PubMed HealthSearch

Biomedical subjects

S Tumolo

Publications and source records attributed to S Tumolo.

At least 19 recordsLinked to original sources

Experience with intraperitoneal alpha-2a interferon.

Eighteen patients affected with epithelial ovarian cancer have been treated by intraperitoneal alpha 2a-Interferon. The usual single dosage was 54 x 10(6) U at weekly intervals for four times (eight times in responders): 10 histologically confirmed complete remissions and 3 partial remissions have been obtained; the toxicity was represented by fever in the majority of the cases, by abdominal discomfort in some cases, and by a mild transitory neurological complication in 1 case. Seventeen of 18 patients were pretreated, and 11 of 18 had only cytologic and/or microscopic disease. alpha 2a-Interferon has proven to be very effective and moderately toxic in microscopic peritoneal disease of ovarian epithelial cancer previously treated with extensive surgery and intravenous cytotoxic chemotherapy.

Female

Whole abdomen radiation therapy after a short chemotherapy course and second-look laparotomy in advanced ovarian cancer.

From April 1983 through December 1989, 42 consecutive patients with diagnosis of epithelial ovarian carcinoma were initially managed by aggressive surgery and three courses of endoperitoneal cis-platinum-based chemotherapy followed by an alternating combination chemotherapy and second-look laparotomy. Patients with residual tumor less than or equal to 2 cm subsequently received whole abdominal radiation therapy (WAR). Twenty-eight patients (42% with no residual disease, 21% with microscopic disease, and 36% with residual disease less than 2 cm) were eligible for WAR. WAR was delivered using an open-field technique up to 22 Gy in 20 fractions followed by a pelvic boost of 18 Gy in 10 fractions. The kidneys were shielded posteriorly at 1100 cGy; hepatic shields were not added. One patient did not complete WAR for lung metastases after 5 radiotherapy fractions. The complete treatment program lasted 8 months (range, 6.8-11). The median follow-up of the 28 patients entered into the study was 50 months. Eight patients are alive and disease-free at 5 years. The overall and disease-free survival rates at 5 years are 45 and 30%, respectively. All but 2 patients relapsed within the abdominopelvic cavity and 3 developed brain metastases. Toxic effects, during WAR, required treatment interruption in all but 4 patients: 3 developed a small bowel obstruction requiring surgery and 1 died of surgical complications in complete remission. The poor disease-free survival and the severe toxicity encountered have been valid indications that WAR should be discontinued as a treatment modality in advanced ovarian cancer at our department.

Abdomen

Evaluation of two consecutive regimens in advanced gastric cancer.

Treatment of gastric cancer still presents a challenge in cancer chemotherapy. In our Institute, from January 1981 to November 1984, 45 patients were given 5-fluorouracil (5FU) 600 mg/m2 Days 1, 8, 29, and 36; doxorubicin (A) 30 mg/m2 Days 1 and 29; mitomycin-C 10 mg/m2 Day 1 (FAM regimen) every 8 weeks. From December 1984 to October 1986, 26 patients were treated with 5FU 300 mg/m2 on Days 1-5, A 40 mg/m2 on Day 1, cisplatin (P) 100 mg/m2 on Day 1 (FAP regimen) every 3 weeks. In the FAM group, 42 patients are evaluable for response; 5 (12%) partial remission (PR), 9 stable disease (SD), and 28 progressions (PRO) were observed. Median duration of response (MDR) was 21 weeks (range 13-45) and the median survival (MS) in the whole group was 27 weeks. In the FAP group, 23 patients are evaluable: 2 CR (9%), 11 PR (47%), 2 SD (9%), and 8 PRO (34%) were observed; CR duration was 24 and 107+ weeks, respectively, MDR of PR was 22 weeks (5-35). The MS of all patients was 16 weeks. Toxicity (WHO criteria) was mild in the FAM group and severe in the FAP group. In spite of a higher objective response rate, the short MS and the severe toxicity observed in the FAP group do not merit recommendation of this regimen in patients with gastric cancer; therefore neither FAM nor FAP appear to be an ideal standard therapy.

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

Combination antibiotic treatment of chemotherapy-induced neutropenia in non-leukemic patients.

