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
3330 - Tumour-infiltrating lymphocytes and BRCA-like status in stage III breast cancer patients treated with intensified carboplatin-based chemotherapy
Presenter: Leonora De Boo
Session: Poster Display session 2
Resources:
Abstract
3971 - Unravelling the biological characteristics of MammaPrint extreme risk subgroups
Presenter: Rajith Bhaskaran
Session: Poster Display session 2
Resources:
Abstract
5871 - Residual Cancer burden as a prognostic factor in a large series of Neoadjuvant chemotherapy. Subgroup analysis per molecular surrogated subtypes
Presenter: Catalina Falo
Session: Poster Display session 2
Resources:
Abstract
5014 - Clinical validation of CanAssist Breast in a Spanish cohort
Presenter: Manjiri Bakre
Session: Poster Display session 2
Resources:
Abstract
2787 - Meta-analysis on association of pathological complete response with long-term survival outcomes in triple-negative breast cancer
Presenter: Peter A. Fasching
Session: Poster Display session 2
Resources:
Abstract
4301 - Immune infiltrate composition across intrinsic subtypes in hormone receptor (HR)+/HER2- early breast cancer (BC) enrolled in the prospective LETLOB trial
Presenter: Gaia Griguolo
Session: Poster Display session 2
Resources:
Abstract
3205 - Frequency of germline mutations in women's cancer susceptibility genes in a large cohort of Chinese breast cancer patients
Presenter: Ning Liao
Session: Poster Display session 2
Resources:
Abstract
4091 - Triple blinded Prospective Study assessing the Impact of Genomics & Artificial Intelligence Watson For Oncology (WFO) on MDT’s Decision of Adjuvant Systemic Therapy for Hormone Receptor Positive Early Breast Carcinoma-
Presenter: Somashekhar Sampige Prasannakumar
Session: Poster Display session 2
Resources:
Abstract
4359 - Prognostic significance of Progesterone Receptor levels in luminal-like Her2- early Breast Cancer patients. A retrospective single Cancer Center analysis.
Presenter: Anna Diana
Session: Poster Display session 2
Resources:
Abstract
1369 - PAM50 HER2-enriched subtype and pathological complete response in HER2-positive early breast cancer: a meta-analysis
Presenter: Francesco Schettini
Session: Poster Display session 2
Resources:
Abstract