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George Rodrigues
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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): George Rodrigues
- Abstract
- Presentation
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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P2.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 961)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.12-10 - Novel Prognostic Model for Limited-Stage Small-Cell Lung Cancer (ID 13999)
16:45 - 18:00 | Author(s): George Rodrigues
- Abstract
Background
There is currently no prognostic model designed specifically for patients with limited-stage small cell lung cancer (SCLC). The objective of this study was to construct a novel prognostic model for this patient population using baseline characteristics readily available in clinic.
a9ded1e5ce5d75814730bb4caaf49419 Method
An institutional retrospective consecutive patient database was constructed by reviewing the charts of patients diagnosed with limited-stage SCLC between January 2000 and December 2013. Baseline patient characteristics, treatment details and outcomes were extracted. The primary endpoint for the prognostic model was overall survival (OS) and the secondary endpoint was progression-free survival (PFS). Univariable and multivariable Cox regression analyses were performed to identify variables associated with OS and PFS. Prognostic models were generated using recursive partitioning analysis (RPA).
4c3880bb027f159e801041b1021e88e8 Result
A total of 398 patients were eligible for analysis. Median follow-up was 8.2 years. The median age was 67 (range: 40-87). Overall, 94% of patients received chemotherapy, 82% received radiotherapy and 65% received both concurrently. Both hypofractionated (40 Gy in 15 fractions) and conventionally-fractionated (50-66 Gy in 25-33 fractions) radiotherapy were used. Prophylactic cranial irradiation was used in 45% of patients. The median OS for the entire cohort was 15.4 months, with a 5-year OS of 19.7%. Overall median PFS was 9.3 months, with a 5-year PFS of 14.1%. On multivariable Cox regression, age, Eastern Cooperative Oncology Group (ECOG) performance status, tumor location and baseline presence of any pleural effusion (non-malignant or unknown status) were prognostic of OS, while performance status and T-stage were prognostic of PFS. RPA model of OS divided patients into favorable (ECOG 0-2, no pleural effusion, middle/upper lobe location: 5-year OS 31%), intermediate (ECOG 0-2, no pleural effusion, non-middle/upper lobe location: 5-year OS 21%) and unfavorable (ECOG 3-4 or any pleural effusion: 5-year OS 5-8%) groups (log-rank p < 0.001). RPA for PFS divided patients into favorable (ECOG 0-2, <=T3: 5-year PFS 21%) and unfavorable (ECOG 3-4 or T4: 5-year PFS 5-9%) groups (log-rank p < 0.001).
8eea62084ca7e541d918e823422bd82e Conclusion
Novel prognostic factors for OS and PFS based on baseline patient characteristics were successfully identified for patients with limited-stage SCLC. RPA prognostic models were able to separate patients into distinct risk groups for OS and PFS. Our results will benefit from further external validation and can be useful in stratifying patients in future prospective studies.
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P2.12-13 - Effectiveness of Hypofractionated Thoracic Radiotherapy in Limited-Stage Small-Cell Lung Cancer: A Propensity Score Analysis (ID 13513)
16:45 - 18:00 | Author(s): George Rodrigues
- Abstract
Background
Hypofractionated thoracic radiotherapy may be advantageous in limited-stage small-cell lung cancer (LS-SCLC) due to shorter overall treatment times, decreased resource utilization, and patient convenience. However, there are no randomized data comparing hypofractionated radiotherapy (HFRT; defined as 40-45 Gy in 15-20 fractions) and high dose conventionally-fractionated radiotherapy (CFRT; defined as >= 60 Gy in 2 Gy fractions) in LS-SCLC patients. The objective of this study was to compare the survival outcomes and toxicities of HFRT and CFRT using propensity score-matched retrospective data to simulate the setting of a clinical trial.
a9ded1e5ce5d75814730bb4caaf49419 Method
This retrospective study examined institutional records of patients diagnosed with LS-SCLC between January 2000 and December 2013 who were treated with HFRT or CFRT. Propensity scores were estimated by logistic regression using age, performance status, concurrent chemoradiation usage and prophylactic cranial irradiation (PCI) usage. Nearest neighbor-matching was performed on a 1:1 basis using a caliper distance of 0.1, without replacement. Overall survival (OS) and progression-free survival (PFS) endpoints were estimated by the Kaplan-Meier method and compared with log-rank tests. Cumulative incidences of normal tissue toxicity were compared with Fisher’s exact tests. A two-sided significance level of 0.05 was used.
