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Biomedical subjects

G Bertelli

Publications and source records attributed to G Bertelli.

At least 19 recordsLinked to original sources
PubMed1996

A feasibility study of accelerated polychemotherapy with cisplatin, epidoxorubicin and cyclophosphamide (PEC) in advanced ovarian cancer.

We have evaluated the feasibility of an increase in dose intensity of the cisplatin, epidoxorubicin and cyclophosphamide (PEC) regimen, with granulocyte colony-stimulating factor (G-CSF) support, in 22 patients with advanced ovarian cancer. Twenty-one patients (95.4%) received six cycles of treatment: of these, 13 (61.9%) were also able to repeat cycles every 14 days as planned. Marrow toxicity was similar to that observed during conventional treatments. No severe mucositis or thrombocytopenia was observed. A clinical complete response was observed in 9 out of 16 evaluable patients (56.2%).

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1996

Effect of adjuvant chemotherapy with or without anthracyclines on the activity and efficacy of first-line cyclophosphamide, epidoxorubicin, and fluorouracil in patients with metastatic breast cancer.

PURPOSE: To evaluate the effect of previous adjuvant chemotherapy with or without anthracyclines on overall survival (OS), progression-free survival (PFS), and objective response (OR) rates of metastatic breast cancer patients treated with cyclophosphamide, epidoxorubicin, and fluorouracil (CEF) as first-line chemotherapy. PATIENTS AND METHODS: Three-hundred twenty-six assessable metastatic breast cancer patients entered onto four consecutive randomized trials performed in our Institution and North-West Oncology Group (GONO) cooperative centers from 1983 to 1994. Patients received CEF-based chemotherapy as first-line therapy and were then evaluated. One hundred forty-four patients (44%) did not receive previous adjuvant chemotherapy, and 143 (44%) and 39 (12%) patients received cyclophosphamide, methotrexate, and fluorouracil (CMF)-based and anthracycline-based adjuvant chemotherapy, respectively. RESULTS: ORs to CEF chemotherapy were observed in 161 patients (49.4%). On univariate analysis, patients who had received prior adjuvant chemotherapy had a significantly lower probability of response than patients who did not: 43% versus 58% (P=.02). No difference between CMF-based (OR rate, 43%) and anthracycline-based (OR rate, 44%) adjuvant chemotherapy was observed. Stepwise logistic regression analysis indicated that adjuvant chemotherapy (P=.005), bone as dominant metastatic site (P=.02), and previous hormonotherapy for metastatic disease (P=.005) were the most important factors in predicting a poor OR rate. The median PFS and OS times of the whole group were 9.8 and 17.9 months, respectively. Patients who did not receive adjuvant chemotherapy had a longer survival time (21.1 months) compared with patients previously treated with CMF-based (15.3 months) or anthracycline-based (15.8 months) adjuvant chemotherapy. Multivariate analysis confirmed adjuvant chemotherapy to be among the strongest prognostic factors associated with both a poor PFS and OS. CONCLUSION: Previous adjuvant chemotherapy adversely affects OR, PFS, and OS in metastatic breast cancer patients treated with the CEF regimen as first-line chemotherapy. No difference was observed between patients previously treated with CMF-based or anthracycline-based adjuvant chemotherapy.

Adult↗
PubMed1995

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↗
PubMed1995

Carboplatin, methotrexate, and vinblastine in outpatients with advanced transitional cell carcinoma of the bladder.

Twenty outpatients with locally advanced (inoperable) or metastatic transitional cell carcinomas of the bladder were treated with carboplatin (300 mg/m2 i.v., day 1) + methotrexate (40 mg/m2 days 1 and 8) + vinblastine (6 mg/m2 days 1 and 8) (CaMV), every 4 weeks. One patient died of disease progression before completing at least 2 cycles of chemotherapy. Seven patients (35%) obtained a partial response; 8 had disease stabilization (40%) and 4 progressed (20%). Median duration of response was 3 months (range: 3-9), and median overall survival was 12+ months (range: 1-18+). None of the patients suffered grade IV toxicities, and no nephro-, neuro-, or ototoxicity was observed.

Aged↗
PubMed1995

Randomized cooperative study of perioperative chemotherapy in breast cancer.

