Author of

• 20039

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  Poster Display Session (ID 63)

  • Event: ELCC 2017
  • Type: Poster Display Session
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1

  • 19876

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    120P - Subgroup analysis of adenocarcinoma patients refractory to first-line chemotherapy from REVEL: A randomized phase III study of docetaxel with ramucirumab or placebo for second-line treatment of stage IV non–small cell lung cancer (NSCLC) (ID 423)

    12:30 - 12:30  |  Author(s): D. Moro-Sibilot
    • Abstract

    Background:
    In the phase III REVEL trial, ramucirumab plus docetaxel significantly improved median overall survival (OS), median progression-free survival (PFS), and objective response rate (ORR) in patients with advanced NSCLC who progressed after first-line platinum therapy, independent of histology. The REVEL trial also showed that ramucirumab plus docetaxel therapy improved median OS, median PFS, and ORR in adenocarcinoma patients who were refractory to first-line platinum therapy and in patients categorized as rapid progressors. Here, we report safety and quality of life (QoL) outcomes in refractory adenocarcinoma patients who participated in the REVEL trial.
    
    Methods:
    Patients were refractory if they had a best response of progressive disease to first-line treatment. Patients were randomized 1:1 to receive docetaxel 75 mg/m[2] in combination with either ramucirumab 10 mg/kg or placebo every 21 days until disease progression, unacceptable toxicity, or death. Treatment-emergent adverse events (TEAEs) were assessed according to the NCI-CTCAE, version 4.0. Quality of life was measured by the Lung Cancer Symptom Scale (LCSS).
    
    Results:
    Of the 1253 patients randomized (ramucirumab + docetaxel: 628; docetaxel + placebo: 625), 17% (ramucirumab + docetaxel: 9%; docetaxel + placebo: 8%) were adenocarcinoma patients refractory to first-line therapy. The safety overview and LCSS scores are presented in the table.rnTable: 120PSafety and QoL Outcomes of Refractory Adenocarcinoma Patients Treated in REVELrn

    rnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrn

    TEAEs, n (%)	Ramucirumab + Docetaxel N = 111	Placebo + Docetaxel N = 101
    Any TEAE	108 (97)	101 (100)
    Grade ≥3 TEAEs	82 (74)	73 (72)
    Serious TEAEs	47 (42)	48 (48)
    TEAEs leading to discontinuation	6 (5)	4 (4)
    TEAEs leading to death	4 (4)	11 (11)
    LCSS scores, time to deterioration	Hazard Ratio (95% CI)
    Loss of appetite	1.45 (0.91, 2.32)
    Fatigue	0.90 (0.58, 1.41)
    Cough	1.29 (0.77, 2.14)
    Dyspnea	1.06 (0.64, 1.76)
    Hemoptysis	1.55 (0.59, 4.07)
    Pain	1.14 (0.71, 1.84)
    Symptom distress	1.12 (0.69, 1.81)
    Activity level	1.01 (0.64, 1.59)
    Global QoL	0.98 (0.63, 1.52)
    Total LCSS	0.81 (0.47, 1.41)
    ASBI	0.83 (0.46, 1.50)

    rnNote: The primary LCSS analysis was time to deterioration, defined as the time from randomization to the first 15 mm increase. ASBI, average symptom burden index; CI, confidence interval; LCSS, Lung Cancer Symptom Scale; QoL, quality of life; TEAE, treatment-emergent adverse event.rn
    
    Conclusions:
    Our analysis did not identify any new safety concerns or increased detriment in QoL for this subgroup of patients. Safety outcomes for refractory adenocarcinoma patients were consistent with the outcomes for refractory patients with all histologies and the intent-to-treat population.
    
    Clinical trial identification:
    NCT01168973
    
    Legal entity responsible for the study:
    Eli Lilly and Company
    
    Funding:
    Eli Lilly and Company
    
    Disclosure:
    M. Reck: Personal fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, Hoffmann-La Roche, Merck Sharp & Dohme, Novartis, and Pfizer. L. Paz-Ares: Personal fees from AMGEM, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, CLOVIS, Eli Lilly and Company, Hoffmann-La Roche, Merck Sharp & Dohme, Novartis, and Pfizer. D. Moro-Sibilot: Personal fees from AMGEN, Ariad, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, Hoffmann-La Roche, Merck Sharp & Dohme, Novartis, and Pfizer. F.A. Shepherd, M. Pérol: Personal fees from Eli Lilly and Company. F. Cappuzzo: Personal fees from AstraZeneca, Hoffmann-La Roche, and Pfizer. K.B. Winfree: Employee of Eli Lilly and Company and reports personal fees from Eli Lilly and Company. E. Alexandris: Employee of Eli Lilly and Company. A. Sashegyi, R. Varea: Employee and shareholder of Eli Lilly and Company.