Clinical Research Papers:
Multicentric survey on dose reduction/interruption of cancer drug therapy in 12.472 patients: indicators of suspected adverse reactions
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Andrea Casadei Gardini1,*, Elena Tenti2,*, Carla Masini2, Oriana Nanni3, Emanuela Scarpi3, Martina Valgiusti1, Silvia Restuccia4, Maria Laura Gallani5, Simonetta Palazzini6, Erica Bianchini7, Silvia Menozzi8, Antonio Maugeri2, Dino Amadori1, Martina Minguzzi2 and Giovanni Luca Frassineti1
1 Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e Cura dei Tumori IRST IRCCS, Meldola, Italy
2 Oncology Pharmacy Laboratory, IRST IRCCS, Meldola, Italy
3 Unit of Biostatistics and Clinical Trials, IRST IRCCS, Meldola, Italy
4 Department of Clinical Pharmacy, University Hospital S. Orsola-Malpighi, Bologna, Italy
5 Department of Clinical Pharmacy, University of Parma, Parma, Italy
6 Department of Clinical Pharmacy, Azienda Ospedaliera della Romagna (AUSL), Rimini, Italy
7 Department of Clinical Pharmacy, University Hospital of Ferrara, Ferrara, Italy
8 Department of Clinical Pharmacy, Hospital S. Maria Nuova, Reggio Emilia, Italy
* These authors have contributed equally to this work
Emanuela Scarpi, email:
Keywords: sorafenib, capecitabine, pharmacovigilance, docetaxel, oxaliplatin
Received: January 15, 2016 Accepted: April 02, 2016 Published: April 22, 2016
Antiblastic drugs have a high number of potential side-effects. Paradoxically, according to the National Network of Pharmacovigilance, the number of reported adverse reactions to these agents is proportionally lower than that registered for non antiblastic drugs. Critical phenomena such as treatment interruptions and significant dose reductions within the first two months of use may be indicators of adverse drug reactions. The aim of the present study was to increase our knowledge of pharmacovigilance to facilitate the actions taken to improve the risk-benefit profile of cancer drugs and, consequently, their safety. This retrospective observational survey was carried out on prescriptions from 1st January 2012 to 31st December 2012.Dose reductions of more than 10% during the first 90 days of therapy were considered as a surrogate indicator of an adverse reaction. Dose interruptions during the first 60 days of therapy were taken into consideration. Of the12,472 patients 1,248 underwent a dose reduction. The drugs that most often required a dose reduction were paclitaxel and oxaliplatin (17.4% and 17.3%, respectively), docetaxel (14.8%), carboplatin (15%), fluorouracil (10.7%) and, among oral medications, capecitabine (6.9%). Of the 1896 patients treated with the same drugs, 9.7% interrupted treatment. Patients required a lower dose reduction than that reported by other authors. Around 15% of cases underwent a 30% dose reduction within three months of starting therapy, indicating a possible adverse reaction. Constant monitoring of dose prescription and continuous training of medical and nursing staff are clearly needed to increase awareness of the importance of reporting adverse events.
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