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PubMed1977

Results with methyl-CCNU and DTIC in metastatic melanoma.

This report is the result of an Eastern Cooperative Oncology Group (ECOG) study. Four hundred and 15 patients with inoperable metastatic malignant melanoma, excluding those with cutaneous metastases only, were randomized to one of three drug treatments: DTIC alone, methyl-CCNU alone, or the combination DTIC plus methyl-CCNU. Responses were seen in 14% of DTIC patients (19/127), 15% of methyl-CCNU patients (18/119) and 14% of DTIC plus methyl-CCNU patients (18/122). Duration of response was the same (14 weeks) for all three treatment groups. There was no difference among the treatments in achieving complete responses. Survival was improved significantly for responders (50 weeks) compared with nonresponders (15 weeks) regardless of treatment regimen. Toxicities were generally tolerable. DTIC caused significantly more gastrointestinal toxicity than methyl-CCNU. Methyl-CCNU caused significantly more bone marrow toxicity than DTIC. There were three drug-related deaths. All occurred in patients on combination DTIC plus methyl-CCNU. Important pretreatment characteristics that favor response are ambulatory status, female, less than 50 years old, no prior chemotherapy and no liver or brain metastases. Patients with favorable characteristics combinations had a 30% response rate, while those with unfavorable characteristic combinations had only a 9% response rate.

Brain Neoplasms↗

PubMed1977

Lack of effectiveness of combined 5- fluorouracil and methyl-CCNU therapy in advanced colorectal cancer.

Fifty-two patients with advanced colorectal cancer were treated with a combination of 5-Fluorouracil (FU) plus methyl-1,3-cis (2-chlorethyl)-1-nitrosourea (MeCCNU). The treatment schedule program consisted of 5-FU, 300 mg/m2 i.v. bolus, daily for 5 days, repeated at 5-week cycles. MeCCNU was administered at a dose of 150 mg/m2 orally on day 1 of the initial 5-day course of FU and repeated at 10-week intervals. Eighty-four percent (44/52) of the patients with advanced measurable disease developed progressive disease by 4 months or one and a half cycles of therapy. Only two patients had definite partial regression of tumor over the period of observation. The median survival of all patients measured from the onset of treatment was 9 months and is comparable to literature reports of untreated advanced colorectal cancer. This therapeutic trial of combined FU and MeCCNU, employing a dose-schedule distinct from but comparable to previous studies has failed to confirm the substantial response rate reported by other investigators and reinforces the need for exploring new drugs and combinations of drugs in advanced colorectal cancer. The use of sequential plasma CEA determinations as a primary monitor of therapy is discussed in relationship to clinical trials and guidelines for determining significant quantitative changes in plasma CEA levels are recommended.

Carcinoembryonic Antigen↗

PubMed1978

Comparison of methyl-CCNU and CCNU in patients with advanced forms of Hodgkin's disease, lymphosarcoma nad reticulum cell sarcoma.

In May 1972, the Cancer and Leukemia Group B initiated a randomized study comparing the effectiveness of CCNU and methyl-CCNU in patients with advanced malignant lymphomas, including Hodgkin's disease (HD), lymphosarcoma (LYS) and reticulum cell sarcoma (RCS). A single dose of 100 mg/m2 of CCNU or 150 mg/m2 of methyl-CCNU was given orally every 6 weeks. In patients with leukopenia or thrombocytopenia, due to prior treatment, this dose was reduced to 70 mg/m2 of CCNU and 100 gm/m2 of methyl-CCNU. Of 109 evaluable patients, 60 received CCNU and 49 received methyl-CCNU. Response rates (complete and partial) to CCNU and methyl-CCNU were respectively 42% (14/33) and 15% (3/20) in HD, 21% (3/14) and 21% (3/14) in LYS, 15% (2/13) and 27% (4/15) in RCS. Responses to methyl-CCNU, but not to CCNU, were seen only in patients who developed significant hematologic toxicity. Responses to both drugs were generally of short duration due to the advanced stage of the disease. Renal, hepatic or neurological toxicity was not observed. In conclusion, CCNU proved to be superior to methyl-CCNU for the treatment of advanced HD. CCNU was also observed to be of higher activity in Hodgkin's than in non-Hodgkin's lymphomas.

