Prednimustine in elderly patients with multiple myeloma: a phase II study.
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Aged↗
Biomedical subjects
U Tirelli
Publications and source records attributed to U Tirelli.
Phase II trial of oral VP 16-213 (etoposide) in patients with advanced head and neck cancer.
We tested VP 16-213 in 16 patients with advanced head and neck cancer after conventional treatments. VP 16-213 was administered orally at the dosage of 100 mg/mq for 5 consecutive days every 3 weeks. No patient achieved an objective response. Toxicity was mild. VP 16-213 given at this dose and schedule revealed no activity in pretreated patients with head and neck cancer.
Aged↗
Morphology of follicular centers in persistent generalized lymphadenopathy.
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Humans↗
Phase II study of teniposide (VM-26) in multiple myeloma.
From September 1979 to December 1983, a phase II trial with teniposide (VM-26) in multiple myeloma (MM) was conducted at our institution. Of the 30 patients entered, 25 were evaluable for response, 12 previously treated with M-2 protocol and 13 previously untreated elderly (greater than or equal to 70 years) patients. A median of nine cycles (range 1-21) of VM-26 was administered. Seven responses (28%) according to Myeloma Task Force criteria were observed with a median duration of 4 months (range 2-12+). Four responses (33%) were observed in the 12 previously treated patients. Overall toxicity was mild. VM-26 seems an active drug in MM, without significant toxicity even in elderly patients.
Adult↗
High-dose versus low-dose cisplatin in advanced head and neck squamous carcinoma: a randomized study.
From November 1981 to February 1983, 64 patients with advanced head and neck squamous carcinoma were randomly treated with either high-dose (120 mg/m2) or low-dose (60 mg/m2) cisplatin. Of the 62 eligible patients, 59 were evaluable: the response rate observed in patients receiving high-dose and low-dose cisplatin was 16.1% and 17.8%, respectively. Survival was superimposable in the two treatment arms. No evidence of dose dependency of cisplatin activity in advanced head and neck squamous carcinoma was noted in this randomized trial.
Carcinoma, Squamous Cell↗
Lymph node immunohistology in intravenous drug abusers with persistent generalized lymphadenopathy.
Lymph node biopsy specimens from 16 intravenous drug abusers with persistent generalized lymphadenopathy were evaluated by immunohistochemical methods using a panel of antisera to detect different cell populations. The 11 cases that we tested on cryostat sections showed an increased number of Leu-2a-positive cells (cytotoxic-suppressor phenotype) in the follicular centers and a significantly reduced helper-to-suppressor T-cell mean ratio when compared with control tissues. In these 11 patients the peripheral helper-suppressor ratio was at the lower normal limit or inverted. Ten cases tested for anti-human T-cell lymphotropic virus type III antibodies were positive. In all 16 cases, immunohistology of paraffin-embedded sections demonstrated a polyclonal B population; 12 of 15 patients tested had polyclonal hypergammaglobulinemia, mostly IgG. The mixed-cell population of the lymph node sinuses was composed mostly of Leu-M1-positive and lysozyme-positive cells and, to a lesser extent, by alpha 1-antichymotrypsin-positive and S100 protein-positive cells. It seems that many of the immunologic dysfunctions found in these patients appear to be reflected in a fairly repetitive immunohistologic pattern.
Acquired Immunodeficiency Syndrome↗
A phase II trial of teniposide (VM 26) in advanced non-Hodgkin's lymphoma, with emphasis on the treatment of elderly patients.
Fifty-four patients entered a phase II trial of teniposide (VM 26) in Stage III (35 patients) and stage IV (19 patients) non-Hodgkin's lymphoma (NHL) classified according to modified Rappaport system. The median age was 71 years (range, 19-85). Thirty-two patients were previously treated at least with combination chemotherapy and radiotherapy, whereas 22 were elderly (range, 70-85 years) untreated patients with a median Karnofsky score of 70. VM 26 was given by IV infusion at 100 mg/m2 weekly for at least 3 doses in "unfavorable" histologic subtypes, and for at least 6 to 9 doses in "favorable" subtypes, prior to the evaluation of response. The overall objective response rate was 43% in the 51 evaluable patients. The median duration of the 12 complete responses (CRs) was 7+ months (26+ to 2). According to the histology, VM 26 was very effective in the six patients with diffuse "histiocytic" (DH) subtype (four CRs, one partial response [PR]), and in the 8 patients with mycosis fungoides (MF) (two CRs, two PRs). Diffuse lymphocytic poorly differentiated and lymphoblastic NHL were less sensitive subtypes to VM 26. Among the 20 evaluable elderly patients a 50% objective response rate was obtained with five CRs. Four CRs and one PR were obtained in the five patients with DH subtype; no response was obtained in the only patient with MF. Toxicity, usually hematologic, was mild, even in elderly patients; neurotoxicity occurred in four instances. VM 26 seemed to be an effective and well-tolerated drug in advanced NHL; this drug should be further evaluated as first line chemotherapy in elderly (greater than or equal to 70 years) previously untreated patients with poor general conditions and DH histology.
