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1.
Ann Oncol ; 27(12): 2283-2288, 2016 12.
Article in English | MEDLINE | ID: mdl-27733375

ABSTRACT

BACKGROUND: To report on long-term results of a phase 3 trial comparing three versus five cycles of adjuvant chemotherapy (CT) with full-dose epirubicin+ifosfamide in high-risk soft tissue sarcomas (STS). METHODS: Patients (pts) were randomized to receive three preoperative cycles of epirubicin 120 mg/m2 and ifosfamide 9 g/m2 (Arm A) or to receive the same three preoperative cycles plus two postoperative cycles (Arm B). Radiotherapy could be either delivered in the preoperative or in the postoperative setting. Non-inferiority of the primary end point, OS, was assessed by the confidence interval of the hazard ratio (HR; Arm A/Arm B) derived from Cox model. RESULTS: Between January 2002 and April 2007, 164 pts were assigned to arm A and 164 to arm B. At a median follow-up (FU) of 117 months (IQ range 103-135 months), 123 deaths were recorded: 58 in Arm A and 65 in Arm B. Ten-year OS was 61% for the entire group of patients: 64% in Arm A and 59% in Arm B. The intention-to-treat analysis confirmed that three cycles were not inferior to five cycles (one-sided 95% upper confidence limit was 1.24). A per protocol analysis was consistent with these results. Pts with leiomyosarcoma and undifferentiated pleomorphic sarcoma (UPS) had the lowest, and the highest response rates, respectively. Consistently, Leiomyosarcoma and UPS had the worse and the best prognosis, respectively. CONCLUSIONS: At a longer FU, the non-inferiority of three cycles of a full-dose conventional CT in comparison to five is confirmed. Response to therapy is also confirmed to be associated with better survival. This regimen is currently tested within an ongoing international trial against three cycles of a neoadjuvant histology-tailored CT (ClinicalTrials.gov Identifier: NCT01710176).


Subject(s)
Chemotherapy, Adjuvant , Leiomyosarcoma/drug therapy , Prognosis , Sarcoma/drug therapy , Adult , Aged , Disease-Free Survival , Female , Follow-Up Studies , Humans , Leiomyosarcoma/pathology , Leiomyosarcoma/radiotherapy , Male , Middle Aged , Risk Factors , Sarcoma/pathology , Sarcoma/radiotherapy , Treatment Outcome
3.
Eur J Dermatol ; 9(1): 43-4, 1999.
Article in English | MEDLINE | ID: mdl-9920987

ABSTRACT

A seventy-four-year-old patient had lupus vulgaris associated with the nodular, confluent ulcerated type of pulmonary tuberculosis. The diagnosis had been missed on several occasions. The presence of cutaneous tuberculosis in developed countries is emphasized again. It is also stressed that chronic dermatosis of unknown nature in an immunocompetent patient may have a tubercular origin. Complete resolution of the disease was achieved after almost two years of anti-tubercular therapy.


Subject(s)
Lupus Vulgaris/etiology , Tuberculosis, Pulmonary/complications , Tuberculosis, Pulmonary/diagnosis , Aged , Back , Diagnosis, Differential , Humans , Immunocompetence , Lupus Vulgaris/pathology , Male
4.
Dermatology ; 193(2): 88-93, 1996.
Article in English | MEDLINE | ID: mdl-8884141

ABSTRACT

BACKGROUND: An unclassified amicrobial pustular dermatosis particularly affecting the main cutaneous folds, external auditory canals and scalp and coexisting with systemic lupus erythematosus has been recently described. OBJECTIVE: We studied 3 young females bearing such cutaneous manifestations in association with subacute cutaneous lupus erythematosus, celiac disease and various serum autoantibodies, respectively, in order to further characterize this possibly new entity. METHODS: Various routine and immunological laboratory tests, histopathologic and direct immunofluorescence examinations and in vitro studies of neutrophil function were performed in each patient. RESULTS: We reported our findings and compared our cases with the few others appearing in the literature. We documented an impaired neutrophil chemotaxis in 2 subjects, but neutrophil dysfunction does not seem to be one of the verifying criteria. CONCLUSIONS: All of these cases may represent a distinctive form in the clinicopathological spectrum of neutrophilic dermatoses (ND) because of the typical distribution and the close link with different autoimmune disorders. Cimetidine in combination with ascorbic acid can be indicated as an effective and safe alternative to the classic medications of ND, although the action of both drugs remains unexplained.


Subject(s)
Autoimmune Diseases/complications , Lupus Erythematosus, Cutaneous/complications , Skin Diseases, Vesiculobullous/complications , Adult , Ascorbic Acid/therapeutic use , Autoantibodies/blood , Autoimmune Diseases/drug therapy , Autoimmune Diseases/immunology , Autoimmune Diseases/pathology , Celiac Disease/complications , Chemotaxis, Leukocyte , Cimetidine/therapeutic use , Ear Canal/pathology , Female , Fluorescent Antibody Technique, Direct , Histamine H2 Antagonists/therapeutic use , Humans , Lupus Erythematosus, Cutaneous/drug therapy , Lupus Erythematosus, Cutaneous/immunology , Lupus Erythematosus, Cutaneous/pathology , Neutrophils/immunology , Neutrophils/physiology , Scalp Dermatoses/complications , Scalp Dermatoses/drug therapy , Scalp Dermatoses/immunology , Scalp Dermatoses/pathology , Skin/pathology , Skin Diseases, Vesiculobullous/drug therapy , Skin Diseases, Vesiculobullous/immunology , Skin Diseases, Vesiculobullous/pathology
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