FA03.04: ACTIVE SURVEILLANCE VS SURGERY IN CLINICALLY COMPLETE RESPONDERS AFTER NEOADJUVANT CHEMORADIOTHERAPY FOR ESOPHAGEAL CANCER: A PROPENSITY-MATCHED STUDY

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 7-7
Author(s):  
Berend Van Der Wilk ◽  
Lisanne Neijenhuis ◽  
B Noordman ◽  
Grard A P Nieuwenhuijzen ◽  
M N Sosef ◽  
...  
Keyword(s):  
Overall Survival ◽  
Esophageal Cancer ◽  
Propensity Score ◽  
Active Surveillance ◽  
Neoadjuvant Chemoradiotherapy ◽  
Complete Response ◽  
Surgery Group ◽  
Significant Difference ◽  
Matched Study ◽  
Dissemination Rate

Abstract Background Nearly one third of esophageal cancer patients show a pathologically complete response in their resection specimens after neoadjuvant chemoradiotherapy (nCRT) according to CROSS regimen. This raises questions whether all patients benefit from surgery or if active surveillance can be applied to patients with a clinically complete response (cCR) after nCRT. This retrospective-multicenter propensity matched study compared outcomes of patients with a cCR after nCRT undergoing active surveillance or standard surgery. Methods Patients that refused surgery after nCRT between 2012–2017 from 4 hospitals were included. For the standard surgery group, patients from the preSANO trial were enrolled. A cCR was defined as endoscopies with multiple (bite-on-bite) biopsies, EUS-FNA and PET-CT showing no residual disease 6 and 12 weeks after completion of nCRT. Optimal propensity-score matching generated a matched cohort (1:2) matched for age, comorbidities, cT, cN, histology of the tumor and biopsy type. For comparison of severity of complications according to Clavien-Dindo (CD) classification, a separate optimal propensity-score matching cohort was generated (1:2) for all patients in the active surveillance group that underwent surgery. Primary outcome was overall survival, secondary outcomes were rate of radically resected tumors, distant dissemination rate and rate of postoperative complications according to the CD-classification. Results 75 patients were identified of whom 50 patients underwent standard surgery and 25 patients underwent active surveillance. 13 of 25 patients in the active surveillance group underwent surgery for locoregional recurrent disease. Median follow-up was 23.7 months for the standard surgery group and 18.8 months for the active surveillance group. There was no statistically significant difference between the groups in overall survival (HR = 0.48, 95%C.I. 0.10–2.2, P = 0.96). In both groups, all tumors were radically resected. There were no statistically significant differences in distant dissemination rate between the active surveillance and standard surgery group (16.0% versus 22.0%, P = 0.76) or in severity of complications (CD ≥ 3;46.2% versus 23.1%, P = 0.16). Conclusion There was no statistically significant difference in overall survival, distant dissemination rate and severity of complications between patients undergoing standard surgery or active surveillance after nCRT. However, since sample sizes were small, especially for the severity of complications, these results should be interpreted with caution. Disclosure All authors have declared no conflicts of interest.

Active surveillance versus surgery in clinically complete responders after neoadjuvant chemoradiotherapy for esophageal cancer: a propensity-matched study

2019 ◽  
Vol 45 (2) ◽  
pp. e7
Author(s):  
B. Van Der Wilk ◽  
L.K.A. Neijenhuis ◽  
B.J. Noordman ◽  
G.A.P. Nieuwenhuijzen ◽  
M.N. Sosef ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Active Surveillance ◽  
Neoadjuvant Chemoradiotherapy ◽  
Matched Study

scholarly journals NEOADJUVANT CHEMORADIOTHERAPY FOLLOWED BY TRANSHITAL ESOPHAGECTOMY IN LOCALLY ADVANCED ESOPHAGEAL SQUAMOUS CELL CARCINOMA: IMPACT OF PATHOLOGICAL COMPLETE RESPONSE

