{"entity":{"id":"tropic","kind":"trial","name":"TROPIC","aka":["TROPIC","EFC6193"],"tldr":"Showed that a second taxane still works after docetaxel has stopped working, adding about two and a half months of life, and that it suppresses the bone marrow hard.","summary":"TROPIC randomised 755 men whose prostate cancer had progressed during or after docetaxel to cabazitaxel 25 mg/m2 (378) or mitoxantrone 12 mg/m2 (377) every 3 weeks, both with prednisone 10 mg daily.\n\nAt the final analysis, median survival was 15.1 months (95 percent confidence interval 14.1 to 16.3) with cabazitaxel and 12.7 months (11.6 to 13.7) with mitoxantrone, hazard ratio for death 0.70 (0.59 to 0.83, p<0.0001). Median progression-free survival was 2.8 months (2.4 to 3.0) against 1.4 months (1.4 to 1.7), hazard ratio 0.74 (0.64 to 0.86, p<0.0001).\n\nThe haematological cost is what determines who can have it. Grade 3 or higher neutropenia occurred in 303 of 378 men on cabazitaxel (82 percent) against 215 of 377 (58 percent), and febrile neutropenia in 28 (8 percent) against five (1 percent). Grade 3 or higher diarrhoea occurred in 23 (6 percent) against one.\n\nIn England NICE TA391 recommends cabazitaxel with prednisone or prednisolone after docetaxel only if the man has an ECOG performance status of 0 or 1, has had at least 225 mg/m2 of docetaxel, and stops at progression or after a maximum of 10 cycles, with the commercial arrangement in place.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00417079","url":"https://clinicaltrials.gov/study/NCT00417079"},{"label":"TROPIC (Lancet 2010)","url":"https://doi.org/10.1016/S0140-6736(10)61389-X"},{"label":"NICE TA391: cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel","url":"https://www.nice.org.uk/guidance/ta391"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cabazitaxel","mitoxantrone","prednisone"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":["castration-resistance","mcrpc-mhspc"],"trials":["proselica","firstana","card","tax-327"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00417079","phase":"3","setting":"Metastatic castration-resistant prostate cancer progressing during or after a docetaxel-containing regimen: prednisone 10 mg daily for everyone, with cabazitaxel 25 mg/m2 or mitoxantrone 12 mg/m2 intravenously every 3 weeks, with overall survival as the primary endpoint","sponsor":"Sanofi-Aventis","result":"Median survival 15.1 against 12.7 months (hazard ratio 0.70, 95 percent confidence interval 0.59 to 0.83); grade 3 or higher neutropenia in 82 percent and febrile neutropenia in 8 percent.","yearReported":2010,"enrolled":755,"enrolledBasis":"randomised","enrolledNote":"755 men were allocated to treatment and all were included in the intention-to-treat analysis.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Cabazitaxel 25 mg/m2 with prednisone","n":378,"value":15.1},{"name":"Mitoxantrone with prednisone","n":377,"value":12.7}],"hr":0.7,"ci":[0.59,0.83],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(10)61389-X"},{"endpoint":"Progression-free survival (median)","unit":"months","arms":[{"name":"Cabazitaxel 25 mg/m2 with prednisone","n":378,"value":2.8},{"name":"Mitoxantrone with prednisone","n":377,"value":1.4}],"hr":0.74,"ci":[0.64,0.86],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(10)61389-X"},{"endpoint":"Grade 3 or higher neutropenia","unit":"%","arms":[{"name":"Cabazitaxel 25 mg/m2 with prednisone","n":378,"value":82},{"name":"Mitoxantrone with prednisone","n":377,"value":58}],"source":"https://doi.org/10.1016/S0140-6736(10)61389-X"}],"replication":"PROSELICA confirmed the efficacy at a reduced 20 mg/m2 dose, and CARD confirmed cabazitaxel beats switching to a second androgen receptor pathway inhibitor."},"route":"/trials/tropic/","neighbours":{"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/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"cabazitaxel","kind":"drug","name":"Cabazitaxel","route":"/drugs/cabazitaxel/"},{"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":"mcrpc-mhspc","kind":"term","name":"mCRPC and mHSPC (castration-resistant vs hormone-sensitive prostate cancer)","route":"/terms/mcrpc-mhspc/"},{"id":"prostate-crpc-sequencing","kind":"term","name":"What follows what in castration-resistant prostate cancer","route":"/terms/prostate-crpc-sequencing/"}],"trial":[{"id":"affinity-custirsen","kind":"trial","name":"AFFINITY","route":"/trials/affinity-custirsen/"},{"id":"card","kind":"trial","name":"CARD","route":"/trials/card/"},{"id":"firstana","kind":"trial","name":"FIRSTANA","route":"/trials/firstana/"},{"id":"proselica","kind":"trial","name":"PROSELICA","route":"/trials/proselica/"},{"id":"tax-327","kind":"trial","name":"TAX 327","route":"/trials/tax-327/"}]}}