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PubMed1975

Modification of radiation injury to normal tissues by chemotherapeutic agents.

The effects of several cancer chemotherapeutic agents on radiation damage to normal intestine, esophagus, and lung tissue were evaluated in LAF 1 mice using quantitative endpoints. In all tissues tested, actinomycin D increased injury and BCNU did not. In the intestine, adriamycin enhanced radiation damage more than any other agent. Bleomycin increased damage in the esophagus but not in the lung or intestine. Cyclophosphamide increased injury only in the lung, where vincristine caused minimal injury, and hydroxyurea, none. Only prednisolone caused significant radioprotection when given at the time of irradiation or at the time of expected death from pulmonary injury.

Animals↗
PubMed1975

Clinical management of advanced gastrointestinal cancer.

Although advanced gastrointestinal cancer is the most commonplace problem encountered by the medical oncologist, this group of diseases has proved exceedingly resistant to past chemotherapy efforts. 5-Fluorouracil (5-FU), accepted by some as standard treatment, had provided only infrequent, incomplete, and fleeting antitumor effects, which are probably more than counterbalanced by its gastrointestinal, mucocutaneous, and hematologic antihost effects. There is no evidence that any manipulation of route or schedule of administration provides any improvement in the therapeutic ratio of 5-FU. There is no evidence that this drug contributes to patient survival when used at any stage of any type of gastrointestinal carcinoma. The search for alternative single drugs to 5-FU has been disappointing. The nitrosoureas and Mitomycin C produce occasional regressions, but they do not match the meager effectiveness of 5-FU; and they, in addition, present the difficult problem of cumulative bone marrow suppression. Recent trials with combination regimens have given some indication that the long stalemate in chemotherapy of gastrointestinal cancer may be breaking. Substantial improvements in frequency of tumor regression have been recorded for gastric carcinoma with combinations of 5-FU and BCNU, 5-FU and methyl CCNU, and 5-FU, Mitomycin C, and cytosine arabinoside; for colorectal carcinoma, with the combination of 5-FU, methyl CCNU, and vincristine; and for carcinoid tumors and islet cell carcinomas, with the combination of 5-FU and Streptozotocin. There are also suggestion that such combination chemotherapy with response rates in the 30 to 50% range may produce increased survival when compared to the untreated patient and patients treated with single-drug regimens. While the accomplishments of chemotherapy for the gastrointestinal cancer patient remain less than spectacular there is nevertheless realistic hope that a respectable contribution can now be made to multidisciplinary efforts applied at a stage of disease with minimal tumor burden.

Adenoma, Islet Cell↗
PubMed1975

Treatment of acute leukemia in adults.

Improvement in the management of acute leukemia in adults has not progressed nearly so rapidly as has the treatment of childhood leukemia. One important difference is that most adults have myeloblastic or related forms of the disease (AML), whereas the majority of children have lymphoblastic leukemia (ALL). However, even adults with ALL fail to respond as well to a similar regimen as do children with the same type of leukemia. In a recent series of patients with ALL who were treated with the complex multiple drug "L-2" protocol, the incidence of complete remission in adults was 78% vs. 99% in children, and the median duration of remission was only 24 months in the adults, whereas it has not yet been reached in the children and is projected to be over 4 years. In AML and the related nonlymphoblastic forms of acute leukemia, therapy is still unsatisfactory in both adults and children. With the best current drug treatment schedules, the incidence of complete remission is now better than 50%, but it is often difficult to compare the exact remission rates in different series because of differences in reporting results. In adults treated with the multiple drug "L-6" protocol, the incidence of remission in previously untreated patients was 56% and the median duration of remission was 10 months. The median survival of all patients (responders and non-responders) was 1 year whereas that of responders only was 2 years. It is encouraging that a significant proportion of those patients with AML who have complete remissions now remain in remission for extended periods; about 45% of patients responding to the "L-6" protocol remained in remission over 1 year, and 18% have been in continuous remission for 2 to over 4 years. Even after discontinuing treatment, some patients with AML stay in remission for long periods, and it is possible that some of them may have been cured. If this proves to be true, it becomes of great importance to determine what is different about the patients who do exceptionally well as compared to the majority who continue to die within a year. However, no consistent nor distinctive favorable prognostic features have yet been identified.

Adolescent↗
PubMed1975

Ph1-positive megakaryoblastic leukemia.

