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Poster Discussion session -Gastrointestinal, non-colorectal

2608 - Quality-of-life (QoL) results from RAINFALL: A randomized, double-blind, placebo (PL)-controlled phase 3 study of cisplatin (Cis) plus capecitabine (Cape) or 5FU with or without ramucirumab (RAM) as first-line therapy for metastatic gastric or gastroesophageal junction (G-GEJ) cancer

Date

19 Oct 2018

Session

Poster Discussion session -Gastrointestinal, non-colorectal

Presenters

Ian Chau

Citation

Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282

Authors

I. Chau1, S. Al-Batran2, A. Luft3, R.D. Kowalyszyn4, C.A. Hernandez5, P. Pfeiffer6, E. Wojcik7, G. Bodoky8, A. Madi9, B. Brenner10, F. De Vita11, G. Folprecht12, K. Peltola13, S. Lorenzen14, C. Denlinger15, A. Liepa16, M. Das16, R. Wei16, C.S. Fuchs17

Author affiliations

  • 1 Department Of Medicine  , The Institute of Cancer Research/Royal Marsden NHS Foundation Trust, SM2 5PT - Sutton/GB
  • 2 Gi Oncology, Nordwest-Krankenhaus, 60488 - Frankfurt am Main/DE
  • 3 Department Of Thoracic Surgery, St. Petersburg Regional Clinic and Hospital, 194291 - Saint Petersburg/RU
  • 4 Oncology, IMO Instituto Multidisciplinario Oncologico, 8500 - Viedma/AR
  • 5 Clínica Osmo, Oaxaca Site Management Organization SC, 68000 - Oaxaca/MX
  • 6 Experimental Research In Medical Cancer Therapy, Odense University Hospital, 5000 - Odense C/DK
  • 7 Department Of Oncology And Chemotherapy, NZOZ Centrum Medyczne HCP, 61-485 - Poznan/PL
  • 8 Oncology, St. László Hospital, 1097 - Budapest/HU
  • 9 The Clatterbridge Cancer Centre Nhs Foundation Trust, Wirral, Department of Molecular and Clinical Cancer Medicine, Institute of Translational Medicine, University of Liverpool, CH63 4JY - Wirral/GB
  • 10 Oncology, Institute of Oncology, Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital, 49100 - Petach Tiqva/IL
  • 11 Medical Oncology, Università degli Studi della Campania “Luigi Vanvitelli”, 80138 - Napoli/IT
  • 12 University Cancer Center, Medical Dept. I  , Universitätsklinikum Dresden, 01307 - Dresden/DE
  • 13 Comprehensive Cancer Centre, Helsinki University Hospital, 00029 - Helsinki/FI
  • 14 Medical Clinic, Heidelberg University Hospital, 81675 - Munich/DE
  • 15 Department Of Hematology/oncology, Fox Chase Cancer Center, 19111 - Philadelphia/US
  • 16 Oncology, Eli Lilly and Company, 46285 - Indianapolis/US
  • 17 Yale Cancer Center, Yale University, 06511 - New Haven/US
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Abstract 2608

Background

RAINFALL met its primary endpoint of improved progression-free survival (HR = 0.75, 95% CI 0.61–0.94, median 5.7 vs 5.4 months), but overall survival was not improved (HR = 0.96). No new safety signals were identified compared with other RAM studies. Here we present the QoL results.

Methods

Patients (pts) with untreated metastatic HER2- G-GEJ cancer were randomized to receive RAM (8 mg/kg D1, D8) or PL every 21 days. All pts received Cape (or 5FU) + Cis. Pts completed the EORTC QLQ-C30 (v3) at baseline (BL), before each cycle, and at 30-day follow-up. QoL scores were standardized to a 0-to-100 scale; ≥10-point change was considered clinically meaningful. Two pre-specified analyses were conducted using the ITT population: (1) time to sustained deterioration (TtSD) was from randomization to first worsened score with no subsequent improved or stable score and compared with an unstratified log-rank test; and (2) post-BL QoL assessments were classified as improved, stable, worsened, or not evaluable; rates of improved+stable were compared with Fisher’s exact test.Table: 616PD

Rates of improved and stable QoL scores for scales with greatest baseline impairment at select cycles

