Combined chemotherapy cyclophosphamide, vinblastine, procarbazine and prednisone (CVPP) vs. CVPP plus CCNU (CCVPP) in Hodgin's disease.
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Adolescent↗
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MACC (methotrexate, adriamycin, cyclophosphamide and CCNU) in advanced lung cancer.
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Adenocarcinoma↗
Chemotherapy for adenocarcinoma of the lung with 5-fluorouracil, cyclophosphamide, and CCNU (FCC).
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Adenocarcinoma↗
MACC chemotherapy for adenocarcinoma and epidermoid carcinoma of the lung: low response rate in a Cooperative Group Study. Eastern Cooperative Oncology Group.
The MACC (methotrexate, adriamycin, cyclophosphamide, CCNU) regimen was administered to 43 patients with advanced epidermoid and adenocarcinoma of the lung. Only 5 patients (12%), all of whom were ambulatory responded with partial remissions. Median time to progression for the 5 responders was 20 weeks from start of treatment. Median survival was 15.5 weeks for patients with epidermoid cancer and 14.4 weeks for those with adenocarcinoma. Hematologic toxicity was severe, with 2 treatment-related deaths during profound myelosuppression. White blood counts below 2000/microliter were reported in 47%, and below 1,000/microliter in 26%. Since the activity of this regimen, given as it was in full doses, is not superior to that achieved with standard doses of single agents which are less toxic, further employment of the MACC regimen is not recommended, either for advanced disease or as a surgical adjuvant.
Adenocarcinoma↗
Therapy of advanced colorectal carcinoma with 5-fluorouracil and cyclophosphamide in combination with either CCNU or methotrexate.
In a prospective, randomized study a combination of 5-FU, Cyclophosphamide, and Methortrexate (FC-MTX) was compared to a similar combination (FC-CCNU) in which CCNU replaced Methotrexate. Of the 54 patients with metastatic colorectal carcinoma entered, 47 were evaluable. Toxicity was similar for the two regimens and was acceptable. No complete responses occurred. No difference in partial response (PR) 2/24 for FC-CCNU vs. 3/23 for FC-MTX, stable response 16/47 overall, or progressive disease 26/47 overall, was observed. Duration of PR was three to ten months. The overall median survival was six months, three months for non-responders and 11 months for responders. These drug combinations employing 5-FU do not improve upon the results reported with 5-FU alone in the treatment of metastatic colorectal carcinoma.
Adenocarcinoma↗
CCNU-chemotherapy of hemispheric supratentorial glioblastoma multiforme.
One hundred and three patients with hemispheric supratentorial glioblastoma multiforme were studied. All patients were operated on and a histologic diagnosis of glioblastoma multiforme was made. Patients were randomly placed in one of three treatment schedules within 3 weeks of surgery: Group A: combined radiation therapy and drug (CCNU) therapy (26 cases); Group B: CCNU given orally every 6-8 weeks (27 cases); Group C: standard radiation therapy alone (50 cases). All patients were periodically controlled by clinical and instrumental (EEG, scan, EMG, CAT) evaluations; laboratory data examinations were also frequently performed. The treatment results have been evaluated according to length of survival, social quality of life, and positive or negative response to chemotherapy. In our opinion the clinical findings are interesting but the statistical results are somewhat negative, especially when the groups of patients are not homogeneous.
Adolescent↗
A trial of outpatient chemotherapy for recurrent head and neck tumors.
A four-drug combination chemotherapy (bleomycin-methotrexate-vinblastine-CCNU) had been used in 38 evaluable patients with recurrent squamous cell carcinoma of the head and neck region on an outpatient basis. A large number of these patients had carcinoma of the oral cavity (45% of total). Nineteen patients (50%) responded to this regimen with a greater than or equal to 50% regression of their measured tumors. The median survival of all patients was 34 weeks. There was one chemotherapy-related death and the overall toxicity was mild. This convenient regimen can be considered a useful alternative to more aggressive therapy.
Aged↗
Chemotherapy of extensive large cell and adenocarcinoma of the lung: a randomized trial in 210 patients.
Two hundred ten patients with advanced adenocarcinoma of the lung were entered into a two-arm randomized trail. Cytoxan + CCNU + methotrexate was compared to Adriamycin and procarbazine. The tumor response to CCM was significantly higher than the tumor response to Adriamycin and procarbazine. No significant difference existed between the two treatments with respect to survival. Initial performance status, weight loss prior to therapy, and response to therapy were all found to be significant prognostic factors. Median survival time relative to responders in both treatment groups was 31.7 weeks and 15.8 weeks for non-responders.
Adenocarcinoma↗
Prophylactic irradiation in bronchogenic small cell anaplastic carcinoma. A comparative trial of localized versus extensive radiotherapy including prophylactic brain irradiation in patients receiving combination chemotherapy.
