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Kenji Suzuki
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OA13 - Ideal Approach to Lung Resection and Novel Perioperative Therapy (ID 146)
- Event: WCLC 2019
- Type: Oral Session
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 9
- Now Available
- Moderators:Tomasz Grodzki, Kenji Suzuki
- Coordinates: 9/10/2019, 11:30 - 13:00, Toronto (1985)
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OA13.01 - SPECS2 Lung Cancer Consortium Prospective Multicenter Validation of Prognostic Signature for Early Stage Squamous Lung Cancer (Now Available) (ID 2723)
11:30 - 13:00 | Presenting Author(s): Raphael Bueno | Author(s): David Harpole, Ming Sound Tsao, David Beer, Mark Watson, Frances Shepherd, William G Richards, Karla Ballman, Xiaofei Wang, zhengming Chen, Ramaswamy Govindan, guoan Chen, christopher Rivard, Fred R. Hirsch
- Abstract
- Presentation
Background
Squamous Lung Cancer (SC) which constitutes 30% of all non-small cell lung cancers (NSCLC) has few targeted therapy options for advanced disease. Surgery for early SC is the best treatment strategy; however, even patients who undergo surgery for stage IA or IB disease are still at a substantial risk for recurrence and death. Adjuvant therapy is not currently indicated for stage I SC smaller than 4 cm. Prior reports suggest gene expression-based signatures that may predict recurrence in patients with stage I SC, but none has been validated or is in clinical use. The SPECS2 Lung Cancer Consortium was assembled to compare and attempt to validate previously published prognostic signature(s) according to the guidelines proposed by Subramanian and Simon (J Natl Cancer Inst 2010; 7:327).
Method
The multi-institutional team assembled 249 frozen SC samples representing six participating institutions (cohort 1). These samples were fully annotated in a redcap database hosted by the independent statistical core. Cohort 2 was assembled utilizing 234 frozen SC samples from a prospective multi-institutional NCTN lung biobanking protocol (NCT00899782). RNA was extracted and profiled with U133A microarrays (Affymetrix) in independent core facilities. The data was transferred directly to the SPECS2 Lung statistical core in collaboration with the Alliance Statistical core and the performance of 6 most promising candidate signatures was evaluated relative to a base model that included only age, gender and AJCC stage (editions 6, 7, 8).
Result
Analysis of Cohort 1 demonstrated that only one signature (Raponi et al, Cancer Res 2006; 66:7466) significantly enhanced prognosis relative to the base model, independent of AJCC edition. This was also observed in Cohort 2, where Uno’s C index associated with AJCC 8th edition stage, sex and age (0.561; 0.468-0.654) was significantly (p <0.05) increased when the prognostic signature was added to the model (0.683; 0.611-0.755).
Conclusion
The SPECS2 Lung Cancer Consortium was successful in validating a previously published prognostic molecular signature for early stage SC using rigorous experimental design. To our knowledge, this is the first unbiased validation of a lung cancer prognostic signature using multi-institutional prospective specimens. These results support a clinical trial designed to evaluate the potential role of adjuvant therapy in completely resected early stage SC.
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OA13.02 - Video-Assisted Thoracoscopic Surgery vs. Thoracotomy for Non-Small Cell Lung Cancer: Survival Outcome of a Randomized Trial (Now Available) (ID 1444)
11:30 - 13:00 | Presenting Author(s): Dongrong Situ | Author(s): Hao Long, Qunyou Tan, Qingquan Luo, Zheng Wang, Gening Jiang, Tie-Hua Rong
- Abstract
- Presentation
Background
Video-assisted thoracoscopic surgery (VATS) has been widely used in the treatment of early-stage non–small cell lung cancer (NSCLC). However, there has not been a robust randomized control trial (RCT) to confirm the non-inferiority of VATS to open lobectomy in term of oncologic efficacy. Therefore, a large multicenter RCT in China was designed and initiated to verify the role of VATS.
Method
A phase 3 RCT was undertaken at five thoracic surgery tertiary centers in China. Patients aged 18-75 years old who were diagnosed of clinically early-stage NSCLCs were randomized in a 1:1 ratio into VATS and thoracotomy groups. Radical lobectomy plus hilar and mediastinal lymph node dissection was the standard surgical intervention. The primary end-point of study was 5-year overall survival (OS). The secondary end-points including 5-year disease-free survival (DFS) and cancer relapse rates would also be reported here. Analysis was by intention to treat. This study is registered with the ClinicalTrials.gov, number NCT01102517.
Result
A total of 508 patients were recruited between January 2008 and March 2014. The final follow-up for 5-year survival analysis was completed in March 2019. And 432 patients were eligible for analysis (222 cases in VATS group and 210 cases in thoracotomy group). The cancer relapse (recurrence and metastasis) rates were 39.2% in VATS group and 36.7% in thoracotomy group respectively (P=0.621). Patients who received VATS lobectomies had a similar 5-year DFS to those who underwent open surgery (58% versus 62%, P=0.686). Finally, the 5-year OS rates were of no significant difference between VATS and thoracotomy groups (74% versus 71%, P=0.497).
