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PubMed2004

Efficacy and feasibility of standard procarbazine, lomustine, and vincristine chemotherapy in anaplastic oligodendroglioma and oligoastrocytoma recurrent after radiotherapy. A Phase II study.

BACKGROUND: To the authors' knowledge, there is a scarcity of accurate data regarding the feasibility of standard chemotherapy with procarbazine, lomustine, and vincristine (PCV) in a homogeneous series of patients with primary anaplastic oligodendroglioma (AO) and oligoastrocytoma (AOA) that was recurrent after surgery and standard radiotherapy. The aim of the current study was to evaluate the overall response rate, toxicity, and time to progression (TTP) with the use of standard PCV in this setting. METHODS: Between November 1994 and September 2000, 37 patients were enrolled in the current study. Of these, 23 had AO (62%) and 14 had AOA (38%). All patients received standard PCV comprised of lomustine (110 mg/m2) on Day 1, procarbazine (60 mg/m2) on Days 8-21, and vincristine (1.4 mg/m2, maximum total 2 mg) on Days 8 and 29. Cycles were repeated every 6 weeks. RESULTS: There were 11 complete responses (CR; 29.7%) and 11 partial responses (PR; 29.7%) reported and 8 patients had stable disease (SD; 21.6%). The response rate was higher in patients with AO compared with patients with AOA (77.2% vs. 22.7%; P = 0. 02). The median TTP, which was 12.3 months overall, was 30.3 months in patients who achieved a CR, 19.1 months in patients who achieved a PR, and 6.1 months in patients with SD. The median TTP was 18.6 months in AO patients and 6.14 in AOA patients. There were no cases of severe toxicity reported although in 16 patients (43%) who were free of disease progression, PCV was discontinued because of toxicity or inadequate recovery after 2 weeks of delay. CONCLUSIONS: PCV chemotherapy was reported to achieved a high response rate and TTP but incurred a high risk of persistent toxicity.

Adult↗

PubMed1980

Biodistribution of 14C-lomustine in an animal tumor model.

A formulation of 14C-lomustine in propylene glycol-ethanol (4:1) was administered intravenously to rats infiltrated with glioma tumors of the astrocytic series (RT6). The organ and tumor distribution of this agent was followed at 1, 4, 12, and 24 hr. Rapid blood disappearance (0-1 hr) of the label concomitant with an increase in all organs except the lung, muscle, and brain was observed. Only the blood, liver, and muscle contained greater than 1% of the dose after 24 hr. The bladder, liver, small bowel, and kidneys concentrated the highest percentages throughout the study. The distribution of 14C-lomustine in the tumor relative to the brain, muscle, and blood showed a maximum 4-12 hr after administration.

Animals↗

PubMed1997

Chemoimmunotherapy with bleomycin, vincristine, lomustine, dacarbazine (BOLD) plus interferon alpha for metastatic melanoma: a multicentre phase II study.

High response rates in patients with metastatic melanoma have been achieved with combination chemoimmunotherapy. A response rate of 62% in 45 patients has been reported for treatment with dacarbazine, bleomycin, vincristine, lomustine (BOLD) plus interferon alpha (IFN-alpha). We conducted a multicentre phase II study to confirm these results. Melanoma patients with distant metastases were treated as outpatients with dacarbazine 200 mg m(-2) on days 1-5, vincristine 1 mg m(-2) on days 1 and 4, bleomycin 15 mg on days 2 and 5 i.v. and lomustine 80 mg orally on day 1, repeated every 4 weeks. IFN-alpha-2b was initiated s.c. on day 8 at 3 MU daily for 6 weeks, and 6 MU t.i.w. thereafter. Forty-three patients entered the study. The median number of metastatic sites was three (range 1-5), and 81% of patients had visceral metastases. Nine patients had brain metastases, and seven patients were systemically pretreated. Among the 41 patients that were evaluable for response, the response rate was 27% (95% CI 14-3%), with one complete and ten partial remissions. The response rate in 25 previously untreated patients without brain metastases was 40% (95% CI 21-61%). Median duration of response was 6 (range 2-14+) months; median overall survival was 5 (1-26) months. The main toxicity was malaise/fatigue. We confirm that BOLD plus IFN-alpha has activity in metastatic melanoma. The lower response rate in our study compared with the previous report is probably related to patient selection, as in the previous study 46% of patients had stage III disease, whereas all our patients had stage IV disease, which is associated with a worse prognosis.

