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Biomedical subjects

S Monfardini

Publications and source records attributed to S Monfardini.

At least 127 records · Page 7Linked to original sources

Cisplatin and mitomycin C in advanced chemotherapy-refractory breast cancer.

A combination of platinum (100 mg/m2 in a 24-h continuous i.v. infusion) and mitomycin C (10 mg/m2 i.v. push at the end of the cisplatin infusion) was administered in 20 patients with advanced breast cancer refractory to conventional treatments (CMF and anthracycline-containing regimens, hormonal therapies). The response rate was 20% (4/20), including one complete response of lung metastases which lasted 12 months. Median duration of partial responses was 4 months. Major toxicity was gastrointestinal and it was superimposable to that observed with other cisplatin-containing regimens. A marked and prolonged asthenia was reported in 6/20 patients (30%), and the regimen's compliance was poor. We conclude that at these doses and schedule, the cisplatin and mitomycin C combination has a limited efficacy in advanced breast cancer patients, and its use is not recommended in pretreated patients.

Adult↗

Partial response to lonidamine of advanced bladder carcinoma: a case report.

A 76 year old woman presented with locally advanced papillary transitional cell carcinoma. The patient had elsewhere had trans-urethral resection and radiotherapy and declined salvage cystectomy. She was treated with Lonidamine (150 mg X 3/day p.o. Repeat CT scan after 8 months showed partial remission. This response was unchanged after 28 months Lonidamine therapy.

Aged↗

Phase II trials with flavone acetic acid (NCS. 347512, LM975) in patients with advanced carcinoma of the breast, colon, head and neck and melanoma.

Phase II trials of flavone acetic acid have been performed in a total of 87 patients including 17 with advanced breast cancer, 23 with advanced colorectal cancer, 25 with advanced malignant melanoma and 22 with advanced head and neck cancer. Patients with colorectal cancer and melanoma had received no prior chemotherapy; in breast and head and neck cancer patients prior chemotherapy had been given with a median of 5 and 2 drugs respectively. The schedule used was a once-weekly regime, with a dose of 4.8 gms/m2 given as a 1 hour infusion, together with alkalinization (with i.v. sodium bicarbonate) given before and after FAA. Reassessment was performed after 6 weekly doses, although in 23 patients fewer than 6 doses were given, because of early disease progression in 15, and undue toxicity in 5. An additional 3 patients died within 72 hours of having received FAA and, although the precise cause of death in each case was not established, FAA toxicity could not be excluded. Treatment was generally manageable, the major manifestations of toxicity comprising uncomfortable warmth and flushes, nausea, diarrhoea, and visual complaints. Hypotension was also documented in 8 patients. No objective responses were seen in any of the patient sub-groups, although disease-stabilization was seen in 3 patients with breast cancer, 1 patient with advanced colorectal cancer, 2 patients with advanced melanoma and 4 patients with head and neck cancer. Further Phase II studies, using a higher dose of 8.6 gm/m2 over 6 hours once weekly, are currently in progress in Europe.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Flavone acetic acid distribution in human malignant tumors.

The pharmacokinetics of flavone acetic acid (FAA) after a dose of 4.8 mg/m2 given i.v. over 1 h was investigated in 13 patients with different solid tumors. The mean volume of distribution and clearance were 52 +/- 4 l/m2 and 2.6 +/- 0.2 l/h x m2, respectively. A tumor or metastasis biopsy was obtained from six patients 2 h after the end of infusion. Tumor FAA levels ranged from 39.6 to 148.8 micrograms/g and were similar to those obtained after a therapeutic i.v. dose of 200 mg/kg FAA in animals bearing Pan/03 tumor, which is very sensitive to the drug. Although FAA tumor concentration could be detected only during one interval and we therefore cannot draw a definitive conclusion, differences in the agent's antitumor activity in mice and patients (i.e. very active in the former and inactive in the latter) are apparently not due to discrepancies in drug distribution and pharmacokinetics.

Adult↗

Head and neck cancer and ageing: a retrospective study in 438 patients.

