RAINBOW: A global, phase III, randomized, double-blind study of ramucirumab plus paclitaxel versus placebo plus paclitaxel patients with previously treated gastric or gastroesophageal junction (GEJ) adenocarcinoma: Quality-of-life (QoL) results.

Authors

null

Salah-Eddin Al-Batran

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

Organizations

Krankenhaus Nordwest, Frankfurt, Germany, University Hospitals Gasthuisberg, Leuven, Belgium, Korea University Guro Hospital, Seoul, South Korea, Szent László Hospital, Budapest, Hungary, Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan, Clinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan, Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan, Bashkortostan Clinical Oncology Center, Ufa, Russia, Department of Internal Medicine and Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea, Royal Marsden Hospital, Sutton, United Kingdom, Hopital Europeen Georges Pompidou, Université Paris V, France, Paris, France, Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan, Eli Lilly and Company, Indianapolis, IN, ImClone Systems, Bridgewater, NJ, Eli Lilly and Company, Heidelberg, Germany, Exploratory Oncology Research & Clinical Trial Center, National Cancer Center, Kashiwa, Japan, Kliniken Essen Mitte Center of Pallative Care, Essen, Germany

Research Funding

Pharmaceutical/Biotech Company

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.

Rates of improvement/stability for select QoL parameters.
RAM+PTX (N=330)
PL+PTX (N=335)
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 Details

Meeting

2014 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT01170663

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr 4058)

DOI

10.1200/jco.2014.32.15_suppl.4058

Abstract #

4058

Poster Bd #

145

Abstract Disclosures