Abdominal Neoplasms↗

PubMed1995

Quality versus quantity of life in the treatment of patients with advanced small-cell lung cancer? A randomized phase III comparison of weekly carboplatin and teniposide versus cisplatin, adriamycin, etoposide alternating with cyclophosphamide, methotrexate, vincristine and lomustine. Swiss Group for Clinical Cancer Research (SAKK).

BACKGROUND: Based on a promising pilot study with weekly carboplatin and teniposide (CBDCA/VM) the Swiss Group for Clinical Cancer Research (SAKK) performed a randomised phase III trial in patients with extensive-disease small-cell lung cancer aimed at the development of an effective palliative treatment with low subjective toxicity. PATIENTS AND METHODS: From September 1989 to September 1991 patients were randomised to a weekly regimen of CBDCA/VM or to our 'standard chemotherapy' of cisplatin, adriamycin and etoposide alternating with cyclophosphamide, methotrexate, vincristine and lomustine (PAV-CyMOC). RESULTS: The trial was closed before the planned accrual of 140 evaluable patients due to a significant survival difference shown by an interim analysis. Of the 61 patients 59 were eligible and included in the final analysis. The results achieved with the PAV-CyMOC regimen were significantly better than those observed in patients treated with weekly CBDCA/VM (remission rate of 65% vs. 29%; p = 0.006). The median survival of patients treated with the PAV-CyMOC combination was significantly longer than that of patients receiving weekly CBDCA/VM (260 days vs. 147 days; p = 0.0035). The 1-year survival rate was 30% in the PAV-CyMOC arm compared to 4% in the CBDCA/VM-treated patients. As expected, side effects including myelosuppression, alopecia and mucositis were significantly more pronounced in patients treated with the PAV-CyMOC regimen. No significant difference was found in patient-rated tumor symptoms and general quality-of-life categories. CONCLUSION: Contrary to our initial expectation that we would achieve similar therapeutic results with less subjective toxicity, in this randomised prospective trial the results achieved by weekly carboplatin and teniposide were significantly inferior in terms of remission rate and survival to those of our 'standard regimen' of cisplatin, adriamycin and etoposide alternating with cyclophosphamide, methotrexate, vincristine and lomustine. The weekly regimen was less toxic than the standard chemotherapy. Whether patients are willing to accept a significant trade-off between quantity and quality of life remains to be evaluated.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2006

Lomustine for the treatment of gastrointestinal mast cell tumour in a dog.

An eight-year-old, male boxer dog was referred for the treatment of a large (5.5 x 5 cm), unresectable visceral mast cell tumour. The dog had a surgical resection performed one month before referral, and it had widespread metastases to the abdominal lymph nodes. The patient was treated with lomustine and prednisone and showed a rapid improvement and increased level of activity, weight gain and consistent tumour reduction. The patient remained in partial remission (defined as a greater than 50 per cent reduction in tumour volume) for seven months. Toxicity was acceptable and was limited to moderate anaemia and two episodes of neutropenia. At the completion of the seven months of therapy, the dog experienced a chemotherapy-induced sepsis, and the owners elected for euthanasia due to financial concerns. At that time, the tumour was still in partial remission. This case report suggests that a combination of lomustine and prednisone is an effective protocol for the palliation of aggressive visceral mast cell tumours.

Animals↗

PubMed2001

Randomized trial of procarbazine, lomustine, and vincristine in the adjuvant treatment of high-grade astrocytoma: a Medical Research Council trial.

