Intraperitoneal paclitaxel prolongs survival in gastric cancer with peritoneal metastases
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The addition of intraperitoneal paclitaxel to systemic capecitabine and oxaliplatin appeared to benefit patients with gastric cancer and peritoneal metastases, according to study results presented at Gastrointestinal Cancers Symposium.
“Peritoneal metastasis is a common problem in patients with gastric cancer, and this unfortunately is not effectively treated by systemic chemotherapy alone given the presence of the peritoneal-plasma barrier,” Daryl Chia, MBBS, surgery resident at National University Health System in Singapore, said during his virtual presentation. “A number of studies have reported promising results with the use of intraperitoneal chemotherapy in addition to systemic chemotherapy; however, a majority of these studies utilize S1 plus a taxane for systemic chemotherapy. At the present moment, the combination of intraperitoneal taxane with a fluoropyrimidine and platinum-based doublet regimen has not been studied in patients with gastric cancer with peritoneal metastases.”
Thus, Chia and colleagues conducted a phase 2 trial to evaluate survival among 44 patients (mean age, 61 ± 9 years; 90% Chinese; 56.8% women) with peritoneal metastases from gastric cancer who received 40 mg/m2 intraperitoneal paclitaxel on days 1 and 8 along with systemic capecitabine dosed at 1,000 mg/m2 orally twice daily on days 1 through 14 and oxaliplatin dosed at 100 mg/m2 via IV on day 1 of up to eight 21-day treatment cycles.
Patients with synchronous peritoneal metastases (n = 36) could undergo conversion surgery with radical gastrectomy if they had a good response to chemotherapy, negative cytology on two consecutive peritoneal fluid assessments, no extraperitoneal metastasis and no peritoneal disease during surgery. Thirteen patients met these criteria and underwent surgery.
Researchers compared outcomes with those of a retrospective historical cohort of 39 patients (mean age, 56 ± 12 years; 61.5% Chinese; 46.2% women) treated with systemic chemotherapy alone. Chia noted that this group was younger (P = .021) and had better baseline performance status (ECOG 0, 76.9% vs. 47.7%; P = .007) than the intraperitoneal treatment group.
OS served as the study’s primary endpoint. PFS and safety served as secondary endpoints.
Results showed a greater proportion of patients in the intraperitoneal paclitaxel group achieved 1-year OS than the historical cohort (67.8% vs. 32.1%), with median OS of 14.6 months vs. 10.6 months (HR = 0.44; 95% CI, 0.26-0.74).
Researchers also reported a PFS benefit, with 35.4% of patients undergoing intraperitoneal paclitaxel achieving 1-year PFS compared with 8.5% of the historical cohort, and median PFS of 9.5 months vs. 4.4 months (HR = 0.39; 95% CI, 0.25-0.66).
In the subgroup of patients who underwent conversion surgery, median OS was 24.2 months, with 84.6% achieving 1-year OS.
Neutropenia was the most common hematologic adverse event of grade 3 or worse, occurring in 18% of patients in the intraperitoneal group. The most common nonhematologic adverse events of grade 3 or worse included electrolyte imbalance (14%), diarrhea (7%) and fever (5%). Port-related complications occurred among 10 patients, four of whom required intervention such as moving or removing the port.
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Chia D, et al. Abstract 165. Presented at: Gastrointestinal Cancers Symposium (virtual meeting); Jan. 15-17, 2021.
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