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PubMed1980

Pulmonary fibrosis following low-dose 1,3-bis (2-chloroethyl)-1-nitrosourea (BCNU) therapy.

Two women, 65 and 55 years old, with metastatic malignant melanoma, were treated with low doses of BCNU for a short period (six and three months, total dose 2500 and 2000 mg). Both patients developed pulmonary fibrosis, which was visible in postmortem examination. In the first woman, lesion development was so widespread as to be considered responsible for death. Because chest x-ray before treatment was not abnormal, we consider BCNU capable of inducing the lesion.

Aged↗
PubMed1980

High-dose combination chemotherapy with autologous bone marrow transplantation in adult solid tumors.

In order to determine whether high-dose combination chemotherapy was active in chemotherapy resistant patients, 19 patients, (9 with small cell bronchogenic carcinoma, 6 with embryonal cell carcinoma, 2 with diffuse histiocytic lymphoma, 1 with Hodgkin's disease and 1 with chondrosarcoma), 18 of whom had had extensive prior chemotherapy and failed, received 23 courses of high-dose chemotherapy with autologous bone marrow infusion (ABMT). Three patients received four courses of cytoxan (2-6 g/m2) and VP-16 (500-600 mg/m2) and 16 patients received 19 courses of cytoxan and VP-16 in these doses plus BCNU (300 mg/m2). Activity was observed in 6 of 8 evaluable small cell bronchogenic carcinoma patients (1 complete response (CR), 4 partial responses (PR), 1 less than PR), in 6 embryonal cell carcinoma patients (3 CR, 2 PR, 1 less than PR), in both patients with diffuse histiocytic lymphoma (1 CR, 1 less than PR), in the patient with Hodgkin's disease (1 PR); and in the patient with chondrosarcoma (stable). Only 2 patients who had received prior cytoxan and VP-16 extensively showed resistance to these programs. The median response duration was 11 weeks (range = 4-55 + weeks). Major toxicity consisted of bacterial infections. Two patients died from treatment related causes. Neutrophils recovered to levels of greater than or equal to 1.5 x 10(9)/liter by days 20-42 (median, day 27) and platelets to levels of greater than 100 x 10(9)/liter by days 21-56 (median, day 32) without any delayed BCNU toxicity. High-dose combination chemotherapy with ABMT causes acceptable toxicity and high response rates of relatively short duration in tumors refractory to conventional chemotherapy.

Adult↗
PubMed1980

DTIC, CCNU, bleomycin and vincristine (BOLD) in metastatic melanoma.

Treatment of 91 consecutive patients having metastatic, Stage IV melanoma who had not received any previous chemotherapy was begun between January 1977 and April 1978. The therapy included bleomycin (B) at 7.5 units subcutaneously in the first course and 15 units in subsequent courses on days 1 and 4; vincristine or Oncovin (O) at 1 mg/m2 intravenously on days 1 and 5; CCNU or lomustine (L) at 80 mg/m2 p.o. on day 1 and DTIC (D) 200 mg/m2 intravenously on days 1 through 5. Evaluable patients (72) were those who had measurable tumours in the viscera and on the skin. Seven patients (9%) responded with complete tumor regression (CR), 22 (31%) with partial regression (PR) (50% or more tumor regression), 12 (17%) with stabilization of disease, and 31 (43%) with progression of the disease. Patients who responded with CR, PR, and stable disease (41 patients) had a median survival of 67 weeks, while those who did not respond (31 patients) had a median survival of 20 weeks (P < .0001). Overall median survival was 31 weeks. The bleomycin-Oncovin-lomustine-DTIC (BOLD) regimen is an effective alternative treatment for metastatic melanoma; there is good tumor response and prolongation of survival in the responding patients. Its overall toxicity is mild to moderate.

Antineoplastic Agents↗
PubMed1980

Chemotherapy of advanced prostatic cancer with adriamycin, BCNU, and cyclophosphamide.

