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References
1. Abstracts from the 15th ESMO World Congress on Gastrointestinal Cancer are published in Annals of Oncology, Volume 24 suppls 4 June 2013 (Ann Oncol 2013 Jun; 24(Suppl 4): 5-130) http://annonc.oxfordjournals.org/content/24/suppl_4.toc
2. Abstract presentation: Thursday, 4 July 2013, 17:25 hrs, Session VII: Gastric Cancer About the ESMO World Congress on Gastrointestinal Cancer The ESMO World Congress on Gastrointestinal Cancer is the premier global event in the field, encompassing malignancies affecting every component of the gastrointestinal tract and aspects related to the care of patients with gastrointestinal cancer, including screening, diagnosis and the latest management options for common and uncommon tumours. It has been endorsed by leading professional societies and organizations.
The ESMO 15th World Congress on Gastrointestinal Cancer has been organized in partnership with ESMO (European Society for Medical Oncology). The Congress is developed and managed by ImedexR, LLC.
ABSTRACT 0007
Adjuvant capecitabine and oxaliplatin (XELOX) for gastric cancer after D2 gastrectomy: final results from the CLASSIC trial
Sung Hoon Noh 1, Sook Ryun Park 2, Han-Kwang Yang 3, Hyun Cheol Chung 1, Ik-Joo Chung 4, Kyung Hee Lee 5, Hyung-Ho Kim 6, Jiafu Ji 7, Jen-Shi Chen 8, Yunni Lim 9, Stella Ha 9, Yung-Jue Bang 3
1 Yonsei University College of Medicine, Seodeamungyu Shinchon-dong 134, Seoul, 2 Research Institute and Hospital, National Cancer Center, Ilsandong-gu, Goyang-si Gyeonggi-do, 3 Seoul National University College of Medicine, Jongno-gu, Seoul, 4 Chonnam National University Hwasun Hospital, Hwasun-Eup, Hwasun-Gun, Jeonnam, 5 Yeungnam University College of Medicine, Nam-gu, Daegu, 6 Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, 7 Beijing Cancer Hospital, Haidian, Beijing, 8 Chang Gung Memorial Hospital, Kwei-Shan Shiang, Taoyuan, 9 Roche Korea Co.,Ltd, Seocho-Gu, Seoul
Background: D2 gastrectomy, which is widely used in East Asia as the preferred surgery for patients with operable gastric cancer, is now recommended in US and European treatment guidelines for gastric cancer. Two phase III trials (ACTS-GC and CLASSIC) have been performed to assess the possible benefits of adjuvant chemotherapy after D2 surgery. ACTS-GC showed a survival benefit with fluoropyrimidine monotherapy after D2 gastrectomy compared with surgery only [Sasako et al. J Clin Oncol 2011;29:4387–93]. The CLASSIC trial compared fluoropyrimidine-oxaliplatin combination therapy (XELOX) with surgery alone; interim results showed that XELOX improved 3-year disease-free survival after D2 gastrectomy compared with surgery only [Bang et al. Lancet 2012;379:315–21]. Improved overall survival was also evident after only 3 years, but the data were immature. We report here the final results from the CLASSIC trial after a median follow-up of 5 years.
Methods: CLASSIC was a multinational open-label randomised phase III trial performed in South Korea, China, and Taiwan. Randomisation was stratified by country and disease stage. Patients with stage II–IIIB gastric cancer who had undergone curative D2 gastrectomy were assigned to adjuvant XELOX (oxaliplatin 130 mg/m2 day 1 plus capecitabine 1000 mg/m2 twice daily days 1-14 q3w) for 8 cycles or surgery alone. The primary endpoint was 3-year disease-free survival. The clinical cut-off date for the prospectively planned final 5-year efficacy analysis was 22 November 2012.
Results: At data cut-off, 103 (20%) patients in the XELOX group and 141 (27%) patients in the surgery alone group had died. This represented a 34% reduction in the risk of death with XELOX versus surgery alone (hazard ratio 0.66, 95% CI 0.51–0.85; p=0.0015 by stratified Cox regression analysis). The 5-year overall survival rate was 78% in the XELOX group and 69% in the surgery alone group (p=0.0029, log-rank test unstratified). 76 (15%) patients in the XELOX group and 135 (26%) patients in the surgery alone group received subsequent, non-protocol-specified anticancer therapies after progression of disease. In the analysis of disease-free survival, 139 (26.7%) patients in the XELOX group and 203 (39.4%) patients in the surgery alone group had relapsed, developed a new gastric cancer or died. This represented a 42% reduction in the risk of an event with XELOX versus surgery alone (hazard ratio 0.58, 95% CI 0.47–0.72; p<0.0001 by stratified Cox regression analysis). The 5-year disease-free survival rate was 68% in the XELOX group and 53% in the surgery alone group (p<0.0001, log-rank test unstratified).
Conclusion: The final analysis of the CLASSIC trial, after a median follow-up of 5 years, supports the findings from the primary analysis performed 2 years earlier. Adjuvant XELOX after curative D2 gastrectomy improves overall survival compared with surgery alone and should be considered as a standard treatment option for patients with operable gastric cancer.
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