2021 ◽  
Vol 34 (3) ◽  
Author(s):  
Iuri Pedreira Fillardi ALVES ◽  
Valdir TERCIOTI JUNIOR ◽  
João de Souza COELHO NETO ◽  
José Antonio Possatto FERRER ◽  
José Barreto Campello CARVALHEIRA ◽  
...  
Keyword(s):  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Esophageal Cancer ◽  
Neoadjuvant Chemoradiotherapy ◽  
Disease Free Survival ◽  
Complete Response ◽  
Pathological Response ◽  
Complete Pathological Response ◽  
Free Survival ◽  
Disease Free

ABSTRACT Background Multimodal therapy with neoadjuvant chemoradiotherapy, followed by esophagectomy has offered better survival results, compared to isolated esophagectomy, in advanced esophageal cancer. In addition, patients who have a complete pathological response to neoadjuvant treatment presented greater overall survival and longer disease-free survival compared to those with incomplete response. Aim: To compare the results of overall survival and disease-free survival among patients with complete and incomplete response, submitted to neoadjuvant chemoradiotherapy, with two therapeutic regimens, followed by transhiatal esophagectomy. Methods: Retrospective study, approved by the Research Ethics Committee, analyzing the medical records of 56 patients with squamous cell carcinoma of the esophagus, divided into two groups, submitted to radiotherapy (5040 cGY) and chemotherapy (5-Fluorouracil + Cisplatin versus Paclitaxel + Carboplatin) neoadjuvants and subsequently to surgical treatment, in the period from 2005 to 2012, patients. Results The groups did not differ significantly in terms of gender, race, age, postoperative complications, disease-free survival and overall survival. The 5-year survival rate of patients with incomplete and complete response was 18.92% and 42.10%, respectively (p> 0.05). However, patients who received Paclitaxel + Carboplatin, had better complete pathological responses to neoadjuvant, compared to 5-Fluorouracil + Cisplatin (47.37% versus 21.62% - p = 0.0473, p <0.05). Conclusions There was no statistical difference in overall survival and disease-free survival for patients who had a complete pathological response to neoadjuvant. Patients submitted to the therapeutic regimen with Paclitaxel and Carboplastin, showed a significant difference with better complete pathological response and disease progression. New parameters are indicated to clarify the real value in survival, from the complete pathological response to neoadjuvant, in esophageal cancer.

Prognostic impact of circumferential resection margin in esophageal cancer with or without neoadjuvant chemoradiotherapy

2020 ◽  
Vol 33 (9) ◽  
Author(s):  
C-Y Liu ◽  
P-K Hsu ◽  
H-S Hsu ◽  
Y-C Wu ◽  
C-Y Chuang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Esophageal Cancer ◽  
Esophageal Squamous Cell Carcinoma ◽  
Circumferential Resection Margin ◽  
Resection Margin ◽  
Neoadjuvant Chemoradiotherapy ◽  
Prognostic Impact ◽  
Medical Centers ◽  
Surgery Group

Summary The prognostic impact of circumferential resection margin (CRM) in surgically resected esophageal squamous cell carcinoma (ESCC) has been controversial. This investigation assessed the prognostic impact of CRM in surgically resected pathologic T3 ESCC patients with or without neoadjuvant chemoradiotherapy (nCRT). We reviewed consecutive p/yp T3 ESCC patients undergoing esophagectomy from two medical centers between January 2009 and December 2016. The cohort was divided into two groups: upfront esophagectomy (upfront surgery) and nCRT followed by esophagectomy (nCRT + surgery). CRM status was assessed and divided into CRM &gt; 1 mm, 0 &lt; CRM &lt; 1 mm, and tumor at CRM. A total of 217 p/yp T3 ESCC patients undergoing esophagectomy (138 patients in the upfront surgery group and 79 in the nCRT + surgery group) were enrolled. In the upfront surgery group, patients with 0 &lt; CRM &lt; 1 mm showed equivalent overall survival to those with CRM &gt; 1 mm (log-rank P = 0.817) and significantly outlived those with tumor at CRM (log-rank P &lt; 0.001). However, in the nCRT + surgery group, CRM &gt; 1 mm failed to show survival superiority to CRM between 0 and 1 mm or involved by cancer (log-rank P = 0.390). In conclusion, a negative CRM, even though being &lt;1 mm, is adequate for pT3 ESCC patients undergoing upfront esophagectomy. In contrast, the CRM status is less prognostic in ypT3 ESCC patients undergoing nCRT followed by esophagectomy.

