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document
A randomized phase II trial of two regimens of moderate dose chemoradiation therapy for patients with non-small cell lung cancer not suitable for curative therapy : Trans Tasman Radiation Oncology Study TROG 03.07 . BACKGROUND There are patients with stage I-III non-small cell lung cancer ( NSCLC ) who are not suitable for curative radical chemoradiation therapy . There are patients with an isolated solitary extracranial metastasis who have improved outcomes compared with those with cranial or multiple metastases . Patients of good performance status receiving moderate dose radiation therapy have improved survival . Two regimens of moderate dose chemoradiation therapy for such patients were compared in a randomized phase II trial . METHODS Patients were eligible if they had stage I-IIIB NSCLC , unsuitable for curative therapy , or stage IV with a PET-detected extracranial solitary metastasis . Patients were randomized to the following groups-arm A : 40 Gy/20 fractions/4 weeks with concurrent weekly vinorelbine 25 mg/m + cisplatin 20 mg/m or arm B : 30 Gy/15 fractions/3 weeks with concurrent weekly gemcitabine 200 mg. Primary end points were feasibility , response rates , and toxicity . Secondary end points were progression-free survival , overall survival , and quality of life . RESULTS Eighty-four patients were randomized . Compliance was above 90 % for both arms . The overall response rate was 51 % in arm A and 38 % in arm B ( p = 0.147 ) . Grade 3/4 toxicity in both arms was acceptable . There was no difference in median progression-free survival between the two arms ( 5.5 versus 5.0 months , p = 0.19 ) . Patients in arm A had longer median survival but this did not reach statistical significance ( 13.1 versus 8.3 months , p = 0.25 ) . No difference in quality of life was observed . CONCLUSIONS Arm A was chosen for a future phase II comparison with radiation therapy alone as it demonstrated a response rate greater than 50 % , and data suggested that arm A had superior survival to arm B .
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Intervention_Physical
chemoradiation therapy
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Intervention_Pharmacological
curative radical chemoradiation therapy
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Intervention_Physical
radiation therapy
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Intervention_Pharmacological
moderate dose chemoradiation therapy
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Intervention_Pharmacological
Gy/20
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Intervention_Pharmacological
weekly vinorelbine 25 mg/m + cisplatin
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Intervention_Pharmacological
Gy/15
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Intervention_Pharmacological
weekly gemcitabine 200 mg.
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Intervention_Pharmacological
radiation therapy
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Outcome_Other
feasibility
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Outcome_Physical
,
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Outcome_Other
response rates
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Outcome_Physical
, and toxicity
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Outcome_Mortality
progression-free survival , overall survival
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Outcome_Other
quality of life
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Outcome_Mental
Compliance
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Outcome_Other
overall response rate
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Outcome_Other
Grade 3/4 toxicity
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Outcome_Mortality
median progression-free survival
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Outcome_Mortality
median survival
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Outcome_Other
quality of
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Outcome_Physical
life
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Outcome_Other
response
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Participant_Condition
patients with non-small cell lung cancer not suitable for curative therapy :
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Participant_Age
Patients were eligible if they had stage I-IIIB NSCLC , unsuitable for curative therapy , or stage IV with a PET-detected extracranial solitary metastasis .
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Participant_Age
Eighty-four patients were randomized .