PMID- 28932193
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220408
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 8
DP  - 2017
TI  - Safety Profile of Anticancer and Immune-Modulating Biotech Drugs Used in a Real 
      World Setting in Campania Region (Italy): BIO-Cam Observational Study.
PG  - 607
LID - 10.3389/fphar.2017.00607 [doi]
LID - 607
AB  - Objectives: To investigate the occurrence of adverse events (AEs) in naive 
      patients receiving biotech drugs. Design: A prospective observational study. 
      Setting: Onco-hematology, Hepato-gastroenterology, Rheumatology, Dermatology, and 
      Neurology Units in Campania Region (Italy). Participants: 775 patients (53.81% 
      female) with mean age 56.0 (SD 15.2). The mean follow-up/patient was 3.48 (95% 
      confidence interval 3.13-3.84). Main outcome measures: We collected all AEs 
      associated to biotech drugs, including serious infections and malignancies. 
      Serious AEs were defined according to the International Conference on 
      Harmonization of Technical Requirements for Registration of Pharmaceuticals for 
      Human Use, clinical safety data management: definitions and standards for 
      expedited reporting E2A guideline. Results: The majority of the study population 
      was enrolled in Onco-hematology and Rheumatology Units and the most common 
      diagnosis were hematological malignancies, followed by rheumatoid arthritis, 
      colorectal cancer, breast cancer, and psoriatic arthritis. The most commonly 
      prescribed biotech drugs were rituximab, bevacizumab, infliximab, trastuzumab, 
      adalimumab, and cetuximab. Out of 775 patients, 320 experienced at least one AE. 
      Most of patients experienced AEs to cetuximab therapy, rituximab and trastuzumab. 
      Comparing female and male population, our findings highlighted a statistically 
      significant difference in terms of AEs for adalimumab (35.90% vs. 7.41%, p < 
      0.001) and etanercept (27.59% vs. 10.00%, p = 0.023). Considering all biotech 
      drugs, we observed a peak for all AEs occurrence at follow-up 91-180 days 
      category. Bevacizumab, brentuximab, rituximab, trastuzumab and cetuximab were 
      more commonly associated to serious adverse events; most of these were possibly 
      related to biotech drugs, according to causality assessment. Three cases of 
      serious infections occurred. Conclusions: The results of our study demonstrated 
      that the majority of AEs were not serious and expected. Few cases of serious 
      infections occurred, while no case of malignancy did. Overall, the safety profile 
      of biotech drugs used in our population was similar to those observed in pivotal 
      trials. Notwithstanding the positive results of our study, some safety concerns 
      still remain unresolved. In order to collect more effectiveness and safety data 
      on biotech drugs, the collection and analysis of real world data should be 
      endorsed as well as the management of post-authorization studies.
FAU - Scavone, Cristina
AU  - Scavone C
AD  - The authors would like to thank all the members of the BIO-Cam group who provided 
      patient data for this study: University Hospital of Universita degli Studi della 
      Campania "Luigi Vanvitelli" Naples; Hospital SG Moscati-Avellino; Istituto 
      Nazionale Tumori-IRCCS "Fondazione G. Pascale" Naples; Hospital AORN Cardarelli 
      Naples; Hospital G Rummo Benevento; Hospital Sant'Anna e San Sebastiano Caserta; 
      University Hospital Universita degli Studi di Napoli Federico II Naples; 
      Fondazione Maugeri Benevento; University Hospital San Giovanni di Dio e Ruggi 
      d'Aragona Salerno; Hospital Ospedale dei Colli Naples.
FAU - Sportiello, Liberata
AU  - Sportiello L
AD  - The authors would like to thank all the members of the BIO-Cam group who provided 
      patient data for this study: University Hospital of Universita degli Studi della 
      Campania "Luigi Vanvitelli" Naples; Hospital SG Moscati-Avellino; Istituto 
      Nazionale Tumori-IRCCS "Fondazione G. Pascale" Naples; Hospital AORN Cardarelli 
      Naples; Hospital G Rummo Benevento; Hospital Sant'Anna e San Sebastiano Caserta; 
      University Hospital Universita degli Studi di Napoli Federico II Naples; 
      Fondazione Maugeri Benevento; University Hospital San Giovanni di Dio e Ruggi 
      d'Aragona Salerno; Hospital Ospedale dei Colli Naples.
