PMID- 26922170
OWN - NLM
STAT- MEDLINE
DCOM- 20160815
LR  - 20220331
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 58
DP  - 2016 May
TI  - Maintenance therapy with pemetrexed and bevacizumab versus pemetrexed monotherapy 
      after induction therapy with carboplatin, pemetrexed, and bevacizumab in patients 
      with advanced non-squamous non small cell lung cancer.
PG  - 30-7
LID - S0959-8049(16)00051-4 [pii]
LID - 10.1016/j.ejca.2016.01.013 [doi]
AB  - OBJECTIVES: Single agent maintenance therapy is widely accepted for advanced 
      non-squamous non small cell lung cancer (NSCLC). However, there is no consensus 
      on the initial and maintenance phase regimens, and the clinical benefit of adding 
      bevacizumab to cytotoxic drugs in the maintenance phase remains unclear. METHODS: 
      Chemotherapy-naive patients with non-squamous NSCLC were randomly assigned to 
      maintenance therapy with pemetrexed and bevacizumab or pemetrexed alone, after 
      achieving disease control after four cycles of induction therapy with carboplatin 
      (area under the curve = 6), pemetrexed (500 mg/m(2)), and bevacizumab (15 mg/kg). 
      The primary end-point was 1-year progression-free survival (PFS) rate. RESULTS: 
      One hundred ten patients were enrolled in the study, with 55 patients assigned to 
      the two groups. The mean 1-year PFS rate was 43.9% (95% confidence interval [CI]: 
      29.6-59.2%) in the combination maintenance group and 35.2% (95% CI: 22.1-51.0%) 
      in the pemetrexed maintenance group, and the difference was not significant (p = 
      0.433). Median PFS measured from enrolment was 11.5 months (95% CI: 7.1-19.0) in 
      the combination maintenance group and 7.3 months (95% CI: 5.7-14.1, hazard ratio: 
      0.73, 95% CI: 0.44-1.19, log-rank p = 0.198) in the pemetrexed maintenance group. 
      Nasal haemorrhage, hypertension, and proteinuria were significantly more frequent 
      in the combination maintenance group, but they were mild and tolerable. 
      CONCLUSION: Both maintenance therapy with pemetrexed alone and pemetrexed and 
      bevacizumab in combination were feasible in patients with non-squamous NSCLC who 
      have achieved disease control after induction therapy with carboplatin, 
      pemetrexed, and bevacizumab. According to the selection design, differences in 
      the superiority between these maintenance therapies were not demonstrated.
CI  - Copyright (c) 2016 Elsevier Ltd. All rights reserved.
FAU - Karayama, Masato
AU  - Karayama M
AD  - Second Division, Department of Internal Medicine, Hamamatsu University School of 
      Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan; Department of Clinical 
      Oncology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 
      431-3192, Japan.
FAU - Inui, Naoki
AU  - Inui N
AD  - Second Division, Department of Internal Medicine, Hamamatsu University School of 
      Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan; Department of Clinical 
      Pharmacology and Therapeutics, Hamamatsu University School of Medicine, 1-20-1 
      Handayama, Hamamatsu 431-3192, Japan. Electronic address: inui@hama-med.ac.jp.
FAU - Fujisawa, Tomoyuki
AU  - Fujisawa T
AD  - Second Division, Department of Internal Medicine, Hamamatsu University School of 
      Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan.
FAU - Enomoto, Noriyuki
AU  - Enomoto N
AD  - Second Division, Department of Internal Medicine, Hamamatsu University School of 
      Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan.
FAU - Nakamura, Yutaro
AU  - Nakamura Y
AD  - Second Division, Department of Internal Medicine, Hamamatsu University School of 
      Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan.
FAU - Kuroishi, Shigeki
AU  - Kuroishi S
AD  - Department of Respiratory Medicine, Ensyu Hospital, 1-1-1 Chuou, Hamamatsu 
      430-0929, Japan.
FAU - Yokomura, Koshi
AU  - Yokomura K
AD  - Department of Respiratory Medicine, Seirei Mikatahara General Hospital, 3453 
      Mikatahara-cho, Hamamatsu 433-8558, Japan.
FAU - Koshimizu, Naoki
AU  - Koshimizu N
AD  - Department of Respiratory Medicine, Fujieda Municipal General Hospital, 4-1-11 
      Surugadai, Fujieda 426-8677, Japan.
FAU - Sato, Masaki
AU  - Sato M
AD  - Department of Respiratory Medicine, Japanese Red Cross Hamamatsu Hospital, 1088-1 
      Kobayashi, Hamamatsu 434-8533, Japan.
FAU - Toyoshima, Mikio
AU  - Toyoshima M
AD  - Department of Respiratory Medicine, Hamamatsu Rosai Hospital, 25 Shougen-cho, 
      Hamamatsu, Japan.
FAU - Shirai, Toshihiro
AU  - Shirai T
AD  - Department of Respiratory Medicine, Shizuoka General Hospital, 4-27-1 Kita-ando, 
      Shizuoka 420-0881, Japan.
FAU - Masuda, Masafumi
AU  - Masuda M
AD  - Department of Respiratory Medicine, Shizuoka City Shimizu Hospital, 1231 
      Miyakami, Shizuoka 424-8636, Japan.
FAU - Yamada, Takashi
AU  - Yamada T
AD  - Department of Respiratory Medicine, Shizuoka City Hospital, 10-93 Ote-cho, 
      Shizuoka 420-8630, Japan.
FAU - Imokawa, Shiro
AU  - Imokawa S
AD  - Department of Respiratory Medicine, Iwata City Hospital, 513-2 Ohkubo, Iwata 
      438-8550, Japan.
FAU - Suda, Takafumi
AU  - Suda T
AD  - Second Division, Department of Internal Medicine, Hamamatsu University School of 
      Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan.
LA  - eng
SI  - JPRN/UMINID000010002
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160227
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 04Q9AIZ7NO (Pemetrexed)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - BG3F62OND5 (Carboplatin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Bevacizumab/*administration & dosage/adverse effects
MH  - Carboplatin/*administration & dosage/adverse effects
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/pathology
MH  - Disease-Free Survival
MH  - Drug Administration Schedule
MH  - Feasibility Studies
MH  - Female
MH  - Humans
MH  - Induction Chemotherapy
MH  - Japan
MH  - Kaplan-Meier Estimate
MH  - Lung Neoplasms/*drug therapy/mortality/pathology
MH  - Maintenance Chemotherapy
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Pemetrexed/*administration & dosage/adverse effects
MH  - Proportional Hazards Models
MH  - Remission Induction
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Bevacizumab
OT  - Carboplatin
OT  - Maintenance therapy
OT  - Non small cell lung cancer
OT  - Pemetrexed
EDAT- 2016/02/29 06:00
MHDA- 2016/08/16 06:00
CRDT- 2016/02/29 06:00
PHST- 2015/09/04 00:00 [received]
PHST- 2015/12/15 00:00 [revised]
PHST- 2016/01/17 00:00 [accepted]
PHST- 2016/02/29 06:00 [entrez]
PHST- 2016/02/29 06:00 [pubmed]
PHST- 2016/08/16 06:00 [medline]
AID - S0959-8049(16)00051-4 [pii]
AID - 10.1016/j.ejca.2016.01.013 [doi]
PST - ppublish
SO  - Eur J Cancer. 2016 May;58:30-7. doi: 10.1016/j.ejca.2016.01.013. Epub 2016 Feb 
      27.