A case of megakaryoblastic leukemia is presented. Megakaryoblastosis and erythrocytic hyperplasia of the bone marrow, thrombocythemia, and hepatosplenomegaly were the essential features; 100% of the marrow-derived metaphases were found to be Ph1-positive. Cytologic and chromosomal findings are compatible with the assumption that all three marrow systems were involved in the leukemic process.

Acute Disease↗
PubMed1975

Correlation of delayed hypersensitivity responses with chemotherapeutic results in advanced Hodgkin's disease.

Delayed skin test responses to several or all of a battery of six antigens were evaluated in 64 patients with disseminated Hodgkin's disease before, during, and after multiple-agent chemotherapy. Before therapy, 53% of patients had one or more positive skin tests, as compared to 55% during intensive chemotherapy, 79% during maintenance therapy, and 100% after discontinuation of all treatment. Pretreatment skin tests were of no value in predicting clinical response to chemotherapy. Response rates, duration of response, and survival were similar among anergic patients and patients with positive skin tests before treatment. There were too few patients who remained anergic after intensive induction chemotherapy to permit a correlation of immunologic reactivity with course. We conclude that skin test responses to recall antigens, before or during aggressive treatment, are more indicative of Hodgkin's disease activity (and also, of the immunosuppressive effects of treatment routines) than of prognosis.

Carmustine↗
PubMed1975

Clinical comparison of the nitrosoureas.

The nitrosourea group of antitumor agents was developed by the Division of Cancer Treatment of the National Cancer Institute. Three nitrosoureas (BCNU, CCNU, MeCCNU) have undergone extensive clinical trials, and two of them (BCNU, CCNU) will soon become commercially available. This paper briefly considers the preclinical development of the nitrosoureas and provides an overview and comparison of the extensive clinical data. Information is given regarding any clinical differences. We discuss general conclusions drawn from the nitrosourea development.

Animals↗
PubMed1975

Chemotherapy of large intestinal carcinoma. Current results and future prospects.

Chemotherapy of advanced stages of large bowel cancer has until recently made little progress since the introduction of 5-FU 16 years ago. While survival is improved for patients who respond, 5-FU alone has made little impact on life span of the overall population of patients. Mitomycin-C and the chloroethyl nitrosourea antitumor agents, and in particular methyl-CCNU, have also demonstrated marginal activity in large bowel cancer. Two recently reported controlled clinical trials of combination chemotherapy have demonstrated response rates that are substantially better than those obtained with 5-FU alone; a 43% response rate in colorectal carcinoma has been reported using a combination of 5-FU, BCNU, vincristine, and DTIC, compared to a 25% response with 5-FU as a single agent; a 44% objective response rate with a combination of 5-FU, methyl-CCNU, and vincristine has been reported to be significantly better than 5-FU alone. 5-FU as an adjuvant following surgical resection with curative intent has not prevented tumor relapse; however, it is hoped that future studies employing more effective drug combinations will result in increased number of patients achieving disease free survival.

Administration, Oral↗
PubMed1976

Non-Hodgkin's lymphoma in children. A comparative study of two modalities of therapy.

Eighty-six children with non-Hodgkin's lymphoma were studied from 1964 to January 31, 1975. Seventy-six percent of the 43 patients in the nonprotocol group had far advanced disease, and 76% had Rappaport's diffuse histology. Only 11% of these patients survived free of disease. The second group of 43 patients received the LSA2L2 protocol. Seventy-six percent had advanced disease and 86% diffuse histology. Of these patients 76% are surviving free of disease with a median observation time of 25+ months. Fifty-one percent of the survivors are off therapy and without evidence of disease. Prognostic factors such as primary sites, stages, histology, and others are discussed. The most important prognostic factor is early and aggressive therapy, and the achievement of a complete response status within 1-2 months from onset of therapy.

Adolescent↗
PubMed1976

Adriamycin, 1,3-bis (2-chloroethyl)-1-nitrosourea (BCNU-NSC 409462), and cyclophosphamide in refractory adenocarcinoma of the breast and other tumors.

Eighty-two patients with metastatic tumor received a therapeutic regimen consisting of BCNU, 100 mg/m2, and cyclophosphamide, 400 mg/m2, both intravenously on day 1, followed by adriamycin, 40 mg/m2, on day 2. Treatment was repeated every 4 weeks. Of 14 evaluable patients with adenocarcinoma of the breast, all resistant to previous chemotherapy and 12 resistant to a five-drug combination chemotherapy program, 12 had objective responses of which seven were good partial responses. Osseous, visceral, and cutaneous metastases responded equally well. Overall, 53% of 68 evaluable patients had objective responses, and 32% had complete or good partial responses. The most encouraging results were in patients with carcinoma of the head and neck, ovarian carcinoma, and multiple myeloma refractory to standard therapy. Significant responses were observed in previously untreated patients with epidermoid carcinoma of the lung, carcinoma of the prostate, and carcinoma of undermined primary. Remissions lasted a median of 5 months. Myelosuppression was moderate in degree and was maximal 2 weeks after treatment. Cumulative thrombocytopenia was apparent but not dose limiting with repeated courses.

