Sunitinib (Sotan) is a multi-targeted oral targeted therapy with both direct anti-tumor effects and anti-neoangiogenic activity. The European Society of Medical Oncology (ESMO) Congress featured a comprehensive exchange of views on the role of sunitinib in oncology treatment by experts and scholars from around the world.
Sotan (sunitinib) for gastrointestinal mesenchymal tumors
The encouraging results demonstrated by sotan (sunitinib) in the treatment of many other types of tumors. In patients with imatinib-resistant or intolerant gastrointestinal mesenchymal tumors (GIST), studies have shown that imatinib and sotan (sunitinib) treatment is effective. Continuous daily dosing of sotan (sunitinib) is a safe and effective dosing strategy for patients with imatinib-resistant or intolerant GIST.
Sunitinib is currently approved in several countries for the treatment of patients with advanced gastrointestinal mesenchymal tumors (GIST) who have failed/untolerated imatinib therapy, based on the results of an international multicenter randomized double-blind placebo-controlled phase III clinical trial published in The Lancet by American academic Demetri et al. At the European Society of Medical Oncology (EMSO) Congress, the investigators re-analyzed the data on the study’s long-term efficacy.
Imatinib-Ineffective GIST Patients: Sotan (sunitinib) Treatment Has Long-Term Survival Benefit
An updated statistical analysis of the study data by Schoffski et al. at the Gasthuisberg University Hospital in Leuven, Belgium, confirmed a long-term survival benefit with an acceptable and predictable long-term treatment safety profile for imatinib-naïve/intolerant GIST patients treated with sotanib (sunitinib). .
In this study, GIST patients who failed imatinib were randomized 2:1 to sunitinib (50 mg/d for 4 weeks per cycle and 2 weeks off) and placebo. Interim analysis showed that tumor growth was significantly slower in the sunitinib group than in the control group. Because the treatment group with sotane (sunitinib) showed significant treatment effects, the study was unblinded early and control patients were crossed over to the sunitinib group for continued treatment.
Throughout the study period, the most common treatment-related adverse events were fatigue, diarrhea, vomiting, and skin discoloration, which were mostly mild, generally tolerable, and effectively managed by dose reduction, discontinuation, or conventional therapy.
Clinical efficacy of Sotan
Sotan adverse reactions
Other】Trade name: Sotan
Generic name: Sunitinib malate
English name: sunitinib malate(Sutent)
Indications】 After taking imatinib mesylate (Glivec) for disease progression or allergic reaction, it is used to treat gastrointestinal stromal tumor (GIST) to treat renal cell tumor and gastrointestinal stromal tumor new drug.
Sunitinib (Sutent) is a novel multi-targeted oral drug for the treatment of tumors. Sunitinib is primarily developed for the treatment of gastrointestinal stromal tumors and metastatic renal cell carcinoma that do not respond to or are intolerant of standard therapies. Sunitinib selectively targets receptors for certain proteins, which are thought to play a molecular switch-like role in tumor growth.
Mechanism of action
Sunitinib is the first of a new class of drugs that can selectively target multiple receptor tyrosine kinases. Inhibition of receptor tyrosine kinases is thought to “starve” tumors by blocking the supply of blood and nutrients needed for tumor growth and to have simultaneous tumor cell killing activity, i.e. sunitinib combines two mechanisms of action: anti-angiogenesis by suspending blood supply to tumor cells and anti-tumor by directly attacking tumor cells.
Sunitinib may represent a new wave of targeted therapies, which can directly attack tumors without the toxic side effects of conventional chemotherapy, and its clinical advantages are obvious.
[Clinical evaluation].
Phase III clinical trials confirmed that sunitinib significantly prolonged tumor progression in patients with gastrointestinal stromal tumors that had been resistant or intolerant to imatinib treatment (6.3 months versus 1.5 months in the placebo group, respectively), and significantly reduced their risk of death by 50%. Sunitinib has also shown encouraging results in phase II clinical trials for the treatment of metastatic breast cancer and neuroendocrine tumors, among others. Sunitinib is now being studied in numerous studies alone or in combination with other antineoplastic agents for the treatment of many other types of solid tumors, including breast, lung, prostate and colorectal cancers.
The U.S. Food and Drug Administration (FDA) recently approved Pfizer’s new anti-cancer drug “Sutent” to treat both gastrointestinal mesenchymal tumors and to inhibit advanced renal cell carcinoma.
The FDA issued a press release saying that this is the first time the agency has approved an anti-cancer drug that can treat two diseases at the same time. “Sutent works by preventing tumor cells from getting the blood and nutrients they need to grow. Clinical trials have shown that the drug slows the growth of mesenchymal tumors in the gastrointestinal tract and reduces the size of kidney cell tumors. The most common side effects of Sutent are diarrhea, skin discoloration, inflammation of the mouth, weakness, and changes in taste.
The FDA prioritized the approval of Sutent, which took less than six months. Before approving the drug for marketing, the FDA also worked with Pfizer to make the drug available to patients who were not enrolled in clinical trials. According to the FDA, more than 1,700 cancer patients in the United States are currently taking the drug.
Pfizer’s anti-tumor drug sunitinib has promising clinical study results
According to data presented at the 2005 American Society of Clinical Oncology (ASCO) annual meeting, Pfizer’s new investigational drug sunitinib malate (SUTENT/SU11248) more than doubled the survival rate of patients with gastrointestinal interstitial tumors (GIST) resistant to imatinib (Gleevec) and significantly reduced tumor growth and spread. Encouraging phase II clinical study results were also observed in other tumor types, including metastatic renal cell carcinoma (mRCC), metastatic breast cancer, and neuroendocrine cancer.