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Junichi Shimizu
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EP1.01 - Advanced NSCLC (ID 150)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.01-32 - Improving the Prognosis of Non-Small Cell Lung Cancer After the Approval of Immune Checkpoint Inhibitors: A Retrospective Analysis (Now Available) (ID 1276)
08:00 - 18:00 | Author(s): Junichi Shimizu
- Abstract
Background
Anti-programmed death-1/programmed death-ligand-1 (PD-1/PD-L1) blockade represents a revolutionary breakthrough in the treatment of advanced non-small-cell lung cancer (NSCLC). However, it remains unclear whether the immunotherapy for PD-1 axis are associated with overall survival (OS) in real world patients.
Method
We retrospectively analyzed consecutive 246 patients with stage IIIB or IV NSCLC who underwent at least 1 regimen of chemotherapy. Patients who have EGFR mutations, ALK/ROS1 rearrangements, or received curative thoracic radiotherapy were excluded. Besides, patients administered any immune checkpoint inhibitors in clinical trials were also excluded. Treatment outcomes were compared between patients who started chemotherapy from January 2012 to December 2014 (cohort A; n=135) and those who started it from January 2016 to December 2017 (cohort B; n=111). Baseline characteristics were balanced using propensity score matching, including variables such as age, sex, performance status (PS), histology, clinical stage, bone metastases, central nervous system (CNS) metastases, liver metastases, pulmonary metastases, and pleural dissemination.
Result
Median OS was 11.4months in cohort A and 16.6mo in cohort B (HR 0.68, 95%CI 0.50-0.93, P=0.016). In 111 propensity-score matching pairs, median OS was 11.2months in cohort A and 16.6months in cohort B (HR 0.68, 95%CI 0.49-0.94, P=0.021), and the 12-month OS rate was 48.7% in cohort A versus 59.9% in cohort B, respectively. PD-1 axis inhibitors were received 13.5% in cohort A and 64.9% in cohort B. Forest plot for the propensity-matched patient analysis demonstrated a significantly better outcome in cohort B, for patients with PS 0 to 1, smokers, number of metastases ≤1, no bone metastases, no CNS metastases, no liver metastases, no pulmonary metastases, pleural metastases, and squamous histology.
Conclusion
This result indicates the appearance of immunity checkpoint inhibitors improved the prognosis of driver-mutation negative NSCLC in real world.
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EP1.14 - Targeted Therapy (ID 204)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.14-44 - Lung Adenocarcinoma with a Rare BRAF V600E K601_W604del Mutation Responded to Dabrafenib Plus Trametinib Treatment: A Case Report (Now Available) (ID 1485)
08:00 - 18:00 | Presenting Author(s): Junichi Shimizu
- Abstract
Background
BRAF V600E mutation can be detected in 1% of lung adenocarcinomas, and far more rarely, complex mutations in addition to BRAF V600E have been reported.
Method
Case presentation: A 42-year-old man was diagnosed with advanced lung adenocarcinoma with stage cT1cN3M1c stageIVB. BRAF V600E mutation was found with in-house molecular testing, so we submitted the same specimen to be analyzed with Oncomine Dx Target test for reimbursement of the subsequent treatment. However, the result was negative for BRAF V600E.
Result
The patient was treated with pembrolizumab (first-line therapy) and then carboplatin, pemetrexed and bevacizumab (second-line therapy). Nevertheless, the disease was progressed, so dabrafenib plus trametinib were used for the third line therapy. One month later CT scan showed a partial response. A subsequent study showed that the V600E mutation accompanied K601_W604 deletion, three bases after the V600E point mutation.
Conclusion
Our clinical experience suggested that some tumors with compound BRAF mutations, such as BRAF V600E K601_W604 del mutation, could respond to dabrafenib plus trametinib treatment, and that rare compound mutations, like this case, may not be detected with the conventional amplicon sequencing, particularly when the additional alterations are acquired at the positions adjacent to hotspots.
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MA03 - Clinomics and Genomics (ID 119)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:Heather A Wakelee, Wilfried Ernst Erich Eberhardt
- Coordinates: 9/08/2019, 10:30 - 12:00, Colorado Springs (1994)
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MA03.11 - Chemotherapy After PD-1 Inhibitors Versus Chemotherapy Alone in Patients with Non–Small Cell Lung Cancer (WJOG10217L) (Now Available) (ID 409)
10:30 - 12:00 | Author(s): Junichi Shimizu
- Abstract
- Presentation
Background
Studies have suggested that chemotherapy after immune checkpoint inhibitors may confer an improved response in patients with non–small cell lung cancer (NSCLC). However, potential selection bias in such studies has not been addressed. We therefore applied propensity score analysis to investigate the efficacy of subsequent chemotherapy after PD-1 inhibitors (CAP) compared with chemotherapy alone.
Method
We conducted a multicenter retrospective cohort study for patients with advanced or recurrent NSCLC who were treated at 47 institutions across Japan between 1 April 2014 and 31 July 2017 with chemotherapy (docetaxel with or without ramucirumab; S-1; or pemetrexed) either after PD-1 inhibitor therapy (CAP cohort) or alone (control cohort). The primary end point was objective response rate (ORR). Inverse probability weighting (IPW) was applied to adjust for potential confounding factors, including age, sex, smoking status, performance status, histology, EGFR or ALK genetic alterations, brain metastasis, and recurrence after curative radiotherapy.
Result
A total of 1439 patients (243 and 1196 in the CAP and control cohorts, respectively) was available for unadjusted analysis. Several baseline characteristics—including age, histology, EGFR or ALK alterations, and brain metastasis—differed significantly between the two cohorts. After adjustment for patient characteristics with the IPW method, ORR was 18.9% for the CAP cohort and 10.8% for the control cohort (ORR ratio, 1.75; 95% confidence interval [CI], 1.25–2.45; P = .001). Median PFS was 3.5 and 2.6 months for the CAP and control cohorts, respectively (hazard ratio [HR], 0.862; 95% CI, 0.743–0.998; P = .048). The PFS rate at 3, 6, and 12 months was 53.3%, 28.5%, and 4.6%, respectively, for the CAP cohort, and 44.3%, 19.7%, and 6.1% for the control cohort. Median OS was 9.8 months for the CAP cohort and 10.3 months for the control cohort (HR, 0.979; 95% CI, 0.813–1.179; P = .822).
Conclusion
After adjustment for selection bias using propensity score–weighted analysis, CAP showed a significantly higher ORR and longer PFS compared with chemotherapy alone, with the primary end point of ORR being achieved. However, these results did not translate into an OS advantage, and no PFS benefit was apparent at 12 months despite the improvement observed at 3 and 6 months. Our findings suggest that prior administration of PD-1 inhibitors may result in a synergistic antitumor effect with subsequent chemotherapy, but that such an effect is transient. CAP therefore does not appear to achieve durable tumor control or confer a lasting survival benefit.
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