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Results for “Prednisone”

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PubMed2006

Initial treatment of idiopathic nephrotic syndrome in children: prednisone versus prednisone plus cyclosporine A: a prospective, randomized trial.

Previous studies of the Arbeitsgemeinschaft für Pädiatrische Nephrologie in children with steroid-sensitive nephrotic syndrome have shown that the length of initial prednisone therapy has an impact on the subsequent relapse rate. The aim of this randomized, prospective, multicenter study was to reduce the number of relapses further by increasing the initial immunosuppression: Patients with an initial attack of nephrotic syndrome were randomly allocated to treatment with 6 wk of 60 mg/m(2) per d prednisone followed by 6 wk of 40 mg/m(2) per 48 h (Pred group) or to the same prednisone treatment plus 8 wk of cyclosporine (Pred+CsA group). The primary end point was first relapse; follow-up was truncated at 2 yr. In the Pred+CsA group (n = 49 patients), the first relapse occurred later compared with the Pred group (n = 55 patients) (median 22.8 versus 12.5 mo). After 6 mo, 10.4% of patients in the Pred+CsA group experienced a first relapse versus 31.5% in the Pred group (P = 0.01); after 1 yr, 36.5 versus 51% (P = 0.15); and after 2 yr, 51 versus 50%. The mean relapse rate per patient was 0.12 versus 0.57 after 6 mo (P = 0.01), 0.63 versus 1.03 after 1 yr (P = 0.02), and 1.03 versus 2.06 after 2 yr (not significant). The significant benefit for adding CsA was lost after 9 to 12 mo. GFR remained unchanged. The subsequent treatment rate with cyclophosphamide was lower in the CsA group (five versus 12 patients) after 2 yr. With the use of logistic regression statistics, children who were younger than 7 yr show a significantly better sustained remission rate with initial CsA treatment for the 2-yr observation time (P = 0.03). It remains questionable, however, whether the intensified initial treatment with CsA could be recommended generally.

Adolescent↗

PubMed2003

A randomized trial of induction therapy (daunorubicin, vincristine, prednisone versus daunorubicin, vincristine, prednisone, cytarabine and 6-thioguanine) in adult acute lymphoblastic leukemia with long-term follow-up: an Eastern Cooperative Oncology Group Study (E3486).

In this study of previously untreated adult acute lymphocytic leukemia (ALL) performed by the Eastern Cooperative Oncology Group, patients were randomized to induction therapy with either DVP (daunorubicin 45 mg/m2 daily, days 1, 2 and 3; prednisone 60 mg/m2 daily orally days 1-35; and vincristine 2 mg intravenously on days 1, 8, 15 and 22) or DATVP (daunorubicin 60 mg/m2 daily, days 1, 2 and 3; cytarabine 25 mg/m2 intravenous bolus followed by 200 mg/m2 daily as a continuous infusion on days 1-5; 6-thioguanine 100 mg/m2 orally every 12 h on days 1-5; vincristine 2 mg intravenously on days 1 and 8; and prednisone 60 mg/m2/day orally, days 1-7. Complete responders to both regimens received the same post-remission therapy, which consisted of a single course of cytarabine 3 gm/m2 infused over 1 h every 12 h for 12 doses. One month later those patients still in remission received six cycles of consolidation therapy with MACHO (cyclophosphamide 650 mg/m2, doxorubicin 40 mg/m2 vincristine 2mg all intravenously on day 1 with prednisone 100 mg/m2 orally daily on days 1-5. Methotrexate 200 mg/m2 intravenously and L-asparaginase 6000 U/m2 were given on day 22 and each course was given every 5 weeks. A single dose of intrathecal methotrexate was also given with each MACHO course. There were 276 evaluable patients randomized in this study. Complete response rates were 71% for DVP and 58% for DATVP. Median durations of complete response were 5.5 and 6.8 months, respectively. Median survival of all randomized patients was 14.4 months in each group. DATVP was more toxic than DVP. Intensification of treatment for adults with ALL may not improve outcome. Progress in the treatment of adults with ALL will require the identification of new agents for this neoplasm.