PURPOSE: Meta-analyses of the published literature suggest a survival benefit to adjuvant chemotherapy for high-grade astrocytoma, which individual small trials have been unable to demonstrate reliably. The Medical Research Council Brain Tumour Working Party initiated the largest randomized trial of adjuvant chemotherapy for glioma in an attempt to provide a definitive answer. PATIENTS AND METHODS: After surgery, patients aged < or = 70 years, with World Health Organization grade 3 or 4 astrocytoma, were randomized to radiotherapy alone (RT) or RT plus procarbazine, lomustine, and vincristine (PCV) chemotherapy (RT-PCV) given at 6-week intervals to a maximum of 12 courses (procarbazine 100 mg/m2 days 1 to 10, lomustine 100 mg/m2 day 1, and vincristine 1.5 mg/m2 (max 2 mg) day 1). A neuropathology panel independently reviewed all cases. To reliably detect a 10% increase in 2-year survival (from 15% to 25%), 600 patients were required. RESULTS: Between September 1988 and May 1997, 15 United Kingdom centers randomized 674 patients (RT = 339 patients; RT-PCV = 335 patients). With a median follow-up for survivors of 3 years, 617 patients have died, (RT = 310 patients; RT-PCV = 307 patients). Median survival was 9.5 months for RT and 10 months for RT-PCV (hazard ratio = 0.95; 95% confidence interval, 0.81 to 1.11; log-rank P = .50). Tests for interaction revealed no significant differences in treatment effect according to tumor grade, age, performance status, or extent of neurosurgery. CONCLUSION: This trial shows no benefit to PCV chemotherapy, and current data exclude an increase in median survival of more than 10 weeks and in a 1- or 2-year survival rate of more than 7% to 8%. This suggests that no-chemotherapy control arms remain ethical in randomized trials in high-grade astrocytoma.

Adult↗

PubMed2006

Long-term chemotherapy with lomustine of intracranial meningioma occurring in a miniature schnauzer.

A 14-year-old male miniature schnauzer was referred to us because it was circling to the right. A mass in the diencephalon was noted on brain magnetic resonance images. The dura was thickened with marked linear enhancement after contrast administration. Based on diagnostic image analysis, this lesion strongly suggested meningioma. The patient's symptoms were well controlled by a combination therapy of prednisolone and lomustine (CCNU), and survived for thirteen months after diagnosis. This case was diagnosed as a meningioma based on histopathological findings. This report describes the clinical findings, imaging characteristics, and pathologic features of a diencephalic and mesencephalic meningioma and long-term survival after lomustine and prednisolone therapy.

Animals↗

PubMed2005

Use of lomustine to treat cutaneous nonepitheliotropic lymphoma in a cat.

A 17-year-old spayed female domestic shorthair cat was referred for evaluation of severe skin lesions, including ulceration, nodule formation, erythema, and alopecia. Cutaneous nonepitheliotropic lymphoma was diagnosed histologically. There was no evidence of visceral organ involvement, but renal function was decreased. The cat was treated with lomustine (45.5 mg/m2, PO, q 21 d), and skin lesions resolved after administration of the third dose. No severe toxicoses were identified. Results suggest that lomustine may be useful for treatment of cutaneous nonepitheliotropic lymphoma in cats; however, optimal dosage, efficacy, and potential adverse effects must be determined.

Animals↗

PubMed1992

Attempted prevention of blast crisis in chronic myeloid leukemia by the use of pulsed doses of cytarabine and lomustine. A Cancer and Leukemia Group B study.

An attempt to prevent the blast crisis in chronic myeloid leukemia by the use of pulsed doses of (cytarabine cytosine arabinoside) and lomustine was attempted as a cooperative group study by Cancer and Leukemia Group B. The basis for this study was to delay the development of blast crisis by pulsing dose of drugs known to be effective against emerging "blast" cells. The experimental arm which consisted of cytarabine and lomustine did not produce overall results superior to conventional treatment with busulfan. This was related to the non-hematologic effects of the combination which produced significant gastrointestinal toxicity leading to relatively early discontinuation of the combination. Nevertheless, the trial design allowed relatively prompt discontinuation of experimental arm and cross-over to conventional treatment with either hydrea or busulfan. No evidence existed that the use of new drug combinations in CML prejudiced the patient's chance to response to conventional chemotherapy. Thus, a role model for future trials in this disease was developed. With the development of the interferons and other experimental forms of therapy this conceptual development may be of significance.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2003

[Suppression of nitric oxide on cytotoxicity of Lomustine in glioma cell line BT- 325].

