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Motohiro Yamashita



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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): Motohiro Yamashita

      • 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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      P2.18-03 - Salvage Surgery After Curative-Intent Chemo and/or Radiation for Locally Advanced Lung Cancer (Now Available) (ID 1756)

      10:15 - 18:15  |  Presenting Author(s): Motohiro Yamashita

      • Abstract
      • Slides

      Background

      A chemo and/or radiotherapy (CRT) was thought to be the curative treatment for locally advanced lung cancer (LALC) before 2017. However, after the CRT the cancer sometimes remained at the treatment field. The radical pulmonary resection after CRT (Salvage surgery) is the option for the curative treatment. The safety and perioperative complications of salvage surgery after CRT for locally advanced lung cancer have been problematic. Thisa study aimed to identify the long-term survival and the operative results of this kind salvage surgery.

      Method

      The Salvage surgery is defined as resection after platinum based 2-drugs CRT or curative dose radiation therapy for LALC. We retrospectively reviewed our medical records in our institute from January 2008 to March 2019 and collected 33 patients who received salvage surgery. This study was approved by our institutinal review board.

      Result

      The mean age at the surgery was 63 years (range 39~86), with 5 women and 28 men. The initial curative-intent therapy were; concurrent CRT in 26, sequential CRT in 2, and stereotactic body radiotherapy in 5. The mean interval from CRT to the surgery was 31 months (range 3~128). All patients except 2 cases underwent complete surgical resection with mediastinal nodal dissection including lobectomy in 20 cases, lobectomy with bronchoplasty in 2 cases, broncho/ pulmonary angioplasty in 7 cases, pneumonectomy in 2 cases. The bronchial stump was covered with pericardial fat tissue or intercostal muscle. Histological type were adenocarcinoma in 19 cases, squamous carcinoma in 10 cases, large-cell-carcinoma in 2 cases, 1 combined cell small-cell carcinoma, and 1 adenosquamous cell carcinoma. The mean operation time was 302 minutes and mean blood loss was 687g. There was no operative mortality nor in-hospital death. Post-operative complication was seen in 12 cases (36%), however there was no broncho-pleural fistula or bronchial dehiscence. The 3-years and 5-years overall survival after the surgery were 70% and 52.3 % with 53 months median follow-up period. Six years after the salvage surgery, there was no recurrence of lung cancer.

      Conclusion

      The salvage surgery after curative-intent chemotherapy and/or radiotherapy for LALC is feasible with cautious patient selection, careful operative procedure, and meticulous perioperative care. Six years after salvage surgery the survivors may be expected to be free from lung cancer recurrence. iaslc 2019 jpeg.jpg

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