A total of 114 patients with bronchogenic small cell anaplastic carcinoma and staged as having regional disease all underwent combination chemotherapy consisting of CCNU, cyclophosphamide, and methotrexate. They were randomized to receive either radiotherapy to the primary tumor and regional lymph nodes (4000 rad) or extensive radiotherapy, which included the brain, adrenals, and upper retroperitoneal lymph nodes. Fifteen patients were free of disease after 18 months of chemotherapy and the treatment was discontinued. Only 3 patients subsequently relapsed. No difference was observed between the two groups of patients in median survival time, response rate, duration of response or relapse pattern, including the frequency of brain metastasis.
Adult↗
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↗
Adriamycin, bleomycin, DIC, CCNU, and prednisone (ABDIC) chemotherapy in MOPP-resistant Hodgkin's disease.
ABDIC was administered to 32 patients with MOPP-resistant Hodgkin's disease. Three were considered nonevaluable because of early death. All patients had received MOPP (medium of eight cycles), and five had also received other chemotherapy. Major radiotherapy had been used in 18 of the 29. Complete remission (CR) occurred in 10 of 29 (34.5%), partial remissions (PR) in 14 (48.2%), and no remissions (NR) in five (17.2%). Median survival and relapse-free survival for CR patients exceeded 28 months. Two relapsed at 8 and 18 months; one died at 9 1/2 months, and the other is disease-free with other treatment at 35 months. Seven of the remaining eight patients are alive without disease (10-35 months); 4 are on maintenance therapy, and the other died from an infection and eosinophilic granuloma of lung without evidence of recurrent Hodgkin's disease. Median survival of PR patients was eight months. One patient with Hodgkin's disease involving the liver is alive at 36 months with further therapy. Median survival of NR patients is 2.5 months, and all died within seven months. Survival of CR patients is greater than PR and NR patients (P = 0.002), and that of PR is greater than NR (P = 0.01). Four of the 29 patients had nodal relapse, and 25 had parenchymal relapse, with no difference in response rates (P = 0.47). ABDIC is useful in Hodgkin's disease patients who have had extensive prior chemotherapy and radiotherapy.
Adolescent↗
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↗
Randomized study of 5-FU and CCNU in pancreatic cancer: report of the Veterans Administration Surgical Adjuvant Cancer Chemotherapy Study Group.
Between the years 1973-1977, 152 male patients from 28 participating Veterans Hospitals with histologically proven nonresectable cancer of the pancreas were randomized in a two-arm study. The treated group was to receive combination chemotherapy with 5-FU and CCNU, and the controls were to receive no chemotherapy. Both groups were comparable with respect to age, amount of weight loss, extent of histologically proved metastases, and operation performed. In the treatment group, drug therapy was begun between 10 and 60 days postoperatively. Intravenous 5-FU, 9 mg/kg, was administered on five consecutive days, and CCNU, 70 mg/m2, was given orally on the first day of each course. In the absence of toxicity, the course was repeated every six weeks for life; 146 drug courses were given. The incidence of toxicity was not great. One or more toxic reactions were reported for one-third of the drug courses administered, but for the most part, these were mild. The most frequent toxic reaction was vomiting in 17% of the courses, and hematologic toxicity-primarily leukopenia-in 15% of the drug courses. There was no evidence of a beneficial effect on survival from drug treatment in the group as a whole or in any subgroup analyzed. The median survival of the control group was 3.9 months, and of the drug-treated group, 3.0 months.
Adenocarcinoma↗
Combination chemotherapy with and without the methanol-extracted residue of bacillus Calmette-Guerin (MER) in extensive non-small-cell lung cancer: a prospective randomized study for the Piedmont Oncology Association.
One-hundred-three patients with extensive non-small-cell lung cancer were entered into a prospective, randomized trial to determine the value of MER as an adjuvant to chemotherapy. Patients were stratified according to histology and performance status. All patients received CCNU, methotrexate, and Adriamycin with 48 patients also receiving MER. All patients had a performance status of 2 or less (less than 50% bedridden), 49% had prior radiation therapy, only one patient had prior chemotherapy, and all had extensive disease. Of the patients, 42% had epidermoid cancer, 21% had large cell cancer, 32% had adenocarcinoma, and 4% had mixed adenosquamous or undifferentiated carcinoma. The response rates and response durations of the two treatment regimens were similar. Of the patients, 18% had an objective response; in 4% it was complete. An additional 29% had a stable response. Median duration of response ranged from 21 to 23 weeks. Median survival rates for non-MER and MER treatment groups were 21.5 and 18.6 weeks, respectively. The four complete responders have a survival of 24, 85, 86+, and 129 weeks. MER did not improve response for hematopoietic tolerance, was associated with significant morbidity, and was poorly tolerated. The value of immunotherapy in lung cancer remains to be established.