OBJECTIVE: To investigate the effect of nitric oxide (NO) on cytotoxicity of Lomustine (CCNU) in vitro. METHODS: CCNU was used to treat human glioma cell line BT-325 with different concentration of cytokines or NO donors, NO levels was measured by Griess assay and cell survival was evaluated by MTT assay. RESULT: (1) Pretreatment with IL-1 beta and LPS markedly suppressed CCNU cytotoxicity in BT-325 cells with a significant increase in NO production (P<0.05). This function could be inhibited by L-NAME. (2) DETA NONOate suppressed cytotoxicity of CCNU to BT -325 cells in a dose-dependent manner (P<0.05). (3) CCNU co-cultured with SNAP for 24 h showed higher cytotoxic to BT-325 cells(P<0.05). CONCLUSION: NO partly suppresses cytotoxicity of Lomustine, which might be associated with chemoresistance of BT-325 cells against CCNU in vitro. NO can also slow the degradation of CCNU in water solution.

Antineoplastic Agents, Alkylating↗

PubMed2000

Lomustine and melphalan cannot be replaced by cyclophosphamide and etoposide without reducing efficacy in MOPPEBVCAD chemotherapy for advanced Hodgkin's disease.

BACKGROUND AND OBJECTIVES: To evaluate the feasibility, toxicity and preliminary results of a potentially less toxic variant of the MOPPEBVCAD chemotherapy regimen for advanced Hodgkin's disease: MOPPEBVCyED, in which cyclophosphamide and etoposide replace lomustine and melphalan, respectively, with the remaining components being unaltered. DESIGN AND METHODS: The study was multicenter, prospective and randomized, and enrolled 67 patients with newly diagnosed stage IIB, III, IV Hodgkin's disease (62 were expected on the grounds of statistical considerations). Radiotherapy was restricted to sites of bulky involvement or to areas that responded incompletely to chemotherapy. Median follow-up was 48 months. RESULTS: Comparing MOPPEBVCAD vs. MOPPEBVCyED, the results were as follows: complete remissions 35/35 vs. 30/32 (plus one partial remission and one disease progression); relapses 5 vs. 8; deaths 2 (one of myelodysplasia) vs. 2; delivered mean dose intensity (DI): lomustine 0.79+/-0.67 vs. cyclophosphamide 0.82+/-0.32; melphalan 0.80+/-0.13 vs. etoposide 0.86+/-0.18; average DI of the 7 drugs common to both regimens 0.73+/-0.10 vs. 0.83+/-0.11; all 9 drugs 0.75+/-0.13 vs. 0.84+/-0.09 (p=0.002); projected 5-year failure-free survival 0.79 vs 0.62; second cancers, two myelodysplasias vs. one carcinoma of the kidney. Toxicities were not statistically different except for heavier thrombocytopenia being recorded with MOPPEBVCAD. INTERPRETATION AND CONCLUSIONS: The higher cumulative and single drug DI recorded with MOPPEBVCyED may reflect better short-term tolerability, but it does not lead to better disease control. Its late toxicity may be expected to be lower in the future but at present it does not seem to be a sufficient reason to substitute MOPPEBVCyED for MOPPEBVCAD.

Adolescent↗

PubMed1979

Quality and duration of survival in glioblastoma multiforme. Combined surgical, radiation, and lomustine therapy.

A retrospective evaluation of the quality and length of survival of 74 patients nonrandomly receiving lomustine, 100 to 110 mg/sq m, following craniotomy and irradiation for glioblastoma multiforme was performed. After surgery all patients were capable of at least partial self-care. Patients receiving postoperative irradiation and lomustine had a median survival of 11.5 months. While receiving chemotherapy, 40% of these patients were capable of at least partial employment; 75% were able to care for themselves. These levels of function were stable for 70% of the average postoperative course (8.0 months), following which a decline ensued.

Activities of Daily Living↗

PubMed1986

Treatment of advanced resistant Hodgkin's disease with lomustine, etoposide, and prednimustine.

