Background: Breast cancer (BC) in young patients (<45 years) is an infrequent disease but current evidence suggest that there is an increase incidence in the last decades. After finishing adjuvant therapy, the risk of relapse or death does not increase with pregnancy. Under 40 years, fertility preservation could be an option because pregnancy after 40 usually requires in vitro fertilization techniques.
Purpose
The on-body injector (OBI) automatically delivers pegfilgrastim the day after chemotherapy (CTx), thus eliminating the need of return visits to the medical office for guideline-compliant pegfilgrastim administration. The CONVENIENCE study aimed to evaluate patient, nurse, and physician preferences as well as health economics for pegfilgrastim administration either with OBI or manually using a pre-filled syringe (PS).
Methods
Patients with early breast cancer, receiving two or three weekly anthracycline/cyclophosphamide or three weekly taxane-based CTx, and patients with Non-Hodgkin lymphoma (NHL) receiving first-line R-CHOP-14 or -21 were randomized 1:1 to receive both pegfilgrastim application forms for four consecutive CTx cycles in an alternating sequence starting either with OBI or PS. Primary endpoint was patient preference, assessed by questionnaires.
Results
A total of 308 patients were evaluable in the per-protocol analysis. Patients slightly preferred OBI over PS (OBI, n = 133, 43.2%; vs. PS, n = 111, 36.0%; p-value = 0.159), while study nurses slightly preferred PS (n = 19, 46.3%) over OBI (n = 18, 43.9%) and physicians clearly preferred PS (n = 24, 58.8%) over OBI (n = 15, 36.6%). Among patients with preference for OBI, saving of time was their major reason for preference (53.4%). Pegfilgrastim was administered 24–72 h after each CTx cycle in 97.6% of OBI and 63.1% of PS applications.
Conclusion
The OBI was slightly preferred by patients and saving time was the major reason for their preference. PS was physicians’ most preferable choice and slightly preferred by nurses. Using OBI, pegfilgrastim was almost always administered within the time period recommended by current guidelines, while it was often not applied as specified using PS.
Trial registration
No: ClinicalTrials.gov No. NCT03619993. Registered on June 25, 2018
among which activation of DNA replication and changes in cell cycle regulation were notable. Organoids which retained regeneration capacity after carboplatin exposure, showed a sustained shift in expression of stemness associated surface marker CD133+ in the subsequent passages as showed by fluorescence-activated cell sorting and Western blot Conclusion We hereby propose OFE assay as a novel functional readout for carboplatin sensitivity. Furthermore, expression profile changes in organoids during acute response to carboplatin provide insights into specific signaling hallmarks that are associated with resistance to carboplatin. and could help identify the cellular mechanism behind the process.
ConclusionIn a pooled analysis of 464 patients, MIRV monotherapy demonstrated ETB in ~10% patients. The safety profile consisted primarily of low-grade gastrointestinal and ocular events and reinforces MIRV's potential to become a new standard of care for FRa-positive ovarian cancer.
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