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.


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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.

Reference

  1. 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