Abstract 1371P
Background
Cisplatin plus pemetrexed (Pe) followed by pemetrexed is one of the efficacious regimens against advanced non-squamous (Sq) non-small Cell Lung Cancer (NSCLC). Although the addition of bevacizumab (Bev) improved the response rate in the treatment of non-Sq NSCLC, there is no sufficient survival data on this regimen. We performed this randomized phase II trial to clarify the efficacy of pemetrexed with bevacizumab as maintenance therapy.
Methods
The eligibility criteria were no prior chemotherapy; stage IIIB or stage IV non-Sq NSCLC; a PS of 0–1; age ≥20 years and <75; EGFR mutation (-); and adequate haematologic, hepatic, and renal function. Patients (pts) received induction chemotherapy of CDDP (75 mg/m2, day 1), Pe (500 mg/m2, day 1), and Bev (15 mg/kg, day 1) every 3 weeks for four cycles. Pts with at least stable disease were randomized to receive Pe plus Bev, or Pe alone. The primary endpoint was progression free survival (PFS) after induction chemotherapy. The sample size was calculated as 54 with a one-sided alpha of 10%, a power of 80%. In addition, monocytic myeloid-derived suppressor cell (M-MDSC) counts from peripheral blood of pts were analysed.
Results
108 pts were enrolled in this study and received induction chemotherapy. 35 pts were randomized to each group (Pe plus Bev group and Pe alone group). The PFS of Pe plus Bev group was significantly superior to that of Pe alone group [211 days vs. 162 days, HR: 0.5585 (0.3356-0.9294), Log-rank P = 0.025]. M-MDSC counts were analysed in 10 of 108 pts. Pre-treatment M-MDSC counts of the pts in the Pe plus Bev group with poor PFS tended to be higher than those with a better PFS (P=0.0724).
Conclusions
Addition of Bev to Pe, as maintenance therapy after treatment with CDDP, Pe and Bev, has been shown to prolong PFS in patients with untreated advanced non-Sq NSCLC. Pre-treatment M-MDSC counts may be related to the effect of the chemotherapy with CDDP, Pe and Bev. (UMIN000010681).
Clinical trial identification
TORG1321 (UMIN000010681).
Editorial acknowledgement
Legal entity responsible for the study
Thoracic Oncology Research Group (TORG).
Funding
Thoracic Oncology Research Group (TORG).
Disclosure
T. Kondo, H. Saito: Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Chugai Pharma. N. Seki: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Lilly Japan; Honoraria (self), Research grant/Funding (institution): Boehringer Ingelheim; Honoraria (self): Daiichi Sankyo; Honoraria (self): MSD Oncology; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Chugai Pharma; Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Bristol-Myers Squibb Japan; Research grant/Funding (institution): Nihon Medi-Physics. A. Bessho: Honoraria (self): Eli Lilly. H. Tanaka: Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Bristol-Myers Squibb; Honoraria (self), Research grant/Funding (institution): Boehringer Ingelheim; Honoraria (self), Research grant/Funding (institution): Chugai pharmaceutical; Research grant/Funding (institution): Ono pharmaceutical; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): Pfizer. H. Yamaguchi: Honoraria (self): Novartis Pharma; Honoraria (self), Research grant/Funding (institution): Chugai Pharmaceutical; Honoraria (self), Research grant/Funding (institution): Boehringer Ingelheim; Honoraria (self), Research grant/Funding (institution): Eli Lilly Japan; Honoraria (self): TAIHO Pharmaceutical; Honoraria (self), Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): Shionogi & Co., Ltd.; Research grant/Funding (institution): Sumitomo Dainippon Pharma Co., Ltd. K. Minato: Research grant/Funding (institution): Taiho Pharmaceutical; Research grant/Funding (institution): Ono Pharmaceutical; Research grant/Funding (institution): Bristol-Myers Squibb. Y. Misumi: Research grant/Funding (institution): Bristol-Myers Squibb. H. Okamoto: Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Takeda pharmaceutical; Research grant/Funding (institution): Chugai pharmaceutical; Research grant/Funding (institution): Taiho pharmaceutical; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Ono Pharmaceutical; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): Daiich Sankyo. All other authors have declared no conflicts of interest.