Borojevic et al. (1999)

Borojevic et al. (1999)
Design: Prospective case series (prognosis), evidence level: 3-
Country: Serbia and Montenegro
Inclusion criteria:
Histologically proven breast cancer
Osteolytic metastases verified radiographically
Bone only metastases
Exclusion criteria:
None reported
Population:
Number of patients = 386, age range 27 to 77 years, median age = 52 years.
Interventions:
Short RT regimes (n = 122):
14 Gy in 2 fractions with 48hr interval
16 Gy in 4 fractions in 4 days

Medium RT regimes (n = 250):
18 Gy in 6 fractions in 6 days
20 Gy in 8 fractions in 8 days

Long RT regimes (n = 14):
30 Gy in 10 fractions in 14 days
40 Gy in 20 fractions in 28 days
Outcomes:
Efficacy, possible impact on quality of life (QOL) and overall survival (OS).

Efficacy was measured using a numerical radiobiological (time/dose/fractionation) factor TDFf - no further description.

Follow-up assessment of metastases was graded according to UICC criteria: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).
Follow up:
Assessment of the effect of treatment was carried out after 2 and 4 months. There are no details of baseline testing.
Results:
The TDFf was similar for the low and medium RT regimes (range: 36.8–38.9) whilst the TDFf was 61.6 for the 30 Gy long RT regime and 66.1 for the 40 Gy regime.

There were significant improvements in lesion response between the 1st and 2nd assessments in patients receiving short and medium RT regimes: 14 Gy (P = 0.004), 16 Gy (P = 0.0001), 18 Gy (P = 7.77 x 10E-5) and 20 Gy (P = 1.11 x 10E-9).

The overall response rate was 29% (n = 112) at the first evaluation but, at this point responders and non-responders were not significantly different in terms of their survival (P > 0.05). By the second assessment point, however, those patients with favourable radiographic findings had superior survival to those patients who did not (P < 0.01).

Median OS = 31 months (range: 4–310).

Median OS for patients with bone-only metastases is not reported but, from the Kaplan Meier graph appears to be in excess of 60 months. 2yr survival is 97.6%, 3 yr survival is 67.36% and 5 yr survival is 45%. Some of these patients developed visceral metastases later in the study and had a shorter survival time (P = 0.01).
General comments:
This is a prospective non-randomised trial undertaken between 1988 and 1996 in former Yugoslavia. Patients were allocated to one of 6 different RT fractionation regimes for either solitary (n = 68) or multiple (n = 318) bone metastases from breast cancer.

Some of the patients have solitary bone metastases and some patients had bone metastases as part of wider metastatic disease but the data are not separately reported for these groups.

This paper pre-dates the systematic review on RT fractionation, and is poorly reported (in some cases contradictory). One outcome (QOL) is not reported at all.

From: Chapter 6, Management of specific problems

Cover of Advanced Breast Cancer
Advanced Breast Cancer: Diagnosis and Treatment.
NICE Clinical Guidelines, No. 81.
National Collaborating Centre for Cancer (UK).
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