P-247 - A follow-up results of team management approach for XELOX therapy in patients with advanced/recurrent colorectal cancer: the SMILE Study (Study of M...

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anticancer agents
Colon and Rectal Cancer
Biological Therapy
Presenter Y. Shibata
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors Y. Shibata1, K. Maeda1, Y. Ogata2, H. Matsuoka1, Y. Munemoto3, H. Bando4, G. Nishimura5, H. Okuda6, M. Nakamura7, I. Terada8, H. Uchida9, T. Shiroiwa10, J. Kishimoto11
  • 1Toyohashi Municipal Hospital, Toyohashi/JP
  • 2Kurume University Medical Center, Kurume/JP
  • 3Fukui-ken Saiseikai Hospital, Fukui/JP
  • 4Ishikawa Prefectural Central Hospital, Kanazawa/JP
  • 5Japanese Red Cross Kanazawa Hospital, Kanazawa/JP
  • 6Keiyukai Sapporo Hospital, Sapporo/JP
  • 7Sapporo City General Hospital, Sapporo/JP
  • 8Toyama Prefectural Central Hospital, Toyama/JP
  • 9Sanokousei General Hospital, Sano/JP
  • 10National Institute of Public Health, Wako/JP
  • 11Kyushu University Hospital, Fukuoka/JP



In recent years, XELOX (capecitabine + oxaliplatin) administered without continuous infusion is widely used for chemotherapy in pts with adv./rec. colorectal cancer. This therapy continues to be very convenient, although measures against side effects during the treatment period and support for home-based care are necessary. We performed a multicenter, prospective, observational study to evaluate an incidence of adverse events, psychological and mental QOL of pts, and an efficacy by a management (intervention) was implemented.


The study group comprised pts with adv./rec. colorectal cancer who received XELOX (+/- bev) as 1st-line treatment. As the interventional method, more than one of the following was performed: 1) support by Tel, 2) dosing instruction by a pharmacist, 3) skin care instruction by a nurse, and 4) patient instruction by a physician. Endpoints were the incidence of G2 or higher hand-foot syndrome (HFS), psychological and mental QOL evaluations, safety, and efficacy. Two kinds of questionnaires (HADS, MAC) were used to evaluate QOL before starting and at cycle 1, 2, 4, 5, and 8 of treatment. PFS[c1] and OS were also determined.


From Apr. 2011 to Sep. 2012, 80 pts were enrolled from 13 sites, and all pts were included in analysis. The pts characteristics were as follows: male/female: 46/34, age median: 63 yrs, bev +/-: 33/47, and intervention 1/2/3/4: 36/68/73/78. The incidence of G2 or higher HFS was 16.3% during 6M after the start of therapy. In particular, the incidence of HFS of G2 or higher for supporting by Tel (36) was 11.1%. This result was similar or lower tendencies than other reports. The treatment continuation rate was 50% at completion of the protocol treatment (6M). PFS rate was 48.8% (39/80) in Sep 2014. A total of 18 of the 80 eligible patients died due to progression of advanced colorectal cancer. There was a little number of the events and MST could not be estimated. By the comparison of the QOL score during each cycle, a tendency of score improvement about anxiety and depression was observed during the periods from start to 4 cycles and a worsening of score was confirmed after 4 cycles


We confirmed that HFS incidence to influence the management was mitigated by the group of Tel support. In regard to QOL, it is necessary to think about not only adverse events but also a progression of the stage of the disease about a time course, and enough consideration is also necessary. The study was a first large-scale, multicenter management study in Japan, and the results of QOL questionnaire are considered to become an important data for a clinical practice in future.