Table 1.
Quality of life values
Parameters n (%) | Patients (%) (n=53)¶ | Prior use of abiraterone | p value | |
---|---|---|---|---|
| ||||
No (n=33) | Yes (n=20) | |||
FACT-P ≥16 points* | 7 (13.0) | 3 (9.1) | 4 (20.0) | 0.2807 |
FACT-P ≥10 points* | 14 (25.9) | 6 (18.2) | 8 (40.0) | 0.1454 |
FACT-P ≥6 points* | 20 (37.0) | 10 (30.3) | 10 (50.0) | 0.2151 |
PCS subscale ≥2 points* | 26 (50.0) | 15 (46.9) | 11 (57.9) | 0.7011 |
PCS pain subscale ≥2 points* | 12 (23.1) | 7 (21.9) | 5 (26.3) | 0.8505 |
Pain response rate‡ | 4 (21.1) | 3 (20.0) | 1 (25.0) | 0.7425 |
Minimally clinically important difference observed on two consecutive cycles where an increase in score on the FACT-P instrument and its subscales indicates improvement in quality of life.
For the FACT-P questionnaire, an evaluable patient is defined as a patient who responds to at least 80 % of the items. FACT–P is a 39-item questionnaire that consists of FACT–G (general), a 27-item self-report questionnaire that measures general health-related quality of life in cancer patients, and the Prostate Cancer Subscale (PCS), a 12-item subscale specifically designed to measure prostate cancer-specific quality of life. The FACT–P total score includes the FACT–G and the PCS. The FACT–P PCS pain-related score includes four questions from the FACT–P interrogating pain specifically.
Pain response was established only for patients with median present pain intensity (PPI) score of 2 or more or mean analgesic score (AS) of 10 points or more at baseline, or both, and was defined as a two-point or greater reduction from baseline median PPI score without an increased AS or a decrease of 50% or more in the AS without an increase in the PPI score, maintained for at least three weeks. FACT-P: Functional Assessment of Cancer Therapy – Prostate.