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P. Balter



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    MINI 37 - SCLC Therapy (ID 165)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Small Cell Lung Cancer
    • Presentations: 1
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      MINI37.10 - Factors Associated with Severe Pneumonitis for Limited Stage Small Cell Lung Cancer (ID 1714)

      18:30 - 20:00  |  Author(s): P. Balter

      • Abstract
      • Presentation
      • Slides

      Background:
      Pneumonitis is a major side effect for the treatment of limited stage small cell lung cancer with concurrent chemotherapy and radiotherapy (CChRT). Prevention is more important than treatment when patients develop grade 3-5 severe pneumonitis (SP). We investigated factors causing SP among patients with limited stage small cell lung cancer (SCLC) treated by CChRT.

      Methods:
      This is a retrospective analysis of 559 patients with limited-stage SCLC treated at a single institution from 1986-2009 with definitive CChRT to a total dose of 45-70 Gray (Gy). Candidate variables included tumor size, year of diagnosis & treatment period (1986-1999 vs. 2000-2009), gender, age, Karnofsky’s Performance Status (KPS), ethnicity, radiation dose, cycles of induction chemotherapy, use of intensity-modulated-radiation-therapy (IMRT) and fractionation. CTCAE v2 before 2003 and CTAE v3 in 2003-2009 were used to evaluate SP Grade 3-5 which were similar. Chi-square test was used for between group comparisons for categorical variables and the median test was used for between group comparisons for continuous variables. Kaplan-Meier estimates were constructed for overall survival (OS), disease-free survival (DFS), local-recurrence-free survival (LRFS), distant metastasis-free survival (DMFS). Analysis was performed using Logistic regression analysis with SP as the primary endpoint.

      Results:
      Of the 559 patients included in this analysis, tumor size was available for 520 patients. Median follow-up was 21.2 months (range 1.2-240.8). Thirty-five (6.2%) patients developed SP (26 Grade-3, 8 Grade-4 & 1 Grade-5). 2D or 3DCRT was used before 2000 and IMRT was usually used for small cell lung cancer in 2000-2009. Univariate analysis (UVA)showed that SP was associated with treatment given in 2000-2009 ( OR 3.93, P<001) ,age ≥ 60 (OR 7.72, P=0.001) ,KPS < 90 (OR 2.22, P=0.02), IMRT (OR 2.3, P= 0.026) and twice daily fractionation( OR 2.38, P=0.03).Induction Chemotherapy reduced SP (OR 0.39, P= 0.023) compared to immediate CChRT. Tumor size (at cut points 3 cm & 5 cm) did not make significant difference regarding SP. Multivariate analysis (MVA) has shown that significantly higher SP was associated with treatment given in 2000-2009 (OR 3.42, P=0.006), age ≥ 60 (OR 7.77, P= 0.001), male (OR 2.12, P=0.047)and twice daily RT (OR 2.45, P=0.026) . OS was significantly reduced among SP group vs. Pneumonitis ≤ Grade 2 (MST 17.9 vs.25 months, P= 0.038) (5-year OS 16 % vs. 27%), respectively. SP were not significantly correlated with DFS, LRFS and DMFS.

      Conclusion:
      Significantly higher SP was seen among patients with limited stage small treated in 2000-2009, age ≥ 60, male and twice daily RT. OS was significantly reduced SP. UVA showed IMRT causing significantly higher SP. MVA did not show IMRT was a significant factor for SP. Tumor size did not show significant difference regarding SP.

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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 - 17:00  |  Author(s): P. Balter

      • 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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