Adjuvant capecitabine plus oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): 5-year follow-up of an open-label, randomised phase 3 trial
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| Název: | Adjuvant capecitabine plus oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): 5-year follow-up of an open-label, randomised phase 3 trial |
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| Autoři: | Sook Ryun Park, Yunni Lim, Wansik Yu, Stella Ha, Hyun Cheol Chung, Yung-Jue Bang, Jin-Hyuk Choi, Hoon Kyo Kim, Han-Kwang Yang, Jen-Shi Chen, Sung Hoon Noh, Sang Woon Kim, Dong Bok Shin, Jong Inn Lee, Jiafu Ji, Ik Joo Chung, Hyung Ho Kim |
| Přispěvatelé: | Sung Hoon Noh, Sook Ryun Park, Han Kwang Yang, Hyun Cheol Chung, Ik Joo Chung, Sang Woon Kim, Hyung Ho Kim, Jin Hyuk Choi, Hoon Kyo Kim, Wansik Yu, Jong Inn Lee, Dong Bok Shin, Jiafu Ji, Jen Shi Chen, Yunni Lim, Stella Ha, Yung Jue Bang, Noh, Sung Hoon, Chung, Hyun Cheol |
| Zdroj: | The Lancet Oncology. 15:1389-1396 |
| Informace o vydavateli: | Elsevier BV, 2014. |
| Rok vydání: | 2014 |
| Témata: | Male, 0301 basic medicine, Deoxycytidine/analogs & derivatives, Drug-Related Side Effects and Adverse Reactions, Organoplatinum Compounds, Fluorouracil/adverse effects, Deoxycytidine, Drug-Related Side Effects and Adverse Reactions/pathology, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, Gastrectomy, Stomach Neoplasms, Antineoplastic Combined Chemotherapy Protocols, Chemotherapy, Humans, Adjuvant/adverse effects, Organoplatinum Compounds/adverse effects, 10. No inequality, Deoxycytidine/administration & dosage, Stomach Neoplasms/drug therapy, Capecitabine, Aged, Neoplasm Staging, Antineoplastic Combined Chemotherapy Protocols/administration & dosage, Deoxycytidine/adverse effects, Stomach Neoplasms/pathology, Middle Aged, 3. Good health, Oxaliplatin, Fluorouracil/analogs & derivatives, Stomach Neoplasms/surgery, Fluorouracil/administration & dosage, Chemotherapy, Adjuvant, Female, Organoplatinum Compounds/administration & dosage, Fluorouracil, Follow-Up Studies |
| Popis: | The CLASSIC trial was done to compare adjuvant capecitabine plus oxaliplatin versus observation after D2 gastrectomy for patients with stage II or III gastric cancer. The planned interim analysis of CLASSIC (median follow-up 34 months) showed that adjuvant capecitabine plus oxaliplatin significantly improved disease-free survival, the primary endpoint, compared with observation after D2 gastrectomy. We report the 5-year follow-up data from the trial.CLASSIC was a phase 3, randomised, open-label study done at 35 cancer centres, medical centres, and hospitals in China, South Korea, and Taiwan. Patients with stage II-IIIB gastric cancer who underwent curative D2 gastrectomy were randomly assigned (1:1) after surgery to receive adjuvant chemotherapy with capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m(2) twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m(2) on day 1) for 6 months or observation alone. Randomisation was stratified by country and disease stage with a permuted block (size four) design. Neither patients nor investigators were masked to treatment assignment. The primary outcome was 3-year disease-free survival in the intention-to-treat population. This analysis presents the final preplanned assessment of outcomes after 5 years. The study is registered with ClinicalTrials.gov, NCT00411229.We enrolled 1035 patients: 520 were randomly assigned to adjuvant capecitabine and oxaliplatin, and 515 to observation. Median follow-up for this analysis in the intention-to-treat population was 62·4 months (IQR 54-70). 139 (27%) patients had disease-free survival events in the adjuvant capecitabine and oxaliplatin group versus 203 (39%) patients in the observation group (stratified hazard ratio [HR] 0·58, 95% CI 0·47-0·72; p |
| Druh dokumentu: | Article |
| Popis souboru: | 1389~1396 |
| Jazyk: | English |
| ISSN: | 1470-2045 |
| DOI: | 10.1016/s1470-2045(14)70473-5 |
| Přístupová URL adresa: | https://pubmed.ncbi.nlm.nih.gov/25439693 https://pubmed.ncbi.nlm.nih.gov/25439693/ http://repository.ajou.ac.kr/handle/201003/12549 https://www.thelancet.com/pdfs/journals/lanonc/PIIS1470204514704735.pdf http://ir.yu.ac.kr/handle/YU.REPOSITORY/30448?mode=full https://europepmc.org/article/MED/25439693 https://yonsei.pure.elsevier.com/en/publications/adjuvant-capecitabine-plus-oxaliplatin-for-gastric-cancer-after-d |
| Rights: | Elsevier TDM CC BY NC ND |
| Přístupové číslo: | edsair.doi.dedup.....f64559561b38d069582fb45db75241ed |
| Databáze: | OpenAIRE |
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Nájsť tento článok vo Web of Science | Abstrakt: | The CLASSIC trial was done to compare adjuvant capecitabine plus oxaliplatin versus observation after D2 gastrectomy for patients with stage II or III gastric cancer. The planned interim analysis of CLASSIC (median follow-up 34 months) showed that adjuvant capecitabine plus oxaliplatin significantly improved disease-free survival, the primary endpoint, compared with observation after D2 gastrectomy. We report the 5-year follow-up data from the trial.CLASSIC was a phase 3, randomised, open-label study done at 35 cancer centres, medical centres, and hospitals in China, South Korea, and Taiwan. Patients with stage II-IIIB gastric cancer who underwent curative D2 gastrectomy were randomly assigned (1:1) after surgery to receive adjuvant chemotherapy with capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m(2) twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m(2) on day 1) for 6 months or observation alone. Randomisation was stratified by country and disease stage with a permuted block (size four) design. Neither patients nor investigators were masked to treatment assignment. The primary outcome was 3-year disease-free survival in the intention-to-treat population. This analysis presents the final preplanned assessment of outcomes after 5 years. The study is registered with ClinicalTrials.gov, NCT00411229.We enrolled 1035 patients: 520 were randomly assigned to adjuvant capecitabine and oxaliplatin, and 515 to observation. Median follow-up for this analysis in the intention-to-treat population was 62·4 months (IQR 54-70). 139 (27%) patients had disease-free survival events in the adjuvant capecitabine and oxaliplatin group versus 203 (39%) patients in the observation group (stratified hazard ratio [HR] 0·58, 95% CI 0·47-0·72; p |
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| ISSN: | 14702045 |
| DOI: | 10.1016/s1470-2045(14)70473-5 |