Rilevazione retrospettiva multicentrica degli usi on-label e off-label dei farmaci chemioterapici utilizzati nei regimi di condizionamento nel trapianto di midollo osseo

Translated title of the contribution: Off-label uses of cytotoxic drugs in conditioning regimens for bone marrow transplantation: A retrospective multicenter survey

Cecilia Orsi, Michele Cecchi, Andrea Messori, Erminia Caccese, Sabrina Trippoli, Elena Oldani, Alberto Bosi, Stefano Guidi, Benedetta Bartolozzi, Andrea Bacigalupo, Maria Teresa Vanliant, Teresa Lamparelli, Emilio Paolo Alessandrino, Francesca Patriarca, Roberto Raimondi, Carlo Borghero

Research output: Contribution to journalArticle

Abstract

Background. In Italy the use of anticancer drugs outside approved indications (off-label) is frequent. The objective of this retrospective study was to evaluate off-label and on-label uses in the conditioning regimens for patients receiving autologous or allogeneic stem-cell transplantation (SCT). Patients and methods. Six Italian hospitals participated in the study. We retrospectively examined all patients who received SCT in these centres over the period from June to September 2006. Results. A total of 133 patients were studied; 75.9% of the schedules used were off-label (N=101) and 24.1/% were on-label (N=32). The three most frequent therapeutic regimens were: melphalan (labelled for conditioniong regimens in patients with multiple mieloma), BEAM (off-label) and BUCY (off-label). Conclusion. Our results show that the majority of current conditioning regimens are off-label. However, this use is well-established and homogeneous across the 6 centres. Our study was completed in February 2007 and emphasized the need for a better regulation on this topic. This then happened with the AIFA Determination of 29 May 2007 that presented a revised list of on-label and off-label uses of anti-cancer drugs reimbursed by National Health System and implicitly approved the off-label uses contained in the list.

Original languageItalian
Pages (from-to)374-380
Number of pages7
JournalGiornale Italiano di Farmacia Clinica
Volume21
Issue number4
Publication statusPublished - Oct 2007

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Off-Label Use
Bone Marrow Transplantation
Pharmaceutical Preparations
Stem Cell Transplantation
Melphalan
Italy
Appointments and Schedules
Retrospective Studies
Surveys and Questionnaires
Health
Neoplasms

ASJC Scopus subject areas

  • Pharmacology (medical)

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Rilevazione retrospettiva multicentrica degli usi on-label e off-label dei farmaci chemioterapici utilizzati nei regimi di condizionamento nel trapianto di midollo osseo. / Orsi, Cecilia; Cecchi, Michele; Messori, Andrea; Caccese, Erminia; Trippoli, Sabrina; Oldani, Elena; Bosi, Alberto; Guidi, Stefano; Bartolozzi, Benedetta; Bacigalupo, Andrea; Vanliant, Maria Teresa; Lamparelli, Teresa; Alessandrino, Emilio Paolo; Patriarca, Francesca; Raimondi, Roberto; Borghero, Carlo.

In: Giornale Italiano di Farmacia Clinica, Vol. 21, No. 4, 10.2007, p. 374-380.

