Responsibility of the pharmaceutical industry in health safety

Under this title will be recalled the responsibilities exerted by the Pharmaceutical Industry in two different fields: in the field of drug production, which has to meet the most rigorous constraints in matter of quality (Good Manufacturing Practices, quality assurance...) under supervision of the pharmaceutical structure; in the field of drug use: after the initial evaluation of the benefit/risk ratio, on which in based the drug registration, it is the responsibility of the Industry to contribute constantly to the good use of medicines and to its optimization (information of health professionals, patient information, pharmacovigilance, and if necessary sanitary safety measures...).     

Lung metastases from follicular thyroid cancer: a report of a clinical case and a review of the literature

The authors report a case of follicular thyroid cancer in "hot nodule" with micronodular synchronous lung metastases. The treatment consisted in TT associated with radioiodine therapy at the dose of 170 mCi with remission of cancer after six months of follow-up. Follicular variant is a prognostic unfavorable factor such as synchronous or metachronous pulmonary metastases. In those patients prognostic unfavorable variants are also age over 40 years, a poor radiofixation capacity, and a lesion of diameter up 1 cm. A strictly instrumental follow-up is mandatory to obtain diagnosis in a subclinical stage. In such cases the radiometabolic therapy agree to a remission of cancer with high survival after many years. TT yet represents a "minimal" surgical treatment for an accurate radioisotopic diagnosis.     

Gastric metastasis from renal cell carcinoma fourteen years after radical nephrectomy

We report one case of solitary gastric metastasis from renal cell carcinoma following radical excision of the primary tumour 14 years previously. During evaluation for a severe anaemia with melaena, a patient underwent upper gastrointestinal endoscopy that evidenced the presence of a small polypoid lesion in the body of the stomach. Endoscopic biopsy revealed renal cell carcinoma. There was no evidence of further metastatic disease. A subtotal gastric resection with Roux-en-Y gastrojejunal reconstruction was performed. After 6 months follow-up, the patient was disease-free. This case confirms the potential of renal cell carcinoma for late and solitary metastasis with circumscribed local invasiveness and suggests that endoscopic resection may be feasible.     

Familial juvenile hypertrophy of the breast.

OBJECTIVE: Juvenile (virginal) hypertrophy of the breast (JHB) is a relatively rare condition leading to gigantomastia in peripubertal females. The pathology is limited usually to the breast, with otherwise normal growth and development and without any other deformities. The rapid growth of the breast (bilateral or unilateral) in adolescent girls leads to significant physical and psychological difficulties. This gigantomastia is treated surgically by breast reduction or mastectomy and its modification. Familial JHB was described only once in the literature, and its etiology is unknown. RESULTS: We report here on a familial pattern of juvenile hypertrophy of the breast accompanied by congenital anonychia. To the best of our knowledge, this is the first report of such a presentation. Our study dealt with four members of the same family, related through their fathers, enduring congenital anonychia of hands and feet with no functional limitation and who showed rapid uncontrolled breast enlargement in prepubertal age. This was severe enough to cause the curtailment of their social activity and cessation of schooling. The mothers of all four patients had normal breasts and nails, whereas their fathers had anonychia. The genetic basis for the association between the two clinical findings is yet to be determined. CONCLUSION: The four girls underwent breast reduction surgery.     

Long-term outcomes among localized prostate cancer survivors: health-related quality-of-life changes after radical prostatectomy, external radiation, and brachytherapy.

