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14 september 2018: lees ook dit artikel: 

https://kanker-actueel.nl/ema-legt-beperkingen-op-aan-gebruik-van-radium-223-xofigo-bij-uitgezaaide-prostaatkanker-nadat-studies-uitwijzen-dat-dit-kan-leiden-tot-meer-botbreuken-en-vroegtijdig-overlijden-in-vergelijking-met-placebo.html

4 september 2016: Bron: The Lancet: DOI: http://dx.doi.org/10.1016/S1470-2045(16)30173-5

Wanneer Radium-223 wordt toegevoegd aan andere behandelingen zoals Abiraterone en enzalutamide bij hormoon resistente in de botten uitgezaaide prostaatkanker dan geeft dat een betere overall overleving, minder pijn en betere kwaliteit van leven.  Ook geeft de combinatie Radium-223 plus denosumab langere overall overleving. 

Mediane overall overleving was langer bij die patiënten die ook abiraterone, enzalutamide, of beide ontvingen in vergelijking met die patienten die geen van deze medicijnen kregen:  (mediane overleving = nog niet bereikt versus 13 maanden) en in vergelijking met die patiënten die denosumab ontvingen blijkt Radium-223  (Xgeva) mediane overleving nog niet bereikt versus 13 maanden.

De meeste graad 3 bijwerkingen waren bloedarmoede bij 32 (5%) patiënten, thrombocytopenia bij 15 (2%) patiënten, neutropenie bij 10 (1%) patiënten en leucopenie bij 9 (1%) patiënten. Totale aantal ernstige bijwerkingen (graad 3 of meer) werden gemeld bij 243 (35%) patiënten.

Dit blijkt uit de resultaten van de ALSYMPCA studie.

Radium-223

In deze open label studie kregen 696 patiënten minimaal 1 keer een injectie met Radium-223  De injecties werden iedere 4 weken gegeven tot maximaal 6 injecties. Andere behandelingen en of medicijnen werden toegestaan. Totaal 403 patienten ontvingen alle 6 de injecties.

Hier de resultaten uit de studie die ik maar niet verder vertaal want zijn goed te begrijpen neem ik aan:

Resultaten:

  • Median follow-up was 7·5 months (IQR 5–11) and 210 deaths were reported;
  • median overall survival was 16 months (95% CI 13–not available ).
  • In an exploratory analysis of overall survival with predefined factors, median overall survival was longer for: patients with baseline alkaline phosphatase concentration less than the upper limit of normal (ULN; median NA, 95% CI 16 months–NA) than for patients with an alkaline phosphatase concentration equal to or greater than the ULN (median 12 months, 11–15);
  • patients with baseline haemoglobin levels 10 g/dL or greater (median 17 months, 14–NA) than for patients with haemoglobin levels less than 10 g/dL (median 10 months, 8–14);
  • patients with a baseline Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 (median NA, 17 months–NA) than for patients with an ECOG PS of 1 (median 13 months, 11–NA) or an ECOG PS of 2 or more (median 7 months, 5–11);
  • For patients with no reported baseline pain (median NA, 16 months–NA) than for those with mild pain (median 14 months, 13–NA) or moderate–severe pain (median 11 months, 9–13).
  • Median overall survival was also longer in patients who received radium-223 plus abiraterone, enzalutamide, or both (median NA, 95% CI 16 months–NA) than in those who did not receive these agents (median 13 months, 12–16),
  • and in patients who received radium-223 plus denosumab (median NA, 15 months–NA) than in patients who received radium-223 without denosumab (median 13 months, 12–NA).

Het volledige studierapport: Radium-223 and concomitant therapies in patients with metastatic castration-resistant prostate cancer: an international, early access, open-label, single-arm phase 3b trial is tegen betaling in te zien.