Conclusion
The non-inferiority of VATS to thoracotomy lobectomy was confirmed in our RCT in terms of oncologic efficacy for clinically early-stage NSCLCs.
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OA13.03 - Predicting Postoperative Recurrence in Completely Resected EGFR-Mutant Non-Small Cell Lung Cancer: Value of IHC Markers (Now Available) (ID 998)
11:30 - 13:00 | Presenting Author(s): Zhengfei Zhu | Author(s): tiantian Guo, Jianjiao Ni, Yuan Li
- Abstract
- Presentation
Background
EGFR mutations are detected in up to 50% of non-small cell lung cancer (NSCLC) and recent studies indicate that EGFR-mutant NSCLC is a heterogeneous disease with varying co-mutations, diverse histologic subtypes and distinct expression of oncoproteins. However, the risk factors and clinical patterns of postoperative recurrence among patients with completely resected EGFR-mutant NSCLC have not been fully understood. Moreover, the prognostic values of routinely used immunohistochemical (IHC) markers in NSCLC are seldom reported.
Method
Consecutive patients with curative resected NSCLC and confirmed EGFR mutations at Fudan University Shanghai Cancer Center from January 2007 to December 2017, were retrospectively enrolled. The initial recurrence sites were recorded and categorized into five groups: thoracic recurrence, brain recurrence, neck recurrence, abdominal recurrence, and bone recurrence. The indicators of overall and site-specific recurrence were identified using the Cox regression model, where a panel of routinely used IHC markers (including Her2, Ki67, TTF-1, CK20, CK7, CK5/6, p53, RRM1, NapsinA, p40, syn, Bcl-2, CDX2, ERCC1 and p63) were incorporated. A nomogram was developed based on variables selected in multivariate analysis. The bootstrapping method (1000 repetitions) was applied to internally validate the nomogram
Result
After a median follow-up of 32 (range, 5-122) months, disease recurrence was observed in 197(37.1%) out of the 531 patients, with a median recurrence-free survival (RFS) of 19 (95% CI, 16.63-21.37) months. Most patients (n=136; 69.0%) had thoracic recurrence, followed by brain recurrence (n=41; 20.8%), bone recurrence (n=41; 20.8%), abdominal recurrence (n=14; 7.1%), and neck recurrence (n=13; 6.6%). Sex, tumor size, Ki67, and N stage were independent indicators of thoracic recurrence. Tumor size, N stage, CK20, and Syn were independent indicators of brain recurrence. N stage and Ki67 were independent indicators of bone recurrence. N stage was the independent indicator of abdominal recurrence and neck recurrence. Tumor size, Ki67, CK20, and N stage were independently associated with overall recurrence, and thus a nomogram predicting the 1-, 2-, and 3-year RFS probability was developed based on these four factors. The concordance index (C-index) was 0.723 (95% confidence interval, 0.675 to 0.771) and the calibration curves displayed good agreement between the predicted RFS and the actual observation.
Conclusion
Independent prognostic indicators based on clinic-pathological parameters and routinely used IHC markers were identified to predict overall and site-specific recurrence, which may help to identify optimal candidates for adjuvant therapies and design individualized surveillance strategies among patients with completely resected EGFR-positive NSCLC
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OA13.04 - Discussant - OA13.01, OA13.02, OA13.03 (Now Available) (ID 3794)
11:30 - 13:00 | Presenting Author(s): Kemp Kernstine
- Abstract
- Presentation
Abstract not provided
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OA13.05 - NADIM Study: Updated Clinical Research and Outcomes (Now Available) (ID 1670)
11:30 - 13:00 | Presenting Author(s): Mariano Provencio | Author(s): Ernest Nadal, Amelia Insa, Rosario Garcia Campelo, JOAQUIN Casal, Manuel Dómine, Margarita Majem, Delvys Rodriguez-Abreu, Alex Martinez-Marti, Javier De Castro Carpeno, Manuel Cobo, Guillermo López-Vivanco, Elvira Del Barco, Reyes Bernabe, Nuria Viñolas, Isidoro Barneto, Santiago Viteri, Paloma Martin Martorell, Maria Jove, Virginia Calvo De Juan, Bartomeu Massuti
- Abstract
- Presentation
Background
Patients with stage IIIA (N2 or T4N0) are potentially curable but median overall survival is only around 15 months
Method
A Phase II, single-arm, open-label multicenter study of resectable stage IIIA N2-NSCLC in adult patients with CT plus IO as neoadjuvant treatment: 3 cycles of nivolumab (NV) 360 mg IV Q3W + paclitaxel 200 mg/m2 + carboplatin AUC 6 IV Q3W followed by adjuvant NV treatment for 1 year. After completing neoadjuvant therapy, all patients underwent tumor assessment prior to surgery. Surgery was performed during the 3rd or 4th week after day 21 of the 3rd neoadjuvant treatment cycle. The study aimed to recruit 46 patients. The primary endpoint was Progression-Free Survival (PFS) at 24 months. Efficacy was explored using objective pathologic response criteria. Here we present the final data on all study patients that underwent surgical assessment.
