PMID- 29572782
OWN - NLM
STAT- MEDLINE
DCOM- 20190327
LR  - 20190327
IS  - 1573-0646 (Electronic)
IS  - 0167-6997 (Linking)
VI  - 36
IP  - 4
DP  - 2018 Aug
TI  - A phase I/II trial of pemetrexed plus radiotherapy in elderly patients with 
      locally advanced non-small cell lung cancer.
PG  - 667-673
LID - 10.1007/s10637-018-0587-8 [doi]
AB  - Background Radiotherapy (RT) is an effective treatment for elderly patients with 
      locally advanced non-small-cell lung cancer (NSCLC); however, no clinical trials 
      have investigated combination RT with pemetrexed (PEM) in chemotherapy-naive 
      patients >/=71 years old. We conducted a phase I/II study to evaluate the 
      appropriate PEM dose, efficacy, and safety of PEM plus RT in elderly patients. 
      Methods Patients >/=71 years with performance status (PS) scores of 0-2 who had 
      pathologically confirmed stage IIIA/IIIB NSCLC received PEM (500 mg/m(2) on day 1 
      of a 28-day cycle, 4 courses) and RT (a single 2 Gy daily fraction on 5 
      consecutive days weekly from day 1; 60 Gy total). The primary endpoint was the 
      objective response rate (ORR); the secondary endpoints were progression-free 
      survival (PFS), overall survival (OS), and adverse events (AEs). Results 
      Forty-one patients with a median age of 79 years were enrolled; 31 were men. 
      Eighteen patients had squamous cell carcinoma, 27 had stage IIIA disease, and 38 
      had PS scores 0-1. The ORR was 80.5%, while the median OS and PFS rates were 24.9 
      and 6.9 months, respectively. Two treatment-related deaths occurred owing to 
      RT-related pneumonitis and severe infection, respectively. Common hematological 
      AEs were leucopenia and neutropenia; common non-hematological AEs were anorexia 
      and constipation. Three patients developed PEM-induced interstitial lung disease; 
      however, most AEs were RT-related. Conclusions Combination PEM and RT shows 
      promising efficacy but relatively severe RT-related toxicities. Therefore, this 
      treatment should be prescribed to elderly patients with caution. Trial 
      registration UMIN 000005036 .
FAU - Tamiya, Akihiro
AU  - Tamiya A
AUID- ORCID: 0000-0003-3599-2583
AD  - Department of Internal Medicine, National Hospital Organization Kinki-chuo Chest 
      Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka, 591-8555, Japan. 
      akihiro1252akihiro@yahoo.co.jp.
FAU - Morimoto, Masahiro
AU  - Morimoto M
AD  - Osaka International Cancer Institute, Osaka-city, Osaka, Japan.
FAU - Fukuda, Shoichi
AU  - Fukuda S
AD  - Department of Internal Medicine, National Hospital Organization Kinki-chuo Chest 
      Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka, 591-8555, Japan.
FAU - Naoki, Yoko
AU  - Naoki Y
AD  - Department of Internal Medicine, National Hospital Organization Kinki-chuo Chest 
      Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka, 591-8555, Japan.
FAU - Ibe, Tatsuya
AU  - Ibe T
AD  - National Hospital Organization Nishisaitama-chuo National Hospital, 
      Tokorozawa-city, Saitama, Japan.
FAU - Okishio, Kyoichi
AU  - Okishio K
AD  - Department of Internal Medicine, National Hospital Organization Kinki-chuo Chest 
      Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka, 591-8555, Japan.
FAU - Goto, Hideto
AU  - Goto H
AD  - National Hospital Organization Yokohama Medical Center, Totsuka-ku, 
      Yokohama-city, Kanagawa, Japan.
FAU - Yoshii, Akihiro
AU  - Yoshii A
AD  - National Hospital Organization Shibukawa Medical Center, Shibukawa-city, Gunma, 
      Japan.
FAU - Kita, Toshiyuki
AU  - Kita T
AD  - National Hospital Organization Kanazawa Medical Center, Kanazawa-city, Ishikawa, 
      Japan.
FAU - Nogami, Naoyuki
AU  - Nogami N
AD  - National Hospital Organization Shikoku Cancer Center, Matsuyama-city, Ehime, 
      Japan.
FAU - Fujita, Yuka
AU  - Fujita Y
AD  - National Hospital Organization Asahikawa Medical Center, Asahikawa-city, 
      Hokkaido, Japan.
FAU - Atagi, Shinji
AU  - Atagi S
AD  - Department of Internal Medicine, National Hospital Organization Kinki-chuo Chest 
      Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka, 591-8555, Japan.
LA  - eng
SI  - UMIN-CTR/UMIN 000005036
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180323
PL  - United States
TA  - Invest New Drugs
JT  - Investigational new drugs
JID - 8309330
RN  - 0 (Antineoplastic Agents)
RN  - 04Q9AIZ7NO (Pemetrexed)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/*radiotherapy
MH  - Chemotherapy, Adjuvant/methods
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/*radiotherapy
MH  - Male
MH  - Neoplasm Staging/methods
MH  - Pemetrexed/*therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Geriatric patients
OT  - Pemetrexed
OT  - Pneumonitis
OT  - Radiotherapy
EDAT- 2018/03/25 06:00
MHDA- 2019/03/28 06:00
CRDT- 2018/03/25 06:00
PHST- 2018/03/02 00:00 [received]
PHST- 2018/03/06 00:00 [accepted]
PHST- 2018/03/25 06:00 [pubmed]
PHST- 2019/03/28 06:00 [medline]
PHST- 2018/03/25 06:00 [entrez]
AID - 10.1007/s10637-018-0587-8 [pii]
AID - 10.1007/s10637-018-0587-8 [doi]
PST - ppublish
SO  - Invest New Drugs. 2018 Aug;36(4):667-673. doi: 10.1007/s10637-018-0587-8. Epub 
      2018 Mar 23.