PS01.182: TOOLS FOR INDIVIDUALIZED SURVIVAL PREDICTION IN ESOPHAGEAL AND GASTROESOPHAGEAL JUNCTION CANCER

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 101-101
Author(s):  
Vaibhav Gupta ◽  
Natalie Coburn ◽  
Biniam Kidane ◽  
Kenneth Hess ◽  
Carolyn Compton ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Conflicts Of Interest ◽  
Data Extraction ◽  
Cell Cancer ◽  
Gastroesophageal Junction ◽  
Tumor Stage ◽  
Survival Prediction ◽  
Cancer Specific Survival ◽  
Curative Intent ◽  
Term Survival

Abstract Background Clinical, pathological and molecular information combined with cancer stage in prognostication algorithms can offer more personalized estimates of survival, which may guide treatment choices. Our aim was to evaluate the quality of prognostication tools in esophageal cancer. Methods We systematically searched MEDLINE & Embase from 2005- 2017 for studies reporting development or validation of models predicting long-term survival in esophageal cancer. We evaluated tools using the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies guidelines and the American Joint Committee on Cancer acceptance criteria for risk models. Results We identified 16 prognostication tools for patients treated with curative intent and one for patients with metastatic disease. These tools frequently excluded adenocarcinoma, contained outdated data and were developed with a limited sample size. Nine tools were developed in China for squamous cell cancer, and 11 used data on patients diagnosed prior to 2010. The majority of tools excluded key prognostic factors such as age and sex. Tumor stage and grade were the most commonly, but not universally, included factors. Twelve tools were designed to predict overall survival; five predicted cancer-specific survival. Bootstrap internal validation was performed for most tools; c-statistics ranged from 0.63–0.77 and graphically evaluated calibration was ‘good’. Five tools were externally validated; c-statistics ranged from 0.70–0.77. Conclusion Existing tools cannot be confidently used for esophageal cancer prognostication in current clinical practice. Better quality tools may help to more individually and accurately estimate disease course, select further treatments, and risk-stratify for future clinical trials. Disclosure All authors have declared no conflicts of interest.

Adjuvant sunitinib following chemoradiotherapy (CRT) and surgery for esophageal cancer: A phase II trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15550-e15550
Author(s):  
A. M. Horgan ◽  
G. Darling ◽  
R. Wong ◽  
A. Visbal ◽  
M. Guindi ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Systemic Disease ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Thoracic Esophagus ◽  
Curative Intent ◽  
Post Surgery ◽  
Grade 3

e15550 Background: Locally advanced esophageal cancer (LAEC) has a 5-year survival of < 30 %. Most patients (pts) fail after curative intent tri-modality treatment with distant metastatic disease. This phase II trial aims to determine if adjuvant targeted therapy, after neoadjuvant CRT plus surgery for resectable LAEC, may impact on systemic disease without significant toxicity. Methods: Pts with LAEC of the thoracic esophagus or gastroesophageal junction, ECOG PS 0,1 and surgical candidates treated with: preoperative Irinotecan (65mg/m2 initially, ammended to 50mg/m2) + Cisplatin (30mg/m2) on weeks 1,2,4,5,7,8 + concurrent conformal radiotherapy (50Gy/25 fractions) on weeks 4–8. Esophagectomy during weeks 15–18. Sunitinib 37.5mg daily (escalating to 50mg daily if tolerated) commenced 4–12 weeks post surgery, for 1 year. Primary endpoint is feasibility and efficacy of adjuvant sunitinib. Planned sample size 36pts. Results: 30pts enrolled from 11/06 to 12/08. Median age 64 yr (43–71), male: 22, adenocarcinoma: squamous 22:6; 10 pts stage IIA, 5 IIB and 13 III. 2 pts excluded with positive PET scan. 28 pts completed CRT - 18 pts (64%) received ≥80% of planned chemotherapy dose, 23 pts (82%) received full radiation dose. Grade 3/4 toxicity included: neutropenia (17/28), diarrhea (7/28), dehydration (4/28), febrile neutropenia (FN) (3/28) and nausea (2/28). 2 deaths on chemotherapy (1 bacterial meningitis, 1 FN) leading to irinotecan dose- reduction. Dysphagia improved in 14/23 pts during CRT. 18 pts have undergone esophagectomy. Complete pathological response in 4 (22%), downstaging in 3 (17%), stable disease in 11 (61%). 2 pts unresectable (metastases at laparotomy). 1 post-operative death due to pulmonary embolus. 9 pts have commenced sunitinib, 6 maintained at starting dose of 37.5mg; 2 dose reductions; 1 discontinued with poor wound healing. Grade 3 toxicity included: leukopenia (2/9), hand-foot reaction (1/9) and depression (1/9). Conclusions: In LAEC, induction Irinotecan/Cisplatin and radiotherapy followed by esophagectomy is associated with a significant but manageable toxicity profile. Early initiation of sunitinib is feasible and well-tolerated. Updated results to be presented. No significant financial relationships to disclose.

