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D Dini

Publications and source records attributed to D Dini.

At least 19 recordsLinked to original sources

The prognostic value of cytogenetics is reinforced by the kind of induction/consolidation therapy in influencing the outcome of acute myeloid leukemia--analysis of 848 patients.

We studied the impact of cytogenetics and kind of induction/consolidation therapy on 848 adult acute myeloid leukemia (AML) patients (age 15-83). The patients received three types of induction/consolidation regimen: standard (daunorubicin and cytosine arabinoside (3/7); two cycles); intensive (idarubicin, cytosine arabinoside and etoposide (ICE), plus mitoxantrone and intermediate-dose Ara-C (NOVIA)); and low-dose (low-dose cytosine arabinoside). CR patients under 60 years of age, if an HLA-identical donor was available received allogeneic stem cell transplantation (allo-SCT); otherwise, as part of the program, they underwent autologous (auto)-SCT. CR rates significantly associated with 'favorable' (inv(16), t(8;21)), 'intermediate' ('no abnormality', abn(11q23), +8, del(7q)) and 'unfavorable' (del (5q), -7, abn(3)(q21q26), t(6;9), 'complex' (more than three unrelated cytogenetic abnormalities)) karyotypes (88% vs 65% vs 36%, respectively; P = 0.0001). These trends were confirmed in all age groups. On therapeutic grounds, intensive induction did not determine significant increases of CR rates in any of the considered groups, with respect to standard induction. Low-dose induction was associated with significantly lower CR rates. Considering disease-free survival (DFS), multivariate analysis of the factors examined (including karyotype grouping) showed that only age > 60 years significantly affected outcome. However, in cases where intensive induction was adopted, 'favorable' karyotype was significantly related to longer DFS (P = 0.04). This was mainly due to the favorable outcome of t(8;21) patients treated with intensive induction. Patients receiving allo-SCT had significantly longer DFS (P = 0.005); in particular, allo-SCT significantly improved DFS in the 'favorable' and 'intermediate' groups (P = 0.04 and P = 0.048, respectively). In conclusion our study could provide some guidelines for AML therapy: (1) patients in the 'favorable' karyotype group seem to have a longer DFS when treated with an intensive induction/consolidation regimen, adopted before auto-SCT instead of standard induction; this underlines the importance of reinforcement of chemotherapy, not necessarily based on repeated high-dose AraC cycles. Allo-SCT, independently of induction/consolidation therapy, should be considered an alternative treatment; (2) patients in the 'intermediate' karyotype group should receive allo-SCT; (3) patients in the 'unfavorable' karyotype group should be treated using investigational chemotherapy, considering that even allo-SCT cannot provide a significantly longer DFS, but only a trend to a better prognosis.

Adolescent↗

Effect of fenretinide on bone mineral density and metabolism in women with early breast cancer.

Prolonged administration of natural or synthetic retinoids has been associated with significant skeletal abnormalities, including osteoporosis. We studied the effects of the synthetic retinoid fenretinide (N-4-hydroxyphenylretinamide, or 4-HPR) administered for a mean of 40 months on bone mineral density and metabolism in 66 consecutive women with early breast cancer belonging to a secondary prevention trial. The mean (+/-SD) bone mineral density at the distal and ultradistal forearm were, respectively, 0.61+/-0.08 and 0.30+/-0.05 g/cm2 in 33 treated women and 0.62+/-0.07 and 0.29+/-0.07 g/cm2 in 33 control women (p = ns for both). Also, no significant difference was observed in markers of bone formation such as bone alkaline phosphatase and osteocalcin, nor in urinary bone resorption markers such as calcium, hydroxyproline, and type I bone collagen cross-linked N-telopeptide (NTx). However, a border-line higher excretion of urinary calcium and NTx was found in the 4-HPR group after adjustment for menopausal status. We conclude that prolonged administration of 4-HPR is not associated with significant alterations of bone mineral density of the forearm. However, a trend towards an increase in bone resorption markers suggests the need for further assessment at different skeletal sites.

Aged↗

The role of pneumatic compression in the treatment of postmastectomy lymphedema. A randomized phase III study.

