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C.S. Baldotto
Moderator of
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OA20 - Immunotherapy and Markers (ID 401)
- Event: WCLC 2016
- Type: Oral Session
- Track: Biology/Pathology
- Presentations: 8
- Moderators:M. Früh, C.S. Baldotto
- Coordinates: 12/07/2016, 11:00 - 12:30, Stolz 2
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OA20.01 - Tumor Mutation Burden (TMB) is Associated with Improved Efficacy of Atezolizumab in 1L and 2L+ NSCLC Patients (ID 6149)
11:00 - 11:10 | Author(s): M. Kowanetz, W. Zou, D.S. Shames, C.A. Cummings, N. Rizvi, A. Spira, G.M. Frampton, V. Leveque, S. Flynn, S. Mocci, G. Shankar, R. Funke, M. Ballinger, D. Waterkamp, D.S. Chen, A. Sandler, G. Hampton, L.C. Amler, P.S. Hegde, M.D. Hellmann
- Abstract
- Presentation
Background:
In NSCLC, atezolizumab (anti-PDL1) efficacy correlates with PD-L1 expression on tumor cells (TC) and tumor-infiltrating immune cells (IC). Here we examined the association between atezolizumab efficacy and TMB assessed by FoundationOne (F1) sequencing panel.
Methods:
Pretreatment tumor specimens from 102 1L and 465 2L+ NSCLC patients enrolled on three Ph 2 atezolizumab monotherapy trials (POPLAR: randomized 2/3L trial comparing atezolizumab vs docetaxel; BIRCH/FIR: single-arm, 1L/2L+ PD-L1‒selected trials) were available for targeted genetic sequencing using the F1 panel of 315 cancer-related genes. TMB was quantified using an updated TMB algorithm and efficacy was assessed in groups defined by the 75th (high) and 50th (median) percentile of each study-specific TMB. Atezolizumab efficacy was examined at Dec 1, 2015 (POPLAR and BIRCH); and Jan 7, 2015 (FIR) data cutoffs.
Results:
Across samples, median TMB was similar in 1L and 2L+ patients (9/MB and 9.9/MB, respectively). In 1L and 2L+ PD-L1–selected patients, atezolizumab benefit was increased in those with ≥ TMB cut-offs (Table). In unselected 2L+ patients from POPLAR, the OS, PFS, and ORR benefits of atezolizumab vs docetaxel were also enhanced in patients with increased TMB. TMB and PD-L1 expression were independently associated with improved atezolizumab efficacy. TMB associations with PD-L1 expression, tumor-infiltrating lymphocyte infiltration and T-effector cell gene expression will be presented.
Conclusion:
For the first time, we demonstrate that TMB assessed with F1 targeted sequencing is associated with improved atezolizumab outcomes in 1L and 2L+ NSCLC. Moreover, this is the first study demonstrating the association of TMB with improved anti-PD-L1/PD-1 efficacy in a randomized trial. Importantly, the association between TMB and atezolizumab efficacy occurred in both unselected and PD-L1-selected patients. Therefore, in addition to PD-L1, TMB may be an independent predictor of improved responsiveness to atezolizumab in advanced NSCLC.Atezolizumab efficacy by TMB subgroups PD-L1‒selected BIRCH+FIR 1L n=102 2L+n=371 Median (≥9/MB) High (≥13.5/MB) Median (≥9.9/MB) High (≥17.1/MB) OS,HR[a] (95% CI) 0.79 (0.39-1.58) 0.45 (0.17-1.16) 0.87 (0.65-1.16) 0.7 (0.49-1.00) PFS,HR[a] (95% CI) 0.58 (0.36-0.94) 0.54 (0.3-0.97) 0.64 (0.5-0.8) 0.5 (0.38-0.67) ORR,above/below cutoff 28%/13% 25%/20% 25%/14% 29%/16% POPLAR 2L+ unselected n=92 Biomarker- evaluable population Median (≥9.9/MB) High (≥15.8/MB) OS,HR[b ] (95% CI) 0.65 (0.38-1.12) 0.48 (0.23-1.04) 0.5 (0.15-1.67) PFS,HR[b] (95% CI) 0.98 (0.63-1.53) 0.49 (0.25-0.93) 0.49 (0.19-1.3) ORR,atezolizumab/docetaxel 13%/15% 20%/4% 20%/8% [a]HR:efficacy-evaluable patients, atezolizumab at/above cutoff vs below.[b]HR:efficacy-evaluable patients, atezolizumab vs docetaxel at/above cutoff.