Adenocarcinoma↗
PubMed1976

Effect of surgical and chemotherapeutic treatment on alpha-fetoprotein levels in patients with hepatocellular carcinoma.

Quantitative determinations of serum alpha-fetoprotein (AFP) by radioimmunoassay in 193 patients with hepatocellular carcinoma have demonstrated a wide variation in serum levels that appear to be relatively constant for each patient by the time that diagnosis is made. If there is no therapeutic intervention the serum AFP usually follows a gradual increase as the tumor progresses. A few patients have a fall in serum AFP as a preterminal event. Various forms of chemotherapy cause only minor and transient decrease in serum AFP. Surgical resection of tumor produces an immediate fall that parallels the catabolic decay rate for AFP. All AFP-positive patients treated with surgery had recurrence of their tumor with a rise in serum AFP preceeding clinical discovery. The correlation of serum AFP and effective treatment is demonstration of the usefulness of this oncofetal protein marker as an indicator of neoplastic activity for hepatocellular carcinoma and tumors with embryonal cell components and possibly for some other entodermally derived neoplasms.

Carmustine↗
PubMed1976

Acute lymphoblastic leukemia in adults and children. Differences in response with similar therapeutic regimens.

Twenty-three adult patients (ages greater than 15 years) and 75 children with acute lymphoblastic leukemia were treated with similar intensive, sequential cytotoxic protocols (L-2). The adult patients have lower remission rate (78%) than the children (98%). The duration of remission and the length of survival are also shorter in adults. The incidence of central nervous system (CNS) relapse in adults (27.7%) is higher than in children (7.1%) suggesting that prolonged prophylactic intrathecal methotrexate as given to the children is more effective than the schedule used for adults where intrathecal methotrexate was given only in the first 2 months of therapy. The low incidence of CNS involvement in children on the L-2 protocol compares favorably with other series reported using a combination of cranial irradiation and intrathecal methotrexate. In both adults and children there seemed to be a higher incidence of CNS involvement in patients with initial white blood cell counts greater than 25,000 cells/mm3.

Adolescent↗
PubMed1976

Lymphosarcoma. A comparison of extended to conservative chemotherapy.

Sixty-three patients with Stage III and IV lymphocytic lymphoma were randomized for induction treatment between a single course of nitrogen mustard and a 14-day course of prednisone (conservative therapy) or sequential rotation of BCNU, nitrogen mustard and cytoxan with intermittent vincristine and prednisone for 6 months (extended therapy). Maintenance therapy by an oral alkylating agent (cytoxan or chlorambucil) with or without prednisone was given. Complete remission occurred in 75% of the conservative and 77% of the extended therapy group. The median duration of remission was similar, and greater than 27 months in both groups, and there was no difference in survival. At 1 year 80% of patients with no prior chemotherapy were in remission vs. 47% of patients with prior chemotherapy (p less than .01). No significant advantage for extended chemotherapy was found. The addition of vincristine was not helpful in induction and prednisone during maintenance did not improve the duration of remission or survival.

Adult↗
PubMed1976

Management of small cell carcinoma of the lung: therapy, staging, and biochemical markers.

A chemotherapeutic regimen consisting of BCNU, cyclophosphamide, vincristine, and procarbazine was evaluated in 43 patients with small cell carcinoma of the lung. The majority of patients received radiation therapy of the primary tumor, but chemotherapy alone was utilized in a group of patients with widely disseminated disease. In addition to thorough staging with radioisotope scans and bone marrow biopsies, a study of calcitonin and histaminase as biochemical markers was performed. The BCVP chemotherapy resulted in a complete and partial response rate of 53% when given alone or in conjunction with radiotherapy. The survival data are preliminary, but the complete responders do have a statistically significant better survival (mean of + -95 days) than the partial responders and nonresponders. Hypercalcitonemia was not detected in our patients, but elevated histaminase activity was found in eight of 24 patients with small cell carcinoma and in only one of 19 patients with squamous and large cell carcinoma.

