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A tolerability and safety analysis of adding granulocyte-macrophage colony-stimulating factor to local radiotherapy in a case series of seven patients with thoracic cancer.

BACKGROUND
Granulocyte-macrophage colony-stimulating factor (GM-CSF) has been demonstrated to improve the anti-cancer effects in combination with radiotherapy. However, the tolerability and safety of adding GM-CSF to radiotherapy in thoracic cancer patients need to be further explored.


METHODS
Between June 2020 and Sep 2020, seven patients with thoracic cancer were treated with concurrent radiotherapy and GM-CSF (200 μg subcutaneously injected q.o.d during the radiotherapy). The primary endpoint was adverse event.


RESULTS
Of seven enrolled patients, four were non-small cell lung cancer, two were small cell lung cancer, and the other one patient was thymic carcinoma. The total dose of GM-CSF that each patient received was at least 3000 μg. All patients had finished the radiotherapy and GM-CSF injection and suffered one or more any grade adverse events. Only one patient had a grade ≥3 hematological adverse event (lymphocytopenia). Grade ≥3 non-hematological toxicities were not observed during the combination treatment. The highest cell counts of white blood cell, neutrophile granulocyte, and monocyte across the treatment were 22.38×109 /L, 18.65×109 /L, and 1.28×109 /L respectively.


CONCLUSIONS
The combination therapy of radiotherapy and GM-CSF (200 μg subcutaneously q.o.d) is tolerable and safe. Further studies are warranted to confirm the effects and optimal total GM-CSF injection doses in the combination of radiotherapy in thoracic cancer patients.