The use of more aggressive chemotherapies in the treatment of patients with some tumors has caused a higher frequency of neutropenia and subsequent serious infections. To verify the role in these patients of a combination therapy of amikacin (300 mg/m2 i.v. every 12 hours) plus ceftazidime (2 g/m2 i.v. every 8 hours) administered as initial empiric treatment, followed in non-responsive cases by a second-line therapy with clindamycin (300 mg/m2 i.v. every 8 hours), we conducted a prospective study in 45 febrile episodes (temperature greater than or equal to 38.5 degrees C) in neutropenic patients (neutrophils less than or equal to 500/ml). The patients' median age was 58 (range, 19-80); 29 were women and 16 were men. The median performance status was 50 (range, 30-90), and 71% of the patients had progressive tumoral disease. Before antibiotic therapy the median duration of fever was 12 hours (range, 4-48 hours). The median granulocyte count was 350/ml (range, 100-500 cells/ml), and the median peak temperature was 38.8 degrees C (range, 38.5-41 degrees C). The median time for neutrophils to rise towards 1000/ml was 4 days (range, 2-12), and the median duration of therapy was 8 days (range, 3-12). Documented bacterial infections were present in 28 patients whereas 17 had clinically possible infections or fever of unknown origin. The infection sites in microbiologically documented infections were: septicemia (12), multiple sites (4), tonsillitis (4), urinary tract (4), pneumonia (2) and fistula (2). Complete response to first-line therapy was obtained in 36 out of 45 episodes (80%; 95% confidence limits from 65% to 90%). Five out of 8 cases responded to second-line therapy with clindamycin for and overall recovery rate of 91%. The amikacin-ceftazidime combination followed by clindamycin in non-responsive cases is effective, with moderate toxicity in non-leukemic febrile neutropenic patients.

Adult

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

Ovarian cancer: ten-year experience in a community hospital.

We reviewed 187 patients with epithelial ovarian cancer treated, from 1975 to 1985, at the Division of Radiotherapy and Medical Oncology, Pordenone General Hospital, Italy. It seemed of interest to report an experience carried out in a community hospital in a consecutive unselected series of patients affected by ovarian cancer. Survival time was evaluated from the day of the primary surgical approach to the end of the study (March 1985). The aim of the study was to confirm in our patient population the importance of some already recognised prognostic factors that influence survival (age, stage, histology, grade, type of surgery and residuum). We also analyzed the effect of the treatment variables chemotherapy and radiotherapy on survival. The general pattern of prognostic factors appears to be in agreement with reports in the literature. In our experience, residual disease and stage were the main important prognostic factors; grade and histology had a secondary relevance, and age did not seem to be a prognostic factor in our population. New chemotherapy regimens and/or radiotherapy did not appear to improve survival. In fact, comparison of the results obtained from 1975-1979 and from 1980-1985 (when more aggressive surgery and cisplatin-containing regimens were employed) showed no statistically significant difference in survival rate. Our data suggest that patients at an early stage can receive a satisfactory quality of care in a general hospital with oncology facilities, provided the surgeon and the pathologist are experienced in ovarian cancer. Patients at stage III but completely surgically resected can also be adequately treated. Patients with advanced disease, considering the lack of established efficacious treatments, should be referred to specialized centers, where new drugs or experimental strategies can be tested.

Adult

Intermittent pelvic arterial infusion with peptichemio, doxorubicin, and cisplatin for locally advanced and recurrent carcinoma of the uterine cervix.

The preliminary results of intraarterial chemotherapy with peptichemio, doxorubicin, and cisplatin as part of a multimodality treatment in locally advanced and recurrent cervical carcinomas are reported. Treatment consisted of a bilateral sequential infusion of peptichemio 20 mg, doxorubicin 10 mg and cisplatin 20 mg in a 6-hour period via an external infusion pump. After a rest period of 4 days, treatment restarted until maximum response or toxicity. Twenty-five patients, 12 with primary advanced (four Stage IIb, eight Stage III) and 13 with recurrent tumors were treated. All previously untreated patients obtained objective response. In particular, two patients with Stage IIb and III disease, respectively, achieved a complete response. Nine of 13 patients with recurrent disease (69%) were responsive, too, and therefore an overall objective response rate of 84% was achieved. Responses were noted after a median of five cycles of chemotherapy, whereas hematologic toxicity observed in all but one patient, was encountered after a median of four cycles. Toxicity of grade 1 and 2 was noted in 19 patients (76%), whereas of grade 3 and 4 in only 5 (20%). One treatment-related death, due to sepsis during myelosuppression, was reported. Catheter-related toxicity was noted in four patients causing femoral thrombosis in two. In one case a bypass operation was required. After intraarterial chemotherapy, all 21 responsive patients were eligible for radical surgery and 18 (86%) underwent both surgery and postoperative radiation therapy. Surgery was excluded in three patients. In these three cases radiation therapy alone was employed. In this series, the schedule of intraarterial chemotherapy employed was very effective. Patient accrual is ongoing in order to confirm the response rate so far obtained and to evaluate, with a longer follow-up, the impact of this multidisciplinary approach on local control and survival.

