Burden of cremophor-related paclitaxel therapy on patients with ovarian cancer: A patient focused study from the United Kingdom, Germany, and Spain.

person Diana Brixner Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT info_outline Diana Brixner, Anke-Peggy Holtorf, Bhagyashree Oak, Sumudu Dehipawala, Clive Whitcher, Kate McKinley, Kyle Martin, Nandini Hadker, Ayesha Bhatia

Authors person Diana Brixner Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT info_outline Diana Brixner, Anke-Peggy Holtorf, Bhagyashree Oak, Sumudu Dehipawala, Clive Whitcher, Kate McKinley, Kyle Martin, Nandini Hadker, Ayesha Bhatia Organizations Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT, Health Outcomes Strategies, GmbH, Basel, Switzerland, Trinity Life Sciences, Waltham, MA, Trinity Life Sciences, New York, NY, Inceptua Limited, Windsor, United Kingdom, Elevar Therapeutics, Salt Lake City, UT, Trinity Life Sciences, Princeton, NJ Abstract Disclosures Research Funding Pharmaceutical/Biotech Company Background: Cremophor EL (CrEL) is a solubilizer used in paclitaxel and is associated with side effects (i.e., hypersensitivity reactions, peripheral neuropathy). Current CrEL-containing therapies require long infusion times (2-4 hours) and pre-medication with steroids to manage these side-effects. However, the holistic burden of CrEL on patients is not well studied. This study aimed to characterize the burden associated with CrEL-paclitaxel treatment on patients with ovarian cancer, including clinical, safety, and quality of life (QoL) implications. Methods: This quantitative, Institutional Review Board (IRB) approved, cross-sectional survey of patients (≥18 years) who received ≥3 cycles of CrEL-containing paclitaxel within the prior 6 months was conducted in UK, Germany, and Spain in 2021. Data were collected via a web-enabled instrument including a screener, questionnaire, and validated Functional Assessment of Cancer Therapy (FACT)-Taxane scale. Results are reported overall for the 3 countries. Results: Of the 90 patients surveyed, the mean age was 38.8 years. Most patients reported improvement of QoL (77%), treatment effectiveness (77%), less need for pre-medications (74%), and manageable/less disruptive infusion times and schedules (71%) as extremely desirable treatment attributes. Prior to or during chemotherapy, 41% of patients reported receiving steroids. Most patients (71%) experienced 3-6 side effects related to ovarian cancer treatment. Of the patients that experienced neuropathy (27%), the side effect lasted for up to 1 week for 54% of patients, and over multiple cycles of treatment (> 3 weeks) for 13% of patients. Of the 82% of patients eligible to complete the FACT-Taxane scale, 62% were somewhat to very much bothered by the side effects of paclitaxel. Half of these patients reported tingling/numbness in their hands/feet, moderately or very often. Patients reported an average of 4.8 hours as the time taken for their travels to/from the infusion center and receive their medication. Additionally, 91% of patients needed caregiver support for an average of 16 hours per week. 51% of patients reduced their work hours due to treatment and 58% reported a substantial impact on work productivity. To cover treatment costs, 63% purchased supplemental insurance. Conclusions: The patient-reported burden of treatment associated with CrEL-containing paclitaxel is significant and complex. Multiple treatment side effects occur in most patients which are burdensome and can recur and/or persist with future treatment cycles. There is an unmet need for an effective therapy that reduces treatment burden for patients and improves tolerability through fewer side effects, a reduced need for premedication, and shorter infusion time.