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Cancer Aug 1994The efficacy and toxicity of total body irradiation (TBI) in patients with chronic lymphocytic leukemia (CLL) and low grade non-Hodgkin's lymphomas (NHL) were evaluated. (Clinical Trial)
Clinical Trial
BACKGROUND
The efficacy and toxicity of total body irradiation (TBI) in patients with chronic lymphocytic leukemia (CLL) and low grade non-Hodgkin's lymphomas (NHL) were evaluated.
METHODS
Between January 1984 and September 1992, 81 consecutive patients, 40 affected with CLL and 41 with low grade NHL, with symptomatic Stage III and IV disease, were treated with TBI followed by prednimustine. TBI was given with a 6 MV linear accelerator, applying two opposite alternating fields, including total body, with two fractions of 15 cGy given per week (3-day interval). A total dose of 150 cGy was given over 5 weeks. Six to nine courses of prednimustine (100 mg/m2 orally for 5 consecutive days every 4 weeks) was administered 2 months after TBI treatment as consolidation therapy.
RESULTS
Of 40 patients with CLL, 18 (Group I; median age 58.5 years) were younger than 65 years and 22 (Group II; median age 73 years) were older. The overall response rates were 78% in Group I and 91% in Group II, with a median response time of 16.5 and 16 months, respectively. Hematologic toxicity was 72% in Group I and 73% in Group II. It was reversible in all but one heavily pretreated patient who died of progressive anemia and thrombocytopenia after TBI alone. In the 40 patients with CLL, the response rate was 85%; there were 5 complete responses (CRs) (12.5%) and 29 partial responses (PRs) (72.5%). Of the 41 patients with NHL, 29 (Group I; median age 55 years) were younger than 65 years and 12 (Group II; median age 71.5) were older. The overall response rate in both groups was 83%, with median response times of 18.5+ and 14.5+ months for Groups I and II, respectively. Hematologic toxicity was 59% in Group I, whereas it was 50% in Group II. It was reversible in all patients. Overall, in the 41 patients with symptomatic Stage III and IV low grade NHL, the response rate was 82.8%; there were 10 CRs (24.3%) and 24 PRs (58.5%). The prednimustine regimen was generally well tolerated.
CONCLUSIONS
In our experience, TBI given in a dose of 150 cGy in 10 fractions twice a week, followed by prednimustine, is an effective treatment for patients with CLL and patients with low grade NHL. This treatment also is effective in patients older than 65 years. The toxicity is acceptable, particularly when TBI and prednimustine are given as initial treatment. Pretreated patients should be monitored strictly.
Topics: Age Factors; Aged; Aged, 80 and over; Combined Modality Therapy; Drug Administration Schedule; Humans; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Middle Aged; Prednimustine; Radiotherapy Dosage; Treatment Outcome; Whole-Body Irradiation
PubMed: 8039128
DOI: 10.1002/1097-0142(19940801)74:3<978::aid-cncr2820740330>3.0.co;2-b -
Anti-cancer Drugs Jun 1994Forty patients with invasive bladder tumors were consecutively treated and followed between June 1986 and February 1993. The treatment included systemic chemotherapy... (Clinical Trial)
Clinical Trial
Forty patients with invasive bladder tumors were consecutively treated and followed between June 1986 and February 1993. The treatment included systemic chemotherapy combining cyclophosphamide, epirubicin and cisplatin (CEP) or methotrexate, vinblastine, epirubicin and cisplatin (M-VEP) along with intravesically applied BCG vaccine. The treatment was well tolerated by the patients. No relevant toxic effects requiring hospitalization or fatalities due to the treatment were observed. Toxic manifestations of a hematologic nature were considerably less frequent than usual, nausea and vomiting being among the most frequently observed toxic signs on the second day of application of cisplatin. The side effects resulting from intravesically applied BCG vaccine showed no significant difference in terms of severity and variety from those due to its application in superficial tumors. A median follow-up of 50.3 months (range 6-80 months) showed an objective response to the treatment as follows: complete and partial response in 27 out of 40 (67.5%) and a complete clinical response in eight out of 40 (20%). Ten patients with partial response and stabilization had complete surgical response after operative treatment. The recurrence rate in patients with a complete response and a complete surgical response was 33% (six out of 18). The survival rate was 78% at 1 year, 70% at 2 years and 68% at 4 years. A complete response to the treatment of concomitant carcinoma in situ was observed in three patients. The lack of comparative and randomized studies and insufficient clinical experience did not allow an overall assessment of the therapeutic opportunities that our combined immunochemotherapy offers.(ABSTRACT TRUNCATED AT 250 WORDS)
Topics: Administration, Intravesical; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; BCG Vaccine; Cisplatin; Combined Modality Therapy; Epirubicin; Etoposide; Female; Follow-Up Studies; Humans; Immunotherapy, Active; Lomustine; Male; Methotrexate; Middle Aged; Neoplasm Invasiveness; Prednimustine; Urinary Bladder Neoplasms; Vinblastine
PubMed: 7919454
DOI: 10.1097/00001813-199406000-00006 -
Orvosi Hetilap May 1994The authors treated 21 advanced, pretreated Hodgkin's disease patients with CEP (CCNU, etoposide, prednimustine) polychemotherapy between March 1988 and February 1993.... (Review)
Review
The authors treated 21 advanced, pretreated Hodgkin's disease patients with CEP (CCNU, etoposide, prednimustine) polychemotherapy between March 1988 and February 1993. Complete remission was achieved in 4 patients, partial remission in 8 patients, while 9 patients were unresponsive to treatment. None of the complete responders relapsed during the follow-up period, and the median duration of remission was 24 months. The median survival for the unresponsive and partially responsive patients was less than half a year. Side-effects included gastrointestinal symptoms, myelosuppression and alopecia, but treatment-related deaths did not occur. The present data confirm the favourable impact of CEP polychemotherapy on pretreated, advanced Hodgkin's disease patients.
