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PubMed1991

Thoracic radiation therapy alone compared with combined chemoradiotherapy for locally unresectable non-small cell lung cancer. A randomized, phase III trial.

OBJECTIVE: To compare the survival of patients with medically inoperable or unresectable stage III non-small cell lung cancer treated with thoracic radiotherapy alone or in combination with chemotherapy. DESIGN: Randomized, prospective phase III trial. SETTING: Multi-institutional cooperative oncology group. PATIENTS: A total of 121 patients were enrolled in the study, of whom 7 (5.8%) were ineligible. All patients were ambulatory and had measurable or evaluable disease. Before they were randomized, patients were stratified by ECOG performance score, histologic type, maximum tumor diameter, and NCCTG institution. INTERVENTIONS: Radiotherapy consisted of a total of 5000 cGy in 5 weeks with a 1000 cGy boost in 5 fractions to a small tumor field. Combined modality therapy was MACC which is intravenous methotrexate, intravenous doxorubicin, intravenous cyclophosphamide, and oral lomustine (CCNU), on day 1 and 28. Chemotherapy was followed by identical thoracic radiotherapy 4 weeks after the second cycle of chemotherapy. Four weeks after thoracic radiotherapy was completed, patients received another two cycles of identical chemotherapy. Patients who had progression of disease after chest irradiation only were treated with MACC chemotherapy. MAIN RESULTS: Major clinical responses were observed in 31 of 56 (55%; 95% Cl, 42% to 68%) patients treated with combination therapy and 37 of 58 (64%; Cl, 51% to 76%) treated with radiation only (P greater than 0.2). The median time to progression was 192 days with radiotherapy only compared with 199 days for combined modality therapy (P greater than 0.2). The median survival time was 313 days compared with 317 days, respectively (P greater than 0.2). The 1-, 2-, and 5-year survival rates after thoracic radiation only were 45% (Cl, 32% to 58%), 16% (Cl, 6% to 25%), and 7%. With chemoradiotherapy, the survival rates were 46% (Cl, 33% to 60%), 21% (Cl, 11% to 32%), and 5%, respectively. Myelosuppression was significantly greater for the combined modality therapy arm (P = 0.002). CONCLUSION: Chemotherapy with MACC, in combination with thoracic radiotherapy, did not result in significant survival advantage compared with radiation alone (P greater than 0.2) in patients with medically inoperable or unresectable stage III non-small cell lung cancer.

Adult↗
PubMed2000

Interleukin-2 plus chemotherapy for patients with metastatic melanoma.

We studied the activity of recombinant interleukin-2 (IL2) in combination with multiagent chemotherapy in the treatment of patients with disseminated malignant melanoma. Patients were randomized to receive the same dose of lymphokine by constant 24 h intravenous infusion (CI) or by subcutaneous bolus (SB) injection. Twenty-two patients, 18 males and four females with a median age of 44 years (range 32-73 years) were randomized to receive IL2 5 million units/m2 once daily by SB injection or by CI, 5 days/week for 2 weeks. All patients received a chemotherapy regimen consisting of lomustine (CCNU) 75 mg/m2 on day 14, bleomycin 10 units/day by CI for 5 days (days 14-19) and cisplatin 75 mg/m2 on day 19. Patients were retreated after a 3 week interval. There were four complete responses and one partial response in the CI arm and two partial responses in the SB arm. The median duration of response was 38 weeks (range 26-107 weeks). The median duration of survival was 6.7 months in non-responders and 11.1 months in responders. The overall response rate was 32%. Since responses were brief and all the responding patients progressed after a median of 38 weeks, the study was terminated before accrual goals were met.

Adult↗
PubMed2000

Adjuvant chemotherapy following radical surgery for non-small-cell lung cancer: a randomized study on 70 patients.