Clinical Trials as Topic↗

PubMed1978

5FU infusion with mitomycin-C versus 5 FU infusion with methyl-CCNU in the treatment of advanced colon cancer: a Southwest Oncology Group Study.

The Southwest Oncology Group (SWOG) in a randomized trial evaluated 5FU infusions in combination with either Mitomycin-C or Methyl-CCNU in patients with disseminated large bowel cancer. A response rate of 18% was noted on the 5FU-Mitomycin limb as compared to 16% on the Methyl-CCNU arm (p = .39). Median survival for all treated patients was 43 weeks on both arms. Myelosuppression was found to be more significant on the Mitomycin-C arm. Regression analysis demonstrated that performance status, sex, and primary site were significant pretreatment characteristics for predicting survival. The response rates associated with this burdensome method of 5FU administration in combination with either Mitomycin-C or Methyl-CCNU appear to offer little advantage over bolus 5FU alone.

Adenocarcinoma↗

PubMed1978

Combination chemotherapy against B16 melanoma: bleomycin/vinblastine, bleomycin/cis-diamminedichloroplatinum, 5-fluorouracil/BCNU and 5-fluorouracil/methyl-CCNU.

Four antitumor drug combinations which are currently in clinical use were evaluated experimentally using the murine B16 melanoma model. Bleomycin plus vinblastine produced an increase in life span over either of the two agents alone against both intraperitoneal and subcutaneous B16. This combination also resulted in a large number of long-term survivors. Bleomycin plus cis-platinum produced slight enhancement against subcutaneous B16, but showed no advantage against intraperitoneal B16. The combination of 5-fluorouracil plus methyl-CCNU significantly increased survival time against the intraperitoneal tumor, and produced long-term survivors as well. The combination of 5-fluorouracil plus BCNU was not more effective than BCNU or 5-fluorouracil alone. These data were compared with the degree of success reported from the clinics against a variety of solid human neoplasms.

Animals↗

PubMed1978

Chemotherapy studies in primary liver cancer: a prospective randomized clinical trial.

One hundred and sixty-eight patients with unresectable primary liver cancer were prospectively studied by members of the Eastern Cooperative Oncology Group. These patients were randomized to receive treatment with oral 5-Fluorouracil (5FU), oral 5-Fu plus Streptozotocin, oral 5-Fu plus Methyl-CCNU or Adriamycin. The single agent treatments (oral 5-Fu and Adriamycin) were associated with less gastrointestinal toxicity than were the oral 5-Fu treatment combinations. A total of 15 partial responses were reported. Adriamycin appears to be the most active agent and responsible for 9 of the 15 responses. No response was seen in any of the 48 patients randomized to oral 5-Fu alone. The survival associated with oral 5-Fu alone was significantly shorter than the survival time associated with the remaining 3 treatment programs among both North American and South African patients. A multivariate model of survival was formulated. Covariates of prognostic significance were treatment, initial performance status and sex. South African black patients had a shorter survival time than North American black patients. Excluding oral 5-Fu from consideration, prognostic variables appeared to dominate any differences between the remaining treatments under study.

Adenoma, Bile Duct↗

PubMed1978

Sequential chemoimmunotherapy of colorectal cancer: evaluation of methotrexate, Baker's Antifol and levamisole.

Fifty-two untreated patients with colorectal cancer were randomized to receive 5-fluorouracil (5-FU) alternating either with methotrexate (MTX) or Baker's Antifol (BAF) with or without the immunostimulant, levamisole (Program I). Fifty-five patients who had received prior treatment were randomized to receive methyl-CCNU (Me) with MTX or BAF (Program II). Fifteen of these patients had failed to respond to initial therapy with 5-FU plus MTX or BAF and subsequently received Me plus the alternate antifol. Overall response rate for each of programs I and II was 10%. The responses were 1/11 with 5-FU-MTX plus levamisole, 2/12 with 5-FU-MTX, 1/8 with 5-FU-BAF plus levamisole, 0/8 with 5-FU-BAF, 2/20 with Me-MTX and 2/21 with Me-BAF. The median survival times (MST) for patients receiving Programs I and II were 10 and 5 months, respectively. The MST for all patients receiving MTX was significantly longer than that of patients receiving BAF Survival was not influenced by levamisole administration. Both chemotherapy programs were well tolerated. The sequential administration of 4 active agents failed to improve the results of treatment of colorectal cancer.

