Quality-of-life and performance status results from the phase III RAINBOWstudy of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma

S. E. Al-Batran, E. Van Cutsem, Sang Cheul Oh, G. Bodoky, Y. Shimada, S. Hironaka, N. Sugimoto, O. N. Lipatov, T. Y. Kim, D. Cunningham, P. Rougier, K. Muro, A. M. Liepa, K. Chandrawansa, M. Emig, A. Ohtsu, H. Wilke

Research output: Contribution to journalArticle

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Abstract

Background: The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine-platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses. Patients and methods: Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/ m2) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of =10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥ 2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. Results: Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥ 1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR <1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥ 2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥ 1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥ 2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation. Conclusion: In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration. ClinicalTrials.gov: NCT01170663.

Original languageEnglish
Article numbermdv625
Pages (from-to)673-679
Number of pages7
JournalAnnals of Oncology
Volume27
Issue number4
DOIs
Publication statusPublished - 2016 Apr 1

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Esophagogastric Junction
Paclitaxel
Stomach
Adenocarcinoma
Placebos
Quality of Life
Survival
Therapeutics
Random Allocation
Platinum
Proportional Hazards Models
Health Status
Disease-Free Survival
ramucirumab
Neoplasms

Keywords

  • EORTC QLQ-C30
  • EQ-5D
  • Gastric cancer
  • GEJ cancer
  • Quality of life
  • Ramucirumab

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Quality-of-life and performance status results from the phase III RAINBOWstudy of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. / Al-Batran, S. E.; Van Cutsem, E.; Oh, Sang Cheul; Bodoky, G.; Shimada, Y.; Hironaka, S.; Sugimoto, N.; Lipatov, O. N.; Kim, T. Y.; Cunningham, D.; Rougier, P.; Muro, K.; Liepa, A. M.; Chandrawansa, K.; Emig, M.; Ohtsu, A.; Wilke, H.

In: Annals of Oncology, Vol. 27, No. 4, mdv625, 01.04.2016, p. 673-679.

Research output: Contribution to journalArticle

Al-Batran, SE, Van Cutsem, E, Oh, SC, Bodoky, G, Shimada, Y, Hironaka, S, Sugimoto, N, Lipatov, ON, Kim, TY, Cunningham, D, Rougier, P, Muro, K, Liepa, AM, Chandrawansa, K, Emig, M, Ohtsu, A & Wilke, H 2016, 'Quality-of-life and performance status results from the phase III RAINBOWstudy of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma', Annals of Oncology, vol. 27, no. 4, mdv625, pp. 673-679. https://doi.org/10.1093/annonc/mdv625
Al-Batran, S. E. ; Van Cutsem, E. ; Oh, Sang Cheul ; Bodoky, G. ; Shimada, Y. ; Hironaka, S. ; Sugimoto, N. ; Lipatov, O. N. ; Kim, T. Y. ; Cunningham, D. ; Rougier, P. ; Muro, K. ; Liepa, A. M. ; Chandrawansa, K. ; Emig, M. ; Ohtsu, A. ; Wilke, H. / Quality-of-life and performance status results from the phase III RAINBOWstudy of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. In: Annals of Oncology. 2016 ; Vol. 27, No. 4. pp. 673-679.
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abstract = "Background: The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine-platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses. Patients and methods: Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/ m2) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of =10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥ 2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. Results: Of the 665 patients randomized, 650 (98{\%}) provided baseline QLQ-C30 and EQ-5D data, and 560 (84{\%}) also provided data from ≥ 1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR <1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥ 2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥ 1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥ 2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation. Conclusion: In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration. ClinicalTrials.gov: NCT01170663.",
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T1 - Quality-of-life and performance status results from the phase III RAINBOWstudy of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma

AU - Al-Batran, S. E.

AU - Van Cutsem, E.

AU - Oh, Sang Cheul

AU - Bodoky, G.

AU - Shimada, Y.

AU - Hironaka, S.

AU - Sugimoto, N.

AU - Lipatov, O. N.

AU - Kim, T. Y.

AU - Cunningham, D.

AU - Rougier, P.

AU - Muro, K.

AU - Liepa, A. M.

AU - Chandrawansa, K.

AU - Emig, M.

AU - Ohtsu, A.

AU - Wilke, H.

PY - 2016/4/1

Y1 - 2016/4/1

N2 - Background: The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine-platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses. Patients and methods: Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/ m2) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of =10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥ 2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. Results: Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥ 1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR <1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥ 2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥ 1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥ 2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation. Conclusion: In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration. ClinicalTrials.gov: NCT01170663.

AB - Background: The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine-platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses. Patients and methods: Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/ m2) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of =10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥ 2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. Results: Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥ 1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR <1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥ 2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥ 1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥ 2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation. Conclusion: In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration. ClinicalTrials.gov: NCT01170663.

KW - EORTC QLQ-C30

KW - EQ-5D

KW - Gastric cancer

KW - GEJ cancer

KW - Quality of life

KW - Ramucirumab

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