588P - HRQOL during adjuvant chemotherapy with capecitabine in patients after surgery for colon cancer: additional study of JFMC37-0801

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Anticancer agents
Psychosocial Aspects of Cancer
Colon and Rectal Cancer
Biological Therapy
Presenter Yusuke Kinugasa
Authors Y. Kinugasa1, T. Shiroiwa2, M. Nakamura3, R. Nezu4, S. Hazama5, T. Fukuda6, M. Ishiguro7, J. Sakamoto8, S. Saji9, N. Tomita10
  • 1Colon And Rectal Surgery Dept., Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 2Department Of Hygiene And Public Health, Teikyo University School of Medicine, Tokyo/JP
  • 3Aizawa Comprehensive Cancer Center, Aizawa Hospital, 390-8510 - Nagano/JP
  • 4Department Of Surgery, Osaka Rosai Hospital, Osaka/JP
  • 5Department Of Digestive Surgery And Surgical Oncol, Yamaguchi University Graduate School of Medicine, JP-755-8505 - Yamaguchi/JP
  • 6Center For Public Health Informatics, National Institute of Public Health, Saitama/JP
  • 7Translational Oncology Dept., Tokyo Medical and Dental University, Graduate School, 113-8519 - Tokyo/JP
  • 8Young Leaders Program, Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo/JP
  • 9,, Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo/JP
  • 10Division Of Lower Gi, Department Of Surgery, Hyogo College of Medicine, Hyogo/JP



The JFMC37-0801 trial is a phase III trial designed to validate superiority of 1-year treatment with capecitabine to 6 months treatment as adjuvant chemotherapy for stage III colon cancer. Health related quality of life (HRQOL) and cost-effectiveness have been evaluated as an additional study. We analyzed impact of prolonged treatment with capecitabine on patients' HRQOL.


Capecitabine (2500 mg/m2/day) was orally given on days 1-14, followed by a 7-day rest. Enrolled patients were randomly assigned to group A (received 8 courses of capecitabine) or group B (16 courses). In patients agreed to participate to the additional study, HRQOL was evaluated by self-administered questionnaire at the start of the protocol treatment, 3, 6, 9, 12, 15 and 18 months. The questionnaire includes Functional Assessment of Cancer therapy-C (FACT-C) and EuroQol 5 Dimension (EQ-5D).


In 1306 patients enrolled to the JFMC37-0801 trial, HRQOL of 171 participants (81 in group A, 90 in group B) were evaluated. Mean age of the patients in group A and B was 63.3 and 64.5 years-old, respectively. Among a total of 1197 points of survey, 959 questionnaires (80.1%) were retrieved. Recovery rates of questionnaires tended to decrease with time after finishing treatment. Through the entire survey period, mean score of FACT-C (96.9-103) and EQ-5D (0.85-0.93) were satisfactory. In longitudinal analysis of the change from baseline score, the scores tended to increase after finishing the treatment period in both group A and group B. Significant difference between the score of group A and group B was not observed in each survey point. No difference by age and tumor stage was also observed.


HRQOL of the patients received postoperative adjuvant chemotherapy with capecitabine was satisfactory through the survey period. There was no significant difference of HRQOL between 8 and 16 courses of capecitabine treatment.


J. Sakamoto: Junichi Sakamoto is a director of the Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC).

S. Saji: Shigetoyo Saji is a director of the Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC).

All other authors have declared no conflicts of interest.