A phase II trial of Adriamycin, BCNU, and cyclophosphamide was performed in 29 patients with advanced prostatic carcinoma (Southeastern Cancer Study Group protocol SEG 76 PR 0102P). Therapy consisted of BCNU 100 mg/m2, plus cyclophosphamide, 300 mg/m2 i.v., on day 1, followed by Adriamycin, 30 mg/m2 i.v., on day 2. Therapy was repeated every four weeks. In 27 evaluable patients refractory to prior estrogen therapy, one patient had a complete response, six patients had partial responses, and two patients had objective improvement (complete plus partial response rate 26%, and overall response rate 33%). Responders had a median time to progression of disease of 5.5 months, compared with a median time to progression of 4.0 months for those patients with stable disease. The median survival of responders was 9.3 months, compared with 6.7 months for stable disease and 3.9 months for patients with progression. Patients with higher pretreatment performance status did not have higher response rates. No life-threatening toxicity was observed. Only five patients had nadir platelet counts below 50,000/mm3, and only six patients had nadir granulocyte counts below 750/mm3. This regimen palliates the effects of hormone-resistant metastatic prostatic carcinoma.

Carmustine↗
PubMed1981

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↗
PubMed1981

Response of cultured human brain tumors to nitrosoureas: correlation with clinical data.

An in vitro microcytotoxicity assay was utilized to determine the sensitivity of 58 cultured human malignant gliomas to the chemotherapy agent 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU). Of 58 such tumors, 42 (72%) showed a statistically significant cytotoxic response to BCNU in this assay. For those responding tumor lines, the cytotoxic index ranged from 0.25 to 0.76, with most clustered at the 0.40 level. To determine the therapeutic predictive relevance of such microcytotoxicity testing, the clinical course of patients receiving postoperative radiation therapy plus two or more doses of nitrosourea chemotherapy, as well as two or more computerized tomographic scans, was evaluated. In the 14 patients meeting all these criteria, tumor size increased in all five patients whose tumors did not respond to BCNU in the microcytotoxicity test. Six of the nine patients whose tumors in culture showed significant sensitivity to BCNU in vitro showed a clear decrease in tumor size over periods ranging from 17 to 48 months. Tumors in two patients increased in size, and one remained unchanged over the interval studied. These data support the concept that in vitro microcytotoxicity testing can be predictive of clinical response. Further study of this correlation seems warranted.

Adult↗
PubMed1981

Phase II study--intra-arterial BCNU therapy for metastatic brain tumors.

Thirty-one patients with metastatic brain tumors (MBT) from lung cancer and ten patients with MBT from melanoma received BCNU, 100 mg/m2, every four weeks by intracarotid and/or vertebral artery infusion into each involved site. Twenty-five patients with lung cancer and all melanoma patients are currently evaluable. Twelve patients with lung cancer had complete and partial responses lasting from 1 to 14 months. Four of them with the histologic diagnosis of small cell carcinoma, one with large cell carcinoma and one with squamous cell carcinoma showed complete response. None of the patients with melanoma MBT experienced any response. All of the patients had periorbital erythralgia and/or occipital pain during the infusion. Four patients manifested mild focal seizures during the infusion or 6 to 24 hours after the treatment. Transient confusion with disorientation was observed in two patients 4 and 24 hours, respectively, after a BCNU infusion. Two patients developed reversible thrombocytopenia after the fifth course of the IA chemotherapy. Median survival of patients with MBT from lung carcinoma was 4 months, with two of them still alive at 10 and 14 months, respectively. Only one patients of the 25 with lung carcinoma died from MBT. Failure to control the primary disease resulted in the deaths of a vast majority of the patients.

Adenocarcinoma↗
PubMed1981

Pulmonary fibrosis: a complication of 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) therapy.

A pediatric patient is reported who experienced fatal progressive pulmonary fibrosis as a complication of 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) therapy. The patient received a cumulative dosage of 1.29 g (1.72 g/m2) over a two-year period as adjuvant therapy for a medulloblastoma. Two and one-half years after cessation of therapy, cough, tachypnea and fatigue were noted. Progressive pulmonary insufficiency developed. Pulmonary pathologic findings included interstitial fibrosis and alveolar dysplasia. Other cases of BCNU pulmonary toxicity are cited from the medical literature.

