Objective: To determine whether isotretinoin (or 13cis-retinoic acid) decreases the risk of second primary cancers in patients previously treated for cure of head and neck squamous cell carcinoma. Design: Randomized, double-blind, placebocontrolled trial. Setting: Two head and neck multidisciplinary cancer clinics in university teaching hospitals taking cases from 4 to 5 million people in Queensland, Australia, combined to enter appropriate patients into this trial. Patients: One hundred fifty-one patients with their first head and neck squamous cell carcinoma treated with high expectation for cure and living close by. They were randomized into 3 arms to receive 3 years of treatment. Interventions: Patients took isotretinoin at a high dose (1.0 mg/kg per day) or a moderate dose (0.5 mg/kg per day) or placebo. Group 1 took the high dose for 1 year and then the moderate dose for 2 years. Group 2 took the moderate dose for 3 years. Group 3 took placebo for 3 years. Main Outcome Measures: The diagnosis of a second primary malignancy of the head and neck, lung, or bladder was regarded as the end point signifying failure of therapy. Issues of drug adverse effect profile and impact on survival were measured. Results: There was no significant difference in the occurrence of second primary disease (P = .90), the recurrence of primary disease (P = .70), or disease-free time (P=.80) between the treatment and nontreatment arms. Numbers were too small to find differences in survival. Conclusion: With evidence that retinoid treatment adversely affects survival of lung cancer and with this drug not significantly decreasing the incidence of second primary tumors of head and neck squamous cell carcinoma, the use of this drug in head and neck cancer patients for second cancer prophylaxis is not indicated.

This trial investigated the anti-schistosomal activity of mirazid in comparison with that of praziquantel in Schistosoma mansoni-infected Egyptian patients. The sample population was composed of 1,131 individuals (459 school children and 672 household members). Screening for S. mansoni was conducted using the standard Kato Katz technique. Four slides from a single stool sample were examined before treatment, and four slides per sample from stool samples obtained on three consecutive days were examined post-treatment. All positive eligible subjects were randomly assigned into two groups, the first received mirazid at a dose of 300 mg/day for three consecutive days, and the second received praziquantel at a single dose of 40 mg/kg. All treated subjects were examined 4-6 weeks post-treatment. Mirazid showed low cure rates of 9.1% and 8.9% in S. mansoni-infected school children and household members, respectively, compared with cure rates of 62.5% and 79.7%, respectively, in those treated with praziquantel. Therefore, we do not recommend mirazid as an agent to control schistosomiasis.

The present study evaluated the use of 3 types of Cysteine Protease Inhibitors (CPIs) with praziquantel (PZQ) as chemotherapy against schistosomiasis mansoni in mice. All groups were going to assessment of fluromethylketone (FMK), Vinyl Sulfone (VS) and Sodium Nitro Prussid (SNP) by measurement of parasitological, immunological and histological parameters. In our study, The ova count/gm liver or intestine on with PZQ treatment showed 99.1 and 95.2% Percent Reduction (PR), respectively compared to control group. The most effective CPI was FMK when combined with PZQ recording 99.8 and 99.6% PR for liver and intestine, respectively. Regarding to the oogram pattern, FMK, VS and SNP treatment either at 3 or 5 wk PI revealed marked decrease in the immature and mature ova counts and an increase of the dead ova percentages. The effect of CPIs was studied on the PR of Mean Granuloma Diameter (MGD) and Mean Granuloma Number (MGN) of infected treated groups compared to infected control and PZQ treated groups. FMK treatment proved to be highly was effective against S. mansoni in mice disintegrating ova and reduction in granulomatous size and numbers. The microscopic examination of liver sections of infected mice showed a large cellular granuloma with living central ova. sections of Infected mice liver treated with FMK or VS alone or combined with PZQ showed a great reduction in granuloma size as small cellular granuloma with central degenerated ova. We observed that these CPIs alone or combined with PZQ could effectively block schistosomal activity and prevented its growth and differentiation. Briefly, the best schistosomicidal effect of CPIs, that gained by drug administration orally in a dose of 50 mg kg(-1) mouse, was observed with FMK. This was followed by VS and lastly with SNP. These results gave evidence that CPIs can selectively arrest parasite replication without untoward toxicity to the host.

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