Adult↗
Treatment of grade III and IV astrocytoma with high-dose irradiation: schedule and chemotherapy.
From October 1978 to June 1981, 35 consecutive patients with grade III-IV malignant glioma were treated with a concentrated course of radiotherapy (two cycles of 17 Gy in two sessions over a 3-day period) with a cobalt unit, followed by chemotherapy with vincristine and BCNU. In the 30 evaluable patients, no complete remission, seven partial remissions, 23 stable disease, and no progression were encountered. Median duration of response was 6 months (range 4-11+). Median survival time was 9 months (range 7-19); radically resected patients survived longer than those with inoperable tumor. Toxicity of treatment was acceptable; however, two patients with brain stem tumors had acute neurologic toxicity following the first radiotherapy session.
Adult↗
Phase II study of VM 26 in extensively pretreated breast cancer.
A significant activity of VM 26 in solid tumors has been established in brain tumors, bladder cancer, and neuroblastoma. Preliminary favorable results in breast cancer stimulated a phase II study at our institution to define the activity of VM 26 in patients with advanced, homogeneously pretreated breast cancer.
Adult↗
Etoposide (VP-16-213) in malignant brain tumors: a phase II study.
Twenty-two consecutive patients with recurrent malignant brain tumors after radiation therapy and systemic combination chemotherapy with BCNU and vincristine, four of whom were not evaluable due to early death, were treated with etoposide (VP-16-213) (50-100 mg/m2 for five days every three weeks). Response, defined as improvement in both clinical examination and computed tomography scan in absence of glucocorticoids dosage increase, was observed in three (17%) of 18 evaluable patients, lasting greater than 21, seven, and two months, respectively. Six additional patients had stable disease for greater than 10, seven, four, four, three, and two months: all of them had improvement of clinical symptoms but no variation in their scans. Overall median survival from the start of VP-16-213 was 4.5 months (range, 1-23 + months), whereas patients with response or stable disease had a median survival of eight months. Overall, treatment was well tolerated. In 10 patients concomitant plasma and cerebrospinal fluid samples were evaluated with a high-performance liquid chromatographic method for drug assay. The concentration of VP-16-213 in cerebrospinal fluid was less than 1% that found in plasma, even in the two patients with response. The activity of etoposide in patients with malignant, lomustine-vincristine-resistant brain tumors suggests an interesting potential use for this drug.
Adolescent↗
Malignant lymphoma, undifferentiated, Burkitt's type in north-east Italy.
Burkitt's lymphoma occurred in 15 Italian patients seen at Pordenone General Hospital over a period of seven years representing 8% of all malignant lymphomas seen in the same period. All patients were born and lived in a region of 100 miles radius around the north-eastern Italian town of Pordenone. Five patients lived in the same rural village, and another two were distant relatives. There were eleven males and four females; the median age was 29 years (range 9-68) with ten patients older than 15 years. Primary tumor was in the gastrointestinal tract regions in nine patients and in lymph nodes in six patients. Epstein-Barr virus serology was positive in one of the 12 patients tested. According to the Ziegler staging system, three patients were stage A, three stage AR, five stage C and four stage D. Treatment consisted in surgical removal of bulky tumor followed by combination chemotherapy in seven patients, combination chemotherapy alone in seven patients and palliative radiotherapy in one. Median survival was significantly higher in patients who have obtained an objective response than in those who have not (11.5 versus 4 months). Median survival was not significantly influenced by age, stage and treatment. This report would emphasize that in Europe there are areas of relatively high incidence of Burkitt's lymphoma, and the province of Pordenone is one of these: it must be considered in the histological diagnosis of lymphoma in these areas.
Adolescent↗
Non-platinum-containing combination chemotherapy for stage III-IV head and neck squamous carcinoma.
