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

Ravit Geva*, Juanita Lopez, Sarah Danson, Heikki Joensuu, Avivit Peer, Samuel J. Harris, Fabricio Souza, Kaline M.C. Pereira, Ruth Perets

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)1092-1101
Number of pages10
JournalEuropean Journal of Nuclear Medicine and Molecular Imaging
Issue number5
StatePublished - 1 May 2019


FundersFunder number
Bayer Pharma AG
SciStrategy Communications
Bayer HealthCare
Pharmaceuticals Bayer


    • Bone metastases
    • Cancer
    • Paclitaxel
    • Radium-223 dichloride
    • Safety


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