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PubMedDate not supplied

Animal model for liver dysfunction using lomustine in Wistar rats.

AIM: To induce intrahepatic cholestasis in rats using lomustine 1(2-chloroethyl)-3-cyclohexyl-l-nitrosourea (CCNU). METHODS: Doses of 10 mg, 20 mg and 30 mg/Kg body weight of CCNU were injected intraperitoneally in separate groups of animals. RESULTS: With 10 mg/Kg body weight of CCNU, serum bilirubin levels increased for up to 72 hours and then slowly returned to normal. With a dose of 20 mg/Kg body weight of CCNU, serum bilirubin, AST, ALT and alkaline phosphatase levels increased for 72 hours and then returned to normal over 4-5 weeks. With a dose of 30 mg/Kg body weight peak levels of serum bilirubin were reached on day 17. Pathological studies were carried out after injection of 30 mg/Kg body weight of CCNU. After 72 hours hepatocytes were normal, with minimal nonspecific inflammation and bile duct proliferation. After 16 days, triaditis was observed with deposition of collagen. Focal fibrosis was also noticed. There was no significant abnormality of hepatocytes. After 75 days, hepatocytes showed focal ballooning. Bile duct proliferation was seen invading the parenchyma. Nodules of hepatocytes separated by irregular fibrous bands indicated cirrhosis. CONCLUSIONS: An animal model of intrahepatic cholestasis has been developed using CCNU; this model may be used to assess the utility of hepatobiliary radiopharmaceuticals.

Animals↗
PubMed1992

[Combination of chemotherapy (vindesine, lomustine, cisplatin, cyclophosphamide) and thoracic radiotherapy in nonresectable non-small cell bronchial carcinoma: final results of a phase II clinical trial].

Seventy-five patients with locally advanced non small cell lung carcinoma were entered in a phase II study combining chemotherapy (vindesine, lomustine, cisplatin and cyclophosphamide) and radical thoracic radiotherapy delivering a total dose of 60-65 Gy. Patients were regularly assessed by radiological and fiberoptic bronchoscopy examinations in order to evaluate local control. An objective response was observed in 22 patients (29%) after initial chemotherapy (2 complete remissions and 20 partial responses). The complete response rate after the combined schedule was 30%. Toxicity of this combination was acceptable. Median survival was 13.5 months. Actuarial risk of developing distant metastases at 3 years was 60%. However, the main cause of failure was local with 80% of uncontrolled or recurrent thoracic tumor in the first 2 years of follow-up. The present study shows that local control remains a major problem in the management of patients with inoperable non metastatic non small cell lung cancer.

Adult↗
PubMed1992

Combined chemotherapy (cisplatin, cyclophosphamide, lomustine and vincristine) and multifractionation radiotherapy in inoperable nonmetastatic squamous cell lung cancer.

A modified protocol was used in the treatment of inoperable nonmetastatic squamous cell lung cancer which consisted of three courses of induction chemotherapy with cisplatin, cyclophosphamide, lomustine and vincristine. Radiotherapy was delivered in multifractionated regime, daily two fractions of 1.5 Gy, 4 hours apart up to the total dose of 51 Gy. During 1985-1989, 77 patients were entered into the study. Twenty-six patients did not complete treatment, but were evaluated for the response rate and in survival analysis. There were 29 patients with Stage I and II, and 48 patients with Stage III lung cancer. After combined treatment CR was 15%, PR 39% and RR 54%. One- to four-year overall survival of 48 evaluable patients with Stage III were: 58%, 30%, 17% and 7%, respectively. The overall survival of the whole treatment group was significantly better than the survival of historical control group of 65 patients treated by radiotherapy only.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2005

Combination chemotherapy with carmustine and cisplatin followed by procarbazine, lomustine, and vincristine for adult high-grade astrocytoma.