Adolescent↗

PubMed1990

Low-dose ciclosporin, prednisone, and azathioprine after initial immunosuppression with ciclosporin and prednisone in a pediatric renal transplant population.

The use of a triple therapy regimen after initial immunosuppression with prednisone and ciclosporin in the pediatric age groups has not been described. Twenty-two patients were switched to low-dose ciclosporin, prednisone, and azathioprine due to toxicity, noncompliance, and long-term ciclosporin treatment. The acute rejection rate was 13.5%; one graft was lost to irreversible rejection. No infections occurred. There was no difference in the frequency of return to dialysis in the group converted to triple therapy when compared to a control group remaining on double therapy with prednisone and ciclosporin. The efficacy and safety of changing immunosuppression in the pediatric age group needs to be confirmed in a prospective, randomized fashion.

Actuarial Analysis↗

PubMed1976

A comparison of cyclophosphamide, vincristine, and prednisone (COP) with nitrogen mustard, vincristine, procarbazine, and prednisone (MOPP) in the treatment of nodular, poorly differentiated, lymphocytic lymphoma.

This study was designed to test the efficacy and toxicity of COP (cyclophosphamide, vincristine, and prednisone) and MOPP (nitrogen mustard, vincristine, prednisone, and procarbazine) in 13 previously untreated patients with disseminated, nodular, poorly differentiated, lymphocytic lymphoma, and to test for patient cross-resistance to the regimens. Complete remission was initially achieved in six of eight patients on COP and three of five on MOPP. Three patients were crossed over to the alternative induction regimen because of progressive disease after an initial partial response; one was crossed over because of toxicity. On crossover, four patients achieved complete remission, two on either regimen. Durations of unmaintained complete remission range from 6-46+ months, with 8/13 still in their first complete remission. Only one patient has died, while in remission, from progressive Kaposi's sarcoma; one was lost to follow-up while in complete remission at 44 months; the others (85%) remain alive 33-54 months from the initiation of chemotherapy. MOPP was significantly more toxic with respect to thrombocytopenia, duration of myelosuppression, and cumulation of toxicity. Because of its more acceptable toxicity, COP is recommended as initial therapy for patients with nodular, poorly differentiated, lymphocytic lymphoma. MOPP or another regimen of non-crossresistant combination chemotherapy would be more appropriate for primary treatment failures.

Adult↗

PubMed1985

Treatment of chronic lymphocytic leukemia in advanced stages. A randomized trial comparing chlorambucil plus prednisone versus cyclophosphamide, vincristine, and prednisone.

Ninety-six patients with advanced chronic lymphocytic leukemia (CLL) (Stage C; anemia and/or thrombocytopenia of nonimmune origin) were randomized to receive either chlorambucil (CLR) (0.4 mg/kg orally, day 6) plus prednisone (PDN) (60 mg/m2 orally, days 1-5) every 2 weeks or cyclophosphamide (600 mg/m2 intravenously, day 6), vincristine (1 mg/m2 intravenously, day 6) and prednisone (60 mg/m2 orally, days 1-5) (COP) each month for 5 months. Complete remission (CR) was defined as the total disappearance of signs and symptoms related to the disease. Partial remission (PR) was considered to be achieved when, after treatment, the clinical stage changed to a less advanced one. Thirty (59%) responses (8% CR) with CLR plus PDN and 14 (31%, 2% CR) with COP were observed (P less than 0.01). The survival was not significantly different for the two groups. Patients previously treated had a lower number of responses (11/35, 31%) than those with no previous treatment (33/61, 54%) (P less than 0.05). Patients who attained a CR or a good PR had longer survivals (median not reached) than those with a poor PR (median, 25.2 months) or those who did not respond to treatment (median, 11.5 months) (P less than 0.005).

