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Biomedical subjects

T F Pajak

Publications and source records attributed to T F Pajak.

At least 109 records · Page 6Linked to original sources
PubMed1984

Predicting the response of head and neck cancers to radiation therapy with a multivariate modelling system: an analysis of the RTOG head and neck registry.

Two thousand and sixty-six patients with primary head and neck cancers were entered in the RTOG Head and Neck Cancer Registry between 1977 and 1980. Nine hundred and ninety-seven (997) evaluable patients were treated initially with radiation therapy alone. Tumor site, T-stage, N-stage, histology, degree of infiltration, degree of differentiation, patient age, sex and Karnofsky performance score were all prospectively recorded. T-stage (p less than .001), N-stage (p = .007), primary site (p less than .001), and initial Karnofsky performance score (p less than .001) proved to be significant factors independently predictive of primary tumor clearance. Using these factors, a multivariate response model was constructed to predict primary tumor response. The predictive accuracy of the model proved to be highly reliable, and was tested by comparing the predicted vs. observed complete tumor clearance rates for each independent variable. For primary sites, the predicted number of complete responses vs. observed were: oral cavity, 139.8 predicted vs. 139 observed; nasopharynx, 51.8 predicted vs. 51 observed; oropharynx, 174.8 predicted vs. 176 observed, supraglottic larynx, 314.4 predicted vs. 318 observed; glottic larynx, 314.4 predicted vs. 318 observed; and hypopharynx, 49.4 predicted vs. 46 observed. For the entire group of patients predicted to have a 90% or better complete primary tumor response (including T3 and T4 tumors), 94% remained in initial complete remission at the primary site at one year, and 87% at two years. An accurate multivariate response model, such as the one presented in this paper, should prove to be a useful tool in selecting patients with head and neck cancers suitable for treatment with radiation therapy alone.

Adult↗
PubMed1984

Breast cancer in young women treated definitively with radiotherapy. An early report.

Between 1977 and 1982, 34 breast cancers in 33 women aged less than or equal to 35 years were treated with primary radiotherapy following excisional biopsy and axillary lymph node dissection. The records of these cases were reviewed and compared to 156 women greater than age 35 with 157 breast cancers treated similarly during the same time period. Analysis of these cases was limited to patients with invasive cancers who were AJC Stages I or II. In the women less than or equal to age 35, there were only six failures (two with locoregional failure only and four with distant metastases). The treated breast was preserved in all of the younger women except for the two patients with locoregional failure only who were treated for salvage with a mastectomy. The actuarial freedom from breast relapse alone at 3 years was 96% in women less than or equal to 35 years vs. 97% in women greater than 35 years. Freedom from locoregional relapse only was 88% vs. 95% at 3 years in the above groups, and the actuarial disease-free survival at 3 years was 76% vs. 87%, respectively. None of the above comparisons between younger and older women are statistically different. We conclude that definitive radiation therapy for Stages I and II carcinoma of the breast in women less than or equal to age 35 yields similar results to those for women greater than 35. Such treatment achieves excellent preservation of the breast and should continue to be considered as an alternative to mastectomy.

Adult↗
PubMed1984

The effects of prior radiation therapy and age on the frequency and duration of complete remission among various four-drug treatments for advanced Hodgkin's disease.

The current report examines the clinical response observed in 137 patients with advanced Hodgkin's disease who had relapsed from an initial complete response following radiation therapy (RTF) in comparison to 280 patients with no prior therapy (NPT). Patients were prospectively randomized to therapy with a four-drug combination chemotherapy program to determine whether CCNU and/or vinblastine are more effective than mechlorethamine and/or vincristine when combined with procarbazine and prednisone. The frequency of complete remission (CR) was 75% for the RTF group compared to 60% of those with NPT (P = .005). In the RTF group, those patients receiving a nitrosourea (CCNU) had a significantly greater CR frequency than those receiving mechlorethamine (P = .006). Significant risk factors favoring longer duration of remission were age less than 40 (P = .005), the absence of splenic involvement (P = .007), and the use of CCNU-containing programs (P = .015). The advantage for CCNU-containing programs was seen only in patients less than 40 years of age. In this study, the strongest factors favorably affecting response to therapy were prior RTF, age less than 40 years, and treatment with a nitrosourea (CCNU).