Adolescent↗

PubMed1978

Chemotherapy of advanced measurable colon and rectal carcinoma with oral 5-fluorouracil, alone or in combination with cyclophosphamide or 6-thioguanine, with intravenous 5-fluorouracil or beta-2'-deoxythioguanosine or with oral 3(4-methyl-cyclohexyl)-1(2-chlorethyl)-1-nitrosourea: a Phase II-III study of the Eastern Cooperative Oncology Group (EST 4273).

In a randomized multi-institutional trial of the Eastern Cooperative Oncology Group, 316 patients with advanced measurable colorectal adenocarcinoma were treated with a weekly schedule of 5-fluorouracil given orally and intravenously with oral-5-fluorouracil in combination with cyclophosphamide or 6-thioguanine, or with oral Methyl CCNU administered once every eight weeks. On failure or progression, 133 protocol patients crossed-over to a secondary therapy, while 116 other patients previously treated with 5-fluorouracil off protocol were randomized to treatment with Methyl CCNU or B-2'-deoxythioguanosine. Response rates among patients who had received no prior chemotherapy were 18% to oral 5-FU, 15% to intravenous 5-FU and to MeCCNU, 12% to 5-FU and 6-thioguanine and 5% to cyclophosphamide and 5-FU, with little activity (3% response rate) in crossover or previously treated patients. Treatment with 5-FU, particularly oral 5-FU was associated with the least drug-related toxicity. Hematologic toxicity was greatest with Methyl CCNU, but was no more frequent in previously treated than in untreated patients. A tendency toward cumulative bone marrow depression was noted. 5-FU was effective only in ambulatory patients, whereas responses among non-ambulatory patients were seen only in the group treated with Methyl-CCNU.

Adenocarcinoma↗

PubMed1979

A randomized study of two different schedules of methyl CCNU, 5-FU and vincristine for metastatic colorectal carcinoma.

Sixty-seven patients with measurable colorectal carcinoma were randomized to receive two different schedules of Methyl CCNU, 5-FU and Vincristine (MOF). The treatment schedule consisted of Methyl CCNU 150 mg/m2 po q 70 days, 5-FU 300 mg/m2 iv for 5 consecutive days q 35 days, and Vincristine 1 mg/m2 IV q 35 days. The same total dose was used in each arm; in MOF A, the Methyl CCNU was given on day 1, while in MOF B, the Methyl CCNU was divided and given over 5 consecutive days. In MOF A, there was a 10% partial response rate and a 10% minor response rate. In MOF B, the partial response rate was 12% and the minor response rate was 21%. This difference is not statistically significant, but the patients in MOF B experienced less gastrointestinal toxicity (p less than .001).

Adult↗

PubMed1979

Chemotherapy versus chemoimmunotherapy in advanced adenocarcinoma of the colon and rectum: a prospective randomized study.

The combination of vincristine, methyl-CCNU, and methotrexate with or without MER-BCG achieved a 2% complete response (CR) and a 11% partial response (PR) with a median duration of 25-29 weeks in 124 evaluable patients with advanced adenocarcinoma of the colon and rectum. Responses were seen in previously untreated patients and in patients refractory to 5-fluorouracil. The median survival of these objective responders (CR + PR) was 57 weeks. The addition of MER-BCG did not appear to influence response rate or duration of survival and was accompanied by significant toxicity. Response was significantly correlated with performance status, sex, and disease free interval and survival with alkaline phosphatase and performance status. Patients with advanced colorectal carcinoma should be stratified according to these variables.

Adenocarcinoma↗

PubMed1979

A randomized comparison of two dosage schedules of methyl CCNU: three-week versus six-week treatments.

Two dose schedules of methyl CCNU were compared for drug effect and toxicity. One hundred thirteen patients were stratified by tumor site, performance status, and prior chemotherapy and randomized to 100 mg/m2 q 3 wk or 200 mg/m2 q 6 wk orally. Response rates were similar (12% vs. 18%, respectively, in the major tumor sub-types studied) and survival was equivalent. Hematologic toxicity, however, was significantly different, with earlier time to the most severe blood count depressions, more frequent occurrence of severe depression, and a larger percentage of patients requiring dosage reduction on the 6-week regimen. We conclude that the 3-week regimen is superior due to its improved tolerance and is recommended especially for combination drug therapy.

