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Biomedical subjects

S Frytak

Publications and source records attributed to S Frytak.

At least 73 records · Page 4Linked to original sources
PubMed1981

Concomitant radiation therapy and cis-diamminedichloroplatinum (II) in patients with advanced head and neck cancer.

Three patients with locally advanced head and neck squamous cell cancer received concomitant radiation therapy (XRT) and cis-diamminedichloroplatinum (CDDP). The dose of 6,000 rads was to be administered in two 3,000-rad courses separated by 3 weeks. The CDDP, 30 mg/m2, was to be given intravenously on days 2 and 12 of each half of XRT. We were especially concerned with the occurrence of an abscess in one patient and an abscess with hemorrhage in another. In addition, each patient experienced severe and intractable nausea, vomiting, and a pervasive feeling of ill-health which seemed out of proportion to that usually observed from either XRT or CDDP alone. If the findings in this pilot study are confirmed, the toxicity of XRT with concurrent CDDP as used in our study may well obviate routine clinical usage.

Aged↗
PubMed1981

A case for preplanned thoracic and prophylactic whole brain radiation therapy in limited small-cell lung cancer.

Thirty patients with previously untreated limited small-cell lung cancer were treated in a prospectively randomized trial comparing chemotherapy versus chemotherapy plus prophylactic whole brain radiation therapy. Without preplanned thoracic radiation therapy in addition to the chemotherapy, 78% of patients failed in the lung (52% in the lung solely) as the first site of treatment failure. In those patients not receiving prophylactic whole brain irradiation, 73% failed in the CNS at the time of first and second failure versus 13% of the group randomized to prophylactic whole brain radiation therapy (and those two before the radiation was given). A strong case can be made for the use of both preplanned thoracic and prophylactic whole brain radiation therapy in conjunction with combination chemotherapy, at least until much more effective chemotherapy is found.

Aged↗
PubMed1981

An evaluation of low-dose cisplatin as part of combined modality therapy of limited small cell lung cancer.

Sixty-two patients with previously untreated limited stage small cell lung cancer were treated in a prospectively randomized trial comparing thoracic irradiation plus combination chemotherapy with VP-16-213, vincristine (Oncovin), cyclophosphamide, and Adriamycin (VOCA) or those same four drugs plus low-dose (40 mg/m2) cisplatin (VOCAP). The addition of the cisplatin in eight courses of planned chemotherapy did not significantly improve either time to tumor progression of survival or alter sites of disease progression. It did, however, worsen the degree and frequency of nausea, vomiting, and myelosuppression. We did not identify any benefit from the usage of low-dose cisplatin as employed in this study.

Adult↗
PubMed1981

Thoracic radiation therapy and Adriamycin/cisplatin-containing chemotherapy for locally advanced non-small-cell lung cancer.

One-hundred nine patients with limited-stage unresectable non-small-cell lung cancer were treated with Adriamycin--cisplatin-based combination chemotherapy and thoracic irradiation. Of this number, 73 received chemotherapy (one course) prior to irradiation and 37% (27/73) had tumor regression following chemotherapy alone. Sixty-eight percent of patients (73/107) experienced tumor regression following combined chemotherapy and irradiation. Age more than 65 years, a malignant ipsilateral pleural effusion, and no response to chemotherapy alone were all strong negative prognostic factors. Three-year survivals were as follows: all 109 patients, 14.0%; 89 patients without malignant pleural effusion, 17.0%; 71 patients with neither a malignant pleural effusion nor malignant ipsilateral supraclavicular adenopathy, 23.1%.

Adult↗
PubMed1981

A controlled clinical and immunological evaluation of immunotherapy with Bacillus Calmette--Guerin in patients with metastatic cancer.

One hundred thirty adult patients with metastatic solid tumors were studied to evaluate the therapeutic results, toxicity, and immunological effects of three BCG preparations given intradermally by the multiple puncture time technique on either a monthly or weekly schedule: Tice lyophilized BCG, Pasteur lyophilized BCG, and Pasteur fresh-frozen BCG. Patients were randomly assigned in a double-blind manner to receive one of the BCG preparations or saline placebo administered in an identical manner. A battery of immunological tests were performed pretreatment and serially during the investigation. None of the 82 patients with measurable indicator lesions experienced an objective tumor response, nor were there any differences in survival among patients receiving any of the BCG preparations compared to placebo. Toxicity consisted of mild to moderate local cutaneous reactions and liver function abnormalities in BCG-treated patients with no significant differences between BCG preparations. Improvements in each of the assays of immune function performed occurred with roughly equal frequency among patients receiving BCG or placebo. It was not possible to demonstrate any significant clinical or immunological benefit from BCG administration in this patient population with the methodology employed.

Adult↗
PubMed1980

Phase II evaluation of AMSA in patients with metastatic lung cancer.