BACKGROUND: We have reported that carmustine (BCNU) and cisplatin administered before, during, and after radiotherapy did not improve the survival of patients with high-grade astrocytomas and were associated with more serious toxicities than radiotherapy plus BCNU. In an attempt to improve survival, we studied a combination regimen procarbazine, lomustine, and vincristine (PCV) after radiotherapy in addition to BCNU and cisplatin during radiotherapy. METHODS: From 1994 through 1998, 42 patients were enrolled in the study. Of these, 20 had glioblastoma multiforme and 22 had anaplastic astrocytoma. The patients had a median age of 48.5 years. All patients had subtotal or total resection, or biopsy as the initial procedure. Then, all patients were treated with BCNU and cisplatin concurrently during radiotherapy followed by PCV after radiotherapy. RESULTS: The median time to follow up for survivors was 13.8 months (range, 1.7-108.2 months). The median time to tumor progression was 7.2 months (range, 0-88.7 months) and median survival time was 13.3 months (range, 1.7-88.7 months). The only factor that had a conventionally significant effect on the overall survival was resectability. Patients who had received subtotal/total resection had a longer median survival compared with patients who had received biopsy only (18.0 vs. 9.5 months). This combined modality treatment program was associated with reversible grade 3 to 4 hematological toxicity in 10 patients, with grade 3 ototoxicity in one patient and grade 2 neurotoxicity in one patient. CONCLUSION: A combination of BCNU and cisplatin with cranial irradiation followed by PCV was moderately toxic and appeared to offer no obvious survival advantages compared with radiotherapy plus BCNU and cisplatin alone.

Adolescent↗
PubMed2005

Treatment of patients of high-risk group of medulloblastoma with the adjuvant lomustine, cisplatin, and vincristine chemotherapy.

UNLABELLED: The prognosis of children with medulloblastoma, primitive neuroectodermal tumor of cerebella, is poor especially in case of disseminated disease. Bad outcome of this disease encouraged the investigators to look for new more effective and safer ways of medulloblastoma treatment that would be able to improve the prognosis and quality of live for children with medulloblastoma. Adjuvant chemotherapy administered after radiotherapy prolongs the time to progression as well as overall survival for high-risk group of medulloblastoma patients, while such results vary little in standard-risk medulloblastoma group. OBJECTIVE: To evaluate effectiveness of adjuvant chemotherapy while treating high-risk medulloblastoma patients. PATIENTS AND METHODS: A total of 18 patients with disseminated and non-totally removed medulloblastoma admitted to high-risk group aged from 3 to 18 years were enrolled in this study. Nine of these patients were treated by radiotherapy alone and the adjuvant chemotherapy with CCNU (lomustine), cisplatinum, and vincristine after radiotherapy was administered to the other nine patients. RESULTS: Full response was determined in all patients of adjuvant chemotherapy group and only in 3 children out of 9 in radiotherapy group (33.3%) (p<0.01). The rate of the relapse was 100% in radiotherapy and 11.1% in adjuvant chemotherapy group that differed statistically reliably in both group patients (p<0.001). Mean time to progression among patients of radiotherapy group was 9+/-2 months and 47+/-8 months among of the patients of adjuvant chemotherapy group (p<0.01). Two years free to progression survival in adjuvant chemotherapy group was 88.9%, in radiotherapy group - 0%. Two-year overall survival in these groups was 71.1 and 22.2%, respectively (p<0.01). CONCLUSION: With this research we proved that adjuvant chemotherapy, prescribed after standard radial (craniospinal and local) treatment, statistically reliably improves survival indices of patients from high risk group and has to be prescribed to all patients from this risk group.

Adolescent↗
PubMed1990

Phase II study of lomustine, cytarabine, mitoxantrone, and prednisone (CAMP) combination chemotherapy for doxorubicin-resistant intermediate- and high-grade malignant non-Hodgkin's lymphoma.

A phase II study was conducted to evaluate the efficacy and toxicity of lomustine, cytarabine, mitoxantrone and prednisone (CAMP) chemotherapy in doxorubicin-resistant intermediate- and high-grade malignant non-Hodgkin's lymphomas (NHL). Among 30 patients, the complete remission rate was 27% (duration: 10, 16, 22, 35, 35+, 42+, 51+, 55+ months) and the partial remission rate was 20%. Median survival for complete responders was more than 4 years. The best responses were seen in patients with relapsed NHL compared to those with primary refractory NHL. Toxicity was mainly related to myelosuppression. The results suggest that the CAMP schedule can be applied on an outpatient basis with satisfactory efficacy in patients with relapsing intermediate- and high-grade malignant NHL.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1987

Lomustine, etoposide, vindesine, and dexamethasone (CEVD) in Hodgkin's lymphoma refractory to cyclophosphamide, vincristine, procarbazine, and prednisone (COPP) and doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD): a multicenter trial of the German Hodgkin Study Group.