OBJECTIVE: To evaluate the efficacy of adjuvant chemotherapy after radical surgery for non-small-cell lung cancer (NSCLC). METHODS: Seventy patients with NSCLC (stages I-III) undergoing radical surgery were randomized into two groups. Group 1 (n = 35): combination group, which received adjuvant chemotherapy with cyclophosphamide 300 mg/m2, vincristine 1.4 mg/m2, adriamycin 50 mg/m2, and lomustine 50 mg/m2 on day 1, and cisplatin 20 mg/m2 on days 1-5. The treatment was repeated every 4-6 weeks for 4 cycles, followed by oral administration of ftorafur (FT-207) 600-900 mg/d for 1 year. Group 2 (n = 35): surgery group, which received surgical treatment only. RESULTS: The overall 5-year survival rate was 48.6% in the combination group versus 31.4% in the surgery group, and difference between the two groups was not statistically significant (chi 2 = 3.09, P > 0.05). The 5-year survival rate for patients with stage III disease was 44% and 20.8% in the combination and surgery groups, respectively, showing a statistically significant difference (chi 2 = 5.28, P < 0.025). The 5-year survival rates of patients in stages I-II in the two groups were 60.0% and 54.5%, respectively, and were not significantly different (chi 2 = 0.03, P > 0.75). CONCLUSION: Postoperative adjuvant chemotherapy provides statistically significant improvement in the 5-year survival rate only in patients with stage III NSCLC.

Adult↗
PubMed2002

Evaluation of naphthal-NU, a 2-chloroethylnitrosourea derivative of naphthalimide, as a mixed-function anticancer agent.

Naphthal-NU, 2-[2-[3-(2-chloroethyl)-3-nitrosoureido]ethyl]-1H-benz[de]isoquinoline-1,3-dione (Compound 1) has been synthesized as a rationally designed new mixed-function anticancer agent from 1,8-naphthalic anhydride. Its chemical alkylating activity compared with CCNU as standard compound indicated that it possesses greater alkylating activity than the latter. Its antitumour efficacy was assessed in vivo in two murine ascites tumours namely Sarcoma-180 (S-180) and Ehrlich ascites carcinoma (EAC) by measuring the increase in median survival times (MST) of drug treated (T) over untreated control (C) mice. Three clinical drugs namely CCNU (lomustine), endoxan (cyclophosphamide) and 5-fluorouracil (5-FU) were used as positive controls for comparison. Compound 1 has displayed excellent and reproducible antitumoural activity having curative effects in these tumours comparable with CCNU and 5-FU. It has also significantly increased the life span of mice bearing highly advanced tumour for 10 days before the drug challenge. Its toxicity was also assessed in vivo in normal and in S-180 bearing mice by measuring drug-induced changes in hematological parameters, femoral bone marrow and splenic cellularity sequentially on days 9, 15 and 21 following drug treatment at the optimum dose of 50 mg/kg from day 1 to 7. The results indicated that the compound did not adversely affect hematopoiesis. Drug-induced hepatotoxicity and nephrotoxicity were also evaluated at its optimum dose on those days but no such toxicities were detected. It was further screened in vitro in 6 different human tumour cell lines but no significant activity was observed in those lines.

Animals↗
PubMed1992

[Early results of the treatment of Hodgkin's disease in adults using the seven-drug cytostatic protocol].

65 adult patients with Hodgkin's disease were treated acc. to multidrug protocol proposed by I. Koza et al. including doxorubicin, vincristine, vinblastine, bleomycin, procarbazine, lomustine and prednisone. 4 drugs (3 cytostatics and prednisone) including cycles were given repeatedly every 4 weeks. In the group of first line therapy (39 persons) 61.5% CR and 23% PR was obtained i.e. 84.5% therapeutic responses. The protocol used as salvage therapy resulted in 30% CR and 23% PR. Undesirable gastrointestinal effects were observed less commonly than after ABVD and CVPP schemes but myelosuppressive effect was more often seen and required attenuation of cytostatic drugs doses in the further cycles of therapy. The considered protocol seems to be a valuable one approaching to -but not achieving- the results of MOPP and ABVD schemes: is better tolerated because of elimination of strong emetic cytostatics (chlormethine and decarbazine) but late toxicity could be evaluable only after several years.

