Biomedical subjects

D Crivellari

Publications and source records attributed to D Crivellari.

76 records · Page 5Linked to original sources

PubMedDate not supplied

High-dose epirubicin in locally advanced operable noninflammatory breast cancer: a feasibility trial.

AIMS AND BACKGROUND: Anthracyclines are among the most active agents for the treatment of patients with locally advanced breast cancer. The aim of our study was to evaluate the feasibility and activity of a relatively high-dose regimen with 4-epirubicin plus normal doses of cyclophosphamide over a short period of time without the use of hematologic growth factors as adjuvant in resected locally advanced breast cancer. METHODS: Between January 1990 and June 1992, 43 consecutive patients, premenopausal or postmenopausal < 60 yrs, were surgically resected and then treated with epirubicin plus cyclophosphamide for at least 4 cycles (maximum 6). Electron beam (6-10 MeV energy) radiotherapy was delivered on the chest wall in patients with pathological skin infiltration (pT4b). RESULTS: Median age was 46 years (range, 27-59); 37 were premenopausal and 6 postmenopausal. The total number of administered cycles was 202 (6 in 15 patients and 4 in 28 patients); 195/202 (96.5%) were administered at full dose, and 7 (3.5%) were reduced to 75% of the planned dosage. The three-year disease-free survival was 67% for stage IIIa and 61% for stage IIIb patients. The three-year overall survival was 88% and 79%, respectively. Local relapse only was reported in one patient (2%), distant relapse in 11 patients (25%), and local and distant relapse in four patients (9%). Toxicity was acceptable and mainly hematologic. CONCLUSIONS: Our trial showed that the regimen is feasible without the use of hematologic growth factors. In this era of cost containment, the use of this short-term, high-dose induction course instead of repetitive courses of conventional dose regimens merits further evaluation, possibly in a large randomized trial.

Adult↗

PubMedDate not supplied

Tamoxifen as adjuvant after surgery for breast cancer and tamoxifen or placebo as chemoprevention in healthy women: different compliance with treatment.

AIM: The aim of this study was to investigate whether tamoxifen toxicity and treatment discontinuations differed in the adjuvant versus chemopreventive setting. METHODS: At our Institutions 119 postmenopausal breast cancer patients were randomized from August 1987 to March 1995 to tamoxifen only within adjuvant studies (International Breast Cancer Study Group studies VII and IX) and 202 healthy hysterectomized women aged 35-70 years were randomized from November 1993 to May 1996 in a multicenter, double-blind, placebo-controlled chemoprevention study (Italian Tamoxifen Prevention Study). The tamoxifen dose was 20 mg/day for 5 years in all studies. Median age was 66 years (54-85) in the adjuvant studies and 53 years (37-69) in the chemoprevention study. Median treatment duration was 238 and 120 weeks, respectively. RESULTS: Patients treated within adjuvant studies experienced more hot flashes, vaginal discharge and/or bleeding, bone marrow depression and weight gain than those treated in the chemoprevention study, consistent with the fact that a proportion of women in the latter study were receiving placebo. Temporary discontinuation occurred in 2.5% of patients in the adjuvant studies and in 5.4% of women in the chemoprevention study (difference not statistically significant). Permanent discontinuation was more frequent in the chemoprevention study than in the adjuvant ones (26.7% vs 15.1%--P< 0.05). CONCLUSIONS: In summary, our data show that, although the toxicity of tamoxifen is superimposable in the two settings, a larger proportion of women treated as chemoprevention discontinue treatment spontaneously. Due to the double-blind nature of the chemoprevention study, the impact of the toxicity of tamoxifen upon compliance in the chemopreventive setting cannot be ascertained.

Adult↗

PubMedDate not supplied

Does the information level of cancer patients correlate with quality of life? A prospective study.

AIMS AND BACKGROUND: The aim of the study was to evaluate the impact of information level on quality of life in cancer patients previously studied for their information level. PATIENTS AND METHODS: The information level was determined by means of a questionnaire that explored the degree of information on diagnosis and status of disease, the patient's interpretation of his/her disease status, and his/her satisfaction with the information received. Quality of life was evaluated, some months after evaluation of the information level, by means of the Functional Living Index for Cancer (FLIC) and the State-Trait Anxiety Inventory (STAI 1-2). RESULTS: A total of 175 patients were studied. Information was adequate in 53.7% of patients. An adequate level of information was present more frequently among patients aged < or = 65 years and in those patients followed at a cancer institute. There was no difference in the quality of life of adequately versus inadequately informed patients. Satisfaction with the information received influenced quality of life in both age groups. Objective clinical variables (active disease present and ongoing treatment) negatively affected quality of life in patients <65 years, whereas the subjective perception of the presence of disease was associated with a worse quality of life in older patients. CONCLUSIONS: In the study, although the level of information did not affect the quality of life, satisfaction with the information was associated with a better quality of life. The finding stresses the importance of a sensible disclosure of diagnosis and prognosis.

Adult↗

PubMedDate not supplied

Pharmacology of chronic oral daily administration of idarubicin.

Idarubicin (4-demethoxydaunorubicin) (IDA) is a daunorubicin analogue with substantial activity in hematologic malignancies and solid tumors. Among several reasons, IDA is of interest because of its main metabolite derivative, the C-13 alcohol analogue, idarubicinol (IDOL). Previous studies have suggested that IDOL, unlike other anthracycline metabolic derivatives, possesses a striking growth-inhibitory activity in tumor cell lines. This suggests that IDOL, like IDA could be useful in circumventing MDR. IDA is bioavailable in an oral dosage form. After oral administration of IDA to the patients, the concentration of IDOL quickly exceeds that of IDA and is retained in the plasma for a longer period. Hence, administration of IDA to cancer patients results ina much greater overall exposure of the tumor to IDOL than to the parent compound. At the Oncology Center (CRO) in Aviano we performed a dose-finding and pharmacokinetic (PK) study of chronic daily oral IDA with intrapatient escalation in patients with metastatic breast cancer (MBC). All the patients were pretreated with anthracyclines (the cumulative dose was 530 mg and 264 mg, respectively, for epirubicin and (DOX) and had at admittance a PS < or = 2 and a left ventricular ejection fraction > 50%. IDA (1 mg capsules) was administered orally twice a day for 21 days every two weeks. Treatment was continued at escalating doses until progression or intolerance. Twenty-five patients were enrolled. MTD has not yet been reached and clinical results are reported in Table 1. Treatment was well-tolerated in all but one patient (300 ANC at day 28). Three patients had tox G3 ANC for more than three weeks after 3, 6, and 7 mg doses, respectively. Two of them stopped chemotherapy after 1 cycle and 1 patient stopped after 2 cycles (6 mg doses). Despite previous treatments with anthracyclines (the mean cumulative dose before entering the study was 530 and 264 mg, respectively, for epirubicin and DOX) no cardiotoxicity due to IDA treatment was observed. This trial demonstrates the feasibility of chronic daily IDA administration. At the dosage reported, treatment was generally well tolerated. The PK findings (high IDOL concentrations) and the unexpected G4 myelotoxicity in patients with the highest IDOL plasma concentrations suggest that IDOL is clinically relevant.

Administration, Oral↗