinomycin D in stage III and IV melanoma with or without methanol-extracted residue of Bacillus Calmette-Guérin.

Patients with stage III and IV melanoma were randomly assigned to receive procarbazine (100 mg/m2, Days 1--10), vinblastine (5 mg/m2, Days 1 and 8), and actinomycin D (0.5 mg/m2, Days 1 and 8) with or without methanol-extracted residue (MER) of bacillus Calmette-Guerin (200 micrograms in five sites). In patients with measurable disease, 20% (eight of 40 patients) responded with only the combination chemotherapy while 15% (six of 39 patients) responded with the MER added. Toxicity was tolerable except for some instances of severe, gastrointestinal toxicity associated with procarbazine. MER as given in this study, failed to either increase the response rate or prolong survival.

Antineoplastic Agents↗
PubMed1979

Hypersensitivity reactions to iv melphalan during treatment of multiple myeloma: Cancer and Leukemia Group B experience.

Ten patients developed allergic reactions to iv melphalan (L-PAM) during therapy for multiple myeloma. The incidence of such reactions was 2.4% among 425 patients receiving iv L-PAM with or without other drugs and 3.9% among 255 patients receiving iv L-PAM alone. Only one such reaction was demonstrated in 294 patients who initially received oral L-PAM. The median day of first reaction to iv L-PAM was Day 222 (range, Days 44-909) and the median total dose prior to a reaction was 185 mg (range, 51-250 mg). Of five patients who subsequently received oral L-PAM, four developed a reaction similar to that experienced with the iv drug.

Administration, Oral↗
PubMed1979

Improved survival of increased-risk myeloma patients on combined triple-alkylating-agent therapy: a study of the CALGB.

Two hundred fifty-two previously untreated evaluable patients with multiple myeloma were entered into a study testing a regimen of three intravenous alkylating agents, melphalan, cyclophosphamide, and carmustine (BCNU), given in combination (BCMP) against a regimen employing oral melphalan (MP). Both regimens included a tapering course of prednisone. Objective responses based on the Myeloma Task Force criteria were significantly more frequent in the group receiving BCMP. Survival for the entire group of BCMP-treated patients was not significantly better than that for MP-treated patients (p = 0.62). However, when the survival of the poor-risk (high tumor cell load) group of patients treated with BCMP was compared with the survival of the poor-risk (high tumor cell load) group of patients treated with MP, an improvement in survival attributable to BCMP therapy was seen (p = 0.049 and 0.02, respectively). In the good-risk (low and intermediate tumor cell load) group, BCMP treatment resulted in a trend toward poorer survival, but this did not achieve statistical significance (p = 0.080 and 0.23, respectively). These results indicate that optimal therapy in myeloma may be dependent on the extent of disease at the time of first treatment. Additional studies to explore the effects of treatment intensity and duration are needed in order to design improved myeloma treatment based on the patient's extent of disease.

Alkylating Agents↗
PubMed1979

Multiple myeloma resistant to melphalan: treatment with cyclophosphamide, prednisone, and BCNU.

Eighty-nine patients with multiple myeloma resistant to melphalan were randomized to receive cyclophosphamide plus prednisone (CP) (47 patients) or cyclophosphamide plus BCNU plus prednisone (CBP) (42 patients). No differences were detected in the two groups prior to therapy. Objective responses occurred in three (7%) of the CP patients and in seven (17%) of the CBP patients. About 40% of the patients in each group achieved some response. Toxic reactions consisted mainly of leukopenia and thrombocytopenia. Median survival was not different in the two groups. The median survival time was 31 months among those patients with an objective response and 9.4 months among those without an objective response. The addition of BCNU to CP increased the frequency of objective response, but not significantly. This triple combination (CBP) cannot be recommended.

Carmustine↗
PubMed1978

Vincristine, prednisone and L-asparaginase in the induction of remission in children with acute lymphoblastic leukemia following relapse.

Two hundred and twenty-seven children with recurrent acute lymphoblastic leukemia were treated with various combinations of vincristine, prednisone, cyclophosphamide and L-asparaginase in an approach to the induction of remission. The combination of L-asparaginase 1,000 mu/kg iv q.d. x 10, vincristine 2.0 mg/m2iv q.w. x 4 and prednisone 40 mg/m2 p.o.q.d. x 28 days was found to be highly effective. The incidence of remission was 73%. No significant improvement was achieved when cyclophosphamide was added to this regimen. Various combinations of cytosine arabinoside, cyclophosphamide, vincristine, prednisone, BCNU or CCNU failed to maintain remission duration for more than two or three months. Neither BCNU nor CCNU prevented the development of CNS leukemia.

Adolescent↗