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Makoto Takahama
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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): Makoto Takahama
- 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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P2.05 - Interventional Diagnostic/Pulmonology (ID 168)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Interventional Diagnostics/Pulmonology
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.05-19 - The Patency of Right Upper Lobe Bronchus After Y-Stent Placement Affect Outcome on Malignant Tracheobronchial Stenosis (Now Available) (ID 1646)
10:15 - 18:15 | Author(s): Makoto Takahama
- Abstract
Background
Dumon silicone Y-stent is useful for releasing the tracheobronchial stenosis. We often encounter patients with tumors involving the carina between the bronchus to the right upper lobe and bronchus intermedius. However, there has not been ideal stenting for such cases, especially to maintain the patency of the right upper lobe bronchus. We investigated the clinical outcome in patients with malignant tracheobronchial stenosis, especially focused on the patency of right upper lobe bronchus after Y-stent placement.
Method
From January 2012 until December 2018, 102 patients who had placed Y-stent on malignant tracheobronchial stenosis in our department were examined retrospectively. This study involved 73 male and 29 female. The mean age was 64 years (range, 30-91 years). Fifty-nine patients had lung cancer, 29 had esophageal cancer, and 14 had other carcinomas. All procedures were carried out in the operating room under general anesthesia, and the stents were implanted via rigid bronchoscopy. The patients were divided into two groups based on the patency of right upper bronchus: patency group (P group, n=73) and stenosis /occlusion group (S group, n=29).The clinicopathological features, clinical course, and the survival after stenting of the groups were compared.
Result
Stents were implanted and symptoms were resolved in all cases. No operative death occurred. Stent indwelling types were only Y-stent in 69 patients and Y-stent with additional self-expanding metallic stent (SEMS) in 33. Although there was no difference between the two groups in age, gender, preoperative Hugh-Jones classification, hospitalization days, and size of Y-stent, esophageal cancer was significantly more frequent in P group. The total length of placed stent was significantly longer in S group (median 10.5cm) compared to P group (8cm) (p<0.01) and the postoperative Hugh-Jones classification (I or II) in S group (47%) was inferior compared to the P group (72%). After stent placement, 67% of the P group could be treated chemotherapy/radiotherapy to primary disease, while only 43% of the S group was received these because of their poor general condition (p = 0.03).The median survival time (MST) and 1-year survival rate of the two groups was 7 months and 32% (P group), and 2 months and 17% (S group), respectively (p<0.01).
Conclusion
The patency of right upper lobe bronchus after Y-stent placement affects not only the improvement of postoperative Hugh-Jones classification but also the administration of subsequent treatment to primary disease and associated to their clinical outcome.