Result
At the time of submission, the 46 patients had been included. None of the patients were withdrawn from the study preoperatively due to progression or toxicity. 41 patients had undergone surgery and all tumors were deemed resectable with R0 resection in all cases. Intention to treat analysis shows 35 patients (85%; 95% CI, 71; 94%) achieved major pathologic response (MPR) of which 25 (71%; 95% CI, 54; 85%) were complete pathologic responses (CPR). Downstaging was seen in 38 (93%; 95% CI, 80; 98%) of cases. The median follow-up was 13.8 months (P25; P75: 11.7; 16.6 months) for both the whole series and resected patients, and 12 month PFS was 95.7% (95% CI, 84; 99%).
Conclusion
This is the first multicentric study to test CT-IO in the neoadjuvant setting in stage IIIA. Neoadjuvant CT-IO with nivolumab in resectable IIIA NSCLC yields a complete pathologic response rate that is higher than ever seen previously, together with a promising PFS which may translate into increased overall survival. EudraCT Number: 2016-003732-20. Clinical trial information: NCT 03081689.
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OA13.06 - Surgical Outcomes Following Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab in Non-Small Cell Lung Cancer - NEOSTAR Study (Now Available) (ID 2041)
11:30 - 13:00 | Presenting Author(s): Boris Sepesi | Author(s): Tina Cascone, William N. William, Heather Lin, Cheuk Leung, Annikka Weissferdt, Garrett L Walsh, David Rice, Jack Roth, Reza J Mehran, Wayne L Hofstetter, Mara Antonoff, Frank Fossella, Frank E Mott, Xiuning Le, Ferdinandos Skoulidis, Jianjun Zhang, Lauren Averett Byers, Vincent Lam, Bonnie Glisson, Jonathan Kurie, George Blumenschein, Anne Tsao, Charles Lu, Mehmet Altan, Yasir Elamin, Don Lynn Gibbons, Vassiliki A Papadimitrakopoulou, Jack Lee, John Victor Heymach, Ara A Vaporciyan, Stephen Swisher
- Abstract
- Presentation
Background
Surgical outcomes following neoadjuvant immune checkpoint inhibitors (ICIs) are limited. We report 90-day perioperative results of the NEOSTAR phase II trial of neoadjuvant nivolumab or nivolumab/ipilimumab in resectable non-small cell lung cancers (NSCLCs).
Method
44 pts with stage I-IIIA NSCLC (AJCC 7th) were randomized to nivolumab (3 mg/kg IV, days 1, 15, 29, n=23) or nivolumab/ipilimumab (1 mg/kg IV, day 1, n=21) with resection planned between 3-6 weeks after last dose. Surgical approach and extent of resection were at surgeons’ discretion.
Result
39 (89%) patients underwent R0 resection, of those 2 (5%) were resected off trial after additional induction chemotherapy (1 nivolumab, 1 nivolumab/ipilimumab). Among 37 patients, 21 underwent surgery following nivolumab and 16 following nivolumab/ipilimumab. Median age 66 (43-83) years, 24 (65%) male, 33 (89%) white, 22 (59%) adenocarcinoma, 22 (59%) stage I, 9 (24%) stage II, 6 (16%) stage IIIA.
5 (11%) were not resected, 1 (1/23, 4%) after nivolumab (stage II), 4 (4/21, 19%) after nivolumab/ipilimumab (1 stage I, 1 stage II, 2 stage IIIA). Reasons for unresectability were change in surgeon’s judgement (n=2), toxicity (n=1), progression (n=1), and declining pneumonectomy (n=1). Median time to surgery was 31 days (range 21-87). 8 (22%) operations were delayed beyond 42 days, 5 after nivolumab/ipilimumab (5/16, 31%) and 3 after nivolumab (3/21, 14%).
33 (89%) underwent lobectomy, 2 (5%) pneumonectomy, 1 (3%) segmentectomy and 1 (3%) wedge resection. 27 (73%) had thoracotomy, 7 (19%) thoracoscopy, 3 (8%) robotic approach. 2 (5%) were electively converted from thoracoscopy to thoracotomy. Median operative time was 147 minutes (71-315), median blood loss was 100cc (50-1000), and median length of stay was 4 days (1-18).
