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Hak Choy



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    MA 13 - New Insights of Diagnosis and Update of Treatment (ID 674)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Early Stage NSCLC
    • Presentations: 1
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      MA 13.08 - Long Term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927): a Randomized Phase II Study of 2 SBRT Schedules for Lung Cancer (ID 7390)

      15:45 - 17:30  |  Author(s): Hak Choy

      • Abstract
      • Presentation
      • Slides

      Background:
      NRG Oncology RTOG 0915/NCCTG N0927 was a randomized lung stereotactic body radiotherapy (SBRT) trial of 34 Gy in 1 fraction (arm 1) versus 48 Gy in 4 fractions (arm 2) designed to select the better of the 2 regimens by comparing them at 1 year (yr): first by rates of pre-specified protocol-specified adverse events (psAEs), then by primary tumor control for each arm. 34 Gy emerged as the least toxic yet equally efficacious regimen. Herein, we update those results with long-term follow-up.

      Method:
      This phase II North American multicenter study of patients aged 18 yrs or older with medically inoperable non-small cell lung cancer with biopsy-proven peripheral (≥2 cm from the central bronchial tree) T1 or T2, N0 (clinically node negative by positron emission tomography), M0 tumors was designed to detect 1-yr psAEs rates >17% as primary endpoint. Primary tumor failure (PTF) (either infield or marginal failure) and local failure (either infield, marginal, or involved lobe failure) [with death without failure considered as a competing event]; overall survival (OS); disease-free survival (DFS) and progression-free survival (PFS) were secondary endpoints, but the study was not designed for statistical comparisons of these outcomes. The study opened in September 2009 and closed in March 2011. Updated data were analyzed through November 14, 2016.

      Result:
      Ninety four patients were accrued, with 86 eligible for analysis: 41 in arm 1 and 45 in arm 2, after 8 cases were excluded. Median follow-up time was 3.8 yrs for all patients, and 5.1 yrs for those alive at analysis. The grade 3 and higher treatment-related toxicity profile was unchanged since previous report, with specifically no new high grade chest wall or grade 5 events. Four of 48 Gy patients had subsequent grade 3 changes in spirometry since meeting the primary endpoint. Medians (in yrs) for 34 Gy and 48 Gy were: 4.1 vs. 4.0 for OS, and 2.6 vs. 2.8 for DFS, respectively. Five-yr outcomes as % (95% CI) for 34 Gy and 48 Gy were: PTF rate of 7.9 (2.0, 19.5) vs. 6.8 (1.7, 16.9); OS of 28.8 (15.4, 43.8) vs. 40.2 (24.9, 55.0); PFS of 19.1 (8.5, 33.0) vs. 31.8 (18.6, 45.9); and second primary rate of 15.5 (6.1, 28.9) vs. 13.3 (5.3, 25.1), respectively. Distant failure as the sole failure or a component of first failure was numerically higher in the 34 Gy arm (7 (46.7%)), but in the 48 Gy arm, rate of second primary development was higher (7 (43.8%)). Approximately 1/3 of patients’ causes of death was unknown, and another 1/3 was related to causes other than cancer or treatment.

      Conclusion:
      No excess in late-appearing toxicity was seen in either arm. Primary tumor control rates at 5 yrs were similar by arm. Median survival times of 4 yrs for each arm suggest similar efficacy pending any larger studies appropriately powered to detect survival differences.

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    P3.08 - Locally Advanced Nsclc (ID 724)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Locally Advanced NSCLC
    • Presentations: 1
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      P3.08-004 - Phase I/II Trial of Nab-Paclitaxel or Paclitaxel Plus Carboplatin with Concurrent Radiation for Inoperable Stage IIIA/B NSCLC (ID 10220)

      09:30 - 16:00  |  Author(s): Hak Choy

      • Abstract
      • Slides

      Background:
      To determine the overall survival of Nab-Paclitaxel (Nab) or Paclitaxel (P) plus Carboplatin (C) with concurrent radiation therapy (RT) followed by consolidative chemotherapy (CT) with Nab-C or PC for patients (pts) with Stage IIIA/B Non-small cell lung cancer (NSCLC) when compared to historical controls and to assess for the safety of each regimen to guide further investigation

      Method:
      This phase I/II trial randomized 98 pts (6 pts phase I; 92 pts phase II). 75 pts were eligible for analysis on the phase II portion. For the phase I portion, weekly 50mg/m[2] of Nab and C AUC 2 was administered with concurrent thoracic RT (60-66 Gy) followed by CT comprising 100mg/m[2] Nab on days 1,8,15 (of a 21 day cycle) and C AUC 6 on day 1 for 2 cycles. For the randomized phase II portion, patients received either arm A) weekly 50mg/m[2] P and C AUC 2 or arm B) weekly 40mg/m[2] of Nab and C AUC 2 with concurrent RT followed by consolidative 200mg/m[2] P and C AUC 6 every three weeks for 2 cycles or 100mg/m[2] Nab on days 1,8,15 (of a 21 day cycle) and C AUC 6 on day 1 for 2 cycles. The primary end point was 2-year overall survival of 50% or greater.