Brain Neoplasms↗
PubMed1981

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↗
PubMed1982

Improved regional selectivity of hepatic arterial BCNU with degradable microspheres.

Starch microspheres 40 micrometers in diameter, which are rapidly degraded by serum amylase, have been administered through hepatic arterial catheters to five patients with primary and metastatic liver cancer to determine whether (1) arterial blood flow through the liver could be temporarily blocked, and (2) such occlusion at the level of the arteriolar capillary bed would enhance regional uptake and catabolism and decrease systemic exposure to simultaneously administered hepatic arterial bischlorethylnitrosourea (BCNU). It was possible with 10 ml of microspheres (9 X 10(6) microspheres/ml) injected into the hepatic artery to transiently (for 15-30 minutes) reduce hepatic flow by 80-100% in the five patients. When BCNU (50 mg/m2 in one minute) was given with microspheres there was a 30-90% reduction in systemic nitrosourea exposure and in peak levels. No myelosuppression was noted and hepatic toxicity consisted of acute pain due to BCNU and 1.5-2.0 fold transient enzyme elevations. One patient with cholangiocarcinoma showed a partial response lasting three months; three patients had stable disease and one patient with colon carcinoma had progressive disease. Thus, this pilot study suggests that concurrent intra-arterial microspheres and BCNU may have the potential to improve selective regional drug effect with marked diminution in systemic toxicity.

Carmustine↗
PubMed1982

Acute nonlymphoblastic leukemia: prognostic factors in adults with long-term follow-up.

Seventy-nine adult patients with acute nonlymphoblastic leukemia (ANLL) were treated on the L-6 protocol at Memorial Sloan-Kettering Cancer Center between May 1970 and January 1974. Forty-two patients achieved a complete remission (CR) and nine of these are still disease free, with a minimum of seven years of follow-up. An extensive statistical analysis has been carried out on a large number of pretreatment and treatment characteristics to identify factors related to CR and remission duration. Multivariate regression techniques yielded as favorable characteristics associated with CR, in order of importance: young age at diagnosis, the presence of Auer rods at diagnosis, and treatment with Pseudomonas vaccine. A regression model for remission duration identified as favorable prognostic factors for long-term remission: at most two courses of induction therapy, an intermediate age range, and a low platelet count at diagnosis.

Acute Disease↗
PubMed1982

Comparison of oral melphalan, CCNU, and BCNU with and without vincristine and prednisone in the treatment of multiple myeloma. Cancer and Leukemia Group B experience.

A total of 361 evaluable patients with previously untreated multiple myeloma were randomized to receive oral melphalan (0.15 mg/kg/day for seven days, followed by 0.05 mg/kg/day after recovery from the nadir of the leukocytes), BCNU (150 mg/m2 intravenously every six weeks) or CCNU (100 mg/m2 orally every six weeks). All patients received a tapering six-weeks) or CCNU (100 mg/m2 orally every six weeks). All patients received a tapering six-week course of prednisone starting at 0.8 mg/kg for the first two weeks. At week 22, one-half of the patients were randomized to receive vincristine (1 mg/m2) and prednisone (0.6 mg/kg for seven days) every two months in addition to previous therapy. The melphalan treated patients showed a significantly higher overall objective response frequency (59%), according to Myeloma Task Force criteria, when compared to those treated with BCNU (40%) or CCNU (42%). The survivals for all patients were not statistically different for the three treatment programs. However, the good-risk patients treated with melphalan had significantly longer survival (P = 0.02) than the equivalent patients who received BCNU or CCNU. The addition of vincristine and prednisone at week 2 did not significantly increase the percentage of subsequent objective responses or prolong the subsequent survival of any treatment group. It is concluded that oral melphalan is superior to BCNU and CCNU in producing objective responses and in prolonging survival in good risk patients.