Perioperatively, pulmonary complications occurred in 8 (22%) patients: 8 (22%) prolonged air leak, 2 (5%) pneumonitis/pneumonias, 1 (3%) empyema, and 1 (3%) bronchopleural fistula (BPF). 1 (3%) died from complications of BPF and steroid therapy for pneumonitis. 4 (11%) developed atrial fibrillation, 1 (3%) diarrhea, 1 (3%) ileus, and 1 (3%) transient ischemic attack.
Surgeons subjectively judged 15/37 (40%) of operations to be more complex than usual with 7/37 (19%) lasting > 4 hours.
Conclusion
Following three cycles of neoadjuvant ICIs 89% of patients underwent complete R0 resection, including two patients who received additional induction chemotherapy off trial. Five marginally operable patients who didn’t proceed to resection, and one perioperative mortality highlight the importance of cautious patient selection for neoadjuvant ICIs in the management of operable NSCLC.
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OA13.07 - Neoadjuvant Atezolizumab in Resectable NSCLC Patients: Immunophenotyping Results from the Interim Analysis of the Multicenter Trial LCMC3 (Now Available) (ID 1755)
11:30 - 13:00 | Presenting Author(s): Filiz Oezkan | Author(s): Kai He, Dwight Hall Owen, Maciej Pietrzak, Ju Hwan Cho, Rhonda Kitzler, Rebecca Pearson, Valerie W. Rusch, Jamie E. Chaft, Robert Suh, Justin D Blasberg, Karen L Reckamp, Dan J Raz, Peter J Kneuertz, Lauren Fiorillo, Edward Garon, Alan Nicholas, Ann Johnson, Katja Schulze, Jessica Grindheim, Romain Banchereau, See-Chun Phan, Paul A Bunn, Jr, David J Kwiatkowski, Bruce E Johnson, Mark G Kris, Ignacio Wistuba, Jay M Lee, Gerard Lozanski, David P Carbone
- Abstract
- Presentation
Background
The immune mechanisms dictating response and resistance to PD-(L)1 blockade are not well understood in early stage non-small cell lung cancer (NSCLC). Understanding these mechanisms will be key to improve outcomes and identify the next generation of predictive biomarkers of response to these therapies. Here, we present updated immunophenotyping at time of interim analysis of LCMC3, a multicenter trial of neoadjuvant atezolizumab in resectable NSCLC (NCT02927301).
Method
Patients received 2 cycles of atezolizumab before resection. Tumor, LN biopsies and PB were obtained pre-atezolizumab and at surgery. Paired PB, screening and surgical LN were analyzed using IMMUNOME flow cytometry. Plasma-based cytokine arrays were performed on a subset of patients. Immunophenotypic analyses were correlated with treatment effect, major pathologic response (MPR, primary endpoint) and preoperative treatment-related adverse events (preop-TRAE).
Result
We report on 55 patients with paired PB samples (analyzed within 72h after collection) and completed surgery. We observed preop-TRAE in 32/55 patients (18 grade 1, 13 grade 2, 1 grade 3). CD1c+ and CD141+ myeloid cells (MC) were lower at baseline in patients developing preop-TRAEs, while monocytic M-MDSCs were higher in those patients. Senescent T cells decreased in patients with preop-TRAE and increased in patients with non-preop-TRAE. After treatment, the absolute cell counts of late activated CD4+and CD8+T cells decreased in patients achieving MPR. LN IMMUNOME data, cytokine data and 12-month follow-up (DFS, OS) will be reported.
Conclusion
Preliminary immunophenotyping data from the interim analysis showed significantly lower baseline immunosuppressive cell subsets in patients with preop-TRAE and decreased late activated CD4+and CD8+T cells from PB in patients with MPR.These results, together with additional LN IMMUNOME and cytokine analyses, may improve our understanding of immunophenotypic features associated with outcome, and changes induced by neoadjuvant atezolizumab in early stage NSCLC patients.
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OA13.08 - Discussant - OA13.05, OA13.06, OA13.07 (Now Available) (ID 3795)
11:30 - 13:00 | Presenting Author(s): Harvey I Pass
- Abstract
- Presentation
Abstract not provided
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OA13.09 - Robert J. Ginsberg Lectureship Award for Surgery (Now Available) (ID 3899)
11:30 - 13:00 | Presenting Author(s): Giulia Veronesi
- Abstract
- Presentation
Abstract not provided
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EP1.08 - Oligometastatic NSCLC (ID 198)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Oligometastatic NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.08-02 - Surgical Indication for Postoperative Regional Lymph Node Oligo-Recurrence in Non-Small Cell Lung Cancer (ID 220)
08:00 - 18:00 | Author(s): Kenji Suzuki
- Abstract
Background
Currently, evidence-based guidelines for therapy to treat regional lymph node (LN) oligo-recurrence in post-resection non-small cell lung cancer (NSCLC) are limited. We investigated the clinical outcome of surgery for LN oligo-recurrence in post-resection NSCLC.