scholarly journals Treatment and Survival Analysis for 40-year SEER Data on Upper Esophageal Cancer

2021 ◽  
Author(s):  
Ming-Chuang Zhu ◽  
Guoliang Li ◽  
Peng Xiong ◽  
Min Zhu
Keyword(s):  
Esophageal Cancer ◽  
Neoadjuvant Radiotherapy ◽  
Cancer Specific Survival ◽  
Term Survival ◽  
Regional Stage ◽  
Kaplan Meier ◽  
Seer Data ◽  
Localized Disease ◽  
Regional Disease ◽  
Cox Proportional Hazard Regression

Abstract Background: Upper esophageal cancer (UEC) is rare in western countries. We elucidated the survival outcomes of UEC and analyzed factors associated with prognosis of UEC using the Surveillance, Epidemiology, and End Results (SEER) database.Methods: Cases of UEC (C15.3 and C15.0) arising during the period from 1973 to 2013 were identified and selected. Esophageal cancer-specific survival (ECSS) and overall survival (OS) rate were calculated by Kaplan–Meier method. Cox proportional hazard regression was used to analyze predictive factors.Results: Since 1973, there has been a significant increase (1973-1982 vs. 2004-2013) in median OS (7 months vs. 10 months, p<0.001) and median ECSS (7 months vs. 11months, p < 0.001) among patients with UEC. The ECSS and OS of surgery without radiation (SWR) and radiation plus surgery (R+S) were superior to those of radiation without surgery (RWS). For patients with localized disease, ECSS and OS were highest among patients treated with SWR, compared with patients with R+S and RWS. For patients with regional disease, ECSS and OS were highest among patients with R+S, compared with SWR or RWS. Among patients with regional-stage squamous cell carcinoma (SCC), OS was higher with neoadjuvant radiotherapy or adjuvant radiotherapy, compared with SWR. Multivariate analysis showed that radiotherapy sequence was dependently associated with OS among patients with regional-stage SCC.Conclusion: Although survival of patients with UEC has gradually increased since 1973, the long-term survival among this patient population remains poor. Effective treatments for UEC include surgery, radiotherapy, and combination of surgery and radiotherapy.

RA09.03: PERINEURAL INVASION (PNI) IN ESOPHAGEAL CANCER: IMPROVING THE VALUE OF MODERN STAGING: A META-ANALYSIS

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 40-40
Author(s):  
Xue-Feng Leng ◽  
Yi Zhu ◽  
Lei Cheng ◽  
Xin Cheng ◽  
Jian Jin ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Perineural Invasion ◽  
Conflicts Of Interest ◽  
Meta Analysis ◽  
Cancer Staging ◽  
Tumor Stage ◽  
Prognostic Information ◽  
New Information ◽  
Disease Staging ◽  
N Stage

