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J.S. Ahn
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MA06 - Locally Advanced NSCLC: Risk Groups, Biological Factors and Treatment Choices (ID 379)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:P. Van Houtte, M. Zemanová
- Coordinates: 12/05/2016, 16:00 - 17:30, Strauss 2
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MA06.03 - Recurrence Dynamics after Trimodality Therapy (Neoadjuvant Chemoradiotherapy and Surgery) in Stage IIIa(N2) Lung Cancer (ID 4963)
16:12 - 16:18 | Author(s): J.S. Ahn
- Abstract
- Presentation
Background:
In IIIa(N2) Non-small cell lung cancer (NSCLC), various strategies to cure have been tried but the major cause of mortality is still the recurrence. Therefore, understanding of the dynamics of recurrence is important to improve the treatment outcome. We investigated the timing and patterns of recurrence after treatment of IIIA(N2) NSCLC with trimodality treatment (neoadjuvant chemoradiotherapy and surgery).
Methods:
An institutional database of consecutive patients between 1997 and 2013 (N = 574) was reviewed retrospectively. Eligible patients had pathologically proven N2 disease of NSCLC and completion of a planned trimodality treatment. First events involving the development of loco-regional recurrence, distant metastases or both were considered. The hazard rate function was used to evaluate the dynamics of recurrence.
Results:
The 5-year overall survival rate was 47% and the 5-year recurrence free survival rate was 29%. Among the 299 patients (52.1% of total) who experienced recurrence, 26 (8.7%) had loco-regional recurrences, 248 (82.9%) had distant metastases, and 25 (8.4%) had both. The most frequent sites of distant metastases were lung (n=102, 41%), brain (n=63, 25%), and bone (n=63, 25%). The hazard rate function for the overall recurrence revealed the peak at approximately 8 months after surgery then the down-slope pattern before 38 months. A similar risk pattern was found in distant metastasis but low and steady risk pattern was detected in loco-regional recurrence. In distant metastases, similar patterns were found in individual organs, however, earlier peak at approximately 5 months presented in brain metastasis. A comparison of histology showed that adenocarcinoma exhibited higher recurrence hazard rate of distant metastasis than squamous cell carcinoma with similar pattern of recurrence (p=0.03). The status of nodal clearance after induction therapy exhibited that ypN2 patients (n= 229, 39.9%) had highest hazard rate (p=0.03). The recurrence hazard rate of ypN0 was the least, but the extent was not smaller, they showed approximately one of third of ypN2 at peak.
Conclusion:
The hazard rate of loco-regional failure after trimodality therapy was low. But the hazard rate of distant metastasis was considerably high yet and shifted to left with the peak within 12 moths after surgery. This study guides the intensive surveillance immediate after completion of trimodality therapy to identify risk groups of early recurrence and to develop therapeutic strategy.
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P1.05 - Poster Session with Presenters Present (ID 457)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Early Stage NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.05-048 - Effect of Adjuvant Chemotherapy on the Patterns and Dynamics of Recurrences in Resected Stage II(N1) Lung Adenocarcinoma (ID 4990)
14:30 - 14:30 | Author(s): J.S. Ahn
- Abstract
Background:
Although the complete surgical resection in most cases of the non-small cell lung carcinoma with N1 involvement is feasible, a considerable number of patients develop recurrence and the disease course is highly variable. Timing and pattern of recurrence are essential to explain strong prognostic heterogeneity, however, research focusing on these subjects have rarely been reported. We investigated the patterns of recurrences and event rates over time in patients with completely resected N1-stageII lung adenocarcinoma.
Methods:
We retrospectively reviewed the medical records of 333 patients who underwent a complete surgical resection for N1-stage II lung adenocarcinoma. Survival curves were generated using the Kaplan-Meier method, and the event dynamics was estimated using the hazard function.