Fifteen patients with Hodgkin's disease resistant to the chemotherapy combinations of cyclophosphamide, vinblastine, procarbazine and prednisone and doxorubicin, bleomycin, vinblastine, and dacarbazine were treated with lomustine, etoposide, and prednimustine. Four of them achieved complete remission and two achieved partial remission (overall response rate, 40%). The median duration of response was 5.5 months, with two complete responders relapsing at 4 and 17 months and the other two remaining disease-free at 7 and 18 months, whereas disease progression was observed at 2.5 and 6 months in the partial responders. Extrahematological toxicity was scarce. Severe myelosuppression was observed in only three patients. These results indicate that lomustine, etoposide, and prednimustine can play a role in the treatment of advanced resistant Hodgkin's disease.

Adolescent↗

PubMed1977

Combination chemotherapy with doxorubicin and lomustine. Treatment of refractory Hodgkin's disease.

Ten patients with advanced Hodgkin's disease refractory to combination therapy with nitrogen mustard, vincristine sulfate, procarbazine, and prednisone (MOPP) were treated with a combination of doxorubicin hydrochloride and lomustine. Toxicity was acceptable. Five patients (50%)attained complete remission (median duration, 15 months). Three patients attained a partial remission (median duration, four months). Survival ranged from three to more than 40 months, and five patients are still alive. One patient remains disease-free after a course of radiation therapy to a site of localized nodal relapse. The doxorubicin-lomustine regimen has induced meaningful remissions in a patient population with very refractory disease.

Administration, Oral↗

PubMed1988

Bleomycin, vincristine, lomustine, and DTIC chemotherapy for metastatic melanoma.

Forty-six consecutive, evaluable patients with a diagnosis of metastatic melanoma without prior chemotherapy were treated with bleomycin, vincristine, lomustine, and DTIC (BOLD). Treatment was repeated every 28 days for two cycles. Complete restaging then was performed, and response to treatment was determined. Of the 46 patients, five (11%) achieved a complete response, five (11%) achieved a partial response, nine (19%) obtained disease stabilization, and 27 (59%) had progressive disease. If four patients who died of rapidly progressive disease are included, the response rate drops to 20%. Overall median survival was 6 months. These results are inferior to the 40% and 46% response rates reported by other investigators. The modest response rate toxicity and expense of the regimen do not support its use in metastatic melanoma except, perhaps, in selected patients with soft tissue and/or lung metastasis.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1990

Results of treatment of children with recurrent medulloblastoma/primitive neuroectodermal tumors with lomustine, cisplatin, and vincristine.

Primitive neuroectodermal tumors/medulloblastoma (PNET/MB) are the most common posterior fossa tumors in childhood. Despite surgery and radiation therapy, 40% to 50% of children with PNET/MB will have recurrent disease. Various chemotherapeutic agents are transiently effective in recurrent PNET/MB, but long-lasting responses are rarely attainable. To increase the rate and duration of response in children with recurrent PNET/MB, the authors treated seven patients (ages 2-18 years; median, 10 years) with lomustine (CCNU) (100 mg/m2), cisplatin (CPDD) (90 mg/m2) and vincristine (VCR) (1.5 mg/m2; maximum, 2 mg) in a 6-week cycle for a maximum of eight cycles. Six of six evaluable patients responded to chemotherapy. Four patients had a complete response; three with complete disappearance of tumor by imaging studies; and one with eradication of extraneural disease for a median of 24 months from relapse (13-29 months). Overall disease-free survival was 18.5 months. All six patients have subsequently died of recurrent tumor. Major toxicities consisted of reversible bone marrow suppression (six of six), high frequency hearing loss (six of six) and decreased renal function (three of six). All patients required dosage modification for toxicity. A regimen of CCNU, VCR, and CPDD is effective therapy in children with relapsed PNET/MB and can produce relatively long-term disease control with good quality of life. Further investigation into the efficacy of this combination as adjuvant chemotherapy in newly diagnosed high-risk PNET/MB is now being performed.