Abstract Background Esophageal cancer treatment is largely determined by tumor stage. Despite improvements made in the treatment of different types of this malignant disease, staging has still in continuous renewal. The role of perineural invasion (PNI) in staging remains debated. We have assessed the relation of PNI with metastatic pattern to evaluate whether PNI might add significant new information to staging. Methods We performed a systematic literature search that was focused on the PNI in esophageal cancer published up to February 2018. Studies with neoadjuvant-treated patients were excluded. Data on T stage, N stage and other characteristics were extracted. Data were analyzed for the relevance of the presence of PNI, lymph node metastases, and the tumor invasion on the depth of esophageal structure and outcomes. Results A total of 9 cohorts were retrieved, covering 2207 patients. PNIs are invariably associated with poor outcome. Moreover, a total analysis of 2207 patients showed improved PNI in T3 + T4 (OR = 0.25, 95% CI: 0.15–0.44, and P < 0.00001), 674 of 2204 patients showed PNI more favored in N positive (OR = 0.61, 95% CI: 0.38–0.96, and P = 0.03), and 461 of 1788 patients showed improved PNI in G3 + G4 (OR = 0.70, 95% CI: 0.54–0.92, and P = 0.010) compared with T1 + T2, N − , and G1 + G2 patients, respectively. Conclusion PNI is an adverse prognostic factor in esophageal cancer. We have shown that PNIs have valuable prognostic information in advanced T, N stage and poor cell differentiation. Therefore, we propose that PNI may provide a vital clue to esophageal cancer staging in the future. Disclosure All authors have declared no conflicts of interest.

P221 THE ROLE OF SUBCARINAL LYMPH NODE DISSECTION IN ESOPHAGECTOMY - A 5-YEAR SINGLE CENTER EXPERIENCE

2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
Eustratia Mpaili ◽  
Dimitrios Schizas ◽  
Maria Mpoura ◽  
Ilias Vagios ◽  
Constantinos Zografos ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Lymph Node ◽  
Lymph Nodes ◽  
Lymph Node Dissection ◽  
Squamous Cell ◽  
Cell Cancer ◽  
Gastroesophageal Junction ◽  
Neoadjuvant Treatment ◽  
Node Dissection ◽  
Subcarinal Lymph Node

Abstract Aim To evaluate the involvement of subcarinal lymph node dissection (SLND) in the surgical treatment of esophageal cancer, as well as its impact on surgical outcomes following esophagectomy. Background & Methods Data on patients that underwent esophagectomy from 01/03/2014 to 01/03/2019 were prospectively collected and retrospectively reviewed. Based on the medical records, the following parameters were collected and analyzed: patient demographics, histopathological parameters, surgical- oncological outcomes. All patients were staged according to the AJCC 8th edition. Results A total of 79 patients underwent Ivor Lewis or McKeown esophagectomy for either squamous cell carcinoma (n= 7 patients) or adenocarcinoma of the esophagus or gastroesophageal junction (n= 72 patients). In 26 cases, esophagectomy was performed without SLND, while 53 cases underwent SLND. Among the 53 patients, 50 (94.3%) were men, and 3 (5.7 %) were women. Mean age was 61.4 years, (range 34-78). Mean nodal harvest was 34.7 lymph nodes per patient. Lymph node invasion was noted in 33 patients (62.2%), with a mean of 9 positive lymph nodes per patient. Subcarinal lymph nodes were involved in 5 out of 53 patients (9.4%). The ratio of positive subcarinal lymph nodes to resected ones was 1/2 (50%), 3/3 (100%), 1/2 (50%), 1/2 (50%) and 1/1 (100%) for each patient. Final histopathological report showed adenocarcinoma of moderate or poor differentiation (G2 2/5, G3 3/5) in all five patients (100%). Four out of 5 patients had not received neoadjuvant treatment and their pathological staging was T3N3M0. One patient had received neoadjuvant chemotherapy and his final staging was ypT3N2M0. Noteworthy, the seven patients diagnosed with squamous carcinoma, were subjected to SLND and were 100% negative for invasion histologically. Conclusion Subcarinal lymph nodes were infiltrated in 9.4% of patients operated for esophageal cancer. In the squamous cell cancer group, the relative infiltration rate was notably 0%. It seems that omission of subcarinal lymph node dissection during transthoracic esophagectomy cannot be justified.

scholarly journals Phase III Trial of Trimodality Therapy With Cisplatin, Fluorouracil, Radiotherapy, and Surgery Compared With Surgery Alone for Esophageal Cancer: CALGB 9781

