Radium-223 in combination with paclitaxel in cancer patients with bone metastases : safety results from an open-label, multicenter phase Ib study

Show full item record



Permalink

http://hdl.handle.net/10138/301425

Citation

Geva , R , Lopez , J , Danson , S , Joensuu , H , Peer , A , Harris , S J , Souza , F , Pereira , K M C & Perets , R 2019 , ' Radium-223 in combination with paclitaxel in cancer patients with bone metastases : safety results from an open-label, multicenter phase Ib study ' , European Journal of Nuclear Medicine and Molecular Imaging , vol. 46 , no. 5 , pp. 1092-1101 . https://doi.org/10.1007/s00259-018-4234-6

Title: Radium-223 in combination with paclitaxel in cancer patients with bone metastases : safety results from an open-label, multicenter phase Ib study
Author: Geva, Ravit; Lopez, Juanita; Danson, Sarah; Joensuu, Heikki; Peer, Avivit; Harris, Samuel J.; Souza, Fabricio; Pereira, Kaline M. C.; Perets, Ruth
Contributor: University of Helsinki, Heikki Joensuu / Principal Investigator
Date: 2019-05
Language: eng
Number of pages: 10
Belongs to series: European Journal of Nuclear Medicine and Molecular Imaging
ISSN: 1619-7070
URI: http://hdl.handle.net/10138/301425
Abstract: Purpose Concomitant treatment with radium-223 and paclitaxel is a potential option for cancer patients with bone metastases; however, myelosuppression risk during coadministration is unknown. This phase Ib study in cancer patients with bone metastases evaluated the safety of radium-223 and paclitaxel. Methods Eligible patients had solid tumor malignancies with >= 2 bone metastases and were candidates for paclitaxel. Treatment included seven paclitaxel cycles (90 mg/m(2) per week intravenously per local standard of care; 3 weeks on/1 week off) plus six radium-223 cycles (55 kBq/kg intravenously; one injection every 4 weeks, starting at paclitaxel cycle 2). The primary end point was percentage of patients with grade 3/4 neutropenia or thrombocytopenia during coadministration of radium-223 and paclitaxel (cycles 2, 3) versus paclitaxel alone (cycle 1). Results Of 22 enrolled patients, 15 were treated (safety population), with 7 completing all six radium-223 cycles. Treated patients had primary cancers of breast (n = 7), prostate (n = 4), bladder (n = 1), non-small cell lung (n = 1), myxofibrosarcoma (n = 1), and neuroendocrine (n = 1). No patients discontinued treatment from toxicity of the combination. In the 13 patients who completed cycle 3, the rates of grade 3 neutropenia in cycles 2 and 3 were 31% and 8%, respectively, versus 23% in cycle 1; there were no cases of grade 4 neutropenia or grade 3/4 thrombocytopenia. Breast cancer subgroup safety results were similar to the overall safety population. Conclusion Radium-223 was tolerated when combined with weekly paclitaxel, with no clinically relevant additive toxicities. This combination should be explored further in patients with bone metastases.
Subject: Bone metastases
Cancer
Paclitaxel
Radium-223 dichloride
Safety
SKELETAL-RELATED EVENTS
PROSTATE-CANCER
EMITTING RA-223
BREAST-CANCER
SURVIVAL
3126 Surgery, anesthesiology, intensive care, radiology
Rights:


Files in this item

Total number of downloads: Loading...

Files Size Format View
Geva2019_Articl ... 23InCombinationWithPac.pdf 508.6Kb PDF View/Open

This item appears in the following Collection(s)

Show full item record