Materials and Methods
This study was approved by the local Ethical Committee and was performed
in accordance with the ethical standards of the 1964 Declaration of
Helsinki and its later amendments. All patients signed a written
Informed Consent. The present single-center prospective study enrolled
173 consecutive patients affected by symptomatic bone metastases from
mCRPC, eligible for
223Ra-therapy7,19 and treated in our
Nuclear Medicine Unit, from September 2013 to the time of the analysis
(July 2018). Currently, 223Ra-therapy consists of an
intravenous injection of 55 KBq/Kg of body weight, dispensed every 28
days, for a total of 6 cycles6. QoL was evaluated by
asking patients to answer both the European Organization for Research
and Treatment of Cancer Quality of Life Questionnaire C30
(EORTC QLQ-C30, version 3.0), and the EORTC Bone Metastasis Module
(QLQ-BM22). The unavailability of the baseline QoL assessment
represented an exclusion criterion from the study. The QLQ-C30
questionnaire represents a specific tool for the assessment of QoL in
cancer patients20. The QLQ‐C30 (version 3.0) is
composed of both multi-item scales and single‐item measures. These
include 5 functional scales (cognitive, CF; emotional, EF; physical, PF;
role, RF; and social functioning, SF), 3 symptom scales (fatigue, FA;
nausea/vomiting, NV; and pain, PA), a global health status/QoL scale and
5 single items assessing additional symptoms (appetite loss, AP;
constipation, CO; diarrhea, DI; dyspnea, DY; and sleep disturbance, SL)
and perceived financial impact, FI. Each of the multi-item scales
includes a different set of items—no item occurs in more than 1 scale.
All scales and single‐item measures range in score from 0–100. A high
scale score represents a higher response level. Thus, a high score for a
functional scale represents a high/healthy level of functioning. A high
score for the global health status/QoL represents a high QoL. A high
score for a symptom scale/item represents a high level of
symptomatology/problems. The Bone Metastasis Module (QLQ-BM22) consists
of an additional disease-specific module for patients with bone
metastases21. The 22‐item EORTC QLQ‐BM22 questionnaire
assesses disease symptoms related to bone metastasis, including painful
sites, functional interference, painful characteristics, and
psychosocial aspects as multi‐item scales. We scaled all items from one
(not at all) to four (very much). In this questionnaire, a higher score
in the case of symptom scales is indicative of greater distress, while a
higher score in the case of functional scales indicates greater
functional ability. Questionnaires were completed by patients without
any kind of conditioning from relatives or medical staff, and were
submitted at baseline, at the end of each treatment cycle, and at each
follow-up evaluation, performed at 3 months, 6 months and 12 months
after the end of 223Ra-therapy. Among 173 patients
enrolled, 5 were excluded from the study because of the unavailability
of the baseline QoL assessment. Other baseline clinical data relevant to
the OS analysis, specifically age, height, weight, Hb, platelets (PLT),
ECOG-PS, PSA and tALP, have been collected and taken into account in the
statistical analysis. OS was established from the date of the first
administration of 223Ra until the date of death from
any cause.