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Fruquintinib prolongs survival in previously treated metastatic colorectal cancer
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Fruquintinib significantly extended OS compared with placebo among adults with metastatic colorectal cancer who underwent at least two prior lines of chemotherapy, according to results of a randomized phase 3 study conducted in China.
“Although patients who progress after receiving two lines of systemic chemotherapy may still have good performance status, third-line treatment options are limited,” Shukui Qin, MD, PhD, of People’s Liberation Army Cancer Center of Bayi Hospital in China, and colleagues wrote. “There is, therefore, a strong unmet clinical need for treatment options in the third-line setting for metastatic colorectal cancer, especially in China.
Fruquintinib (Hutchison China MediTech Limited; Eli Lilly) is a vascular endothelial growth factor receptor inhibitor that blocks new blood vessel growth associated with tumor proliferation.
Qin and colleagues conducted a double-blind, placebo-controlled, multicenter trial that included 416 Chinese adults (mean age, 54.6 years; 61.3% men) with metastatic colorectal cancer that had progressed after at least two lines of chemotherapy.
Researchers randomly assigned 278 patients to receive 5 mg daily fruquintinib for 21 days, followed by 7 days off. The other 138 patients received placebo.
Treatment continued until disease progression, intolerable toxicity or study withdrawal.
OS served as the primary outcome. Secondary outcomes included PFS, objective response rate and disease control rate.
Patients assigned fruquintinib achieved significantly longer median OS (9.3 months vs 6.6 months; HR = 0.65; 95% CI, 0.51-0.83) and PFS (3.7 months vs. 1.8 months; HR = 0.26; 95% CI, 0.21-0.34).
A higher percentage of patients assigned fruquintinib experienced grade 3 or grade 4 treatment-emergent adverse events (61.2% vs. 19.7%). Patients assigned fruquintinib appeared nearly three times as likely to experience serious adverse events (15.5% vs. 5.8%) and to require hospitalization (14.4% vs. 5.1%).
Researchers acknowledged several study limitations.
Standard treatment for metastatic colorectal cancer in China differs from that of Western countries, as only one-third of patients had undergone prior treatment with anti-VEGF or anti-EGFR antibodies.
Also, neither regorafenib (Stivarga, Bayer) or TAS-102 (Lonsurf, Taiho Oncology) were available in China at the time the study was conducted. Consequently, researchers could not conduct fruquintinib with those agents.
“Among Chinese patients with metastatic colorectal cancer who had tumor progression following at least two prior chemotherapy regimens, oral fruquintinib compared with placebo resulted in a statistically significant increase in OS,” the researchers wrote. “Further research is needed to assess efficacy outside China.” – by Andy Polhamus
Disclosures: Qin reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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