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J. Roth



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    P2.02 - Poster Session/ Treatment of Localized Disease – NSCLC (ID 210)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Localized Disease - NSCLC
    • Presentations: 1
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      P2.02-032 - Phase II Clinical Trial of Stereotactic Ablative Radiotherapy (SABR) in Surgically Operable Stage I Non-Small Cell Lung Cancer (STARS) (ID 1254)

      09:30 - 09:30  |  Author(s): J. Roth

      • Abstract
      • Slides

      Background:
      Standard therapy for operable clinical stage I non-small cell lung cancer (NSCLC) is lobectomy with sampling or dissection of mediastinal lymph nodes. Stereotactic ablative radiotherapy (SABR) has produced local control rates in excess of 95% and has become standard care for medically inoperable stage I NSCLC. However, the role of SABR in operable stage I NSCLC remains controversial due to concerns about the risk of local or nodal recurrence after SABR, either of which could lead to worse OS than that after standard surgery. We report here the preliminary outcome using SABR in clinically operable stage I NSCLC.

      Methods:
      Patients with clinical T1A(<3 cm)N0M0 biopsy proven operable NSCLC who meet criteria for lobectomy are being enrolled. All patients are staged with chest CT, PET/CT imaging, and EBUS. 54 Gy in 3 fractions was used for peripheral lesions and 50 Gy in 4 fractions for central lesions, respecting critical normal tissue dose volume constraints. SABR plans are typically optimized by using 6 to 12 coplanar or non-coplanar 6-MV photon beams (3-D CRT or IMRT) or Cyberknife or one to three arcs (VMAT). Daily CT-on-rail or a cone-beam CT scans or tumor tracking was used during each radiotherapy fraction.

      Results:
      Enrollment was started in September 2009, temporally closed in 2013 with 20 patients and re-opened in 2014. The study is ongoing and 58 patients have been enrolled up to date. The median follow-up time for the first 20 patients was 40 months; for all patients, median follow up was 7 months (range 0.8-49.6 months, interquartile 4.7, 22.8 months). No deaths have occurred to date. There was one local failure in the treated lobe that was salvaged with lobectomy. There were 5 cases of regional mediastinal lymph node progression treated with concurrent chemo/radiotherapy. Three of these cases had suspicious lymph nodes by CT and PET before SABR but were enrolled because EBUS was negative. One patient developed distant metastasis and was treated with chemotherapy. No one had grade 3-5 toxicity. Six patients had grade 2 chest wall pain (10.3%) and three patients developed grade 2 pulmonary toxicity (5%).

      Conclusion:
      SABR is well tolerated with minimal toxicity and promising local control and survival. More stringent mediastinal staging is recommended in the future.

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    P2.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 213)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Locoregional Disease – NSCLC
    • Presentations: 1
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      P2.03-017 - Pre-Operative Chemotherapy Followed by Surgery for N2 Non-Small Cell Lung Cancer: A 15-Year Experience (ID 3152)

      09:30 - 09:30  |  Author(s): J. Roth

      • Abstract

      Background:
      The ideal approach to patients with N2 non-small cell lung cancer (NSCLC) remains controversial. While pathological confirmation of nodal status is advocated, in clinical practice patients with suspicious radiographic evidence of N2 disease are frequently assigned to pre-operative therapy without pathological confirmation. Herein, we review our experience with pre-operative chemotherapy followed by surgery in patients with N2 NSCLC and compare outcomes of biopsy proven N2 disease and those patients who were diagnosed based on PET/CT alone.

      Methods:
      A prospectively entered institutional database was accessed to identify all patients with N2 NSCLC treated by pre-operative chemotherapy followed by surgery from 1999 to 2014. Data were verified by chart review. Patients without biopsy or PET-based evidence of N2 disease were excluded.

      Results:
      We identified 113 patients of whom 57 had biopsy proof of cN2 and 56 were cN2 based on PET-positivity. See Table 1 for patient demographic and clinico-pathologic variables. Median survival for the cohort was 53.3 months and there was only 1 (0.88%) peri-operative death at 90 days. Three and 5-year survival rates were 63.8% and 39.7%, respectively. Locoregional recurrences occurred in 16.8% of patients. Induction chemotherapy resulted in a significant PET response (SUV reduction > 6) in 38.5% of cases (15/39) where pre- and post-treatment imaging was available. Only 8.77% of patients remained pN2 after pre-operative chemotherapy in those patients who had pre-treatment pathological confirmation. No survival differences were noted between patients with biopsy proven N2 and those with PET-positive N2 nodes (Figure 1).

      Demographic and clinico-pathologic variables.
      Variables Biopsy proven N2 (N=57) PET positive N2 (N=56) P value Total cohort (N=113)
      Median age (range) 64(38-80) 62(43-77) 0.763 63(38-80)
      Male gender 25(46.3) 28(54.90) 0.378 53(50.48)
      Mean FEV1 (%pred) 85.78 86.54 0.798 86.16
      Mean DLCO (%pred) 81.89 82.28 0.916 82.08
      Type of surgery 0.743
      Wedge/Segmentectomy 3(5.26) 4(7.14) 7(6.19)
      Lobectomy 48(84.21) 44(78.57) 92(81.42)
      Pneumonectomy 6(10.53) 8(14.29) 14(12.39)
      Post-operative treatment 0.094
      None 24(42.11) 27(48.21) 51(45.13)
      Chemo 1(1.75) 15(26.79) 6(5.31)
      Radiation 6(5.31) 9(16.07) 41(36.28)
      Chemoradiation 6(10.53) 9(16.07) 9(16.07)
      Pathological N stage 0.090
      N0 20(35.09) 22(39.29) 42(37.17)
      N1 32(56.14) 22(39.29) 54(47.79)
      N2 5(8.77) 12(21.43) 17(15.04)
      Figure 1



      Conclusion:
      Pre-operative chemotherapy followed by surgery for N2 NSCLC in a well-selected cohort results in good short and long-term outcomes. When pathological confirmation of N2 disease requires invasive staging, it may be acceptable to forgo such tests without compromising patient outcomes. Further prospective studies are needed to determine the ideal treatment regimen for these complex patients.