Multiple myeloma treatment results interpreted by patient-reported outcomes

06-13-2006

Relapsed and refractory multiple myeloma (MM) treatment could be assessed by patient-reported outcomes (PRO).

According to a study from Belgium, "Bortezomib, a boronic acid dipeptide, has been recently introduced as a new approach to treating MM. The goal of this work was to evaluate the added value of PRO in the interpretation of bortezomib clinical trial outcomes. Two hundred two patients with relapsed, refractory MM were treated with bortezomib as part of the SUMMIT (Study of Uncontrolled Multiple Myeloma Managed with Proteasome Inhibition Therapy) study."

"Patients were administered the following four PRO measures at several time points: the European Organisation for Research and Treatment of Cancer (EORTC) core Quality of Life Questionnaire (QLQ-C30) and the myeloma-specific module (QLQ-MY24), the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale, and the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG) Neurotoxicity (Ntx) scale. Minimal important difference (MID) thresholds were used to define patients as improved, stable, or worsened. A survival analysis was conducted to assess the predictive power of PRO data," explained D. Dubois and colleagues, Janssen Pharmaceutica.

"For the total population, there was a positive change between baseline and best end point. Consistent with the clinical responses, change in PRO scores showed statistically significant differences between response groups with PRO improvement in patients with complete response (CB) or partial response (PR), mostly stable scores in patients with minor response or no change, and deterioration in most scores for patients with progressive disease. Change in scores for neuropathy-related symptoms was reasonably stable.

"In contrast, fatigue scores significantly improved for patients with CR or PR. When various MID thresholds were applied, the proportion of improved patients exceeded 35% for several domains within all change group definitions. Moreover, survival analysis results demonstrated the additional prognostic information PRO data can provide to supplement clinical data," stated the scientists.

The researchers concluded, "This study demonstrated the complementary value for PRO assessments in further interpreting clinical response, the impact of adverse effects, and patient prognosis in clinical trials."

Dubois and colleagues published the results of their research in the Journal of Clinical Oncology (Descriptive and prognostic value of patient-reported outcomes: The bortezomib experience in relapsed and refractory multiple myeloma. J Clin Oncol, 2006;24(6):976-982).

For additional information, contact D. Dubois, Janssen Pharmaceutica, Johnson & Johnson Pharmaceutical Service, Tumhoutseweg 30, B-2340 Beerse, Belgium.

The publisher of the Journal of Clinical Oncology can be contacted at: American Society Clinical Oncology, 330 John Carlyle St., Ste. 300, Alexandria, VA 22314, USA.

Keywords: Beerse, Belgium, Bortezomib, Cancer Therapy, Clinical Trial, Cancer Drugs, Gynecology, Multiple Myeloma, Patient-Reported Outcomes, Oncology, Pharmaceuticals, Quality of Life, Cancer Therapy.

This article was prepared by Clinical Oncology Week editors from staff and other reports. Copyright 2006, Clinical Oncology Week via NewsRx.com.