Gemcitabine plus erlotinib does not improve disease-free survival (DFS) or overall survival (OS) compared to gemcitabine alone in patients with pancreatic ductal adenocarcinoma (PDAC), according to a study published in the Journal of Clinical Oncology.1
For this phase 3 CONKO-005 study, researchers randomly assigned 436 patients with PDAC to receive intravenous (IV) gemcitabine 1000 mg/m2 on days 1, 8, and 15 for 4 cycles plus daily erlotinib 100 mg (GemErlo) or IV gemcitabine alone (Gem) for 6 cycles.
At the median follow-up of 54 months, 177 (81%) of patients receiving GemErlo and 184 (85%) of patients receiving Gem experienced disease recurrence.
The median duration of therapy was 22 weeks in both treatment arms. There was no difference in the median DFS between the two treatment arms; the GemErlo arm had a median DFS of 11.4 months (95% CI, 9.3-13.2) compared with 11.4 months (95% CI, 9.2-13.6) in the Gem arm (hazard ratio [HR], 0.94; 95% CI, 0.76-1.15; P = .26).
There was no significant difference in OS between the GemErlo arm (24.5 months [95% CI, 21.1-27.8]) and the Gem arm (26.5 months [95% CI, 22.4-30.6])(P = .61), but the GemErlo arm trended towards long-term survival more so than the Gem arm (estimated survival after 1, 2, and 5 years for GemErlo was 77%, 53%, and 25% compared with 79%, 54%, and 20%, for Gem, respectively).
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The most frequently reported grade 3 to 4 adverse events included neutropenia, leukopenia, increase in gamma glutamyl transferase, diarrhea, and fatigue. The occurrence or grade of rash was found to have no effect in survival, which was a secondary aim for the study.
- Sinn M, Bahra M, Liersch T, et al. CONKO-005: adjuvant chemotherapy with gemcitabine plus erlotinib versus gemcitabine alone in patients after R0 resection of pancreatic cancer: a multicenter randomized phase III trial. J Clin Oncol. 2017 Aug 18. doi: 10.1200/JOC.2017.72.6463