Adult↗
PubMed1983

The effect of adjuvant chemotherapy on cosmesis and complications in patients with breast cancer treated by definitive irradiation.

From 1978 to 1981, 46 patients received primary radiotherapy following excisional biopsy and axillary staging procedure for Stages I and II carcinoma of the breast. The patients were divided into 2 groups: 27 patients who received radiation and completed 12 cycles of adjuvant chemotherapy (CMF or CMFP) and 19 patients who received radiation alone. All patients received radiation to the breast and regional nodes (4600-5000 rad) and a boost to the site of the primary tumor (1500-2000 rad). Median follow-up from completion of radiation was 26 months in the non-adjuvant and 24 months in the adjuvant group with a range of 12 to 49 months. Cosmesis was judged to be good to excellent in 89% (17/19) of the patients receiving radiation alone and 81% (22/27) of the patients receiving adjuvant chemotherapy. Fair to poor cosmesis in the adjuvant group was attributed primarily to increased fibrosis and reduction of breast size. The single complication for which there was an increased incidence in the adjuvant group was arm edema (22 vs. 0%). The incidence of arm edema was unrelated to T stage, type of axillary surgical procedure, number of positive nodes, addition of prednisone or sequencing of chemotherapy. Further efforts should be directed towards minimizing complications and maximizing cosmesis without sacrificing relapse-free survival in patients receiving primary radiotherapy and adjuvant chemotherapy for early breast cancer.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1983

Locally recurrent breast carcinoma: the effect of adjuvant chemotherapy on prognosis.

A group of 72 patients who had received radiotherapy between 1972 and 1980 for isolated local-regional recurrence of breast cancer was studied; 38 had received adjuvant chemotherapy and 34 had not. The two groups were comparable except for the initial nodal status and median time from mastectomy to recurrence. Outcome was not significantly different for the two groups in terms of response to radiotherapy, incidence of re-recurrence, distant metastases, and three-year survival. The length of the disease-free interval and the response to radiotherapy were the only factors studied that were significantly related to survival.

Antineoplastic Agents↗
PubMed1983

Four-drug combination chemotherapy (methotrexate, cyclophosphamide, hexamethylmelamine, and CCNU) for non-small cell bronchogenic carcinoma: a Cancer and Leukemia Group B study.

Ninety-eight evaluable patients with nonresectable regional or metastatic non-small cell bronchogenic carcinoma were treated with a four-drug combination chemotherapy program of methotrexate, cyclophosphamide, hexamethylmelamine, and CCNU (MCHC). Fifteen partial or complete responses (15%) were obtained, all but one of which occurred in good performance status (0-1) patients. While "responders lived longer than non-responders", this was due more to initial performance status among responding patients than to achievement of partial (greater than 50%) or complete disease regression. Evaluation of those patients with good performance status (PS 0-1), indicated no statistically significant differences in median survival time for complete response and partial response patients compared to patients with "improved" or "stable" disease status in this group. This combination of modestly active single agents produced disappointing results in our lung cancer population. A search for more active single agents in lung cancer is necessary.

Altretamine↗
PubMed1982

Comparison of oral melphalan, CCNU, and BCNU with and without vincristine and prednisone in the treatment of multiple myeloma. Cancer and Leukemia Group B experience.

