Background
Among women, ovarian cancer is the 5th most common type of cancer. The risk of getting this cancer in one lifetime is 1 in 78.
Treatment with Apatinib plus Doxil vs Doxil alone showed better efficacy with a manageable side effect for patients with platinum-resistant recurrent ovarian cancer, according to results from the phase 2 “APPROVE trial” (NCT04348032).
Apatinib [Aitan® (brand name in China)], also known as Rivoceranib, is a novel, small molecule, selective vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor and is the second anti-angiogenic drug to be approved in China for the treatment of advanced or metastatic gastric cancer.
Doxil is Liposomal doxorubicin, it is an anthracycline-type chemotherapy drug that is used to treat certain types of cancer (such as ovarian cancer, AIDS-related Kaposi’s sarcoma, multiple myeloma). It works by slowing or stopping cancer cell growth.
About the APPROVE Trial – Ovarian Cancer Patients
A total of 152 patients were enrolled and randomly assigned to either the Apatinib arm or the Doxil alone arm.
Doxil was given at 40 mg/m2 on day 1 every 4 weeks for up to 6 cycles in both groups. Apatinib was given at 250 mg once daily.
Study Results
A progression event or death was experienced in 47.4% of patients in the Apatinib group and 67.6% in the Doxil alone arm.
The median time-to-disease-progression during the treatment (also called Progression-Free Survival, PFS) was 5.8 months in the Apatinib arm compared with 3.3 months for Doxil alone.
The median Survival in the Apatinib arm was 23.0 months compared with 14.4 months in the Doxil alone arm.
In the Apatinib group, the treatment worked in 81.5% of patients vs 53.1% in the Doxil alone group.
Side Effects
Apatinib dose reductions were necessary in 12.2% of patients and 6.8% required Doxil dose reductions.
In the Apatinib group, 3.8% of patients discontinued treatment because of side effects.
The most common severe side effects were decreased white blood cell count and decreased neutrophil counts.
Those treated with Apatinib had an increase in Hand-Foot Syndrome, Hypertension and Proteinuria compared with the Doxil alone group.
No patients died from side effects.
In Conclusion – Ovarian Cancer Patients
Results from the phase 2 APPROVE trial showed Apatinib plus Doxil improved efficacy and safety compared with Doxil alone for patients with platinum-resistant recurrent ovarian cancer.
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