257 CHEMORADIOTHERAPY FOLLOWED BY ACTIVE SURVEILLANCE VERSUS SURGERY FOR ESOPHAGEAL CANCER: A SYSTEMATIC REVIEW AND INDIVIDUAL PATIENT DATA META-ANALYSIS

2020 ◽  
Vol 33 (Supplement_1) ◽  
Author(s):  
B Van Der Wilk ◽  
B Eyck ◽  
W Hofstetter ◽  
J Ajani ◽  
G Piessen ◽  
...  
Keyword(s):  
Overall Survival ◽  
Esophageal Cancer ◽  
Active Surveillance ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Random Effect ◽  
Neoadjuvant Chemoradiotherapy ◽  
Patient Data ◽  
Surveillance Strategy ◽  
Recurrence Rates

Abstract   Up to 50% of patients with esophageal cancer have a pathologically complete response after neoadjuvant chemoradiotherapy (nCRT) plus surgery. An active surveillance strategy may be feasible in patients with a complete clinical response (cCR) after nCRT. The aim of this study was to perform a meta-analysis using data of individual patients that underwent active surveillance with surgery for recurrent disease versus standard surgery after nCRT. Methods A systematic search was performed in Embase, Medline, Web of Science, Scopus and Cochrane from inception to February 2020. Studies were sought that reported on overall survival and recurrence rates in patients with cCR after nCRT that underwent active surveillance versus standard surgery. Authors were contacted to supply individual patient data. Pooled hazard ratio (HR) comparing survival outcomes and distant dissemination rates (DDR) between patients with cCR undergoing active surveillance or standard surgery were estimated using a random-effect meta-analysis. Cumulative incidence of locoregional recurrences in active surveillance were assessed using a Cox Frailty model. Results Seven studies including 788 patients (256 active surveillance and 532 surgery) were identified. All authors provided anonymized patient data. Pooled two- and five-year overall-survival was 75% and 58% for active surveillance and 76% and 60% for standard surgery with a pooled HR of 1.04 (95%CI:0.73–1.49) (Figure 1). Two-years DDR was 18% and 19% for active surveillance and standard surgery, respectively (HR 1.10,95%CI:0.75–1.63). Locoregional recurrence rate necessitating esophagectomy in patients undergoing active surveillance was 24% at one year, 33% at two years and 38% at five years. Active surveillance patients undergoing postponed surgery had R0 in 91% of cases. Conclusion Overall survival is comparable in patients undergoing active surveillance with postponed surgery compared to standard surgery after neoadjuvant chemoradiation. Distant dissemination rate is also comparable between both groups. During active surveillance, local regrowths developing after two years are rare. Although these data support an active surveillance strategy, randomized trials have to be completed before an active surveillance strategy can be actively proposed to patients with esophageal cancer.

scholarly journals Updated protocol of the SANO trial: a stepped-wedge cluster randomised trial comparing surgery with active surveillance after neoadjuvant chemoradiotherapy for oesophageal cancer

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ben M. Eyck ◽  
◽  
Berend J. van der Wilk ◽  
Bo Jan Noordman ◽  
Bas P. L. Wijnhoven ◽  
...  
Keyword(s):  
Overall Survival ◽  
Active Surveillance ◽  
Oesophageal Cancer ◽  
Neoadjuvant Chemoradiotherapy ◽  
Complete Response ◽  
Phase Iii ◽  
Residual Tumour ◽  
Trial Protocol ◽  
Stepped Wedge ◽  
Cluster Randomised