PURPOSE: The aim of this multicentric randomized trial was to determine whether reducing the interval between surgery and chemotherapy improves the outcome of breast cancer patients. PATIENTS AND METHODS: Between June 1985 and July 1992, 600 breast cancer patients, clinical stages T1-3A,N0-2,M0 were randomly assigned to a perioperative cycle (PC) of cyclophosphamide 600 mg/m2, epidoxorubicin 60 mg/m2, and fluorouracil 600 mg/m2 (CEF). Node-negative (N-) patients did not receive any further treatment. Node positive (N+) patients received 11 cycles if previously given PC, or 12 cycles of CEF alternated with cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2 (CMF). In addition, N+ patients received concomitant or sequential 5-year tamoxifen therapy. RESULTS: At a median follow-up duration of 5.7 years, no significant difference in survival (88% v 84%, P = .3) between the two treatment arms was seen. However, a difference of borderline significance in relapse-free survival (RFS; 76% v 70%, P = .053) was evident. A significant survival advantage for the PC arm was detected only in the estrogen receptor-negative (ER-) patients (P = .003). RFS was significantly improved in N- patients, postmenopausal patients, and ER- patients. Multivariate analyses show that pathologic tumor size, nodal status, receptor status, and treatment (only in ER- patients) are significantly correlated with survival and RFS. PC toxicity did not influence wound healing. CONCLUSION: This study provides preliminary evidence that PC positively affects relapse rate and survival in some subgroups, namely, ER- patients.

Adult↗
PubMed1995

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↗
PubMed1995

Prevention and management of extravasation of cytotoxic drugs.

Extravasation of certain cytotoxic agents during peripheral intravenous administration may cause severe local injuries. Most extravasation can be prevented with the systematic implementation of careful administration techniques. However, the management of this complication, the aim of which is to prevent progression to tissue necrosis and ulceration, remains an important challenge in the care of cancer patients. Many antidotes have been evaluated experimentally and a few may be able to reduce the local toxicity of the more common vesicant cytotoxic drugs. Because no randomised trial on the management of cytotoxic drug extravasation in humans has ever been completed, recommendations must be based on the more consistent experimental evidence and on cumulative clinical experience from available case reports and uncontrolled studies, which are reviewed in this article. Empirical guidelines recommend the use of topical dimethylsulfoxide (DMSO) and cooling after extravasation of anthracyclines or mitomycin, locally injected hyaluronidase after extravasation of vinca alkaloids, and locally injected sodium thiosulfate (sodium hyposulfite) after extravasation of chlormethine (mechlorethamine; mustine). Plastic surgery may be necessary when conservative treatment fails to prevent ulceration. The possibility of late local reactions must also be considered in the management of patients receiving chemotherapy.

Adrenal Cortex Hormones↗
PubMed1994

What do advanced cancer patients know of their disease? A report from Italy.

The aim of this work was to investigate the awareness of diagnosis, prognosis and meaning of palliative treatment in Italian patients with advanced, incurable cancers. A group of 100 patients, referred to a Medical Oncology facility, were interviewed. Only 38 patients were aware of the malignant neoplastic nature of their disease. The remaining patients believed they had a benign neoplasia, non-neoplastic disease, or were unable to define their illness. No patient had a correct idea of the poor prognosis of the disease. Only 11.5% of 87 patients receiving chemotherapy had a correct perception of the palliative intent of the treatment, while most believed that the chemotherapy was "preventive". Dissatisfaction with the information received was expressed by a minority of patients. The awareness of diagnosis was better among women and patients with a higher educational background. Withholding the truth from cancer patients still seems very common in Italy.

Adult↗
PubMed1994

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↗
PubMed1993

Impact of irradiation of residual breast on adjuvant chemotherapy dose intensity.

The chemotherapy dose intensity for breast cancer has been recently considered to be an important factor in determining clinical outcome. Many trials have shown routine postoperative irradiation to have a detrimental effect on the delivered dose of adjuvant chemotherapy. In this paper the impact of radiotherapy on the dose intensity of adjuvant chemo- or hormonotherapy was evaluated in 237 breast cancer patients. 177 patients had radical mastectomy and 60 quadrantectomy followed by radiotherapy. Chemotherapy comprised 6 cycles of FEC (5-fluorouracil, epidoxorubicin, cyclophosphamide) alternated to 6 cycles of CMF (cyclophosphamide, methotrexate, 5-fluorouracil)+tamoxifen for 5 years. There were no significant differences in the adjuvant chemotherapy dose intensity in the mastectomy group compared to the radiotherapy group.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1993

Second-line hormonotherapy for breast cancer. Uselessness of first-line continuation.

The hypothesis that the results of second line hormonotherapy for breast cancer may be ameliorated with continuation of the first line has been explored in a randomized trial. Patients progressing under tamoxifen were randomly allocated to aminoglutethimide and hydrocortisone acetate with or without tamoxifen continuation. No difference has been observed between the two arms in terms of response rate and progression-free overall survival.

Aged↗
PubMed1993

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↗
PubMed1993

[The treatment of postoperative shivering with nefopam hydrochloride].

After having considered the physiopathological mechanism of shivering, the authors have estimated in a randomised study the effects of the resolution of shivering by nefopam hydrochloride. This drug a dose of 0.20 mg/kg resolved the symptoms in 100% of cases and the placebo hasn't resolved a case so that case it also obtained the same effects. The authors have proved the efficacy of the nefopam hydrochloride in the control of postoperative shivering in the recommended dose.

Adolescent↗
PubMed1992

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↗