120P - Subgroup analysis of adenocarcinoma patients refractory to first-line chemotherapy from REVEL: A randomized phase III study of docetaxel with ramuc...

Date 07 May 2017
Event ELCC 2017
Session Poster Display Session
Topics Non-Small-Cell Lung Cancer, Locally Advanced
Non-Small-Cell Lung Cancer, Metastatic
Cancer Immunology and Immunotherapy
Lung and other Thoracic Tumours
Presenter Martin Reck
Citation Annals of Oncology (2017) 28 (suppl_2): ii28-ii51. 10.1093/annonc/mdx091
Authors M. Reck1, L. Paz-Ares2, D. Moro-Sibilot3, F.A. Shepherd4, F. Cappuzzo5, K.B. Winfree6, E. Alexandris6, A. Sashegyi6, R. Varea6, M. Pérol7
  • 1Department of Thoracic Oncology, Airway Research Center North, Member of the German Center for Lung Research, Lung Clinic Grosshansdorf, 8022927 - Grosshansdorf/DE
  • 2Virgen del Rocio University Hospital, Sevilla/ES
  • 3Thoracic Oncology Unit Teaching Hospital A Michallon, Grenoble/FR
  • 4Princess Margaret Cancer Centre, Toronto/CA
  • 5dIstituto Toscano Tumori-Ospedale-Civile-Livorno, Livorno/IT
  • 6Eli Lilly and Company, Indianapolis/US
  • 7Léon-Bérard Cancer Center, Lyon/FR

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/m2 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: 120P

Safety and QoL Outcomes of Refractory Adenocarcinoma Patients Treated in REVEL

rnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrn
TEAEs, n (%)Ramucirumab + Docetaxel N = 111Placebo + Docetaxel N = 101
Any TEAE108 (97)101 (100)
Grade ≥3 TEAEs82 (74)73 (72)
Serious TEAEs47 (42)48 (48)
TEAEs leading to discontinuation6 (5)4 (4)
TEAEs leading to death4 (4)11 (11)
LCSS scores, time to deteriorationHazard Ratio (95% CI)
Loss of appetite1.45 (0.91, 2.32)
Fatigue0.90 (0.58, 1.41)
Cough1.29 (0.77, 2.14)
Dyspnea1.06 (0.64, 1.76)
Hemoptysis1.55 (0.59, 4.07)
Pain1.14 (0.71, 1.84)
Symptom distress1.12 (0.69, 1.81)
Activity level1.01 (0.64, 1.59)
Global QoL0.98 (0.63, 1.52)
Total LCSS0.81 (0.47, 1.41)
ASBI0.83 (0.46, 1.50)
rn

Note: 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.

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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.