Phase II Trial of Paclitaxel Poliglumex (CT-2103) in Pre- and Post-Menopausal Women on Hormonal Replacement Therapy with Non-Small Cell Lung Cancer

    May 2011 in “ Journal of Clinical Oncology ”
    Marta Batus, Roozbeh Mohajer, Dorota Pach, Soumit K. Basu, Mary J. Fidler, Philip Bonomi
    TLDR Further testing of paclitaxel poliglumex for this cancer treatment is not justified.
    The Phase II trial investigated paclitaxel poliglumex (CT-2103) as a single-agent therapy in 29 women with advanced non-small cell lung cancer (NSCLC) who had high estradiol levels and were on hormonal replacement therapy. The study aimed to assess progression-free survival (PFS) and overall survival, with secondary endpoints including safety and response. Patients received CT-2103 every 21 days, with an average of 2.8 cycles. The median time to progression was 44 days, and median overall survival was 223 days. While 37.9% of patients had stable disease and 3.4% had a partial response, the treatment was well-tolerated with minor toxicities such as grade 1 and 2 peripheral neuropathy. Despite some positive preliminary results, the study concluded that further testing of this treatment strategy was not justified due to the PFS and overall survival outcomes.
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