Logo Medical Science Monitor

Call: +1.631.470.9640
Mon - Fri 10:00 am - 02:00 pm EST

Contact Us

Logo Medical Science Monitor Logo Medical Science Monitor Logo Medical Science Monitor

23 February 2019 : Clinical Research  

Addition of Zoledronate to Chemotherapy in Patients with Osteosarcoma Treated with Limb-Sparing Surgery: A Phase III Clinical Trial

Shenglong Li1EF*, Peng Chen2AC, Yi Pei1BD, Ke Zheng1AF, Wei Wang1ABD, Enduo Qiu1BCE, Xiaojing Zhang1ACE

DOI: 10.12659/MSM.913236

Med Sci Monit 2019; 25:1429-1438

Abstract

BACKGROUND: Zoledronate has anti-bone resorption activity and is reported to reduce skeletal-related events. The objective of this study was to test the hypothesis that addition of zoledronate in chemotherapy is safe and effective in osteosarcoma.

MATERIAL AND METHODS: A total of 798 patients, age 25 years and above, with newly diagnosed high-grade surgically salvageable malignant osteosarcoma, were included in the trial. All patients had received standard chemotherapies (n=399). In addition, in a standard chemotherapy regimen, patients enrolled in the zoledronate group also received 10 courses of 4 mg intravenous infusions of zoledronate (n=399). Limb-sparing surgery was performed by orthopedic surgeons (n=798). Clinical assessment, laboratory monitoring, overall survival, event-free survival, and treatment-emergent adverse effects were evaluated. The chi-square independence-samples test was used for statistical analysis at 95% confidence level.

RESULTS: The histopathological response was the same for both groups (p=0.12). Addition of zoledronate to chemotherapy improved skeletal event-free survival (p=0.04) but decreased overall survival (p=0.02). Zoledronate induced hypocalcemia (p<0.0001), hypophosphatemia (p<0.0001), cardiotoxicity (p<0.0001), lung metastases (p=0.03), flu-like syndrome (p<0.0001), and ototoxicity (p=0.02), and elevated serum aspartate aminotransferase (p<0.0001) and serum alanine aminotransferase (p<0.0001).

CONCLUSIONS: The addition of zoledronate to standard chemotherapy in high-grade resectable osteosarcoma is detrimental and is not advised.

Keywords: Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Osteosarcoma, Survival Rate, Bone Neoplasms, Cisplatin, Combined Modality Therapy, Methotrexate, zoledronic acid

Add Comment 0 Comments

Editorial

01 February 2025 : Editorial  

Editorial: Current Approaches to Screening for Lung Cancer in Smokers and Non-Smokers

Dinah V. Parums

DOI: 10.12659/MSM.948255

Med Sci Monit 2025; 31:e948255

0:00

In Press

Clinical Research  

Procedure Dynamics in Transfemoral vs Transradial Cerebral Angiography: A Retrospective Study

Med Sci Monit In Press; DOI: 10.12659/MSM.947603  

Clinical Research  

Predicting Cerebral Small Vessel Disease Burden Based on Thromboelastography in Patients with Acute Ischemi...

Med Sci Monit In Press; DOI: 10.12659/MSM.946303  

Clinical Research  

Long-Term Outcomes of Implanon in Managing Adenomyosis: A 3-Year Prospective Study

Med Sci Monit In Press; DOI: 10.12659/MSM.945972  

Laboratory Research  

Linear Dimensional Accuracy in Maxillomandibular Records: A Comparative Study of Scannable and Transparent ...

Med Sci Monit In Press; DOI: 10.12659/MSM.947265  

Most Viewed Current Articles

17 Jan 2024 : Review article   6,969,459

Vaccination Guidelines for Pregnant Women: Addressing COVID-19 and the Omicron Variant

DOI :10.12659/MSM.942799

Med Sci Monit 2024; 30:e942799

0:00

16 May 2023 : Clinical Research   701,879

Electrophysiological Testing for an Auditory Processing Disorder and Reading Performance in 54 School Stude...

DOI :10.12659/MSM.940387

Med Sci Monit 2023; 29:e940387

0:00

01 Mar 2024 : Editorial   25,628

Editorial: First Regulatory Approvals for CRISPR-Cas9 Therapeutic Gene Editing for Sickle Cell Disease and ...

DOI :10.12659/MSM.944204

Med Sci Monit 2024; 30:e944204

0:00

28 Jan 2024 : Review article   20,173

A Review of IgA Vasculitis (Henoch-Schönlein Purpura) Past, Present, and Future

DOI :10.12659/MSM.943912

Med Sci Monit 2024; 30:e943912

0:00

Your Privacy

We use cookies to ensure the functionality of our website, to personalize content and advertising, to provide social media features, and to analyze our traffic. If you allow us to do so, we also inform our social media, advertising and analysis partners about your use of our website, You can decise for yourself which categories you you want to deny or allow. Please note that based on your settings not all functionalities of the site are available. View our privacy policy.

Medical Science Monitor eISSN: 1643-3750
Medical Science Monitor eISSN: 1643-3750