Kasalicky & Krajska (1998)

Kasalicky & Krajska (1998)
Design: Prospective case series (therapy), evidence level: 3
Country: Czech Republic (sometimes also rendered as Czechia
Inclusion criteria:
Skeletal metastases
WBC ≥ 2,500 per mm3
Platelets ≥ 100,000 per mm3
Life expectancy > 3 months
Exclusion criteria:
None stated
Number of patients = 23.
118 patients received a single i.v. injection of Sr-89 at a dose of 150 MBq

Overall, 76 patients received a second, 36 a third, 21 a fourth and 8 a fifth dose. Total doses = 256 (number not stated for MBC patients).

A second dose was given not less than 3 months after the initial treatment. Only initial treatment results are presented by sub-group.
The sum of several factors:

Change in condition: subjective by patient (−1 to +2)
Analgesia: objective by medical staff and by patient (−1 to +3)
Mobility: subjective - pain sensation when walking (−1 to +2)
Pain palliation: subjective by patient & analgesia use (−1 to +2)
Follow up:
Baseline Karnofsky performance scale (KPS) was assessed together with routine examination including biochemical and haematological criteria, ECG and routine X-rays. Frequency of follow- up assessment was not stated.

Skeletal disease was confirmed by scintigraphy (99 mTcMDP).

Follow-up period was 3 years during which time 76 patients (64.4% of study total) died.
Scores after first treatment

Change in condition:
Mild improvement = 10
Definite improvement = 13

Quantity decreased by 20–45% = 15
Quantity decreased by 50–80% = 7
Analgesics discontinued = 1

Unchanged = 2
Less restricted = 20
Unrestricted = 1

Pain palliation:
Unchanged = 2
Mild pain relief = 3
Marked relief or no pain = 18
Overall score after first administration:
Mild improvement = 10 (43.5%)
Substantial improvement = 10 (43.5%)
Dramatic improvement = 3 (13%)

Mean duration of benefit (number of patients not known):
1st dose = 3.08 months (± 0.48)
2nd dose = 3.58 months (± 0.92)
3rd dose = 3.88 months (± 1.21)
4th dose = 5.63 months (± 3.0)
5th dose = 5.33 months (± 2.36)
General comments:
This paper reports a larger prospective case series which enrolled patients with various primary cancers, including 23 with MBC. Only the response to first dose was given in sub-groups.

This works suffers the usual shortcomings of an observational study without a control and the patient number is very low.

From: Chapter 6, Management of specific problems

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Advanced Breast Cancer: Diagnosis and Treatment.
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