Adult

A phase II study of AMSA in head and neck cancer.

AMSA was given to 22 evaluable patients with advanced head and neck cancer with measurable lesions. The starting dose was 90-120 mg/m2 by i.v. infusion over 45 min every 3 weeks. The dose of AMSA was escalated by 30 mg/m2 in absence of bone marrow toxicity. At least two cycles were given prior to the evaluation of response. Only one patient with oropharyngeal cancer achieved a partial response, lasting for 20 weeks. Toxicity was mild and mainly hematological. We conclude that AMSA given at this dose and schedule has little activity in head and neck cancer.

Adult

Phase II study of five-day continuous infusion of vinblastine in patients with metastatic renal-cell carcinoma.

Vinblastine 5-day continuous infusion in metastatic renal-cell carcinoma was evaluated in a Phase II trial. The dosage varied from 1.4 to 1.6 mg/m2/day every 3 weeks according to previous treatment and performance status (PS). From September 1983 to January 1986, 25 consecutive patients entered the study; 21 were evaluable for response and 23 were evaluable for toxicity. The median number of cycles administered was three (range, one to six). One complete response (liver) lasting 5 months, one partial response (lung) lasting 3 months, 12 cases of stable disease, and seven progressions were noted. Toxicity (WHO criteria) was relevant and mainly hematological: one treatment-related death occurred. Vinblastine continuous infusion did not demonstrate significant antineoplastic activity against metastatic renal-cell carcinoma.

Adult

Combination of amikacin and ceftazidime as empiric treatment of febrile leukopenic patients affected by solid tumors.

A combination of amikacin and ceftazidime was used as initial empiric therapy for the treatment of 25 evaluable febrile episodes (temperature greater than or equal to 38.5 degrees C) in leukopenic adult patients (wbc less than or equal to 1,000/mm3) with solid tumors, characterized by poor prognosis because of low performance status (median Karnofsky score: 50) and progressive disease (76% of cases). Nineteen (76%) of the 25 episodes responded to the initial empiric antibiotic combination. In the microbiologically documented infections, there was no significant difference in the response rate between bacteremia (67%) and localized infections (81%). The response in localized infections caused by gram-negative organisms (81%) was similar to that obtained in gram-positive organisms (82%), whereas gram-positive bacteremia responded better than gram-negative (100 vs 50%). No serious side effects were observed. Reversible nephrotoxicity occurred in 12% and hypokalemia in 20% of the patients treated. This antibiotic combination is a safe and efficacious empiric therapy for infections in leukopenic patients with solid neoplasia.

Adult

Local neurotoxicity after intra-arterial cisplatin in head and neck cancer.

Neurotoxicity after intra-arterial administration of cisplatin, alone or in combination with other chemotherapeutic agents, is not yet well-documented. In our experience with 63 previously untreated patients with head and neck cancer, we observed four patients with cranial nerve impairment ipsilateral to the cannulated artery. The first patient has already been reported, whereas the other three are the subject of the present report. Overall, all three patients developed cranial peripheral palsy a few days after the end of intra-arterial cisplatin and after a median total dose of 200 mg (range, 160-250). The nerves involved were the 12th in the first patient, the seventh in the second, and the ninth, tenth, 11th, and 12th in the third patient. Complete recovery of the palsy was noted only in the first patient. The patient reported previously had developed a cranial nerve palsy involving the ninth, tenth, 11th, and 12th nerves of the right side. The low incidence of this toxicity (6.3% in our experience) and the very high objective remission rate achieved by the intra-arterial administration of cisplatin justify the continuation of such an approach to obtain the maximum tumor regression and to research the individual predisposing factors.

Aged

Intra-arterial continuous infusion of cis-diamminedichloroplatinum in untreated head and neck cancer patients.

