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Randomized Adjuvant Chemotherapy of EGFR-Mutated Non-Small Cell Lung Cancer Patients with or without Icotinib Consolidation Therapy.

Feng S, Wang Y, Cai K, Wu H, Xiong G, Wang H, Zhang Z - PLoS ONE (2015)

Bottom Line: Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitor (EGFR-TKI) confers a significant survival benefit.DFS at 12 months was 100% for icotinib-treated patients and 88.9% for chemotherapy-only patients (p = 0. 122).At 18 months DFS for icotinib-treated vs. chemotherapy-only patients was 95.2% vs. 83.3% (p = 0. 225), respectively, and at 24 months DFS was 90.5% vs. 66.7% (p = 0. 066).

View Article: PubMed Central - PubMed

Affiliation: Department of Thoracic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.

ABSTRACT

Background: Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitor (EGFR-TKI) confers a significant survival benefit. This study assessed the efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection of stage IB to ⅢA EGFR-mutated NSCLC.

Methods: Patients with surgically resected stage IB (with high risk factors) to ⅢA EGFR-mutated NSCLC were randomly assigned (1:1) to one of two treatment plans. One group received four cycles of platinum-based doublet chemotherapy every three weeks, and the other group received platinum-based chemotherapy supplemented with consolidation therapy of orally administered icotinib (125 mg thrice daily) two weeks after chemotherapy. The icotinib treatment continued for four to eight months, or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity. The primary endpoint was disease-free survival (DFS).

Results: 41 patients were enrolled between Feb 9, 2011 and Dec 17, 2012. 21 patients were assigned to the combined chemotherapy plus icotinib treatment group, while 20 patients received chemotherapy only. DFS at 12 months was 100% for icotinib-treated patients and 88.9% for chemotherapy-only patients (p = 0. 122). At 18 months DFS for icotinib-treated vs. chemotherapy-only patients was 95.2% vs. 83.3% (p = 0. 225), respectively, and at 24 months DFS was 90.5% vs. 66.7% (p = 0. 066). The adverse chemotherapy effects predominantly presented as gastrointestinal reactions and marrow suppression, and there was no significant difference between the two treatment groups. Patients in the chemotherapy plus icotinib treatment group showed favorable tolerance to oral icotinib.

Conclusions: The results suggest that chemotherapy plus orally icotinib displayed better DFS compared with chemotherapy only, yet the difference in DFS was not significant. We would think the preliminary result here was promising, and further trials with larger sample sizes might confirm the efficiency of adjuvant TKI in selected patients.

Trial registration: ClinicalTrials.gov NCT02430974.

No MeSH data available.


Related in: MedlinePlus

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Mentions: 113 patients were assessed for the inclusion criteria between Feb 9, 2011 and Dec 17, 2012, 72 were excluded mostly for EGFR wild-type NSCLC. 41 patients were randomly assigned to the chemotherapy-only (n = 20) or chemotherapy plus icotinib (n = 21) treatment group. Two patients in the chemotherapy group did not receive any study treatment after random assignment and were removed from the analysis. The data cutoff for the primary analysis was Dec 30, 2014. There were 18 patients in the chemotherapy-only group and 21 patients in the chemotherapy plus icotinib group (Fig 1). Among the enrolled patients, 17 (43.6%) had high-risk stage IB, 10 (25.6%) had stageⅡ, and 12 (30.8%) had stage ⅢA NSCLC. Because the sample size is smaller than 40 cases, the Fisher's exact probability method was used to analyze unordered enumeration data instead of the scheduled χ2 test. Baseline demographics and disease characteristics were balanced between the two treatment groups (Table 1).


Randomized Adjuvant Chemotherapy of EGFR-Mutated Non-Small Cell Lung Cancer Patients with or without Icotinib Consolidation Therapy.

Feng S, Wang Y, Cai K, Wu H, Xiong G, Wang H, Zhang Z - PLoS ONE (2015)

Trial profile.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4608803&req=5

pone.0140794.g001: Trial profile.
Mentions: 113 patients were assessed for the inclusion criteria between Feb 9, 2011 and Dec 17, 2012, 72 were excluded mostly for EGFR wild-type NSCLC. 41 patients were randomly assigned to the chemotherapy-only (n = 20) or chemotherapy plus icotinib (n = 21) treatment group. Two patients in the chemotherapy group did not receive any study treatment after random assignment and were removed from the analysis. The data cutoff for the primary analysis was Dec 30, 2014. There were 18 patients in the chemotherapy-only group and 21 patients in the chemotherapy plus icotinib group (Fig 1). Among the enrolled patients, 17 (43.6%) had high-risk stage IB, 10 (25.6%) had stageⅡ, and 12 (30.8%) had stage ⅢA NSCLC. Because the sample size is smaller than 40 cases, the Fisher's exact probability method was used to analyze unordered enumeration data instead of the scheduled χ2 test. Baseline demographics and disease characteristics were balanced between the two treatment groups (Table 1).

Bottom Line: Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitor (EGFR-TKI) confers a significant survival benefit.DFS at 12 months was 100% for icotinib-treated patients and 88.9% for chemotherapy-only patients (p = 0. 122).At 18 months DFS for icotinib-treated vs. chemotherapy-only patients was 95.2% vs. 83.3% (p = 0. 225), respectively, and at 24 months DFS was 90.5% vs. 66.7% (p = 0. 066).

View Article: PubMed Central - PubMed

Affiliation: Department of Thoracic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.

ABSTRACT

Background: Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitor (EGFR-TKI) confers a significant survival benefit. This study assessed the efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection of stage IB to ⅢA EGFR-mutated NSCLC.

Methods: Patients with surgically resected stage IB (with high risk factors) to ⅢA EGFR-mutated NSCLC were randomly assigned (1:1) to one of two treatment plans. One group received four cycles of platinum-based doublet chemotherapy every three weeks, and the other group received platinum-based chemotherapy supplemented with consolidation therapy of orally administered icotinib (125 mg thrice daily) two weeks after chemotherapy. The icotinib treatment continued for four to eight months, or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity. The primary endpoint was disease-free survival (DFS).

Results: 41 patients were enrolled between Feb 9, 2011 and Dec 17, 2012. 21 patients were assigned to the combined chemotherapy plus icotinib treatment group, while 20 patients received chemotherapy only. DFS at 12 months was 100% for icotinib-treated patients and 88.9% for chemotherapy-only patients (p = 0. 122). At 18 months DFS for icotinib-treated vs. chemotherapy-only patients was 95.2% vs. 83.3% (p = 0. 225), respectively, and at 24 months DFS was 90.5% vs. 66.7% (p = 0. 066). The adverse chemotherapy effects predominantly presented as gastrointestinal reactions and marrow suppression, and there was no significant difference between the two treatment groups. Patients in the chemotherapy plus icotinib treatment group showed favorable tolerance to oral icotinib.

Conclusions: The results suggest that chemotherapy plus orally icotinib displayed better DFS compared with chemotherapy only, yet the difference in DFS was not significant. We would think the preliminary result here was promising, and further trials with larger sample sizes might confirm the efficiency of adjuvant TKI in selected patients.

Trial registration: ClinicalTrials.gov NCT02430974.

No MeSH data available.


Related in: MedlinePlus