Abstract Background The Surgery As Needed for Oesophageal cancer (SANO) trial compares active surveillance with standard oesophagectomy for patients with a clinically complete response (cCR) to neoadjuvant chemoradiotherapy. The last patient with a clinically complete response is expected to be included in May 2021. The purpose of this update is to present all amendments to the SANO trial protocol as approved by the Institutional Research Board (IRB) before accrual is completed. Design The SANO trial protocol has been published (10.1186/s12885-018-4034-1). In this ongoing, phase-III, non-inferiority, stepped-wedge, cluster randomised controlled trial, patients with cCR (i.e. after neoadjuvant chemoradiotherapy no evidence of residual disease in two consecutive clinical response evaluations [CREs]) undergo either active surveillance or standard oesophagectomy. In the active surveillance arm, CREs are repeated every 3 months in the first year, every 4 months in the second year, every 6 months in the third year, and yearly in the fourth and fifth year. In this arm, oesophagectomy is offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant metastases. The primary endpoint is overall survival. Update Amendments to the study design involve the first cluster in the stepped-wedge design being partially randomised as well and continued accrual of patients at baseline until the predetermined number of patients with cCR is reached. Eligibility criteria have been amended, stating that patients who underwent endoscopic treatment prior to neoadjuvant chemoradiotherapy cannot be included and that patients who have highly suspected residual tumour without histological proof can be included. Amendments to the study procedures include that patients proceed to the second CRE if at the first CRE the outcome of the pathological assessment is uncertain and that patients with a non-passable stenosis at endoscopy are not considered cCR. The sample size was recalculated following new insights on response rates (34% instead of 50%) and survival (expected 2-year overall survival of 75% calculated from the moment of reaching cCR instead of 3-year overall survival of 67% calculated from diagnosis). This reduced the number of required patients with cCR from 264 to 224, but increased the required inclusions from 480 to approximately 740 patients at baseline. Conclusion Substantial amendments were made prior to closure of enrolment of the SANO trial. These amendments do not affect the outcomes of the trial compared to the original protocol. The first results are expected late 2023. If active surveillance plus surgery as needed after neoadjuvant chemoradiotherapy for oesophageal cancer leads to non-inferior overall survival compared to standard oesophagectomy, active surveillance can be implemented as a standard of care.

761 PATIENT PREFERENCES FOR ACTIVE SURVEILLANCE VERSUS STANDARD SURGERY AFTER NEOADJUVANT CHEMORADIOTHERAPY IN ESOPHAGEAL CANCER TREATMENT

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Merel Hermus ◽  
Berend Wilk ◽  
Gerlise Collee ◽  
Rebecca Chang ◽  
Bo Noordman ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Cancer Patients ◽  
Active Surveillance ◽  
Neoadjuvant Chemoradiotherapy ◽  
Complete Response ◽  
Treatment Preference ◽  
Patient Treatment ◽  
Treatment Preferences ◽  
Future Health ◽  
Depth Interviews

