Overall survival with 3 or 6 months of adjuvant chemotherapy in Italian TOSCA phase 3 randomised trial
| Autor: | Piero Marchetti, Nicoletta Pella, Katia Fiorella Dotti, Lorenza Rimassa, R. Labianca, Ludovica Ciuffreda, A. Zaniboni, Monica Ronzoni, Alberto Sobrero, Valeria Pusceddu, Tosca Investigators, Maurizio Cantore, Daris Ferrari, Vittorina Zagonel, Eliana Rulli, Gerardo Rosati, Evaristo Maiello, M.G. Zampino, Maria Banzi, Fausto Petrelli, M. Yasmina, Sara Lonardi |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Phases of clinical research Gastroenterology Disease-Free Survival law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial FOLFOX law Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Capecitabine Neoplasm Staging business.industry Standard treatment Hazard ratio Hematology Confidence interval Oxaliplatin 030104 developmental biology Oncology Italy Chemotherapy Adjuvant 030220 oncology & carcinogenesis Fluorouracil Neoplasm Recurrence Local business medicine.drug |
| Zdroj: | Annals of oncology : official journal of the European Society for Medical Oncology. 32(1) |
| ISSN: | 1569-8041 |
| Popis: | Background Oxaliplatin-based adjuvant chemotherapy is the standard treatment of high-risk colon cancer (CC). A shorter duration (3 months) can achieve a similar outcome [in terms of relapse-free survival (RFS)] to a longer duration. This study reports the overall survival (OS) analysis of the three or six colon adjuvant (TOSCA) phase III study. It assessed different adjuvant chemotherapy durations in patients with resected high-risk stage II and stage III CC. Material and methods TOSCA was an open-label, phase III, multicentre, non-inferiority trial conducted in 130 Italian centres. Patients were randomly assigned, in a 1 : 1 ratio, to receive 3 months of standard doses of FOLFOX/CAPOX, or 6 months of FOLFOX/CAPOX. Patients with histologically confirmed high-risk stage II and III CC were included, with RFS being the primary end point. OS was a secondary end point. Results From June 2007 to March 2013, 3759 patients were accrued. At a median follow-up of 7 years, the hazard ratio (HR) for RFS of the 3-month versus 6-month arms was 1.13; 95% confidence interval (CI) 0.99-1.29, P for non-inferiority = 0.380, P for superiority = 0.068, crossing the non-inferiority limit of 1.20. This result did not allow us to reject the null hypothesis of the inferiority of the 3-month arm. The HR for OS of the 3-month versus 6-month arms was 1.09 (95% CI 0.93-1.26, P for superiority = 0.288). At the last follow-up analysis, the absolute OS difference between arms was Conclusions The present analysis of the TOSCA trial does not indicate any significant difference in OS between the treatment groups. The extra benefit provided by the longer treatment should be balanced against the extra toxicity of more prolonged therapy. The trial is registered with ClinicalTrials.gov , registration number: NCT0064660. |
| Databáze: | OpenAIRE |
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