Antineoplastic Agents↗
PubMed1982

Post-therapeutic acute malignant myeloproliferative syndrome and acute nonlymphocytic leukemia in non-Hodgkin's lymphoma.

In a prospective randomized study of treatment with radiation therapy (RT) or RT + chemotherapy (CT) for patients with non-Hodgkin's lymphoma Stages I-III, one patient developed an acute malignant myeloproliferative syndrome (AMMS) and four others acute nonlymphocytic leukemia (ANLL). There was correlation between the intensity of treatment and development of this complication: Among patients treated with local radiation with or without chemotherapy no cases of AMMS or ANLL were observed. However, patients treated with total lymphoid irradiation alone (TLI) had an observed to expected ratio of 162. Among patients treated with TLI plus CT this ratio increased to over 1000. The cytogenetic, clinical, and hematologic abnormalities of these patients are discussed.

Adult↗
PubMed1983

Pulmonary fibrosis subsequent to high doses of CCNU for chronic myeloid leukemia.

Two patients treated for chronic myeloid leukemia with high doses of CCNU (1100 mg/m2 and 1240 mg/m2, respectively) developed a fatal pulmonary fibrosis. This side effect has never been reported for this nitrosourea but only for BCNU and methyl-CCNU. The responsibility of CCNU in the pathogenesis of pulmonary fibrosis seems very likely. The possibility that the underlying disease or other chemotherapeutic agents may increase the risk of pulmonary toxicity can, however, be discussed. In addition, 13 other adults treated for chronic myeloid leukemia with various doses of CCNU were reviewed. No respiratory symptoms appeared in the ten patients who were given less than 950 mg/m2. Three patients who received more than 1100 mg/m2 developed pulmonary symptoms with the same clinical and radiologic pattern as in the two cases with pathologic documents, and two of them died from acute respiratory failure. Although lung specimens were lacking from these three patients, it is suggested that the pulmonary toxicity of CCNU may be dose-related.

Adult↗
PubMed1983

Comparison of postoperative radiotherapy and combined postoperative radiotherapy and chemotherapy in the multidisciplinary management of malignant gliomas. A joint Radiation Therapy Oncology Group and Eastern Cooperative Oncology Group study.

Recently, the RTOG and ECOG concluded a joint randomized study on malignant gliomas that was in progress for the past five years. A total of 626 patients entered this protocol. Sixty-seven percent of the 535 evaluable patients have died and thus this represents a preliminary report of a major joint clinical trial. The objective of this study was to evaluate the efficacy after neurosurgery of three new treatment options as compared with control treatment of radiotherapy alone. The four options were: (1) control radiation; 6000 rad/6-7 weeks to whole brain; (2) a higher radiation dose; Control dose plus a booster dose of 1000 rad/1-2 weeks to the tumor; (3) control radiation dose plus BCNU (80 mg/m2/day IV X 3 and repeat BCNU every 8 weeks); (4) Control radiation dose plus combination methyl-CCNU (125 mg/m2/day orally X 1 and repeat methyl-CCNU every 8 weeks), and DTIC (150 mg/m2/day IV X 5 and repeat DTIC every 4 weeks). All pertinent patient characteristics were studied and several important prognostic factors have been identified. Notably, age, histologic type (Astrocytoma with anaplastic foci, versus glioblastoma multiforme), initial performance status, time since first symptoms and presence or absence of seizure. At this time, it appeared that there was no treatment option which was significantly better than the control. The study identified that age was the most important prognostic factor. Patients who were younger than age 40 years had an 18-month survival of 64%, patients who were age 40-60 years had an 18-month survival of 20%, and patients who were older than age 60 had an 18-month survival of 8%. The study also demonstrated that a modified histologic classification of anaplastic astrocytoma versus glioblastoma provided better prognostic information than the astrocytoma grading system of Kernohan. Patients with anaplastic astrocytoma had a median survival of 27 months as compared to 8 months for patients with glioblastoma. In further evaluation of any beneficial effect of chemotherapy, it was identified that only among the 40-60-year-old groups, BCNU treated patients appeared to have significantly increased survival than patients in the control groups (P = 0.01, one-sided). Similarly, methyl-CCNU + DTIC was suggestively better than the control (P = 0.08, one-sided). The higher radiation dose, 7000 rad/8-9 weeks appeared to give no significantly better survival over the control dose option. Both BCNU and methyl-CCNU + DTIC produced some toxicity. The combination of methyl-CCNU + DTIC was more toxic than BCNU, producing severe or worse thrombocytopenia in 23% of the patients as compared to 6% on BCNU.