Fifty-four patients with metastatic lung cancer were treated with AMSA. Patients with a performance score of 0-1, no prior chemotherapy, and normal liver function received a dose of 35 mg/m2/day iv for 3 days every 4 weeks; patients with a performance score of 2-3, any prior chemotherapy, or abnormal liver functions received a dose of 30 mg/m2/day on the same schedule. Among 53 evaluable patients, responses were noted in one with adenocarcinoma and in two with squamous cell carcinoma (overall response rate, 6%). We conclude that AMSA has limited activity in lung cancer when used in this schedule except perhaps in previously untreated squamous cell carcinoma. Only a limited number of patients with large cell or small cell carcinoma were treated.

Adenocarcinoma↗
PubMed1980

A role of cis-dichlorodiammineplatinum(II) in squamous cell lung cancer.

Forty-one patients with advanced squamous cell lung cancer and no prior chemotherapy were entered in a prospectively randomized trial comparing dianhydrogalactitol plus Adriamycin (DA) versus DA plus cis-dichlorodiammineplatinum(II) (DAP). The DAP regimen was superior to the DA regimen in regression rate (53% versus 27%), median regression duration (255 versus 122 days), median time to tumor progression (approximately 175 versus 58 days), and median survival time (185 versus 126 days). Patients who were greater than 60 years old responded particularly well to the DAP regimen and accounted for most of the survival advantage. Nausea, vomiting, and myelosuppression were more frequent and severe with the DAP regimen. This study seems to indicate a role of cis-dichlorodiammineplatinum(II) in patients with advanced squamous cell lung cancer. The particular advantage noted for older patients needs further evaluation.

Adult↗
PubMed1979

Failure of high-dose vitamin C (ascorbic acid) therapy to benefit patients with advanced cancer. A controlled trial.

One hundred and fifty patients with advanced cancer participated in a controlled double-blind study to evaluate the effects of high-dose vitamin C on symptoms and survival. Patients were divided randomly into a group that received vitamin C (10 g per day) and one that received a comparably flavored lactose placebo. Sixty evaluable patients received vitamin C and 63 received a placebo. Both groups were similar in age, sex, site of primary tumor, performance score, tumor grade and previous chemotherapy. The two groups showed no appreciable difference in changes in symptoms, performance status, appetite or weight. The median survival for all patients was about seven weeks, and the survival curves essentially overlapped. In this selected group of patients, we were unable to show a therapeutic benefit of high-dose vitamin C treatment.

Aged↗
PubMed1979

VP-16, cyclophosphamide, adriamycin and cis-platinum (V:CAP-I) in patients with metastatic adenocarcinoma of the lung.

In an attempt to improve upon the 42% regression rate of the CAP-I regimen in patients with advanced adenocarcinoma of the lung, VP-16 was added to that regimen. VP-16, as a single agent, had a response rate of 12.5% (3/24) In a similar group of patients. The new regimen, V:CAP-I, had a tumor regression rate of 35% (7/20) and an estimated median survival of 171 days. Hence, we were unable to conclude that the addition of VP-16 to the CAP-I regimen statistically improved the regression rate of the CAP-I regimen.

Adenocarcinoma↗
PubMed1979

A phase I study of chlorozotocin (NSC 178248).

Chlorozotocin was administered by rapid intravenous infusion to 35 patients with advanced cancer on either single-day of five-consecutive-day schedules. Total doses per course ranged from 12.5 to 200 mg/m2. On either administration schedule, dose limiting toxicities were thrombocytopenia and leukopenia at total doses of 150 mg/m2 to 200 mg/m2. Repetitive courses of drug may produce progressive impairment of renal and bone marrow function. Nausea and vomiting were infrequent and mild without definite relationship to dose. Minor reversible nondose related increases in SGOT and in serum creatinine occurred at all doses on both schedules. The plasma half-life of intact N-nitroso groups averaged 9.5 minutes after rapid intravenous administration of doses up to 40 mg/m2 and 12.5 minutes after doses of 150 or 200 mg/m2. No differences between plasma half-lives were seen between identical doses given on the first and fifth days of the five-day schedule. Objective tumor regression was noted in one patient with bronchogenic large cell carcinoma and one patient with metastatic melanoma.

Adult↗
PubMed1979

Delta-9-tetrahydrocannabinol as an antiemetic for patients receiving cancer chemotherapy. A comparison with prochlorperazine and a placebo.

The antiemetic activity and side-effects of delta-9-tetrahydrocannabinol (THC) were evaluated in 116 patients (median age 61 years) receiving combined 5-fluorouracil and semustine (methyl CCNU) therapy for gastrointestinal carcinoma. In a double-blind study, patients were randomized to receive THC, 15 mg orally three times a day, prochlorperazine, 10 mg orally three times a day, or placebo. The THC had superior antiemetic activity in comparison to placebo, but it showed no advantage over prochlorperazine. Central nervous system side-effects, however, were significantly more frequent and more severe with THC. With the dosage and schedule we used, and in our patient population of largely elderly adults, THC therapy resulted in an overall more unpleasant treatment experience than that noted with prochlorperazine or placebo. Although THC may have a role in preventing nausea and vomiting associated with cancer chemotherapy, this role must be more clearly defined before THC can be recommended for general use.

