Annual Meeting Proceedings Part 1 - American Society of Clinical ...

TPS8118 General Poster Session (Board #41C), Mon, 1:15 PM-5:15 PM
PILLAR-2: A randomized, double-blind, placebo-controlled, phase III
study of adjuvant everolimus in poor-risk diffuse large B-cell lymphoma
(DLBCL). Presenting Author: Tongyu Lin, Department of Medical Oncology,
Sun Yat-sen University Cancer Center, Guangzhou, China
Background: Effective DLBCL adjuvant therapy after first-line chemotherapy
is needed as high-risk DLBCL is associated with a poor 4-year
overall survival (OS) rate (Sehn et al, Blood 2007;109:1857-61). In a
phase II study of the oral mammalian target of rapamycin inhibitor
everolimus in relapsed, aggressive non-Hodgkin lymphoma, DLBCL patients
(n�47) had a 30% overall response rate (Witzig et al, Leukemia
2011;25:341-7). Methods: PILLAR-2 is an ongoing international, randomized,
double-blind, phase 3 study designed to compare everolimus efficacy
and safety with that of placebo in poor-risk DLBCL patients who achieved
complete response (CR) with first-line rituximab-based chemotherapy
(R-chemo) (ClinicalTrials.gov: NCT00790036; sponsor: Novartis Pharmaceuticals).
Eligibility criteria include age �18 years; confirmed stage II
bulky, III, or IV DLBCL and International Prognostic Index 3-5 at diagnosis;
confirmed CR per revised International Workshop Response Criteria for
malignant lymphoma (Cheson et al, J Clin Oncol 2007;25:579-86) after
first-line R-chemo regimen completed 6-14 weeks before study drug start;
Eastern Cooperative Oncology Group performance status �2; no ongoing or
post–R-chemo radiation; and no myelosuppressive chemotherapy or biologic
therapy within 3 weeks. Patients are randomized 1:1 to everolimus 10
mg once daily or matching placebo and treated for 12 months or until
disease relapse, unacceptable toxicity, or death. Radiologic tumor assessment
is performed at baseline, every 12 weeks during years 1 and 2, every
24 weeks during years 3 and 4, and annually thereafter until start of new
anticancer therapy or 5 years after last patient randomization. The primary
endpoint is disease-free survival (DFS). Secondary endpoints are OS,
lymphoma-specific survival, and safety. Expected enrollment is 687
patients. Final analysis will be performed when 279 DFS events occur;
survival follow-up will continue until 338 deaths occur and the last
randomized patient has been followed for �5 years. Currently, 422
patients are enrolled. The data monitoring committee last reviewed the trial
in July 2011 and recommended that it continue as planned.
Lymphoma and Plasma Cell Disorders
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