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JAMA Oncol. 2017 Jan 1;3(1):68-75. doi: 10.1001/jamaoncol.2016.3000.

Association of Survival Benefit With Docetaxel in Prostate Cancer and Total Number of Cycles Administered: A Post Hoc Analysis of the Mainsail Study.

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Erasmus MC Cancer Institute, Department of Medical Oncology, Rotterdam, the Netherlands.
US Oncology Research, Houston, Texas3Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada.
Yale Cancer Center, Division of Oncology, Department of Medicine, New Haven, Connecticut.
NSHI Dorozhnaya Clinical Hospital of OAO Russian Railways, Rostov-on-Don, Russia.
Department of Uro-Oncology, Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Warsaw, Poland.
San Camillo and Forlanini Hospitals, Department of Medical Oncology, Rome, Italy.
Texas Oncology, Austin.
University Hospital del Mar-IMIM, Barcelona, Spain10Dana Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.
US Oncology Research, Houston, Texas11Rocky Mountain Cancer Centers, Aurora, Colorado.
Catalan Institute of Oncology, Department of Medical Oncology, Barcelona, Spain.
Department of Clinical Oncology, The Christie NHS Foundation Trust and Institute of Cancer Sciences, University of Manchester, Manchester, England.
Department of Urology, Rechts der Isar Medical Center, Technische Universität München, München, Germany.
State Institution of Healthcare " Regional Clinical Oncology Dispensary", Omsk, Russia.
Centre Léon Bérard, Department of Medical Oncology, Lyon, France.
Department of Clinical Oncology, Royal Marsden Hospital, London, England.
Medical Oncology Department, Groupe Hospitalier Universitaire Caremeau Place du Professeur Robert Debré, Nîmes, France.
Celgene Corporation, Summit, New Jersey.



The optimal total number of docetaxel cycles in patients with metastatic castration resistant prostate cancer (mCPRC) has not been investigated yet. It is unknown whether it is beneficial for patients to continue treatment upon 6 cycles.


To investigate whether the number of docetaxel cycles administered to patients deriving clinical benefit was an independent prognostic factor for overall survival (OS) in a post hoc analysis of the Mainsail trial.

Design, Setting, and Participants:

The Mainsail trial was a multinational randomized phase 3 study of 1059 patients with mCRPC receiving docetaxel, prednisone, and lenalidomide (DPL) or docetaxel, prednisone, and a placebo (DP). Study patients were treated until progressive disease or unacceptable adverse effects occurred. Median OS was found to be inferior in the DPL arm compared with the DP arm. As a result of increased toxic effects with the DPL combination, patients on DPL received fewer docetaxel cycles (median, 6) vs 8 cycles in the control group. As the dose intensity was comparable in both treatment arms, we investigated whether the number of docetaxel cycles administered to patients deriving clinical benefit on Mainsail was an independent prognostic factor for OS. We conducted primary univariate and multivariate analyses for the intention-to-treat population. Additional sensitivity analyses were done, excluding patients who stopped treatment for reasons of disease progression and those who received 4 or fewer cycles of docetaxel for other reasons, minimizing the effect of confounding factors.

Main Outcomes and Measures:

Total number of docetaxel cycles delivered as an independent factor for OS.


Overall, all 1059 patients from the Mainsail trial were included (mean [SD] age, 68.7 [7.89] years). Treatment with 8 or more cycles of docetaxel was associated with superior OS (hazard ratio [HR], 1.909; 95% CI, 1.660-2.194; P < .001), irrespective of lenalidomide treatment (HR, 1.060; 95% CI, 0.924-1.215; P = .41). Likewise, in the sensitivity analysis, patients who received a greater number of docetaxel cycles had superior OS; patients who received more than 10 cycles had a median OS of 33.0 months compared with 26.9 months in patients treated with 8 to 10 cycles; and patients who received 5 to 7 cycles had a median OS of 22.8 months (P < .001).

Conclusions and Relevance:

These findings suggest that continuation of docetaxel chemotherapy contributes to the survival benefit. Prospective validation is warranted.

[Indexed for MEDLINE]

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