Adult↗
PubMed1976

Amphotericin B plus 1,3-bis (2-chloroethyl)-1-nitrosourea (BCNU-NSC no. 409962) in advanced cancer. Phase I and preliminary phase II results.

Twenty-one patients with advanced metastatic cancer received amphotericin B (AmB) plus BNUC in a Phase I chemotherapy trial. Of 11 patients with measurable metastases from bronchogenic carcinoma, five had partial antitumor responses lasting 1.5 to 12+ months, and one had objective improvement. Only two of six patients with other types of tumors had objective improvement of short duration. No consistent evidence of immunologic stimulation was observed in eight patients studied. These results suggest that amphotericin B may increase the therapeutic ratio of BCNU, and further trials of this new concept in chemotherapy of advanced tumors are in progress. The dose-limiting toxicity was myelosuppression, usually thrombocytopenia. No enhancement of BCNU toxicity by the addition of AmB was observed. The recommended dose for future studies is: AmB, 7.5 mg/m2 on day 1, 15 mg/m2 on day 1, 30 mg/m2 on days 3 and 4; plus BCNU, 250 mg/m3 on day 4. The regimen is repeated every 6 to 8 weeks.

Amphotericin B↗
PubMed1977

Combination chemotherapy with bis chloroethyl nitrosourea (BCNU), vincristine and dimethyl triazeno imidazole carboxamide (DTIC) in disseminated malignant melanoma.

One hundred thirty two patients with disseminated malignant melanoma were treated using a combination of BCNU, vincristine and imidazole carboxamide. A response rate of 23% was observed, while 16% had stable disease. The patients' median survival was 42 months from diagnosis and 5.3 months from the onset of treatment. These results are not significantly different from therapy with imidazole carboxamide alone. Patients on this study were observed to have a significant reduction in the number of lymphocytes in their peripheral blood (mean 1800/mm3, median 1550/mm3). Patients with lymphopenia prior to the onset of therapy (86%) had a similar response rate but a shorter median survival (4.4 months vs. 7.8 months, P = .03) than patients with normal lymphocyte levels. These findings are compatible with recent observations on the importance of host immunocompetence in patients with malignant melanoma. Eosinophil levels were not closely correlated with response, although among patients with eosinophil counts of greater than 300/mm3 (22%), a slightly higher response rate (29%) was observed (P = .13). Eosinophilia did not influence patient survival.

Carmustine↗
PubMed1977

Combination chemotherapy of malignant melanoma with imidazole carboxamide, BCNU and vincristine.

Forty patients with disseminated malignant melanoma were treated with triple combination chemotherapy consisting of Imidazole Carboxamide, BCNU and Vincristine. Seventeen of 40 patients (42.5%) showed significant responses including three complete responses. Responses were seen in cutaneous, lymph node and pulmonary metastases. Nine instances of hepatic metastases were unaffected by therapy but 68% of the skin and nodal patients responded. The median response duration was only 4 months and the median survival of responders was 9.5 months compared to a 2 month median survival of non-responders. Half of the responders died of CNS metastases. The short duration of response, the resistance of hepatic metastasis and the high incidence of cerebral recurrence necessitate additional therapeutic approaches to this disease.

Adult↗
PubMed1977

Bis chloroethyl nitrosourea, vincristine, dimethyl triazeno imidazole carboxamide and chlorpromazine combination chemotherapy in disseminated malignant melanoma.

One hundred twenty-one patients with disseminated malignant melanoma were treated with BCNU, vincristine, DTIC, and chlorpromazine (BVD). A response rate of 22% was observed; 28% of the patients had stable disease and 50% had increasing disease. Similar response rates were obtained with both the high dose and low dose treatment schedules. Patients who exhibited some degree of improvement during their initial course of treatment had the highest overall response rate (72%) to BVD chemotherapy. The median survival from onset of therapy was six months for all patients and 18 months for patients who responded to chemotherapy. The median duration of response was 9.9 months. Thus, the addition of chlorpromazine to BVD chemotherapy did not increase tumor response, and the overall results obtained were comparable to DTIC alone. Patients were found to be lymphopenic prior to the onset of therapy. Their median absolute lymphocyte count was 1800/mm3. Those patients with absolute lymphocyte counts above the 2710/mm3 normal mean had significantly higher response rates (35% vs. 19%, P less than .05) and longer survivals (9.8 months vs. 4.3 months, P less than .05) than patients with lower initial lymphocyte levels. Pretreatment eosinophil and monocyte counts were not closely correlated with patient response or survival.

Carmustine↗