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OA20.02 - Neoantigen Targeting in NSCLC Patients with Complete Response to Anti-PD-1 Immunotherapy (ID 4352)
11:10 - 11:20 | Author(s): K.N. Smith, V. Anagnostou, P. Forde, J. Brahmer, V. Velculescu, D. Pardoll
- Abstract
- Presentation
Background:
Anti-PD-1 immunotherapy has resulted in durable clinical responses in heavily pretreated patients with non-small cell lung cancer (NSCLC). While NSCLC is typically seen as non-immunogenic, there is a 15-20% objective response rate and a median duration of response of 17 months in patients treated with the PD-1 inhibitor, nivolumab. This duration of response has not been reported with other systemic therapies in advanced NSCLC. While tumor PD-L1 expression may be a biomarker of sensitivity to anti-PD-1 therapy, and the number of somatic mutations may play a role in PD-1 upregulation on T cells, the mechanisms underlying response vs. progressive disease have yet to be fully elucidated.
Methods:
Whole exome sequencing and mutation-associated neoantigen (MANA) prediction was performed on tumor sections from two advanced NSCLC patients with complete response to nivolumab. Peptides representing MANAs were synthesized and tested against PBMC in a 10-day cultured IFNg ELISpot assay. Reactive MANAs were assessed in binding and stability assays. TCR sequencing was performed on reactive cell cultures and on DNA obtained from tumor resections to match MANA-reactive TCR clones with clones that were infiltrating the tumor.
Results:
The mean mutational burden in NSCLC as reported previously is 360 sequence alterations. In our study, patient 1 had 30 sequence alterations and patient 2 had 314. Despite the difference in mutational load, MANA reactivity was detected in peripheral blood of both patients >1 year after being declared cancer-free. TCR clones of MANA-reactive peripheral T cells were detected in tumor resections and were expanded in MANA-stimulated T cell cultures. Binding and stability assays confirmed that these MANAs bind to their cognate HLA with high affinity and stability.
Conclusion:
These findings show that NSCLC tumors with differential mutational burden can show regression following checkpoint blockade and suggest that the quality of mutations may be more influential in immunogenicity than the overall quantity of mutations. Our data also show that MANA reactivity may be the underlying mechanism by which T cells eliminate tumor following anti-PD-1 immunotherapy. Additional studies should evaluate mechanisms of enhancing MANA reactivity in patients who do not respond to checkpoint blockade and should further validate the link between MANA reactivity and clinical response to anti-PD-1.
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- Abstract
- Presentation
Background:
IL-7/IL-7 receptor (IL-7R) interactions have been shown to prevent apoptosis in lung cancer cells and promote stromal pro-tumor immune cell homing and differentiation. The aim of this study is to investigate the correlation between tumoral IL-7R expression and stromal pro-tumor immune cells (FoxP3+ Tregs and CD163+ M2 macrophages) and to determine prognostic impact of the combination of these markers in lung adenocarcinomas.
Methods:
In resected stage I lung adenocarcinoma (n=913; 1995-2009), antigen expression of IL-7R, FoxP3 and CD163 was evaluated by immunohistochemistry (IHC) using tissue microarrays and mRNA expression was quantified by RT-PCR. Prognosis was analyzed by both recurrence free probability (RFP) and lung cancer-specific survival (LCSS).
Results:
In IHC analysis, high tumoral IL-7R, stromal FoxP3, and stromal CD163 expression were individually associated with lymphatic/vascular invasion, and increasing percentage of solid histological patten. A correlation was seen between IL-7R, FoxP3 and CD163 expression by mRNA and IHC analyses (Figure1). The co-existence of high expression of these 3 markers was found in 16% of patients and was associated with worse outcomes (Figure2). In multivariable analysis, triple marker co-existence was an independent risk factor for RFP (p=0.004) and LCSS (p=0.008).
