Pons et al. (1997)

Pons et al. (1997)
Design: Prospective case series (therapy), evidence level: 3
Country: Spain
Inclusion criteria:
MBC with multiple (not defined) bone metastases
Bone pain
Bad response to conventional analgesia
Platelets > 100,000 per mm3
Leucocytes > 3,000 per mm3
Life expectancy > 3 months
Exclusion criteria:
-
Population:
Number of patients = 26, age range 39 to 70 years, mean age = 58 years.
Interventions:
Single i.v. injection of Sr-89 at a dose of 148 MBq (4mCi)

16 patients received a second, and 3 patients a third, dose at a point when, following a previous treatment, measurable pain returned.
Outcomes:
Efficacy of pain palliation as measured by assessment of pain score, analgesia score and KPS:

Good response: increase in KPS, decrease in pain (≥ 4) and analgesia (≥ 1) scores
Partial response: increase in KPS, decrease in pain (2 or 3 points) and no change in analgesia scores
No response: No variation or decrease in KPS, no variations or an increase in pain or analgesia scores
Follow up:
Baseline physical examination, Karnofsky performance assessment, blood count, laboratory testing and bone scintigraphy was performed. Full blood counts were re-assessed at 1, 3 and 6 months after treatment.

Pain score was calculated as the product of severity (0–3) and frequency (0–3). Analgesia score was assessed on a 5-point scale (EORTC). Pain relief was assessed 3 months after each treatment.

The extent of skeletal involvement was calculated by bone scan index (BSI) from 0–100 (Blake). Scans were evaluated by independent reviewers.

Follow-up was for a period of 6 months. 5 patients died before this time and hence their clinical response was not evaluated.
Results:
Pain decreased during the 2nd or 3rd week after treatment and reached a peak in weeks 5 and 6.

Clinical response (n = 26 doses)
Good: 62% (35% of which involved both a decrease in pain and analgesia and 27% of which were incomplete)
Partial: 31%
No response: 8%

No patients required blood transfusion for haematological depression. Whilst platelets and leucocytes were depressed, they returned to normal values within 6 months. Grade 1 or 2 leucocyte toxicity occurred in 19% MBC patients and grade 1 thrombocytopenia was also experienced by 19% of this group.
General comments:
This paper reports a prospective case series of 76 patients of who only 26 had MBC but whose outcomes were reported separately. All patients received Sr-89 for pain palliation; some in multiple doses over time.

This paper deals with a mixed population of prostate and MBC patients and only the first treatment outcome was reported by sub-group.

Of 16 patients receiving subsequent doses of Sr-89, 4 had MBC but efficacy was reported overall - the clinical response to the second dose was good (63%) and partial (37%).

Incomplete responses were scored as ‘good’ which obviously could give an over inflated assessment of efficacy.

The authors reported no decrease in tumour markers and therefore opine that SR-89 is not tumoricidal.

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).
Copyright © 2009, National Collaborating Centre for Cancer.

No part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licenses issued by the Copyright Licensing Agency in the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page.

The use of registered names, trademarks etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use.

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.