PMID- 32733606
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220415
IS  - 1758-8340 (Print)
IS  - 1758-8359 (Electronic)
IS  - 1758-8340 (Linking)
VI  - 12
DP  - 2020
TI  - Intrathecal pemetrexed combined with involved-field radiotherapy as a first-line 
      intra-CSF therapy for leptomeningeal metastases from solid tumors: a phase I/II 
      study.
PG  - 1758835920937953
LID - 10.1177/1758835920937953 [doi]
LID - 1758835920937953
AB  - PURPOSE: A phase I/II study of intrathecal pemetrexed (IP) combined with 
      involved-field radiotherapy (IFRT) was performed to determine feasibility, 
      safety, and antitumor activity for leptomeningeal metastases (LM) from solid 
      tumors. METHODS: Participants first received induction IP administration, 
      followed by concomitant radiotherapy within 3 days. The concomitant regimen 
      consisted of IP (pemetrexed 10 mg, dexamethasone 5 mg, once per week, 4 times in 
      4 weeks) and IFRT (40 Gy in 20 fractions). Six participants were recruited to 
      assess feasibility in phase I, and then 28 patients were recruited further. All 
      patients were assessed to investigate safety, efficacy, and outcomes. RESULTS: 
      Between April 2018 and December 2018, 34 patients (male: 15; female: 19; median 
      age: 56 years) were enrolled, including non-small-cell lung cancer (21), 
      small-cell lung cancer (5), breast cancer (4), and others (4). Thirty-two 
      patients received concurrent therapy and 25 (74%) patients completed the 
      treatment. Major adverse events (AEs) consisted of myelosuppression, the 
      elevation of hepatic aminotransferases, and radiculitis. Total AEs rate was 53% 
      (18/34), including 6 (18%) patients with grade 3 and 1 (3%) with grade 4 AEs. The 
      response rate was 68% (23/34). The median overall survival was 5.5 (0.3-16.6) 
      months. Median neurological progression-free survival (NPFS) was 3.5 (0.3-15.2) 
      months. Six-month NPFS rate was 47%. One-year survival rate was 21.6%. 
      CONCLUSION: IP at a 10 mg dose on a schedule of 1-2 times per week presented good 
      efficacy and safety in CSF. The concomitant regimen is an efficacious therapeutic 
      option for LM patients with solid tumors. TRIAL REGISTRATION: This study (IPLM) 
      was registered at https://register.clinicaltrials.gov [ClinicalTrials.gov 
      identifier: NCT03507244].
CI  - (c) The Author(s), 2020.
FAU - Pan, Zhenyu
AU  - Pan Z
AD  - Department of Radiation-Oncology, The First Hospital of Jilin University, 
      Changchun, China.
FAU - Yang, Guozi
AU  - Yang G
AD  - Department of Radiation-Oncology, The First Hospital of Jilin University, 
      Changchun, China.
FAU - He, Hua
AU  - He H
AD  - Cancer Center, The First Hospital of Jilin University, Changchun, China.
FAU - Cui, Jiuwei
AU  - Cui J
AD  - Cancer Center, The First Hospital of Jilin University, Changchun, China.
FAU - Li, Wei
AU  - Li W
AD  - Cancer Center, The First Hospital of Jilin University, Changchun, China.
FAU - Yuan, Tingting
AU  - Yuan T
AD  - Department of Radiology, The First Hospital of Jilin University, Changchun, 
      China.
FAU - Chen, Kunzhi
AU  - Chen K
AD  - Department of Radiation-Oncology, The First Hospital of Jilin University, 
      Changchun, China.
FAU - Jiang, Tongchao
AU  - Jiang T
AD  - Department of Radiation-Oncology, The First Hospital of Jilin University, 
      Changchun, China.
FAU - Gao, Pengxiang
AU  - Gao P
AD  - Department of Radiation-Oncology, The First Hospital of Jilin University, 
      Changchun, China.
FAU - Sun, Yanan
AU  - Sun Y
AD  - Department of Radiation-Oncology, The First Hospital of Jilin University, 
      Changchun, China.
FAU - Cong, Xiaofeng
AU  - Cong X
AD  - Cancer Center, The First Hospital of Jilin University, Changchun, China.
FAU - Li, Zhi
AU  - Li Z
AD  - Cancer Center, The First Hospital of Jilin University, Changchun, China.
FAU - Wang, Yongxiang
AU  - Wang Y
AD  - Department of Clinical Laboratory, The First Hospital of Jilin University, 
      Changchun, China.
FAU - Pang, Xiaochuan
AU  - Pang X
AD  - Department of Clinical Laboratory, The First Hospital of Jilin University, 
      Changchun, China.
FAU - Song, Yuanyuan
AU  - Song Y
AD  - Department of Clinical Laboratory, The First Hospital of Jilin University, 71 
      Xinmin Street, Changchun, 130021, China.
FAU - Zhao, Gang
AU  - Zhao G
AUID- ORCID: 0000-0003-0403-5561
AD  - Department of Neuro-Oncological Surgery, The First Hospital of Jilin University, 
      71 Xinmin Street, Changchun, 130021, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT03507244
PT  - Journal Article
DEP - 20200717
PL  - England
TA  - Ther Adv Med Oncol
JT  - Therapeutic advances in medical oncology
JID - 101510808
PMC - PMC7370561
OTO - NOTNLM
OT  - intrathecal chemotherapy
OT  - leptomeningeal metastases
OT  - pemetrexed
OT  - radiotherapy
OT  - solid tumor
COIS- Conflict of interest statement: The authors declare that there is no conflict of 
      interest.
EDAT- 2020/08/01 06:00
MHDA- 2020/08/01 06:01
PMCR- 2020/07/17
CRDT- 2020/08/01 06:00
PHST- 2019/12/31 00:00 [received]
PHST- 2020/05/21 00:00 [accepted]
PHST- 2020/08/01 06:00 [entrez]
PHST- 2020/08/01 06:00 [pubmed]
PHST- 2020/08/01 06:01 [medline]
PHST- 2020/07/17 00:00 [pmc-release]
AID - 10.1177_1758835920937953 [pii]
AID - 10.1177/1758835920937953 [doi]
PST - epublish
SO  - Ther Adv Med Oncol. 2020 Jul 17;12:1758835920937953. doi: 
      10.1177/1758835920937953. eCollection 2020.