Conclusion:
Tumoral IL-7 receptor is a potential target for lung adenocarcinoma immunotherapy. Figure 1 Figure 2
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OA20.04 - Discussant for OA20.01, OA20.02, OA20.03 (ID 7098)
11:20 - 11:35 | Author(s): W. Hilbe
- Abstract
- Presentation
Abstract not provided
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OA20.05 - The Influence of Neoadjuvant Chemotherapy, on Immune Response Profile in Non-Small Cell Lung Carcinomas (ID 5738)
11:35 - 11:45 | Author(s): E.R. Parra, J. Rodriguez-Canales, C. Behrens, M. Jiang, A. Pataer, A.M. Correa, S. Swisher, B. Sepesi, A. Weissferdt, N. Kalhor, W.N. William Jr, J.J. Lee, J. Heymach, C. Moran, J. Zhang, D.L. Gibbons, I. Wistuba
- Abstract
- Presentation
Background:
The clinical efficacy observed with PD-1/PD-L1 inhibitors in non-small cell lung carcinoma (NSCLC) has prompted to characterize the immune response in lung tumors treated with chemotherapy. Our goal was to determine the characteristics of immune microenvironment of localized, surgically resected, NSCLCs from patients who received and did not receive neo-adjuvant chemotherapy. Using multiplex immunofluorescence (mIF) and image analysis, we investigated PD-1/PD-L1 expression, and quantified tumor infiltrating lymphocytes (TILs) and tumor associated macrophages (TAMs).
Methods:
We studied formalin-fixed and paraffin embedded (FFPE) tumor tissues from 111 stage II and III resected NSCLC, including 61 chemonaïve (adenocarcinoma, ADC=33; squamous cell carcinoma, SCC=28) and 50 chemotherapy-treated (ADC=30; SCC=20) tumors. mIF was performed using the Opal 7-color fIHC Kit™ and analyzed using the Vectra™ multispectral microscope and inForm™ Cell Analysis software (Perkin Elmer, Waltham, MA). The markers studied were grouped in two 6-antibody panels: Panel 1, AE1/AE3 pancytokeratins, PD-L1 (clone E1L3N), CD3, CD4, CD8 and CD68; and Panel 2, AE1/AE3, PD1, Granzyme B, FOXP3, CD45RO and CD57.
Results:
Positive PD-L1 expression (>5%) in malignant cells (MCs) was detected in 48% (n=53/111) of NSCLCs. Overall, chemotherapy-treated tumors showed significantly higher percentages of MCs expressing PD-L1 (median, 18.2%) than chemo-naïve cases (median, 1.8%; P=0.033). Higher densities of inflammatory cells expressing granzyme B (P=0.036), CD57 (P=0.001) and PD-1 (P=0.016) were detected in chemotherapy-treated NSCLCs compared with chemo-naïve tumors. In contrast, lower densities of FOXP3-positive regulatory T cells were detected in chemotherapy-treated tumors when compared with chemo-naïve cases (P=0.032). Following chemotherapy ADCs exhibited significantly higher levels of CD57-positive cells (P<0.0001) and lower density of FOXP3-positive cells (P=0.002) than chemo-naïve tumors. Chemotherapy-treated SCCs demonstrated higher density of PD-1-positive cells than chemo-naïve tumors (P=0.004). In chemotherapy-treated cancers, lower levels of CD4 helper T positive cells and tumor associated macrophages (TAMs) CD68-positive cells were associated with worse overall survival (OS; P=0.04 and P=0.005, respectively) in univariate analysis. In chemotherapy-treated ADC patients, lower levels of CD68-positive (P=0.010) and higher levels of FOXP3-positive cells correlated with worse OS (P=0.044).
Conclusion:
We developed a robust mIF panel of 10 markers to study inflammatory cells infiltrates in FFPE NSCLC tumor tissues. Chemotherapy-treated NSCLCs exhibited higher levels of PD-L1 expression and T cell subsets compared to chemo-naïve tumors, suggesting that chemotherapy activates specific immune response mechanisms in lung cancer. (Supported by CPRIT MIRA and UT Lung SPORE grants, and MD Anderson Moon Shot Program).