2008 ◽  
Vol 26 (7) ◽  
pp. 1086-1092 ◽  
Author(s):  
Joel Tepper ◽  
Mark J. Krasna ◽  
Donna Niedzwiecki ◽  
Donna Hollis ◽  
Carolyn E. Reed ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Radiation Therapy ◽  
Gastroesophageal Junction ◽  
Concurrent Chemotherapy ◽  
Phase Iii ◽  
Node Dissection ◽  
Term Survival ◽  
Trimodality Therapy ◽  
Carcinoma Of The Esophagus ◽  
Primary Treatment Modality

Purpose The primary treatment modality for patients with carcinoma of the esophagus or gastroesophageal junction has been surgery, although primary radiation therapy with concurrent chemotherapy produces similar results. As both have curative potential, there has been great interest in the use of trimodality therapy. To this end, we compared survival, response, and patterns of failure of trimodality therapy to esophagectomy alone in patients with nonmetastatic esophageal cancer. Patients and Methods Four hundred seventy-five eligible patients were planned for enrollment. Patients were randomly assigned to either esophagectomy with node dissection alone or cisplatin 100 mg/m2 and fluorouracil 1,000 mg/m2/d for 4 days on weeks 1 and 5 concurrent with radiation therapy (50.4 Gy total: 1.8 Gy/fraction over 5.6 weeks) followed by esophagectomy with node dissection. Results Fifty-six patients were enrolled between October 1997 and March 2000, when the trial was closed due to poor accrual. Thirty patients were randomly assigned to trimodality therapy and 26 were assigned to surgery alone. Patient and tumor characteristics were similar between groups. Treatment was generally well tolerated. Median follow-up was 6 years. An intent-to-treat analysis showed a median survival of 4.48 v 1.79 years in favor of trimodality therapy (exact stratified log-rank, P = .002). Five-year survival was 39% (95% CI, 21% to 57%) v 16% (95% CI, 5% to 33%) in favor of trimodality therapy. Conclusion The results from this trial reflect a long-term survival advantage with the use of chemoradiotherapy followed by surgery in the treatment of esophageal cancer, and support trimodality therapy as a standard of care for patients with this disease.

scholarly journals Does Cardiopulmonary Testing Help Predict Long-Term Survival After Esophagectomy?

2021 ◽  
Author(s):  
Jakub Chmelo ◽  
Rachel A. Khaw ◽  
Rhona C. F. Sinclair ◽  
Maziar Navidi ◽  
Alexander W. Phillips
Keyword(s):  
Esophageal Cancer ◽  
Roc Analysis ◽  
Multivariable Analysis ◽  
Cardiopulmonary Exercise Testing ◽  
High Rate ◽  
Major Surgery ◽  
Curative Intent ◽  
Term Survival ◽  
Long Term Survival

Abstract Background Esophagectomy is associated with a high rate of morbidity and mortality. Preoperative cardiopulmonary fitness has been correlated with outcomes of major surgery. Variables derived from cardiopulmonary exercise testing (CPET) have been associated with postoperative outcomes. It is unclear whether preoperative cardiorespiratory fitness of patients undergoing esophagectomy is associated with long-term survival. This study aimed to evaluate whether any of the CPET variables routinely derived from patients with esophageal cancer may aid in predicting long-term survival after esophagectomy. Methods Patients undergoing CPET followed by trans-thoracic esophagectomy for esophageal cancer with curative intent between January 2013 and January 2017 from single high-volume center were retrospectively analyzed. The relationship between predictive co-variables, including CPET variables and survival, was studied with a Cox proportional hazard model. Receiver operation curve (ROC) analysis was performed to find cutoff values for CPET variables predictive of 3-year survival. Results The study analyzed 313 patients. The ventilatory equivalent for carbon dioxide (VE/VCO2) at the anerobic threshold was the only CPET variable independently predictive of long-term survival in the multivariable analysis (hazard ratio [HR], 1.049; 95% confidence interval [CI], 1.011–1.088; p = 0.011). Pathologic stages 3 and 4 disease was the other co-variable found to be independently predictive of survival. An ROC analysis of the VE/VCO2 failed to demonstrate a predictive cutoff value of 3-year survival (area under the curve, 0.564; 95% CI, 0.499–0.629; p = 0.056). Conclusions A high VE/VCO2 before esophagectomy for malignant disease is an independent predictor of long-term survival and may be an important variable for clinicians to consider when counseling patients.

