RT Journal Article
SR Electronic
T1 An Exploratory Randomized Phase II Trial Comparing CDDP Plus S-1 With Bevacizumab and CDDP Plus Pemetrexed With Bevacizumab Against Patients With Advanced Non-squamous Non-small Cell Lung Cancer
JF Anticancer Research
JO Anticancer Res
FD International Institute of Anticancer Research
SP 2483
OP 2491
DO 10.21873/anticanres.13368
VO 39
IS 5
A1 KYOICHI KAIRA
A1 HISAO IMAI
A1 RYOUSUKE SOUMA
A1 REIKO SAKURAI
A1 YOSUKE MIURA
A1 NORIAKI SUNAGA
A1 NORIMITSU KASAHARA
A1 YUSUKE TSUKAGOSHI
A1 YASUHIKO KOGA
A1 SHINSUKE KITAHARA
A1 MIE KOTAKE
A1 KOICHI MINATO
A1 ICHIRO NARUSE
A1 YASUTSUGU FUKUSHIMA
A1 TAKESHI HISADA
A1 TAMOTSU ISHIZUKA
YR 2019
UL http://ar.iiarjournals.org/content/39/5/2483.abstract
AB Background/Aim: It remains unclear which chemotherapeutic regimens are better for the addition of bevacizumab. We conducted an exploratory randomized phase II trial comparing first-line S-1 plus cisplatin with bevacizumab and pemetrexed plus cisplatin with bevacizumab in patients with advanced non-squamous non-small cell lung cancer (NSCLC). Patients and Methods: Chemotherapy-naïve patients received S-1 (80 mg/m2) from day 1 to day 14 plus cisplatin (80 mg/m2) on day 1 with bevacizumab (15 mg/kg) on day 1, followed by maintenance with bevacizumab plus S-1 (SCB) on day 1 every 3 weeks and pemetrexed (500 mg/m2) on day 1 plus cisplatin (75 mg/m2) on day 1 with bevacizumab (15 mg/kg) on day 1 followed by maintenance bevacizumab plus pemetrexed (PCB) on day 1 every 3 weeks. The expression of thymidylate synthase (TS) was analyzed using immunohistochemistry. Results: Forty-eight patients were enrolled in this study, and eligible patients were randomly assigned at 1:1 ratio to receive SCB (n=24) or PCB (n=24). The median number of chemotherapy and maintenance therapy for SCB and PCB was 4 (range, 1-6 cycles) and 4 (range, 2-6 cycles), and 5 (range, 0-39 cycles) and 5 (range, 0-28 cycles), respectively. The overall response rate (ORR) for PCB and SCB were 54.2% and 83.3%, respectively (p=0.06). The median progression-free survival (PFS) and overall survival (OS) for PCB and SCB were 406 and 351 days, (p=0.96), and 678 and 1190 days, respectively (p=0.23). The mild adverse events were observed in both regimens. TS expression was more predictive of the chemotherapeutic response in SCB compared to PCB, but not for PFS. Conclusion: The combination regimen of SCB was identified as having a similar activity and tolerability to that of PCB in patients with advanced non-squamous NSCLC.