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Brian Yaremko



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    OA06 - Early Stage Lung Cancer: Outcomes and Interventions (ID 902)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Treatment of Early Stage/Localized Disease
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 13:30 - 15:00, Room 202 BD
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      OA06.06 - MISSILE-NSCLC: A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early-Stage Non-Small Cell Lung Cancer (ID 13028)

      14:25 - 14:35  |  Author(s): Brian Yaremko

      • Abstract
      • Presentation
      • Slides

      Background

      Stereotactic Ablative Radiotherapy (SABR) has emerged as a standard treatment option in patients with medically inoperable early-stage non-small cell lung cancer (NSCLC), yet the pathologic complete response (pCR) rate after SABR is unknown. Neoadjuvant SABR in operable patients has been proposed as a mechanism of improving local control and inducing anti-tumor immune activity.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This phase II study (NCT02136355) enrolled patients with biopsy-proven clinical T1-2N0M0 NSCLC who were candidates for surgical resection. Patients underwent neoadjuvant SABR using a risk-adapted fractionation of 54 Gy/3 fractions, 55 Gy/5 or 60 Gy/8. Surgical resection took place 10 weeks after SABR. Patients also underwent dynamic FDG-PET and dynamic contrast-enhanced CT prior to SABR and approximately 2 weeks prior to surgery. The primary endpoint was the pCR rate, and secondary endpoints included local, regional, and distant recurrence, quality of life using the FACT Trial Outcome Index (TOI), and toxicity.

      4c3880bb027f159e801041b1021e88e8 Result

      Accrual began in Sept 2014 and completed in August 2017 with 40 patients enrolled. Median age was 69 years (range 44–83 years), and 58% were female. Thirty-one patients (78%) had T1 tumors and 9 (23%) had T2 tumors; histology was adenocarcinoma (n=26; 65%), squamous cell (n=13; 33%) and NSCLC not otherwise specified (n=1; 3%). Baseline FEV1 was median 73% percent predicted (range 50%–117%). Nine patients (23%) received the 3-fraction regimen, 21 (53%) received 5 fractions and 10 (25%) received 8 fractions. Thirty-five patients underwent surgery and were evaluable for the primary endpoint. The pCR rate was 60% (95% CI 44%–76%). 30-day and 90-day post-surgical mortality rates were both 0%. Eighteen percent of patients had grade 3 or 4 toxicities, most commonly pulmonary in nature (Grade 4: atelectasis and respiratory failure [n=1]; Grade 3: pneumonia/pneumonitis [n=2]; bronchopleural fistula [n=1]). In the patients receiving surgery, 2-year outcomes were: overall survival 77%, local control 100%, regional control 53% and distant control 76%. There were no significant changes in FACT-TOI score within the first year of follow-up.

      8eea62084ca7e541d918e823422bd82e Conclusion

      The pCR rate after SABR for T1 and T2 NSCLC was 60%. Toxicity of the combined approach appears favorable, compared to historical series of surgery alone, and there was no perioperative mortality. Larger studies are needed to determine the clinical role of this combined treatment approach.

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