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Published on: July 31, 2016
A phase II, randomized, double-blind, placebo-controlled multicenter trial of Endostar in patients with metastatic
Chuanliang Cui1, Lili Mao, Zhihong Chi
1Department of Renal Cancer and Melanoma, The Key laboratory of Carcinogenesis and Translational Research, Ministry of Education, Peking University Cancer Hospital & Institute, Beijing, China.
Abstract:
Endostatin is a potent endogenous angiogenic inhibitor with implicated antitumor activity. However, efficacy of recombinant human endostatin (rhES) in clinical trials is controversial, and application of rhES in treatment of metastatic melanoma awaits further investigations. This phase II trial evaluated the efficacy and safety of a soluble and stable rhES (Endostar) plus dacarbazine in patients with metastatic melanomas that contains no mutations in c-kit and BRAF genes. A total of 110 patients received placebo plus dacarbazine (250 mg/m², n = 54) or Endostar (7.5 mg/m²) plus dacarbazine (250 mg/m², n = 56). The primary end points were progression-free survival (PFS) and overall survival (OS). Median PFS in the Endostar plus dacarbazine arm was 4.5 months versus 1.5 months in the placebo plus dacarbazine arm (hazard ratio (HR) = 0.578; P = 0.013). There were statistically significant improvements in OS (median, 12.0 months versus 8.0 months; HR, 0.522; P = 0.005) in favor of the Endostar plus dacarbazine arm. The regimen was generally well tolerated and had a manageable toxicity profile. Our trial suggests that Endostar plus dacarbazine is well tolerated in patients with metastatic melanoma harboring no genetic mutations popular for targeted therapy and yields a significant improvement in PFS and OS.
Insights
Recombinant human endostatin (rhES) combined with dacarbazine significantly improved progression-free survival and overall survival in metastatic melanoma patients lacking common genetic mutations. This combination therapy demonstrated a favorable safety profile, offering a new treatment avenue.
Area of Science:
- Oncology
- Medical Research
- Clinical Trials
Background:
- Endostatin is an endogenous angiogenic inhibitor with potential antitumor effects.
- Clinical efficacy of recombinant human endostatin (rhES) in cancer treatment remains under investigation.
- The role of rhES in metastatic melanoma, particularly in patients without specific genetic mutations, requires further evaluation.
Purpose of the Study:
- To assess the efficacy and safety of a soluble and stable rhES formulation (Endostar) combined with dacarbazine in patients with metastatic melanoma.
- To evaluate the impact of Endostar plus dacarbazine on progression-free survival (PFS) and overall survival (OS) in this patient population.
- To determine the tolerability and toxicity profile of the Endostar plus dacarbazine regimen.
Main Methods:
- A phase II clinical trial involving 110 patients with metastatic melanoma lacking c-kit and BRAF mutations.
- Patients were randomized to receive either Endostar (7.5 mg/m²) plus dacarbazine (250 mg/m²) or placebo plus dacarbazine (250 mg/m²).
- Primary endpoints included progression-free survival (PFS) and overall survival (OS).
Main Results:
- Median PFS was significantly improved in the Endostar plus dacarbazine arm (4.5 months) compared to the placebo arm (1.5 months) (HR = 0.578; P = 0.013).
- Overall survival (OS) was also significantly extended in the Endostar plus dacarbazine group (median 12.0 months) versus placebo (median 8.0 months) (HR = 0.522; P = 0.005).
- The Endostar plus dacarbazine regimen was well-tolerated with a manageable toxicity profile.
Conclusions:
- Endostar plus dacarbazine demonstrates significant improvements in PFS and OS for metastatic melanoma patients without common targeted therapy mutations.
- The combination therapy is well-tolerated and presents a viable treatment option for this specific patient group.
- Further investigation into rhES as a therapeutic agent for metastatic melanoma is warranted.