Adolescent↗
PubMed1990

Hodgkin's disease in children: correlation of clinical characteristics, staging procedures, and treatment at the University of Minnesota.

The cases of 63 children treated for Hodgkin's disease were retrospectively evaluated according to clinical and laboratory characteristics at initial appearance, clinical and pathologic staging, and treatment for their effects on survival and disease-free survival. An initial erythrocyte sedimentation rate over 50 mm/h was common in patients who ultimately had a relapse. There was no correlation between the size of the mediastinal mass at diagnosis and occurrence of relapse. A residual mediastinal mass was found in 22% of patients after 1 year of treatment regardless of its size at initial appearance. With a median follow-up time of 10.5 years, the overall survival rate is 89%, and disease-free survival rate is 71%. The disease-free survival rates for patients with stages I-IV disease are 92, 81, 78, and 40%, respectively. Relapses occurred in 7 of 22 (36%) patients with positive staging laparotomy despite radiotherapy for three with stage IA and IIA disease, chemotherapy alone for two with stage IIIB disease, or chemotherapy for one with stage IIIB and one with stage IVB disease. Of patients who had no evidence of abdominal Hodgkin's disease at a staging laparotomy, 6 of 34 (19%) had a relapse. These included one with stage IA and five stage IIA disease, all treated with radiotherapy alone. Treatment of stage III and IV disease with regimens including CCNU (lomustine) or cyclophosphamide, plus vinblastine sulfate or vincristine sulfate, prednisone, and procarbazine hydrochloride with or without radiation therapy yielded poor results, with 6/7 having a relapse.

Adolescent↗
PubMed1991

Comparison of two non-cross-resistant combinations (ABVP/LOPP) with COPP plus bleomycin in the treatment of advanced Hodgkin's disease.

Eighty patients with advanced Hodgkin's disease were randomized either to treatment with combination of doxorubicin, bleomycin, vinblastine, and prednisone (ABVP), alternating with lomustine, vincristine, procarbazine, and prednisone (LOPP)--Group A, or to combination of cyclophosphamide, vincristine, procarbazine, prednisone, and low dose of bleomycin (COPP-Bleo)--Group B. Thirty-nine out of 41 patients (95%) in Group A achieved complete remission (CR) as compared to 25 CR in 39 patients (64%) in Group B. Patients with systemic symptoms, bulky disease, and nodular sclerosis achieved significantly more CR after treatment with ABVP/LOPP regimen than with COPP-Bleo regimen. Ninety percent of patients are alive in Group A (median observation time 97+ months) as compared to 58% in Group B (median observation time 97+ months). Ninety-two percent of complete responders are in CR in Group A as compared to 53% of complete responders in Group B. These differences between both groups are significant. More serious (WHO grade III and IV) myelosuppression as well as stomatitis and alopecia were observed in Group A. Gastrointestinal toxicity and neurotoxicity was more frequent in Group A. No patient died due to toxicity in Group A as compared to one patient in Group B. Non-cross-resistant alternating regimen ABVP/LOPP was more effective in the treatment of advanced Hodgkin's disease than the COPP-Bleo regimen, especially for patients with advanced Stage IVB Hodgkin's disease.

Adolescent↗
PubMed1992

Combination chemotherapy MOCCA in resistant and relapsing multiple myeloma. Finnish Leukaemia Group.

80 patients with resistant or relapsing multiple myeloma received a combination of vincristine, cyclophosphamide, lomustine, melphalan and methylprednisolone (MOCCA) as a second-line chemotherapy. 27 of them were resistant to primary chemotherapy with alkylating agents, and 53 had relapsed after initially responding to these drugs. An objective response was achieved in 39 patients (49%): in 14 patients who were primarily resistant (52%) and in 25 patients who had a relapse (47%). Of 41 patients relapsing during maintenance chemotherapy 14 (34%) responded, while 11 of 12 patients (92%) treated for a relapse off-therapy responded. The median duration of response was 22 months. Severe complications, in most cases infections, occurred in 30% of patients, and were fatal in 9% of the cases. According to our experience the five-drug combination MOCCA is an effective second-line chemotherapy for myeloma patients primarily resistant to or relapsing after therapy with single alkylating agents.