Aged↗

PubMed2006

Combined cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) improves response rates but not survival and has lower hematologic toxicity compared with combined mitoxantrone, chlorambucil, and prednisone (MCP) in follicular and mantle cell lymphomas: results of a prospective randomized trial of the German Low-Grade Lymphoma Study Group.

BACKGROUND: In patients with advanced-stage follicular lymphoma (FL) and mantle cell lymphoma (MCL), conventional chemotherapy remains a noncurative approach, and no major improvement in overall survival has been achieved in recent decades. METHODS: The German Low-Grade Lymphoma Study Group performed a randomized trial comparing combined cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) chemotherapy with combined mitoxantrone, chlorambucil, and prednisone (MCP) chemotherapy as first-line therapy for patients with advanced-stage FL or MCL. RESULTS: Three hundred sixty-three patients with advanced-stage FL (n = 277 patients) or MCL (n = 86 patients) entered the trial and were evaluable fully. CHOP resulted in a significantly higher overall response rate in patients with FL (91% vs. 82%; P = .026) and a similar tendency in patients with MCL (87% vs. 73%; P = .080). However, no significant differences were observed in the time to treatment failure or in overall survival. CHOP produced significantly more nonhematologic toxicities, whereas MCP was associated with more severe hematologic side effects. The proportion of patients who successfully underwent peripheral blood stem cell collection was significantly lower after MCP (44% vs. 93% after CHOP; P = .0003). CONCLUSIONS: Taking into account that, currently, chemotherapy regularly is combined with rituximab as first-line therapy for FL and MCL, the data from this study may have an impact on the type of chemotherapy to be applied in such combinations. Particularly in younger, high-risk patients who are candidates for autologous stem cell transplantation, CHOP should be preferred over MCP.

Adult↗

PubMed1977

Cyclophosphamide, vincristine, and prednisone (CVP) versus adriamycin, bleomycin, and prednisone (ABP) in stage IV non-Hodgkin's lymphomas.

In stage IV non-Hodgkin's lymphomas, CVP (cyclophosphamide, vincristine, and prednisone) was randomly compared to ABP (adriamycin, bleomycin, and prednisone). Of 62 patients entered into the study, 57 (CVP 27, ABP 30) were considered evaluable for comparison. In patients with liver and/or marrow involvement a second biopsy was performed to define complete remission (CR). CR occurred in 48% of patients treated with CVP and in 50% of those given ABP. The median duration of CR was 10.5 and 20.5 months, respectively. The difference is not statistically significant. Also, the survival of complete responders was not significantly different between the two treatment groups. After cross-over, secondary treatment with CVP produced an overall response rate of 40% (six of 15), compared to 50% (six of 12) obtained with ABP. In the ABP group, four patients developed a reversible interstitial penumonia. In two other patients, cardiomyopathy (fatal in one) was observed. In conclusion, although complete remission was similar in both groups, cumulative toxicity occurred in few patients given ABP. However, this combination could represent an effective alternative treatment to be used either in CVP failures or sequence with CVP.

Adolescent↗

PubMed1992

A study of toxicity and comparative therapeutic efficacy of vindesine-prednisone vs. vincristine-prednisone in children with acute lymphoblastic leukemia in relapse. A Pediatric Oncology Group study.

Vindesine (des-acetyl Vinblastine) is a synthetic derivative of vinblastine, and was produced with the hope that it would have less neurotoxicity and hematopoietic toxicity than other vinca alkaloids. Phase I and II studies also demonstrated significant activity in lymphoid malignancies, especially Acute Lymphoblastic Leukemia (ALL). The present study was designed to compare therapeutic effectiveness of twice weekly vindesine (2 mg/M2/dose) plus Prednisone (60 mg/M2/dose) (Treatment 1) to weekly Vincristine (2 mg/M2/dose) plus Prednisone (60 mg/M2/day) (Treatment 2). All patients were less than 21 years of age, and had documented bone marrow relapse (blast count > 25%). In 39 patients presumed sensitive to vincristine, there were 11 complete responses out of 20 patients (55%) randomized to receive vindesine/prednisone and 7 complete responses out of 19 patients (37%) treated with Vincristine/Prednisone. In 37 patients resistant to vincristine, there were 7 complete responses (19%). Vindesine was more toxic than Vincristine. Major toxicities of vindesine included paraesthesias, peripheral neuropathy and ileus. Vindesine hematological toxicity appeared greater, but such toxicity is hard to assess in patients with bone marrow disease. In this study, vindesine and vincristine had similar efficacy, but vindesine use was associated with more toxicity.

