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A phase I study of S-1 with concurrent radiotherapy in elderly patients with locally advanced non-small cell lung cancer.

Abstract A phase I study was performed to evaluate dose-limiting toxicity and the recommended dose for the oral fluoropyrimidine S-1 administered concurrently with thoracic radiotherapy (TRT) in elderly (≥ 70 years of age) patients with locally advanced non-small cell lung cancer.
PMID
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A phase I study of S-1 with concurrent thoracic radiotherapy in elderly patients with localized advanced non-small cell lung cancer.

Authors

Mayor MeshTerms
Keywords
Journal Title investigational new drugs
Publication Year Start




PMID- 22623066
OWN - NLM
STAT- MEDLINE
DCOM- 20131126
LR  - 20171019
IS  - 1573-0646 (Electronic)
IS  - 0167-6997 (Linking)
VI  - 31
IP  - 3
DP  - 2013 Jun
TI  - A phase I study of S-1 with concurrent radiotherapy in elderly patients with
      locally advanced non-small cell lung cancer.
PG  - 599-604
LID - 10.1007/s10637-012-9833-7 [doi]
AB  - BACKGROUND: A phase I study was performed to evaluate dose-limiting toxicity and 
      the recommended dose for the oral fluoropyrimidine S-1 administered concurrently 
      with thoracic radiotherapy (TRT) in elderly (>/= 70 years of age) patients with
      locally advanced non-small cell lung cancer. METHODS: S-1 was administered on
      days 1 to 14 and 22 to 35 at oral doses of 65 or 80 mg m(-2) day(-1). TRT was
      administered in 2-Gy fractions five times weekly for a total dose of 60 Gy.
      Twelve previously untreated patients were treated with S-1 at 65 (n=6) or 80
      (n=6) mg m(-2) day(-1). RESULTS: All patients completed the planned 60 Gy of TRT.
      Dose-limiting toxicity included pneumonitis (n=2), infection (n=1), and
      stomatitis (n=1), each of grade 3, but each event was reversible. The recommended
      dose for S-1 was determined to be 80 mg m(-2) day(-1). No patient experienced
      toxicity of grade 4. The dose intensity of S-1 was well maintained and the
      combination of S-1 plus TRT was well tolerated overall. The overall response rate
      was 83.3 %, with a median survival time of 34.0 months. CONCLUSIONS:
      Administration of S-1 at 80 mg m(-2) day(-1) on days 1 to 14 and 22 to 35 can be 
      safely combined with concurrent TRT in elderly patients with locally advanced
      non-small cell lung cancer.
FAU - Hasegawa, Yoshikazu
AU  - Hasegawa Y
AD  - Department of Medical Oncology, Kishiwada City Hospital, Osaka, Japan.
FAU - Okamoto, Isamu
AU  - Okamoto I
FAU - Takezawa, Ken
AU  - Takezawa K
FAU - Miyazaki, Masaaki
AU  - Miyazaki M
FAU - Tsurutani, Junji
AU  - Tsurutani J
FAU - Yonesaka, Kimio
AU  - Yonesaka K
FAU - Morinaga, Ryotaroh
AU  - Morinaga R
FAU - Tsuya, Asuka
AU  - Tsuya A
FAU - Terashima, Masaaki
AU  - Terashima M
FAU - Kudoh, Toshihiro
AU  - Kudoh T
FAU - Azuma, Koichi
AU  - Azuma K
FAU - Kurata, Takayasu
AU  - Kurata T
FAU - Nishikawa, Tatsuyuki
AU  - Nishikawa T
FAU - Fukuoka, Masahiro
AU  - Fukuoka M
FAU - Nishimura, Yasumasa
AU  - Nishimura Y
FAU - Nakagawa, Kazuhiko
AU  - Nakagawa K
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
DEP - 20120524
PL  - United States
TA  - Invest New Drugs
JT  - Investigational new drugs
JID - 8309330
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 0 (Drug Combinations)
RN  - 150863-82-4 (S 1 (combination))
RN  - 1548R74NSZ (Tegafur)
RN  - 5VT6420TIG (Oxonic Acid)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antimetabolites, Antineoplastic/*administration & dosage/adverse effects
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/*radiotherapy
MH  - Dose-Response Relationship, Drug
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/*radiotherapy
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Oxonic Acid/*administration & dosage/adverse effects
MH  - Tegafur/*administration & dosage/adverse effects
EDAT- 2012/05/25 06:00
MHDA- 2013/12/16 06:00
CRDT- 2012/05/25 06:00
PHST- 2012/03/12 00:00 [received]
PHST- 2012/05/08 00:00 [accepted]
PHST- 2012/05/25 06:00 [entrez]
PHST- 2012/05/25 06:00 [pubmed]
PHST- 2013/12/16 06:00 [medline]
AID - 10.1007/s10637-012-9833-7 [doi]
PST - ppublish
SO  - Invest New Drugs. 2013 Jun;31(3):599-604. doi: 10.1007/s10637-012-9833-7. Epub
      2012 May 24.