Adult↗
PubMed1983

Intensive 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU), NSC #4366650 and cryopreserved autologous marrow transplantation for refractory cancer. A phase I-II study.

One hundred forty-three patients with refractory cancer were treated with intensive BCNU (600-2850 mg/m2) and autologous marrow transplantation to determine the maximum tolerated dose and antitumor effects of this regimen. Recovery from severe pancytopenia in less than 4 weeks after transplantation occurred in 92.8% of evaluable patients, suggesting the efficacy of the autologous marrow in limiting the prolonged myelosuppression anticipated with intensive BCNU. Serious extramedullary toxicity was encountered at BCNU 1200 mg/m2, where a 9.5% incidence of fatal interstitial pneumonitis and a 3.0% incidence of fatal hepatic necrosis was observed. Higher BCNU doses, 1500 to 2850 mg/m2, were associated with a 35.3% incidence of fatal hepatotoxicity. Fatal encephalomyelopathy was encountered in two patients given BCNU 2250 and 2850 mg/m2. One patient who received the highest cumulative dose of BCNU (3450 mg/m2 in 2 courses) died of cardiac necrosis. Other serious extramedullary toxicities were not encountered, even in the 14 patients who survived from 1 to nearly 5 years after BCNU therapy. Antitumor responses occurred in 40.0% of evaluable patients; a dose effect could not be evaluated due to patient heterogeneity. The BCNU doses associated with acceptable toxicity, 600 to 1200 mg/m2, produced a 37.5% total and an 11.3% complete response (CR) rate, including five patients with prolonged CRs of 1 to nearly 5 years. Notable among the CRs was the 25.0% CR rate in previously untreated metastatic melanoma, and the production of CRs in malignant disease in the central nervous system (CNS) including melanoma, lung cancer, adenocarcinoma of unknown primary, acute leukemia and glioblastoma multiforme. It is concluded that augmented doses of BCNU can be given when autologous marrow transplantation is used to limit myelosuppression. Lung and liver toxicity prevent the use of BCNU doses greater than 1200 mg/m2; neurotoxicity, and perhaps cardiotoxicity, are manifestations of the highest doses used in this study. The antitumor activity of BCNU 600 to 1200 mg/m2 remains to be determined for most neoplasms; these results suggest improved results in melanoma and CNS malignancy compared to conventional-dose BCNU therapy.

Adolescent↗
PubMed1983

Acute myelogenous leukemia as a second malignant neoplasm following the successful treatment of advanced Hodgkin's disease.

Of 209 Hodgkin's disease patients treated at least 6 months with a five-drug combination of induction chemotherapy and having a complete remission, four patients developed acute myelogenous leukemia (AML) as a second malignant neoplasm. The overall relative risk for development of AML is 185.0 (P less than 0.05) and the mean time to occurrence of AML is 5.3 years (median, 5.25 years). When examining patient subgroups, the highest relative risk noted was 338.5 (P less than 0.05) for that group of patients receiving an additional 6 months of postinduction MOPP (nitrogen mustard, vincristine, procarbazine, and prednisone). Patients receiving only 6 months of induction BVCPP (BCNU, vinblastine, cyclophosphamide, procarbazine, and prednisone) had a relative risk of 166.2 (P less than 0.05). These data results are consistent with previous reports that patients treated for Hodgkin's disease are at high risk for development of AML. However, to date, no patients in this series have developed second malignancies other than AML.

Adult↗