689P - Disease progression clinically judged without confirmation by image diagnosis in a randomized phase III trial of advanced gastric cancer (JCOG9912)

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Gastric Cancer
Presenter Hiroki Kawai
Authors H. Kawai1, N. Boku2, Y. Yamada3, N. Fuse4, H. Yasui5, A. Sawaki6, W. Koizumi7, J. Mizusawa8, K. Nakamura8, A. Takashima8
  • 1Department Of Endoscopy, Nagoya City West Medical Center, 462-8508 - Nagoya/JP
  • 2Department Of Clinical Oncology, St. Marianna University School of Medicine, 216-8511 - Kawasaki/JP
  • 3Medical Oncology, National Cancer Center Hospital, JP-104-0045 - Tokyo/JP
  • 4Division Of Gastrointestinal Oncology And Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa/JP
  • 5Division Of Gi Oncology, Shizuoka Cancer Center, Shizuoka/JP
  • 6Department Of Clinical Oncology, Nagoya Daini Red Cross Hospital, Nagoya/JP
  • 7Department Of Gastroenterology/gastrointestinal Oncology, Kitasato University Schoool of Medicine, Sagamihara/JP
  • 8Japan Clinical Oncology Group Data Center, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo/JP



In advanced gastric cancer (AGC), some type of progression such as peritoneal metastasis are hardly detected by imaging, and progression was sometimes judged clinically (C-PD) apart from imaging-determined progression (I-PD). Thus, C-PD is regarded as a PFS event as well as I-PD in most cooperative group trials. However, it has rarely been reported how often C-PD is observed in the clinical trials of AGC. Objectives of this study are to evaluate the proportion of C-PD and to compare the backgrounds and outcomes between C-PD and I-PD.


JCOG9912 is a large-scale randomized phase III trial comparing 5-FU continuous infusion (5-FUci), irinotecan plus cisplatin and S-1 in AGC. Among all randomized patients (n = 704), protocol treatments were terminated in 697 patients at the final analysis, and the reasons for off-treatment were prospectively classified as PD (n = 545), toxicities (n = 59), patient's refusal (n = 73), death (n = 3) and others (n = 17). We retrospectively categorized patients with PD to I-PD and C-PD by reviewing the case report forms.


The proportion of C-PD was only 4.4% (I-PD: n = 520, C-PD: n = 24, unknown: n = 1) among those who terminated treatment due to PD. There were some differences in patient backgrounds between I-PD and C-PD; age (median 63, 61.5 years old), diffuse type (51.0%, 70.8%), target lesion (+) (77.5%, 66.7%), sum of longest diameter of target lesions (median 9.3cm, 7.9cm), treatment arm of 5-FUci (36.2%, 45.8%), and second line chemotherapy (+) (83.1%, 70.8%). Median PFS in I-PD and C-PD were 3.7 months and 3.8 months (HR = 0.94 [0.63-1.42] in univariate analysis, HR = 0.93 [0.61-1.42] in multivariate analysis. Median OS in I-PD and C-PD were 11.1 months and 9.3 months (HR = 1.19 [0.78-1.80] in univariate analysis, HR = 1.25 [0.82-1.93] in multivariate analysis).


The proportion of C-PD was far less than expected. Although the PFS in I-PD and C-PD were almost identical, there were some differences in patient background and clinical courses after PD.


N. Fuse: I have research funding to disclose from Taiho Pharmaceutical and Yakult Honsha.

All other authors have declared no conflicts of interest.