Thirty-two patients with advanced Hodgkin's lymphoma resistant to cyclophosphamide, vincristine, procarbazine, and prednisone (COPP) and doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) were treated with a salvage chemotherapy regimen consisting of lomustine, etoposide, vindesine, and dexamethasone (CEVD). Twenty-seven patients were treated because of primary resistance to COPP/ABVD, and five patients were treated in early relapse (less than 12 months) after COPP/ABVD-induced complete remission. Fourteen patients (44%) achieved complete remission, and four patients achieved partial remission, with an overall response rate of 56%. Two partial responders achieved complete remission after additional radiotherapy. Four of five patients in early relapse after COPP/ABVD achieved complete remission. Consolidation radiotherapy was given for only one complete responder. Median duration of complete remission is greater than 10 months, and median survival is greater than 26 months. The treatment was well-tolerated. The main side effects were leukopenia, thrombocytopenia, mild nausea/vomiting, and cushingoid side effects. CEVD is a very active and well-tolerated salvage chemotherapy regimen in patients with Hodgkin's disease resistant to or relapsing after COPP and ABVD.

Adolescent↗
PubMed1985

Eastern Cooperative Oncology Group phase II studies in advanced measurable colorectal cancer. I. Razoxane, Yoshi-864, piperazinedione, and lomustine.

During a 6-month interval, Eastern Cooperative Oncology Group randomized 127 patients who had received prior chemotherapy, and who had advanced measurable, surgically incurable colorectal cancer, to receive piperazinedione (PZD), Yoshi-864, or razoxane (ICRF-159). The observed response (and median survival) rates were: PZD, one of 35 patients (17 weeks); Yoshi-864, one of 34 (19 weeks), and ICRF-159, none of 38 (23 weeks). Among 107 evaluable patients, there were five episodes of life-threatening toxicity with PZD (one death) and four with ICRF-159 (two deaths). In the same protocol, 42 evaluable patients who had not received prior chemotherapy were randomized to be treated with lomustine (CCNU) or one of the three drugs in the "previously treated" trial. One CR (41 weeks) was seen with ICRF-159 and two PRs were seen with CCNU. Life-threatening toxicity occurred in three patients, two who received CCNU (one death) and one who received PZD. No survival advantage was seen. We do not encourage further phase II trials in colorectal cancer with the agents studied.

Antibiotics, Antineoplastic↗
PubMed1985

Lomustine, vincristine, and procarbazine in the treatment of metastatic malignant melanoma.

Sixty-five previously untreated patients with metastatic malignant melanoma were treated with lomustine, vincristine, and procarbazine. Sixty-four patients were evaluable for response, with a response rate of 13%. Only one complete response was observed, in a patient with nodal disease only. Three partial responses were observed in patients with disease confined to soft tissue, and four partial responses were observed in patients with pulmonary metastases. Median survival for all patients was 22 weeks. We conclude that this regimen offers no improvement compared to other drug combinations.

Adult↗
PubMed1986

Schedule-dependent potentiation of lomustine cytotoxicity by amphotericin B in mice.

The sensitivity of leukemia cells of AKR/J mice to subsequent lomustine [1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea (CCNU)] exposure was found to vary with time following the ip administration of a single dose or multiple doses of amphotericin B (AmB) (0.5 mg/mouse/dose). Following 1 dose of AmB, leukemia cell sensitivity to CCNU, as measured by a spleen colony assay, reached a maximum by 24 hours with a tenfold increase in cell killing noted over cell killing with CCNU alone (0.15 mg/mouse). Two pretreatments with AmB separated by 24 hours led to a hundredfold increase in cell killing, whereas 4 pretreatments, each separated by 24 hours, gave more than a thousandfold increase in cytotoxicity by 8 hours, gave more than a thousandfold increase in cytotoxicity by 8 hours. Increasing the AmB dose, given as a single injection 24 hours before CCNU, resulted in increased potentiation of CCNU cytotoxicity, which reached a maximum at 0.5 mg/mouse. The kinetics of cell killing following either CCNU alone or the combination of AmB and CCNU were similar, although the extent of cell killing was greater with the combination. The AmB plasma pharmacokinetics for single doses showed a dose-dependent serum peak level and a half-life of about 24 hours for doses up to 1 mg/mouse. Nonlinearity was noted at the dose level of 2 mg/mouse because of saturation of absorption from the peritoneal cavity. These data are of importance for the optimal sequencing and dosing of these drugs for future clinical trials.