To evaluate whether age over 70 years represents a prognostic factor in head and neck cancer, we reviewed all cases observed between 1981 and 1984. Four hundred and thirty-eight (438) patients were considered in relation to three age groups (less than or equal to 59, 60-69, and greater than or equal to 70 years, defined as non-elderly, mid-elderly and elderly respectively). The main parameters analyzed included histological diagnosis (no difference emerged among the three age groups); anatomical site (hypopharyngeal carcinoma was most frequent in non-elderly patients); TNM stage (an higher incidence of early stages was seen in the elderly); performance status (better in the non-elderly); previous illnesses (life-style related diseases were more frequent in the non-elderly); contraindications to surgery (more frequent in the elderly); surgical treatment ('en bloc' resections were more often employed in the non-elderly); post-operative complications and local control (no difference between the three groups); multiple primary malignancies (head and neck, oesophagus and lung were more frequent in non-elderly patients) and survival (no difference). Although age affects several features of head and neck cancer patients, it does not appear from the present study to be an independent prognostic factor for local control and survival. With regard to survival, stage appeared to be the most important prognostic factor.

Age Factors↗

AIDS-associated non-Hodgkin's lymphoma in Italy: intravenous drug users versus homosexual men. The Italian Cooperative Group on AIDS-Related Tumors (GICAT).

Because of growing evidence that there are differences in the natural history of HIV infection in intravenous drug users (IVDU) and homosexual men, the clinicopathological features and response to treatment of AIDS-related non-Hodgkin's lymphomas (NHL) were analyzed in 150 cases (96 IVDU and 31 homosexual men) by the Italian Cooperative Group on AIDS-related tumors. Twenty-three patients fell within other risk groups. The median age was 26 years for the IVDU and 38 for the homosexual men. Forty percent of patients in both of the risk groups manifested full-blown AIDS prior to development of the lymphoma. In both groups, most of the NHL were of high or intermediate type (IVDU 96%, homosexual men 86%). In high-grade NHL, Burkitt's type lymphoma was present in 40% of the homosexual men and in 29% of the IVDU (a non-significant difference), while an immunoblastic lymphoma was diagnosed in 46% of IVDU and 27% of homosexual men (non-significant). No oral localizations were observed, and one homosexual presented with a rectal lymphoma. Almost half of the patients (47%) received no antineoplastic treatment because of rapid disease progression or of diagnosis only at post-mortem. Intensive combination regimens administered in one-third of both IVDU and homosexual men (compared to CHOP or CHOP-like combinations) provided more CR (3/13 vs 3/24 in IVDU and 2/3 vs 1/7 in homosexuals), although the overall survivals with both the intensive and less intensive chemotherapy protocols remained similar. Overall, the median survival was 3.7 months for IVDU and 3.6 months for homosexual men. The most reliable predictors for survival were opportunistic infections at onset in IVDU.(ABSTRACT TRUNCATED AT 250 WORDS)

Acquired Immunodeficiency Syndrome↗

Phase II study of teniposide (VM26) in cutaneous T-cell lymphomas.

A Phase II study of teniposide (VM26) in cutaneous T-cell lymphoma (CTCL) was performed in 15 patients affected by stage III, IV according to TNM (mycosis fungoides or Sézary syndrome). All patients were pretreated, and VM26 was administered at a dose of 100 mg/m2 weekly for at least 3 weeks. Objective responses were observed in 40% of the patients, with two complete responses lasting 26 and 46 months. The drug was well tolerated in elderly patients and deserves further evaluation either for inclusion in first-line combination regimens or for palliative treatment in heavily pretreated or elderly patients.

Adult↗

Combination chemotherapy specifically devised for elderly patients with unfavorable non-Hodgkin's lymphoma.

The results of a prospective trial with a specifically devised chemotherapy regimen in elderly patients with unfavorable non-Hodgkin's lymphoma (NHL) are reported. Between April 1983 and April 1986, 37 consecutive patients 70 years old or more (median age 80) received etoposide and prednimustine (E + P) 100 mg/m2 p.o. for 5 days every 21 days. Thirteen patients were previously treated. Objective response rate in the 35 evaluable patients is 66% with 46% complete response. The objective response rate in the 22 previously untreated patients is nearly 70% with 50% complete response. Median survival is 14 months. The overall toxicity was reasonably acceptable. There were 5% (2 patients) treatment-related deaths, but in an unselected elderly population. We experienced the usefulness of a properly oriented clinical approach to elderly patients with NHL. We suggest that a combination regimen E + P, suitable for oral administration, may be safely employed in elderly patients with unfavorable NHL.

Administration, Oral↗

Characterization of AIDS-associated tumors in Italy: report of 435 cases of an IVDA-based series.