Abstract   The need for standard surgical resection in esophageal cancer patients after neoadjuvant chemoradiotherapy (nCRT) is subject of debate. Possibly, active surveillance (AS) is an option for patients with a clinically complete response (cCR), in whom no vital tumor cells are detected after nCRT. In a large Dutch multicenter randomized trial (SANO trial), standard surgery is compared to AS in patients with a cCR. Within this trial, we performed a side-study on patient treatment preferences. Methods Esophageal cancer patients, who declined participation in the SANO-trial due to a strong treatment preference for either AS or surgery were included. In-depth interviews were held on patient’s motives for their treatment choice. First, personal motives were addressed in an open manner, and later specific topics were addressed: earlier experiences with illness and health care, future health expectations, emotional motives, religious or spiritual believes and values in life. Data was recorded, transcribed verbatim and qualitatively analyzed according to the grounded theory principles. In addition, questionnaires on health literacy, coping, anxiety and decision regret were administered at two time points. Results Forty patients participated: twenty preferred AS and twenty standard surgery. The central principle for all patients is striving for safety while dealing with the threat of cancer. However, patients express different coping strategies in dealing with this threat. Patients preferring AS rely on trusting their bodies and good outcomes, while questioning the need for surgery. Patients preferring surgery try to minimize insecurity by eliminating the source of the cancer, while arguing that chances for undergoing surgery are high anyway. Interestingly, for either treatment option comparable arguments were used, with the most striking one of wishing ‘not to become a patient’. Conclusion Patients’ preferences in the treatment of esophageal cancer are determined by the way they cope with the threat of cancer. Since the arguments given for either AS or standard surgery can be comparable or even similar, the need for healthcare professionals to discuss what truly matters to their patients is of high importance. Subsequently, attuning to the personal needs of esophageal cancer patients will benefit the decision making process on future treatment.

Is salvage radiotherapy optimal to patients with occult cervical cancer undergoing inadvertent simple hysterectomy? A propensity score-matched analysis of a nationwide clinical oncology database

2021 ◽  
Author(s):  
Yanhong Wang ◽  
Yi Ouyang ◽  
Jingjing Su ◽  
Lihua Xiao ◽  
Zhigang Bai ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Propensity Score ◽  
Radical Surgery ◽  
Figo Stage ◽  
Salvage Radiotherapy ◽  
Radiotherapy Group ◽  
Surgery Group ◽  
Group Matching

Abstract Objective We used National Cancer Institute’s Surveillance, Epidemiology and End Result database to assess the role of salvage radiotherapy for women with unanticipated cervical cancer after simple hysterectomy. Methods Patients with non-metastatic cervical cancer and meeting inclusion criteria were divided into three groups based on treatment strategy: simple hysterectomy, salvage radiotherapy after hysterectomy and radical surgery. Parallel propensity score-matched datasets were established for salvage radiotherapy group vs. simple hysterectomy group (matching ratio 1: 1), and salvage radiotherapy group vs. radical surgery group (matching ratio 1:2). The primary endpoint was the overall survival advantage of salvage radiotherapy over simple hysterectomy or radical surgery within the propensity score-matched datasets. Results In total, 2682 patients were recruited: 647 in the simple hysterectomy group, 564 in the salvage radiotherapy group and 1471 in the radical surgery group. Age, race, histology, grade, FIGO stage, insured and marital status and chemotherapy were comprised in propensity score-matched. Matching resulted in two comparison groups with neglectable differences in most variables, except for black race, FIGO stage III and chemotherapy in first matching. In the matched analysis for salvage radiotherapy vs. simple hysterectomy, the median follow-up time was 39 versus 32 months. In the matched analysis for salvage radiotherapy vs. radical surgery, the median follow-up time was 39 and 41 months, respectively. Salvage radiotherapy (HR 0.53, P = 0.046) significantly improved overall survival compared with simple hysterectomy, while salvage radiotherapy cannot achieve similar overall survival to radical surgery (HR 1.317, P = 0.045). Conclusions This is the largest study of the effect of salvage radiotherapy on overall survival in patients with unanticipated cervical cancer. Salvage radiotherapy can improve overall survival compared with hysterectomy alone, while cannot achieve comparable survival to radical surgery.