Method
From 2008 to 2017, 14 patients received R0 resection for regional LN oligo-recurrence after initial NSCLC R0 surgery. Eligible patients met these criteria: A, no recurrences without regional LN by PET-CT and brain-MRI; B, LN recurrence within 3 regions. We investigated the characteristics of surgically curable NSCLC patients with postoperative regional LN oligo-recurrence, including recurrence-free survival (RFS) and overall survival (OS).
Result
Ten patients were male and 4 were women. The median age was 69 years (62-86). Pathological findings in initial surgery was as follow; adenocarcinoma in 9, squamous cell carcinoma in 5, pathological stage I in 6, II in 4, and IIIA. The regional number of LN recurrence was as follow; 1 region in 11, 2 regions in 1, and 3 regions in 2. The median number of pathological metastatic LN were 2 (1-8). The median size of LN oligo-recurrence was 19 mm (14-38). All the oligo-recurrence LN had uptake in PET-CT. All the recurrent LN site was out of the dissection range at initial surgery. The median period from the initial surgery to oligo-recurrence was 18.1 months (7.0-66.5). The median operation time was 134 minutes (52-452), and median bleeding volume was 15 ml (2-2593). SVC reconstruction was performed in 1. Postoperative complication was detected in 3 cases; arrhythmia in 2 and graft occlusion in 1. There were no cases of perioperative death. EGFR mutation was detected in 4 cases. After LN dissection, 9 patients were followed up without treatment, and the other 5 patients underwent chemotherapy. Six patients (42.8%) out of 14 were recurrence-free after LD dissection. Compared recurrence-free patients with recurrence patients after LN dissection, pathological only one LN of oligo-recurrence (p < 0.01) and EGFR wild type (p = 0.04) were significant in the recurrence-free group. LN oligo-recurrence in only one region also tended to be more frequent in the recurrence-free group (p = 0.09). Pathological N or stage in initial surgery, size of LN oligo-recurrence, recurrence-free interval after initial surgery were no significant difference between recurrence-free and recurrent group. The median RFS and OS after LN resection in all 14 patients was 24.2 and 66.3 months. The 2-year and 5-year RFS rates after LN resection were 52.7% and 35.2%. Eight patients were recurrence after LN dissection; 4 were locoregional and the others were distant. Of the 8 relapsed patients, only 2 patients survive with EGFR-TKI.
Conclusion
Surgery for postoperative regional LN oligo-recurrence in NSCLC should be indicated for the patients with only one LN of oligo-recurrence in only one region or EGFR wild type.
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IBS06 - Multimodality Treatment - Realtime Data from National Registries (Ticketed Session) (ID 37)
- Event: WCLC 2019
- Type: Interactive Breakfast Session
- Track: Mesothelioma
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 07:00 - 08:00, Dublin (1997)
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IBS06.03 - Japanese Data (Now Available) (ID 3333)
07:00 - 08:00 | Author(s): Kenji Suzuki
- Abstract
- Presentation
Abstract
Backgrounds
Annual surveys of cardiothoracic surgery throughout Japan has been conducted by the Japanese Association for Thoracic Surgery (JATS) since 1986 in order to establish the statistics for the number of procedures by operative category1. Regarding malignant pleural mesothelioma (MPM), however, only annual case numbers of both diffuse and localized MPM have been registered since 1996. From 2009 onward, surgical technique, 30-day mortality, and in-hospital mortality have been also described. According to the JATS survey, all-kind of surgery for MPM increased 76% during 1996 and 2016: 164 cases in 1996 and 289 cases in 2016. JATS survey also revealed dramatic increase of pleurectomy/decortication (P/D) cases during 2009 to 2016: proportion of P/D surgery in all curative-intent surgery was 1.4% (2/142) in 2009 and 53.3% (73/137) in 2016.
Methods
In 2011, the National Clinical Database (NCD) of Japan adopted an annual web-based nationwide data collection system2. Since NCD is associated with the Japanese Surgical Board Certification System, it contains detailed perioperative clinical information such as preoperative patient characteristics, operation time, blood loss, intraoperative accidents, pathological TNM stages, postoperative adverse events, redo-surgery, 30-day and in-hospital mortality, cause of death, and so on. Approximately 10 million surgical procedures from >5000 hospitals have been collected by 2017.
An NCD specifically for general thoracic surgery was launched in 20143.
This time, we conducted an analysis on MPM surgery in Japan using the Japan NCD.