FAU - Sullo, Maria G
AU  - Sullo MG
AD  - The authors would like to thank all the members of the BIO-Cam group who provided 
      patient data for this study: University Hospital of Universita degli Studi della 
      Campania "Luigi Vanvitelli" Naples; Hospital SG Moscati-Avellino; Istituto 
      Nazionale Tumori-IRCCS "Fondazione G. Pascale" Naples; Hospital AORN Cardarelli 
      Naples; Hospital G Rummo Benevento; Hospital Sant'Anna e San Sebastiano Caserta; 
      University Hospital Universita degli Studi di Napoli Federico II Naples; 
      Fondazione Maugeri Benevento; University Hospital San Giovanni di Dio e Ruggi 
      d'Aragona Salerno; Hospital Ospedale dei Colli Naples.
FAU - Ferrajolo, Carmen
AU  - Ferrajolo C
AD  - The authors would like to thank all the members of the BIO-Cam group who provided 
      patient data for this study: University Hospital of Universita degli Studi della 
      Campania "Luigi Vanvitelli" Naples; Hospital SG Moscati-Avellino; Istituto 
      Nazionale Tumori-IRCCS "Fondazione G. Pascale" Naples; Hospital AORN Cardarelli 
      Naples; Hospital G Rummo Benevento; Hospital Sant'Anna e San Sebastiano Caserta; 
      University Hospital Universita degli Studi di Napoli Federico II Naples; 
      Fondazione Maugeri Benevento; University Hospital San Giovanni di Dio e Ruggi 
      d'Aragona Salerno; Hospital Ospedale dei Colli Naples.
FAU - Ruggiero, Rosanna
AU  - Ruggiero R
AD  - The authors would like to thank all the members of the BIO-Cam group who provided 
      patient data for this study: University Hospital of Universita degli Studi della 
      Campania "Luigi Vanvitelli" Naples; Hospital SG Moscati-Avellino; Istituto 
      Nazionale Tumori-IRCCS "Fondazione G. Pascale" Naples; Hospital AORN Cardarelli 
      Naples; Hospital G Rummo Benevento; Hospital Sant'Anna e San Sebastiano Caserta; 
      University Hospital Universita degli Studi di Napoli Federico II Naples; 
      Fondazione Maugeri Benevento; University Hospital San Giovanni di Dio e Ruggi 
      d'Aragona Salerno; Hospital Ospedale dei Colli Naples.
FAU - Sessa, Maurizio
AU  - Sessa M
AD  - The authors would like to thank all the members of the BIO-Cam group who provided 
      patient data for this study: University Hospital of Universita degli Studi della 
      Campania "Luigi Vanvitelli" Naples; Hospital SG Moscati-Avellino; Istituto 
      Nazionale Tumori-IRCCS "Fondazione G. Pascale" Naples; Hospital AORN Cardarelli 
      Naples; Hospital G Rummo Benevento; Hospital Sant'Anna e San Sebastiano Caserta; 
      University Hospital Universita degli Studi di Napoli Federico II Naples; 
      Fondazione Maugeri Benevento; University Hospital San Giovanni di Dio e Ruggi 
      d'Aragona Salerno; Hospital Ospedale dei Colli Naples.
FAU - Berrino, Pasquale M
AU  - Berrino PM
AD  - The authors would like to thank all the members of the BIO-Cam group who provided 
      patient data for this study: University Hospital of Universita degli Studi della 
      Campania "Luigi Vanvitelli" Naples; Hospital SG Moscati-Avellino; Istituto 
      Nazionale Tumori-IRCCS "Fondazione G. Pascale" Naples; Hospital AORN Cardarelli 
      Naples; Hospital G Rummo Benevento; Hospital Sant'Anna e San Sebastiano Caserta; 
      University Hospital Universita degli Studi di Napoli Federico II Naples; 
      Fondazione Maugeri Benevento; University Hospital San Giovanni di Dio e Ruggi 
      d'Aragona Salerno; Hospital Ospedale dei Colli Naples.
FAU - di Mauro, Gabriella
AU  - di Mauro G
AD  - The authors would like to thank all the members of the BIO-Cam group who provided 
      patient data for this study: University Hospital of Universita degli Studi della 
      Campania "Luigi Vanvitelli" Naples; Hospital SG Moscati-Avellino; Istituto 
      Nazionale Tumori-IRCCS "Fondazione G. Pascale" Naples; Hospital AORN Cardarelli 
      Naples; Hospital G Rummo Benevento; Hospital Sant'Anna e San Sebastiano Caserta; 
      University Hospital Universita degli Studi di Napoli Federico II Naples; 
      Fondazione Maugeri Benevento; University Hospital San Giovanni di Dio e Ruggi 
      d'Aragona Salerno; Hospital Ospedale dei Colli Naples.