From May 1980 to November 1981, 51 consecutive patients with locally advanced, recurrent or metastatic head and neck squamous carcinoma were treated with 2 successive outpatient chemotherapeutic regimens including adriamycin, cyclophosphamide, vincristine, bleomycin, methotrexate and 5-fluorouracil with or without mitomycin-C. A 34% objective response rate was obtained with acceptable toxicity and good patient compliance. The presence of mitomycin-C did not influence response rate. Median survival was 9 months.
Antineoplastic Combined Chemotherapy Protocols↗
Chlorozotocin treatment of advanced gastrointestinal cancer.
From April 1981 to December 1981, 34 consecutive patients with advanced gastrointestinal cancer were treated with chlorozotocin at the dosage of 40 mg/m2 daily for 5 consecutive days (30 mg/m2 in patients pretreated with chemotherapy) every 6 weeks. In the 30 patients evaluable for response, a 3.3% objective response rate was encountered. Toxicity was not significant and consisted mainly in reversible myelosuppression. Median survival was 3 months. At the dosage and schedule used, chlorozotocin does not seem to be an effective agent in the treatment of advanced gastrointestinal cancer.
Aged↗
cis-platinum and etoposide combination chemotherapy of advanced non-oat cell bronchogenic carcinoma.
From December 1981 to November 1982, a consecutive series of 37 patients with advanced non-oat cell bronchogenic carcinoma were treated with cis-platinum and etoposide in doses of 20 mg/m2 and 75 mg/m2, respectively, for 5 consecutive days every 3 weeks. Among the 33 evaluable patients, one complete response, 11 partial responses, five minor responses, seven unchanged states, and nine cases of progression were noted. Median duration of response was 30+ weeks. Toxicity was significant, but no treatment-related deaths were encountered. Combined cis-platinum and etoposide can provide significant palliation in approximately one-third of patients with the doses and schedule used.
Adult↗
Adriamycin, vineristine, and prednisone (HOP) in the treatment of malignant histiocytosis.
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Adult↗
Carcinoembryonic antigen (CEA) in the follow-up of disease-free breast cancer patients.
Carcinoembryonic antigen (CEA) assays (2536) were performed in 380 disease-free breast cancer patients after radical mastectomy. In the 334 evaluable patients with 3 or more determinations, the overall relapse rate after a median follow-up of 29 months was 11%. Of 203 patients with normal CEA values, 19 (9.3%) relapsed. In the 50 patients with the highest CEA value greater than 20 ng/ml, the relapse rate was 26%; in the 12 patients with gradually increasing CEA elevations it was 50%. However, CEA was unable to predict recurrence in N- patients. Premastectomy N+ was significantly associated with greater than 20 ng/ml or gradually increasing CEA values, suggesting the lack of an independent prognostic value of CEA in our patient population.
Breast Neoplasms↗
Estramustine phosphate (Estracyt) treatment of T3-T4 prostatic carcinoma.
From September, 1978, to November, 1980, 69 consecutive patients with locally advanced (T3-T4) prostatic adenocarcinoma, with or without distant metastases, were treated with oral estramustine phosphate. Dosage was 15 mg/kg/day for 2 months, followed by 5 mg/kg/day until progression. In the 48 evaluable patients with progressive disease that entry in the study, 1 complete response, 7 partial responses, 31 disease stabilizations, and 9 progressions were encountered (81.2% NPCP response rate). Karnofsky performance status equal to or less than 50 was predictive of poor response to estramustine phosphate. In the 10 evaluable patients with stabilized disease at entry in the study after orchiectomy, 2 complete responses, 4 partial responses, 3 disease stabilization, and 1 progression were noted. The major side effects observed were gynecomastia, nausea, and vomiting.
Adenocarcinoma↗
VM26 in malignant hematological diseases. A phase II study.
From August 1979 to April 1981, 33 consecutive patients with malignant hematological diseases, entered this phase II study. Sixteen patients had NHL, eight CLL, four Myeloma, three HD, one ALL, and one Polycythaemia vera. Two patients were unevaluable because of early death. The median age was 67 years. Eight patients were not pretreated with drugs. Two CR (5+, 20+ weeks) were obtained among NHL patients, whereas five PR were observed among two NHL, one CLL, one Myeloma, and one HD patients, respectively. Toxicity was almost exclusively hematologic and occurred in ten patients, in one of them causing severe myelosuppression. Moreover, severe asthenia, attributable to VM26, was encountered in three patients, in one requiring the suspension of the treatment.
Drug Evaluation↗