Krankenhaus Nordwest, Frankfurt, Germany
Salah-Eddin Al-Batran , Eric Van Cutsem , Sang Cheul Oh , Gyorgy Bodoky , Yasuhiro Shimada , Shuichi Hironaka , Naotoshi Sugimoto , Oleg N. Lipatov , Tae-You Kim , David Cunningham , Philippe Rougier , Kei Muro , Astra M. Liepa , Shaila Ballal , Michael Emig , Atsushi Ohtsu , Hansjochen Wilke
Background: Ramucirumab (RAM) added to paclitaxel (PTX) resulted in statistically significantly improved overall survival, progression-free survival and response rate for previously treated patients (pts) with advanced gastric or GEJ cancer (Wilke et al, GI Cancer Symposium 2014). Here we present the secondary endpoint of QoL. Methods: Pts who had previously received fluoropyrimidine- and platinum-based therapy were randomized to receive RAM 8 mg/kg IV or placebo (PL) on Days 1 and 15 every 4 weeks (wks); both arms received PTX 80 mg/m2on Days 1, 8 and 15. Pts completed the EORTC QLQ-C30 (v3) at baseline, every 6 wks from start of therapy and at discontinuation. Time to deterioration (TtD) in each QoL parameter was defined as randomization to first worsening of ≥10 points (on 100-point scale). Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. In addition, scores were classified as improved or worsened if changed by ≥10 points relative to baseline, otherwise classified as stable. Results: Of 665 pts randomized, 322/330 (98%) of RAM+PTX and 328/335 (98%) of PL+PTX pts provided baseline (BL) QoL data and 87% and 81%, respectively, provided both BL and post-BL data. BL scores were similar between arms. Of the 15 QoL parameters, 14 had HRs <1, indicating similar or longer TtD in QoL for RAM+PTX. HRs <0.75 were observed for emotional functioning and nausea/vomiting and >1 for diarrhea. For all QoL parameters and at all on-therapy assessment times, the proportion of pts reporting improved or stable scores was numerically greater for RAM+PTX; in general, more pts were classified as stable than improved. Conclusions: For pts with advanced gastric cancer, addition of RAM to PTX did not impair QoL. Compared with PL+PTX, QoL was maintained for a longer time and more pts reported stable or improved scores. Clinical trial information: NCT01170663.
RAM+PTX (N=330) |
PL+PTX (N=335) |
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Wk 6 | Wk 12 | Wk 6 | Wk 12 | |
Global QoL | 53% | 36% | 50% | 27% |
Physical functioning | 56% | 41% | 47% | 28% |
Fatigue | 45% | 35% | 42% | 25% |
Pain | 56% | 41% | 49% | 27% |
Appetite loss | 60% | 43% | 54% | 30% |
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Abstract Disclosures
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