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Biomedical subjects

D Crivellari

Publications and source records attributed to D Crivellari.

At least 55 records · Page 3Linked to original sources
PubMed1991

Treatment patterns in elderly patients (greater than or equal to 70 years) with breast carcinoma. A retrospective study of the Gruppo Oncologico Clinico Cooperativo del nord-Est (GOCCNE).

The pattern of treatment used in elderly women affected by breast carcinoma was evaluated in a retrospective study by the North-East Clinical Cooperative Group in Italy (GOCCNE). Six divisions were involved in the study. The medical records of 115 elderly women were reviewed; the women's median age was 75 years (range, 70-93). Surgery was used in 70/72 operable patients (97%), although limited surgery plus radiotherapy was used in only 7.5%. Most stage II patients were treated with adjuvant tamoxifen, as were younger postmenopausal patients, according to the guidelines of the Bethesda Consensus Meeting. Comorbid conditions are of particular concern in therapy planning, considering that more stage III patients died of competing causes than for disease progression. The role of chemotherapy was very marginal.

Age Factors↗
PubMed1991

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↗
PubMed1991

Natural killer (NK) and lymphokine activated killer (LAK) cell activity in patients (PTS) treated with flavone acetic acid (FAA).

Natural killer (NK) cell activity was measured in nine patients with different solid tumors treated with flavone acetic acid (FAA). In three of them, NK cell activity was significantly increased, in two instances even after repeated courses of treatment. A significant increase in lymphokine activated killer (LAK) cell activity was also observed in three of four patients after in vivo treatment with FAA and in vitro incubation of lymphocytes with recombinant Interleukin-2. We observed some inter-individual variability in drug clearance, but no apparent correlation between drug plasma levels (neither peak nor AUC values) and the effects on NK and LAK activity.

Adjuvants, Immunologic↗
PubMed1991

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↗
PubMed1990

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↗
PubMed1990

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↗
PubMed1989

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↗
PubMed1989

Low-dose aminoglutethimide plus steroid replacement in advanced breast cancer patients resistant to conventional therapies.

In an attempt to define the activity and toxicity of low-dose aminoglutethimide plus steroid replacement in advanced breast cancer, we treated 40 patients with aminoglutethimide 500 mg/day + hydrocortisone 50 mg/day. Previous treatment consisted of additive hormones in 29 patients, oophorectomy in 8, and chemotherapy in 32. Among the 37 patients evaluable for response and toxicity, 5 objective responses (16.2%) and 20 stable diseases (54%) were noted. Toxicity, absent in 23 patients (62.1%) and mild in 14, consisted mainly of Grade I (WHO) nausea, drowsiness, cutaneous rash, and dizziness. Responders and patients with stable disease experienced a similar survival (median not reached at 22 months). Aminoglutethimide at low doses appears to be beneficial in patients refractory to conventional therapies even if the objective response rate is low.

Adult↗
PubMed1987

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↗
PubMed1987

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↗
PubMed1987

Phase II study of esorubicin (4'-deoxydoxorubicin) in locally advanced or metastatic head and neck carcinoma.

Sixteen patients with locally advanced or metastatic head and neck cancer were treated with esorubicin (4'-deoxydoxorubicin) at a dose of 30-35 mg/m2 i.v. every 3 weeks. One patient was lost to the follow up after one cycle, whereas in the 15 evaluable cases a total of 34 courses were administered (median per patient: 2, range: 1-6). Pretreatment for parameter lesions consisted of radiotherapy in 5, chemotherapy in 3 and both treatments in 1 patients respectively. Overall, one partial response, one stable disease and 13 progressions were documented. Severe (grade 3 and 4) leukopenia, thrombocytopenia and anemia were noted in 3, 1 and 1 patients respectively. The only patient developing leukopenia and thrombocytopenia of grade 4 subsequently died because of pneumonia. On the other hand, non-hematologic toxicity was generally mild. At this dose and schedule, esorubicin demonstrated an activity less than 20% in head and neck cancer and therefore, no further evaluation is warranted.