Results (Table 1)
In the period of 4 years between 2014 and 2017, a total of 622 curative-intent surgery was performed in Japan. Median age was 66 years (IQR, 61-71), and 87.6% were male. A median BMI was 22.6 (20.3-24.8), and 77.3% was ECOG PS0. Induction therapy was given in 40.8% of patients. Extrapleural pneumonectomy was performed in 279 patients (44.9%) and P/D in 343 (55.1%). Blood transfusion was required in 320 (51.4%) patients (Figure 1). Injury of major intrathoracic organ occurred in 22 (3.5%) patients. Morbidity rate was 40.0% (249/622). Thirty-day mortality and in-hospital mortality were 1.1% and 3.2%, respectively (Table 1).
Conclusion
In addition to the above JATS survey and Japan NCD, a nationwide, prospective, observational study of patients with MPM has just completed 2-year’s patient accrual4. It is promising that these Japanese data will substantially contribute to understanding MPM in near future.
1 Thoracic and cardiovascular surgery in Japan in 2016. Committee for Scientific Affairs, The Japanese Association for Thoracic Surgery, Shimizu S, Endo S, Natsugoe S, et al. Gen Thorac Cardiovasc Surg 2019; 67: 377-411.
2 http://www.ncd.or.jp/
3 Development of an annually updated Japanese national clinical database for chest surgery in 2014. Endo S, Ikeda N, Kondo T, et al. Gen Thorac Cardiovasc Surg 2016; 64: 569-576.
4 Shintani Y, Hasegawa S, Takuwa T, et al. Prospective registry database of patients with malignant mesothelioma: Directions for a future Japanese registry-based lung cancer study. J Thorac Dis 2018; 10: 1968-71
Table 1 EPP (n=279) P/D (n=343) Total (n=622) age (median, IQR) 65 (59-69) 67 (63-73) 66 (61-71) male sex 250 (89.6%) 295 (86.0%) 545 (87.6%) BMI (median, IQR) 22.3 (20.2-24.2) 23 (20.4-25.1) 22.6 (20.3-24.75) PS 0 215 (77.1%) 266 (77.6%) 481 (77.3%) 1 57 (20.4%) 65 (19.0%) 122 (19.6%) 2-4 5 ( 1.8%) 10 ( 2.9%) 15 ( 2.4%) unknown 2 ( 0.7%) 2 ( 0.6%) 4 ( 0.6%) Induction therapy 103 (36.9%) 151 (44.0%) 254 (40.8%) Blood transfusion 159 (57.0%) 161 (46.9%) 320 (51.4%) Major organ injury 12 ( 4.3%) 10 ( 2.9%) 22 ( 3.5%) Morbidity 126 (45.2%) 123 (35.9%) 249 (40.0%) 30-day mortality 3 ( 1.1%) 4 ( 1.2%) 7 ( 1.1%) in-hospital mortality 9 ( 3.2%) 11 ( 3.2%) 20 ( 3.2%) 
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MA06 - Challenges in the Treatment of Early Stage NSCLC (ID 124)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 1
- Now Available
- Moderators:Florentino Hernando-Trancho, Ayten Kayi Cangir
- Coordinates: 9/08/2019, 13:30 - 15:00, Colorado Springs (1994)
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MA06.06 - A Phase III Study of Adjuvant Chemotherapy in Patients with Completely Resected, Node-Negative Non-Small Cell Lung Cancer (Now Available) (ID 285)
13:30 - 15:00 | Author(s): Kenji Suzuki
- Abstract
- Presentation
Background
Post-operative UFT (tegafur/uracil) has been shown to prolong survival of Japanese patients with completely resected, p-stage I (T1> 2 cm) non-small cell lung cancer (NSCLC). This trial, the Japan Clinical Oncology Group (JCOG) 0707, aimed at estimating the efficacy of S-1 (tegafur/gimeracil/oteracil) compared to UFT as adjuvant therapy in this population.
Method
Eligible patients had received complete resection with lymph node dissection for p-stage I (T1-2N0M0, T1> 2 cm, by 5thEdition UICC TNM) NSCLC, within 56 days of enrollment. Patients were randomized to receive: oral UFT 250mg/m2/day for 2 years (Arm A), or oral S-1 80mg/m2/day for 2 weeks and 1 week rest, for 1 year (Arm B). The initial primary endpoint was overall survival (OS). Based upon the monitoring in Jun. 2013, which showed the combined OS of the 2 arms better than expected (4-year OS of 91.6% vs. presumed 5-year OS of 70-76.5%), it was judged to be underpowered. The study protocol was amended so that the primary endpoint is relapse-free survival (RFS). With the calculated sample size of 960, this study would detect the superiority of Arm B over Arm A with power 80% and one-sided type I error of 0.05, assuming the 5-year RFS of 75% in Arm A and the hazard ratio of 0.75.