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OA20.06 - Prospective ImmunogenomiC PrOfiling of Non-Small Cell Lung Cancer - The ICON Project (ID 5560)
11:45 - 11:55 | Author(s): B. Sepesi, I. Team, J. Heymach, P. Sharma, J. Allison, B. Fang, J. Zhang, H. Wagner, E. Bogatenkova, I. Wistuba, S. Swisher, C. Bernatchez, D.L. Gibbons
- Abstract
- Presentation
Background:
Previous attempts to define tumor and stromal immunologic environment in non-small cell lung cancer (NSCLC) utilized archival tissue. We established prospective comprehensive immonogenomic profiling protocol in NSCLC (ICON Project). The goal is to integrate immunomic, genomic, transcriptomic, proteomic, demographic, clinical, pathologic, and outcome data from 100 surgically resected early stage NSCLC.
Methods:
Tumor and normal lung tissue are collected at the time of surgery, blood samples before and after surgery. Tumor samples are processed for tumor infiltrating lymphocyte (TILs) isolation and expansion; development of patient derived xenografts (PDX), immunohistochemical immune markers, and immunopeptidome profiling. Blood samples are analyzed with flow cytometry.
Results:
57 patients with median age of 65 years (27 males) have been enrolled within 5 months, of which 33 (66%) contributed samples to the study. Four were never smokers, with others being former or current smokers. Majority (N=27) had adenocarcinoma, 4 squamous cell carcinoma, and 2 pleomorphic carcinoma. 15 patients had stage I, 11 stage II, and 7 stage III disease; 5 patients received induction chemotherapy. Median tumor size was 3.5 cm and 29 underwent R0 and 4 R1 resection. Pre-REP TIL expansion was successful in the majority of samples (68.2%, n=22). Twelve PDX models with a take rate of 40% have been generated. Interim analysis of tumor samples by IHC demonstrated higher median distribution of all cell types: CD3+ T cells, cytotoxic T cells CD8+, PD1+ cells, tumor associated macrophages (TAM) CD68+, TAM CD68+PD-L1+, CD20+B cells, memory T cells CD45R0, natural killer cells CD57+, regulatory FOXP3+ T cells, and cytotoxic granzyme B cells (cells/mm[2]) in the stroma as compared to the tumor compartment. Intra-tumoral regulatory FOXP3+T cells were more abundant in squamous cell carcinomas compared to adenocarcinomas (median 312 vs 51 cells/mm[2], p = 0.05). Higher concentration of intra-tumoral CD68+PD-L1+ expressing cells was observed following neoadjuvant chemotherapy (median 97 vs 60 cells/mm[2] no chemo; p= 0.077), as was the concentration of memory T cells CD45R0 (median 129 vs 30 cells/mm[2], no chemo; p = 0.077). Mass spectrometry-based immunopeptidome analysis identified several thousand peptides, of which 4 promising antigens have been chosen for further development as immunotherapeutic T-cell targets.
Conclusion:
The ICON is an ongoing, ambitious prospective project that aims to define the baseline immunologic characteristics of surgically resectable NSCLC. The rapid enrollment illustrates the enthusiasm for tumor immunoprofiling amongst patients and physicians alike. Data from this patient cohort will serve as a baseline comparison for upcoming neoadjuvant immunotherapy trials.
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OA20.07 - HHLA2, a New Immune Checkpoint Member of the B7 Family, is Widely Expressed in Human Lung Cancer and Associated with Mutational Status (ID 5184)
11:55 - 12:05 | Author(s): H. Cheng, M. Janakiram, A.C. Borczuk, J. Lin, W. Qiu, H. Liu, J. Chinai, B. Halmos, R. Perez-Soler, X. Zang
- Abstract
- Presentation
Background:
Immunotherapy with antibodies against B7/CD28 family members, including PD-1, PD-L1, and CTLA-4 has shifted the treatment paradigm for non-small-cell lung carcinoma (NSCLC) with improved clinical outcome. HHLA2 is a newly discovered member of the family. By regulating T-cell function, HHLA2 could contribute to tumor immune suppression and thus be a novel target for cancer immunotherapy. There is limited information and critical need to characterize its expression profile and clinical significance in NSCLC.
Methods:
We performed immunohistochemistry with an HHLA2-specific antibody (clone 566.1) using tissue microarrays constructed from 679 NSCLC tumor tissues, including 392 cases in the discovery set and 287 cases in the validation cohort. We also studied clinico-pathological characteristics of these patients.
