Quality of Life With Docetaxel and ADT in Prostate Cancer

Roxanne Nelson, BSN, RN

January 08, 2016

SAN FRANCISCO — In men with metastatic hormone-sensitive prostate cancer, survival is better when docetaxel chemotherapy is added to androgen-deprivation therapy (ADT), but there have been concerns about the toxicity of docetaxel.

Findings from a new study, however, show that the adverse events are short-lived and that, overall, patients treated with ADT and docetaxel enjoy a high quality of life.

"Many patients fear chemotherapy and think they are going to be sick for months and months," said lead researcher Linda J. Patrick-Miller, PhD, from the University of Chicago Medical Center. "But at about 6 months, patients felt almost 'back to normal,' and by 12 months, they felt as they did before treatment."

In fact, patients who did receive the combination therapy reported a better quality of life at 12 months than those who received ADT alone.

Dr Patrick-Miller presented the study results here at the Genitourinary Cancers Symposium 2016.

"Patients did experience symptoms while getting active treatment," she told Medscape Medical News, "but it did not have a long-term impact on overall quality of life or on emotional well-being."

She noted that this isn't like some cancer therapies, which might only confer a modest benefit. "Adding docetaxel to hormone therapy has a significant impact on survival," she said.

Practice Changing

In their quality-of-life analysis, Dr Patrick-Miller and her colleagues examined data from the pivotal ECOG E3805 CHAARTED trial.

When the CHAARTED results were presented at the 2014 Annual Meeting of the American Society of Clinical Oncology, survival findings were hailed as "practice-changing" and "transformative." There were fewer deaths with ADT plus docetaxel than with ADT alone (104 vs 137), and median overall survival was better with the combination than with the monotherapy (57.6 vs 44.0 months; hazard ratio, 0.47; P = .0003).

However, the addition of docetaxel to the regimen led to increased toxicities, including fever with suppressed white cell count in 6% of patients and "a significant impact on nerve function." In addition, 1% of 397 patients in the combination group died as a result of the treatment.

The researchers used a separate subscale to measure specific taxane-related quality of life, Dr Patrick-Miller pointed out. "As expected, it was lower in the group that received docetaxel, although they did have side effects, like neuropathy."

Quality-of-Life Analysis

In the CHAARTED trial, 397 patients were randomized to ADT plus six cycles of docetaxel every 3 weeks, and 393 were randomized to ADT alone.

In the quality-of-life analysis, the Functional Assessment of Cancer Therapy–Prostate (FACT-P) and the Functional Assessment of Cancer Therapy–Taxane (FACT-Taxane) were administered at baseline and at 3, 6, 9, and 12 months after randomization.

In the combination group, the FACT-P score was 2.7 points lower at 3 months than at baseline (P = .003), but at 12 months, it was only 0.7 points lower. In the monotherapy group, the FACT-P score was a nonsignificant 1.1 points lower at 3 months than at baseline, but at 12 months, it was a significant 4.2 points lower (P = .0001).

Overall, there was a significant difference between the combination and monotherapy groups in FACT-P scores at 3 months (P = .02) and at 12 months (P = .04). At 3 months, scores in the combination group were lower than those in the monotherapy group, but at 12 months, scores in the combination group were higher.

Patients in the combination group reported significant improvements in emotional well-being at 3 months, which were sustained at 12 months.

Compelling Suggestion

"The paradigm for prostate cancer treatment has evolved over the past several years," said Sumanta Pal, MD, from the City of Hope Comprehensive Cancer Center in Los Angeles.

"There had initially been a move to defer chemotherapy to later lines of treatment, behind novel endocrine therapies, but more recent data have moved it back up front," he explained.

One of the reservations that physicians and patients have is related to the adverse-effect profile, which has an intrinsic effect on a patient's quality of life, Dr Pal told Medscape Medical News.

"I think these data offer the compelling suggestion that although there may be some decrement in quality of life during treatment with chemotherapy, the quality of life returns to baseline and perhaps even improves thereafter," he said. "One of the challenges with chemotherapy is that we often anticipate lasting consequences, and with docetaxel, we worry about long-term side effects."

But having said that, at least in the context of the CHAARTED trial, most patients were able to return to some semblance of normal life after chemotherapy, Dr Pal added.

The study was funded by National Institutes of Health. Dr Patrick-Miller has disclosed no relevant financial relationships. Several of the researchers have disclosed relationships with industry, as noted in the abstract.

Genitourinary Cancers Symposium (GUCS) 2016: Abstract 286. Presented January 7, 2016.

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