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1291PPHASE || STUDY OF PEMETREXED + CARBOPLATIN + BEVACIZUMAB AS FIRST-LINE THERAPY FOR NONSQUAMOUS NON-SMALL CELL LUNG CANCER WITH EGFR MUTATION, RESULT OF INDUCTION THERAPY: CENTRAL JAPAN LUNG STUDY GROUP (CJLSG) 0910 TRIAL.

ABSTRACT Aim: In advanced non-squamous (sq) non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutation (MT), EGFR-tyrosine kinase inhibitor (TKI) showed better response rate (RR) and longer progression-free survival (PFS) than standard chemotherapy, but showed almost the same overall survival (OS). Recently, chemotherapy with bevacizumab (Bev) showed higher RR, and maintenance therapy with Bev or pemetrexed (Pem) showed longer PFS. But, there have been few reports of chemotherapy with Pem and Bev including maintenance therapy in patients(pts) with EGFR-MT. According to the result of IPASS study, response to standard chemotherapy in pts with EGFR-MT is also better than in pts without EGFR mutation. Therefore, we thought chemotherapy containing Pem and Bev may be more effective in EGFR-MT pts. This study was designed to evaluate the efficacy and safety of combination therapy with Pem, carboplatin (Cb) and Bev followed by Pem plus Bev maintenance therapy for non-sq NSCLC pts with EGFR-MT. Methods: Patients receive Pem 500mg/m2 day1 + Cb AUC 6 day1 + Bev 15mg/kg day1, every 3 weeks, 4-6 cycles (induction therapy. Patients who achieved disease control receive Pem 500mg/m2 day1 + Bev 15mg/kg day1, every 3 weeks until disease progression (maintenance therapy). Key inclusion criteria are as follows: histologically or cytologically proven non-sq NSCLC, EGFR mutation (exon 19 deletion or L858R), stage IIIB or IV, or recurrent disease after surgery (rec), no prior chemotherapy, age: 20-74. Results: Thirty-two eligible pts were enrolled between July 2010 and July 2012, two pts refused after enrollment . The median age was 65.5 years (range, 47–74); 13/17 males/females; 1/27/2 with IIIB/IV/rec; 29/1/ with adenocarcinoma/large cell carcinoma. In the induction therapy, the median number of cycles was 6. In 29 pts, there were 15 partial responses with an RR of 51.7% . SD was observed in 14 pts and DCR was 100% and 24 pts (82.7%) followed by maintenance therapy. Major adverse events were grade 3-4 neutropenia in 14 pts (46.7%), grade 3 anemia in 6 pts (20.0%), grade 3-4 thrombocytopenia in 6 pts (20.0%), grade 3 diarrhea in 2 pts(6.7%), grade 3 nausea and grade 3 anorexia in 1 pt (3.3%). There was no treatment-related death. Conclusions: This study suggested that chemotherapy, including maintenance therapy is also useful in patients with EGFR-MT. Disclosure: All authors have declared no conflicts of interest.