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Mitsuhiro Takenoyama
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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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EP1.01-105 - Experience in Treating Recurrent Non-Small Lung Cancer Patients After Surgery with Immune-Checkpoint Inhibitor (Now Available) (ID 1148)
08:00 - 18:00 | Author(s): Mitsuhiro Takenoyama
- Abstract
Background
Recent rapid advancements in the development of chemotherapy, including immune checkpoint inhibitors (ICIs), such as program death-1 (PD-1) inhibitor or program death-ligand 1 (PD-L1) inhibitors, in the field of non-small cell lung cancer (NSCLC) have remarkably prolonged patients’ survival.
Several clinical trials currently underway are assessing the efficacy of ICIs in adjuvant chemotherapy (AC) following complete resection of Stage I-IIIA NSCLC. One of the issues with AC for completely resected NSCLC is the limited proportion of patients who benefit from such treatment, as some patients will experience recurrence despite AC while others will not experience recurrence even without AC.
Given the emergence of adverse events (AEs), including immune-related AEs at a constant rate, the appropriate timing of treatment with ICI remains unclear whether AC or at the time of recurrence.
Method
In this single-institutional retrospective study, to clarify the treatment effect of ICIs in terms of the survival or response, we reviewed 21 patients treated with ICIs for recurrent NSCLC who had undergone complete surgical resection between March 2016 and October 2018.
Result
The median age was 61 years old (range: 47-75 years old). There were 16 men and 5 women. Thirteen patients had adenocarcinoma, 5 had squamous cell carcinoma, and 3 had others. The PD-L1 expression by 22C3 antibody was <1% in 7 patients, 1%-50% in 3 patients, >50% in 5 patients and not done in 6 patients, and the treatment lines of ICIs was first- to second-line in 8 patients and third-line or later in 13 patients. The response was partial response (PR) in 3 patients, stable disease (SD )in 10 patients, progressive disease (PD) in 6 patients and not evaluable in 2 patients. The median overall survival time from the initial administration of ICIs was 22.8 (2.0-80.1) months, while that from surgical resection was 63.7 (9.5-109.7) months.
Conclusion
The efficacy of administering ICIs after recurrence should be compared with that of AC with ICIs.
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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): Mitsuhiro Takenoyama
- 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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P1.01 - Advanced NSCLC (ID 158)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.01-04 - A Phase II Trial of Weekly Nab-Paclitaxel in the Salvage Setting for Advanced Non-Small Cell Lung Cancer: Results of NICE Salvage Study (ID 1534)
09:45 - 18:00 | Author(s): Mitsuhiro Takenoyama
- Abstract
Background
The optimal treatment in patients with advanced non-small cell lung cancer (NSCLC) after failing second- or third-line chemotherapy, i.e. NSCLC in salvage setting, has yet to be established. A small study reported that solvent-based paclitaxel (sb-P) monotherapy was safe and efficacious and could be a treatment option for NSCLC in salvage setting (Anticancer Res 2005). Nanoparticle albumin-bound paclitaxel (nab-P) showed a higher overall response rate (ORR) and better tolerability than sb-P when combined with carboplatin (CBDCA) as a first-line chemotherapy (J Clin Oncol 2012). These results suggest that nab-P monotherapy could be better therapeutic option than sb-P monotherapy for NSCLC in salvage setting. We therefore planned NICE Salvage study aiming to assess the efficacy and safety of nab-P monotherapy for NSCLC patients in salvage setting.
Method
NICE Salvage study was a multicenter single arm phase II study. Eligibility criteria included patients aged >= 20 years, with PS 0-2 and adequate organ function, and who have failed two or three prior lines of chemotherapy including at least a platinum-containing regimen for pathologically-proven advanced NSCLC. Patients who had treatment history with sb-P or nab-P, or had tumors harboring EGFR mutation or ALK fusion gene were excluded. Nab-P was administered at a dose of 80 mg/m2 on days 1,8 and 15 of a 28-days cycle and repeated until progressive disease, unacceptable toxicity, or patient’s refusal. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), ORR, disease control rate (DCR), efficacy according to prior use of docetaxel, quality of life, and safety. The study is powered to detect a 1.5-month improvement in median PFS in the investigational arm beyond the 2.0-month median PFS estimated from historical data. Assuming a one-sided 0.10 level of Type I error and 80% power, target sample size is calculated at 35. (UMIN000016173).
