Entry Detail
| General information | |
| Database: | DB00475 |
| Objective: | Patientreported outcomes may help inform treatment choice in advanced/metastatic renal cell carcinoma (RCC), particularly between approved targeted therapies with similar efficacy. This doubleblind crossover study evaluated patient preference for pazopanib or sunitinib and the influence of healthrelated quality of life (HRQoL) and safety factors on their stated preference. |
| Authors: | Escudier B, et al |
| Title: | Randomized, controlled, doubleblind, crossover trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES Study. |
| Journal: | J Clin Oncol. |
| Year: | 2014 |
| PMID: | 24687826 |
| Trial Design | |
| Clinical Trial Id: | NCT01064310 |
| Agent: | pazopanib |
| Target: | Plateletderived growth factor receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 |
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced renal cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | doubleblind, multicenter, phase IIIb crossover study |
| Key Patients Feature: | Adult patients ( 18 years) who had no prior systemic therapy for theirlocallyadvancedormetastaticRCCandhadanEasternCooperativeOncologyGroup performance status of 0 or 1 and adequate hematologic, hepatic, renal, and blood coagulation function were eligible. Patients with non-clear cellhistology and nonmeasurable disease by RECIST were also eligible. Majorexclusion criteria included history or evidence of brain metastases, GI abnormalities, presence of uncontrolled infection, or cardiovascular abnormality. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | sunitinib |
| Treatment Info: | pts were randomly assigned to pazopanib 800 mg per day for 10 weeks, a 2week washout, and then sunitinib 50 mg per day (4 weeks on, 2 weeks off, 4 weeks on) for 10 weeks, or the reverse sequence. |
| Primary End Point: | patient preference for a specific treatment, was assessed by questionnaire at the end of the two treatment periods. |
| Secondary End Point: | reasons for preference, physician preference, safety, and HRQoL. |
| Patients Number: | 169 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Less fatigue and better overall quality of life were the main reasons for preferring pazopanib, with less diarrhea being the most cited reason for preferring sunitinib. Physicians also preferred pazopanib (61%) over sunitinib (22%); 17% expressed no preference. Adverse events were consistent with each drug¡¯s known profile. Pazopanib was superior to sunitinib in HRQoL measures evaluating fatigue, hand/foot soreness, and mouth/throat soreness. |
| Conclusions: | This innovative crossover trial demonstrated a significant patient preference for pazopanib over sunitinib, with HRQoL and safety as key influencing factors. |