Aged↗
PubMed1976

Superior vena caval obstruction due to small-cell anaplastic lung carcinoma. Response to chemotherapy.

Among 38 patients with bronchogenic carcinoma, small-cell type, eight patients had superior vena caval obstruction (SVCO) of recent onset. Seven of these patients were initially treated with combination chemotherapy (lomustine, cyclophosphamide, and methotrexate). One patient who had SVCO was treated initially by radiotherapy, with subsequent chemotherapy. In each patient, resolution of the syndrome was prompt, usually was complete by seven days, and was accompanied by objective tumor shrinkage. Symptoms of SVCO were transiently aggravated by the initiation of treatment in only one patient. In one individual treated by chemotherapy alone and in one treated by chemotherapy plus radiotherapy, SVCO recurred after initial control. Chemotherapy is an effective form of management of SVCO caused by small-cell carcinoma of the lung.

Carcinoma, Bronchogenic↗
PubMedDate not supplied

Lonidamine in the combined treatment of malignant gliomas. A randomized study.

Lonidamine (LND) is a drug that interferes with energy metabolism of cancer cells, principally inhibiting aerobic glycolytic activity, by its effect on mitochondrially-bound hexokinase (HK). In such way LND could impair energy-requiring processes, as recovery from potentially lethal damage, induced by radiation treatment and by some cytotoxic drugs. A randomized study started in November 1983, to evaluate the efficacy of LND in association with radiotherapy as first line treatment in malignant gliomas, after surgical procedure. LND was also used in association with Lomustine (CCNU) at the moment of documented clinical and neuroradiological recurrence. At the present time 60 patients entered the study, and 47 are evaluable. Present preliminary results are not statistically significant, however indicate that LND tends to prolong the median survival time and the rate of one year survivors.

Adult↗
PubMed1990

[Experiences with a new second-line protocol in the treatment of pretreated and advanced Hodgkin disease].

Between 1983 and 1987, we treated 16 patients with Hodgkin's disease, according to a post-COPP and a post-ABVD protocol, respectively. All patients had received previous treatment, including megavoltage cobalt radiotherapy, and were in advanced stages of disease, mostly with immunosuppression/immune deficiency. The protocol of lomustine, etoposide, adriamycin, methotrexate and prednisolone was commenced after the above therapy had failed or was not tolerated. Compared to the previously used chemotherapy, the 3 new cytotoxic agents were well tolerated. A complete remission was obtained in 4 patients and a partial remission in 9. In 2 patients, there was a temporary partial remission only. In more than half the patients, a positive effect on the clinical course was recorded. Viewed as a whole, a favourable objective and subjective result ensued. This LEAMP second-line protocol was found to be effective and well tolerated.

Adolescent↗
PubMed1986

CCNU, etoposide, and prednimustine (CEP) in refractory Hodgkin's disease.

Starting in February 1980, 58 patients with Hodgkin's disease refractory to both MOPP and ABVD received as third-line chemotherapy a combination of CCNU or lomustine, etoposide, and prednimustine (CEP). Complete response (CR) was achieved in 40% of cases and partial response (PR) in 14%. The median duration of CR was greater than 15 months, and the median survival of complete responders was longer than 24 months. In addition, CEP alternating with ABVD was given to 21 patients refractory to MOPP chemotherapy. In this series, CR was documented in 67% of patients with a median duration of 24+ months and a median survival of 36+ months. Treatment was generally well tolerated, and all acute side effects were reversible. Present findings indicate that CEP is an effective regimen in patients refractory to MOPP and ABVD.

Antineoplastic Combined Chemotherapy Protocols↗
PubMedDate not supplied

Third-line chemotherapy with CAVP (CCNU, melphalan, etoposide and prednisone) in refractory Hodgkin's disease.

