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A. Jemal
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MINI 20 - Surgery (ID 137)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:G. Veronesi, R. Flores
- Coordinates: 9/08/2015, 16:45 - 18:15, 201+203
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MINI20.02 - Risk-Adjusted Margin Positivity (RAMP) Rate as a Surgical Quality Metric for Non-Small-Cell Lung Cancer in the US National Cancer Data Base (NCDB) (ID 1247)
16:45 - 18:15 | Author(s): A. Jemal
- Abstract
- Presentation
Background:
Surgical resection is the most important curative treatment modality for early-stage non-small-cell lung cancer (NSCLC). However, incomplete (margin-positive) resection is associated with inferior survival. We sought to develop a valid facility-based quality metric to measure surgical quality, adjusting related patient demographic and clinical characteristics.
Methods:
We identified facilities that performed cancer-directed surgery for patients diagnosed with AJCC stage I-IIIA NSCLC in the NCDB between 2004 and 2011. We used a multivariate logistic regression model, adjusting for patient risk-mix in each facility, to predict the expected number of risk-adjusted margin positivity (RAMP) cases for each facility. We divided the number of observed margin positivity (OMP) cases by the expected number of RAMP cases to obtain an observed: expected (O/E) ratio for each facility. We categorized facility performance as low outlier (O/E ratio<1 and p<.05), high outlier (O/E ratio>1 and p<.05), or non-outlier. Facility characteristics across performance categories were compared by chi-square test. Five-year unadjusted overall survival (OS) rates were estimated by Kaplan-Meier analyses and compared across categories with the log-rank test.
Results:
A total of 96,596 NSCLC stage I-IIIA patients underwent surgery in 941 facilities. The overall OMP rate was 4.6%. We identified 73 facilities as low outliers (mean O/E ratio=0.41), 755 as non-outliers (mean O/E ratio=1.28) and 113 as high outliers (mean O/E ratio=2.78). Compared to patients treated at high-outlier facilities, patients treated at low-outliers were more likely to be privately insured (34.7%[Low] vs. 32.9%[High]), reside in high-income neighborhoods, have no comorbidity (51.7% [Low] vs. 41.9 [High], p<.001), have adenocarcinoma (62.4%[Low] vs. 58.1%[High], p<.001), stage IA disease (41.6%[Low] vs. 39.6%[High], p<.001) and receive sub-lobectomy (11.7%[Low] vs. 9.9%[High], p<.001). Low-outlier facilities were more likely to be teaching/research or NCI-designated programs (54.8% [Low] vs. 18.5% [High], p<.001) and in the highest quartile of total cancer surgical volume (90.4% [Low] vs. 34.5% [High], p<.001) and lung cancer surgery volume (42.5% [Low] vs. 29.2% [High], p<.001) (Table 1). They also had smaller proportions of uninsured/Medicaid patients (45.2% [Low] vs. 36.2% [High], p=.006). The 5-year unadjusted OS estimates were: 0.62 (low-outliers), 0.58 (non-outliers), 0.57 (high-outliers); log-rank p<.001. Table 1. Facility characteristics across performance categoriesHigh-Outlier(N=113) Non-Outlier(N=755) Low-Outlier(N=73) p-value N(%) Census_region Northeast 18(15.9) 154(20.4) 19(26.0) 0.03 Midwest 39(34.5) 223(29.5) 15(20.6) South 37(32.7) 257(34.0) 35(48.0) West 19(16.8) 121(16.0) 4(5.5) Facility_type Community_Cancer_Program 23(20.4) 164(21.7) 0(0.0) <0.001 Comprehensive_Community_Cancer_Program 62(54.9) 419(55.5) 28(38.4) Teaching/Research 17(15.0) 128(17.0) 28(38.4) NCI_program 4(3.5) 17(2.3) 12(16.4) Other 7(6.2) 27(3.6) 5(6.9) Proportion_of_Medicaid/uninsure_patients Q1(low) 25(22.1) 206(27.3) 13(17.8) 0.006 Q2 16(14.2) 204(27.0) 20(27.4) Q3 41(36.3) 174(23.1) 21(28.8) Q4(high) 31(27.4) 171(22.7) 19(26.0) Lung_cancer_surgery_as_a_proportion of_all_surgery Q1(low) 8(7.1) 73(9.7) 0(0.0) <0.001 Q2 37(32.7) 224(29.7) 9(12.3) Q3 35(31.0) 226(29.9) 33(45.2) Q4(high) 33(29.2) 232(30.7) 31(42.5) Total_cancer_surgery_volume Q1(low) 12(10.6) 98(13.0) 0(0.0) <0.001 Q2 32(28.3) 193(25.6) 0(0.0) Q3 30(26.6) 253(33.5) 7(9.6) Q4(high) 39(34.5) 211(28.0) 66(90.4)
Conclusion:
Facility performance in lung cancer surgery can be captured by using the RAMP rate. Low-outlier facilities delivered superior OS than high-outliers. RAMP metrics could allow facilities to understand their performance and serve as a quality improvement benchmark.