Aged↗
PubMed1987

Alternating tamoxifen and medroxyprogesterone acetate in postmenopausal advanced breast cancer patients--short and long term endocrine effects.

The endocrine effects of alternating tamoxifen and medroxyprogesterone acetate have been evaluated in 26 post-menopausal patients with metastatic breast cancer. Endocrine evaluations included the RIA determination of plasma levels of sex-hormone binding globulin, follicle-stimulating hormone, luteinizing hormone, estradiol, prolactin, cortisol, and testosterone. The evaluation of the study parameters at different intervals during therapy indicates that with this schedule an alternate sequential effect on the endocrine system is achievable because each drug exerts its own endocrine activity that is completely reversed when the other drug is administered. We can hypothesize that the same alternate activity as seen on the endocrine system could be obtained also on other tissues and organs including tumors.

Breast Neoplasms↗
PubMed1987

Sequential combination of tamoxifen and high dose medroxyprogesterone acetate: therapeutic and endocrine effects in postmenopausal advanced breast cancer patients.

A sequential combination of tamoxifen and medroxyprogesterone acetate has been evaluated in 42 postmenopausal untreated patients with metastatic breast cancer. Patients received tamoxifen 10 mg b.i.d., days 1-14, followed by medroxyprogesterone acetate 500 mg b.i.d., days 15-28, orally in an alternating sequence until progression. Twenty-two out of 40 evaluable patients showed an objective response to treatment (55%, 95% confidence limits 38-75%). A significantly higher response rate was observed in patients with age greater than or equal to 70 years, with soft tissue dominant lesions and with only one metastatic site. Median time to progression was 41 weeks and the median survival time 88 weeks. In 4 cases treatment was discontinued because of severe toxicity while in the remaining patients no toxicity (20 patients) or mild side effects (17 patients) have been observed. After 2 months of therapy, this combination showed a progestogenic effect on the endocrine parameters inducing a significant decrease of SHBG, gonadotropins, testosterone and cortisol. These preliminary clinical results and the moderate toxicity of the sequential combination support the need to further investigate this approach.

Adult↗
PubMed1987

Cisplatin and 5-fluorouracil combination chemotherapy in advanced and/or metastatic colorectal carcinoma: a phase II study.

The possible synergism of cisplatin (P) and 5-fluorouracil was studied in 38 consecutive patients with advanced or metastatic colorectal carcinoma. Cisplatin 60 mg/m2 i.v.q. 4 weeks and fluorouracil 600 mg/m2 i.v. weekly were administered for at least 2 cycles, on an out-patient basis, to 24 males and 14 females with a median age of 57 years and a median PS of 80 (Karnofsky). Evaluable lesions were: primary unresectable tumor in 2 patients, local recurrence in 11, liver, lung, bone and soft tissue metastases in 21, 7, 2 and 3 patients respectively. With a median number of 3 cycles administered to 35 evaluable patients, 6 partial responses, 16 unchanged and 13 progressions were observed. Responses were observed in the liver (2 patients), lungs (1) and soft tissues (3). Median remission duration was 15 weeks, median duration of 'unchanged' was 12 weeks. The overall median survival was 24 weeks (30.5 weeks for responders and 22.5 weeks for non-responders). Six patients were pretreated with chemotherapy not containing cisplatin (mainly adjuvant 5-FU). None of them responded. Toxicity was very tolerable with moderate nausea, vomiting and alopecia in the majority of the patients; bone marrow toxicity was generally mild with no blood transfusions required, no complications of myelosuppression (sepsis or bleeding) and no chemotherapy-related deaths. In this experience the combination of low dose cisplatin with fluorouracil, does not appear to significantly enhance 5-FU toxicity and the response rate is not superior to that reported with 5-FU alone. However, better designed schedule combinations with optimal doses, sequences and exposure time of the 2-drug regimen, seem necessary to obtain the biochemical events that support the potentiation.

Adenocarcinoma↗
PubMed1987

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↗
PubMed1987

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↗
PubMed1986

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↗