      Result:
      Median follow up was 14.3 months. 2 patients experienced dose-limiting toxicities on the phase I portion as defined per protocol (grade 3 febrile neutropenia and grade 4 thrombocytopenia) leading to a dose reduction of concurrent Nab from 50mg/m[2 ]to 40mg/m[2] for the phase II portion. On the Phase II portion, Grade 3+ esophagitis was 3 and 2 pts, Grade 3+ pneumonitis was 3 and 5 pts and Grade 4+ hematological adverse events was 3 and 8 pts on A and B arms respectively. The 1- and 2-year overall survival rates for arm A and B were 80.6% (95%CI 63.4-90.3) and 69.2% (51.2-81.7); and 72.5% (48.4-86.8) and 56.5% (33.7-74.1) respectively. The 1- and 2-year progression free survival were 57.5% (38.7-72.5) and 46.1% (29.2-61.5); and 45.5% (24.7-64.3) and 20.7% (6.5-40.3) for arm A and B respectively.

      Conclusion:
      For pts with locally advanced Stage IIIA/B NSCLC, both arms A and B provided 2-year overall survival rates greater than 50%. The addition of Nab to chemoradiation was overall well tolerated, prompting potential interest going forward. Further analyses of quality of life measurements are currently underway. This project was supported by Celgene. Clinical Trial information: NCT01757288

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    PC 01 - 1-1. Surgery vs Non-Surgical Local Treatment for Small-Sized NSCLC (ID 581)

    • Event: WCLC 2017
    • Type: Pros & Cons
    • Track: Early Stage NSCLC
    • Presentations: 1
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      PC 01.01 - SABR as First Line Treatment Option (ID 7822)

      15:45 - 16:45  |  Presenting Author(s): Hak Choy

      • Abstract
      • Presentation
      • Slides

      Abstract:
      Surgery has historically been the primary treatment option for patients with Stage I non–small-cell lung cancer (NSCLC). Although Stage I NSCLC is technically curable, the presence of significant co morbidity increases the risk of postoperative complications and reduces the potential role of surgery even early stage NSCLC. Because nonsurgical treatment options such as conventional radiotherapy have historically achieved suboptimal outcomes, some have argued that the risks associated with surgery in patients with severe COPD were justified. The reason for poor tumor control with conventional radiation therapy has been shown to be due to insufficient total radiation doses which is usually 60 Gy or lower. Dose escalation with CRT have shown that a total dose of just above 80 Gy seems to be tolerable while doses exceeding 90 Gy, necessary for optimal tumor control, were associated with high risk of unacceptable lung toxicity. Since the 2000s, stereotactic body radiation therapy has rapidly spread as medical physics improved. Stereotactic body radiation therapy has been revealed to be equivalent to surgery in tumor ablation. With stereotactic body radiotherapy (SBRT) the radiation dose to normal tissue is minimized and the dose per fraction can be increased resulting in biologic doses up to twice as high as in CRT. This has resulted in improvement of local tumor control rates up to 88% to 100%, comparable to the rates after surgery. SBRT is a safe and effective treatment option for these patients, with outcomes that do not appear to be inferior to surgery. SBRT is not associated with the considerable initial risks of operative mortality and prolonged hospitalization. Patients who do undergo surgery may benefit from avoiding open lobectomy, instead using less invasive approaches such as video-assisted thoracoscopic surgery or open segmentectomy. All patients with Stage I NSCLC and severe COPD should be evaluated in a multidisciplinary setting and afforded an informed decision of the risks and benefits of both surgery and SBRT. In role of SBRT can also be extended even in patients with oligometastases and oligo-recurrence, the oligometastases and oligo-recurrence who sometimes cured with only local therapy. Radiotherapy (RT) can cause immunogenic tumor cell death resulting in cross-priming of tumor-specific T-cells, acting as an in situ tumor vaccine; however, SBRT alone has limit in inducing effective anti-tumor immunity resulting in systemic tumor rejection. Immunotherapy can complement SBRT to help overcome tumor-induced immune suppression, as demonstrated in many pre-clinical tumor models. There are many trials underway for combinations of different immunotherapies and SBRT.

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