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2 results on '"Spagnoletti, Ilaria"'

1. Randomised Phase II Trial (NCT00637975) Evaluating Activity and Toxicity of Two Different Escalating Strategies for Pregabalin and Oxycodone Combination Therapy for Neuropathic Pain in Cancer Patients.

Author

Garassino, Marina Chiara, Piva, Sheila, La Verde, Nicla, Spagnoletti, Ilaria, Iorno, Vittorio, Carbone, Claudia, Febbraro, Antonio, Bianchi, Anna, Bramati, Annalisa, Moretti, Anna, Ganzinelli, Monica, Marabese, Mirko, Gentili, Marta, Torri, Valter, and Farina, Gabriella

Subjects
CANCER treatment, ADJUVANT treatment of cancer, THERAPEUTICS, NEUROLOGICAL disorders, PREGABALIN, OXYCODONE, DRUG dosage, DRUG efficacy, DRUG tolerance, CLINICAL trials
Abstract

Purpose: Neuropathic pain is commonly associated with cancer. Current treatments include combination opioid and adjuvant therapies, but no guidelines are available for dose escalation strategies. This phase II study compared the efficacy and tolerability of two dose escalation strategies for oxycodone and pregabalin combination therapy. Methods: Patients (N = 75) with oncological neuropathic pain, previously untreated with pregabalin, were recruited in 5 Italian institutions between 2007 and 2010. Patients were randomised to two different dose escalation strategies (arm A; N = 38) oxycodone at a fixed dose with increasing pregabalin doses; (arm B; N = 37) pregabalin at a fixed dose with increasing oxycodone doses. Patients were evaluated from daily diaries and follow-ups at 3, 7, 10, and 14 days after beginning treatment with a numerical rating scale (NRS), neuropathic pain scale (SDN), and well-being scale (ESAS). The primary endpoint was a ≥1/3 reduction in pain (NRS); secondary endpoints included the time to analgesia and adverse effects. The study had a 90% probability of detecting the best strategy for a true difference of at least 15%. Results: More patients in arm A (76%) than arm B (64%) achieved ≥1/3 overall pain reduction even after controlling for baseline factors (gender, baseline pain). Group A reported fewer side effects than group B; constipation 52.8% vs. 66.7%; nausea: 27.8% vs. 44.4%; drowsiness: 44.4% vs. 55.6%; confusion: 16.7% vs. 27.8%; itching: 8.3% vs. 19.4%. Conclusions: Both strategies effectively controlled neuropathic pain, but according to the adopted selection design arm A is preferable to arm B for pain control. Trial Registration: ClinicalTrials.gov NCT00637975 [ABSTRACT FROM AUTHOR]

Published
2013
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2. Two mutations of BRCA2 gene at exon and splicing site in a woman who underwent oncogenetic counseling

Author

Generoso Bevilacqua, Grazia Lombardi, Caterina Condello, Ilaria Spagnoletti, Stefano Pepe, Matilde Pensabene, Ma Caligo, A. Contegiacomo, I. Capuano, Pensabene, Matilde, Spagnoletti, Ilaria, Capuano, Ida, C., Condello, Pepe, Stefano, Contegiacomo, Alma, Lombardi, Gaetano, G., Bevilacqua, and M. A. C. a. l. i. g., O.

Subjects
DNA Mutational Analysis, BRCA-2, Breast Neoplasms, Genetic Counseling, Biology, Risk Assessment, Exon, Germline mutation, Humans, Genetic Predisposition to Disease, Genetic Testing, Gene, Germ-Line Mutation, Genetics, BRCA2 Protein, Ovarian Neoplasms, Splice site mutation, BRCA1 Protein, Intron, Hematology, Exons, Middle Aged, Prognosis, mutations, oncogenetic counseling, Stop codon, Pedigree, Gene Expression Regulation, Neoplastic, brast cancer, Phenotype, Oncology, RNA splicing, Cancer research, Female, RNA Splice Sites, Apoptosis Regulatory Proteins
Abstract

Background Although most BRCA sequence variants are clearly deleterious and unequivocally pathogenetic, several are still classified as variants of unknown significance. Patients and methods We followed families undergoing oncogenetic counseling from risk identification to risk definition by genetic testing and risk management. Results We identified two germline mutations in the BRCA2 gene in a woman with breast and ovarian cancer. One sequence alteration was 859/G>A in exon 7 (V211I). The other second sequence alteration (IVS13-2A>T) affected the splicing site in intron 13. The latter alteration is not yet listed in the Breast Cancer Information Core database. RT–PCR resulted in transcription of a sequence lacking exon 7 and a subsequent anomalous stop codon in exon 9 thereby confirming altered messenger RNA (mRNA) maturation. Amplification of the mutation in intron 13 resulted in transcription of a sequence lacking exon 14 and an anomalous stop codon in exon 15 thereby confirming altered mRNA maturation. Both mutations led to a truncated BRCA2 protein in its carboxy-terminal region. Conclusion The two BRCA2 mutations identified affect mRNA splicing fidelity and play a pathogenetic role in breast and ovarian cancer.

Published
2009

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