PMID- 16446342
OWN - NLM
STAT- MEDLINE
DCOM- 20060213
LR  - 20181203
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 24
IP  - 4
DP  - 2006 Feb 1
TI  - Randomized phase II trial comparing nitroglycerin plus vinorelbine and cisplatin 
      with vinorelbine and cisplatin alone in previously untreated stage IIIB/IV 
      non-small-cell lung cancer.
PG  - 688-94
AB  - PURPOSE: To investigate the efficacy and safety of nitroglycerin plus vinorelbine 
      and cisplatin in patients with previously untreated stage IIIB/IV non-small-cell 
      lung cancer (NSCLC) as the experimental arm for the next phase III trial. 
      PATIENTS AND METHODS: One hundred twenty patients with stage IIIB/IV NSCLC were 
      randomly assigned to vinorelbine 25 mg/m2 on days 1 and 8 and cisplatin 80 mg/m2 
      on day 1, with transdermally applied nitroglycerin (25 mg/patient daily for 5 
      days; arm A) or with placebo patch (arm B) every 3 weeks for a maximum of four 
      cycles in a double-blind and controlled trial. Primary efficacy end points were 
      the best confirmed response rate and time to disease progression (TTP). RESULTS: 
      The response rate in arm A (72%; 43 of 60 patients) was significantly higher than 
      that for patients in arm B (42%; 25 of 60 patients; P < .001). Median TTP in arm 
      A was longer than that in arm B (327 v 185 days). No severe adverse effect was 
      recognized for either arm. The rate of grade 1 to 2 headache in arm A (30%; 18 of 
      60 patients) was significantly higher than that in arm B (2%; one of 60 patients; 
      P < .001, chi(2) test). CONCLUSION: Use of nitroglycerin combined with 
      vinorelbine and cisplatin may improve overall response and TTP in patients with 
      stage IIIB/IV NSCLC. The arm A regimen is being evaluated in a large phase III 
      trial.
FAU - Yasuda, Hiroyasu
AU  - Yasuda H
AD  - Department of Geriatric and Respiratory Medicine, Tohoku University School of 
      Medicine, Seiryo-machi, Aoba-ku, Sendai, Japan. yasuda@geriat.med.tohoku.ac.jp
FAU - Yamaya, Mutsuo
AU  - Yamaya M
FAU - Nakayama, Katsutoshi
AU  - Nakayama K
FAU - Sasaki, Takahiko
AU  - Sasaki T
FAU - Ebihara, Satoru
AU  - Ebihara S
FAU - Kanda, Akio
AU  - Kanda A
FAU - Asada, Masanori
AU  - Asada M
FAU - Inoue, Daisuke
AU  - Inoue D
FAU - Suzuki, Tomoko
AU  - Suzuki T
FAU - Okazaki, Tatsuma
AU  - Okazaki T
FAU - Takahashi, Hidenori
AU  - Takahashi H
FAU - Yoshida, Motoki
AU  - Yoshida M
FAU - Kaneta, Tomohiro
AU  - Kaneta T
FAU - Ishizawa, Kota
AU  - Ishizawa K
FAU - Yamanda, Shinsuke
AU  - Yamanda S
FAU - Tomita, Naoki
AU  - Tomita N
FAU - Yamasaki, Miyako
AU  - Yamasaki M
FAU - Kikuchi, Akiko
AU  - Kikuchi A
FAU - Kubo, Hiroshi
AU  - Kubo H
FAU - Sasaki, Hidetada
AU  - Sasaki H
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Vascular Endothelial Growth Factor A)
RN  - 5V9KLZ54CY (Vinblastine)
RN  - G59M7S0WS3 (Nitroglycerin)
RN  - Q20Q21Q62J (Cisplatin)
RN  - Q6C979R91Y (Vinorelbine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/blood/*drug therapy/pathology
MH  - Cisplatin/*administration & dosage
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/blood/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Neoplasm Staging
MH  - Nitroglycerin/administration & dosage
MH  - Survival Analysis
MH  - Treatment Outcome
MH  - Vascular Endothelial Growth Factor A/blood
MH  - Vinblastine/administration & dosage/analogs & derivatives
MH  - Vinorelbine
EDAT- 2006/02/01 09:00
MHDA- 2006/02/14 09:00
CRDT- 2006/02/01 09:00
PHST- 2006/02/01 09:00 [pubmed]
PHST- 2006/02/14 09:00 [medline]
PHST- 2006/02/01 09:00 [entrez]
AID - 24/4/688 [pii]
AID - 10.1200/JCO.2005.04.0436 [doi]
PST - ppublish
SO  - J Clin Oncol. 2006 Feb 1;24(4):688-94. doi: 10.1200/JCO.2005.04.0436.