Results:
The median recurrence-free survival was 36.8 months. The life table survival analysis showed that the 1-year, 3-year and 5-year recurrence free survival rates were 85.1%, 50.2% and 36.6%, respectively. Approximately 151(45.2%) patients experienced recurrence, and the patterns of recurrences included loco-regional in 41 patients (27.2%), distant in 68 (45.0%), and both in 42 (27.8%). Most commonly involved organs were the lung (n=77, 47.0%), followed by lymph nodes (n=41, 27.2%), bone (n=31, 20.5%), and brain (n=30, 19.9%). There were 228 patients received adjuvant chemotherapy. Patients treated with adjuvant chemotherapy showed better recurrence free survival (chemotherapy group vs non-chemotherapy group; median survival 42.5 months vs 25.4 months), and post-recurrence survival(chemotherapy group vs non-chemotherapy group; median survival 39.8 months vs 22.6 months) compared to those of patients without adjuvant chemotherapy. The multivariate analysis revealed that adjuvant chemotherapy was significantly correlated with recurrence free survival (p=0.004) and post recurrence survival (p=0.001). Patients underwent adjuvant chemotherapy had less distant (p=0.014) and less lung (p=0.045) recurrence, while there is no difference in loco-regional (p=0.837) and brain (p=0.997) recurrence. The recurrence hazard curve demonstrated similarly shaped and sized initial and second peak at 16 and 24months, followed by a smaller peak at 40months. The temporal distribution of the recurrence risk varied depending on adjuvant chemotherapy. A visual inspection of the hazard curves suggested that the patients without adjuvant chemotherapy exhibited earlier and higher first peaks with higher hazard rate over time.
Conclusion:
In the patients who underwent completely resected N1-stageII lung adenocarcinoma, adjuvant chemotherapy not only reduced the recurrence hazard, but also delayed the recurrence, altered pattern of recurrence and improved post-recurrence survival.
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P2.02 - Poster Session with Presenters Present (ID 462)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.02-044 - Impact of N2 Extent and Nodal Response on Survival after Trimodal Treatment for Stage IIIA-N2 Non-Small Cell Lung Cancer (ID 4662)
14:30 - 14:30 | Author(s): J.S. Ahn
- Abstract
Background:
Mediastinal nodal downstaging is an important prognostic factor of neoadjuvant concurrent chemoradiotherapy (CCRT) for stage IIIA-N2 non-small cell lung cancer (NSCLC) and the role of trimodal treatment remains controversial in patients with persistent N2 disease. We aimed to investigate survival outcomes based on the extent of pre-CCRT nodal involvement and mediastinal nodal response in patients who underwent neoadjuvant CCRT for stage IIIA-N2 NSCLC.
Methods:
A retrospective review of patients with N2 disease who underwent neoadjuvant CCRT followed by surgery at our institution was performed and survival outcomes were compared according to the extent of pre-CCRT mediastinal nodal involvement and mediastinal nodal response to CCRT. Extensive lymph node involvement was defined by short-axis diameter of lymph nodes > 2cm measured at computed tomography or involvement of 2 or more mediastinal lymph node stations.
Results:
From 2003 to 2013, 407 patients underwent curative-intent surgery after neoadjuvant CCRT for NSCLC with pathologically proven N2 disease. The mean age was 59 years (314 men, 77%) and histologic type included adenocarcinoma in 233 patients (57%), squamous cell carcinoma in 141 (35%), and large cell carcinoma in 11 (2.7%). Seventy-nine patients (19%) had extensive N2 disease on pre-CCRT imaging tests. The extent of surgery included lobectomy in 311 patients (76%), pneumonectomy in 43 (11%), and sleeve resection in 15 (3.7%). Post-CCRT pathologic nodal status was ypN0 in 155 patients (38%), ypN1 in 56 (14%), and ypN2 in 196 (48%). With a mean follow-up of 41 months, median overall survival (OS) and recurrence-free survival (RFS) were 73 months and 18 months, respectively. The 5-year OS and RFS rates were 61% and 42% in ypN0-1 and 40% and 13% in ypN2, respectively (OS, p=0.0032; RFS, p<0.0001). For patients with ypN0-1, the 5-year OS and RFS rates were 60% and 52% in extensive N2 disease and 61% and 40% in non-extensive N2 disease, respectively (OS, p=0.8106; RFS, p=0.1218). For patients with ypN2, the 5-year OS and RFS rates were 22% and 12% in extensive N2 disease and 47% and 12% in non-extensive N2 disease, respectively (OS, p=0.0403; RFS, p=0.4842).
