for cabazitaxel and four for mitoxantrone. The most frequent clinically significant grade 3/4 adverse events were neutropenia (cabazitaxel (82%) vs. mitoxantrone (58%)). The marginal efficacy of cabazitaxel vs. mitoxantrone is 2.4 months for OS and 1.4 months for PFS. Considering OS as efficacy parameter, the incremental costefficacy ratio (ICER) calculated for the two treatments is €147.389. When PFS is considered, the ICER calculated is €248.871. Conclusions Based on this analysis, the ICERs calculated for cabazitaxel are too high for it to be considered a cost-effective option in the treatment of mHRPC, when compared with mitoxantrone, in patients previously treated with a docetaxel-containing regimen. No conflict of interest.

BackgroundPatients with tuberous sclerosis often develop facial angiofibromas that can be successfully treated with topical 1% sirolimus ointments. Nevertheless, this ointment’s greasy nature can produce acne, causing patients to refuse the treatment.PurposeTo devise a non-oily formula for topical sirolimus for patients with tuberous sclerosis and facial angiofibromas who develop acne due this ointment.Material and methodsWe reviewed the literature searching for standard procedures for making alternative topical formulations of sirolimus. In addition, the physicochemical properties of sirolimus were considered in order to find the most suitable formulation for this particular case.ResultsNo standard ways were found of producing oil-free formulations of sirolimus. We decided to compound a 0.2% sirolimus gel with the following procedure. First, prepare a 2% carmellose gel. For this, heat aqua conservans (Nipagin 0.25 g + Nipasol 0.11 g + distilled water 500 mL) to 50°C. In a mortar, mix 2 g of sodium carboxymethylcellulose and 10 g of glycerol. Then, add the content of the mortar to 88 g of heated aqua conservans and stir the mixture until room temperature is reached. Once the carmellose gel has been prepared, weigh 0.2 g of sirolimus and add a few drops of glycerol to it. Slowly, pour the carmellose gel onto the sirolimus, mixing them by stirring, until 100 g has been added. Let it stand for 12 h until the gel is homogeneous. We give it an expiry date of 2 months, stored in an opaque container and at room temperature (below 25°C). Mask and gloves must be used throughout the procedure.ConclusionWe found a way to formulate sirolimus in non-oily excipients in order to diminish the development of acne with its use. Further studies will be needed to determine the efficacy of this formula in the treatment of facial angiofibromas of patients with tuberous sclerosis and the improvement of the acne presented by these patients.References and/or acknowledgementsNo conflict of interest.

BackgroundPatients with chemosensitive neuroendocrine tumours are often treated with a capecitabine protocol (750 mg/m2 /12 h day 1 to day 14) and temozolomide (200 mg/m2 /24 h day 10 to day 14).A patient treated with this protocol in our centre presented with chromatopsia and night blindness. Capecitabine and temozolomide are drugs with well known ophthalmologic adverse effects but none of their drug labels suggests they can cause these symptoms.PurposeTo evaluate the causality between chromatopsia and night blindness and treatment with capecitabine and temozolomide.Material and methodsThe patient was interviewed to gather information and the medical records were analysed to reject any other cause of the symptoms.A search was conducted in OVID and PubMed. The terms visual alterations, chromatopsia and night blindness or nyctalopia and capecitabine and temozolomide were used. The Micromedex database was also checked.The local pharmacovigilance agency was notified and data were included in the Spanish Pharmacovigilance System database (number 20.202).The probability of the symptoms being adverse drug reactions was assessed with the Naranjo algorithm.ResultsThe patient remarded that the symptoms improved on the week off treatment and worsened when he restarted capecitabine. After a thorough ophthalmologic examination, no structural alterations were found. He had no brain metastases.No other reports of similar symptoms due to these two drugs were found in the literature or in Micromedex.According to the local pharmacovigilance agency, another case of chromatopsia and two cases of nyctalopia due to capecitabine and none due to temozolomide have been reported in the European Pharmacovigilance database.According to the Naranjo algorithm, the likelihood of the event being a temozolomide adverse drug reaction is possible (score 1) whereas it is definitely a capecitabine adverse drug reaction (score 9).ConclusionCapecitabine seemed to be the cause of chromatopsia and night blindness in this patient. As such adverse effects have not been published before, we think it is important to take this report into account and to consider that capecitabine may be the cause of these ophthalmic alterations in similar situations.No conflict of interest.

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