A total of 361 evaluable patients with previously untreated multiple myeloma were randomized to receive oral melphalan (0.15 mg/kg/day for seven days, followed by 0.05 mg/kg/day after recovery from the nadir of the leukocytes), BCNU (150 mg/m2 intravenously every six weeks) or CCNU (100 mg/m2 orally every six weeks). All patients received a tapering six-weeks) or CCNU (100 mg/m2 orally every six weeks). All patients received a tapering six-week course of prednisone starting at 0.8 mg/kg for the first two weeks. At week 22, one-half of the patients were randomized to receive vincristine (1 mg/m2) and prednisone (0.6 mg/kg for seven days) every two months in addition to previous therapy. The melphalan treated patients showed a significantly higher overall objective response frequency (59%), according to Myeloma Task Force criteria, when compared to those treated with BCNU (40%) or CCNU (42%). The survivals for all patients were not statistically different for the three treatment programs. However, the good-risk patients treated with melphalan had significantly longer survival (P = 0.02) than the equivalent patients who received BCNU or CCNU. The addition of vincristine and prednisone at week 2 did not significantly increase the percentage of subsequent objective responses or prolong the subsequent survival of any treatment group. It is concluded that oral melphalan is superior to BCNU and CCNU in producing objective responses and in prolonging survival in good risk patients.

Antineoplastic Agents↗
PubMed1982

Effect of methanol extraction residue of Bacillus Calmette-Guerin in advanced Hodgkin's disease.

One-hundred-ninety-six patients with Stage III and IV Hodgkin's disease were prospectively randomized to receive either treatment with the methanol extraction residue of Bacillus Calmette-Guerin (MER/BCG) or no immunotherapy. Prior to the MER/BCG randomization, patients received six courses of induction and two years of maintenance chemotherapy so that a group with a presumptively low tumor burden could be established. Only patients achieving a complete remission were evaluated. During the first two years of immunotherapy, the MER/BCG group had a relapse frequency twice that of controls. The overall crude relapse frequency and disease-free survival were similar between the two treatment groups. The MER/BCG dose schedule used in this study was associated with a high frequency of unacceptable toxicity. Ulcerations of greater than 1 cm occurred in one-third of the patients with associated pain, fever, and occasional lymphadenopathy. A high degree of patient noncompliance (36%) was observed. Age (P = 0.002), prior radiotherapy (P = 0.032), and chemotherapy (P = 0.044) were prognostic factors found to significantly influence remission duration. These factors were balanced between patients treated with immunotherapy and those who were not. MER/BCG therapy did not significantly delay or prevent relapse.

Adult↗
PubMed1982

Cyclophosphamide, doxorubicin, vincristine, and low-dose continuous infusion bleomycin in non-Hodgkin's lymphoma: Cancer and Leukemia Group B Study No. 7804.

Fifty-eight evaluable patients with non-Hodgkin's lymphoma were treated with a low dose, 120-hour continuous intravenous infusion of bleomycin in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone. Pharmacokinetic data, obtained in six patients, confirm that steady-state plasma concentrations of bleomycin can be attained even with the administration of 2 units/day of the drug. Neither clinical pulmonary toxicity nor subclinical pulmonary changes, as determined by serial measurement of the single breath carbon monoxide-diffusing capacity, were observed. Compared to similar chemotherapeutic programs utilizing bolus administration of bleomycin, pulmonary toxicity may be reduced. Response frequencies among 37 previously untreated patients were similar to those obtained using the same chemotherapeutic agents but with intravenous bolus administration of bleomycin. In addition, 18 of 21 patients who had received prior chemotherapy responded. Low dose, continuous intravenous infusion of bleomycin may improve the therapeutic index of combination chemotherapy programs for non-Hodgkin's lymphoma.

Adult↗
PubMed1982

Diffuse malignant mesothelioma. Prospective evaluation of 69 patients.