Amphotericin B↗
PubMed1987

Third-line chemotherapy for resistant Hodgkin's disease with lomustine, etoposide, and methotrexate.

Thirty-two patients with recurrent Hodgkin's disease have been treated with an oral regimen employing lomustine (CCNU, 100 mg/m2 orally on Day 1); etoposide (VP-16, 100 mg/m2 orally on Days 1-3 and 21-23); and methotrexate (30 mg/m2 orally on Days 1, 8, 21, and 28). The regimen was repeated every 6 weeks. Most patients had been treated with MOPP (mechlorethamine, vincristine, procarbazine, and prednisone) and ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine); 20 had had prior irradiation. Lymph node was the predominant site of disease and the majority of patients had B symptoms. Four patients achieved complete response (13%), with a median duration of 33+ months, and 11 achieved partial response (34%), with a median duration of 5 months, for an overall response rate of 47%. The major toxic effect was severe myelosuppression, which occurred in six patients; there were no treatment-related deaths. This oral regimen was easy to administer in heavily pretreated patients with poor venous access and had minimal toxicity.

Administration, Oral↗
PubMed1987

Metastatic malignant melanoma treated with procarbazine, vincristine and lomustine (POC).

Fourteen consecutive melanoma patients with evaluable metastatic disease were treated with combination chemotherapy including procarbazine, vincristine and lomustine (POC). All but two patients had been previously treated with single agent chemotherapy (dacarbazine 11 patients, melphalan plus hyperthermia 1 patient). One transient partial response and 4 stable disease were noted. Median overall survival was 5 months. In our experience POC seems unlikely to improve the response rate compared with other chemotherapy combinations. Patient characteristics can partially explain the contrasting results reported in the literature.

Adult↗
PubMed1985

Enhancement of the antitumor efficacy of lomustine by the radiosensitizer RSU 1069.

Previous investigations have shown that combining the radiation sensitizer misonidazole with conventional alkylating chemotherapeutic agents can lead to a therapeutic advantage. More recently, another sensitizer, RSU 1069, has been reported to give an enhancement of antitumor agent efficacy similar to that observed with misonidazole, but at an approximately tenfold lower sensitizer dose. One chemotherapeutic agent whose activity has been modified by sensitizers to a greater extent in tumors than in critical normal tissues is the nitrosourea lomustine (CCNU). The present studies evaluated the therapeutic benefit of combining RSU 1069 and CCNU in KHT sarcoma-bearing C3H/HeJ mice. The drugs were administered ip, and tumor response was assessed by measuring the survival of clonogenic KHT cells 22-24 hours after treatment. Normal tissue toxicity was determined using peripheral wbc counts 3 days after treatment and a 30-day lethality assay. Combining CCNU with a 0.38-mmol/kg dose of RSU 1069 increased tumor cell killing by a factor of approximately 1.9. Wbc toxicity and 30-day animal lethality increased with CCNU dose, but the addition of RSU 1069 enhanced either endpoint only slightly (factor of 1.0-1.2). The addition of RSU 1069 to CCNU treatment, therefore, led to a significant therapeutic benefit.

Animals↗
PubMed1985

Combined chemotherapy (vindesine, lomustine, cisplatin, and cyclophosphamide) and radical radiotherapy in inoperable nonmetastatic squamous cell carcinoma of the lung.

Thirty-three evaluable patients with locally advanced squamous cell carcinoma of the lung were entered in a phase II study combining chemotherapy (vindesine, lomustine, cisplatin, and cyclophosphamide) and radical radiotherapy. Fourteen patients had an objective response rate of 42% (two complete responses and 12 partial responses) with the first two cycles of chemotherapy. All patients received radiation therapy to the primary tumor, mediastinum, and supraclavicular nodes, and responders to chemotherapy received four additional cycles. On final evaluation, 18 patients (54.5%) achieved complete response and six patients (18%) achieved partial response. The objective response rate was 73% with the combined therapy. The median survival was 15.9 months. Toxicity was acceptable. We conclude that our results justify a phase III study comparing combined treatment versus radiotherapy alone.

Adult↗
PubMed1977

Chemotherapy for bronchogenic carcinoma. Methotrexate, doxorubicin, cyclophosphamide, and lomustine.

