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Norihito Okumura



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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
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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): Norihito Okumura

      • Abstract
      • Presentation
      • Slides

      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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    P2.18 - Treatment of Locoregional Disease - NSCLC (ID 191)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.18-15 - Surgical Outcomes of Pneumonectomy After Induction Therapy for Non-Small-Cell Lung Cancer (Now Available) (ID 905)

      10:15 - 18:15  |  Presenting Author(s): Norihito Okumura

      • Abstract
      • Slides

      Background

      The mortality of pneumonectomy after induction therapy (IT) for locally advanced non-small-cell lung cancer (NSCLC) is reported to be as high as 26%. However, pneumonectomy after IT has also been reported of having an acceptable safety and favorable outcomes. We retrospectively reviewed the postoperative outcomes of this procedure.

      Method

      Between April 2004 and September 2016, of 179 patients who underwent neoadjuvant therapy, 20 consecutive patients (11.2%) underwent pneumonectomies for locally advanced NSCLC after IT in our institution. Perioperative management, mortality, postoperative complications and survival were retrospectively analyzed.

      Result

      Eighteen patients were men, and the median age was 64 years (range, 38 to 79). Clinical stages (7th edition of TNM classification) were as follows: Stage IIA(n=2), Stage IIB(n=1), StageIIIA(n=15), and StageIIIB(n=2). There were 7 right and 13 left resections. Three patients underwent pneumonectomy after induction chemotherapy and 17 underwent after induction chemoradiation. A pathological complete response(Ef.3)due to IT was obtained in 8 patients (40%). In all cases the bronchial stumps were covered with autologous tissue including pedunculated intercostal muscle or mediastinal fat pad. There were no deaths within 30 days. However, one patient died within 90 days after transferring to a rehabilitation hospital. Postoperative complications of all grades were seen in 15 patients (75%), with major complications (Clavien-Dindo classification ≥IIIa) in 5 patients (25%). Major complications were all late-phase empyema, one with BPF and 4 without BPFs, which were all cured with surgical interventions. 5-year overal and recucurence free suvavals were 56.1 % and 47.4%, respectively. The average observation period of alive patients was 2500 days (range, 836 to 5144 days).survival.jpg

      Conclusion

      Our results suggest that pneumonectomy after IT for locally advanced NSCLC is a feasible and valuable treatment option. However, due to a high complication rate, surgery by experienced surgeons and careful postoperative management are essential for successful outcomes.

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