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D.H. Lee
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-012 - Clinical Implications of Isolated Bone Failure without Systemic Disease Progression During EGFR-TKI Treatment (ID 1201)
09:30 - 17:00 | Author(s): D.H. Lee
- Abstract
Background:
Bone metastasis and skeletal-related events (SREs) such as pathologic fracture and spinal cord compression are common in advanced lung cancer. This study was aimed to investigate the characteristics of disease progression focused on SREs during EGFR-TKI treatment.
Methods:
We retrospectively reviewed the medical records of 3,085 Korean patients with advanced non-small cell lung cancer who were treated with gefitinib or erlotinib between 2004 and 2014. SRE associated with aggravation of bone metastasis was termed ‘bone failure (BF)’. BFs were classified into 2 categories according to the presence of accompanying disease progression of preexisting cancer lesions in extra-skeletal organs; isolated bone failure (IBF) versus non-IBF.
Results:
The incidence of SREs during EGFR-TKI treatment was 4.7% (146/3085). Among them, 60 patients experienced IBF without aggravation of disease in extra-skeletal organs. IBF was more frequent in clinical benefit group (responders and stable ≥ 6 months) than in non-clinical benefit group (53.5% vs 13.3%; P < 0.001). Adenocarcinoma histology and clinical benefit from EGFR-TKI were independent risk factors for IBF (adenocarcinoma: adjusted hazard ratio [HR] 10.283; 95% confidence interval [CI] 1.148 – 92.121; P= 0.037, clinical benefit from TKI: adjusted HR 9.463; 95% CI 3.027 – 29.584; P < 0.001). The time from the start of EGFR-TKI to the occurrence of SRE was significantly longer in IBF than that in non-IBF (9.8 vs 5.2 months; P= 0.054). Moreover, patients with IBF exhibited longer survival time from the initiation of TKI (20.1 vs 7.7 months; P = 0.008) and from the occurrence of SRE (9.2 vs 1.9 months; P = 0.006). Multivariate analysis showed that IBF was one of independent prognostic factors for better survival although the statistical significance was marginal (adjusted HR 0.492; 95% CI 0.237 – 1.021; P = 0.057).
Conclusion:
IBF without systemic disease progression frequently occurs in patients with clinical benefits from EGFR-TKI treatment and shows the better survival requiring more active treatment.
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-077 - A Randomized, Phase II Study of Nimotuzumab Plus Gefitinib vs Gefitinib in Advanced Non-Small Cell Lung Cancer After Platinum- Based Chemotherapy (ID 1176)
09:30 - 17:00 | Author(s): D.H. Lee
- Abstract
Background:
Nimotuzumab is a humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody. We aim to evaluate the efficacy of dual inhibition of EGFR with nimotuzumab plus gefitinib in advanced non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.
Methods:
An open label, randomized, phase II trial was conducted in 6 centers; 160 patients were randomized (1:1) to either nimotuzumab (200mg, IV weekly) plus gefitinib (250mg p.o. daily) or gefitinib alone until disease progression or intolerable toxicities. The primary endpoint was progression free survival (PFS) rate at 3 months. Secondary endpoints included PFS, overall survival (OS), overall response rate (ORR) and safety.
Results:
A total of 155 patients (78 in nimotuzumab plus gefitinib, 77 in gefitinib) were evaluable for efficacy and toxicity. Patient characteristics were well balanced in both groups. Majority of patients had adenocarcinoma histology (65.2%) and ECOG performance status 0 to 1 (83.5%). Among 102 patients with EGFR mutation results available, activating EGFR mutation was documented in 27 patients (12/50 in nimotuzumab plus gefitinib, 15/52 in gefitinib). With a median follow-up of 12.1 months, PFS rate at 3 months was 37.2% in nimotuzumab plus gefitinib and 48.1% in gefitinib [HR 1.03; 95% CI, 0.71–1.40; P=0.98]. Median PFS and OS were 2.0 months and 14.0 months in nimotuzumab plus gefitinib and 2.8 months and 13.2 months in gefitinib [HR 1.03, 95% CI 0.71-1.41, P=0.98 for PFS; HR 0.86, 95% CI 0.57–1.30, P=0.47 for OS]. The ORRs were 14.1% in nimotuzumab plus gefitinib and 22.1% in gefitinib, which was not statistically significant (P=0.76). As expected, patients with EGFR mutation showed significantly longer survival than those with wild-type EGFR or unknown EGFR mutation status (10.3 vs. 1.2 vs. 2.7 months, P < 0.001 for PFS; 23.5 vs. 13.5 vs. 10.5 months, P= 0.001 for OS). Combined treatment of nimotuzumab plus gefitinib did not show superior PFS compared to gefitinib alone in patients with EGFR mutation (13.5 vs. 10.2 months in gefitinib alone, P=0.30) and patients with wild-type EGFR (0.9 vs. 2.0 months in gefitinib alone, P=0.90). The median PFS was not significantly different between two treatment arms according to histology (2.8 vs. 2.9 months in gefitinib alone for adenocarcinoma, P=0.64; 1.2 vs. 2.8 months in gefitinib alone for non-adenocarcinoma, P=0.35). Adverse events (AEs) in both treatment arms were mostly grade 1 to 2 and easily manageable. Importantly, combined EGFR inhibition with nimotuzumab and gefitinib did not increase EGFR inhibition-related AEs, such as acneiform rash (32.4 vs. 30.3% in gefitinib alone, P=0.38), diarrhea (30.7 vs. 35.7% in gefitinib alone, P=0.32), and stomatitis (11.5 vs. 13.4% in gefitinib alone, P=0.19). There was no treatment-related death.
Conclusion:
The dual inhibition of EGFR with nimotuzumab plus gefitinib did not show superiority over gefitinib alone for second-line treatment of advanced NSCLC (NCT01498562).
