Abstract | BACKGROUND: METHODS: Patients with stage T1-3pN2M0 non-small-cell lung cancer were randomly assigned in a 1:1 ratio to concurrent induction chemotherapy (two cycles of cisplatin [50 mg/m(2) on days 1, 8, 29, and 36] and etoposide [50 mg/m(2) on days 1-5 and 29-33]) plus radiotherapy (45 Gy) in multiple academic and community hospitals. If no progression, patients in group 1 underwent resection and those in group 2 continued radiotherapy uninterrupted up to 61 Gy. Two additional cycles of cisplatin and etoposide were given in both groups. The primary endpoint was overall survival (OS). Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00002550. FINDINGS: 202 patients (median age 59 years, range 31-77) were assigned to group 1 and 194 (61 years, 32-78) to group 2. Median OS was 23.6 months (IQR 9.0-not reached) in group 1 versus 22.2 months (9.4-52.7) in group 2 (hazard ratio [HR] 0.87 [0.70-1.10]; p=0.24). Number of patients alive at 5 years was 37 (point estimate 27%) in group 1 and 24 (point estimate 20%) in group 2 (odds ratio 0.63 [0.36-1.10]; p=0.10). With N0 status at thoracotomy, the median OS was 34.4 months (IQR 15.7-not reached; 19 [point estimate 41%] patients alive at 5 years). Progression-free survival (PFS) was better in group 1 than in group 2, median 12.8 months (5.3-42.2) vs 10.5 months (4.8-20.6), HR 0.77 [0.62-0.96]; p=0.017); the number of patients without disease progression at 5 years was 32 (point estimate 22%) versus 13 (point estimate 11%), respectively. Neutropenia and oesophagitis were the main grade 3 or 4 toxicities associated with chemotherapy plus radiotherapy in group 1 (77 [38%] and 20 [10%], respectively) and group 2 (80 [41%] and 44 [23%], respectively). In group 1, 16 (8%) deaths were treatment related versus four (2%) in group 2. In an exploratory analysis, OS was improved for patients who underwent lobectomy, but not pneumonectomy, versus chemotherapy plus radiotherapy. INTERPRETATION: FUNDING: National Cancer Institute, Canadian Cancer Society, and National Cancer Institute of Canada.
|
Authors | Kathy S Albain, R Suzanne Swann, Valerie W Rusch, Andrew T Turrisi 3rd, Frances A Shepherd, Colum Smith, Yuhchyau Chen, Robert B Livingston, Richard H Feins, David R Gandara, Willard A Fry, Gail Darling, David H Johnson, Mark R Green, Robert C Miller, Joanne Ley, Willliam T Sause, James D Cox |
Journal | Lancet (London, England)
(Lancet)
Vol. 374
Issue 9687
Pg. 379-86
(Aug 01 2009)
ISSN: 1474-547X [Electronic] England |
PMID | 19632716
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
|
Chemical References |
|
Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, radiotherapy, surgery)
- Cisplatin
(administration & dosage)
- Combined Modality Therapy
- Etoposide
(administration & dosage)
- Female
- Humans
- Logistic Models
- Lung Neoplasms
(drug therapy, radiotherapy, surgery)
- Male
- Markov Chains
- Middle Aged
- Pneumonectomy
- Proportional Hazards Models
- Radiotherapy Dosage
- Survival Rate
- Treatment Outcome
|
|
Join CureHunter, for free Research Interface BASIC access!
Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease.
Find out why thousands of doctors, pharma researchers and patient activists
around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!
|