Results:
Overall, HHLA2 was not detected in most of normal lung tissue but expressed in 66% of NSCLC across different subtypes. In particular, EGFR–mutated NSCLC was significantly associated with higher tumor HHLA2 expression in both discovery (EGFR vs. WT: 76% vs. 53%, P=0.01) and validation cohorts (89% vs. 69%, P=0.01). In one of the two cohorts, HHLA2 expression was higher in lung adenocarcinoma as compared to squamous and large cell histology, non-Hispanic White vs. Hispanics, and tumors with high tumor infiltrating lymphocyte (TIL) density. In the multivariate analysis, EGFR mutation status and high TIL intensity were independently associated with HHLA2 expression in lung adenocarcinoma.
Conclusion:
HHLA2 is widely expressed in NSCLC and is associated with EGFR mutation and high TILs in lung adenocarcinoma. It is potentially a novel target for lung cancer immunotherapy.
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OA20.08 - Discussant for OA20.05, OA20.06, OA20.07 (ID 7099)
12:05 - 12:20 | Author(s): H. Popper
- Abstract
- Presentation
Abstract not provided
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Author of
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MA09 - Immunotherapy Combinations (ID 390)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Chemotherapy/Targeted Therapy/Immunotherapy
- Presentations: 1
- Moderators:M. Sebastian, E.B. Garon
- Coordinates: 12/06/2016, 14:20 - 15:50, Strauss 2
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MA09.12 - Discussant for MA09.09, MA09.10, MA09.11 (ID 7082)
15:38 - 15:50 | Author(s): C.S. Baldotto
- Abstract
- Presentation
Abstract not provided
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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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P2.02-030 - Consolidation Chemotherapy Following Concurrent Chemoradiation for Stage III Non-Small Cell Lung Cancer: A Brazilian Multicentric Cohort (ID 4670)
14:30 - 14:30 | Author(s): C.S. Baldotto
- Abstract
Background:
Locally advanced stage III grossly accounts for 25% newly diagnosed non-small cell lng cancer (NSCLC) cases. Albeit some patients (pts) are amenable to surgical resection, most will be treated with concurrent chemoradiation (CRT), whilst the addition of consolidation chemotherapy (CC) is still a debatable topic. We decided to look into the impact of CC in stage III NSCLC Brazilian pts treated in the daily clinical practice.
Methods:
We retrospectively collected data of stage III NSCLC pts treated in five different Brazilian cancer institutions from Jan/2007 to Dec/2011, whom have received CRT followed or not by CC. Eligible pts were ≥18yo and must have been treated with cisplatin or carboplatin plus etoposide, paclitaxel or vinorelbine, concurrently with thoracic irradiation (RT). Patients treated with surgery or neoadjuvant chemotherapy were excluded. Primary endpoint was overall survival (OS) from the date of diagnosis. Association between CC and clinical variables and demographics were evaluated by Pearson´s Chi-square test (Χ²). Survival curves were calculated by Kaplan-Meier method and compared by log-rank test. Univariate and multivariate analysis were made using Cox proportional model (CPM). P-values<0.05 were deemed statistically significant.
Results:
We collected data from 165 pts. Median age was 60yo (range: 27-79) and most pts were male (69.1%), Caucasian (77.9%), current or former smoker (93.3%), and staged as IIIB (52.7%). Adenocarcinoma was the most common histologic type (47.9%). Weight loss>5% and ECOG-PS 2 were observed in 39.1% (n=61) and 14.6% (n=24), respectively. Median follow-up was 25 mo. CC was administered to 27 pts. The only variable associated with CC was T stage (Χ²(4) = 11.410, p=0.022), with more T3 tumors receiving CC than expected. We observed no statistically significant difference in OS between patients treated or not with CC (p=0.211), although 3-year OS rate was numerically higher in CC pts (40% vs. 31%). Median OS in was 24 and 25 months in CC and no CC groups, respectively (HR 1.408, 95%CI 0.814-2.434). A total delivered RT dose ≥ 61Gy was the only variable independently associated with improved survival (HR 0.617, 95%CI 0.419-0.909, p=0.012).
