Adding dasatinib to docetaxel + prednisone does NOT improve OS in men with mCRPC

As one of our readers has already noted, a paper presented today at the Genitourinary Cancers Symposium did not report an overall survival benefit in the so-called READY trial.

The READY trial was well designed as a multinational, randomized, double-blinded, placebo-controlled, Phase III study. Patients with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) were randomized to either docetaxel + prednisone + dasatinib (DPD) or to docetaxel + prednisone + a placebo (DPP).

Docetaxel was administered intravenously at 75 mg/m2 every third week; low-dose prednisone was taken daily; and men randomized to treatment with dasatinib took 100 mg of this drug once daily (or the placebo as appropriate). The primary endpoint of this trial was overall survival and there were numerous secondary endpoints.

Here are the core study data, as presented today by Araujo et al.:

  • The trial enrolled 1,522 men with chenotherapy-naive mCRPC.
    • 762 patients were treated with DPD.
    • 760 patients were treated with DPP.
  • The median follow-up was 19 months.
  • There was no difference in overall survival (OS) between patients in the two arms of this trial.
    • Median OS was 21.5 months in the DPD arm.
    • Median OS was 21.2 months in the DPP arm.
    • The hazard ratio [HR] was 0.99.
  • With respect to secondary endpoints
    • There was no significant difference in the overall response rates (31.9 percent for DPD vs. 30.5 percent for DPP).
    • There was a potentially significant difference in median time to first skeletal-related event (TFSRE; not reached for DPD vs. 31.1 months for DPP; HR = 0.81).
    • There was no significant difference in median progression-free survival (11.8 months for DPD vs. 11.1 months for DPP; HR = 0.92).
    • There was no significant difference in median time to PSA progression (8.0 months for DPD vs. 7.6 months for DPP; HR = 0.91).
    • There was no significant difference in pain reduction (66.6 percent for DAD vs. 71.5 percent for DAP).
  • 23 percent of DPD patients and 14 percent of DPP patients received therapy for < 3 months.
  • The most common adverse events in the DAD arm included diarrhea, fatigue, alopecia, and nausea.
  • Serious adverse events (Grade 3-4) were more common in the DAD arm and included anemia (8.0 vs.5.9 percent), neutropenia (6.2 vs. 5.5 percent), hypocalcemia (3.5 vs.3.1 percent), gastrointestinal bleeding (2.6 vs.1.3 percent), and pleural effusion (1.3 vs. 0.4 percent).

Araujo et al. conclude that  the addition of dasatinib to standard-of-care chemotherapy in men with mCRPC did not improve OS; that there was a modest reduction in the risk of TFSRE with DPD vs. DPP; and that no unexpected toxicities were observed in response to treatment with dasatinib.

3 Responses

  1. Do you have a link or a copy of this poster? Were you able to locate one? Thanks

  2. Sorry … No. I don’t. … Only the link to the abstract.

  3. In this day and age, I thought online access to posters in these conferences would be available somehow. Anyway, a picture of this poster just got posted on the UroToday web site.

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