A combination chemotherapy (MACC) consisting of methotrexate, doxorubicin hydrochloride (Adriamycin), cyclophosphamide, and lomustine (CCNU) was given to 41 patients with stage III bronchogenic carcinoma, 34 of whom had disseminated disease. The objective response rate was 46% for all patients with a median actuarial survival of nine months. Response was seen in all cell types, including four of ten patients with squamous cell carcinoma, six of 17 with adenocarcinoma, and six of seven with small-cell anaplastic carcinoma. Prolongation of survival was apparent for patients of all cell types. Toxic reactions were moderate and allowed for easy outpatient use.

Adenocarcinoma↗
PubMed1983

Cyclophosphamide, vincristine, lomustine, cisplatin, and doxorubicin in the treatment of non-small cell lung cancer.

Fifty-four patients (47 of whom were evaluable) with non-small cell lung cancer were treated with a five-drug regimen consisting of cyclophosphamide, vincristine, lomustine, cisplatin, and doxorubicin. Six complete and 16 partial responses were achieved, for an overall response rate of 47% (22 of 47 patients). Response by cell type was as follows: epidermoid carcinoma, 41% (seven of 17 patients); adenocarcinoma, 42% (eight of 19); and large cell carcinoma, 64% (seven of 11). Response in patients with limited disease was 48% (11 of 23 patients) and in patients with extensive disease, 46% (11 of 24). Previously untreated patients had response rates of 53%, versus 22% in those with prior therapy.

Adenocarcinoma↗
PubMed1983

Randomized study for the treatment of adult advanced Hodgkin's disease: mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) versus lomustine, vinblastine, and prednisone.

Forty-seven patients with advanced Hodgkin's disease were entered in a prospective, randomized trial comparing MOPP (mechlorethamine, vincristine, procarbazine, and prednisone) with a regimen containing lomustine (CCNU), vinblastine, and prednisone (CCNU-VP). Both groups were comparable for the variables of age, stage, substage (symptoms), histology, prior radiation, and sites of involvement. Seventy-two percent of CCNU-VP-treated patients achieved a pathologically documented complete remission (CR) compared to 41% of the MOPP-treated group. Two additional patients treated with MOPP had remission documented only clinically but have been long-term, disease-free survivors. There was a greater frequency of CR in the patients who had received previous irradiation when compared to patients with no prior irradiation. After a median follow-up of greater than 89 months, there is no statistical difference between the two treatment groups in survival (45% for MOPP and 60% for CCNU-VP). Further, no statistical difference in survival for the two treatment groups was noted when compared by histology, stage, or symptoms. The CCNU-VP combination was better tolerated with significantly less nausea and emesis. The alternative drug regimen of CCNU-VP appears to be as effective as MOPP in producing CR and long-term survival in patients with advanced Hodgkin's disease.

Adult↗
PubMed1984

Combination cytotoxic chemotherapy with procarbazine, vincristine, and lomustine (POC) in disseminated malignant melanoma: 8 years' follow-up.

Forty-four consecutive ambulatory patients (24 male, 20 female; median age, 56 years [range, 21-76]) with evaluable disseminated malignant melanoma (stages III/IV) were entered in this study from October 1, 1975, to July 21, 1980 (last follow-up, October 31, 1983); they were treated with procarbazine (100 mg/,m2 orally; maximum dose, 150 mg) on Days 1-10, vincristine (1.4 mg/m2 iv; maximum dose, 2 mg) on Days 1 and 8, and lomustine (150 mg/m2 orally; maximum dose, 200 mg) on Day 1, repeated every 4-6 weeks. Twenty-one patients (48%) showed objective responses; 11 of these (25%) were complete responses. Nine patients had received previous chemotherapy, but none were treated with the drugs used in this protocol. Responses were seen mainly in cutaneous and/or nodal sites and pulmonary metastases. The median duration of remission was 10 months and the median survival of responders was 21 months compared to 5 months for nonresponders. Four responding patients are still alive and in complete response for 70+, 83+, 94+, and 95+ months, while one is alive, but in progression (83+ months). The toxicity of this regimen was clinically tolerable and hospitalization was not required. In our initial study the response rate was 60% (18 responses among 30 patients) and this regimen continues to have significant antitumor activity against disseminated malignant melanoma.

Adult↗