Docetaxel also delayed disease progression, assessed by either prostate-specific antigen (PSA) rise or appearance of new metastases or symptom worsening. At 1-year, the proportion of patients with PSA levels less than 0.2 ng/mL was 11.7% in the ADT-alone group versus 22.7% in the ADT-plus-docetaxel group (P < 0.0001). Median time to castration-resistant prostate cancer (biochemical, symptoms, or radiographic, in months) was 14.7 months in the ADT-alone arm versus 20.7 months in the ADT-plus-docetaxel arm (HR, 0.56; 95% CI: 0.44-0.70, P < 0.0001). Median time to clinical progression was 19.8 months in the ADT-alone group versus 32.7 months in the ADT-plus-docetaxel group (HR, 0.49; 95% CI 0.37-0.65, P < 0.0001).
A total of 74% of chemotherapy doses were administered with no dose modifications. Nonhematologic grade 3/4 toxicities in the ADT-plus-docetaxel arm included allergic reaction, fatigue, colitis/diarrhea, stomatitis, motor and sensory neuropathy, and thromboembolism. Grade 3/4 hematologic toxicities included anemia, thrombocytopenia, neutropenia, febrile neutropenia, and infection with neutropenia. The worst grade hematologic and nonhematologic toxicity per patient was grade 3 in 16% of patients and grade 4 in 12% of patients. There was one sudden death. No deaths were reported for treatment on ADT alone.
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“These results demonstrate how we can use ‘old tools’ in new, more powerful ways to improve and extend patients’ lives,” said ASCO president Clifford A. Hudis, MD, FACP, in a press release. “This study is also a powerful testimony to the importance of National Cancer Institute–led research, as both of these drugs are available in generic form today and this research might have otherwise not been pursued.”
The combination benefited all stratified subgroups. Quality-of-life data from this study will be analyzed and reported at a later time.
- Sweeney C, Chen YH, Carducci MA et al. Abstract LBA2. Presented at: 2014 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2014; Chicago, IL.