A randomized phase II trial of cisplatin plus gemcitabine versus carboplatin plus gemcitabine in patients with completely resected non-small cell lung cancer: Hokkaido Lung Cancer Clinical Study Group Trial (HOT0703).
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Biomarkers, Tumor
/ metabolism
Carboplatin
/ administration & dosage
Carcinoma, Non-Small-Cell Lung
/ drug therapy
Cisplatin
/ administration & dosage
DNA-Binding Proteins
/ metabolism
Deoxycytidine
/ administration & dosage
Disease-Free Survival
Endonucleases
/ metabolism
Female
Humans
Lung Neoplasms
/ drug therapy
Male
Middle Aged
Postoperative Period
Ribonucleoside Diphosphate Reductase
/ metabolism
Treatment Outcome
Gemcitabine
Adjuvant chemotherapy
Gemcitabine
Non-small cell lung cancer
Platinum
Journal
Cancer chemotherapy and pharmacology
ISSN: 1432-0843
Titre abrégé: Cancer Chemother Pharmacol
Pays: Germany
ID NLM: 7806519
Informations de publication
Date de publication:
07 2020
07 2020
Historique:
received:
19
10
2019
accepted:
15
06
2020
pubmed:
22
6
2020
medline:
20
2
2021
entrez:
22
6
2020
Statut:
ppublish
Résumé
This study evaluated the efficacy and safety of platinum plus gemcitabine (P/G) combinations as postoperative adjuvant chemotherapies for non-small cell lung cancer. Patients with postoperative stage IB-IIIA non-small cell lung cancer were randomly assigned to receive either cisplatin plus gemcitabine (GP arm) or carboplatin plus gemcitabine (GC arm) every 3 weeks for four cycles. The primary endpoint was 2-year disease-free survival (DFS). Secondary endpoints were safety, feasibility, overall survival (OS), and biomarker analyses. A total of 102 patients were randomized (stage IB, 22%; II, 36%; IIIA, 42%; histology: 74% adenocarcinoma). Of the 51 patients in each arm, 37 (73%) completed 4 cycles. During follow-up (median 5.8 years; range 0.1-9.7 years), estimated DFS and OS rates at 2 years were 59.6% and 86.3% with GP and 68.0% and 86.3% with GC, respectively. No significant difference in DFS was noted between arms (P = 0.163), although 3-, 4-, and 5-year DFS rates were higher with GC. Hematological toxic effects were comparable and non-hematological toxic effects were infrequent. DFS was significantly higher in the excision repair cross-complementation group 1 (ERCC1)-low group than in the ERCC1-high group for the GP arm (P = 0.045). Both P/G combination regimens were feasible and well-tolerated, and thus may represent valid options for postoperative adjuvant treatment of non-small cell lung cancer. Although no significant differences in DFS were evident between regimens, the present data favor the adoption of GC for further evaluation. UMIN-CTR ( https://www.umin.ac.jp/ctr/ ) identifier: UMIN000000913.
Identifiants
pubmed: 32564128
doi: 10.1007/s00280-020-04104-1
pii: 10.1007/s00280-020-04104-1
doi:
Substances chimiques
Biomarkers, Tumor
0
DNA-Binding Proteins
0
Deoxycytidine
0W860991D6
Carboplatin
BG3F62OND5
RRM1 protein, human
EC 1.17.4.1
Ribonucleoside Diphosphate Reductase
EC 1.17.4.1
ERCC1 protein, human
EC 3.1.-
Endonucleases
EC 3.1.-
Cisplatin
Q20Q21Q62J
Gemcitabine
0
Banques de données
UMIN-CTR
['UMIN000000913']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
117-127Références
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