PILLAR-2: PHASE 3 STUDY OF ADJUVANT EVEROLIMUS VERSUS PLACEBO IN PATIENTS WITH POOR-RISK DIFFUSE LARGE B-CELL LYMPHOMA WHO ACHIEVED COMPLETE REMISSION WITH RITUXIMAB-COMBINED CHEMOTHERAPY
Author(s): ,
Franco Cavalli
Affiliations:
Oncology Institute of Southern Switzerland,Bellinzon,Switzerland
,
Kensei Tobinai
Affiliations:
Department of Hematology,National Cancer Center Hospital,Tokyo,Japan
,
Luigi Rigacci
Affiliations:
Hematology Department,Azienda Ospedaliero Universitaria Careggi,Florence,Italy
,
Takashi Ikeda
Affiliations:
Division of Hematology and Stem Cell Transplantation,Shizuoka Cancer Center,Shizuoka,Japan
,
Anna Vanazzi
Affiliations:
Division of Clinical Haemato-Oncology,Istituto Europeo di Oncologia,Milan,Italy
,
Masayuki Hino
Affiliations:
Department of Clinical Hematology and Diagnostics,Osaka University Graduate School of Medicine,Osaka,Japan
,
Yuankai Shi
Affiliations:
Department of Medical Oncology,National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College,Beijing,China
,
Jiri Mayer
Affiliations:
University Hospital Brno,Brno,Czech Republic
,
Luciano J Costa
Affiliations:
University of Alabama,Birmhingham,United States
,
Carlos D Bermudez Silva
Affiliations:
Instituto Nacional de Cancerologia,Bogota,Colombia
,
Jun Zhu
Affiliations:
Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs,Beijing,China
,
David Belada
Affiliations:
Fourth Department of Internal Medicine - Hematology,Charles University Hospital and Faculty of Medicine,Hradec Králové,Czech Republic
,
Kamal Bouabdallah
Affiliations:
Department of Haematology,CHU Haut-Lévèque,Bordeaux,France
,
Joseph G Kattan
Affiliations:
Hotel Dieu De France University Hospital,Beirut,Lebanon
,
Cassandra Wu
Affiliations:
Novartis Oncology, Novartis Pharmaceuticals Corporation,East Hanover,United States
,
Jenna Fan
Affiliations:
Novartis Oncology, Novartis Pharmaceuticals Corporation,East Hanover,United States
,
Anne-Laure Louveau
Affiliations:
Novartis Pharma,Paris,France
,
Maurizio Voi
Affiliations:
Novartis Oncology, Novartis Pharmaceuticals Corporation,East Hanover,United States
Thomas E Witzig
Affiliations:
Mayo Clinic,Rochester,United States
EHA Learning Center. Cavalli F. Jun 11, 2016; 135341
Dr. Franco Cavalli
Dr. Franco Cavalli
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Abstract
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Abstract: LB705

Type: Poster Presentation

Presentation during EHA21: On Saturday, June 11, 2016 from 17:30 - 19:00

Location: Poster area (Hall H)

Background
The high-risk of relapse in patients (pts) with diffuse large B-cell lymphoma (DLBCL) who achieved a complete response (CR) to first-line rituximab-based chemotherapy (R-chemo) highlights the need for effective treatments to improve outcomes.

Aims
The phase 3 PILLAR-2 (NCT00790036) study aimed to reduce DLBCL relapse after 1 year of adjuvant everolimus (EVE) treatment to poor-risk patients (International Prognostic Index [IPI] ≥3) who had achieved a CR with R-chemo.

Methods
Pts with histologically confirmed stage III/IV poor-risk (IPI ≥3) DLBLC who had a PET/CT-confirmed CR to first-line R-chemo were randomized 1:1 to EVE 10 mg/day or placebo (PBO) for 1 year or until disease relapse, unacceptable toxicity, or death. The primary endpoint was disease-free survival (DFS) by local assessment using revised IWRC. Secondary endpoints were overall survival (OS), lymphoma-specific survival (LSS), and safety.

Results
Enrolled pts (N = 742) were randomly assigned to EVE (n = 372) or PBO (n = 370). Among randomized pts, 48% in the EVE arm and 67% in the PBO arm completed study treatment per protocol. The main reasons for discontinuation were AEs (EVE, 30%; PBO, 12%) and relapsed disease (EVE, 7%; PBO, 13%). Median follow-up was 50.4 months (range, 24.0–76.9 months). Overall, 47% of pts were ≥65 years, 50% were men, and 42% had an IPI of 4+5. In the primary analysis DFS was not significantly different between EVE and PBO (Log-rank p = 0.276). The 2-year DFS rates (95% CI) were 78% (73-82%) with EVE and 77% (72-81%) with PBO.  The 2-year OS rates were 91% with EVE and 88% with PBO (Hazard Ratio [HR], 0.75; 95% CI: 0.51-1.10). Results of exploratory subgroup analyses showed a trend favoring EVE over PBO for both DFS and OS in pts with IPI 4+5, in males, and in pts <65 years of age (Table).  There was also a trend favoring EVE over PBO for LSS (Table). Common grade 3/4 AEs with > 3% difference for EVE vs PBO included neutropenia, stomatitis, CD4 lymphocytes decreased, lymphopenia and anemia. During study treatment, 5 pts in the EVE arm and 2 pts in the PBO arm died.

Conclusion
Adjuvant EVE for 1 year did not improve DFS in poor-risk pts with DLBCL who achieved a CR after R-chemo. Trends favoring adjuvant EVE for DFS and OS in selected pt subgroups and for LSS in the overall population suggest that EVE may provide anti-lymphoma activity in poor-risk DLBCL that warrants further investigation.



Session topic: Aggressive Non-Hodgkin lymphoma - Clinical

Keyword(s): Diffuse large B cell lymphoma, Phase III
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