Adolescent↗

PubMed2006

Treatment of bendamustine and prednisone in patients with newly diagnosed multiple myeloma results in superior complete response rate, prolonged time to treatment failure and improved quality of life compared to treatment with melphalan and prednisone--a randomized phase III study of the East German Study Group of Hematology and Oncology (OSHO).

PURPOSE: This randomized phase III study compared bendamustine and prednisone (BP) to standard melphalan and prednisone (MP) treatment in previously untreated patients with multiple Myeloma (MM). PATIENTS AND METHODS: To be included, patients had to have histologically and cytologically proven stage II with progressive diseases or stage III MM. They were randomly assigned to receive BP (n=68) or MP (n=63). The primary endpoint was the time to treatment failure (TTF). Secondary endpoints included survival, remission rate, toxicity and quality of life. RESULTS: The overall response rate was 75% in the BP and 70% in the MP group. A significantly higher number of patients treated with BP achieved a complete remission than did patients receiving MP (32 vs. 13%; P=0.007), and the maximum response was achieved more rapidly in patients treated with BP compared to those receiving MP (6.8 vs. 8.7 cycles; P<0.02). TTF and remission duration were significantly longer in the BP group. Patients receiving BP had higher QoL scores and reported pain less frequently than patients receiving MP. CONCLUSION: BP is superior to MP with respect to complete remission rate, TTF, cycles needed to achieve maximum remission and quality of life and should be considered the new standard in first-line treatment of MM patients not eligible for transplantation.

Adult↗

PubMed1999

Cyclosporine, methotrexate, and prednisone compared with cyclosporine and prednisone for prevention of acute graft-vs.-host disease: effect on chronic graft-vs.-host disease and long-term survival.

Graft-vs.-host disease (GVHD) is a major predictor of outcome following allogeneic bone marrow transplantation (BMT). For patients alive at day 100 after BMT, the presence or absence of chronic GVHD is one of the most important determinants of survival and quality of life. We wished to determine the effects on chronic GVHD of two regimens used for the prophylaxis of acute GVHD: cyclosporine, methotrexate, and prednisone (CSA/MTX/PSE) and cyclosporine and prednisone (CSA/PSE). One hundred forty-nine evaluable patients were entered into the acute GVHD study. As of 31 March 1997, 63 months after the last patient underwent BMT, the median survival time was 4.5 years (range 0.09-9.9). The incidence of chronic GVHD was independent of the prophylactic regimen (55 vs. 54%), and extensive chronic GVHD occurred in 25 and 24% of patients receiving CSA/MTX/PSE and CSA/PSE, respectively. Of note, the median Karnofsky performance status of both groups was 100% (range 70-100%), reflecting the low incidence of extensive chronic GVHD. Survival rates free of chronic GVHD were 52 vs. 42% (p = 0.29) for patients receiving CSA/MTX/PSE vs. CSA/PSE. The incidence of relapse was also similar in both groups of patients. These data suggest that the combinations of CSA/MTX/PSE and CSA/PSE result in comparable chronic GVHD-free survival without an increase in leukemic relapse.

Acute Disease↗

PubMed1996

Effect of interferon on the health-related quality of life of multiple myeloma patients: results of a Nordic randomized trial comparing melphalan-prednisone to melphalan-prednisone + alpha-interferon. The Nordic Myeloma Study Group.

