1202P - Pemetrexed (Pem) and cisplatin (Cis) with concurrent thoracic radiation after Pem + Cis induction in patients (pts) with unresectable locally advan...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Locally Advanced
Surgery and/or Radiotherapy of Cancer
Presenter Pilar Garrido Lopez
Citation Annals of Oncology (2014) 25 (suppl_4): iv417-iv425. 10.1093/annonc/mdu348
Authors P. Garrido Lopez1, S. Novello2, W. Engel-Riedel3, M. Serke4, P. Giraud5, C.M. Visseren-Grul6, S. Ameryckx7, V. Soldatenkova8, N. Chouaki9
  • 1Medical Oncology, Hospital Ramon y Cajal, ES-28034 - Madrid/ES
  • 2Thoracic Oncology Unit, University of Turin, Orbassano/IT
  • 3Lunc Clinic Merheim, Hospital of Cologne, Cologne/DE
  • 4Thoracic Oncology, Hemer Lung Clinic, Hemer/DE
  • 5Department Of Oncology, Radiotherapy, Georges Pompidou European Hospital, Paris/FR
  • 6Medical Oncology, Eli Lilly, Houten/NL
  • 7Clinical Trial Management Oncology, Lilly S.A. Eli Lilly Benelux N.V, Brussels/BE
  • 8European Statistics Oncology, Lilly Deutschland GmbH, Bad Homburg/DE
  • 9Medical Oncology, Eli Lilly and Company, Neuilly-sur-Seine/FR

Abstract

Aim

This single arm multicenter Phase II study showed that Pem-Cis induction chemotherapy (CT) followed by full-dose Pem-Cis + concurrent radiotherapy (RT) was well tolerated and effective in pts with LA NS-NSCLC. The 1 yr PFS rate (primary endpoint) was 51% (ECCO 2013). Here, we present final data for younger vs. elderly pts (≤70/ > 70 yrs).

Methods

Pts with unresectable Stage IIIA/B NS-NSCLC (AJCC V6) and ECOG-PS 0-1 received two 21-day cycles of Pem 500/Cis 75 mg/m2 on Day (d)1 (supplementation per Pem label). Eligible pts who did not progress continued with 2 cycles of full dose Pem-Cis + concurrent RT (66 Gy, 33 fractions).

Results

Of 73/17 pts ≤70/ > 70 yrs enrolled, 59/16 (81/94%) completed induction CT and started concurrent CT + RT (≤70/ > 70 yrs: male 56/59%, ECOG-PS 0 66/65%, adeno 89/94%, Stage IIIA 32/53%). The 1 yr PFS rate [95%CI] was 44.9% [32.6%, 56.4%] in pts ≤70 yrs and 53.3% [26.3%, 74.4%] in pts >70 yrs. Median OS was 26.2 mo in pts ≤70 yrs and 25.1 mo in pts >70 yrs. ORR (CR + PR) in pts ≤70/ > 70 yrs was 59/65%, DCR (CR + PR + SD) was 74/94%. Tumor response in pts >70 yrs included 2 CRs (1 after CT + RT alone). 53 of 59 pts ≤70 yrs and 12 of 17 pts >70 yrs starting CT + RT received the full RT dose. Of the 17 pts >70 yrs overall, 15 received all 4 CT cycles, 3 had ≥1 cycle delay for toxicity, 2 had 1 CT dose reduction, 1 had 1 CT dose omitted. Safety data are reported as table. No elderly, but 1 pt ≤70 yrs died from study-drug related toxicity (enteritis) during Cycle 4. No pt >70 yrs required blood transfusions. During concurrent CT + RT, 1 pt >70 yrs had G2 pneumonitis (no G3/4 pneumonitis).

Safety
% patients
≤70 yrs >70 yrs
TEAE Induction CT N = 73 Concurr CT + RT N = 59 Induction CT N = 17 Concurr CT + RT N = 16
Any 76.7 96.6 82.4 93.8
Related 63.0 93.2 70.6 87.5
G3/4 15.1 42.4 35.3 50.0
Related 11.0 40.7 17.6 43.8
Serious 8.2 23.7 11.8 25.0
Related 2.7 20.3 5.9 25.0

Conclusions

Pem-Cis induction CT followed by full-dose Pem-Cis and concurrent RT was effective in younger (≤70 yrs) and elderly (>70 yrs) pts with good PS. In both age groups, toxicity was manageable and consistent with the known safety profile of pemetrexed.

Disclosure

P. Garrido Lopez: PG has worked as consultant for and has received speaker honoraria from Eli Lilly and Company; W. Engel-Riedel: WE-R has been Advisory Board Member for Eli Lilly, Amgen, Boehringer, and Roche, and has received speaker honoraria from Lilly, Amgen and Pierre Fabre; M. Serke: MS was consultant for ISCLC, Advisory Board Member for Lilly, Roche, Boehringer, and received speaker honoraria from ISCLC, Roche, Lilly, Astra Zeneca, Pfizer and Boehringer. She has received research funding for the study disclosed (S128) from Lilly; P. Giraud: PG has been Advisory Board Member for Merck Serono, and has received honoraria from Astellas and Merck Serono. He also has received research funding from Eli Lilly for the study (S128) disclosed here; C.M. Visseren-Grul: CVG is an employee of Eli Lilly and Company and owns Lilly stock; S. Ameryckx: SA is an employee of Eli Lilly and Company; V. Soldatenkova: VS is an employee of Eli Lilly and Company and owns Lilly stock; N. Chouaki: NC is an employee of Eli Lilly and Company. All other authors have declared no conflicts of interest.