89P - Questionnaire survey on patients’ preference for orally disintegrating tablets or granules of S-1 in postoperative adjuvant treatment for breast ca...

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Early Stage
Pharmacology
Presenter Ippei Fukada
Citation Annals of Oncology (2016) 27 (suppl_9): ix19-ix29. 10.1093/annonc/mdw575
Authors I. Fukada1, Y. Ito1, T. Shibayama1, K. Kobayashi1, N. Teruya2, S. Takahashi3, R. Horii4, F. Akiyama5, T. Iwase2, M. Toi6, S. Ohno7
  • 1Breast Medical Oncology, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 2Breast Surgical Oncology, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 3Medical Oncology, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 4Department Of Pathology, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 5Department Of Pathology, Cancer Institute of JFCR, 135-8550 - Tokyo/JP
  • 6Breast Cancer Unit, Kyoto University Hospital, 606-8507 - Kyoto/JP
  • 7Breast Oncology Center, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP

Abstract

Background

No study has investigated patients’ preference for orally disintegrating tablets (OD) or granules (GN) in patients with breast cancer. In a phase III randomized study of adjuvant one-year treatment with S-1 (tegafur/gimeracil/oteracil) for estrogen-receptor positive, HER2-negative breast cancer (POTENT study), we prospectively compared patients’ preference on two types of dosage forms.

Methods

The subjects were patients assigned to S-1 group in our hospital based on their consent participating the POTENT study. In those registered with even numbers, OD were administered on cycle 1, 2, then GN on cycle 3, 4. In those registered with odd numbers, GN were administered on cycle 1, 2, then OD on cycle 3, 4. Subsequently, patients selected dosage form based on their preference. Primary endpoint was the proportion of patients who selected GN. As a secondary endpoint, the impressions regarding each types were evaluated using the 100-mm Visual Analog Scale (VAS); difficulty in taking (DIT), taste, discomfort and degree of satisfaction (DOS). VAS scores were expressed as the mean±standard error. The Mann-Whitney U-test was used statistically.

Results

Of 73 patients who participated in POTENT study, 38 were assigned to S-1 group and 37 participated in this study. Evaluable answers to questionnaire survey were collected from 30 patients. The proportion of patients who selected GN after taking two types of forms, was 36.7% (11/30). In all patients, the VAS scores compared between GN and OD groups were as following. DIT; 41.2±4.8 vs 23.5±4.2 (p = 0.007), taste; 45.0±5.3 vs 33.3±6.2 (p = 0.122), discomfort; 22.7±4.4 vs 19.7±4.4 (p = 0.538), DOS; 62.7±4.1 vs 72.4±3.9, (p = 0.077). Therefore, GN were significantly more difficulty in taking, whereas OD were likely more satisfactory. Moreover, a significant reduction in DIT was achieved in patients who switched from GN to OD (40.7±6.2 to 23.2±5.9, p = 0.035) and their satisfaction was likely elevated (62.7±5.7 to 76.3±4.9, p = 0.064).

Conclusions

OD were easier or more satisfactory to take than GN. However, some patients preferred GN rather than OD. We recommend S-1 should be initially administered with OD, then switched to GN in accordance with patients’ preference.

Clinical trial indentification

Legal entity responsible for the study

Yoshinori Ito

Funding

N/A

Disclosure

All authors have declared no conflicts of interest.