PubTransformer

A site to transform Pubmed publications into these bibliographic reference formats: ADS, BibTeX, EndNote, ISI used by the Web of Knowledge, RIS, MEDLINE, Microsoft's Word 2007 XML.

Phase II Study of the Efficacy and Safety of High-dose Pemetrexed in Combination with Cisplatin Versus Temozolomide for the Treatment of Non-small Cell Lung Cancer with Brain Metastases.

Abstract The aim of this study was to explore the efficacy and safety of high-dose pemetrexed with cisplatin versus combination with temozolomide in patients with brain metastases (BM) of lung adenocarcinoma. After standard whole-brain radiotherapy (WBRT, 30 Gy/10 fractions), patients with BM of non-small cell lung cancer (NSCLC) were given high-dose pemetrexed (900 mg/m(2)) on day 1 of each cycle (3 weeks), and cisplatin was administered on days 1-3 in the cisplatin-treated group. The temozolomide-treated group was treated as follows: 75 mg/m(2) temozolomide orally with concurrent WBRT followed by 150 mg/m(2) temozolomide on days 1-5 with high-dose pemetrexed (900 mg/m(2)) on day 1 of each cycle (3 weeks). Six cycles later, high-dose pemetrexed (900 mg/m(2)) monotherapy or the best available supportive therapy was administered to both groups. An evaluation was carried out every 2-3 cycles. The primary end-points were objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Secondary end-points included safety and tolerability. Thirty-two patients in the pemetrexed plus cisplatin (PC) group and 28 patients in the pemetrexed plus temozolomide (PT) group were enrolled from November 2013 to October 2015. The ORR was 68.8% and 75%, in the PC and PT groups, respectively, and there was no statistically significant difference between the two groups (p=0.711). The median PFS rates of the PC and PT groups were 13.6 months and 16.9 months, respectively, and the median OS rates of the PC and PT groups were 18.9 months and 19.3 months, respectively. There were no differences in PFS and OS between the two groups. There were no grade 4 or higher side-effects in either group, but grade 3 side-effects such as leucopenia (2/32, 6.3%), nausea/vomiting (2/32, 6.3%), alopecia (1/32, 3.1%), rash (3/32, 9.4%) and renal insufficiency (1/32, 3.1%) were observed in the PC group, whereas the PT-group-only showed the following grade 3 side-effects: leucopenia (1/28, 3.6%) and nausea/vomiting (2/28, 7.1%). The data showed that the PT group achieved the same efficacy in PFS and OS as the PC group but with fewer toxicities. Therefore, high-dose pemetrexed plus temozolomide may be a better regimen for treating NSCLC with BM due to its better safety.
PMID
Related Publications

Final results from a Phase II study of pemetrexed and cisplatin with concurrent thoracic radiation after Pem-Cis induction in patients with unresectable locally advanced non-squamous non-small cell lung cancer (NSCLC).

Pemetrexed and cisplatin as first-line chemotherapy for advanced non-small-cell lung cancer (NSCLC) with asymptomatic inoperable brain metastases: a multicenter phase II trial (GFPC 07-01).

Efficacy and safety of maintenance pemetrexed in patients with advanced nonsquamous non-small cell lung cancer following pemetrexed plus cisplatin induction treatment: A cross-trial comparison of two phase III trials.

Pemetrexed and cisplatin combination with concurrent whole brain radiotherapy in patients with brain metastases of lung adenocarcinoma: a single-arm phase II clinical trial.

Salvage treatment with irinotecan/cisplatin versus pemetrexed/cisplatin in patients with non-small cell lung cancer pre-treated with a non-platinum-based regimen in the first-line setting: a randomized phase II study of the Hellenic Oncology Research Group (HORG).

