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J. Welsh
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P2.02 - Poster Session with Presenters Present (ID 462)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.02-037 - Final Results of Prospective Phase II Study of Adding Erlotinib to Chemoradiation for patients with Stage III Non-Small-Cell Lung Cancer (ID 5748)
14:30 - 14:30 | Author(s): J. Welsh
- Abstract
Background:
Concurrent chemoradiotherapy is the standard of care for inoperable stage III non-small cell lung cancer (NSCLC) patients. We explored if adding erlotinib would increase the effectiveness of chemoradiotherapy, since we have demonstrated radiation sensitization by erlotinib in a preclinical setting using a mouse model.
Methods:
48 patients with stage III NSCLC, PS 0-1, received radiotherapy (63 Gy/35 fractions) on Monday‒Friday, with chemotherapy (paclitaxel 45 mg/m², carboplatin AUC=2) on Mondays, for 7 weeks. All patients also received EGFR-TKI erlotinib (150 mg orally 1/day) on Tuesday–Sunday for 7 weeks followed by consolidation paclitaxel–carboplatin. The primary endpoint was time to progression; secondary endpoints were overall survival (OS), toxicity, response, and disease control and whether any endpoint differed by EGFR mutation status.
Results:
46 out of 48 patients were evaluable for response; 40 were former or never smokers and 41 were evaluated for EGFR mutation status: 37 were wild-type and 4 were found to have mutation (3 exon 19 deletion, 1 exon 21 mutation). Median time to progression was 14 months and did not differ based on EGFR mutation status. Toxicity was acceptable: no grade 5 toxicity, I grade 4, and 11 grade 3). Twelve (26%) had complete responses (10 with wild type (wt) and 2 with mutation (mt) and 1 unknown). At 73.5 months median follow-up (range 46.2 - 93.7 months), 2 and 5 year OS rates were 67.4 % and 36.25%; there were no significant differences by mutation status. Twelve patients had no progression and 34 had local and/or distant metastasis. All 4 patients with EGFR mutation had local control. Eleven of 27 patients failed in the brain (7 wt, 3 mt and 1 unknown).
Conclusion:
Toxicity was acceptable and OS was promising, but time to progression did not meet expectations. The prevalence of distant failures underscores the need for effective systemic therapy. Those patients with EGFR mutation might need induction erlotinib followed by local treatment when they fail locally in the lung or brain which is fairly frequent among EGFR mutated patients.
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P2.05 - Poster Session with Presenters Present (ID 463)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Radiotherapy
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.05-015 - Long-Term Outcomes of Prospective Phase П Clinical Trial for Stereotactic Ablation Radiotherapy in Recurrent NSCLC (ID 5386)
14:30 - 14:30 | Author(s): J. Welsh
- Abstract
Background:
To evaluate the long-term efficacy, pattern of failure, and toxicity of stereotactic ablative radiotherapy (SABR) for recurrent or multiple primary non-small-cell lung cancer (NSCLC).
Methods:
Patients with histologically confirmed, [18]F-fluorodeoxyglucose ([18]F-FDG)-PET staged, recurrent or multiple primary NSCLC, suitable for SABR (<5 cm, not abutting critical structures, met with SABR dose volume constraints),were prospectively enrolled and treated with volumetric image-guided SABR to 50 Gy in 4 fractions (prescribed to planning target volume). Lobar recurrent disease was defined as recurrence in the same lobe with the same histology after definitive therapy from prior NSCLC (n=9); recurrent or oligo-metastatic disease (<3 lesions) was defined as recurrence with same histology within four years in different lobe (n=35). Multiple primary NSCLC was defined as secondary NSCLC with either different histology, or same histology but located in the different lobe with more than 4 years after initial definitive treatment of prior NSCLC (n=16); synchronous tumors was defined as with two early stage NSCLC in the different side (n=3). Four-dimensional computed tomography (4DCT) was used for simulation and planning. Patients were followed with CT or PET/CT every three months for two years, then every 6 months for three years and then annually.
Results:
From February 2006 to April 2013, 63 patients were enrolled and eligible for evaluation. The median age was 70 years (range 45-86) and median follow-up was 4.2 years (the interquartile range 3.0-7.3 years). A total of 5 (7.9%) patients developed cumulative actual local recurrence within PTV and 18 patients (28.6%) developed any cumulative actual recurrence (local, regional and distant) after SABR. Estimated total local failure rates in the same lobe at 3-, 5-year were both 11.2% (95% CI 6.8-15.6). Estimated 3-, 5-year PFS rates were 60.2% (95% CI 53.7-66.7) and 52.6% (95% CI 43.5-61.7), respectively; corresponding overall survival rates were 64.1% (95% CI 58.0-70.2) and 52.9% (95% CI 45.5-60.3). Three (4.8%) patients developed grade 3 treatment-related adverse events (one [1.6%] dermatitis, one [1.6%] chest wall pain, and one [1.6%] radiation pneumonitis). No patient had grade 4 or 5 event.
Conclusion:
This exploratory prospective study showed excellent 5 years local control, minimal toxicity and outstanding 5 years OS and PFS for recurrent or multiple primary NSCLC treated with SABR, indicating a potential cure for some patients. Close follow up and surveillance after initial definitive treatment should be considered to detect early recurrence in NSCLC.