BACKGROUND: Pneumatic compression is a frequently prescribed physical therapy for patients affected by postmastectomy lymphedema but, despite its wide use, its efficacy has not been demonstrated in phase III studies. We performed a randomized study comparing pneumatic compression versus no treatment in patients with postmastectomy lymphedema. PATIENTS AND METHODS: Patients with monolateral postmastectomy lymphedema were randomized to receive two cycles of intermittent pneumatic compression (PC group), i.e., five two-hour sessions per week for two weeks, to be repeated after a five-week interval, or to no treatment (control group). The patients in both groups were instructed as to the prophylactic hygienic care of the limb. Lymphedema was assessed by the sum of differences in circumference measurements between affected and normal limbs ('delta'). Response was defined as a > or = 25% reduction in delta value. RESULTS: Eighty patients entered the study. No statistically significant differences in response rates between the two groups were observed: 20% in the control group (95% CI: 9%-36%), 25% in the PC group (95% CI: 13%-41%, P = 0.59). The absolute mean decrease in delta value was 1.9 +/- 3.7 cm in the PC group and 0.5 +/- 3.3 cm in the control group. CONCLUSIONS: We demonstrated that intermittent pneumatic compression has a limited clinical role in the treatment of postmastectomy lymphedema. Efforts to prevent this complication should be undertaken.

Aged↗

Efficacy of two different ProMACE-CytaBOM derived regimens in advanced aggressive non-Hodgkin's lymphoma. Final report of a multicenter trial conducted by GISL.

BACKGROUND AND OBJECTIVE: To compare the efficacy of ProME(Epidoxorubicin)CE-CytaBOM (PE-C) and ProMI(Idarubicin)CE-CytaBOM (PI-C) in the treatment of adult patients with aggressive non Hodgkin's lymphoma in a multicenter randomized controlled trial performed by 18 centers of the Italian Lymphoma Study Group (GISL). DESIGN AND METHODS: One hundred and twenty-eight and 122 patients were randomly assigned to receive either 6 courses of PE-C or PI-C, respectively. Some patients achieving complete remission with induction therapy participated in another randomized study comparing no further therapy versus maintenance therapy consisting of four blocks of two drugs. RESULTS: The rate of CRs was 62% and 64% for patients treated with PE-C and PI-C, respectively (p = 0.51). The 5-year relapse-free survival was 60% for PE-C and 53% for PI-C (p = 0.29). The estimated relapse-free disease survival rates at 4 years were 75% for patients in the consolidation group and 57% for those in the observation group (p = 0.11). Patients alive in first complete remission 4 years after study entry were estimated to be 39% in the PE-C arm and 38% in the PI-C arm (p = 0.90). The 3-year and 5-year estimated survival rates were 61% and 55% for the PE-C group and 56% and 47% for the PI-C group (p = 0.26). Fatal toxicities occurred in 7 patients (2.9%) with active disease and in 4 patients (1.7%) in complete remission. Stage (p = 0.04), bulky disease (p = 0.02), serum LDH (p = 0.0006), serum albumin (p = 0.0051), hemoglobin (p = 0.0011), performance status (p = 0.0001), International prognostic index (p < 0.0001) and the index proposed by the French group G.E.L.A. (p < 0.0001) were of prognostic value. In a multivariate analysis (Cox regression model) alternatively IPI alone or G.E.L.A. index plus performance status emerged as independent prognostic factors. INTERPRETATION AND CONCLUSIONS: The present study indicates that epirubicin and idarubicin in a combined chemotherapy regimen, have similar activities. The toxic profile also indicates the safety of both anthracyclines at the dosages employed, suggesting their possible dose escalation in a combined chemotherapy setting. PE-C and PI-C were both effective and feasible regimens in an outpatient setting, with acceptable cardiovascular toxicity. The trend toward a better outcome in patients undergoing consolidation therapy after the achievement of a complete remission, warrants further investigation.

Adolescent↗

Combined management in the treatment of epidoxorubicin extravasation. A case report.