From 1974 to 1980, 69 patients with ith diffuse malignant mesothelioma were prospectively evaluated. The initial site of involvement was the pleura in 57 patients and the peritoneum in 12. Previous asbestos exposure was found in 53 patients (77%), with a shorter period of latency for peritoneal (mean, 28 years) than for ith pleural mesothelioma (mean, 35 years) than for pleural mesothelioma (mean, 35 years). Other associated exposure or diseases included talc, mica, familial Mediterranean fever, and diffuse lymphocytic lymphoma (one patient each). Thrombocytosis was common, as were thromboembolic episodes. Survival was significantly better for patients with an epithelial subtype, with pleural versus peritoneal mesothelioma, and for those under 65 years of age. Surgery was never curative, but its extent was correlated with survival and earlier diagnosis. Results of chemotherapy with doxorubicin and 5-azacytidine yielded a somewhat better survival rate than a combined program with doxorubicin and radiotherapy. Survival after chemotherapy was correlated with performance status, response to chemotherapy, and extent of previous surgery.

Adult↗
PubMed1982

Chemotherapy and combined modality therapy for Hodgkin's disease: a progress report on Cancer and Leukemia Group B studies.

Between 1974 and 1977, the Cancer and Leukemia Group B (CALGB) initiated four studies which address current major questions in the therapy for Hodgkin's disease. The efficacy of chemotherapy alone as compared with combined modality therapy in patients with poor-prognostic stages I and II is evaluated in CALGB 7751. Currently, both therapies produce very high complete remission rates in asymptomatic patients; the remission rate is better with combined modality therapy in symptomatic patients. Single and combined modality therapies are compared for stage III patients in CALGB 7451. Complete remission rates have been similar, but relapse-free survival is superior for patients treated with local nodal radiotherapy followed by chemotherapy (P = 0.04). In particular, stage IIIA patients with nodular sclerosis seem to benefit from the inclusion of radiotherapy in their initial treatment. In CALGB 7551, the efficacy of chemotherapy alone versus chemotherapy plus radiotherapy to areas of bulky disease is under study in patients with stages IIIB and IV. Currently, a relapse rate of less than 10% has been seen among sites irradiated, and survival is best for patients treated with radiotherapy bracketed by chemotherapy. Finally, the role of two alternating non-cross-resistant combination chemotherapy programs is being studied in CALGB 7552. Relapse-free and overall survival is better with the doxorubicin-containing regimen than with either the alternating or alternate chemotherapy program. At present, the median followup for each of these studies is less than 5 years. Further observation is required to answer the critical questions relating to prolonged disease-free survival and cure.

Adult↗
PubMed1982

Small cell anaplastic carcinoma of the lung. The Cancer and Leukemia Group B Experience.

Three protocols have been evaluated by the Cancer and Leukemia Group B (CALGB) for the treatment of small cell anaplastic cancer of the lung between 1972 to 1980. The first protocol (CALBG 7283) was a randomized comparison between 4 arms: high dose cyclophosphamide alone, cyclophosphamide plus methotrexate, cyclophosphamide plus methotrexate plus vincristine, and cyclophosphamide plus high-dose methotrexate plus vincristine. Response rate and survival were not significantly different among the 4 arms. Effectiveness of prophylactic brain radiotherapy and usefulness of maintenance chemotherapy were demonstrated. The next protocols (CALGB 7781 and 7782) compared two adriamycin containing regimens: MACC (methotrexate, adriamycin, cyclophosphamide, CCNU) versus CCV/AV (cyclophosphamide, CCNU, vincristine, alternating with adriamycin and vincristine). Split course radiotherapy (total 45 Gy over 4 weeks) was also given to all patients with limited disease (CALGB 7781) as well as prophylactic brian irradiation. Radiotherapy to the chest was also given in an additional arm of CALGB 7782 for patients with extensive disease. No significant differences were seen for response and survival within categories defined by extent of disease. Overall about 25 per cent of patients achieving complete remission remain alive at 2 years. The prognostic impact of different factors including extent of disease, performance of status, age and sex are discussed.

Antineoplastic Agents↗
PubMed1982

Severe neurotoxicity with methyl G: CALGB experience.