RAM+Cape/Cis (N = 326), %PL+Cape/Cis (N = 319), %
Cycle 2 Improved /StableTotalCycle 4 Improved /StableTotalCycle 2 Improved /StableTotalCycle 4 Improved /StableTotal
Global QoL21.2 / 31.352.516.6 / 21.237.721.9 / 31.353.314.1 / 22.937.0
Emotional functioning21.8 / 35.957.719.0 / 28.247.225.4 / 35.460.819.7 / 24.544.2
Fatigue20.9 / 17.538.317.2 / 9.827.019.7 / 23.843.611.9 / 17.629.5
Pain27.6 / 27.655.219.3 / 23.943.327.3 / 26.053.319.4 / 20.139.5
Insomnia20.6 / 37.758.317.2 / 26.443.617.9 / 36.754.515.4 / 23.238.6
Appetite loss21.2 / 33.454.616.6 / 24.841.420.7 / 33.253.916.0 / 21.337.3

Results

Of 645 pts randomized, 312/326 (96%) of RAM+Cape/Cis and 309/319 (97%) of PL+Cape/Cis pts had BL QoL data. Compliance was ≥87% with post-BL assessments while on therapy. BL scores were similar between arms. Based on BL mean scores, highest levels of impairment were seen for global QoL, emotional functioning, fatigue, pain, insomnia, and appetite loss. For all 15 QoL scales, TtSD HRs ranged from 0.80 to 1.13 and all 95% CIs included 1. For all scales and post-BL assessments, rates of improved+stable scores were similar between arms.

Conclusions

For pts with previously untreated, metastatic G-GEJ cancer, QoL was maintained with the addition of RAM to Cape/Cis. Regardless of arm, treatment improved or stabilized most disease-related symptoms.

Clinical trial identification

NCT02314117.

Legal entity responsible for the study

Eli Lilly and Company.

Funding

Eli Lilly and Company.

Editorial Acknowledgement

Eli Lilly and Company contracted with Syneos Health for writing support provided by Andrea Humphries, PhD and editorial support provided by Angela C. Lorio, ELS.

Disclosure

I. Chau: Advisory board: Sanofi Oncology, Eli-Lilly, Bristol-Myers Squibb, MSD, Bayer, Roche, Merck Serono, Five Prime Therapeutics; Research funding: Eli-Lilly, Janssen-Cilag, Sanofi Oncology, Merck-Serono, Novartis; Honorarium: Taiho, Pfizer, Amgen, Eli-Lilly. S-E. Al-Batran: Advisory role: Merck, Roche, Celgene, Lilly, Nordic Pharma, Bristol-Myers Squibb, MSD Sharp & Dohme; Speaker: Roche, Celgene, Lilly, Nordic Pharma, AIO gGmbH, MCI, promedicis, Forum für Medizinische Fortbildung; CEO/founder of IKF Klinische Krebsforschung GmbH; Research grants: Sanofi, Merck, Roche, Celgene, Vifor, Medac, Hospira, Lilly, German Cancer Aid (Krebshilfe), German Research Foundation and the Federal Ministry of Education and Research. G. Bodoky: Consulting or advisory role: Bayer, Ipsen, Janssen, Lilly, Novartis, Pfizer, Roche; Travel, Accommodations, Expenses: Janssen, Lilly, Novartis, Pfizer, Roche. G. Folprecht: Honoraria: Merck KGaA; Consulting or advisory role: Baxalta, Bristol-Myers Squibb, Lilly/ImClone, Merck KGaA, Roche/Genentech; Research funding: Merck KGaA. K. Peltola: Personal fees: Orion Pharma, BMS, Pfizer, Roche, MSD, Ipsen, outside the submitted work; Advisory fees and Stock holder: Faron Pharmaceuticals. C. Denlinger: Honoraria: Eli Lilly and Co; Research support (institutional): Eli Lilly and Co, MedImmune, AstraZeneca, Merrimack, Bristol-Myers Squibb, Genentech. A. Liepa, M. Das, R. Wei: Employee, Stockholder: Eli Lilly and Company. C.S. Fuchs: Consultant fees: Lilly, Entrinsic Health, Genentech, Merck, Sanofi, Five Prime Therapeutics, Merrimack, Bayer, Agios, Taiho, Kew, Bain Capital, Unum; Board member: CytomX. All other authors have declared no conflicts of interest.

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