In a Nordic multi-centre trial, 583 previously untreated multiple myeloma patients were randomized to receive melphalan-prednisone or melphalan-prednisone+ interferon alpha-2b at a dose of 5 million units subcutaneously, 3 d/week. A quality-of-life study was integrated into the trial, using the EORTC QLQ C-30 questionnaire supplemented with 11 questions concerning interferon toxicity. The questionnaire was completed prior to treatment and after 1, 6, 12, 24, 36 and 48 months. 90% of the patients participated in the quality-of-life study, and 83% completed all questionnaires submitted to them. During the first year of treatment the patients on interferon reported significantly more fever, chills, dry skin, fatigue, pain, nausea/vomiting and appetite loss than the control patients. There was a moderate reduction of the global quality-of-life score and slight, non-significant, reductions of physical, emotional, cognitive, social and role functioning scores. After the first year there were no statistically significant differences in any toxicity, symptom or quality-of-life score, except for an increased frequency of dizziness in the interferon group. As only 60% of the patients remained on interferon after 24 months, our data probably underestimate the potential toxicity of the drug. Although there was no significant survival benefit for the interferon patients, a 5-6 months prolongation of the response and plateau phase duration was observed. However, by intention-to-treat analysis, there was no late quality-of-life benefit for the interferon patients to compensate for the early impairment. Thus, the clinical significance of the plateau-phase prolongation is uncertain.

Activities of Daily Living↗

PubMed2001

Randomized clinical trial of thalidomide, cyclosporine, and prednisone versus cyclosporine and prednisone as initial therapy for chronic graft-versus-host disease.

Chronic graft-versus-host disease (CGVHD) is a major cause of morbidity following allogeneic bone marrow transplantation. Thalidomide is active in salvage therapy for high-risk or resistant CGVHD. In a prospective randomized trial, we tested initial therapy with thalidomide. Patients with extensive CGVHD were randomized to receive either cyclosporine and alternate-day prednisone (n = 27, no-thalidomide [no-thal] group) or cyclosporine, prednisone, and thalidomide (200-800 mg/day; n = 27, thal group). Although most patients responded, initial therapy with thalidomide did not improve control of CGVHD. Response rates were 83% versus 89% at 2 months (P = .7), 88% versus 84% at 6 months (P > .8) and 85% versus 73% at 1 year (P = .5) in the thal and no-thal groups, respectively. Multivariate analysis revealed related donor transplant (odds ratio [OR] = 11.3; P =.03) and de novo or quiescent onset of CGVHD (OR = 7.7; P =.04) to be significant predictors of good early response, whereas a platelet count of > or =100,000/microL was a significant predictor of good response (OR = 10.4; P =.04) at 1 year. Survival for the thal and no-thal groups was similar at 1 year (66% versus 74%) and 2 years (66% versus 54%, P = .85). Multivariate analysis revealed progressive onset CGVHD (relative risk [RR] = 4.2; P =.01), unrelated donor (RR = 5.7; P < .01), sex mismatch (RR = 7.9; P < .01), and platelet counts of <100,000/microL (RR = 3.8; P = .01) as significant predictors of poorer survival. These data suggest that despite a high response rate (79% response and 53% complete response) and encouraging survival rates (70% at 1 year and 60% at 2 years), thalidomide offers no clinical benefit when incorporated into initial therapy for CGVHD. The value of thalidomide as salvage therapy requires further study.

Bone Marrow Transplantation↗

PubMed1984

Evidence for the superiority of immunosuppressive drugs and prednisone over prednisone alone in lupus nephritis. Results of a pooled analysis.