Result
From Nov. 2008 to Dec. 2013, 963 patients were enrolled (Arm A : 482, Arm B : 481): median age 66 (range: 33 to 80), male 58%, adenocarcinoma 80%, p-T1/T2 46%/54%. Only 2 received pneumonectomy. >Grade 3 toxicities (hematologic/nonhematologic) were observed in 15.9 (1.5/14.7) % in Arm A, and in 14.9 (3.6/12.1) % in Arm B, respectively. 60.0% of the patients in Arm A and 54.7% of them in Arm B completed the protocol treatment (p=0.10). There were 4 cases of deaths during protocol treatment, probably of cardio-vascular origin, with 1 in Arm A and 3 in Arm B. At the data cut-off of Dec. 2018, the hazard ratio (HR, Arm B vs. Arm A) of RFS was 1.06 (95% confidence interval (C.I.): 0.82-1.36), showing no superiority of S-1 over UFT. The HR of OS was 1.10 (95% C.I.: 0.81-1.50). The 5-year RFS/OS rates were 79.4%/88.8% in Arm A and 79.5%/89.7% in Arm B, respectively. Pre-specified subset analyses for gender, age, smoking, stage, tumor side, lymph node dissection area, pleural invasion and histology revealed no remarkable results; S-1 arm was not superior to UFT arm in each analysis. Of the 77 and 85 OS events for Arm A/Arm B, 45 each (58%/53%, respectively) were due to the NSCLC. During the follow-up period, secondary malignancy was observed in 85 (17.8%) and 84 (17.8%) in Arm A and Arm B, respectively.
Conclusion
Post-operative adjuvant therapy with oral S-1 was not superior to that with UFT in stage I (T>2 cm) NSCLC after complete resection. UFT remains standard in this population. Future investigation should incorporate identification of high-risk population for recurrence, since survival of each arm was so good with substantial number of OS events due to other causes of deaths in this trial.
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P1.09 - Pathology (ID 173)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Pathology
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.09-15 - Hybrid Organoid Reveals That Podoplanin-Positive Cancer-Associated Fibroblasts Enhance Proliferation of Lung Cancer Cell (ID 1027)
09:45 - 18:00 | Author(s): Kenji Suzuki
- Abstract
Background
Podoplanin-positive cancer-associated fibroblasts (CAFs) play an important role in tumor progression. The aim of this study was to evaluate the effect of podoplanin (+) CAFs on the proliferation of cancer cells using a three-dimensional (3D) organoid model.
Method
We examined the success rate of organoid culture containing PC-9 cancer cells and CAFs. Thereafter, we compared the proliferating index (MIB-1 index) of PC-9 cells co-cultured with podoplanin-overexpressing CAFs and control CAFs using organoid specimens. Furthermore, we compared the MIB-1 labeling index of cancer cells in podoplanin (+) CAFs cases (n = 13) and podoplanin (-) CAFs cases (n = 14) using surgically resected adenocarcinoma specimens.
Result
Without CAFs, PC-9 cells did not form any organoid (success rate: 0%). When PC-9 cells were mixed with CAFs (1:10), the mixed cells generated round and steric aggregates (hybrid cancer organoids, success rate: 100%). In three independent experiments, the MIB-1 index of PC-9 cells in hybrid cancer organoids containing podoplanin-overexpressing CAFs was significantly higher than that of PC-9 cells in organoids containing control CAFs (Exp. 1: 40.4% vs. 24.4%; Exp. 2: 40.0% vs. 24.5%; Exp. 3: 40.3% vs. 25.2%; p < 0.001). Surgically resected human tumors revealed that the MIB-1 index of adenocarcinoma cells was significantly higher in the case of podoplanin (+) CAFs than in the case of podoplanin (-) CAFs (34.8% vs. 16.2%; p < 0.01).
Conclusion
Our data suggested that the hybrid cancer organoid model might reflect the growth-promoting effect of podoplanin (+) CAFs in cancer cells, and this new system can be a useful tool for evaluating the tumor microenvironment.
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P1.17 - Treatment of Early Stage/Localized Disease (ID 188)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.17-10 - Prediction of Visceral Pleural Invasion in c-N0 Non-Small Cell Lung Cancer (ID 937)
09:45 - 18:00 | Author(s): Kenji Suzuki
- Abstract
Background
Visceral pleural invasion (VPI) is a tumor invasion pattern and a poor prognostic factor. However, accurate preoperative diagnosis of VPI remains difficult. This study aimed to clarify the clinical and radiological predictors of VPI in patients with c-N0 non-small cell lung cancer (NSCLC).
Method
A retrospective review was conducted in 808 patients with c-N0 NSCLC who underwent complete resection between 2009 and 2014. VPI included pathological pl1 and pl2. Patients with pl3 were excluded. Radiological findings were evaluated based on thin-section CT and PET. The patients were divided into 4 categories according to the following patterns of pleural contact with tumor: a solid component, pleural indentation, a ground glass opacity (GGO) component, and no pleural contact.