4c3880bb027f159e801041b1021e88e8 Result
Among 398 LS-SCLC patients reviewed, 57 patients treated with HFRT and 61 patients treated with CFRT were included in the unmatched analysis. Five-year OS was 26% for the HFRT cohort and 24% for the CFRT cohort (p = 0.82). Five-year PFS was 22% for both cohorts (p = 0.79). Significant differences in age, performance status, concurrent chemoradiation usage and PCI usage were noted in the unmatched cohorts. After propensity score-matching, the balanced cohorts each contained 37 patients. Five-year OS was 25% and 27% (p = 0.72) and 5-year PFS was 25% and 24% (p = 0.63), respectively for the HFRT and CFRT cohorts. Incidence of any esophageal toxicity was not significantly different between the cohorts (92% HFRT vs. 84% CFRT, p = 0.60), though there was a trend towards a higher incidence of any pulmonary toxicity in the CFRT cohort (59% vs. 38%, p = 0.06). Skin toxicity was significantly higher for CFRT (39% vs. 14%, p = 0.01).
8eea62084ca7e541d918e823422bd82e Conclusion
OS and PFS were similar between HFRT and CFRT in balanced cohorts. HFRT was associated with a potentially reduced incidence of pulmonary and skin toxicity. As such, HFRT could result in an improved therapeutic ratio in patients with LS-SCLC. A randomized controlled trial would provide level 1 evidence in this comparison.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P3.04 - Immunooncology (Not CME Accredited Session) (ID 970)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.04-19 - Do Advanced Lung Cancer Patients Derive Similar Survival Benefits from Immunotherapy? A Systematic Review and Meta-Analysis (ID 12649)
12:00 - 13:30 | Author(s): George Rodrigues
- Abstract
Background
Checkpoint inhibitors targeting the programmed death-1 (PD-1)/PD-ligand 1 (L1) pathway have become a standard treatment in advanced non-small cell lung cancer (NSCLC) in the first and second line setting. Yet, subgroup analyses from randomized trials have shown inconsistent results regarding survival benefit in elderly patients (> 65 years old), never-smokers and patients with PD-L1 (-) expressing tumors (<1%). We conducted a systematic review and meta-analysis to assess the efficacy of checkpoint inhibitors in these pre-defined subgroups of patients.
a9ded1e5ce5d75814730bb4caaf49419 Method
The electronic databases PubMed and EMBASE, were searched for relevant randomized trials between January 2005 and December 2017. Pooled hazard ratios (HR) for overall survival (OS) and progression free survival (PFS) were meta-analyzed using the generic inverse variance method. To account for between-studies heterogeneity, random-effect models were used to compute pooled estimates. Subgroup analyses compared patients treated in the first versus second line setting.
4c3880bb027f159e801041b1021e88e8 Result
Seven studies were included. Compared to chemotherapy, a significant reduction in the risk of death was seen with the use of checkpoint inhibitors in the second line independent of PD-L1 expression (4 studies, 2,364 participants, HR=0.79, 95%CI 0.66-0.96 and HR=0.66, 95%CI 0.57-0.78 in PD-L1 (–) and (+) patients respectively). Yet, a PFS benefit was only seen in patients with PD-L1 (+) tumors (2 studies, 852 participants, HR=0.69, 95%CI 0.55-0.88). Similarly, an OS benefit was seen in patients independent of age (5 studies, 3,651 participants, HR=0.77, 95%CI 0.64-0.92 and HR=0.75, 95%CI 0.6-0.94 in elderly and non-elderly patients respectively). Conversely, an OS benefit was only seen in ever-smokers (5 studies, 2,905 participants, HR=0.76, 95%CI 0.63-0.92 in ever-smokers and HR=0.83, 95%CI 0.64-1.08 in never-smokers) and a detrimental effect on PFS in never-smokers (3 studies, 1,426 participants, HR=1.68, 95%CI 1.07-2.63). In subgroup analyses, with the use of checkpoint inhibitors, elderly patients derived an OS benefit only in the second line setting (HR=0.69, 95%CI 0.59-0.81). Furthermore, never-smokers had no OS benefit in the first or second line (HR=1.02, 95%CI 0.54-1.93 and HR=0.79, 95%CI 0.59-1.07 respectively) and worse PFS particularly in the first line (HR=2.3, 95%CI 1.23-4.3).
8eea62084ca7e541d918e823422bd82e Conclusion
In the second line setting, patients with advanced NSCLC derive a survival benefit from checkpoint inhibitors independent of tumor PD-L1 expression and age. However, never-smokers do not benefit from these drugs particularly in the first line. Caution should be exercised when offering checkpoint inhibitors to elderly patients with advanced NSCLC in the first line and further research is needed to define their role in never-smokers.
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