Thirty-one patients affected by recurrent Hodgkin's disease have been treated with an oral combination chemotherapy including lomustine (CCNU 90 mg/sqm, on day 1), melphalan (Alkeran, 7.5 mg/sqm on days 1-5), etoposide (VP-16, 100 mg/sqm on days 6-10) and prednisone (40 mg/sqm on days 1-10). MOPP and ABVD regimens administered sequentially or in alternating fashion had been employed as first choice treatment. The majority of patients had extranodal (80%) and a progressive disease resistant to previous chemotherapy (80%). Complete and partial remission were induced in 8 (26%) and 5 patients (16%), respectively, with an overall response rate of 42%. Median duration of complete remission was 10 months. Patients who did not respond to previous chemotherapies had a significantly lower complete response rate (16%). Myelosuppression was the most frequent complication, with one patient dying of a thrombocytopenic hemorrhage. The oral administration of drugs allowed good patients', compliance with treatment. CAVP is an effective regimen in the management of patients with refractory Hodgkin's disease and the results obtained are comparable with other third-line chemotherapies.

Adolescent↗
PubMed1987

Changes in pulmonary surfactant composition following MACC chemotherapy for lung carcinoma.

Many antineoplastic drugs can derange lung structures, cause necrosis of type I pneumocytes, abnormal proliferation of type II alveolar epithelial cells, and, occasionally, accumulation of inflammatory and immune effector cells. Since type II cells secrete lung surfactant, treatment may alter surfactant composition. In 8 patients with nonresectable lung cancer, we performed bronchoalveolar lavage before and after MACC polychemotherapy (methotrexate, doxorubicin HCl, cyclophosphamide and lomustine). Before treatment, cellular composition and the phospholipid and fatty acid constituents of lavage surfactant were similar to those found in control subjects. After MACC polychemotherapy there was, in all patients, a mild decrease in the number of immune effector cells, without changes in the relative proportion of cell types. In addition, MACC therapy resulted in a significant decrease of phosphatidylcholine levels, and increased levels of phosphatidylglycerol, whereas the levels of palmitic lavage surfactant were decreased. These MACC treatment abnormalities of the phospholipid and fatty acid composition of lung surfactant may reflect preclinical pulmonary toxicity. The decrease in the numbers of bronchoalveolar cells suggests that the changes in surfactant composition may be chemically induced rather than immune mediated.

Adult↗
PubMed1988

Survival analysis of patients with small cell lung cancer.

The effects of different chemotherapy protocols on survival were evaluated in 197 small cell lung cancer patients followed-up between 1974 and 1987 in our unit. Of these, 170 patients had Stage IV disease and 24 had Stage III disease. Thoracic radiotherapy was given to 73 patients of whom 63 had Stage IV disease. Cytotoxic chemotherapy was given in four main protocols consisting of cyclophosphamide (CYC): CYC + vincristine (VCR); CYC + VCR + adriamycin (ADM) and CYC + VCR + ADM + lomustine (CCNU). The latter protocol was associated with the highest survival rates and differed significantly (p less than 0.05) from the others. In patients with extensive disease, both radiotherapy to the primary site and adjuvant immunomodulation in conjunction with the above chemotherapy regimens lacked any beneficial effect on survival.

Adult↗
PubMed1985

Combined-modality treatment of inoperable lung cancer (i.v. immunotherapy, chemotherapy, and radiotherapy).