The authors report the final analysis of a prospective phase I-II study in 53 previously untreated patients with squamous cell carcinoma (48 patients) and other histologic classifications (5 patients) of the head and neck region. Treatment consisted of cisplatin 10 mg infused intra-arterially in a 12-hour period, twice a day for 5 to 10 days via an external infusion pump. After a rest period of 5 to 7 days treatment could be restarted, with the same schedule, until a maximal total dose of 400 mg or toxicity. Patients who received at least 200 mg of cisplatin were considered evaluable for response. In 3 patients catheterization was not performed because of technical difficulties, in 9 treatment was stopped before reaching the total dose of 200 mg, (because of catheter-related toxicity in 7 patients, drug toxicity in 1, and both toxicities in 1); therefore, the patients evaluable for response, drug toxicity and catheter toxicity were 41, 43, and 49 respectively. Overall, 8 patients (19.5%) obtained a complete response (CR) and 20 (48.8%) a partial response (PR) with an objective response rate (RR) of 68.3%. Eleven patients obtained a minor response (MR), whereas only 2 (4.8%) developed a progressive disease (PD). The figures, limited only to squamous cell carcinoma of oral cavity and oropharinx (33 patients), are as follows: CR 8 (24.2%), PR 17 (51.5%), MR 7 (21.2%), and PD 1 (3.0%) for an objective RR of 75.7%. No grade IV and only 5 grade III toxicity were observed; whereas the most frequent grade I and II drug-related toxicities were anemia, transient renal impairment, and thrombocytopenia. Catheter-related toxicity accounted for five central nervous system complications (three transient motor weaknesses, one hemiparesis, one embolism) and six local problems (one coagulation of the catheter, one displacement, and four local extravasations). Intra-arterial cisplatin is, in our experience, an effective treatment and further trials employing cisplatin combination chemotherapy are needed in order to establish the exact role of the intra-arterial approach before definitive local treatments.

Adenocarcinoma

Randomized crossover antiemetic study in cisplatin-treated patients. Comparison between high-dose i.v. metoclopramide and high-dose i.v. dexamethasone.

This prospective, randomized, nonblind study comparing the antiemetic effectiveness of high-dose IV metoclopramide and high-dose IV dexamethasone was performed in 78 advanced cancer patients. Chemotherapeutic treatment consisted in cisplatin at a high-dose (120 mg/m2) (HD-CDDP) and at a low-dose (LD-CDDP), either alone (60 mg/m2) or in combination with other chemotherapeutic agents (50 mg/m2). The evaluation of the effectiveness of antiemetic therapy was based on three parameters: prevention of vomiting ("major protection"), number of emetic episodes, and subjective preference. Out of 78 study patients, 67 were evaluable. Overall, metoclopramide proved to be statistically superior to dexamethasone in preventing vomiting (P less than 0.005), in reducing the median/mean number of emetic episodes (P less than 0.001/0.001), and in subjective preference (P less than 0.01). The results divided between HD-CDDP and LD-CDDP groups were also in favor of metoclopramide for reduction of the median/mean number of emetic episodes (P less than 0.001/0.001 for the HD-CDDP group and P less than 0.001/0.005 for the LD-CDDP group) and in subjective preference (P less than 0.001 and P less than 0.001 for the HD- and LD-CDDP groups, respectively). No statistical differences were noted when LD-CDDP was used in monochemotherapy, whereas when LD-CDDP was used in combination chemotherapy, statistical differences in favor of metoclopramide were noted again for the median/mean number of emetic episodes (P less than 0.01/0.05) and for subjective preference (P less than 0.01), even though the effectiveness of both antiemetic agents was greatly reduced. The evaluation of previously untreated patients reflected the overall results: for the HD-CDDP group all three parameters demonstrated statistical significance in favor of metoclopramide; for the LD-CDDP group, of all three parameters, prevention of vomiting (major protection) was the only one for which there was no significant difference. Mild sedation was the only side effect of metoclopramide. No extrapyramidal reactions were noted during this trial, but concomitant orphenadrine treatment was given. Dexamethasone was always well tolerated. In conclusion, high-dose IV metoclopramide demonstrated its superiority over high-dose IV dexamethasone in all subsets of our population except the LD-CDDP monochemotherapy group, in which the two antiemetics were found to be equivalent in effect.

Adult