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Open AccessArticle
Bevacizumab-Based Therapies in Malignant Tumors—Real-World Data on Effectiveness, Safety, and Cost
by
Elena Chitoran
Elena Chitoran 1,2
,
Vlad Rotaru
Vlad Rotaru 1,2,*
,
Sinziana-Octavia Ionescu
Sinziana-Octavia Ionescu 1,2,*
,
Aisa Gelal
Aisa Gelal 1,2,
Cristina-Mirela Capsa
Cristina-Mirela Capsa 1,3,
Roxana-Elena Bohiltea
Roxana-Elena Bohiltea 1,4,
Madalina-Nicoleta Mitroiu
Madalina-Nicoleta Mitroiu 1,4,
Dragos Serban
Dragos Serban 1,5
,
Giuseppe Gullo
Giuseppe Gullo 6
,
Daniela-Cristina Stefan
Daniela-Cristina Stefan 1 and
Laurentiu Simion
Laurentiu Simion 1,2
1
Medicine School, “Carol Davila” University of Medicine and Pharmacy, 050474 Bucharest, Romania
2
General Surgery and Surgical Oncology Department I, Bucharest Institute of Oncology “Prof. Dr. Al. Trestioreanu”, 022328 Bucharest, Romania
3
Radiology Department, Bucharest Institute of Oncology “Prof. Dr. Al. Trestioreanu”, 022328 Bucharest, Romania
4
Obstetrics and Gynecology Department, “Filantropia” Clinical Hospital, 011132 Bucharest, Romania
5
Surgery Department 4, Bucharest University Emergency Hospital, 050098 Bucharest, Romania
6
Department of Obstetrics and Gynecology, Villa Sofia Cervello Hospital, University of Palermo, 90146 Palermo, Italy
*
Authors to whom correspondence should be addressed.
Submission received: 30 June 2024
/
Revised: 8 July 2024
/
Accepted: 18 July 2024
/
Published: 19 July 2024
Simple Summary
Given the wide usage of Bevacizumab in current oncological practice, it is very important to compare the “real-world” results to those obtained in controlled clinical trials. This study aims to describe the clinical experience of using Bevacizumab in a large cohort of cancer patients in “non-controlled real-world” conditions regarding effectiveness, safety, and cost of therapy. For this purpose, we conducted an open, observational, retrospective study involving all patients treated for solid malignant tumors in the Bucharest Institute of Oncology with “Prof. Dr. Al. Trestioreanu” with Bevacizumab-based systemic therapy, between 2017 and 2021. Bevacizumab re-mains a high-cost therapy, but it can add to clinical benefits (like overall survival, progression-free survival, and response rate) when used in conjunction with standard chemotherapy. Similar results as those presented in various controlled trials are observable even on unselected cohorts of patients in the uncontrolled conditions of “real-world” oncological practice.
Abstract
Overall, it is estimated that more than 3,500,000 patients have received Bevacizumab as part of systemic oncologic treatment. Bevacizumab and its biosimilars are currently marketed in over 130 countries. Given the wide usage of Bevacizumab in current oncological practice, it is very important to compare the “real-world” results to those obtained in controlled clinical trials. This study aims to describe the clinical experience of using Bevacizumab in a large cohort of cancer patients in “non-controlled real-world” conditions with regard to effectiveness, safety, and cost of therapy. Methods: For this purpose, we conducted an open, observational, retrospective study involving all patients treated for solid malignant tumors in the Bucharest Institute of Oncology with “Prof. Dr. Al. Trestioreanu” with Bevacizumab-based systemic therapy, between 2017 and 2021. Results: The study consisted of 657 treatment episodes in 625 patients (F/B = 1.62/1, with a median age of 57.6 years) which were treated for malignant tumors (majority colorectal, non-small cell lung, ovarian, and breast cancer). First-line treatment was administered in 229 patients, and the rest received Bevacizumab as second or subsequent lines of treatment. The overall response rate to Bevacizumab-based therapies was around 60–65% across all indication except for subsequent treatment lines in colorectal and ovarian cancers, where lower values were recorded (27.1%, and 31.5% respectively). Median PFS for the entire cohort was 8.2 months (95% CI 6.8–9.6), and the median OS was 13.2 months (95% CI 11.5–14.9). Usual bevacizumab-related toxicities were observed, including bleeding, hypertension, wound-healing complications, gastrointestinal perforation, other types of fistulas, septic complications, and thromboembolic events. Although the clinical benefits are undeniable, the addition of Bevacizumab to standard chemotherapy increased the overall treatment cost by 213%. Conclusions: Bevacizumab remains a high-cost therapy, but it can add to clinical benefits (like overall survival, progression-free survival, and response rate) when used in conjunction with standard chemotherapy. Similar results as those presented in various controlled trials are observable even on unselected cohorts of patients in the uncontrolled conditions of “real-world” oncological practice. Off-label usage is encountered in clinical practice, and this aspect should be monitored given the potential adverse effects of the therapy.
Share and Cite
MDPI and ACS Style
Chitoran, E.; Rotaru, V.; Ionescu, S.-O.; Gelal, A.; Capsa, C.-M.; Bohiltea, R.-E.; Mitroiu, M.-N.; Serban, D.; Gullo, G.; Stefan, D.-C.;
et al. Bevacizumab-Based Therapies in Malignant Tumors—Real-World Data on Effectiveness, Safety, and Cost. Cancers 2024, 16, 2590.
https://doi.org/10.3390/cancers16142590
AMA Style
Chitoran E, Rotaru V, Ionescu S-O, Gelal A, Capsa C-M, Bohiltea R-E, Mitroiu M-N, Serban D, Gullo G, Stefan D-C,
et al. Bevacizumab-Based Therapies in Malignant Tumors—Real-World Data on Effectiveness, Safety, and Cost. Cancers. 2024; 16(14):2590.
https://doi.org/10.3390/cancers16142590
Chicago/Turabian Style
Chitoran, Elena, Vlad Rotaru, Sinziana-Octavia Ionescu, Aisa Gelal, Cristina-Mirela Capsa, Roxana-Elena Bohiltea, Madalina-Nicoleta Mitroiu, Dragos Serban, Giuseppe Gullo, Daniela-Cristina Stefan,
and et al. 2024. "Bevacizumab-Based Therapies in Malignant Tumors—Real-World Data on Effectiveness, Safety, and Cost" Cancers 16, no. 14: 2590.
https://doi.org/10.3390/cancers16142590
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