San Francisco, CA—Docetaxel added to androgen-deprivation therapy (ADT) improves survival for men with metastatic hormone-sensitive prostate cancer (mHSPC), as shown by the pivotal ECOG 3805 CHAARTED trial.1
The open-label, randomized phase 3 trial was considered practice-changing when results were presented at the 2014 Annual Meeting of the American Society of Clinical Oncology.2 The trial did, however, raise concerns about docetaxel-related adverse events, including grade 3 and 4 febrile neutropenia in 6.2% of patients, grade 3 and 4 infection with neutropenia in 2.3%, and grade 3 sensory and motor neuropathy in 0.5%.
A new analysis of quality of life (QOL) in CHAARTED, presented at the 2016 Genitourinary Cancers Symposium, shows that adverse events reported in the trial were transient, and, overall, patients who received docetaxel in addition to ADT enjoy a good QOL. In fact, the QOL analysis showed that although most patients treated with docetaxel plus ADT had a decreased QOL at 3 months not seen with ADT alone, by 12 months, patients in the docetaxel plus ADT arm had a better QOL than those treated with ADT alone.
“This suggests that docetaxel + ADT does not confer [a] long-term negative impact on QOL for mHSPC,” stated lead author Linda J. Patrick-Miller, PhD, from the University of Chicago Medical Center, IL.
“Many patients fear chemotherapy and think they are going to be sick for months and months. But [we found that] at about 6 months, patients [treated with docetaxel] felt almost ‘back to normal,’ and by 12 months, they felt as they did before treatment,” she said.
In the original study, 397 patients were randomized to ADT plus 6 cycles of docetaxel every 3 weeks, and 393 were randomized to ADT alone. Fewer deaths were reported with ADT plus docetaxel versus ADT alone (104 vs 137), and median overall survival favored ADT plus docetaxel compared with ADT alone: 57.6 months versus 44 months, respectively (P = .0003), representing a 53% improvement in survival with the addition of docetaxel to ADT. These results led to docetaxel being considered a new standard of care, moving it upfront before the development of castration-resistant prostate cancer.
The QOL analysis Dr Patrick-Miller presented used the Functional Assessment of Cancer Therapy–Prostate (FACT-P) and the Functional Assessment of Cancer Therapy–Taxane (FACT-Taxane) to assess patients at baseline, and at 3, 6, 9, and 12 months following initiation of treatment.
In the group treated with ADT plus docetaxel, the FACT-P score was 2.7 points lower at 3 months compared with baseline, but by 12 months, the score was only 0.7 months lower, approaching baseline level. In the ADT-alone group, the FACT-P score was 1.1 points lower than baseline at 3 months, but at 12 months, it was 4.2 points lower than baseline, which was statistically significant (P <.0001).
Comparing both groups of patients, at 3 months the docetaxel-treated group had lower FACT-P scores versus ADT alone, but at 12 months, FACT-P scores were higher for patients who received docetaxel plus ADT.
Overall, there was also a significant difference in FACT-P scores between the ADT plus docetaxel group and the ADT-alone group (P = .02 at 3 months; P = .04 at 12 months). Scores in the emotional well-being domain were significantly higher at 3 and 12 months in the ADT plus docetaxel group.
1. Patrick-Miller LJ, Chen Y-H, Carducci MA, et al. Quality of life (QOL) analysis from E3805, chemohormonal androgen ablation randomized trial (CHAARTED) in prostate cancer (PrCa). Presented at: 2016 Genitourinary Cancers Symposium; January 7-9, 2016; San Francisco, CA. Abstract 286.
2. Sweeney C, Chen Y-H, Carducci MA, et al. Impact on overall survival (OS) with chemohormonal therapy versus hormonal therapy for hormone-sensitive newly metastatic prostate cancer (mPrCa): an ECOG-led phase III randomized trial. Presented at: 50th Annual Meeting of the American Society of Clinical Oncology; May 30-June 3, 2014; Chicago, IL. Abstract LBA2.