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ORAL 20 - Chemoradiotherapy (ID 124)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:G. Blumenschein, J.Y. Chang
- Coordinates: 9/08/2015, 10:45 - 12:15, 201+203
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ORAL20.07 - Survival Impact of Post-Operative Therapy Modalities after Incomplete and Complete Surgical Resection for Non-Small Cell Lung Cancer in the US (ID 1417)
10:45 - 12:15 | Author(s): A. Jemal
- Abstract
- Presentation
Background:
Incomplete resection of potentially curable Non-Small Cell Lung Cancer (NSCLC) is a significantly negative clinical event for which adjuvant radiotherapy, chemotherapy, or combined chemo-radiotherapy is often used to reduce mortality risk. After complete (R0) resection, randomized controlled trials and the PORT meta-analysis show radiotherapy to be harmful to patients with stage I-II disease, and of marginal benefit in patients with N2-positive stage IIIA. After incomplete resection (R1/R2), current National Comprehensive Cancer Network (NCCN) guidelines recommend radiotherapy for stage IA/IB and chemo-radiotherapy for patients with stage IIA-IIIA. Adjuvant therapy recommendations after R1/R2 resection have never been verified.
Methods:
With the objective of validating NCCN post-operative therapy guidelines, we evaluated patients with surgically resected pathologic stage I-IIIA NSCLC in the National Cancer Data Base from 2004-2011. Recipients of pre-operative adjuvant therapy and those with no lymph nodes examined were excluded. Post-operative therapy modalities were classified as chemotherapy, radiotherapy, chemo-radiotherapy, or no treatment. Analyses were adjusted for patient demographic, clinical, and surgical characteristics, as well as institutional characteristics. Analyses were conducted by margin status and stage groups based on NCCN classifications (Table I). Unadjusted stage-specific 5-year overall survival (OS) estimates were calculated based on the Kaplan-Meier method and compared across post-treatment modalities with the log-rank test. Survival was modeled with Extended Cox Regression to adjust for all covariates and allow for non-proportional hazards.
Results:
Among 98,176 NSCLC patients who underwent curative-intent surgery during 2004-2011, 48% were male, 79% white, 34% privately insured, and 58% Medicare insured, with a median age of 68 years. The 5-year OS estimates by treatment modality are shown in Table I (NCCN recommendations highlighted). Margin negative patients with stage IA or IB/IIA who received post-operative radiotherapy had significantly lower OS compared to those with no treatment (both p-values<0.0001). We also observed lower OS with post-operative radiotherapy in margin positive patients with stage IA (p-value=0.0006) and IB/IIA (p-value=0.0302). Survival was significantly higher in persons with stages IB-IIIA who received post-operative chemotherapy compared to no treatment (all p-values<0.0001). Fully adjusted modeling analyses (not shown) yielded similar results.5 Year Survival (P-Value) NCCN Categorized Group Margin Positive Margin Negative Stage IA (T1ab,N0) No Treatment 60%(Ref) 71%(Ref) Chemo-Only 64%(0.86) 74%(0.33) Radiotherapy-Only 24%(0.0006) 47%(<0.0001) Chemo+Rad 44%(0.17) 43%(<0.0001) (N=458) (N=41279) Stage IB (T2a,N0) & Stage IIA (T2b,N0) No Treatment 48%(Ref) 57%(Ref) Chemo-Only 66%(0.0002) 69%(<0.0001) Radiotherapy-Only 30%(0.0302) 41%(<0.0001) Chemo+Rad 39%(0.28) 48%(<0.0001) (N=1016) (N=29111) Stage IIA (T1ab-T2a,N1) & Stage IIB (T3,N0;T2b,N1) No Treatment 27%(Ref) 39%(Ref) Chemo-Only 35%(<0.0001) 55%(<0.0001) Radiotherapy-Only 26%(0.84) 29%(<0.0001) Chemo+Rad 36%(<0.0001) 43%(0.0194) (N=1549) (N=15543) Stage IIIA (T1-3,N2;T3,N1) No Treatment 15%(Ref) 26%(Ref) Chemo-Only 25%(0.0013) 41%(<0.0001) Radiotherapy-Only 11%(0.76) 19%(0.0551) Chemo+Rad 26%(<0.0001) 39%(<0.0001) (N=1109) (N=8111)
Conclusion:
In patients with negative margins, results from the NCDB are consistent with randomized clinical trials and stage-specific NCCN post-operative adjuvant therapy recommendations. However, the NCCN recommendation of post-operative adjuvant radiotherapy for patients with early stage NSCLC with a positive resection margin is not supported by our results and should be further investigated in a randomized clinical trial.