Authors

Mayor MeshTerms
Keywords

Lung adenocarcinoma

WBRT

high-dose pemetrexed

metastases

temozolomide

Journal Title anticancer research
Publication Year Start




PMID- 28739776
OWN - NLM
STAT- MEDLINE
DA  - 20170725
DCOM- 20170803
LR  - 20170803
IS  - 1791-7530 (Electronic)
IS  - 0250-7005 (Linking)
VI  - 37
IP  - 8
DP  - 2017 Aug
TI  - Phase II Study of the Efficacy and Safety of High-dose Pemetrexed in Combination 
      with Cisplatin Versus Temozolomide for the Treatment of Non-small Cell Lung
      Cancer with Brain Metastases.
PG  - 4711-4716
AB  - The aim of this study was to explore the efficacy and safety of high-dose
      pemetrexed with cisplatin versus combination with temozolomide in patients with
      brain metastases (BM) of lung adenocarcinoma. After standard whole-brain
      radiotherapy (WBRT, 30 Gy/10 fractions), patients with BM of non-small cell lung 
      cancer (NSCLC) were given high-dose pemetrexed (900 mg/m2) on day 1 of each cycle
      (3 weeks), and cisplatin was administered on days 1-3 in the cisplatin-treated
      group. The temozolomide-treated group was treated as follows: 75 mg/m2
      temozolomide orally with concurrent WBRT followed by 150 mg/m2 temozolomide on
      days 1-5 with high-dose pemetrexed (900 mg/m2) on day 1 of each cycle (3 weeks). 
      Six cycles later, high-dose pemetrexed (900 mg/m2) monotherapy or the best
      available supportive therapy was administered to both groups. An evaluation was
      carried out every 2-3 cycles. The primary end-points were objective response rate
      (ORR), progression-free survival (PFS), and overall survival (OS). Secondary
      end-points included safety and tolerability. Thirty-two patients in the
      pemetrexed plus cisplatin (PC) group and 28 patients in the pemetrexed plus
      temozolomide (PT) group were enrolled from November 2013 to October 2015. The ORR
      was 68.8% and 75%, in the PC and PT groups, respectively, and there was no
      statistically significant difference between the two groups (p=0.711). The median
      PFS rates of the PC and PT groups were 13.6 months and 16.9 months, respectively,
      and the median OS rates of the PC and PT groups were 18.9 months and 19.3 months,
      respectively. There were no differences in PFS and OS between the two groups.
      There were no grade 4 or higher side-effects in either group, but grade 3
      side-effects such as leucopenia (2/32, 6.3%), nausea/vomiting (2/32, 6.3%),
      alopecia (1/32, 3.1%), rash (3/32, 9.4%) and renal insufficiency (1/32, 3.1%)
      were observed in the PC group, whereas the PT-group-only showed the following
      grade 3 side-effects: leucopenia (1/28, 3.6%) and nausea/vomiting (2/28, 7.1%).
      The data showed that the PT group achieved the same efficacy in PFS and OS as the
      PC group but with fewer toxicities. Therefore, high-dose pemetrexed plus
      temozolomide may be a better regimen for treating NSCLC with BM due to its better
      safety.
CI  - Copyright(c) 2017, International Institute of Anticancer Research (Dr. George J. 
      Delinasios), All rights reserved.
FAU - He, Qiaowei
AU  - He Q
AD  - Department of Neurosurgery, the Affiliated Yantai Yuhuangding Hospital of Qingdao
      University, Yantai, P.R. China.
FAU - Bi, Xizhuang
AU  - Bi X
AD  - Department of Neurology, the Affiliated Yantai Yuhuangding Hospital of Qingdao
      University, Yantai, P.R. China.
FAU - Ren, Chao
AU  - Ren C
AD  - Department of Neurology, the Affiliated Yantai Yuhuangding Hospital of Qingdao
      University, Yantai, P.R. China [email protected]
FAU - Wang, Yong
AU  - Wang Y
AD  - Department of Neurosurgery, Shandong Cancer Hospital, Jinan, P.R. China.
FAU - Zou, Peng
AU  - Zou P
AD  - Department of Neurosurgery, the Affiliated Yantai Yuhuangding Hospital of Qingdao
      University, Yantai, P.R. China.
FAU - Zhang, Hongtao
AU  - Zhang H
AD  - Department of Neurosurgery, the Affiliated Yantai Yuhuangding Hospital of Qingdao
      University, Yantai, P.R. China.
FAU - Chi, Nan
AU  - Chi N
AD  - Department of Neurosurgery, the Affiliated Yantai Yuhuangding Hospital of Qingdao
      University, Yantai, P.R. China.
FAU - Xiu, Chunming
AU  - Xiu C
AD  - Department of Neurosurgery, the Affiliated Yantai Yuhuangding Hospital of Qingdao
      University, Yantai, P.R. China.
FAU - Wang, Yunbo
AU  - Wang Y
AD  - Department of Neurosurgery, the Affiliated Yantai Yuhuangding Hospital of Qingdao
      University, Yantai, P.R. China.
FAU - Tao, Rongjie
AU  - Tao R
AD  - Department of Neurosurgery, Shandong Cancer Hospital, Jinan, P.R. China.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PL  - Greece
TA  - Anticancer Res
JT  - Anticancer research
JID - 8102988
RN  - 04Q9AIZ7NO (Pemetrexed)
RN  - 7GR28W0FJI (Dacarbazine)
RN  - Q20Q21Q62J (Cisplatin)
RN  - YF1K15M17Y (temozolomide)
SB  - IM
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Brain Neoplasms/diagnosis/*drug therapy/mortality/*secondary
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/*pathology
MH  - Cisplatin/administration & dosage
MH  - Combined Modality Therapy
MH  - Dacarbazine/administration & dosage/analogs & derivatives
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Neoplasm Staging
MH  - Pemetrexed/administration & dosage
MH  - Risk Factors
MH  - Survival Analysis
MH  - Treatment Outcome
MH  - Tumor Burden
OTO - NOTNLM
OT  - Lung adenocarcinoma
OT  - WBRT
OT  - high-dose pemetrexed
OT  - metastases
OT  - temozolomide
EDAT- 2017/07/26 06:00
MHDA- 2017/08/05 06:00
CRDT- 2017/07/26 06:00
PHST- 2017/05/19 [received]
PHST- 2017/07/07 [revised]
PHST- 2017/07/07 [accepted]
AID - 37/8/4711 [pii]
PST - ppublish
SO  - Anticancer Res. 2017 Aug;37(8):4711-4716.