Lenz HJ, et al. - Researchers undertook this phase II study that compared etirinotecan pegol (EP) versus irinotecan as second-line treatment for KRAS-mutant, irinotecan-naïve, metastatic colorectal cancer (mCRC). As per findings, EP was active and safe for the aforementioned condition.

Methods

• Researchers randomized patients to EP 145 mg/m² or irinotecan 350 mg/m² Q21d until disease progression/unacceptable toxicity.
• Progression-free survival (PFS) with response determined by central radiologic review (RECIST version 1.1) was observed as the primary endpoint.

Results

• Due to evolving standards of care, the study was terminated before completing accrual.
• Randomization was performed of 83 patients.
• EP versus irinotecan resulted in longer median PFS (4.0 versus 2.8 months, respectively; HR 0.65; 95% CI 0.40–1.04; P = 0.07); six-month PFS rates were 32.8 and 15.4%, respectively.
• Median OS of 9.6 and 8.4 months were noticed in EP and irinotecan arms, respectively (HR 0.91; 95% CI 0.56–1.49); ORRs were 10 and 5%, respectively (P = 0.676).
• Median DOR was significantly longer in EP arm (7.9 versus 1.4 months; P = 0.018).
• For EP and irinotecan, the most common grade-3/4 adverse events were diarrhea (21 vs 20%), neutropenia (10 vs 22%), abdominal pain (14 vs 5%), nausea (14 vs 2%), and vomiting (12 vs 7%), respectively.