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ORAL 34 - Quality/Survival/Prognosis in Localized Lung Cancer (ID 153)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
- Moderators:B.C. Cho, R.L. Keith
- Coordinates: 9/09/2015, 16:45 - 18:15, 201+203
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ORAL34.07 - Prevalence, Prognostic Implications and Survival Modulators of Incompletely Resected Non-Small Cell Lung Cancer (NSCLC) in the US (ID 650)
16:45 - 18:15 | Author(s): A. Jemal
- Abstract
- Presentation
Background:
The survival impact of incomplete resection of NSCLC has never been systematically quantified, nor has the value of postoperative adjuvant therapy in this situation. Current clinical practice guidelines are based on single-institutional retrospective studies with few patients. The studies have contradictory findings about the survival impact of non-R0 resection and the benefit of adjuvant therapy.
Methods:
We analyzed pathologic stage I-IIIA NSCLC resections in the National Cancer Data Base from 2004 to 2011 to determine clinical, socio-demographic and institutional factors associated with margin involvement using multivariate logistic regression models. We compared the survival of patients with and without positive margins and evaluated the impact of postoperative adjuvant therapy, using proportional hazards models.
Results:
Of 112,998 resections over 8 years, 5335 (4.72%) had positive margins. This population represents >4-fold the sum of all previous English-language publications on margin-positive resections. The annual incomplete resection rate was stable over the 8-year time-span, ranging between 4.38% and 5.23% (trend-test p=0.07). Patient demographic and clinical factors associated with increased adjusted odds ratio (aOR) of incomplete resection included black race (p=0.006), age-based Medicare insurance (p=0.006), urban residence (p=0.01), squamous histology, high tumor grade, tumor overlapping more than 1 lobe, tumor location in the main bronchus, and advanced pathologic stage (p < .001 for all clinical factors). Surgery performed at Community Cancer Programs (p=0.002), institutions with high proportions of underinsured patients (p=0.01), and institutions with lower cancer resection volumes (p=0.006), also had increased aOR. The crude 5-year survival rate of patients with complete v incomplete resection was 58.5% v 33.8% (p < 0.001). The survival difference persisted when patients were stratified by tumor size, T-category and aggregate American Joint Committee on Cancer stage. The survival curve of patients with margin-positive stage I disease overlapped that of patients with completely resected stage II. Patients with incompletely resected stage II disease had worse survival than those with completely resected stage III disease. The survival detriment was consistent at 1, 3, and 5 years. After incomplete resection, adjuvant chemotherapy was associated with improved 5-year survival across all stages (p<0.01); radiotherapy was associated with worse survival in stage I patients (p<0.001), and had no significant impact in patients with stage II and III disease; chemo-radiation therapy had no significant impact in patients with stage I, but was associated with improved survival in patients with stage II and III disease (p<0.001).
Conclusion:
Margin involvement significantly impaired survival after NSCLC resection, irrespective of stage. Causative institutional and provider practices should be identified, to minimize this adverse outcome. Postoperative adjuvant chemotherapy mitigated the mortality risk independently of stage, whilst postoperative radiotherapy exacerbated the risk in patients with stage I disease, and chemoradiation therapy was associated with improved survival in patients with stage II and III disease. These findings need validation in prospective clinical trials.
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