Result
VPI occurred in 173 patients (21.4%), with a significantly higher incidence of pathological nodal involvement than those without VPI (32.9% vs 10.6%, p<0.001). Of the 357 patients with pleural contact by a solid component, 248 patients with pleural indentation, and 203 patients with pleural contact by a GGO component/no pleural contact, 152 (42.6%), 21 (8.5%), and none (0%) had VPI, respectively. The length of pleural contact by a solid component was positively correlated to VPI (p<0.001). Receiver-operating characteristic curve analysis revealed a cutoff length of 1 mm, indicating the importance of the presence of pleural contact by a solid component. Multivariate logistic regression analysis revealed that pleural contact pattern, pure-solid tumor, SUVmax, and CEA were independent significant predictors of VPI. Adjusted ORs (95%CI) of pleural contact by a solid component and pleural indentation were 181 (11.8–NA) and 40.1 (2.55–633), respectively (in reference to a GGO component/no pleural contact).
Conclusion
Pleural contact by a solid component was the most relevant predictor of VPI. VPI was reflected by malignant clinical (high CEA) and radiological features (high SUVmax, pure-solid tumor) and a pleural contact pattern (solid component, indentation).
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P2.17 - Treatment of Early Stage/Localized Disease (ID 189)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.17-03 - Surgical Outcomes of Repeated Anatomical Pulmonary Resection for the Ipsilateral Second Lung Cancers (ID 390)
10:15 - 18:15 | Author(s): Kenji Suzuki
- Abstract
Background
The opportunity of pulmonary resection for metachronous second lung cancers is increasing as an effective surgical strategy for properly selected patients in the course of postoperative follow-up after thoracic surgery for the first lung cancer. However, the surgical indication is controversial regarding the repeated pulmonary resection for the ipsilateral second lung cancer.
Method
Among surgically resected 3316 non-small cell lung cancer (NSCLC) from 2008 to 2018, ipsilaterally detected 104 metachronous second lung cancers (3.6%) was retrospectively reviewed with regard to the surgical outcomes and clinicopathological characteristics. In this study, re-anatomical resection was defined as a repeated anatomical surgery for ipsilateral secondary NSCLC after major lung resection for primary NSCLC. Overall survival (OS) was estimated using the Kaplan-Meier method. Survival outcomes were evaluated using Cox proportional hazard model. A difference was considered statistically significant when the p-value was less than 0.20 in the univariable, and 0.05 in the multivariable models.
Result
Of all, 61 (67%) were male with an average age of 67y at the second surgery. Pathological-stage I disease was found in 65 (63%). Histologically, adenocarcinoma was frequent in 80 (77%) cases. Seventy-seven (74%) was diagnosed as second primary. The 3y-OS after the second lung resection was 80.1%. Multivariate analysis revealed that radiological pure-solid tumor, pack-year smoking were the independent prognosticators of the OS (p=0.045, 0.001). Operative procedures were not associated with the survival outcomes (re-anatomical: 81.8%, others: 78.2%, p=0.816), however, re-anatomical resection was an independently significant predictor of the postoperative morbidity after the second surgery (p=0.035). Therefore, we focused on the 58 cases that underwent re-anatomical resection. Among them, postoperative morbidity (G3 or more in the CTCAE 4.0) was found in 20 (35%). A multivariable analysis revealed tumor size and postoperative morbidity were the independently significant prognosticators (p=0.003, 0.026). The 3y-OS of tumor less than 20mm was excellent (91.9% vs. 66.6%, p=0.008). Furthermore, we classified them into 2 groups based on the operative modes, i.e., completion pneumonectomy (CP; n=26) and the other re-anatomical resections to avoid CP (non-CP; n=32). The details of non-CP were ipsilateral secondary lobectomy/segmentectomy after the primary lobectomy/segmentectomy in 28 and completion lobectomy after the primary segmentectomy in 4, respectively. Among them, right side operation was more frequent in the non-CP (54% vs. 84%, p=0.011), while intra-pericardial procedure was employed more in the CP (85% vs. 47%, p=0.005). In contrast, the oncological outcomes (3y-OS; 75.8% vs. 87.1%, p=0.881), technical aspects including operative time (242min vs. 234min, p=0.802), bleeding amount (334ml vs. 242ml, p=0.521), blood transfusion (15% vs. 19%, p=0.736), arterial reconstruction (19% vs. 28%, p=0.431), or postoperative morbidity (27% vs. 41%, p=0.275) was similar between CP and non-CP.
Conclusion
Re-anatomical pulmonary resections for the ipsilateral second lung cancers are oncologically feasible but predictive for the postoperative morbidity. In particular, non-CP could be effective strategy to avoid CP for lung preservation, however, this procedure is technically challenging as well as CP, and strict caution would be warranted for the perioperative management. While oncological outcome of small-sized lung cancer is fully favorable even in case that repeated anatomical resection would be needed.
