{"entity":{"id":"paper-de-bono-tropic-cabazitaxel-lancet-2010","kind":"paper","name":"TROPIC: prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel","aka":["TROPIC","de Bono 2010 cabazitaxel"],"tldr":"The first drug shown to extend life after docetaxel has stopped working. Cabazitaxel, a taxane designed to get past the pumps that expel docetaxel from resistant cells, added about two and a half months, at the cost of a high rate of low white cell counts.","summary":"Johann de Bono and the TROPIC investigators randomised 755 men whose metastatic castration-resistant prostate cancer had progressed during or after docetaxel to cabazitaxel or mitoxantrone, each with 10 mg of oral prednisone daily. It was an open-label phase 3 trial with overall survival as the primary endpoint.\n\nBefore TROPIC there was nothing after docetaxel. The trial opened the second line and, in the same period as abiraterone and enzalutamide, turned castration-resistant prostate cancer from a single-treatment disease into a sequencing problem. The toxicity is the reason cabazitaxel is used carefully: 82 percent of patients had grade 3 or higher neutropenia and 8 percent had febrile neutropenia, which is why growth factor support became routine.","asOf":"2026-09-25","links":[{"label":"Lancet 2010","url":"https://doi.org/10.1016/s0140-6736(10)61389-x"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/20888992/"},{"label":"ClinicalTrials.gov NCT00417079","url":"https://clinicaltrials.gov/study/NCT00417079"}],"tags":["prostate-evidence"],"related":["paper-tannock-tax-327-docetaxel-prednisone-nejm-2004","paper-scher-affirm-enzalutamide-nejm-2012","chemotherapy-roadmap","prostate-roadmap"],"cancers":["prostate","prostate-mcrpc"],"sections":["chemotherapy"],"technologies":[],"targets":[],"drugs":["cabazitaxel","docetaxel","mitoxantrone","prednisone"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":["castration-resistance","hazard-ratio"],"trials":[],"people":["johann-de-bono"],"bottlenecks":["b-resistance","b-toxicity-qol"],"keyPapers":[],"journals":["lancet"],"dependsOn":[],"notes":[],"journal":"The Lancet","year":2010,"doi":"10.1016/s0140-6736(10)61389-x","pmid":"20888992","authors":"de Bono JS, Oudard S, Ozguroglu M, et al.","paperType":"rct","findings":["Median survival 15.1 months (95 percent confidence interval 14.1 to 16.3) with cabazitaxel against 12.7 months (11.6 to 13.7) with mitoxantrone.","Hazard ratio for death 0.70 (95 percent confidence interval 0.59 to 0.83; p less than 0.0001).","Median progression-free survival 2.8 months against 1.4 months (hazard ratio 0.74, 0.64 to 0.86; p less than 0.0001).","Grade 3 or higher neutropenia in 303 of 377 cabazitaxel patients (82 percent) against 215 (58 percent) on mitoxantrone; febrile neutropenia in 28 (8 percent) against 5 (1 percent).","Grade 3 or higher diarrhoea in 23 patients (6 percent) against 1 (less than 1 percent)."],"whatItMeans":"Proof that a cancer resistant to one taxane is not resistant to all of them, and the beginning of treatment sequencing in castration-resistant disease. The CARD trial later showed that after an androgen receptor drug has failed, cabazitaxel beats switching to the other androgen receptor drug.","caveats":["Open-label, so the quality-of-life and adverse event reporting are not blinded.","The comparator, mitoxantrone, had never been shown to extend survival, so the control arm represents palliation rather than an active alternative.","Haematological toxicity is substantial and the trial predates routine primary granulocyte colony-stimulating factor prophylaxis; the 25 mg per square metre dose was later shown to be reducible to 20 mg with similar efficacy."],"changedPractice":true,"participants":755},"route":"/key-papers/paper-de-bono-tropic-cabazitaxel-lancet-2010/","neighbours":{"paper":[{"id":"paper-therap-lancet-2021","kind":"paper","name":"[ 177 Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial","route":"/key-papers/paper-therap-lancet-2021/"},{"id":"paper-scher-affirm-enzalutamide-nejm-2012","kind":"paper","name":"AFFIRM: increased survival with enzalutamide in prostate cancer after chemotherapy","route":"/key-papers/paper-scher-affirm-enzalutamide-nejm-2012/"},{"id":"paper-tannock-tax-327-docetaxel-prednisone-nejm-2004","kind":"paper","name":"TAX 327: docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer","route":"/key-papers/paper-tannock-tax-327-docetaxel-prednisone-nejm-2004/"}],"roadmap":[{"id":"chemotherapy-roadmap","kind":"roadmap","name":"Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs","route":"/roadmaps/chemotherapy-roadmap/"},{"id":"prostate-roadmap","kind":"roadmap","name":"Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch","route":"/roadmaps/prostate-roadmap/"}],"cancer":[{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"}],"drug":[{"id":"cabazitaxel","kind":"drug","name":"Cabazitaxel","route":"/drugs/cabazitaxel/"},{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"mitoxantrone","kind":"drug","name":"Mitoxantrone","route":"/drugs/mitoxantrone/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"}],"company":[{"id":"sanofi","kind":"company","name":"Sanofi","route":"/companies/sanofi/"}],"term":[{"id":"castration-resistance","kind":"term","name":"Castration-resistant prostate cancer (CRPC)","route":"/terms/castration-resistance/"},{"id":"hazard-ratio","kind":"term","name":"Hazard ratio (HR)","route":"/terms/hazard-ratio/"}],"person":[{"id":"johann-de-bono","kind":"person","name":"Johann de Bono","route":"/people/johann-de-bono/"}],"bottleneck":[{"id":"b-resistance","kind":"bottleneck","name":"Acquired resistance to every therapy","route":"/bottlenecks/b-resistance/"},{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"}],"journal":[{"id":"lancet","kind":"journal","name":"The Lancet","route":"/journals/lancet/"}],"idea":[{"id":"idea-prostate-randomise-the-sequence-not-only-the-drugs","kind":"idea","name":"Randomise the order of treatment, not only the drugs: a strategy platform for metastatic prostate cancer","route":"/ideas/idea-prostate-randomise-the-sequence-not-only-the-drugs/"}]}}