Adult↗
PubMed1979

A comparative clinical and immunological assessment of methanol extraction residue of Bacillus Calmette-Guérin versus placebo in patients with advanced cancer.

Eighty-four patients with advanced cancer refractory to conventional therapeutic modalities were randomly assigned in double-blind fashion to one of three intradermal treatment regimens: "high"-dose methanol extraction residue fraction of Bacillus Calmette-Guérin (MER) (2.0 mg); "low"-dose MER (0.5 mg); or 0.9% NaCl solution placebo. Toxicity, consisting primarily of cutaneous inflammation and ulceration, was limited to patients receiving MER and was most severe with the high-dose regimen. Pretreatment clinical and immunological parameters were comparable between patient groups. Although a significant number of patients had increases in various immune parameters according to the criteria used, there was no appearent advantage to MER given in either dosage schedule compared to placebo. Patient survival was not affected by either MER regimen compared to placebo. This investigation failed to demonstrate any significant clinical or immunological benefit from MER given in two dosage regimens in patients with advanced cancer with the laboratory methodology used and emphasizes the importance of appropriate controls in evaluating immunostimulants in humans.

BCG Vaccine↗
PubMed1979

Treatment of advanced breast cancer with cyclophosphamide, 5-fluorouracil, and prednisone with and without methanol-extracted residue of BCG.

The value of immunotherapy as an adjuvant to chemotherapy for advanced breast cancer is an unsettled question. To clarify this issue, 71 women with measurable or evaluable metastatic breast cancer were randomized to receive cyclophosphamide, 5-fluorouracil, and prednisone (CFP) with or without methanol-extracted residue of Bacillus Calmette-Guerin (MER). The total regression rates were 52% (CFP) and 39% (CFP + MER), including complete regression rates of 13% (CFP) and 65% (CFP + MER). The median duration of regressions for CFP-treated patients was 257-261 days and for CFP + MER-treated patients was 385 days. The median time to progression was 248-261 days in the CFP group and 159 days in the CFP-MER group. Projected median survival for both treatment groups is 20 months. Immunotherapy (MER) as used in this study does not appear to augment regression rates or vurvival for patients with advanced breast cancer receiving CFP.

Antineoplastic Agents↗
PubMed1978

Repeated adjuvant chemotherapy with phenylalanine mustard or 5-fluorouracil, cyclophosphamide, and prednisone with or without radiation, after mastectomy for breast cancer.

172 patients who had had mastectomy for breast cancer were treated by repeated adjuvant chemotherapy, either with phenylalanine mustard (P.A.M.) or a combination of cyclophosphamide, 5-fluorouracil, and prednisone (C.F.P.) with and without radiotherapy. Tumours recurred significantly more frequently and mortality tended to be higher in P.A.M.-treated patients than in patients on other treatment. The interval between surgery and disease recurrence was significantly shorter for P.A.M.-treated premenopausal but not postmenopausal patients than for patients of equivalent menstrual status treated with C.F.P. with or without radiation. The associations in premenopausal patients between the mode of treatment and both survival and the disease-free interval were significant before and after adjustment for variations between the treatment groups in the number of involved lymph nodes and the size of the primary tumour.

Adult↗
PubMed1978

Randomized phase II clinical trial of adriamycin, methotrexate, and actinomycin-D in advanced measurable pancreatic carcinoma: a Gastrointestinal Tumor Study Group Report.

Sixty-six patients with advanced pancreatic carcinoma were randomized to receive single agent chemotherapy with either adriamycin, methotrexate, or actinomycin-D using conventional dose, route and schedule of administration. All patients had measurable lesions which were used to objective assessment of response. For adriamycin, 2 of 25 patients (8%) evidenced a partial response (2 of 15 (13%) previously untreated patients). One of 25 patients treated with methotrexate and one of 28 received actinomycin-D responded. The duration of responses ranged from 43-64 days for those patients with no chemotherapy prior to study entry. The median survival of patients who received adriamycin as initial treatment was 12 weeks compared to 8 weeks for methotrexate and 6 weeks for actinomycin-D therapy.

Adult↗
PubMed1978

Early clinical study of an intermittent schedule for maytansine (NSC-153858): brief communication.

Maytansine, an ansa macrolide, was evaluated in an early clinical trial in 40 adult patients with various solid tumors. Severe nausea and vomiting, sometimes associated with watery diarrhea and abdominal cramps, and liver function abnormalities, mainly elevation of serum glutamic--oxaloacetic transaminase levels, together constituted what we considered dose-limiting toxicity. Mild hematologic toxicity (mainly thrombocytopenia), neurotoxicity, and possibly cardiac toxicity were also noted. No antitumor effect was seen. An iv dose of 0.750 mg/m2 on days 1, 3, and 5 (total dose, 2.25 mg/m2) repeated every 4 weeks is recommended for Phase II trials.

Adult↗