Adenocarcinoma↗

PubMed1979

Chemotherapy of nonirradiated malignant gliomas. Phase II: study of the combination of methyl-CCNU, vincristine, and procarbazine.

Twenty-eight adult patients with nonirradiated malignant gliomas of the brain were administered a combination of methyl-CCNU (130 mg/m2, p.o., day 1), vincristine (2 mg/m2, i.v., day 1) and procarbazine (100 mg/m2, p.o., days 2 to 15) (MVP), scheduled to be given at successive 6 week intervals. Nineteen (67.9%) were not responsive to MVP and 9 (32.1%) were. Of 16 who had previous partial resection of their tumors, 8 (50%) responded to MVP and 8 (50%) did not. Of 12 who had previous biopsy, only 1 (8.3%) responded. Overall 1-year survival rate for the 28 patients was 28.6%. Major side effects of MVP were leukopenia, thrombocytopenia, pulmonary emboli, and thrombophlebitis, detected mainly during the first 20 to 24 weeks of treatment.

Adult↗

PubMed1979

Phase I-II study of ftorafur and methyl-CCNU in advanced colorectal cancer.

The combination of Ftorafur (NSC-148958) and methyl-CCNU (NSC-95441) was evaluated in 36 patients with advanced colorectal cancer. The principle toxicities encountered were myelosuppression, gastrointestinal, and neurological. There were no complete responses and only 5/34 (14.7%) patients achieved a partial response. Methyl-CCNU and Ftorafur does not appear to be an effective combination in advanced adenocarcinoma of the colon and rectum.

Adenocarcinoma↗

PubMed1979

5 FU infusion with mitomycin-C vs. 5 FU infusion with methyl-CCNU in the treatment of advanced upper gastrointestinal cancer: a Southwest Oncology Group Study.

A randomized trial was conducted by the Southwest Oncology Group (SWOG) in advanced carcinoma of the stomach and pancreas. Patients were assigned to receive monthly 5-fluorouracil 96-hour continuous infusions with either bolus mitomycin-C or oral methyl-CCNU. Mitomycin-C and methyl-CCNU were administered every eight weeks. The 5 FU-mitomycin combination produced a 14% and 22% response rate in disseminated stomach and pancreatic carcinoma, respectively. The combination of infusion 5 FU and methyl-CCNU achieved responses in 9% and 5% of stomach and pancreatic tumors, respectively. There was no significant difference in survival between limbs for either tumor. Median survival in gastric carcinoma on the 5 FU-mitomycin regimen was 25 weeks vs. 18 weeks on the 5 FU-METHYL-CCNU arm. In pancreatic carcinoma median survival on the mitomycin limb was 19 weeks as compared to 17 weeks on the methyl-CCNU program. Leukopenia was greater for the first course on the mitomycin limb. Regression analysis demonstrated that performance status was the most important pretreatment characteristic for predicting survival in both tumors. Neither 5 FU infusion combination appears to significantly alter the dismal prognosis of advanced upper gastrointestinal neoplasms.

Antineoplastic Agents↗

PubMed1980

Therapy for metastatic colorectal carcinoma with a combination of methyl-CCNU, 5-fluorouracil vincristine and streptozotocin (MOF-Strep).

Seventy-seven previously untreated patients with measurable metastatic colorectal carcinoma were treated with a combination of methyl-CCNU, 5-fluorouracil (5-FU), vincristine and streptozotocin (MOF-Strep). The treatment schedule consisted of methyl-CCNU, 30 mg/m2 for 5 consecutive days q 10 weeks; 5-FU, 300 mg/m2 IV for five consecutive days q 5 weeks; vincristine, 1 mg IV q 5 weeks; and streptozotocin, 500 mg/m2 IV weekly. Two (3%) patients achieved complete remission (CR); 22 (29%) patients, a partial remission (PR); and 13 (18%) patients, a minor remission (MR). The median duration of remission was eight months (range, 4-25+months) for patients obtaining CR/PR status, and six months (range, 4-15 months) for MR status. The median survival time was 14 months for patients achieving CR/PR versus seven months for non responders. Comparison with a previous study of MOF at Memorial Sloan-Kettering Cancer Center, showed that the MOF-Strep combination produced a significant (P = 0.004) increase in the number of complete and partial remissions, 32% versus 11%, and in survival, 11 versus 9 months, (P = 0.003), respectively.