Topics: Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols; Clinical Protocols; Etoposide; Female; Hodgkin Disease; Humans; Lomustine; Male; Middle Aged; Prednimustine
PubMed: 8015814
DOI: No ID Found -
Seminars in Hematology Apr 1994
Clinical Trial Comparative Study Randomized Controlled Trial
New aspects in the treatment of advanced low-grade non-Hodgkin's lymphomas: prednimustine/mitoxantrone versus cyclophosphamide/vincristine/prednisone followed by interferon alfa versus observation only--a preliminary update of the German Low-Grade Lymphoma Study Group.
Topics: Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Cyclophosphamide; Germany; Humans; Interferon-alpha; Lymphoma, Non-Hodgkin; Middle Aged; Mitoxantrone; Prednimustine; Prednisone; Vincristine
PubMed: 8073307
DOI: No ID Found -
Seminars in Hematology Apr 1994
Clinical Trial
Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Combined Modality Therapy; Etoposide; Female; Humans; Lymphoma, Non-Hodgkin; Male; Mitoxantrone; Prednimustine; Prospective Studies; Remission Induction
PubMed: 8073302
DOI: No ID Found -
Acta Oncologica (Stockholm, Sweden) 1994
Topics: Aged; Cisplatin; Female; Humans; Middle Aged; Myoclonus; Ovarian Neoplasms; Prednimustine
PubMed: 8142134
DOI: 10.3109/02841869409098387 -
Anticancer Research 1993In experimental and clinical phase II trials GnRH agonists were shown to possess antitumor activity in ovarian cancer. The outcome of prostatic cancer was also improved... (Clinical Trial)
Clinical Trial
In experimental and clinical phase II trials GnRH agonists were shown to possess antitumor activity in ovarian cancer. The outcome of prostatic cancer was also improved experimentally by a combination of cytostatic chemotherapy and GnRH analogs. Encouraged by these results, we administered micro-encapsulated triptorelin (Decapeptyl CR), 3.75 mg on the first day of each chemotherapy course, to 15 patients with advanced ovarian cancer in addition to adjuvant, carboplatin-containing chemotherapy (Carboplatin, Epirubicin, Prednimustine and Carboplatin, Etoposide) after radical surgery. Patients received a total of 6 courses. After the completion of combined chemotherapy GnRH analogs were continued for another 6 months at 28-day intervals. Results were compared with those obtained in a group of 15 ovarian cancer patients receiving the same chemotherapy regimen without GnRH medication. At a median follow-up of 36 months no significant differences were seen in terms of response, survival and time to progression. However, patients undergoing chemotherapy+triptorelin tended to show a more positive outcome than those on chemotherapy alone. G1 and G2 tumors in particular were found to respond better to the combined treatment regimen.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Female; Humans; Middle Aged; Neoplasm Staging; Ovarian Neoplasms; Pilot Projects; Triptorelin Pamoate
PubMed: 8135470
DOI: No ID Found -
Haematologica 1993Bulky mediastinal involvement is a challenging presentation of Hodgkin's disease (HD). Radiotherapy alone has provided a good response rate but also a high percentage of... (Clinical Trial)
Clinical Trial
BACKGROUND
Bulky mediastinal involvement is a challenging presentation of Hodgkin's disease (HD). Radiotherapy alone has provided a good response rate but also a high percentage of recurrences, and therefore many studies have been initiated to evaluate combined modality treatment.
METHOD
In a prospective study 23 stage IIA/IIIB HD patients treated with ABVD/MOPP alternating chemotherapy and radiotherapy were evaluated with regard to overall (OS) and disease-free survival (DFS), acute and long-term toxicity.
RESULTS
A 95% CR rate was obtained. Ten-year actuarial OS and DFS were 83 and 91%, respectively. Two patients (8.8%) relapsed 8 and 9 months after achieving CR. One patient (4.4%) died following severe bone marrow failure 25 months after diagnosis. No clinically evident acute or chronic cardiac or pulmonary toxicity was evident, and no second malignancies were observed. At the end of therapy 7/14 evaluable women became amenorrheal and remained so at their last follow-up. Two male patients were considered azoospermic on the basis of laboratory evaluation at the end of therapy, and after 68 and 122 months, respectively; 4 of 5 male patients had sexual intercourse freely but did not fertilize their partners.
