Gemcitabine Plus Erlotinib in RASH-positive Patients With Metastatic Pancreatic Cancer

Summary

In the current study it is examined whether patients with good risk factors (age \<75 years, total serum bilirubin \< 1,5xULN, no history of cardiovascular diseases) treated with gemcitabine and erlotinib who developed skin rash of any grade during the first 4 weeks of treatment have a comparable outcome as patients who receive FOLFIRINOX.

Timeline

Start

2012-07

Primary completion

2015-07

Completion

2017-12

Outcome

Met primary endpoint

paper Ninety patients were deemed positive for skin rash by the end of the run-in phase, showing a 1-year survival rate of 40.0% (95% confidence interval [CI] 29.8-50.9). PMID 29549862 ↗

Publications

• Weiss L, Heinemann V, Fischer LE, Gieseler F, Hoehler T, Mayerle J, Quietzsch D, Reinacher-Schick A, Schenk M, Seipelt G, Siveke JT, Stahl M, Vehling-Kaiser U, Waldschmidt DT, Dorman K, Zhang D, Westphalen CB, von Bergwelt-Baildon M, Boeck S, Haas M. Three-month life expectancy as inclusion criterion for clinical trials in advanced pancreatic cancer: is it really a valid tool for patient selection? Clin Transl Oncol. 2024 May;26(5):1268-1272. doi: 10.1007/s12094-023-03323-1. Epub 2023 Oct 4.
• Haas M, Siveke JT, Schenk M, Lerch MM, Caca K, Freiberg-Richter J, Fischer von Weikersthal L, Kullmann F, Reinacher-Schick A, Fuchs M, Kanzler S, Kunzmann V, Ettrich TJ, Kruger S, Westphalen CB, Held S, Heinemann V, Boeck S. Efficacy of gemcitabine plus erlotinib in rash-positive patients with metastatic pancreatic cancer selected according to eligibility for FOLFIRINOX: A prospective phase II study of the 'Arbeitsgemeinschaft Internistische Onkologie'. Eur J Cancer. 2018 May;94:95-103. doi: 10.1016/j.ejca.2018.02.008. Epub 2018 Mar 20.

Drugs

Indications