Abstract 3187
Background
REGATTA is a phase III trial to compare chemotherapy alone (arm A) and reduction surgery followed by chemotherapy (arm B) for advanced gastric cancer with a single non-curable factor. The trial failed to show superiority of reduction surgery, which could be partially explained by poor compliance of chemotherapy in arm B. This exploratory analysis aims to clarify whether upfront surgery has survival benefit in patients (pts) who could continue chemotherapy for some period, enrolled in REGATTA.
Methods
In REGATTA, 175 pts were assigned to arm A (86 pts) and arm B (89 pts). S-1 80 mg/m2 for 3 weeks and CDDP 60 mg/m2 on day 8 was repeated every 6 weeks. The pts were limited to those for whom chemotherapy was continued at 2, 4, or 6 months after randomization (cohort-2M, cohort-4M, or cohort-6M, respectively) and pts who underwent gastrectomy in arm A were excluded. The overall survival (OS) was defined as the duration from the date at 2, 4, or 6 months after randomization to the date of the death from any cause or to the last date of contact for a surviving pt.
Results
Examined pts were 130 (59 in arm A and 71 in arm B) in cohort-2M, 111 (50 in arm A and 61 in arm B) in cohort-4M, and 90 (43 in arm A and 47 in arm B) in cohort-6M, respectively. In cohort-2M, the median survival time (MST) was 14.1 months (m) (95% CI, 11.7-16.6) in arm A and 12.6 m (9.9-15.9) in arm B with hazard ratio (HR) of 0.935 (0.641-1.635). The OS was 9.7% (3.2-20.5) in arm A and 17.9% (9.2-28.8) in arm B at 3-year. In cohort-4M, the MST was 13.1 m (10.3-18.8) in arm A and 11.5 m (8.4-15.1) in arm B with HR of 0.954 (0.629-1.448). The OS was 11.5% (3.8-24.0) in arm A and 21.2% (11.0-33.6) in arm B at 3-year. In cohort-6M, the MST was 13.8 m (9.8-22.1) in arm A and 10.9 m (6.6-16.6) in arm B with HR of 0.860 (0.535-1.383). The OS was 13.2% (4.3-27.0) in arm A and 26.0% (13.1-41.0) in arm B at 3-year.
Conclusions
Among pts having certain period of chemotherapy, there seem to be more long survivors in arm B than the arm A. Reduction surgery may still be promising if chemotherapy compliance after surgery could be improved.
Clinical trial identification
UMIN000001012, Feb 2008.
Editorial acknowledgement
Legal entity responsible for the study
Japan Clinical Oncology Group (JCOG).
Funding
The Ministry of Health, Labour and Welfare of Japan and the Korean Gastric Cancer Association.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
3159 - Anlotinib for advanced hepatocellular carcinoma: interim results from the phase II ALTER0802 study
Presenter: AiPing Zhou
Session: Poster Display session 2
Resources:
Abstract
3191 - The efficacy and safety of lenvatinib in patients who did not meet the inclusion criteria of the phase 3 trial (REFLECT trial) and those with BCLC Stage B hepatocellular carcinoma - A nationwide multicenter study in Japan-
Presenter: Azusa Sakamoto
Session: Poster Display session 2
Resources:
Abstract
1529 - Prognostic and predictive value of baseline alpha-fetoprotein (AFP) in patients with advanced hepatocellular carcinoma (HCC) treated with ramucirumab from two phase 3 studies (REACH, REACH-2)
Presenter: Andrew Zhu
Session: Poster Display session 2
Resources:
Abstract
2767 - Effect of second-line cabozantinib on health states for patients with advanced hepatocellular carcinoma (aHCC) after sorafenib: QTWiST analysis from the CELESTIAL study
Presenter: Nicholas Freemantle
Session: Poster Display session 2
Resources:
Abstract
2150 - Alpha-fetoprotein (AFP) response in patients with unresectable hepatocellular carcinoma (HCC) in the phase 3 RESORCE trial
Presenter: Jordi Bruix
Session: Poster Display session 2
Resources:
Abstract
3437 - Phase I/II trial of NBTXR3 activated by SBRT in patients with hepatocellular carcinoma or liver metastasis
Presenter: Marc Pracht
Session: Poster Display session 2
Resources:
Abstract
1758 - Efficacy and safety of ramucirumab (RAM) for advanced hepatocellular carcinoma (HCC) with elevated alpha-fetoprotein (AFP) following first-line sorafenib across age subgroups in two global phase 3 trials (REACH and REACH-2)
Presenter: Masatoshi Kudo
Session: Poster Display session 2
Resources:
Abstract
1192 - Ramucirumab in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha fetoprotein (AFP): An exposure–response analysis
Presenter: Josep Llovet
Session: Poster Display session 2
Resources:
Abstract
1600 - Outcomes of Hepatocellular Carcinoma (HCC) Patients Treated with Nivolumab: The Mount Sinai Hospital Experience.
Presenter: Sirish Dharmapuri
Session: Poster Display session 2
Resources:
Abstract
2364 - Pembrolizumab vs Chemotherapy in Patients With Advanced/Metastatic Adenocarcinoma (AC) or Squamous Cell Carcinoma (SCC) of the Esophagus as Second-Line Therapy: Analysis of the Chinese Subgroup in KEYNOTE-181
Presenter: Jia Chen
Session: Poster Display session 2
Resources:
Abstract