Chemoradiotherapy plus surgery versus surgery alone for resectable esophageal cancer: A systematic review of randomized control trials.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 94-94
Author(s):  
Basile M. Njei ◽  
Juliet Appiah ◽  
Ivo C. Ditah ◽  
John W. Birk
Keyword(s):  
Quality Of Life ◽  
Esophageal Cancer ◽  
Adverse Events ◽  
Cell Cancer ◽  
Group Versus ◽  
Prolonged Survival ◽  
Cochrane Library ◽  
Term Survival ◽  
Surgery Group

94 Background: Several trials have demonstrated better survival when surgery is combined with neoadjuvant chemotherapy and concurrent radiotherapy (CRT) in the treatment of esophageal cancer (EC). However, it is unclear whether survival benefits are counterbalanced by a poor quality of life due to the adverse effects of the combination therapy. The aim of this study was to compare the efficacy and safety of CRT plus surgery versus surgery alone. Methods: Two authors independently conducted a comprehensive search of the Cochrane library PUBMED, MEDLINE, and published proceedings from major oncologic cancer meetings from January 1980 to July 2011. The titles and abstracts of all potentially relevant studies were screened for eligibility. In addition to overall outcome measures, subgroup analysis by histology of EC (squamous cell cancer [SCC] and adenocarcinoma [AC]), was also performed. Analysis was done using the fixed effect model. The Begg’s and Egger’s tests with visual inspection of the funnel plot were used to assess for population bias. Results: Fifteen studies involving 1,957 patients were included in the analysis. There was an overall statistically significant increase in the 5-year survival for the CRT plus surgery group versus the surgery only group (RR 1.47, 95% CI 1.24-1.76). By histological type, only patients with SCC showed prolonged survival: RR 1.53, 95% CI 1.26-1.85. We equally found an overall significant increase in grade 3 and 4 adverse events in the CRT plus surgery group compared to the group with surgery alone (RR 1.73, 95% CI 1.15-2.60). Again, a significant increase in serious adverse events was observed only in the sub-group of patients with SCC (RR 1.81, 95% CI 1.14-2.86). There was no evidence of heterogeneity or publication bias in these analyses. Conclusions: Overall, CRT plus surgery can improve long-term survival in EC patients. The results seem to be limited only to patients with SCC and not AC. However, the prolonged survival comes at the cost of poorer quality of life due to a higher incidence of adverse events. For the moment we recommend that the decision on what treatment strategy to use be based on informed patient preference.

Prognostic analysis of esophageal squamous cell cancer patients who received neoadjuvant chemoradiotherapy combined with surgery.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 97-97
Author(s):  
Xue Li ◽  
Daxuan Hao ◽  
Yuanyuan Yang ◽  
Yougai Zhang ◽  
Xiaoyuan Wu ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Prognostic Factors ◽  
Squamous Cell Cancer ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Advanced Esophageal Cancer ◽  
Term Survival ◽  
Locally Advanced Esophageal Cancer

