Clinical benefit and quality of life in patients with advanced biliary tract cancer receiving gemcitabine plus capecitabine (GemCap): Results from a multicenter phase II trial (SAKK 44/02)

Abstract

15531 Background: In patients (pts) with advanced biliary tract cancer receiving palliative chemotherapy, no information is available on clinical benefit response (CBR) and quality of life (QL). Methods: Pts with pathologically confirmed, untreated, locally advanced, unresectable or metastatic biliary tract cancer with Karnofsky Performance Status (KPS) 60–80, and/or daily analgesic consumption ≥10 mg morphine equivalents, and/or pain intensity ≥20 (range 0–100) received gemcitabine 1 g/m2 IV on days 1 & 8 and capecitabine 650 mg/m2 orally twice daily on days 1–14 of a 3-week cycle for up to 8 cycles. CBR criteria were rated prior to randomization and on treatment: pts rated pain intensity (0–100) and analgesic consumption daily; physicians rated KPS and weight weekly. CBR was defined as improvement from baseline for ≥4 consecutive weeks either in pain and KPS, or stability in one but improvement in the other, or stability in pain and KPS but improvement in weight. Stable CBR (SCBR) was defined as stability in all 4 criteria. Pts rated QL indicators at baseline, weekly during cycles 1–3, and then twice per cycle. The primary endpoint was the proportion of pts with CBR or SCBR within the first 3 cycles. Associations between QL and CBR, objective response (OR), time to progression (TTP) and overall survival (OS) were described. Results: All 44 pts (median age: 65 years) enrolled from 6 Swiss centers between 2003 and 2006 completed baseline CBR and QL assessments. On treatment, 95% (771/812) of CBR and 92% (560/607) of QL assessments were completed. In the first 3 cycles, 16 pts (36%) had a CBR and 15 pts (34%) a SCBR. Baseline QL scores were moderate to good. Most QL indicators improved from cycle 3 onward. There was no QL difference between CBR and SCBR. Up to cycle 3, pts with no CBR (NCBR) reported worse scores than responders (CBR & SCBR) in several QL indicators. Pts with no OR, TTP<4 months, or OS ≤9 months had worse baseline scores in most QL indicators. Conclusions: GemCap is associated with high CBR and SCBR rates. The observation that poorer QL scores at baseline may be associated with a NCBR or unfavorable OR, TTP or OS outcomes needs further investigation. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Roche Roche Roche