PURPOSE: We sought to elucidate long-term changes in health-related quality-of-life (HRQOL) outcomes by prospectively re-evaluating a well-characterized cohort of prostate cancer (PC) survivors 4 to 8 years after primary treatment. PATIENTS AND METHODS: Patients who had been evaluated previously at a median of 2.6 years after radical prostatectomy (RP), external radiation (three-dimensional conformal radiation therapy [3-D CRT]), or brachytherapy (BT) were recontacted at a median of 6.2 years after treatment. The clinical relevance of long-term HRQOL impairment among survivors was established by comparison with controls of similar age. Factors associated with HRQOL changes during this interval were evaluated. RESULTS: Of the 964 eligible men, 709 (73.5%) completed measurable questionnaires. In four domains (urinary irritative-obstructive, urinary incontinence, bowel, and sexual), significant HRQOL differences were detected for at least one of the therapy groups, compared with controls (all P < .05). During the 4-year interval, significant improvement was observed for the urinary irritative-obstructive (P < .0001) and bowel (P < .0001) domains among BT patients, whereas urinary incontinence HRQOL worsened for both the BT (P = .0017) and 3-D CRT (P = .0008) treatment groups. Overall sexual HRQOL deteriorated for the 3-D CRT cohort (P = .0017), as well as for controls (P = .0136). Among RP patients, significant HRQOL changes were not observed. CONCLUSION: During a 4-year interval from earlier to longer-term phases of PC treatment survivorship, sexual, urinary, and bowel dysfunction remain significant concerns among early-stage PC treatment survivors, compared with control men. Although postprostatectomy HRQOL remains relatively stable during this interval, disease-specific HRQOL continues to evolve among men treated with BT and 3-D CRT.     

Upfront high-dose sequential therapy (HDS) versus VACOP-B with or without HDS in aggressive non-Hodgkin's lymphoma: long-term results by the NHLCSG.

BACKGROUND: There is not univocal concordance for using high-dose sequential therapy (HDS) as first-line treatment for aggressive non-Hodgkin's lymphoma (NHL). We designed this study to evaluate the usefulness of HDS followed by high-dose therapy (HDT) with autologous stem cell transplantation as front-line treatment in different subsets of aggressive NHL. PATIENTS AND METHODS: Among 223 patients aged 15-60 years with aggressive, advanced stage NHL, 106 patients were randomized to VACOP-B (etoposide, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin) for 12 weeks (plus HDS/HDT in case of persistent disease) (arm A), and 117 patients to VACOP-B for 8 weeks plus upfront HDS/HDT (arm B). RESULTS: According to the intention-to-treat analysis, the complete response rate was 75% for arm A and 72.6% for arm B. With a median follow-up of 62 months there was no difference in 7-year probability of survival (60% and 57.8%; P = 0.5), disease-free survival (DFS) (62% and 71%; P = 0.2) and progression-free survival (PFS) (44.9% and 40.9%; P = 0.7) between the two arms. Subgroup analyses confirmed that the best results in terms of survival, DFS and PFS were achieved by patients with large B-cell NHL without bone marrow (BM) involvement, independently of the treatment arm. Results were poorer in other categories of patients and poorest in patients with BM involvement. CONCLUSIONS: Aggressive NHL patients do not benefit from upfront HDS/HDT.     

Surgical treatment of secondary hyperparathyroidism

BACKGROUND: Surgical treatment in the patient effected by secondary hyperparathyroidism consists in subtotal parathyroidectomy or total parathyroidectomy plus autotransplantation of parathyroid tissue. METHODS: The results obtained with surgical treatment of 6 patients observed in the years 1995-1996 are analyzed. Two glands were hyperplastic in four patients, 3 in the others. Every patient was submitted to a subtotal parathyroidectomy. RESULTS: Postoperative course was marked by transient hypoparathyroidism in one case. After 18 months of follow-up, no recurrences were observed. CONCLUSIONS: It is pointed out that in case of secondary hyperparathyroidism subtotal parathyroidectomy represents the surgical treatment of choice, according with literature data. Otherwise total parathyroidectomy plus autotransplantation, characterized by a more complex surgical technique, lead to the same results.     

A persistent tracheocutaneous fistula closed with two hinged skin flaps and rib cartilage interpositional grafting

Persistent tracheal fistula after tracheostomy decannulation is a recognized sequel to long-term tracheostomy use, causing important morbidity including difficult to vocalization and control of air secretions, recurrent pulmonary infections, and cosmetic and social problems. Herein, we reported a new method for closure of persistent tracheocutaneous fistula with rib cartilages. Compared to other techniques previously reported, the variations of our strategy were the use of temporary metal-covered tracheal stent and the hinged turnover skin bi-flaps reinforced with rib cartilage grafts. Rib cartilages were useful in order to reconstruct the trachea and prevent stenosis. Since it become difficult to obtain the maintenance of the trachea stability until healing of suture was well established, a covered metallic stent was also inserted to avoid flap collapse. The stent was removed 3 months later. Six months follow-up showed normal tracheal patency.