Hier het abstract van de studie zoals gepubliceerd in The Lancet:

Combining Radium-223 With Other Therapies May Be of Benefit in Metastatic Castration-Resistant Prostate Cancer

Radium-223 and concomitant therapies in patients with metastatic castration-resistant prostate cancer: an international, early access, open-label, single-arm phase 3b trial

Prof Fred Saad, MDcorrespondencePress enter key for correspondence information
,
Joan Carles, MD
,
Prof Silke Gillessen, MD
,
Prof Axel Heidenreich, MD
,
Daniel Heinrich, MD
,
Jeremy Gratt, BA
,
Jérémy Lévy, ScD
,
Prof Kurt Miller, MD
,
Prof Sten Nilsson, MD
,
Oana Petrenciuc, MD
,
Marcello Tucci, MD
,
Prof Manfred Wirth, MD
,
Judith Federhofer, MD
,
Prof Joe M O'Sullivan, MD
for the Radium-223 International Early Access Program Investigators
Members of Radium-223 International Early Accesss Program Investigators are listed in the appendix

DOI: http://dx.doi.org/10.1016/S1470-2045(16)30173-5

Summary

Background

In the previously reported ALSYMPCA trial in patients with castration-resistant prostate cancer and symptomatic bone metastases, overall survival was significantly longer in patients treated with radium-223 dichloride (radium-223) than in patients treated with placebo. In this study, we investigated safety and overall survival in radium-223 treated patients in an early access programme done after the ALSYMPCA study and before regulatory approval of radium-223.

Methods

We did an international, prospective, interventional, open-label, single-arm, phase 3b study. Enrolled patients were aged 18 years or older with histologically or cytologically confirmed progressive bone-predominant metastatic castration-resistant prostate cancer with two or more skeletal metastases on imaging (with no restriction as to whether they were symptomatic or asymptomatic; without visceral disease but lymph node metastases were allowed). Patients received intravenous injections of radium-223, 50 kBq/kg (current recommendation 55 kBq/kg after implementation of National Institute of Standards and Technology update on April 18, 2016) every 4 weeks for up to six injections. Other concomitant anticancer therapies were allowed. Primary endpoints were safety and overall survival. The safety and efficacy analyses were done on all patients who received at least one dose of the study drug. The study has been completed, and we report the final analysis here. This study is registered with ClinicalTrials.gov, number NCT01618370, and the European Union Clinical Trials Register, EudraCT number 2012-000075-16.

Findings

Between July 22, 2012, and Dec 19, 2013, 839 patients were enrolled from 113 sites in 14 countries. 696 patients received one or more doses of radium-223; 403 (58%) of these patients had all six planned injections. Any-grade treatment-emergent adverse events occurred in 523 (75%) of 696 patients; any-grade treatment-emergent adverse events deemed to be related to treatment were reported in 281 (40%) patients. The most common grade 3 or worse treatment-related treatment-emergent adverse events were anaemia in 32 (5%) patients, thrombocytopenia in 15 (2%) patients, neutropenia in ten (1%) patients, and leucopenia in nine (1%) patients. Any grade of serious adverse events were reported in 243 (35%) patients. Median follow-up was 7·5 months (IQR 5–11) and 210 deaths were reported; median overall survival was 16 months (95% CI 13–not available ). In an exploratory analysis of overall survival with predefined factors, median overall survival was longer for: patients with baseline alkaline phosphatase concentration less than the upper limit of normal (ULN; median NA, 95% CI 16 months–NA) than for patients with an alkaline phosphatase concentration equal to or greater than the ULN (median 12 months, 11–15); patients with baseline haemoglobin levels 10 g/dL or greater (median 17 months, 14–NA) than for patients with haemoglobin levels less than 10 g/dL (median 10 months, 8–14); patients with a baseline Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 (median NA, 17 months–NA) than for patients with an ECOG PS of 1 (median 13 months, 11–NA) or an ECOG PS of 2 or more (median 7 months, 5–11); and for patients with no reported baseline pain (median NA, 16 months–NA) than for those with mild pain (median 14 months, 13–NA) or moderate–severe pain (median 11 months, 9–13). Median overall survival was also longer in patients who received radium-223 plus abiraterone, enzalutamide, or both (median NA, 95% CI 16 months–NA) than in those who did not receive these agents (median 13 months, 12–16), and in patients who received radium-223 plus denosumab (median NA, 15 months–NA) than in patients who received radium-223 without denosumab (median 13 months, 12–NA).

Interpretation

Our findings show that radium-223 can be safely combined with abiraterone or enzalutamide, which are now both part of the standard of care for patients with metastatic castration-resistant prostate cancer. Furthermore, our findings extend to patients who were asymptomatic at baseline, unlike those enrolled in the pivotal ALSYMPCA study. The findings of prolonged survival in patients treated with concomitant abiraterone, enzalutamide, or denosumab require confirmation in prospective randomised trials.

Funding

Pharmaceutical Division of Bayer.


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