WAILEA, Hawaii — Perioperative administration of Rh-Endostatin with traditional chemotherapy improved outcomes for patients with stage IIB osteosarcoma, according to study results presented at Connective Tissue Oncology Society.
“[The regimen] could significantly improve the distant metastasis-free survival and overall survival of [these patients],” Xiaohui Niu, MD, of the department of orthopedic oncology at Beijing Ji Shui Tan Hospital in China, said during a presentation. “This is a preliminary and exciting result. It is the first drug that could improve OS in the past 30 years. A randomized multicenter clinical trial is needed.”
Chemotherapy significantly improved OS of patients with osteosarcoma. Five-year OS rates range from 60% to 80%, and limb salvage rates range from 85% to 90%.
However, lung metastasis can occur, typically within 2 years of surgery. Survival of patients with these metastases has not changed in the past 3 decades.
Rh-Endostatin (Endostar, Simcere-Medgenn Bioengineering) is an antiangiogenic agent used extensively for the treatment of non-small cell lung cancer.
Niu and colleagues conducted a prospective nonrandomized controlled study to assess the efficacy and safety of perioperative Rh-Endostatin in conjunction with chemotherapy for patients with stage IIB osteosarcoma.
Researchers enrolled 388 patients (216 males) treated at Beijing Ji Shui Tan Hospital from January 2008 to April 2012.
Investigators excluded 58 patients from the final analysis, resulting in a control group of 272 patients (median age, 17 years; 180 males) and a treatment group of 58 patients (median age, 17 years; 36 males).
Patients in the control group received preoperative chemotherapy, surgery and postoperative chemotherapy. Patients in the treatment group received the same regimen, plus four cycles of Rh-Endostatin in the perioperative period. Each cycle consisted of 15 mg on days 1 to 14 every 3 weeks.
Metastases, distant metastasis-free survival and OS served as key outcome measures.
Median follow-up was 57 months.
Results showed no difference in local recurrence rates with Rh-Endostatin or without (5.2% vs. 9.2%).
However, patients assigned Rh-Endostatin appeared significantly more likely to achieve 5-year distant metastasis-free survival (79% vs. 61%; P = .009), 5-year PFS (78% vs. 60%; P = .015) and 5-year OS (86% vs. 75%; P = .028).
Also, a higher percentage of patients assigned RH-Endostatin remained free of metastasis after 1 year (88% vs. 78%).
“Rh-Endo could significantly decrease the first year’s metastasis,” Niu said. “The decreased metastasis in the first year possibly may improve overall survival.”
Researchers reported no difference in adverse drug reactions between groups. – by Mark Leiser
For more information:
Niu X, et al. Abstract 2784460. Presented at: Connective Tissue Oncology Society Annual Meeting; Nov. 8-11, 2017; Maui.
sclosure: Niu reports no relevant financial disclosures. Please see the abstract for a list of all other researchers’ relevant financial disclosures.