Survey on adverse events associated with drug therapy for breast cancer patients

Abstract

Background: In the breast cancer treatment, there may be a gap between patients' information needs and physicians' perceptions. To address this issue, we conducted a comprehensive questionnaire survey aimed to assess the specific information needs of patients regarding the adverse events (AEs) associated with treatment.

Methods: A web-based questionnaire survey (UMIN000049280: Registered on October 31, 2022) was conducted in patients with a history of breast cancer treatment. Responses were obtained regarding AEs experienced, AEs for which remedies were identified, AEs patients sought to prevent, and pre-treatment information on AEs patients desired to have.

Results: Data from 435 breast cancer patients were analyzed. The most common AEs reported included hair loss (93.3%), malaise/fatigue (89.4%), nail changes (83.2%), dysgeusia (69.0%), leukopenia/white blood cell decreased (65.1%), neuropathy (62.3%), and nausea/vomiting (61.4%). Financial anxiety was reported in 35.2% of the participants. AEs for which a minority of patients found effective solutions included neuropathy (20.3%), financial anxiety (21.6%), edema (24.3%), joint pain (26.0%), and malaise/fatigue (26.7%). Patients expressed the greatest desire to avoid hair loss (34.7%), followed by nausea/vomiting (23.7%), interstitial lung disease/pneumonitis (5.5%), malaise/fatigue (5.1%), and dysgeusia (5.1%). The most commonly requested pre-treatment information regarding AEs was their duration, followed by prevention methods, management strategies, time to onset, and the impact on daily life.

Conclusions: This survey highlights the existence of significant unmet medical needs among breast cancer patients, due to the inadequate solutions available for managing AEs associated with various therapeutic agents. In addition, the survey revealed that patients have different information needs regarding different types of AEs.

Keywords: Adverse events; Breast cancer; PRO; Patients’ need; Questionnaire survey.

Fig. 1

Percentage of AEs experienced. Responses were obtained for AEs experienced from a list of 18 options*, with multiple choices allowed. *nausea/vomiting, diarrhea, constipation, dysgeusia (no taste, feels bad to eat), stomatitis (pain or discomfort in or around the mucous membranes of the mouth), malaise/fatigue, skin changes (skin redness, unevenness, and pigmentation, etc.), nail changes (discoloration, deformation, and thinning, etc.), hair loss, edema, neuropathy (numbness), leukopenia/WBC decreased, fever, interstitial lung disease/pneumonitis, joint pain, depression/poor concentration, insomnia (can not sleep, waking up at night, sleepiness during the day), financial anxiety (financial concerns regarding treatment costs)

Fig. 2

Percentage of financial anxiety by personal annual income. The percentage of respondents who answered that they had felt financial anxiety or want to avoid financial anxiety by personal annual income

Fig. 3

Percentage of AEs for which a solution was found. Respondents selected AEs they experienced for which they found a solution (manageable or acceptable)

Fig. 4

Percentage of AEs that patients want to avoid by selection order. Respondents selected 5 AEs that they want to avoid (1st is the AE they most want to avoid)

Fig. 5

Percentage of AEs information that the patients wanted to know (multiple answers). Respondents answered the information they wanted to know about each AE (nausea/vomiting, malaise/fatigue, stomatitis, hair loss, leukopenia/WBC decreased, skin and nail changes, and neuropathy) before treatment from a list of 12 items (multiple choices allowed). Regarding stomatitis, skin and nail changes, and hair loss, visual information such as photographs were presented as choices. The definition of AEs by Grade in CTCAE ver. 5.0 was modified to make the wording easier for respondents to understand, and the questionnaire was conducted. Nausea/vomiting, malaise/fatigue, stomatitis, and neuropathy; grade1: intervention not indicated, grade 2: limiting age appropriate instrumental activities of daily living (ADL), grade 3: limiting self care ADL. Hair loss; grade 1: a different hair style may be required to cover the hair loss, but it does not require a wig or hair piece to camouflage, grade 2: a wig or hair piece is necessary if the patient desires to completely camouflage the hair loss, grade 3: none. Leukopenia/WBC decreased; grade 1: abnormal laboratory values that do not affect anticancer therapy, grade 2: abnormal laboratory values that require a reduced dose of anticancer drugs, grade 3: abnormal laboratory values that require withdrawal of anticancer drugs. Skin and nail changes; grade 1: skin and nail changes intervention not indicated, grade 2: changes in a limited area or changes that require general treatment, grade 3: changes that require specialized treatment