# TAX 327: docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer

Source: https://onco.cc/key-papers/paper-tannock-tax-327-docetaxel-prednisone-nejm-2004/  
OnCo record `paper-tannock-tax-327-docetaxel-prednisone-nejm-2004` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first treatment ever shown to help men live longer once prostate cancer stopped responding to hormones. Docetaxel every three weeks added about two and a half months to median survival compared with the older drug, and made pain and quality of life better as well.

## Summary

Ian Tannock and colleagues randomised 1,006 men with metastatic hormone-refractory prostate cancer, all taking 5 mg of prednisone twice daily, to mitoxantrone every three weeks, docetaxel every three weeks, or weekly docetaxel. The primary endpoint was overall survival, with pain, prostate-specific antigen and quality of life as secondary endpoints, each compared against mitoxantrone.

Mitoxantrone had been approved in 1996 on palliation alone: it relieved pain and did not extend life. TAX 327 is where prostate cancer got a drug that did both, and where the three-weekly schedule beat the weekly one, which is why the three-weekly schedule is the one still used. Twenty years later docetaxel is given much earlier, at the first diagnosis of metastatic disease, on the strength of CHAARTED and STAMPEDE.

## Fields

- Kind: Key paper
- Last checked: 2026-09-25
- Also known as: TAX 327; Tannock 2004 docetaxel prostate
- Tags: prostate-evidence
- Journal: New England Journal of Medicine
- Year: 2004
- DOI: 10.1056/nejmoa040720
- Authors: Tannock IF, de Wit R, Berry WR, et al.
- Findings: Median survival 16.5 months with mitoxantrone, 18.9 months with docetaxel every three weeks and 17.4 months with weekly docetaxel.; Hazard ratio for death with three-weekly docetaxel 0.76 (95 percent confidence interval 0.62 to 0.94; P equals 0.009); with weekly docetaxel 0.91 (0.75 to 1.11; P equals 0.36).; A decrease in serum prostate-specific antigen of at least 50 percent in 32 percent, 45 percent and 48 percent of the three groups respectively (P less than 0.001 for both docetaxel comparisons).; Predefined reductions in pain in 22 percent, 35 percent (P equals 0.01) and 31 percent (P equals 0.08).; Improvements in quality of life in 13 percent, 22 percent (P equals 0.009) and 23 percent (P equals 0.005); adverse events were more common in the docetaxel groups.
- What it means: The end of therapeutic nihilism in castration-resistant prostate cancer. It is also the trial that set the field's expectation of what a positive result looks like in this disease: a hazard ratio near 0.75 and a median gain measured in months, not years.
- Caveats: Median survival gain of 2.4 months against mitoxantrone, at the cost of more adverse events.; The control was mitoxantrone, a drug approved for palliation and never shown to extend survival, so the comparison is against a low bar.; The trial population was fitter than the average man with castration-resistant disease; performance status 2 patients were a minority.

## Sources

- N Engl J Med 2004: https://doi.org/10.1056/nejmoa040720
- PubMed: https://pubmed.ncbi.nlm.nih.gov/15470213/
- Europe PMC: https://europepmc.org/article/MED/15470213

## Connected records

- key papers: [CHAARTED: chemohormonal therapy in metastatic hormone-sensitive prostate cancer](https://onco.cc/key-papers/paper-chaarted-nejm-2015/), [SWOG 9916: docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer](https://onco.cc/key-papers/paper-petrylak-swog-9916-docetaxel-estramustine-nejm-2004/), [TROPIC: prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel](https://onco.cc/key-papers/paper-de-bono-tropic-cabazitaxel-lancet-2010/)
- roadmaps: [Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs](https://onco.cc/roadmaps/chemotherapy-roadmap/), [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](https://onco.cc/roadmaps/prostate-roadmap/)
- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- fronts: [Chemotherapy](https://onco.cc/fronts/chemotherapy/)
- drugs: [Docetaxel](https://onco.cc/drugs/docetaxel/), [Mitoxantrone](https://onco.cc/drugs/mitoxantrone/), [Prednisone](https://onco.cc/drugs/prednisone/)
- terms: [Castration-resistant prostate cancer (CRPC)](https://onco.cc/terms/castration-resistance/), [Hazard ratio (HR)](https://onco.cc/terms/hazard-ratio/), [PSA (prostate-specific antigen)](https://onco.cc/terms/psa/), [Quality of life](https://onco.cc/terms/quality-of-life/)
- people: [Ian F. Tannock](https://onco.cc/people/ian-tannock/), [Nicholas James](https://onco.cc/people/nicholas-james/)
- bottlenecks: [Acquired resistance to every therapy](https://onco.cc/bottlenecks/b-resistance/), [Toxicity and quality of life are undervalued](https://onco.cc/bottlenecks/b-toxicity-qol/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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