97 Background: The neoadjuvant chemoradiotherapy (nCRT) combined with surgery is hopeful to improve the prognosis of locally advanced esophageal cancer but it remains contentious. Several studies showed that nCRT could significantly improve 5-year OS rate of locally advanced esophageal cancer. However, other clinical trials did not come to the same conclusion. This study retrospectively analyzed the esophageal squamous cell cancer (ESCC) patients who received nCRT combined with surgery in our hospital to investigate the prognostic factors for the patients’ survival. Methods: 96 patients with ESCC who received nCRT combined with surgery in our hospital from January 2007 to December 2014 were retrospectively analyzed. They were diagnosed with preoperation stage T3-4N0-1M0. Among them, 34 cases were in stage IIc and 62 cases were in stage IIIc. Prognostic factors for these patients were analyzed. Results: 26 (27.1%) patients received pathologic complete response (pCR) and 80 (83.3%) patients had downstage. The 1-, 3-, 5-year OS rates of all patients were 91.5%, 63.5%, 55.1%. The 1-, 3-, 5-year OS rates of tumor regression grading(TRG) 1, 2, 3 were 88.9%, 54.1%, 36.5% vs 88.4%, 56.4%, 48.6% vs 95.5%, 90.4%, 90.4%(Р = 0.014). The 1-, 3-, 5-year OS rates of pCR and non-pCR were 95.5%, 90.4%, 90.4% vs 88.6%, 55.6%, 45.4%(Р = 0.004). The 1-, 3-, 5-year OS rates of pathological lymph node negative(ypN-) and positive(ypN+) were 97.3%, 71.1%, 59.8% vs 66.7%, 33.3%, 33.3%(Р = 0.002). The 1-, 3-, 5-year OS rates of downstage and no-downstage were 94.9%, 73.9%, 65.6% vs 75.0%, 18.8%, 12.5% (Р = 0.000). Multivariate analyses identified pathologic lymph nodal status (RR = 2.193, 95%CI:1.018-4.726, Р = 0.045) and downstage category (RR = 3.520, 95%CI:1.638-7.568, Р = 0.001) were significant independent prognostic parameters. Conclusions: The nCRT combined with surgery achieved a high rate of long-term survival without increasing postoperative complications in patients with locally advanced ESCC. TRG was closely associated with patient’s prognosis, especially for patients with pCR. Pathologic lymph nodal status and downstage category were independent influencing factors for long-term survival.

Outcomes of octogenarians with esophageal cancer: an analysis of the National Cancer Database

2018 ◽  
Vol 32 (10) ◽  
pp. 1-8 ◽  
Author(s):  
C T Bakhos ◽  
A C Salami ◽  
L R Kaiser ◽  
R V Petrov ◽  
A E Abbas
Keyword(s):  
Esophageal Cancer ◽  
Postoperative Mortality ◽  
Multimodality Treatment ◽  
Tumor Stage ◽  
Multimodality Therapy ◽  
National Cancer Database ◽  
Term Survival ◽  
Younger Patients ◽  
Long Term Survival

SUMMARYThe optimal treatment of esophageal cancer in octogenarians is controversial. While the safety of esophagectomy has been demonstrated in elderly patients, surgery and multimodality therapy are still offered to a select group. Additionally, the long-term outcomes in octogenarians have not been thoroughly compared to those in younger patients. We sought to compare the outcomes of esophageal cancer treatment between octogenarians and non-octogenarians in the National Cancer Database (2004–2014). The major endpoints were early postoperative mortality and long-term survival. A total of 107,921 patients were identified [octogenarian—16,388 (15.2%)]. Compared to non-octogenarians, octogenarians were more likely to be female, of higher socioeconomic status, and had more Charlson comorbidities (p &lt; 0.001 for all). Octogenarians were significantly less likely to undergo esophagectomy (11.5% vs. 33.3%; p &lt; 0.001) and multimodality therapy (2.0% vs. 18.5%; p &lt; 0.001), a trend that persisted following stratification by tumor stage and Charlson comorbidities. Both 30-day and 90-day mortality were higher in the octogenarian group, even after multivariable adjustment (p ≤ 0.001 for both). Octogenarians who underwent multimodality therapy had worse long-term survival when compared to younger patients, except for those with stage III tumors and no comorbidities (HR: 1.29; p = 0.153). Within the octogenarian group, postoperative mortality was lower in academic centers, and the long-term survival was similar between multimodality treatment and surgery alone (HR: 0.96; p = 0.62). In conclusion, octogenarians are less likely to be offered treatment irrespective of tumor stage or comorbidities. Although octogenarians have higher early mortality and poorer overall survival compared to younger patients, outcomes may be improved when treatment is performed at academic centers. Multimodality treatment did not seem to confer a survival advantage compared to surgery alone in octogenarians, and more prospective studies are necessary to better elucidate the optimal treatment in this patient population.

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