1281P - Maintenance therapy for nonsquamous non-small cell lung cancer (NSQNSCLC): patient-reported symptoms, performance status (PS) and efficacy

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Presenter Coleman Obasaju
Authors C. Obasaju1, L. Bowman2, P. Wang1, W. Shen3, K.B. Winfree2, E.N. Smyth2, M. Boye2, W. John1, C.P. Belani4
  • 1Oncology, Eli Lilly and Company, Indianapolis/US
  • 2Global Health Outcomes, Eli Lilly and Company, Indianapolis/US
  • 3Global Statistics, Eli Lilly and Company, Indianapolis/US
  • 4Cancer Institute, Penn State Milton S. Hershey Medical Center, Hershey/US

Abstract

Purpose

Ciuleanu et al. (2009) showed that pemetrexed (Pem) maintenance therapy is well-tolerated and offers significantly superior overall survival (OS) and progression-free survival (PFS) versus (vs) placebo (pbo) in patients (pts) with advanced nsqNSCLC. This retrospective analysis assessed the effect of maintenance therapy on OS and PFS by baseline patient-reported symptom burden and PS.

Methods

Data from 481 nonsquamous pts were analyzed. Symptom burden of 464 pts was captured with baseline values of the Lung Cancer Symptom Scale (LCSS), which includes 6 disease-specific symptom items (anorexia, fatigue, cough, dyspnea, pain, hemoptysis), each ranging from 0 (no symptoms) to 100 (worst symptoms). Average symptom burden index (ASBI) is the mean of the 6 items. Symptom subgroups were defined by ASBI: low symptom burden (LSB; ASBI < 25) and high symptom burden (HSB; ASBI ≥ 25). Multivariate Cox models were used to evaluate the maintenance treatment effect within ASBI subgroups adjusting for 9 demographic/clinical (DC) factors, including ECOG PS and stage of disease. Similarly, maintenance treatment effects within PS 0, 1 subgroups were evaluated.

Results

Controlling for PS and other DC factors, pts with LSB (n = 333) and HSB (n = 131) who received maintenance therapy had improved PFS vs pbo: 5.1 vs 2.4 months [mos] (hazard ratio [HR] 0.49, p < 0.001) for LSB and 3.7 vs 2.8 mos (HR 0.50, p = 0.003) for HSB. LSB pts had improved OS vs pbo (median OS 17.5 vs 11.0 mos, HR 0.63, p = 0.001), but HSB pts did not (median OS 11.8 vs 10.6 mos, HR 1.02, p = 0.92). PS was associated with patient-reported symptoms. PS 0 pts had lower mean LCSS scores than PS 1 pts for fatigue, pain, and ASBI (each p < 0.05). PS subgroup results are similar to the symptom-burden analysis: improved PFS in PS 0, 1 pts and improved OS in PS 0 pts.

Conclusion

NsqNSCLC pts with LSB and HSB at the end of induction therapy experienced significant improvements in PFS with Pem maintenance therapy. This translated into improved OS for LSB pts. These data suggest that maintenance therapy, rather than a break in treatment or “chemo holiday,” is an appropriate treatment strategy for nsqNSCLC pts at successful completion of induction therapy.

Disclosure

C. Obasaju: Employed by and own stock in Eli Lilly and Company.

L. Bowman: Employed by and own stock in Eli Lilly and Company.

P. Wang: Employed by and own stock in Eli Lilly and Comany.

W. Shen: Employed by and own stock in Eli Lilly and Company.

K.B. Winfree: Employed by and own stock in Eli Lilly and Company.

E.N. Smyth: Employed by and own stock in Eli Lilly and Company.

M. Boye: Employed by and own stock in Eli Lilly and Company.

W. John: Employed by and own stock in Eli Lilly and Company.

C.P. Belani: Served on advisory board for Eli Lilly and Company