Conclusion:
Pre-CCRT non-extensive N2 disease was associated with better OS, but was not with better RFS in patients with persistent N2 disease. Patients who achieved mediastinal downstaging showed acceptable OS and RFS regardless of N2 extensiveness. Considering heterogeneity of N2, the indication of neoadjuvant CCRT needs to be differentiated according to the extent of pre-CCRT nodal involvement and post-CCRT mediastinal nodal response.
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-038 - Phase III Trial of Pemetrexed/Carboplatin vs Pemetrexed Only in Chemo-Naïve Elderly Non-SQCC NSCLC Patients Aged ≥ 70 (ID 5036)
14:30 - 14:30 | Author(s): J.S. Ahn
- Abstract
Background:
We aimed to compare pemetrexed/carboplatin doublet (PC) versus pemetrexed singlet (P) as induction therapy in chemotherapy-naïve elderly patients aged 70 or more with advanced non-squamous non–small-cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Methods:
In this open-label multicenter phase III randomized trial, elderly patients aged 70 or more with advanced non-squamous NSCLC, ECOG PS of 0-1, no prior chemotherapy, adequate organ function and measurable disease were assigned to PC doublet (P, 500 mg/m2; C, area under the curve of 5) or P singlet (500 mg/m2) after stratified randomization according to center, gender and Charson Comorbidity Index (CCI). The treatment was given every 3 weeks till disease progression, unacceptable toxicity or withdrawal of consent. However, carboplatin was given for only the first four cycles during induction therapy period. The primary end point was progression-free survival (PFS). Secondary endpoints included overall survival, response rate, and safety.
Results:
A total of 267 eligible patients were enrolled from six centers between March 2012 and October 2015; median age was 74 years (70~86); 95% had PS of 1; 68% were men; and 61% had CCI of 1 or more. The median PFS was 5.4 months for PC doublet and 4.2 months for P singlet, respectively (hazard ratio [HR], 0.85; 95% CI, 0.65 to 1.11; P= 0.2353). The median survival time was 12.5 months for PC and 9.0 months for P, respectively (HR, 0.86; 95% CI, 0.62 to 1.21; P =0.4108). The objective response rates for PC doublet and P singlet were 34.7% and 25.9%, respectively (p=0.1387). The most common adverse events in PC doublet arm were anemia (9.6%), fatigue (8%) and pneumonia (6.4%) while those in P singlet arm were pneumonia (4.2%), fatique (3.3%) and anemia (2.5%) in descending of frequency.
Conclusion:
The addition of carboplatin to pemetrexed during induction therapy period did not show the improvement of survival time in elderly patients aged 70 or more with advanced non-squamous NSCLC and ECOG PS of 0-1 even though it increased the response rate numerically. Updated data will be presented.
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-053 - A Randomized, Open Label, Phase II Study Comparing Pemetrexed plus Cisplatin versus Pemetrexed Alone in EGFR Mutant NSCLC after EGFR-TKI: QOL Data (ID 5401)
14:30 - 14:30 | Author(s): J.S. Ahn
- Abstract
Background:
Various therapeutic strategies are available for NSCLC patients who develop disease progression on first-line EGFR-TKI. Platinum doublet is usually recommended, however, it has not been established which cytotoxic regimens are preferable for these patients. We conducted a prospective randomized phase II trial to compare the clinical outcomes between pemetrexed plus ciplatin combination therapy with pemetrexed monotherapy after failure of first-line EGFR-TKI.