Adenocarcinoma↗
Phase II trials of Baker's antifol, bleomycin, CCNU, streptozotocin, tilorone, and 5-fluorodeoxyuridine plus arabinosyl cytosine in metastatic breast cancer.
A total of 202 patients with advanced breast cancer were entered into two prospectively randomized Phase II trials conducted by the Eastern Cooperative Oncology Group, in an effort to identify promising agents and combinations for previously treated cases. Patients in Study 1 received bleomycin, CCNU, or streptozotocin and those in Study 2 received tilorone, Baker's antifol, or a combination of 5-fluorodeoxyuridine plus arabinosyl cytosine. Partial responses were seen only with bleomycin, Baker's antifol, and 5-fluorodeoxyuridine plus arabinosyl cytosine. The median times to treatment failure ranged from 3.6 weeks to 5.7 weeks, and the median survival times, from 8 weeks to 25 weeks for tilorone and bleomycin, respectively. Toxic reactions was primarily hematologic and gastrointestinal, but skin, neurologic, respiratory, and renal abnormalities were noted in some treatment arms. The treatment schedules outlined and the toxic effects noted provide background information that might prove useful in designing complex new chemotherapeutic programs, since there is pharmacological rationale for incorporating some of the agents tested into present standard combination chemotherapy regimens.
Antineoplastic Agents↗
Nephrotoxicity of nitrosoureas.
Irreversible and progressive renal parenchymal damage and functional impairment occurred in the majority of patients receiving at least six courses (200 mg/m2 of BCNU and/or methyl CCNU at eight-week intervals) of nitrosoureas for therapy of malignant brain tumors. Seventeen of 18 patients who received at least six courses and all nine patients who received more than ten courses developed impaired renal function as judged by elevation of blood urea nitrogen and/or serum creatinine or decrease in filtration rate as determined by inulin clearance. Four patients have developed uremia. Renal tissue obtained from seven patients demonstrated tubular atrophy, interstitial fibrosis and glomerular sclerosis. This remarkably high incidence of renal damage occurred without a phase of acute renal failure and in the absence of significant urinary abnormalities, while producing an insidiously progressive interstitial renal lesion.
Adolescent↗
Four-drug combination chemotherapy in advanced lung cancer: methotrexate, doxorubicin, cyclophosphamide and CCNU.
One-hundred-twenty patients with advanced lung cancer were treated by the MACC (methotrexate, doxorubicin (Adriamycin), cyclophosphamide and CCNU) regimen. Ninety-eight patients were evaluated. Objective complete response occurred in one case for 27+ months. Partial response was observed in 20 patients lasting for a median of 4.7 months. The overall objective response rate was 21% and the median duration of response was 5.5 months. Stable disease was noted in 44 patients with a median time to progression of 4.7 months from the start of treatment. Tumor progression occurred in 33 cases. There was a significant prolongation of median actuarial survival of responders (11.2 months) vs. stable disease (6.2 months) or vs. non-responders (3.8 months, P less than 0.05). The median actuarial survival for the whole group was 7.3 months. Bone marrow toxicity including thrombocytopenia (less than 100,000 cells/mm3) occurred in 16 patients and leukopenia (less than 3000 cells/mm3) in 24 patients. Forty-seven patients had no hematologic toxicity. Other adverse reactions were nausea and vomiting (50%), stomatitis (16%), alopecia (5%), cardiotoxicity (1%) and fever during leukopenia (1%).
Adenocarcinoma↗
Phase III study of CCNU, cyclophosphamide, adriamycin, vincristine, and VP-16 in small-cell carcinoma of the lung.
A comparison of CTX + CCNU and CTX + CCNU + procarbazine as initial systemic treatment was made in 440 evaluable patients with small-cell carcinoma of the lung. The overall response rate for patients receiving the three-drug combination was 57% (11% CR) compared with 44% (9% CR) for the two-drug combination. Median survival times were similar, 27 (with procarbazine) and 29 weeks (without procarbazine). Nonresponders to the initial treatment received ADR, ADR + VCR, and ADR + VP-16 with overall response rates of 14% (2 of 14), 27% (9 of 33), and 30% (15 of 51), respectively. Median survivals for nonresponders, as measured from day 42, were 15 weeks (ADR), 21 weeks (ADR + VCR), and 22 weeks (ADR + VP-16). Responders to the initial treatment either continued on the initial therapy or received a non-cross-resistant combination chemotherapeutic regimen (ADR + VCR) alternating with the initial therapy. There is also the suggestion that responders who received the cycled therapy after day 42 survived significantly longer than responders who did not switch treatments until relapse, 38 vs. 29 weeks.
Aged↗