Conclusion:
CC did not improve OS in stage III NSCLC patients after concurrent CRT. RT dose < 61 Gy negatively impacted OS.
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-047 - Local Experience in an Expanded Access Program of Nivolumab in Advanced Non-Small Cell Lung Cancer in Brazil (ID 4782)
14:30 - 14:30 | Author(s): C.S. Baldotto
- Abstract
Background:
Nivolumab is a new standard-of-care in platinum-refractory Non-small cell lung cancer (NSCLC), with significant survival increment in comparison to docetaxel shown in two phase 3 trials. Herein, we report the local experience in an expanded access program in Brazil.
Methods:
Patients with recurrent or metastatic NSCLC, treated with at least one prior chemotherapy regimen, were potentially eligible. Overall, three hundred twenty-one patients were screened in the country, and 287 were enrolled. Around 10% of these (N=29) were treated in a single cancer institution in Rio de Janeiro. The aim was to describe the early outcome in these 29 patients.
Results:
Median age was 64 years (range 37-83), most patients were male (62%), white (66%), smoker or former smoker (21% and 55%, respectively). Most cases (59%) were classified as non-squamous, and only 3 had a documented EGFR mutation. Sixty-two percent had received 2 or more prior chemotherapy lines. After a median follow-up of 4.9 months (95% CI, 4.2-5.5), 1 partial response (3%) was documented, and 13 patients (45%) presented with disease stabilization by RECIST 1.1. Median PFS and OS were not reached, and 6-month OS was 52%. Seventeen patients (59%) had at least 1 adverse event, the most common being asthenia (9 patients). Only 1 (3%) grade 3 event was documented.
Conclusion:
Nivolumab was well tolerated and led to disease control in 48% of patients in this early analysis, after a short follow-up. Survival data will be updated for presentation.
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P3.07 - Poster Session with Presenters Present (ID 493)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Regional Aspects/Health Policy/Public Health
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.07-020 - Implementation of an International Value-Based Standard Set of Outcomes for Lung Cancer Patients in a Brazilian Center (ID 5826)
14:30 - 14:30 | Author(s): C.S. Baldotto
- Abstract
Background:
Measurement of value is increasingly important in cancer care, specially in lower-income countries. Grupo COI is a Brazilian private cancer care institution, member of the ICHOM (International Consortium for Health Outcomes Measurement) working group for lung cancer standard set definition. We report here feasibility and results for the first year of implementation.
Methods:
Lung cancer (LC) patients inclusion started on June/2015. Data were prospectively obtained from medical charts and patients interviews. All patients signed an informed consent (IC) and were only included if they would receive entire treatment at our center. ICHOM standard set outcomes included survival, complications during or within six months of treatment, baseline demographic, clinical, and tumor information and patient-reported quality of life evaluation (EORTC QLQ-C30 and QLQ-LC13) .
Results:
A total of 392 LC patients were admitted at COI, but only 120 patients (30.6%) met inclusion criteria. Main reasons for exclusion were partial cycle of care at COI (64.9%) and any treatment started before IC signature (11.3%). Median follow up was 7.9 months and baseline clinical data are presented in Table 1. Patient reported outcomes (PROs) were obtained from paper and phone calls. PROs assessment deviations were reported in 49 patients (38.5%) and reasons for them were application date error (63.2%) and patient or family refusal (36.7%). Cost data are being registered for future analysis. Table 1. Baseline Clinical and Demographic CharacteristicsMedian age - years (variation) 68 (36 – 91) Gender Male 57 (47%) Female 63 (52%) Educational Level Primary 21 (17%) Secondary 36 (30%) Tertiary 63 (52%) Performance status 0-1 101 (84%) 2 6 (5%) 3-4 0 Non specified 13 (10%) Histology Adenocarcinoma 66 (55%) Squamous-cell carcinoma 29 (24%) Small cell carcinoma 12 (10%) Others 13 (10%) Stage I-II 21 (17%) III 29 (24%) IV 70 (58%)
Conclusion:
Applying an international value-based outcome standard set at a Brazilian institution is feasible. Based on these first data, improvements on PROs assessment methodology are being considered, like self-report electronic forms. Some inclusion criteria should also be revised to avoid this large number of patients exclusion, in order to reproduce a real-world scenario.
