Quality of life data and the CHAARTED trial

As regular readers will be aware, the data from the CHAARTED trial were the first to show that combining androgen deprivation (ADT) with docetaxel chemotherapy has a significant, life-extending benefit in at least some men newly diagnosed with metastatic prostate cancer.

A new paper to be presented at the upcoming Genitourinary Cancers Symposium is now offering some interesting insights into patient quality of life associated with combination ADT + docetaxel chemotherapy among men treated in the CHAARTED study. The new paper by Patrick-Miller et al. (abstract no. 286; “Quality of life (QOL) analysis from E3805, chemohormonal androgen ablation randomized trial (CHAARTED) in prostate cancer (PrCa)”) reports on quality of life data collected at baseline (prior to initial treatment) as well as at 3, 6, 9, and 12 months after randomization of patients to one or other of the two study arms:

  • Arm A: ADT + 6 cycles of docetaxel chemotherapy every 3 weeks (N = 397)
  • Arm B: ADT alone (N = 393)

The patients were asked to complete validated quality of life instruments that included the Functional Assessment of Cancer Therapy –Prostate (FACT-P) instrument as scheduled above. The results provided by the quality of life studies were as follows:

  • Evaluable quality of life instruments were completed by
    • 91 percent of patients in Arm A at baseline
    • 88 percent of patients in Arm B at baseline
    • 87 percent of patients in Arm A at 3 months
    • 80 percent of patients in Arm B at 3 months
    • 70 percent of patients in Arm A at 12 months
    • 67 percent of patients in Arm B at 12 months
  • Based on the FACT-P scores patients in Arm A reported
    • A 2.7 ± 0.9 point decrease in quality of life from baseline at 3 months (p = 0.003)
    • An 0.7 ± 1.1 point decrease in quality of life from baseline at 12 months (which was not statistically significant)
  • Also based on the FACT-P scores, patients in Arm B reported
    • A 1.1 ± 1.0 point decrease in quality of life from baseline at 3 months (which was not statistically significant)
    • A 4.2 ± 1.1 point decline in quality of life from baseline at 12 months (p = 0.0001)

Patrick-Miller and her colleagues conclude that docetaxel treatment in combination with ADT

is associated with decreased [quality of life] on treatment (at 3 months) not seen with ADT alone. However, 12-month [quality of life] was better for the patients who had docetaxel [+ ADT] versus ADT alone, returning to baseline. This suggests that docetaxel + ADT does not confer long-term negative impact on [quality of life] for [men with metastatic, hormone-sensitive prostate cancer].

Of course the other way to look at these data are that neither form of treatment actually improved quality of life for any of the patients at up to 12 months of follow-up. What is clear, however, is that quality of life for the men treated with ADT + docetaxel did return to a close-to-baseline level after 12 months, and this set of men did also live for significantly longer! By comparison, quality of life for men being treated with ADT alone declined significantly over time, and this set of men also had a lower overall survival time.

One Response

  1. There’s another interpretation that may be plausible ….

    Men on ADT + chemotherapy have a rapid deterioration in quality of life after the second or third infusion that smothers the quality of life side effects of ADT. Maybe a man loses libido, but who cares if he feels so lousy from the docetaxel!

    After 12 months, the chemotherapy side effects have hopefully worn off, his hair has grown back, and compared to the “chemo times”, he feels way better and hardly notices the fatigue, etc., in comparison.

    The man on ADT alone just sees a steady worsening over time.

    It would be interesting to measure responses in both arms after 18 months …..

    For me, this study falls into the “No sh**, Sherlock” category!

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