CONCLUSIONS
In our opinion and in agreement with available literature, chemotherapy has a fundamental place alongside radiotherapy in the treatment of bulky mediastinal HD. Combined modality treatment improves the disease-free survival obtained with radiotherapy or chemotherapy alone. In our experience a high percentage of patients (83%) can be considered cured without the need for second-line therapy. However, long-term and especially gonadal toxicity greatly influence the quality of life of these patients. Therefore treatment must be personalized according to age, sex, cardiopulmonary status and desire to preserve reproductive function.
Topics: Actuarial Analysis; Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Combined Modality Therapy; Dacarbazine; Doxorubicin; Etoposide; Female; Hodgkin Disease; Humans; Infertility; Lomustine; Male; Mechlorethamine; Mediastinal Neoplasms; Middle Aged; Prednimustine; Prednisone; Procarbazine; Prospective Studies; Radiotherapy, High-Energy; Remission Induction; Salvage Therapy; Survival Analysis; Treatment Outcome; Vinblastine; Vincristine
PubMed: 7507457
DOI: No ID Found -
Annals of Oncology : Official Journal... May 1993An oral combination chemotherapy for breast cancer may be of advantage for many patients, if its activity is equivalent to that of i.v. treatments. The bioavailability... (Clinical Trial)
Clinical Trial
BACKGROUND
An oral combination chemotherapy for breast cancer may be of advantage for many patients, if its activity is equivalent to that of i.v. treatments. The bioavailability of oral idarubicin and of oral doxifluridine allows for their use in an oral 3 drug regimen.
PATIENTS AND METHODS
Idarubicin 29 mg/m2 was given on day 1, doxifluridine 1500 mg and prednimustine 60 mg were given daily for 10-14 days (7 days/m2) in 17 patients with advanced breast cancer. Cycles (1 to 18) were repeated every 4 weeks or delayed if required by toxic effects.
RESULTS
Nine responses were observed with durations ranging from 2 to 16 months. Responding lesions were the primary tumor, or skin, liver and bone metastases. WHO grade 3-4 toxic effects included leukopenia (7 patients), diarrhea and emesis (2 and 1 patient). There were no toxic deaths.
CONCLUSIONS
If our results are confirmed, this oral 3-drug-combination is a safe and effective treatment that may improve the quality of lives of breast cancer patients with poor venous access.
Topics: Administration, Oral; Adult; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Female; Floxuridine; Humans; Idarubicin; Middle Aged; Prednimustine
PubMed: 8353076
DOI: 10.1093/oxfordjournals.annonc.a058524 -
European Journal of Cancer (Oxford,... 1993153 women with advanced breast cancer were randomly allocated for treatment with SMF [prednimustine (Sterecyt) + methotrexate + 5-fluorouracil, 83 patients] or CMF... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
153 women with advanced breast cancer were randomly allocated for treatment with SMF [prednimustine (Sterecyt) + methotrexate + 5-fluorouracil, 83 patients] or CMF (cyclophosphamide+methotrexate+5-fluorouracil, 70 patients). Prednimustine was administered orally 100 mg/m2 daily, for 5 days, and cyclophosphamide was administered orally 100 mg/m2, for 14 days, each, every 4 weeks. Methotrexate was given at a dose of 40 mg/m2 and 5-fluorouracil at 600 mg/m2 on day 1 and 8, every 4 weeks. Leucovorin was used in 39 patients to alleviate mucositis. The two treatment groups were balanced in terms of age, performance status, lymph node status, histology, menopausal status and previous therapy. Response was evaluated in 140 patients. Of 76 patients treated with SMF, 4 had a complete and 21 a partial response (CR+PR = 33%), 40 had no change (NC) and 11 had progressive disease (PD). Of 64 patients treated with CMF, 3 had a complete and 18 a partial response (CR+PR = 33%), 30 had no change (NC) and 13 had progressive disease (PD). Time to treatment failure and survival were similar in both groups. A relationship between haematological and gastrointestinal toxicity and therapeutic efficacy was demonstrated with a superior survival and response rate recorded for patients with such toxicity than in patients without. Haematological toxicity was, in general, mild to moderate with no difference between the two groups. Alopecia (P = 0.008), nausea/vomiting (P = 0.02) and euphoria (P = 0.03) were more common in the CMF-treated group. Diarrhoea was more common in the SMF group (P = 0.03). In conclusion, SMF seems to be as efficient as CMF with regard to response rate, time to treatment failure and survival. However, SMF was tolerated better than CMF.
Topics: Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Cyclophosphamide; Female; Fluorouracil; Humans; Methotrexate; Middle Aged; Prednimustine; Prognosis; Treatment Failure
PubMed: 8518020
DOI: 10.1016/s0959-8049(05)80296-5