In an effort to clarify the role of immunosuppressive drugs in the management of lupus nephritis, we pooled data from all published clinical trials in which patients had been randomly assigned to receive either prednisone alone or prednisone plus cyclophosphamide or azathioprine. The pooled analysis showed that patients receiving immunosuppressive drugs had less renal deterioration (P = 0.006), were less likely to have end-stage renal disease (P = 0.023), and were less likely to die from kidney disease (P = 0.024) than patients receiving steroids alone. There were no significant differences with respect to deaths from nonrenal causes or overall mortality. When cyclophosphamide and azathioprine were considered separately, both were associated with a 40 per cent reduction in the rates of adverse renal outcomes, although because the treatment groups were smaller, many of these differences were not statistically significant. A power analysis showed that a study of 100 high-risk patients (development of renal insufficiency in 50 per cent) would be needed to prove that an immunosuppressive agent is 50 per cent superior to steroids alone in preventing renal deterioration. We conclude that immunosuppressive drugs and steroids together are more effective than steroids alone in treating lupus nephritis and that published trials have reached false negative conclusions because of small sample sizes.

Azathioprine↗

PubMed1999

Alternating combination chemotherapy COP (cyclophosphamide, vincristine, prednisone) and MP (melphalan, prednisone) in multiple myeloma: a multicenter phase II study (JCOG8906). Lymphoma Study Group of the Japan Clinical Oncology Group.

BACKGROUND: The main form of cytotoxic treatment for multiple myeloma (MM) is conventional dose chemotherapy at present. METHOD: Between November 1989 and December 1991, a multicenter phase II study of alternating conventional dose combination chemotherapy (CCT) with COP (cyclophosphamide, vincristine, prednisone) and MP (melphalan and prednisone) to evaluate its clinical usefulness for overt MM patients was conducted by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG). RESULTS: Eighty-one previously untreated patients were enrolled in the study. For 69 eligible patients, the response rate was 50.7% [95% confidence interval (CI) 38.4-63.0%]. The median survival time was 38.5 (95% CI 32.0-44.4) months. The survival rate at 3 and 5 years was 50.7 and 27.3%, respectively. Grade 4 toxicity by the criteria of the World Health Organization consisted of anemia in eight patients, leucocytopenia in three, cardiac in one and hepatic in two, but there was no treatment-related death. CONCLUSION: The COP-MP regimen for overt MM is thought to be one of the effective CCTs according to the results of the present phase II study.

Adult↗

PubMed1991

A randomized trial of cyclophosphamide, doxorubicin, and prednisone versus cyclophosphamide, 5-fluorouracil, and prednisone in patients with metastatic breast cancer.

Ninety-four patients were entered in a clinical trial assessing the clinical activity of cyclophosphamide, doxorubicin, and prednisone (CAP) versus a combination of cyclophosphamide. 5-Fluorouracil, and prednisone (CFP) in patients with advanced breast cancer. Objective response rates were comparable, 49% for CFP and 46% for CAP. There was no statistical difference between the duration of response of the two regimens or in time to progression. Most importantly, survival differences were not apparent. Both regimens were clinically tolerable and toxicities, for the most part, were comparable. Thus, no therapeutic advantage existed for either of these polychemotherapy regimens in patients with advanced breast cancer.

Adult↗

PubMed1990

A prospective randomized trial of prednisone versus no prednisone maintenance therapy in cyclosporine-treated and azathioprine-treated renal transplant patients.