Research output: Contribution to journalArticle

Orsi, C, Cecchi, M, Messori, A, Caccese, E, Trippoli, S, Oldani, E, Bosi, A, Guidi, S, Bartolozzi, B, Bacigalupo, A, Vanliant, MT, Lamparelli, T, Alessandrino, EP, Patriarca, F, Raimondi, R & Borghero, C 2007, 'Rilevazione retrospettiva multicentrica degli usi on-label e off-label dei farmaci chemioterapici utilizzati nei regimi di condizionamento nel trapianto di midollo osseo', Giornale Italiano di Farmacia Clinica, vol. 21, no. 4, pp. 374-380.
Orsi, Cecilia ; Cecchi, Michele ; Messori, Andrea ; Caccese, Erminia ; Trippoli, Sabrina ; Oldani, Elena ; Bosi, Alberto ; Guidi, Stefano ; Bartolozzi, Benedetta ; Bacigalupo, Andrea ; Vanliant, Maria Teresa ; Lamparelli, Teresa ; Alessandrino, Emilio Paolo ; Patriarca, Francesca ; Raimondi, Roberto ; Borghero, Carlo. / Rilevazione retrospettiva multicentrica degli usi on-label e off-label dei farmaci chemioterapici utilizzati nei regimi di condizionamento nel trapianto di midollo osseo. In: Giornale Italiano di Farmacia Clinica. 2007 ; Vol. 21, No. 4. pp. 374-380.
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abstract = "Background. In Italy the use of anticancer drugs outside approved indications (off-label) is frequent. The objective of this retrospective study was to evaluate off-label and on-label uses in the conditioning regimens for patients receiving autologous or allogeneic stem-cell transplantation (SCT). Patients and methods. Six Italian hospitals participated in the study. We retrospectively examined all patients who received SCT in these centres over the period from June to September 2006. Results. A total of 133 patients were studied; 75.9{\%} of the schedules used were off-label (N=101) and 24.1/{\%} were on-label (N=32). The three most frequent therapeutic regimens were: melphalan (labelled for conditioniong regimens in patients with multiple mieloma), BEAM (off-label) and BUCY (off-label). Conclusion. Our results show that the majority of current conditioning regimens are off-label. However, this use is well-established and homogeneous across the 6 centres. Our study was completed in February 2007 and emphasized the need for a better regulation on this topic. This then happened with the AIFA Determination of 29 May 2007 that presented a revised list of on-label and off-label uses of anti-cancer drugs reimbursed by National Health System and implicitly approved the off-label uses contained in the list.",
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AU - Orsi, Cecilia

AU - Cecchi, Michele

AU - Messori, Andrea

AU - Caccese, Erminia

AU - Trippoli, Sabrina

AU - Oldani, Elena

AU - Bosi, Alberto

AU - Guidi, Stefano

AU - Bartolozzi, Benedetta

AU - Bacigalupo, Andrea

AU - Vanliant, Maria Teresa

AU - Lamparelli, Teresa

AU - Alessandrino, Emilio Paolo

AU - Patriarca, Francesca

AU - Raimondi, Roberto

AU - Borghero, Carlo

PY - 2007/10

Y1 - 2007/10

N2 - Background. In Italy the use of anticancer drugs outside approved indications (off-label) is frequent. The objective of this retrospective study was to evaluate off-label and on-label uses in the conditioning regimens for patients receiving autologous or allogeneic stem-cell transplantation (SCT). Patients and methods. Six Italian hospitals participated in the study. We retrospectively examined all patients who received SCT in these centres over the period from June to September 2006. Results. A total of 133 patients were studied; 75.9% of the schedules used were off-label (N=101) and 24.1/% were on-label (N=32). The three most frequent therapeutic regimens were: melphalan (labelled for conditioniong regimens in patients with multiple mieloma), BEAM (off-label) and BUCY (off-label). Conclusion. Our results show that the majority of current conditioning regimens are off-label. However, this use is well-established and homogeneous across the 6 centres. Our study was completed in February 2007 and emphasized the need for a better regulation on this topic. This then happened with the AIFA Determination of 29 May 2007 that presented a revised list of on-label and off-label uses of anti-cancer drugs reimbursed by National Health System and implicitly approved the off-label uses contained in the list.

AB - Background. In Italy the use of anticancer drugs outside approved indications (off-label) is frequent. The objective of this retrospective study was to evaluate off-label and on-label uses in the conditioning regimens for patients receiving autologous or allogeneic stem-cell transplantation (SCT). Patients and methods. Six Italian hospitals participated in the study. We retrospectively examined all patients who received SCT in these centres over the period from June to September 2006. Results. A total of 133 patients were studied; 75.9% of the schedules used were off-label (N=101) and 24.1/% were on-label (N=32). The three most frequent therapeutic regimens were: melphalan (labelled for conditioniong regimens in patients with multiple mieloma), BEAM (off-label) and BUCY (off-label). Conclusion. Our results show that the majority of current conditioning regimens are off-label. However, this use is well-established and homogeneous across the 6 centres. Our study was completed in February 2007 and emphasized the need for a better regulation on this topic. This then happened with the AIFA Determination of 29 May 2007 that presented a revised list of on-label and off-label uses of anti-cancer drugs reimbursed by National Health System and implicitly approved the off-label uses contained in the list.

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