Adult↗

PubMed1980

Methyl CCNU and adriamycin for patients with metastatic sarcomas: a Southwest Oncology Group study.

This protocol study (SWOG-7431) combining adriamycin and methyl CCNU (MAD) for metastatic sarcomas was initially used on patients who were refractory to cytoxan, vincristine, and/or actinomycin-D. After the initial good results, the study was expanded to include any untreated patients with metastatic sarcoma. The initial starting dose of adriamycin was 60 mg/M2 on day 1 and 45 mg/M2 on day 22. Methyl CCNU was given once every six weeks at an initial dose of 150 mg/M2 orally. Fifty-five patients received therapy and 53 were evaluable for response. The complete remission rate was 9.4%. The partial remission rate was 35.9%, with a total complete and partial remission rate of 45.3%. The median survival time was ten months. When the combination of cytoxan, DIC, vincristine and adriamycin was used, the response rate was similar and the median survival time in eligible patients was 10 months. The methyl CCNU and adriamycin combination is more convenient for the patient because it necessitates fewer clinic visits and significantly fewer injections than other combinations. These data suggest that treatment with methyl CCNU, when combined with adriamycin, increases the response rate and survival time over adriamycin alone, but that the response is similar to that seen with the combination of cytoxan, DIC, vincristine, and adriamycin.

Age Factors↗

PubMed1980

5-Fluorouracil, methyl-CCNU, and radiotherapy with or without testolactone for localized adenocarcinoma of the exocrine pancreas: a Southwest Oncology Group Study.

Since August 1975, 69 patients with localized pancreatic carcinoma (extent of tumor confined to a 15 cm x 15 cm radiotherapy port) have received either Regimen A, comprising radiotherapy (6,000 rad) to the tumor area with simultaneous combination chemotherapy utilizing methyl-CCNU, 125 mg/m2 orally, every six weeks, and 5-fluorouracil, 400 mg/m2 intravenously, weekly; or Regimen B, comprising Regimen A with the addition of testolactone, 200 mg, orally every day. Thirty-eight patients on Regimen A and 30 patients on Regimen B are currently evaluable. Median survival, which appeared not to be affected by the addition of testolactone, was 38 weeks for those on Regimen A and 30 weeks for those on Regimen B (P = 0.677). The median survival time for all patients was 38 weeks. Good performance status did correlate with improved survival vs. poor performance status (46 weeks vs. 20 weeks, P = .008). Fifteen patients have survived for more than 52 weeks, with the longest survival time being 160 + weeks, and in 3 cases all therapy has been discontinued. However, most patients experienced moderate to severe hematologic toxic reactions. There was one treatment-related death and significant gastrointestinal bleeding developed in 6. Because of the toxic reactions of this program, it should not be considered in favor of similar less aggressive programs.

Adenocarcinoma↗

PubMed1981

A phase II evaluation of methyl CCNU and actinomycin D in the treatment of advanced sarcomas in adults.

Twenty-nine patients with metastatic sarcoma were treated with a combination of methyl CCNU and actinomycin D. Patients with adequate bone marrow reserve received methyl CCNU 100 mg/m2 orally on day 1 and actinomycin D 0.3 mg/m2/day intravenously for five days. Both drugs were repeated every four weeks. Patients with inadequate bone marrow reserve received methyl CCNU 75 mg/m2 and actinomycin D 0.2 mg/m2/day for five days. All patients had received prior chemotherapy and had progressive disease at the start of the study. There was one complete response in a patient with peritoneal mesothelioma which lasted 18 months and the patient is still alive at 38+ months. Ten patients had stable disease including three patients who had responses between 25% to 50%. No responses were seen in 18 patients. The median time to progression for patients with stable disease was five months and for those with progressive disease was two months (P = 0.001). The median survival for patients with stable disease was 20 months compared with three months for patients with progressive disease (P = 0.001). The combination was generally very well tolerated and myelosuppression was insignificant. However, with the dosages and schedule used in this study, the combination of methyl CCNU and actinomycin D does not appear to have significant activity in advanced soft tissue sarcomas. Further studies with this combination are indicated in patients with mesothelioma.

Adult↗