The purpose of this study was to evaluate early (6-12 days) prednisone withdrawal in cyclosporine- and azathioprine-treated renal transplant recipients. Patients, including 8 recipients of live-related donor kidneys and 59 recipients of cadaver donor kidneys, were prospectively randomized to receive maintenance prednisone (PRED) therapy or not (NOPRED) in addition to antilymphocyte globulin, cyclosporine, and azathioprine. Rejection episodes were initially treated with methylprednisolone pulses, and OKT3 monoclonal antibody was used to treat steroid resistant rejections that were verified by biopsy. NOPRED patients were declared protocol failures and returned to PRED therapy if they sustained 2 steroid-sensitive rejection episodes in the first 3 months or an OKT3-treated rejection at any time. Patient and graft survival for the LRD patients in both treatment categories were 100% at 12 months. Patient and graft survival for CAD recipients at one year was 94% and 83% (PRED) and 88% and 77% (NOPRED), respectively. Rejection episodes were more frequent (26 of 32 NOPRED patients vs. 19 of 35 PRED patients P = 0.02) and occurred earlier (4.5 weeks in NOPRED vs. 7.7 weeks in PRED patients) in patients not taking maintenance steroids. Rejection severity was also greater in the NOPRED group, as 15 OKT3-treated rejections occurred in that group whereas only 7 OKT3-treated rejections were observed in the PRED group (P = less than 0.01). The incidence of serious infection was similar in each group. Finally, protocol failure occurred in 40% of the LRD patients and 59% of the CAD patients. These data indicate that initiating maintenance therapy without PRED is safe but is attended by a greater risk of developing rejection. Because of this increased incidence and severity of early rejection episodes in NOPRED patients, we do not advise use of this immunosuppressive strategy in renal transplantation.

Azathioprine↗

PubMed1986

Ciclosporin and prednisone v. prednisone in treatment of Graves' ophthalmopathy: a controlled, randomized and prospective study.

Forty patients with Graves' ophthalmopathy stages III-V were divided into two groups in a random manner according to their year of birth. Group I received prednisone in decreasing dosage. Group II received prednisone at a comparable dosage and ciclosporin. Steroids were discontinued after 10 weeks in the two groups. In the patients of group II, ciclosporin was continued over 12 months. The therapeutic effect was assessed by an activity score based on subjective and objective symptoms (computerized tomography and sonography of the orbit, Hertel values, clinical findings). All signs of endocrine ophthalmopathy improved significantly in both groups (P less than 0.01 in group I; P less than 0.001 in group II). The improvement was significantly greater in group II (P less than 0.05) according to the predefined score. After corticosteroids were discontinued, inflammatory signs recurred in nine patients in group I and in one of group II. During the observation period of 12 months, relapses occurred in eight out of twenty patients in group I and in only one out of twenty in group II. Muscle thickness decreased in nine patients in group II, 6 months after beginning therapy. At this time, the results were not influenced in any of the twenty patients in group I. Microsomal antibodies decreased significantly (P less than 0.001) in the ciclosporin group, whereas no change was seen in the other group. Renal values rose within the normal range in group II. In this group, an infection with Klebsiella pneumoniae occurred in one patient after 4 months of therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1990

Phase III trial of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) versus cisplatin, etoposide, bleomycin and prednisone (CisEBP) for the treatment of advanced non-Hodgkin's lymphoma of high grade malignancy. The Danish Lymphoma Study Group.

The trial included 85 previously untreated patients (median age 61 years) with stage III or IV non-Hodgkin's lymphoma (NHL) of the subtypes centrocytic lymphoma, diffuse centroblastic lymphoma, immunocytoma, immunoblastic lymphoma, or unclassified lymphoma of high grade malignancy. The patients were randomized to 9 monthly treatment cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or CisEBP (cisplatin, bleomycin, etoposide, prednisone). Patients who had failed to achieve even a partial response (PR) after the completion of 2 cycles were switched to the alternative regimen. Complete response (CR) on primary treatment was obtained in 70% (55-83%) of CHOP-treated patients and in 25% (13-41%) of CisEBP-treated patients (p = 0.0004). Secondary CHOP treatment produced CR in 7 (30%) of 24 patients and secondary CisEBP treatment led to CR in 2 (15%) of 14 patients. The median survival was 3.4 years in the CHOP arm and 2.6 years in the CisEBP arm (p = 0.78). Hematologic toxicity was mainly leukocytopenia and anemia in both treatment arms. Non-hematological toxicity was slight, and late toxicity was insignificant. Three treatment-related deaths were noted. We conclude that CHOP induces more remissions than CisEBP in advanced lymphomas of high grade malignancy.

Adult↗