Inadvertent extravasation during intravenous antitumor therapy is not an unusual complication and can cause damage ranging from minor erythema to severe local necrosis. The appropriate management of these iatrogenic accidents as a part of supportive care in oncology has been addressed by several experimental studies, but there has been little clinical study and no conclusive evidence on the best therapeutic strategies to adopt. The case reported here of a patient suffering from severe soft-tissue injury caused by extravasation of epidoxorubicin demonstrates the usefulness of a combined management (medical, surgical and rehabilitative) in the appropriate care of extravasation.

Aged↗

Topical dimethylsulfoxide for the prevention of soft tissue injury after extravasation of vesicant cytotoxic drugs: a prospective clinical study.

PURPOSE: To evaluate the activity and tolerability of dimethylsulfoxide (DMSO) in the prevention of soft tissue toxicity after extravasation of cytotoxic drugs. PATIENTS AND METHODS: From June 1991 to December 1994, all patients who had an extravasation during intravenous (IV) infusion of cytotoxic drugs in our institution were considered for an open, prospective study of preventive treatment with 99% DMSO, applied topically on the extravasation site every 8 hours for 7 days. Intermittent local cooling (for 1 hour three times daily) on the first 3 days was also used. RESULTS: One hundred forty-four patients with extravasations of doxorubicin (n = 11), epirubicin (n = 46), mitomycin (n = 5), mitoxantrone (n = 13), cisplatin (n = 44), carboplatin (n = 6), ifosfamide (n = 14), and fluorouracil (n = 5) entered the study; 127 were assessable. Only one patient suffered an ulceration. The treatment was well tolerated, with mild local burning and a characteristic breath odor being the only side effects of DMSO application, even in cases in which treatment continued for up to 6 weeks to obtain remission of the symptoms of extravasation. CONCLUSION: Topical DMSO is an effective and safe antidote that may be used with local cooling after extravasations of vesicant drugs other than those drugs for which standard interventions are defined.

Administration, Topical↗

[Sulodexide in the prevention of post-mastectomy lymphedema].

Post-mastectomy lymphedema of the upper limb, that can be noticed by 10 to 20 percent of patients with breast cancer, is usually related to some risk factors: use of radiotherapy on the axilla, obesity, venous outflow obstruction, delayed wound healing or infection. The most important contributing factor to postsurgical edema is the development of lymphangitis in the upper limb. Although literature contains numerous accounts on the use of pharmacological agents for the treatment of postmastectomy lymphedema, the results are not satisfactory in term of clinical response and side effects. In the present study we investigate tolerability and feasibility of the use of suledexide in patients, submitted to mastectomy for breast cancer, with an initial lymphedema of the limb omolateral to surgery or other risk factors for the development of a clinical remarkable lymphedema. Our results show that sulodexide is a very satisfactory therapy in term of lack of side effects and good compliance.

Adult↗

Hyaluronidase as an antidote to extravasation of Vinca alkaloids: clinical results.

Skin necrosis is a recognized potential consequence of an inadvertent extravasation of Vinca alkaloids in the surrounding tissues during i.v. administration. Experimental studies suggest that hyaluronidase, an enzyme that degrades hyaluronic acid and improves the absorption of locally injected drugs, can reduce the risk of progressing to skin necrosis. On this basis, we used this enzyme as a local treatment after extravasations of Vinca alkaloids in seven patients. No patient suffered from subsequent skin necrosis. To the best of our knowledge, this is the first clinical report confirming the positive findings of experimental studies on the effectiveness of this antidote.

Extravasation of Diagnostic and Therapeutic Materi↗

Management of acute radiodermatitis. Pharmacological or nonpharmacological remedies?

The medical and nursing literature suggests a wide variety of pharmacological and nonpharmacological approaches to treatment of acute radiation skin damages (erythema, dry and moist desquamation, ulceration), but no specific and standardized therapy. The incidence of radiodermatitis has decreased with mega-voltage instruments, but it can nevertheless influence the therapeutic program and impair quality of life of patients. A study has been conducted to evaluate the tolerability and effectiveness of a nonpharmacological remedy, a mixture of hydrophobic (stearic acid) and hydrophilic (propylene glycol, glycerol, and polyunsaturated alcohols) components in a foam emulsion for the treatment of acute skin injuries following radiotherapy. Thirty-eight of 42 initial patients were evaluable: we observed a complete response in 22 (57.9%), improvement in 14 (36.8%), and failure in only two (5.3%).

