Kerri Fitzgerald

DocwireNews

An investigational oral formulation of&nbsp;paclitaxel&nbsp;improved response compared with the intravenous (IV) formulation in women with metastatic&nbsp;<a href="https://www.docwirenews.com/docwire-pick/hem-onc-picks/denosumab-flops-in-breast-cancer-study/">breast cancer</a>, according to a study presented at the San Antonio <a href="https://www.docwirenews.com/abstracts/hem-onc-abstracts/body-composition-adherence-to-anthracycline-and-taxane-based-chemotherapy-and-survival-after-nonmetastatic-breast-cancer/">Breast Cancer</a> Symposium. However, the oral form is taken with encequidar, which has a time-consuming administration that requires nine consecutive hours of fasting.The pivotal, open-label, randomized, phase III study randomized 402 patients 2:1 to receive oral paclitaxel 205 mg/m&sup2; plus encequidar for three days per week (n=265) or IV paclitaxel 175 mg/m&sup2; every three weeks (n=137).<h2>Improved survival with oral formulation of paclitaxel</h2>Patients receiving the oral formulation had a better overall response rate (primary endpoint) compared with IV (35.8% vs. 23.4%; P=0.011). Responses in the oral paclitaxel cohort were also durable: Confirmed responses of more than 150 days occurred in 51% of responders in the oral group and 38% of responders in the IV group.Ongoing analysis of overall survival favored the oral paclitaxel formulation at the time of reporting (P=0.035), with a median of 27.9 months in the oral cohort compared with 16.9 months&nbsp;in the IV cohort. Ongoing progression-free survival analysis also favored the oral cohort (9.3 months vs. 8.3 months, respectively; P=0.077).There was a lower incidence and severity of neuropathy in the oral cohort compared with IV; at week 23, 17% of the oral group reported any-grade neuropathy compared with 57% of the IV group.&nbsp;Grade 3 neuropathic symptoms were observed in 1% of the oral group and 8% of the IV group.The oral formulation had higher rates of neutropenia, infection, and gastrointestinal adverse events.

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Oral Formulation of Paclitaxel Improves Breast Cancer Response Compared With IV

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An investigational oral formulation of paclitaxel improved response compared with the intravenous (IV) formulation in women with metastatic breast cancer, according to a ...

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