1218 - Prospective, single-arm, post-marketing clinical study of pemetrexed (PEM) and carboplatin combination followed by maintenance PEM in chemo-naïve J...

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Cytotoxic agents
Non-small-cell lung cancer
Biological therapy
Presenter Katsuyuki Hotta
Authors K. Hotta1, K. Kiura1, K. Kubota2, H. Yoshizawa3, S. Enatsu4, R. Sekiguchi4, K. Nakagawa5, T. Tamura2
  • 1Department Of Respiratory Medicine, Okayama University Hospital, 7008558 - Okayama/JP
  • 2Division Of Internal Medicine And Thoracic Oncology, National Cancer Center Hospital, Tokyo/JP
  • 3Bioscience Medical Research Center, Niigata University Medical and Dental Hospital, 9518520 - Niigata-City/JP
  • 4Development Center Of Excellence, Eli Lilly Japan K.K., Kobe/JP
  • 5Medical Oncology, Kinki University School of Medicine, JP-589-8511 - Osaka/JP



Platinum doublet chemotherapy is standard first-line treatment for advanced NSCLC, however, further studies are required to establish the effectiveness of maintenance therapy. The aim of this study was to evaluate the efficacy and safety of Pem/Carboplatin (Cb) followed by Pem in Japanese patients (pts) with advanced non-squamous NSCLC. This study is sponsored by Eli Lilly Japan K.K. (ClinicalTrials.gov: NCT01020786).

Patients and methods

Pts were chemo-naïve with unresectable stage IIIB, IV or postoperative recurrent non-squamous NSCLC, and a PS (ECOG) of 0-1. Pts received Cb AUC 6 and Pem 500 mg/m2 on Day 1 of each 21-day cycle for 4 cycles as induction therapy. Pts who achieved non-PD at the end of the 4-cycle induction therapy could continue Pem as maintenance therapy until PD. The primary endpoint was PFS, and it was assumed that the threshold and the expected values for the median PFS were 5 and 7 months, respectively.


A total of 111 pts were enrolled. Of the 109 treated pts, 75 pts (69%) completed induction therapy and 60 pts (55%) entered maintenance therapy; 15 pts (14%) discontinued in the 4th cycle due to PD (8 pts), AE (4 pts), and investigator or subject decision (3 pts). Pts (n = 109): median age 63 years, stage IV/others (66%/34%), PS 0/1 (34%/66%), EGFR-mutant/wild-type/unknown (22%/58%/20%). Among the 109 pts, 38 pts (35%) achieved PR, 41 pts (38%) SD, and 21 pts (19%) PD. Median PFS and MST from enrollment was 5.6 months (95% CI: 4.3, 7.2) and 20.2 months (95% CI: 16.7, incalculable), respectively. The MST for EGFR (-) pts was 19.4 months; MST could not be calculated for EGER ( + ) pts (17 pts [71%] censored). The most common Gr 3/4 toxicities in the induction and maintenance phases were neutropenia (57%), thrombocytopenia (41%), anemia (31%), whereas Gr 3 febrile neutropenia occurred in 1 pt without any regimen-related deaths.


PFS as the primary endpoint was not better than expected, but other endpoints seemed favorable. Hematologic toxicities were frequently observed. Updated data including MST will be presented at the congress.


S. Enatsu: An employee of Eli Lilly Japan K.K.

R. Sekiguchi: An employee of Eli Lilly Japan K.K.

All other authors have declared no conflicts of interest.