Patients with inoperable non-small cell carcinoma of the bronchus were treated by iv methanol extraction residue of bacillus Calmette-Guérin (MER) followed by combination chemotherapy with methotrexate, doxorubicin, cyclophosphamide, and lomustine (MACC). Radiotherapy was added in patients with localized disease. MER was given iv in four weekly courses. The dose ranged between 0.1 and 0.8 mg/m2/course and was determined according to the skin reactivity to MER. None of the 19 patients treated with iv MER had an objective tumor response during immunotherapy. Five of 16 evaluable patients receiving MACC (31%) achieved partial response. The overall median survival for all 17 patients treated was 11 months according to the protocol. During immunotherapy the following side effects were observed: all patients had fever and chills and most had malaise, nausea and/or vomiting, and headache. Transient abnormalities of liver function tests were found in six patients, and in one patient roentgenographic changes suggestive of lung granulomas were seen. The side effects were more severe during the first course than in the further treatments. Side effects of the MACC combination were comparable to those observed in previously reported studies. Immunological monitoring performed during immunotherapy revealed that iv MER had an unfavorable effect on the immune system. Following four courses there was a decrease in the in vivo skin reactivity to MER and to five recall antigens. Twenty-four hours after the initiation of iv MER there was a tendency for decrease in the lymphoproliferation to phytohemagglutinin, an increase in the indices of the adherent cell suppressor system and the prostaglandin-related suppressor system, and an increase in the percentage of adherent mononuclear cells. No consistent changes in serum lysozyme were found. A transient increase in the total number of peripheral blood leukocytes and a decrease in the number of lymphocytes were noticed 24 hours after iv MER. Taking into account the results of the immunological studies and the overall therapeutic results, we do not feel justified in continuing to use this combined modality treatment.

Adenocarcinoma↗
PubMed1986

Cure rates in small cell and non-small cell carcinoma of the lung utilizing high-dose radiotherapy and chemotherapy.

From 1967 to 1977, 72 patients with small cell carcinoma of the lung were seen. Thirty-five of these patients had unilaterally localized lesions (limited disease) and were treated with cobalt 60 radiation therapy (6,000 rad in six weeks) followed by chemotherapy consisting of cyclophosphamide (Cytoxan), vincristine, methotrexate and lomustine (CCNU) (Group A). The remaining 37 patients with extensive disease were treated with similar chemotherapy alone, or in combination with local palliative radiotherapy to the symptomatic area (Group B). For Group A the five-year survival rate was 20 percent, while for both groups combined, it was only 5 percent.During this same period 560 patients with non-small cell carcinomas were treated. The five-year survival rate for those patients with operable, resectable lesions was 33 percent, while for those with unilateral, inoperable, unresectable lesions, it was 10 percent. Thus, it would appear that the results in limited small cell and non-small cell carcinomas of the lung utilizing high-dose radiotherapy followed by chemotherapy are comparable, and that limited small cell carcinoma of the lung patients with high-dose radiotherapy followed by chemotherapy can survive longer than those patients with stage III, non-small cell lung carcinoma.While the two- to five-year survival rates in small cell carcinoma demonstrate no appreciable differences, in non-small cell carcinomas there are significant two- to five-year survival differences. These improved results probably are due to the increased sensitivity of small cell carcinoma to high-dose local radiotherapy and to the chemotherapeutic vulnerability of circulating and microscopic metastatic cancer cells.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1987

Estrogen receptor-binding affinity and cytotoxic activity of three new estrogen-nitrosourea conjugates in human breast cancer cell lines in vitro.

The hypothesis that more selective antitumor activity may be achieved by cytotoxic agents which selectively bind to estrogen receptors (ER) in human cancer cells was tested. We have synthesized three nitrosourea derivatives of estradiol or hexestrol, and compared the ER binding affinity and cytotoxic activity of these compounds against ER-positive and -negative breast cancer cell lines in vitro. Specific binding to ER in the cytosol of MCF-7 human breast cancer cells was demonstrated in these conjugates: 17 alpha-CNU greater than 17 beta-CNU greater than HEX-CNU greater than lomustine (CCNU). The order of cytotoxicity of these derivatives against human breast cancer cells appeared to correlate with their binding affinity to ER. All three estrogen nitrosourea conjugates were more cytotoxic than CCNU, a clinically useful antitumor nitrosourea which does not bind to ER. The contribution of the estrogen moiety to the cytotoxicity of 17 alpha-CNU was demonstrated by the greater activity of the conjugate than that of a combination of estrogen and CCNU. However, cytotoxicity of these compounds against the receptor-positive MCF-7 and receptor-negative Evsa-T human breast cancer cell lines was similar. The latter finding suggested that cytotoxicity of these conjugates may not be mediated through ER. The difference in stability of these nitrosourea conjugates in aqueous buffer may partly explain their differences in cytotoxicity.

Antineoplastic Agents↗