Methylglyoxal bis-dihydrochloride is a drug that has been available for use in cancer chemotherapy since 1955. In earlier studies, it was used on a daily schedule with resulting severe gastrointestinal toxicity and myelosuppression. To avoid that toxicity, a new weekly schedule has been adopted in several Phase II studies. With the weekly schedule, new types of toxicity have been described and we report four patients who have developed a severe sensory-motor neuropathy with the chemotherapy which appears to be drug-related.

Aged↗
PubMed1982

Effect of age on therapeutic response and survival in advanced Hodgkin's disease.

Although age is a recognized prognostic factor in advanced Hodgkin's disease, there are few data concerning the use of combination chemotherapy in patients greater than 60 years. In two phase III trials of the Cancer and Leukemia Group B, 385 previously untreated patients with stage III or IV Hodgkin's disease received multidrug chemotherapy. All patients received a combination of either mechlorethamine or a nitrosourea, as well as a vinca alkaloid, procarbazine, and prednisone. Two hundred and five patients were less than 40 years of age, 107 were 40-59 years, and 73 were greater than or equal to 60 years. The overall response rates in these three age groups were 70%, 66%, and 40%, respectively. Age at the time of diagnosis was the predominant factor affecting response, and the response rate was not significantly higher in those older patients who received full doses of chemotherapy. Age was also associated with an increased frequency of serious leukopenia and thrombocytopenia. The group of patients greater than or equal to 60 years of age experienced the shortest median time to recurrence, 33 months. The intermediate age group also had a shorter time to recurrence (median, 44 months) than patients less than 40 years (median not yet reached). The low complete response rate and the short duration of response in the patients greater than or equal to 60 years of age resulted in a median survival time of 18 months. Even when the analysis of restricted to just the older patients who received greater than or equal to 90% of the projected drug doses, the complete remission rate, the median time to recurrence (20 months), and the duration of survival (27 months) are still much shorter than in younger patients.

Adult↗
PubMed1982

Multiple myeloma resistant to melphalan: treatment with doxorubicin, cyclophosphamide, carmustine (BCNU), and prednisone.

Sixty-five patients with multiple myeloma resistant to melphalan were randomized to receive cyclophosphamide, doxorubicin (Adriamycin), and prednisone (CAP) (30 patients) or carmustine (BCNU), doxorubicin, and prednisone (BAP) (35 patients). Objective responses occurred in two patients in the CAP group and in seven in the BAP group. Indirect responses were noted in seven additional patients in the CAP group and in six additional patients in the BAP group. Toxic effects consisted mainly of leukopenia and thrombocytopenia. Median survival did not differ between the two treatment groups (CAP, 8.4 months; BAP, 7.7). Objective responders had a longer survival than nonresponders (14.5 vs 7.7 months).

Aged↗
PubMed1982

Influence of renal failure on myelosuppressive effects of melphalan: Cancer and Leukemia Group B experience.

The influence of renal insufficiency on melphalan-induced myelosuppression was examined during the initial 10 weeks of treatment in 295 patients with multiple myeloma. Patients were randomized to receive either oral melphalan (0.15 mg/kg/day for 7 days, followed by 0.05 mg/kg/day after recovery from the wbc count nadir) or iv melphalan (16 mg/m2 every 2 weeks for four doses, followed by a single dose every 4 weeks). All patients received a 6-week tapering course of prednisone. Patients with renal insufficiency (BUN greater than or equal to 30 mg/100 ml) had a significantly higher frequency of severe leukopenia (less than or equal to 1000 cells/mm3) following iv melphalan than did patients with normal renal function (50% vs 15%, respectively; P = 0.007). The latter effect resulted in an increased frequency of drug-related deaths secondary to infection. The frequency of severe thrombocytopenia (less than or equal to 25,000 cells/mm3) was also greater in patients with renal failure following iv melphalan therapy. Reduction of iv melphalan dose to 50% in patients with elevated BUN reduced the frequency of these complications to levels that were not significantly different from those observed in patients with normal renal function. The frequency of severe myelosuppression was independent of renal function in patients receiving oral melphalan. Possible explanations for these findings are discussed.

Blood Urea Nitrogen↗