Acute Disease↗

An analysis of prognostic factors in response to conservative treatment of postmastectomy lymphedema.

Postmastectomy lymphedema of the upper limb is usually managed conservatively. Patients are often advised to use elastic bandages or sleeves during the day: elastic compression is, in fact, generally considered the mainstay of lymphedema therapy by authors who advocate the addition of cyclical instrumental or physical treatments, such as pneumatic compression or manual lymphatic drainage. The results of elastic compression, however, have never been extensively analyzed. In the present study, we describe the patterns of response during six months of use of a standard elastic sleeve in a series of 120 patients with postmastectomy lymphedema. Univariate and multivariate analyses were performed to identify possible prognostic factors for a better or worse response. Overall, limb measurements were reduced by 14.7 percent, with weight gain after surgical treatment resulting as the only significant independent negative factor: patients who did not increase weight after mastectomy achieved nearly a 25 percent reduction of lymphedema. These results should be considered during the selection of patients for protocols of lymphedema treatment and the analysis of results.

Aged↗

Irrigation for colostomized cancer patients: a rational approach.

Management of a colostomy by irrigation is simple and effective. Five hundred and nine patients having a colostomy for rectal cancer during the last 10 years were assessed by our Rehabilitation Department as potential candidates for irrigation. Fifty-two patients were considered unsuitable and 40 refused to learn the technique. The remaining 417 (82%) patients adopted the irrigation method. Of these, 97% achieved full continence of periods of 24 to 48 h. There was no case of colonic perforation. The median duration of irrigation was 230 days; 31.6% had been irrigating from 1 to 5 years and 10.3% for more than 5 years. There was a reduction of more than 50%/24 h in the number of appliances used by patients. Irrigation is a simple, safe and cost-effective means of managing a colostomy. With careful selection of patients, irrigation should be recommended as a routine part of rehabilitation.

Colostomy↗

Conservative treatment of postmastectomy lymphedema: a controlled, randomized trial.

A controlled, randomized trial was carried out to evaluate the effectiveness of a new conservative treatment for postmastectomy lymphedema. Seventy-four patients were randomized to wear only an elastic sleeve for six months (group A) or to receive additionally an induction treatment with electrically stimulated lymphatic drainage (group B). The evaluation of results was focused not only on the mean variations in limb measurements in the two groups, but also on the frequency of clinically significant reductions of lymphedema (i.e., at least 25% compared to the initial values). A mean reduction of limb girth of about 17% was obtained in both groups, without significant differences between the two treatments. An 'objective response', however, was not achieved by the majority of patients. On the other hand, compliance to therapy was good and a significant result could be obtained simply and economically also in the group of patients treated only with the elastic sleeve.

Aged↗

Colostomy irrigation in the elderly. Effective recovery regardless of age.

One hundred forty elderly cancer outpatients with colostomy in the authors' rehabilitation department were included in an analysis of the feasibility, effectiveness, and safety of periodic irrigation of remaining colon with lukewarm tap water with the aim of regaining full continence. Sixteen patients did not have a sufficiently long remaining bowel (cecostomy, transverse colostomy) and 17 were considered unsuitable to learn the technique because of advanced neoplastic disease with poor life expectancy, intercurrent disease, or stomal problems. One hundred seven patients were proposed to perform the irrigation: 17 refused to do so with the remaining 90 able to learn the method without problems. Nearly all patients achieved full continence for at least 24 hours. Three patients refused to continue, and nine interrupted for minor complications. The median duration of irrigation in the whole group is 257 days (range, 1 to 2669 days): 32 patients have been irrigating from one to five years, and 9 patients for more than 5 years. Based on these results, we recommend irrigation as standard rehabilitative treatment for elderly patients.

Age Factors↗