Dataset on chemotherapy-induced nausea and vomiting (CINV) and quality of life (QOL) during multiple chemotherapy cycles among a Chinese breast cancer patient population who were randomized to antiemetic regimens with or without olanzapine

Chemotherapy-induced nausea and vomiting (CINV) are highly distressing symptoms for cancer patients undergoing cytotoxic chemotherapy. This dataset was obtained from a homogenous group of Chinese breast cancer patients who were uniformly planned to receive a highly emetogenic (neo)adjuvant chemotherapy regimen, consisting of doxorubicin and cyclophosphamide (commonly known as AC). Patients were being randomized to one of the two antiemetic regimens: aprepitant, ondansetron and dexamethasone with (the Olanzapine arm) or without olanzapine (the Standard arm). Patients underwent self-reported diaries and questionnaires to record their nausea and vomiting symptoms, use of rescue medication as well as their quality of life (QOL). The primary and secondary endpoints have focused on efficacy analysis during the first cycle of AC chemotherapy; the results have been reported in The Breast [1]. In this Data in Brief article, we provide outcome of the analysis of data collected during multiple cycles of chemotherapy. The data reported here include the proportion of patients with “Complete Response”, “Complete Protection” and “Total Control” of emesis in the acute (0–24 h), delayed (24–120 h) and overall periods (0–120 h), as well as QOL data during all the 4 cycles of AC.


a b s t r a c t
Chemotherapy-induced nausea and vomiting (CINV) are highly distressing symptoms for cancer patients undergoing cytotoxic chemotherapy. This dataset was obtained from a homogenous group of Chinese breast cancer patients who were uniformly planned to receive a highly emetogenic (neo)adjuvant chemotherapy regimen, consisting of doxorubicin and cyclophosphamide (commonly known as AC). Patients were being randomized to one of the two antiemetic regimens: aprepitant, ondansetron and dexamethasone with (the Olanzapine arm) or without olanzapine (the Standard arm). Patients underwent self-reported diaries and questionnaires to record their nausea and vomiting symptoms, use of rescue medication as well as their quality of life (QOL). The primary and secondary endpoints have focused on efficacy analysis during the first cycle of AC chemotherapy; the results have been reported in The Breast [1]. In this Data in Brief article, we provide outcome of the analysis of data collected during multiple cycles of chemotherapy. The data reported here include the proportion of patients with "Complete Response", "Complete Protection" and "Total Control" of emesis in the acute (0-24 h), delayed (24-120 h) and overall periods (0-120 h), as well as QOL data during all the 4 cycles of AC.  All patients were planned for 4 cycles of AC chemotherapy. Prior to each cycle of chemotherapy on Day 1, individual patient filled in self-administered FLIE questionnaire. A diary was given to each patient to bring home, so that she could record the date and time of any vomiting episodes and the use of rescue medication following the chemotherapy infusion for 120 h. Within the diary, there were also nausea ratings (by visual analogue scale, VAS; 0 mm implied no nausea; 100 mm implied nausea that was "as bad as it could be"); on days 2 to 6, each patient rated the symptoms of nausea for the preceding 24 h using the VAS. After patients had completed the diary in the morning of day 6, they immediately completed the FLIE questionnaire again. Description of data collection Prospective cohort of 120 adult women with breast cancer who were randomly assigned to one of the two antiemetic regimens prior to their chemotherapy.

Value of the data
• These data over multiple cycles of chemotherapy are important for understanding and interpretations of the potential benefits of new antiemetic agents in the control of CINV [1] . • Clinicians and researchers working in the fields of oncology, palliative care and general practice may benefit from these data. • The full description of the results provides deeper insights regarding efficacy of different antiemetic regimens when they are administered to cancer patients undergoing highly emetogenic chemotherapy. • While data during the first chemotherapy cycle are often the primary endpoints and are thus invariably reported, data on subsequent chemotherapy cycles are rarely reported in the literature. These data provide a unique opportunity to follow symptoms and QOL of women with breast cancer who underwent 4 cycles of highly emetogenic AC chemotherapy.

Data description
In this Data in Brief article, we first provide the comparison of Complete Response ( Table 1 a and b), Complete Protection ( Table 2 a and b) and Total Control ( Table 3 a and b) of CINV during the acute period, delayed period and overall period across the 4 cycles of chemotherapy among patients who were randomized to one of the two study arms. The raw data based on which analyses were conducted for Complete Response, Complete Protection and Total Control are available in Supplementary File S1, Supplementary File S2 and Supplementary File S3 respectively.
In summary, there was no difference on Complete Response, Complete Protection and Total Control across the four cycles in the Olanzapine arm. However, in the Standard arm, some differences were observed in Complete Response, Complete Protection and Total Control when comparing cycle 1 with other cycles.
We also provide data on QOL data in the overall period during the 4 cycles of chemotherapy in the two study arms. The raw data are available in Supplementary File S4. Based on the data, differences were only detected between the 2 study arms in cycle 1.

Experimental design, materials, and methods
The original study consisted of a homogenous group of Chinese breast cancer patients who were uniformly planned to receive (neo)adjuvant AC chemotherapy. Patients were being randomized to one of the two antiemetic regimens: aprepitant, ondansetron and dexamethasone with or without olanzapine.
Between the two study arms, the primary objective was to compare the antiemetic efficacies in the first cycle of AC. The secondary objectives were to compare QOL in the first cycle of AC and to compare the tolerability and efficacy of the study treatments.
All patients were planned for 4 cycles of AC chemotherapy. Data collected included patients' baseline characteristics. In addition to cycle 1, patients' symptoms and QOL were captured during 2nd-4th cycle of chemotherapy. Individual patient filled in self-administered FLIE questionnaire on day 1 before AC chemotherapy. After chemotherapy, the patients went home with the provision of a diary. Each patient recorded the date and time of any vomiting episodes and the use of rescue medication in the first 120 h after AC chemotherapy. On days 2 to 6, each patient rated the symptoms of nausea for the preceding 24 h using the VAS in the diary. After patients had completed the diary in the morning of day 6, they immediately completed the FLIE questionnaire again.
The primary and secondary study outcomes related to outcomes in cycle 1 have been reported [1] . In this Data in Brief article, we provide outcome of the analysis of data collected during multiple cycles of AC. Three time-frames were assessed during each AC chemotherapy cycle; assessments started from the initiation of AC chemotherapy infusion (0 h) up to beginning of day 6 ( ∼120 h). "Acute" period referred to 0-24 h after the initiation of AC, "delayed" period referred to 24-120 h, while "overall" period referred to 0-120 h The variables measured were the proportion of patients with "Complete Response", "Complete Protection" and "Total Control", definitions of which have been provided in the original report [1] as well as previous studies [2][3][4] . These assessments were done primarily over the "overall" period, and were also conducted separately during "acute" and "delayed" periods of each chemotherapy cycle. QOL data was collected during the overall period of each chemotherapy cycle.
For efficacy analyses over multiple cycles, "Complete Response", "Complete Protection", and "Total Control" over multiple cycles in the acute (0-24 h), delayed (24-120 h) and overall periods (0-120 h) were assessed using chi-square test for dichotomous data. For the analysis of the FLIE questionnaire, the nausea domain, vomiting domain and total score (the sum of the two domains) in the overall period were compared between the two arms using Wilcoxon Rank Sum test for continuous data.