Admin Posted September 17, 2016 Share Posted September 17, 2016 Jim Marshall (not a doctor) said ... How many doses of the chemotherapy drug Taxotere (Docetaxel) will give longest survival? The number of doses you get depends on how your cancer is responding, and how your body is dealing with it. Six doses of Docetaxel seems to be a common aim (as in the CHARTED trial): But doctors give as many as 10 or more Docetaxel doses in a row (and may repeat that in the future if the first sessions gave a good result). No one has done a study to see if giving more than six doses in a row gives longer survival. But as part of another study, some men got more than six doses: 10 or more doses, half were still alive at 33.0 months 8 to 10 doses, half were still alive at 26.9 months 5 to 7 doses, half were still alive at 22.8 months Warning about evidence This is not evidence. It is just a hint. Researchers were looking back at what happened in a failed trial of another drug plus Docetaxel. An actual trial would be needed to provide evidence. But if your doctor keeps you on Docetaxel chemo longer, you know there is a hint it may work better. Warning one about survival numbers These men had very advanced disease - metastatic castrate resistant. Docetaxel is often given earlier in treatment, and survival figures are much higher than here. Warning two about survival numbers Doctors speak of the median survival - when half the men are still alive. That half is the men who respond to the treatment. They don't all suddenly die soon after the median time. A few may, but the survival of the others will be spread out over months and years. ... end Jim Abstract JAMA Oncol. 2016 Aug 25. doi: 10.1001/jamaoncol.2016.3000. [Epub ahead of print] Association of Survival Benefit With Docetaxel in Prostate Cancer and Total Number of Cycles Administered: A Post hoc Analysis of the Mainsail Study. de Morrée ES1, Vogelzang NJ2, Petrylak DP3, Budnik N4, Wiechno PJ5, Sternberg CN6, Doner K7, Bellmunt J8, Burke JM9, Ochoa de Olza M10, Choudhury A11, Gschwend JE12, Kopyltsov E13, Flechon A14, van As N15, Houede N16, Barton D17, Fandi A17, Jungnelius U17, Li S17, Li JS17, de Wit R1. Author information Abstract IMPORTANCE: 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. OBJECTIVE: 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. RESULTS: 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 , 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. PMID: 27560549 DOI: 10.1001/jamaoncol.2016.3000 [PubMed - as supplied by publisher] Link to comment Share on other sites More sharing options...
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