Academic Journal
Atezolizumab plus modified docetaxel, cisplatin, and fluorouracil as first-line treatment for advanced anal cancer (SCARCE C17-02 PRODIGE 60): a randomised, non-comparative, phase 2 study
| Title: | Atezolizumab plus modified docetaxel, cisplatin, and fluorouracil as first-line treatment for advanced anal cancer (SCARCE C17-02 PRODIGE 60): a randomised, non-comparative, phase 2 study |
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| Authors: | Kim, Stefano, Ghiringhelli, Francois, de la Fouchardière, Christelle, Evesque, Ludovic, Smith, Denis, Badet, Nicolas, Samalin, Emmanuelle, Lopez-Trabada Ataz, Daniel, Parzy, Aurelie, Desramé, Jérôme, Baba Hamed, Nabil, Buecher, Bruno, Tougeron, David, Bouché, Olivier, Dahan, Laetitia, Chibaudel, Benoist, El Hajbi, Farid, Mineur, Laurent, Dubreuil, Olivier, Ben Abdelghani, Meher, Pecout, Solange, Bibeau, Frederic, Herfs, Michael, Garcia, Marie-Line, Meurisse, Aurelia, Vernerey, Dewi, Taïeb, Julien, Borg, Christophe |
| Contributors: | Roche |
| Source: | The Lancet Oncology. 25:518-528 |
| Publisher Information: | Elsevier BV, 2024. |
| Publication Year: | 2024 |
| Subject Terms: | atezolizumab, Male, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Oncologie, Docetaxel, Fluorouracil/adverse effects, Middle Aged, Anus Neoplasms, Antibodies, Monoclonal, Humanized, Anus Neoplasms/drug therapy, Sciences de la santé humaine, B7-H1 Antigen, Neoplasm Recurrence, Local/drug therapy, Oncology, Cisplatin/adverse effects, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Squamous Cell, Humans, Female, Fluorouracil, Human health sciences, Cisplatin, Neoplasm Recurrence, Local, Aged |
| Description: | The modified docetaxel, cisplatin, and fluorouracil (mDCF) regimen has shown efficacy and safety as first-line treatment for advanced squamous cell carcinoma of the anus, making it a standard regimen. Inhibitors of programmed cell death protein 1 and its ligand, such as pembrolizumab, nivolumab, retifanlimab, avelumab, and atezolizumab, have shown some antitumour activity as monotherapy in advanced squamous cell carcinoma of the anus that is refractory to chemotherapy. This phase 2 study evaluated the combination of mDCF and atezolizumab as first-line treatment in advanced squamous cell carcinoma of the anus.In this randomised, open-label, non-comparative, phase 2 study, participants from 21 centres (academic, private, and community hospitals and cancer research centres) across France with chemo-naive, metastatic, or unresectable locally advanced recurrent squamous cell carcinoma of the anus, aged 18 years or older, and with an Eastern Cooperative Oncology Group performance status of 0 or 1, were randomly allocated (2:1) to receive either atezolizumab (800 mg intravenously every 2 weeks up to 1 year) plus mDCF (eight cycles of 40 mg per m2 docetaxel and 40 mg per m2 cisplatin on day 1 and 1200 mg per m2 per day of fluorouracil for 2 days, every 2 weeks intravenously; group A) or mDCF alone (group B). Randomisation was done centrally using a minimisation technique and was stratified by age ( |
| Document Type: | Article |
| Language: | English |
| ISSN: | 1470-2045 |
| DOI: | 10.1016/s1470-2045(24)00081-0 |
| Access URL: | https://pubmed.ncbi.nlm.nih.gov/38547895 https://hdl.handle.net/2268/316241 https://doi.org/10.1016/S1470-2045(24)00081-0 |
| Rights: | Elsevier TDM |
| Accession Number: | edsair.doi.dedup.....a9846b0910312de35e9d87f1da7182e9 |
| Database: | OpenAIRE |
| ISSN: | 14702045 |
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| DOI: | 10.1016/s1470-2045(24)00081-0 |