Treatment of classic Kaposi sarcoma with a nicotine dermal patch: a phase II clinical trial.

BACKGROUND: Kaposi sarcoma (KS), a malignancy of dermal endothelial cells that is caused by human herpesvirus 8 (HHV8) infection, is sensitive to perturbations of immunity. Nicotine might be effective against KS because of its immunologic and vascular effects and because smoking is associated with a low risk of KS. OBJECTIVE AND STUDY DESIGN: We conducted a masked, randomized phase 2 clinical trial of transdermal nicotine and placebo patches to assess the safety and efficacy of nicotine against classic KS (cKS). SUBJECTS AND METHODS: Three cKS lesions, predominantly nodules, in each of 24 non-smoking patients were randomly assigned to 15 weeks continuous treatment with nicotine patch (escalated to 7 mg), identical masked placebo patch or no patch. Changes in lesion area and elevation from baseline through six follow-up visits, by direct measurement and by two independent readers using digital photographs of the lesions, were compared using non-parametric and regression methods. Changes in longitudinal levels of HHV8 antibodies and DNA in blood cells were similarly assessed. RESULTS: There were no systemic or serious adverse events, and compliance was good. One patient resumed smoking and discontinued patches, and two patients withdrew at week 12 for unrelated indications. Six (29%) of the remaining 21 suspended use of patches to relieve local skin irritation; four of these six completed the trial at reduced dose. Treatment assignment was not associated with significant or consistent changes in cKS lesion area or elevation, HHV8 viral load or antibodies. CONCLUSION: Transdermal nicotine and placebo patches caused no serious toxicities but had no demonstrable effect on nodular cKS lesions or HHV8 levels.

Combination of vinblastine and bleomycin as first line therapy in advanced classic Kaposi's sarcoma.

BACKGROUND: Classic KS (CKS) mainly affects elderly people, has an irregular course, and is relatively benign for years. However, sometimes the disease may progress rapidly and spread to internal organs, thus necessitating systemic chemotherapy. We therefore decided to carry out a prospective trial using vinblastine and bleomycin, which are active, easy to administer and control, and low cost. METHODS: We treated 29 patients affected by CKS with vinblastine i.v., up to 10 mg in combination with bleomycin i.m., 15 IU every 3 weeks. We administered a median of seven cycles of therapy. RESULTS: All the 29 enrolled patients were evaluated: 21% reached a complete response and 76% had an intermediate response. Toxicity was limited. The maximal response was attained in a median of 5 months, with a mean duration of 4 months. CONCLUSION: The combination of vinblastine and bleomycin achieved a high rate of objective responses in a subgroup of elderly and symptomatic patients, without considerable toxicity. We recommend the combination as first line chemotherapy for advanced CKS.

Comparison between the 21-gauge Urocut needle and the 21-gauge Surecut needle in echo-guided percutaneous biopsy of neoplastic liver lesions.

Fine cutting needles for histology are now widely used in echo-guided biopsies of various organs. In this study we compared the results obtained in the biopsy of neoplastic hepatic lesions using two different 21-gauge cutting needles: Trucut needle (Urocut) and a modified Menghini needle (Surecut). Eighty-five patients with primary or metastatic hepatic neoplasms were biopsied with a Urocut needle and a further 85 patients underwent biopsy with a Surecut needle. The two groups were comparable for size and nature of hepatic neoplasms. The Urocut needle provided a much higher percentage of diagnostic material than the Surecut needle (94.8% vs 70.5%) regardless of the primary or metastatic nature of the lesion or its size. The diagnostic accuracy was only identical for both needles (91.3% for Urocut vs 91.5% for Surecut) whenever the diagnostic material was compared in cases in which both types of needles had been used to take the biopsy specimens. There were no complications in either of the two groups studied. Given the smaller incidence of non-diagnostic biopsies with the Urocut needle, we consider that this needle should be preferred in echo-guided biopsies of neoplastic hepatic lesions.

Extracorporeal lithotripsy of intrahepatic stones with associated strictures of intrahepatic biliary ducts.

BACKGROUND AND AIMS: Intrahepatic stones are a frequent disease in the Eastern world but rare in Western countries. Treatment is complex and often requires surgical intervention. Extracorporeal shock wave lithotripsy is a relatively recent technique, widely used in the treatment of stones in the gallbladder and common bile duct. It can also be used in the treatment of intrahepatic stones. The present study analyses the efficacy of extracorporeal shock wave lithotripsy in intrahepatic stones. PATIENTS AND METHODS: In our study, we used extracorporeal lithotripsy in six cases of intrahepatic stones (mean age 53 years). In five of these cases deformities of the intrahepatic bile ducts were also present: stenoses and angulated strictures. The stones were in the right lobe of the liver in 5 patients, and in both lobes in 1 patient. Four patients had multiple stones and 2 a single stone, all varying in diameter from 6 to 25 mm. The stones were localized radiologically with contrast medium through a drainage tube. The technique does not require anaesthesia. An average of three lithotripsy sessions were necessary, with a mean total of 8050 shock waves per patient. RESULTS: Successful fragmentation was obtained in 5 out of 6 patients, while the remaining subsequently underwent surgery. No complications were observed. CONCLUSIONS: Extracorporeal shock wave lithotripsy proved to be effective, easy to perform and safe for the treatment of intrahepatic stones.