Among patients with advanced gastric cancer, pre- and postsurgical treatment with the anti-PD-1 antibody camrelizumab and a low dose of the VEGFR-2 inhibitor rivoceranib plus the chemotherapies S-1 and oxaliplatin (SOX), a combination known as SOXRC, has been shown to elicit superior responses compared to SOX alone, researchers have found.
Findings from the phase 3 DRAGON IV/CAP 05 study of patients with locally advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma were published in the Journal of Clinical Oncology.
Among 180 patients in the SOXRC and SOX groups, respectively, the rates of pathologic complete response were 18.3% and 5%, respectively, researchers reported. Likewise, major pathologic response rates were 51.1% and 37.8%, respectively.
Of note, the study initially had a third group of patients being treated with high-dose rivoceranib plus SOX, a treatment regimen known as SOXR, but enrollment was stopped based on safety data from the first 103 randomly assigned patients in the three groups, and the study findings published in the Journal of Clinical Oncology reflect the results among the first 360 patients who had the opportunity for surgery in the SOXRC and SOX groups.
“While combined PD-1/VEGFR inhibition plus chemotherapy is not ready for routine use in the neoadjuvant setting for G/GEJ cancers, these study findings offer an encouraging early signal of efficacy,” wrote Journal of Clinical Oncology associate editor Dr. Andrew H. Ko in a relevance statement published alongside the study. “Longer-term data focused on oncologic outcomes will determine whether this enhanced strategy has the potential to be adopted into clinical practice.”
Patients in the study received three cycles of presurgical therapy followed by radical gastrectomy three to six weeks later and then received three cycles of postsurgical therapy four to six weeks later under the same regimen as their presurgical therapy.
Patients in the SOXRC group then received three additional cycles of camrelizumab plus rivoceranib and patients in the SOXR group received three additional cycles of rivoceranib. Researchers could then decide to continue treatment for up to one year for rivoceranib and 17 doses of camrelizumab during the entire course of therapy. In the SOX groups, it was up to researchers to decide whether to continue S-1 for up to a year during treatment.
Researchers reported that in the presurgical phase, treatment-related side effects of any grade occurred among 157, or 88%, of patients in the SOXRC group and 142, or 80%, of patients in the SOX group, with grade 3 (severe) or higher treatment-related side effects occurring in 60 (34%) and 30 (17%) patients, respectively. These side effects resulted in dose interruption, delay or reduction in 74 (41%) and 47 (26%) patients, respectively, with nine (5%) and one (1%) patients discontinuing treatment.
The most common side effects of any grade included decreased neutrophil count (89 patients, or 50%, in the SOXRC group and 53 patients, or 30%, of the SOX group), decreased white blood cell count (88 patients or 49% and 49 patients or 28%) and decreased platelet count (66 patients or 37% and 56 patients or 31%).
Reference
“Pathologic Response of Phase III Study: Perioperative Camrelizumab Plus Rivoceranib and Chemotherapy Versus Chemotherapy for Locally Advanced Gastric Cancer (DRAGON IV/CAP 05)” by Dr. Chen Li et al., Journal of Clinical Oncology.
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