143PD - Bevacizumab and pemetrexed versus pemetrexed alone as maintenance therapy for patients with advanced nonsquamous NSCLC: Results of the expanded SAK...

Date 14 April 2016
Event European Lung Cancer Conference 2016 (ELCC) 2016
Session Predictive models for chemo- and radiotherapy
Topics Cytotoxic agents
Non-small-cell lung cancer
Therapy
Biological therapy
Presenter Oliver Gautschi
Citation Journal of Thoracic Oncology (2016) 11 (supplement 4): S57-S166. S1556-0864(16)X0004-4
Authors O. Gautschi1, Q. Li2, K. Matter-Walstra3, D. Betticher4, M. Frueh5, D. Rauch6, M. Pless7, P. Froesch8, N. Mach9, A. Ochsenbein10
  • 1Medizinische Onkologie, Luzerner Kantonsspital, 6004 - Luzern/CH
  • 2Statistical Office, SAKK Coordinating Center, Bern/CH
  • 3Institute Of Pharmaceutical Medicine, University of Basel Institute of Pharmaceutical Medicine, 4056 - Basel/CH
  • 4Internal Medicine, Medical Oncology, 1700 - Fribourg/CH
  • 5Oncology/hematology, Kantonsspital St. Gallen, St. Gallen/CH
  • 6Medizin, Spital STS AG Onkologiezentrum Thun-Berner Oberland, Thun/CH
  • 7Tumorcenter, Kantonsspital Winterthur, 8401 - Winterthur/CH
  • 8Oncology, IOSI Istituto Oncologico Svizzera Italiana Ospedale Regionale Bellinzona e Valli, Bellinzona/CH
  • 9Oncology, Hôpitaux Universitaires de Genève - HUG, Geneva/CH
  • 10Medical Oncology, Inselspital Bern, Bern/CH

Abstract

Background

The PARAMOUNT trial established maintenance therapy with pemetrexed (P) in patients with advanced, nonsquamous NSCLC. The AVAPERL trial demonstrated encouraging results with bevacizumab (B) plus P, compared with B alone.

Methods

We conducted a nonrandomized phase II trial with two sequential cohorts to compare maintenance therapy with B+P versus P. In the first cohort, 77 patients were treated with 4 cycles of cisplatin 75 mg/m2, P 500 mg/m2 and B 7.5 mg/kg every 3 weeks, followed by B+P maintenance until RECIST progression (Clin Lung Cancer 2015). We expanded the trial by a second cohort, and treated 52 patients with the same chemotherapy, but without B. Here, we present for the first time a comparison of the two cohorts. Inclusion and exclusion criteria and follow up were the same. The primary endpoint was progression-free survival (PFS). Other outcomes of interest were overall survival (OS), overall response (OR), adverse events (AE), and treatment cost.

Results

Median PFS was 6.9 months (95%CI: 5.2–8.4) with B+P and 5.6 months (95%CI: 4.3–6.8) with P. OR was 62% with B+P (95%CI: 51%-73%) and 44% with P (95%CI: 31%-59%). PFS (hazard ratio: 0.7, 95%CI: 0.5–1.0, p value: 0.04) and OR (odds Ratio: 2.1, 95%CI: 1.0–4.3; p = 0.05) were better with B+P than with P. No OS difference was found (hazard ratio: 1.0, 95%CI: 0.7–1.6, p value: 0.89) after a median follow-up of 47 months for pts with P+B and 27 months for pts with P. The rate of AEs grade ≥ 3 was slightly higher with B+P than with P. In a preliminary economic analysis, treatment cost was approximately 1.6 times higher with B+P compared with P (3 months after registration: $10,226/month versus $6,251/month).

Conclusions

Maintenance therapy with B+P increased PFS, but not OS, compared with P alone. A phase III trial is ongoing with OS as primary endpoint (ECOG 5508).

Clinical trial identification

NCT01116219 (Registered 27 April 2010)

Legal entity responsible for the study

SAKK, Bern, Switzerland

Funding

Roche Switzerland, Eli Lilly, Krebsforschung Schweiz and Bernese Cancer League

Disclosure

All authors have declared no conflicts of interest.