The Italian Cooperative Group on AIDS-related tumors has collected 435 cases of HIV-associated tumors since December 1986. The following conclusions can be drawn from this IVDA-based series: (1) at least 15% of AIDS cases are associated with tumors; (2) the number of malignant lymphomas (high-grade non-Hodgkin's lymphoma [NHL], Hodgkin's disease [HD] is comparable to that of Kaposi's sarcoma (KS) (188 vs. 198); (3) KS among AIDS patients is less common than in countries where homosexual men are the main group affected by AIDS. However, KS also affects intravenous drug abusers (IVDA) almost exclusively males, with characteristics similar to those observed among homosexual men; (4) HD is associated with an aggressive course; (5) anal and oral primary tumors as well as oral and anal involvement of NHL are very rare; (6) testicular cancers occur in patients mainly with early HIV infection, without adversely affecting the dosage of radiotherapy and chemotherapy; (7) cervical cancer successfully treated with conization suggests that PAP test screening in young IVDA women is warranted; (8) lung cancer occurs in a young age group with rapid progression and death.

Acquired Immunodeficiency Syndrome↗

High predictivity of galactosyl-hydroxylysine in urine as an indicator of bone metastases from breast cancer.

We measured the urinary excretion of galactosyl-hydroxylysine (GH) and hydroxyproline in two groups of women with breast cancer, with (M+, n = 24) and without (Mo, n = 30) clinical, scintigraphic, or radiological evidence of bone metastases. Both these compounds are excreted in larger amounts in the M+ group than in the Mo patients. However, GH, which is a specific marker for bone collagen, provides better predictivity for bone metastases than does hydroxyproline: 92% sensitivity and 90% specificity vs 74% and 79%, respectively, for hydroxyproline.

Adult↗

A pathologic assessment of tumor residue and stromal changes after intraarterial chemotherapy for head and neck carcinomas. A study on serial sections of the whole surgical specimen.

Thirty-one patients with advanced, biopsy-proven squamous cell carcinoma (SCC) of the head and neck were treated with intraarterial chemotherapy (IAC) and subsequent radical surgery. Cisplatin at 25 mg/d (4 hours of infusion) and bleomycin at 15 mg/d (20 hours of infusion) were administered for 10 consecutive days. Radical surgery was performed after clinical evaluation 2 weeks later. Clinical tumor regression (total disappearance or shrinkage of the tumor mass by more than 50%) was recorded in 28 of 31 (90.3%) patients. Tumor regression was then assessed pathologically using a procedure based on examination of large serial histologic sections of the whole surgical specimen. Tumor residue was classified pathologically according to the TNM categories: RO, no residual tumor (five cases [16.1%]); R1, microscopic residual tumor (tumor residue detectable only at the microscopic level; 12 cases [38.7%]); and R2, macroscopic residual tumor (tumor mass detectable also on the fresh or fixed specimen and/or by the naked eye on the stained tissue sections; 14 cases [45.2%]). Moreover, tumor cell and/or stromal changes possibly associated with tumor regression were found in 77.4% of the cases. Metastatic lymph nodes were found in 12 cases (38.7%), and regression changes were observed in most lymph node metastases. Only standardized, prospective pathologic protocols for the analysis of whole specimens by serial sections permit the assessment of existing tumor residue. The TNM classification of pathologic tumor residue and definitions that we used appear feasible and reliable enough in evaluating postchemotherapeutic tumor regression.

Bleomycin↗

Persistent generalized lymphadenopathy syndrome vs "AIDS"--unrelated malignant lymphoma: comparison of presenting clinical and laboratory findings in 88 patients. AIDS and Related Syndromes Study Group.

The purpose of this report is to document and compare the presenting clinical and laboratory findings of 38 patients, all intravenous drug abusers, with pathologically documented persistent generalized lymphadenopathy (PGL), and of 50 patients with AIDS-unrelated malignant lymphoma (30 with Hodgkin's disease and 20 with non-Hodgkin's lymphoma). All patients, aged 40 years or less, consecutively seen since May 1984 in a single institution in Italy, have prospectively undergone a similar clinico-pathologic approach. In addition to a history of intravenous drug abuse and HIV serology, the results indicate that a history of infection in the previous year, night sweats, weight loss, generalized lymphadenopathy, beta 2 microglobuline, transaminase, T4/T8 ratio less than 1, and polyclonal hypergamma-globulinemia significantly increased among PGL patients compared with patients with AIDS-unrelated malignant lymphoma. In contrast, patients with malignant lymphoma had a significant increase in mediastinal lymph nodes, sedimentation rate, LDH, fibrinogen and anemia. Therefore, at this time of an AIDS epidemic, after histologic diagnosis of reactive lymphadenopathy has been performed in young patients presenting with generalized lymphadenopathy, a request for a second biopsy and other invasive procedures may be avoided if clinical and laboratory data suggest a PGL syndrome. If not already performed, HIV antibody detection should be carried out in this setting.

