17496
document
Chemotherapy for patients with non-small cell lung cancer : the surgical setting of the Big Lung Trial . OBJECTIVES The non-small cell lung cancer ( NSCLC ) meta-analysis suggested a survival benefit for cisplatin-based chemotherapy when given in addition to surgery , radical radiotherapy or 'best supportive care ' . However , it included many small trials and trials with differing eligibility criteria and chemotherapy regimens . The aim of the Big Lung Trial was therefore to run a large pragmatic trial to confirm the survival benefits seen in the meta-analysis . METHODS In the surgery setting , a total of 381 patients were randomised to chemotherapy ( C , 192 patients ) or no chemotherapy ( NoC , 189 patients ) . C was three 3-weekly cycles of cisplatin/vindesine , mitomycin/ifosfamide/cisplatin , mitomycin/vinblastine/cisplatin or vinorelbine/cisplatin . RESULTS Chemotherapy was given before surgery in 3 % of patients whilst 97 % received adjuvant chemotherapy . Baseline characteristics were : median age 61 years , 69 % male , 48 % squamous cell , 93 % WHO PS 0-1 , 27 % stage I , 38 % stage II , and 34 % stage III . Complete resection was achieved in approximately 95 % of patients . In the C group , 13 % received no chemotherapy , 21 % one or two cycles , and 64 % all three cycles of their prescribed chemotherapy ( 60 % of the latter with no delays or modification ) . 30 % had grade 3/4 toxicity , mainly haematological , nausea/vomiting and neutropenic fever , and six patients were reported as having a treatment-related death . 198 ( 52 % ) of patients have died , but there is currently no evidence of a benefit in overall survival to the C group : HR 1.02 ( 95 % CI 0.77-1.35 ) , P = 0.90 ) . CONCLUSIONS This trial has failed to observe a survival benefit with adjuvant chemotherapy following complete resection of stage I-III NSCLC . However , the hazard ratio and 95 % confidence intervals are consistent with the previously reported meta-analysis and two large recently reported trials , which suggest a small survival benefit with cisplatin-based chemotherapy .
17497
Intervention_Pharmacological
Chemotherapy
17498
Intervention_Pharmacological
cisplatin-based chemotherapy
17499
Intervention_Surgical
surgery
17500
Intervention_Surgical
surgery
17501
Intervention_Pharmacological
chemotherapy
17502
Intervention_Control
no chemotherapy
17503
Intervention_Pharmacological
cisplatin/vindesine , mitomycin/ifosfamide/cisplatin , mitomycin/vinblastine/cisplatin or vinorelbine/cisplatin .
17504
Intervention_Pharmacological
Chemotherapy
17505
Intervention_Surgical
surgery
17506
Intervention_Pharmacological
adjuvant chemotherapy .
17507
Intervention_Control
no chemotherapy
17508
Intervention_Pharmacological
chemotherapy
17509
Intervention_Pharmacological
adjuvant chemotherapy
17510
Intervention_Pharmacological
cisplatin-based chemotherapy .
17511
Outcome_Mortality
survival benefits
17512
Outcome_Other
Complete resection
17513
Outcome_Adverse-effects
toxicity , mainly haematological , nausea/vomiting and neutropenic fever
17514
Outcome_Mortality
death
17515
Outcome_Mortality
benefit in overall survival
17516
Outcome_Mortality
survival benefit
17517
Participant_Condition
lung cancer
17518
Participant_Condition
lung cancer
17519
Participant_Sample-size
381
17520
Participant_Sample-size
192
17521
Participant_Sample-size
189