Methods:
Patients with non-squamous NSCLC harboring activating EGFR mutation who have progressed on first-line EGFR-TKI were randomly assigned in a ratio of 1:1 to pemetrexed plus cisplatin or pemetrexed alone. Patients were treated with pemetrexed 500 mg/m[2] and cisplatin 70 mg/m[2] for four cycles, followed by maintenance pemetrexed as single agent every 3 weeks or treated with pemetrexed 500 mg/m[2] monotherapy every 3 weeks until progression. Primary objective wasPFS, and secondary objectives include overall response rate (ORR), OS, health-related quality of life (HRQOL), safety and toxicity profile. The HRQOL was assessed every 2 cycles by using EORTC QLQ-C30 and EORTC QLQ-LC13.
Results:
96 patients were randomized and 91 patients were treated at 14 centers in Korea. The characteristics of pemetrexed plus cisplatin (PC) arm (N=48) and pemetrexed alone (P) arm (N=48) were well balanced; the median age was 60 vs. 64 years old; 37 vs. 33 patients were females; 39 vs. 43 patients were ECOG PS 1. The ORR of PC arm (N=46) was 34.8% (16/46), while P arm (N=45) was 17.8% (8/45). With 20.4 (range 4.1-33.4) months of follow-up, the median PFS was 5.4 months (95% confidence interval [CI], 4.5-6.3) in PC arm and 6.4 months (95% CI, 3.6-9.2) in P arm (p=.313). One-year survival rate was 77% for PC arm, 68% for P arm, respectively. The most common adverse events include anorexia (N=34, 37.4%), nausea (N=24, 26.4%), neuropathy (N=10, 11.0%) and skin change (N=10, 11.0%). Adverse events ≥ Grade 3 were in 12 patients (26.1%) in PC arm and 8 patients (17.8%) in P arm. Dose reduction (5 vs. 2 patients) and dose delay (10 vs. 4 patients) were required more often in PC arm. With 385 pairs of questionnaire of EORTC QLQ-C30 and QLO-LC13 obtained from 94 patients, overall, the time trends of HRQOL were not significantly different between two arms. Further analysis of survival data will be updated.
Conclusion:
Pemetrexed plus cisplatin combination therapy showed higher response rate than pemetrexed monotherapy without significant difference in PFS. There was no significant difference in quality of life between two arms.
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-035 - Comparison of RECIST to Immune-Related Response Criteria (irRC) in Patients with NSCLC Treated with Immune-Check Point Inhibitor (ID 4962)
14:30 - 14:30 | Author(s): J.S. Ahn
- Abstract
Background:
Immune check point inhibitor has become essential therapeutic option for advanced non-small cell lung cancer (NSCLC). Immune-related response in NSCLC has not been well evaluated, thus we assessed the tumor response using Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) and immune-related response criteria (irRC) to identify atypical response in patients with advanced NSCLC treated with immunotherapeutic agents.
Methods:
Patients received immune check point inhibitors (pembrolizumab, atezolizumab, nivolumab, pembrolizumab plus tremelimumab) at Samsung Medical Center between July 2014 and October 2015. The tumor response was assessed according to both RECIST v1.1 and irRC. Pseudoprogression was defined as progressive disease at any time of assessment and not at next assessment per RECIST v1.1 or irRC.
Results:
Figure 1 Total 41 patients were analyzed, most of patients (80.5%) received anti-PD-1 agents (pembrolizumab or nivolumab) and 6 patients were treated with anti-PD-L1, atezolizumab, 2 patients received combination treatment with pembrolizumab and tremelimumab. Two patients showed pseudoprogression followed by regression per RECIST v1.1 not per irRC. 4 patients with progressive disease per RECIST v1.1 were partial response per irRC, objective response was 29.2% per RECIST v1.1 and 34.1% per irRC, respectively. There was no significant difference in response rate between two methods (p=0.923). The median duration of follow-up was 19.8 months, and the median progression-free survival of all patients was 4.5 months (95% CI 2.7-6.3)
Conclusion:
These results suggest that pseuoprogression is not frequently observed in NSCLC, and conventional RECIST v1.1 might underestimate the benefit of immune check point inhibitors. Given the small number of patients studied and short-term follow-up, further study will be warranted whether treatment with immune checkpoint inhibitor beyond RECIST progression can be benefit to patient with advanced NSCLC.