AIDS-Related Complex↗

Retrospective analysis of the CYVADIC regimen in advanced soft tissue sarcomas.

We performed a retrospective review of our data obtained with the original CYVADIC regimen in 31 consecutive patients with advanced soft tissue sarcomas. The treatment consisted of cyclophosphamide 500 mg/m2 i.v. from day 1, vincristine 1.5 mg/m2 in days 1 and 5, doxorubicin 50 mg/m2 i.v. on day 1, and dAcarbazine 250 mg/m2 i.v. from days 1 to 5, repeated every 3 weeks. An objective response was observed in 11/31 patients (35.5%). There were 2 complete remissions (6.5%) lasting 23 and 2 months respectively and 9 partial responses (median duration 7 months, range 1-23). No change was observed in 14 patients, and 6 patients showed progression after a median of 2 cycles of chemotherapy. Toxicity was similar to that already described with this regimen, with alopecia, nausea, vomiting and myelosuppression being the most important side effects. In particular, the median WBC nadir was 1,900/mm3 (range 400-3,600/mm3) whereas the platelet nadir was 181,000/mm3 (range 80,000-358,000/mm3); no patient developed congestive heart failure, and no treatment related death was observed. Still today, after 10 years of use, the CYVADIC regimen is very widely employed as a standard treatment for recurrent or metastatic soft tissue sarcomas, although the original positive results have been confirmed only by a few authors. In our retrospective analysis of a totally unselected population of patients, we too observed a lower activity which is, however, according to a recent review, similar to the mean value of responses obtained in the whole population of treated patients reported in the literature.

Adult↗

Combination chemotherapy with cisplatin and etoposide associated with radiotherapy in the treatment of small-cell lung cancer.

A total of 52 consecutive, previously untreated patients with small-cell lung cancer (SCLC) were scheduled to receive six cycles of a combination of etoposide (75 mg/m2 per day) and cisplatin (20 mg/m2 per day), each cycle given over 5 consecutive days. In all, 28 patients had extensive disease (ED) and 24, limited disease (LD). After three cycles of chemotherapy, all responding patients were given chest radiotherapy (RT) (45 Gy in two split courses and 30 Gy in LD and ED, respectively); only patients with LD who achieved complete remission (CR) after three cycles of chemotherapy were given prophylactic brain irradiation (30 Gy). In the 51 evaluable patients, the overall response rate was 90%, with a 31% CR and a 59% partial remission (PR) rate. In LD and ED patients, 57% and 11% CR rates and 30% and 82% PR rates were noted, respectively. Myelosuppression was the most frequently observed toxicity. The median duration of response was 12 months in LD (range, 3-41 + months) and 7 months (range, 2-12 months) in ED; the median survival was 15 months in LD and 9.3 months in ED, respectively. In all 30% of LD patients are alive and well at a minimal follow-up of 18 months. This trial confirms the activity of the cisplatin-etoposide combination in SCLC.

Aged↗

Mitomycin C treatment of advanced, hormone-resistant prostatic carcinoma: a phase II study.

From February 1984 to February 1987, 29 patients with advanced, hormone-resistant prostatic carcinoma were treated with mitomycin-C at a dose of 20 mg/m2 every 6 weeks (15 mg/m2 in patients greater than 75 years old and in those who had undergone previous radiotherapy). In the 27 evaluable patients, there were no complete remissions (CR), 2 partial remissions (PR), 14 stabilizations (STAB), and 11 cases of progressive disease (PRO). Ten stabilized patients showed significant pain reduction. Toxicity was minimal. The actuarial median survival was 10.8 months. In this study, mitomycin C was not active in terms of CR + PR; however, a beneficial symptomatic effect was frequently observed.

Aged↗