Adolescent↗

PubMed1991

A randomized study of chemotherapy with procarbazine, vincristine, and lomustine with and without radiation therapy for astrocytoma grades 3 and/or 4.

The authors undertook a controlled, prospective, randomized study of 171 patients with supratentorial astrocytoma grades 3 and/or 4 (classified according to Kernohan). All patients were given chemotherapy consisting of procarbazine, vincristine, and lomustine (CCNU) (PVC). Half of the patients received whole-brain irradiation (RT) to a dose of 5800 cGy in the tumor-bearing hemisphere and 5000 cGy in the contralateral hemisphere. After diagnosis of progressive tumor growth, patients received individual treatment. The endpoint of the study was time to progression, but cases were followed until the patients died. Median time to progression (MTP) for the whole randomized population was 21 weeks. Median survival time (MST) was 53 weeks; 18% of patients survived for 2 years or longer. Survival analysis showed that patients less than 50 years of age treated with PVC plus RT had significantly longer MTP (81 weeks) and MST (124 weeks) than all other patients. For patients less than 50 years of age treated with PVC alone, MTP was 21 weeks and MST was 66 weeks. For patients more than 50 years of age treated with PVC plus RT, MTP was 23 weeks and MST was 51 weeks; in the PVC group, MTP was 17 weeks and MST was 39 weeks. Age, Karnofsky index, areas of Grade 2, and absence of extensive necrosis in the tumor were significant prognostic factors in the univariate analyses. Patients less than 50 years of age treated with PVC plus RT had significantly longer survival (P = 0.037) when correcting for these factors in a multi-variate analysis.

Adult↗

PubMed1993

A phase II study of methotrexate, doxorubicin, cyclophosphamide, and lomustine chemotherapy and lonidamine in advanced non-small cell lung cancer.

BACKGROUND: Combination chemotherapy with conventional antiproliferative drugs is becoming the treatment of choice for patients with advanced non-small cell lung cancer (NSCLC), a good performance status, and no major clinical contraindications. Lonidamine (LND), a new drug with an innovative mechanism of action, might potentiate anticancer activity, without increasing toxicity. METHODS: In a Phase II study, 46 patients with advanced NSCLC were assigned to receive chemotherapy with the methotrexate, doxorubicin (Adriamycin, Adria Laboratories, Columbus, OH), cyclophosphamide, and lomustine (MACC) regimen, as originally described, plus LND, 150 mg orally, three times per day. Treatment was continued until progression of disease, occurrence of unacceptable toxic effects, or refusal by the patient (the median duration of MACC treatment was 6 weeks; 7 weeks for LND). RESULTS: For the whole group of patients, actual dose intensities (DI) of MACC and LND were 95% and 67% of those projected (median values), respectively. There was a negative correlation between duration of chemotherapy and the DI of MACC reached in each patient. On the contrary, there was no correlation between the duration of treatment with LND and its DI. The DI of LND and MACC were not correlated with each other. In all, seven objective responses (only partial responses) were observed. The overall median survival time was 42 weeks (confidence limits [CL], 20-52). The median survival length of patients receiving the full dose of LND (450 mg daily for at least 1 week) was 46 weeks (CL, 28-67), as compared with the median survival of 19 weeks (lower CL, 9 weeks) for the remaining patients; this difference was statistically significant (P < 0.05, Breslow test). Toxic effects were as expected with the use of MACC. They were mainly gastrointestinal (any grade of toxicity occurring in 64% of the patients), hematologic (anemia, 44%; leukopenia, 36%; thrombocytopenia, 8%), oral (25%), renal (14%), and cardiac (11%). There was only one treatment-related death, from myocardial infarction and neutropenic sepsis. Uncommon side effects, which were attributed to LND, were mild to moderate and reversible; they included myalgia (26%), asthenia (15%), testicle pain (11%), visual problems (7%), and gastric intolerance (7%). CONCLUSIONS: MACC plus LND is a moderately active regimen in advanced NSCLC, with foreseeable and reversible toxic effects of low-medium grade. Potential enhancements of antitumor activity and possible host survival benefits may be expected by the addition of LND to MACC, but a Phase III study must be performed to identify them.

Aged↗