FAU - Berrino, Liberato
AU  - Berrino L
AD  - The authors would like to thank all the members of the BIO-Cam group who provided 
      patient data for this study: University Hospital of Universita degli Studi della 
      Campania "Luigi Vanvitelli" Naples; Hospital SG Moscati-Avellino; Istituto 
      Nazionale Tumori-IRCCS "Fondazione G. Pascale" Naples; Hospital AORN Cardarelli 
      Naples; Hospital G Rummo Benevento; Hospital Sant'Anna e San Sebastiano Caserta; 
      University Hospital Universita degli Studi di Napoli Federico II Naples; 
      Fondazione Maugeri Benevento; University Hospital San Giovanni di Dio e Ruggi 
      d'Aragona Salerno; Hospital Ospedale dei Colli Naples.
FAU - Rossi, Francesco
AU  - Rossi F
AD  - The authors would like to thank all the members of the BIO-Cam group who provided 
      patient data for this study: University Hospital of Universita degli Studi della 
      Campania "Luigi Vanvitelli" Naples; Hospital SG Moscati-Avellino; Istituto 
      Nazionale Tumori-IRCCS "Fondazione G. Pascale" Naples; Hospital AORN Cardarelli 
      Naples; Hospital G Rummo Benevento; Hospital Sant'Anna e San Sebastiano Caserta; 
      University Hospital Universita degli Studi di Napoli Federico II Naples; 
      Fondazione Maugeri Benevento; University Hospital San Giovanni di Dio e Ruggi 
      d'Aragona Salerno; Hospital Ospedale dei Colli Naples.
FAU - Rafaniello, Concetta
AU  - Rafaniello C
AD  - The authors would like to thank all the members of the BIO-Cam group who provided 
      patient data for this study: University Hospital of Universita degli Studi della 
      Campania "Luigi Vanvitelli" Naples; Hospital SG Moscati-Avellino; Istituto 
      Nazionale Tumori-IRCCS "Fondazione G. Pascale" Naples; Hospital AORN Cardarelli 
      Naples; Hospital G Rummo Benevento; Hospital Sant'Anna e San Sebastiano Caserta; 
      University Hospital Universita degli Studi di Napoli Federico II Naples; 
      Fondazione Maugeri Benevento; University Hospital San Giovanni di Dio e Ruggi 
      d'Aragona Salerno; Hospital Ospedale dei Colli Naples.
FAU - Capuano, Annalisa
AU  - Capuano A
AD  - The authors would like to thank all the members of the BIO-Cam group who provided 
      patient data for this study: University Hospital of Universita degli Studi della 
      Campania "Luigi Vanvitelli" Naples; Hospital SG Moscati-Avellino; Istituto 
      Nazionale Tumori-IRCCS "Fondazione G. Pascale" Naples; Hospital AORN Cardarelli 
      Naples; Hospital G Rummo Benevento; Hospital Sant'Anna e San Sebastiano Caserta; 
      University Hospital Universita degli Studi di Napoli Federico II Naples; 
      Fondazione Maugeri Benevento; University Hospital San Giovanni di Dio e Ruggi 
      d'Aragona Salerno; Hospital Ospedale dei Colli Naples.
CN  - BIO-Cam Group
LA  - eng
PT  - Journal Article
DEP - 20170906
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC5592230
OTO - NOTNLM
OT  - biotech drugs
OT  - observational study
OT  - pharmacovigilance
OT  - real world data
OT  - safety
FIR - Valentini, G
IR  - Valentini G
FIR - Romano, M
IR  - Romano M
FIR - Lo Schiavo, A
IR  - Lo Schiavo A
FIR - Morgillo, F
IR  - Morgillo F
FIR - Nuzzetti, R
IR  - Nuzzetti R
FIR - D'Aniello, R
IR  - D'Aniello R
FIR - Aiezza, M L
IR  - Aiezza ML
FIR - Bizzarro, E
IR  - Bizzarro E
FIR - Dello Stritto, A
IR  - Dello Stritto A
FIR - Di Renzo, G
IR  - Di Renzo G
FIR - Trimarco, V
IR  - Trimarco V
FIR - Valente, V
IR  - Valente V
FIR - Lombardi, M G
IR  - Lombardi MG
FIR - Spatarella, M
IR  - Spatarella M
EDAT- 2017/09/22 06:00
MHDA- 2017/09/22 06:01
PMCR- 2017/09/06
CRDT- 2017/09/22 06:00
PHST- 2017/07/14 00:00 [received]
PHST- 2017/08/22 00:00 [accepted]
PHST- 2017/09/22 06:00 [entrez]
PHST- 2017/09/22 06:00 [pubmed]
PHST- 2017/09/22 06:01 [medline]
PHST- 2017/09/06 00:00 [pmc-release]
AID - 10.3389/fphar.2017.00607 [doi]
PST - epublish
SO  - Front Pharmacol. 2017 Sep 6;8:607. doi: 10.3389/fphar.2017.00607. eCollection 
      2017.