PMID- 23634194
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20130502
LR  - 20211021
IS  - 1758-8340 (Print)
IS  - 1758-8359 (Electronic)
IS  - 1758-8340 (Linking)
VI  - 5
IP  - 3
DP  - 2013 May
TI  - A phase II single-arm study of induction chemotherapy with cisplatin and 
      gemcitabine followed by concurrent cisplatin and gemcitabine with thoracic 
      radiation for unresectable locally advanced non-small cell lung cancer.
PG  - 159-68
LID - 10.1177/1758834013481021 [doi]
AB  - OBJECTIVES: The aim of this study was to evaluate the efficacy and tolerability 
      of the combination of cisplatin-gemcitabine with concurrent thoracic radiotherapy 
      for locally advanced non-small cell lung cancer (LA-NSCLC). METHODS: This was a 
      phase II, multicenter, open-label, single-arm trial in treatment-naive patients 
      with stage IIIA and IIIB LA-NSCLC. After three induction cycles with gemcitabine 
      1250 mg/m(2) plus cisplatin 80 mg/m(2), two concurrent chemoradiotherapy cycles 
      with gemcitabine 300 mg/m(2), cisplatin 80 mg/m(2), and radiotherapy (63 Gy) were 
      administered. The primary endpoint was response rate after induction chemotherapy 
      followed by concurrent chemoradiotherapy. Secondary endpoints included time to 
      progressive disease (TtPD), overall survival (OS), and safety. RESULTS: Overall, 
      49 patients (median age 63.4 years; 73.5% male; Karnofsky performance status 
      scores of 80, 85, 90, and 100 [16.3%, 2.0%, 49.0%, and 32.7%, respectively]; 
      disease stage IIIA or IIIB 28.6% and 71.4%, respectively) were enrolled and 
      treated. Response rate was 38.8% (95% confidence interval [CI] 25.2-53.8%). 
      Median TtPD was 11.4 months (95% CI 9.4-12.9). Median OS was 21.8 months (95% CI 
      17.5-26.0), with 1- and 2-year survival rates of 70.8% and 43.7%, respectively. 
      Overall, six patients discontinued from study treatment due to adverse events 
      (AEs), of which two were serious AEs. The most relevant grade 3/4 AEs were 
      neutropenia and thrombocytopenia in induction chemotherapy and chemoradiotherapy, 
      and grade 3 events related to radiation in acute chemoradiotherapy, e.g. 
      dysphagia, radiation pneumonitis, and radiation esophagitis. CONCLUSIONS: 
      Induction chemotherapy followed by concurrent chemoradiotherapy with gemcitabine 
      (300 mg/m(2)) and cisplatin was associated with acceptable toxicity. The observed 
      median OS time was 21.8 months. Response evaluation was difficult as in many 
      cases it was not possible to differentiate tumor progression from local 
      radiofibrosis.
FAU - Driesen, Peter
AU  - Driesen P
AD  - AZ Turnhout, Rubensstraat 166, 2300 Turnhout, Belgium.
FAU - Lambrechts, Marc
AU  - Lambrechts M
FAU - Kraaij, Kees
AU  - Kraaij K
FAU - Soldatenkova, Victoria
AU  - Soldatenkova V
FAU - Chouaki, Nadia
AU  - Chouaki N
FAU - Colinet, Benoit
AU  - Colinet B
LA  - eng
PT  - Journal Article
PL  - England
TA  - Ther Adv Med Oncol
JT  - Therapeutic advances in medical oncology
JID - 101510808
PMC - PMC3630482
OTO - NOTNLM
OT  - LA-NSCLC
OT  - concurrent chemoradiotherapy
OT  - gemcitabine
COIS- Conflict of interest statement: Dr Peter Driesen, Dr Marc Lambrechts, and Dr 
      Benoit Colinet were investigators in the study. Dr Driesen stated that he 
      received reimbursement for travel expenses related to the study. Dr Colinet and 
      Dr Lambrechts have no other relevant financial interest in this publication. Kees 
      Kraaij, Victoria Soldatenkova, and Nadia Chouaki are fulltime employees of Eli 
      Lilly.
EDAT- 2013/05/02 06:00
MHDA- 2013/05/02 06:01
PMCR- 2013/05/01
CRDT- 2013/05/02 06:00
PHST- 2013/05/02 06:00 [entrez]
PHST- 2013/05/02 06:00 [pubmed]
PHST- 2013/05/02 06:01 [medline]
PHST- 2013/05/01 00:00 [pmc-release]
AID - 10.1177_1758834013481021 [pii]
AID - 10.1177/1758834013481021 [doi]
PST - ppublish
SO  - Ther Adv Med Oncol. 2013 May;5(3):159-68. doi: 10.1177/1758834013481021.