Innovative Sequence of Docetaxel–Gemcitabine Based on Preclinical Data in the Treatment of Advanced Non-Small Cell Lung Cancer: A Phase I Study

    February 2005 in “ Lung Cancer ”
    Toni Ibrahim, Wainer Zoli, Giovanni Luca Frassineti, Anna Tesei, I. Colantonio, Manuela Monti, Dino Amadori
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    TLDR The new chemotherapy combination for advanced lung cancer showed a 35.7% response rate but caused significant side effects.
    In a 2005 phase I study, researchers assessed a new chemotherapy regimen combining docetaxel (DOC) and gemcitabine (GEM) in 15 patients with stage IIIB-IV non-small cell lung cancer (NSCLC). The treatment involved administering DOC on day 1 and GEM on days 3 and 8, every 21 days, with dose escalation to determine the maximum tolerated dose (MTD). The study was halted at the fifth dose level due to significant toxicities, including grade 4 febrile neutropenia. Neutropenia was the most common adverse effect, and other side effects included diarrhea, nausea, vomiting, mucositis, and alopecia. Out of 14 evaluable patients, there was one complete response, four partial responses, four stable diseases, and five disease progressions. The overall response rate was 35.7%, and a phase II trial was planned using the fourth dose levels.
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