Treatment patterns & safety of docetaxel in Chinese real-world clinical practice: a multicenter non-interventional observational study of docetaxel administration as adjuvant therapy in operable early breast cancer patients

Aim/Background

This trial investigated the real-world treatment patterns of docetaxel as adjuvant therapy in operable early breast cancer patients.

Methods

Chinese female patients (≥ 18 years) with operable breast cancer administrated with docetaxel (Taxotere®) contained adjuvant chemotherapy after radical resection were enrolled. The primary end point was the frequencies of treatment patterns of docetaxel in early breast cancer adjuvant setting. Univariate comparative analyses were employed to explore the frequencies and proportions of subjects receiving different G-CSF treatments and proportions of subjects considering different reasons for treatment choices.

Results

502 patients from 24 sites in China were enrolled, of which 475 (94.6%) subjects were included in the full analysis set. For docetaxel adjuvant treatment patterns, patients had regimens in combination with anthracyclines (150), sequential with anthracyclines (224), in combination or sequential with other chemotherapies (88), and other regimens(13), respectively. The most frequently reported treatment-emergent adverse event related to docetaxel was blood and lymphatic system disorders (22.7%, 108/475). No patients withdrew due to SAEs induced by docetaxel, and no life-threatening SAE was reported. Among 475 patients, 258 (54.3%), 35 (7.4%), and 108 (22.7%) patients received true highest G-CSF as primary prophylaxis, secondary prophylaxis, and treatment, respectively. G-CSF was chosen based on the following considerations: clinical experience (417, 87.8%), comprehensive guidelines and clinical research data (308, 64.8%), consideration of chemotherapies (243, 51.2%), individual factors (171, 36.0%), expected and controllable adverse reactions (151, 31.8%).

Conclusions

Combination/sequential with anthracyclines are the most frequently applied treatment patterns in operable breast cancer. Hematological toxicity is the most frequently reported AE but well-tolerated. A proportion of doctors have started to initiate prophylaxis with G-CSF for patients, but there is still a gap with the recommendations from the guidelines.

Clinical trial identification

This is a registry study, we did not register in NIH or any other European equivalent. The internal registry number in Sanofi is DOCET_L_06072.

Disclosure

All authors have declared no conflicts of interest.