Result
Thirty-eight patients were enrolled and a patient was excluded from efficacy and safety analysis. Patient’s characteristics (n = 38) were as follows: median age = 68 years, male/female = 31/7, adenocarcinoma/squamous cell carcinoma /others = 20/15/3. Median PFS and OS was 3.5 month (95% confidence interval (CI), 1.7-3.8), and 13.4 month (95%CI, 9.1-25.1), respectively. ORR and DCR were 10.8% (95%CI, 2.9-24.8 ) and 56.8% (95%CI, 38.3-71.3 ), respectively. Grade 3 or 4 treatment-related adverse events were neutropenia (10.8%), anemia (2.7%), hepatotoxicity (2.7%) and diarrhea (2.7%). One treatment-related death (pulmonary infection) was observed.
Conclusion
This study failed to meet predefined primary endpoint. However the results showed that nab-P monotherapy was moderately efficacious and well-tolerated, suggesting the need for further investigation for NSCLC in salvage setting.
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P2.10 - Prevention and Tobacco Control (ID 176)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Prevention and Tobacco Control
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.10-07 - Does Short-Term Cessation of Smoking Before Lung Resections Reduce the Complication Risk? (Now Available) (ID 1591)
10:15 - 18:15 | Author(s): Mitsuhiro Takenoyama
- Abstract
Background
Smoking cessation is one of the most important preoperative preparatory acts before thoracic surgery; however, the optimal timing for preoperative smoking cessation has not been clarified. In this study, we examined the effect of short-term smoking cessation before pulmonary resection for preventing postoperative pulmonary complications (PPCs).
Method
We enrolled 753patients who underwent curative surgical resection for thoracic malignancies from 3institutions. We instructed patients with a smoking history to quit smoking by at least four weeks prior to surgery in order to reduce the incidence of pulmonary events. We collected information on the preoperative smoking status, duration of smoking cessation before surgery, and occurrence of postoperative pulmonary complications. Study subjects were classified into three groups based on their smoking status. Recent smokers were defined as any who had smoked within two months before surgery, and former smokers were defined as those who had abstained from smoking for more than two months prior to the operation. Never-smokers were defined as those who had never smoked. We examined the relationship between the duration of the preoperative smoke-free period and the development of PPCs.
Result
The mean age of the patients was 68 years old, including 426 males and 327 females. Former smoker accounted for 48% (n =361) of the cases, followed by never smokers (n=287, 38%) and recent smokers (n=105, 14%). Surgery was performed for 660 primary lung cancer and 93 metastatic lung tumor. The types of procedures performed included lobectomy (n=542), pneumonectomy (n=11), wedge resection (n=167) and segmentectomy (n=33). PPCS were observed 62 cases (8%) among all patients. The incidence of PPCS among recent, former and never-smokers was 15%, 8% and 6%, respectively (p=0.01). The mean duration of post-operative chest tube drainage among recent, former and never-smokers 3.2, 2.2 and 2.2 days, respectively (p=0.04). The mean post-operative hospital stay among recent, former and never-smokers was 12.1, 10.6 and 10.2 days, respectively (p=0.07). There were no cases of 30-day mortality.
Conclusion
Cigarette smoking was associated with PPCS such as respiratory failure, pneumonia, empyema, atelectasis and prolonged air leakage. In addition, cigarette smoking generated a harmful effect for post-operative short-term outcome. Smoking abstinence for at least 2 months prior to surgery was not shown to reduce the incidence of PPCs.