P82 A PROPENSITY SCORE MATCHED COHORT STUDY TO EVALUATE THE ASSOCIATION OF LYMPH NODE RETRIEVAL WITH LONG-TERM OVERALL SURVIVAL IN PATIENTS WITH ESOPHAGEAL CANCER

2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
R van der Werf, Leonie ◽  
Marra, PhD Elske ◽  
S Gisbertz, PhD Suzanne ◽  
P L Wijnhoven, PhD Bas ◽  
I van Berge Henegouwen, PhD Mark
Keyword(s):  
Esophageal Cancer ◽  
Propensity Score ◽  
Neoadjuvant Chemoradiotherapy ◽  
Stage Migration ◽  
Matched Cohort ◽  
Term Survival ◽  
Node Negative ◽  
Pathological Staging ◽  
Lymph Node Retrieval

Abstract Introduction Previous studies evaluating the association of LN yield and survival presented conflicting results and many may be influenced by confounding and stage migration. This study aimed to evaluate whether the quality indicator ‘retrieval of at least 15 lymph nodes (LNs)’ is associated with better long-term survival and more accurate pathological staging in patients with esophageal cancer treated with neoadjuvant chemoradiotherapy and resection. Methods Data of esophageal cancer patients who underwent neoadjuvant chemoradiotherapy and surgery between 2011-2016 was retrieved from the Dutch Upper Gastrointestinal Cancer Audit. Patients with <15 LNs and ≥15 LNs were compared after propensity score matching based on patient and tumor characteristics. The primary endpoint was 3-year survival. To evaluate the effect of LN yield on the accuracy of pathological staging, pathological N-stage was evaluated and 3-year survival was analyzed in a subgroup of patients node-negative disease. Results In 2260 of 3281 patients (67%) ≥15 LNs were retrieved. In total, 992 patients with ≥15 LNs were matched to 992 patients with <15 LNs. The 3-year survival did not differ between the two groups (57% versus 54%, p=0.28). pN+ was scored in 41% of patients with ≥15 LNs versus 35% of patients with <15 LNs. For node-negative patients, the 3-year survival was significantly better for patients with ≥15 LNs (69% versus 61%, p=0.01). Conclusions In this propensity score matched cohort, 3-year survival was comparable for patients with ≥15 LNs, although increasing nodal yield was associated with more accurate staging. In node-negative patients, 3-year survival was higher for patients with ≥15 LNs.

681 PATTERN OF RECURRENCE IN PATIENTS WITH A PATHOLOGICALLY COMPLETE RESPONSE AFTER NEOADJUVANT CHEMORADIOTHERAPY AND SURGERY FOR OESOPHAGEAL CANCER

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Marloes Jongh ◽  
Ben M Eyck ◽  
Leonie R Werf ◽  
Eelke L A Toxopeus ◽  
J Jan B Lanschot ◽  
...  
Keyword(s):  
Overall Survival ◽  
Radiation Field ◽  
Oesophageal Cancer ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Complete Response ◽  
Distant Recurrence ◽  
Time To Recurrence ◽  
Phase Ii And Iii ◽  
Pattern Of Recurrence

Abstract   Neoadjuvant chemoradiotherapy (nCRT) and surgery is a widely used treatment for locally advanced resectable oesophageal cancer, with 20 and 50% of patients having a pathological complete response (pCR). Disease, however, still recurs in 20–30% of these patients. The aim of this study was to assess the pattern of recurrence in patients with pCR after nCRT and surgery. Methods All patients with pCR after neoadjuvant chemoradiotherapy and surgery included in the phase II and III ChemoRadiotherapy for Oesophageal followed by Surgery Study (CROSS) trials (April 2001—March 2009) and after the CROSS trials (September 2009—October 2017) were identified. The site of recurrence was compared to the applied radiation and surgical fields. Outcomes were median time to recurrence, overall and progression-free survivals. Results A total of 141 patients with a median follow-up of 100 (interquartile range [IQR] 64–134) months were included. Some 29 of 141 patients (21%) developed recurrence. Of these, four (14%) had isolated locoregional recurrence, 15 (52%) distant recurrence only and ten (34%) had both locoregional and distant recurrence. Among the 14 patients with locoregional recurrences, five were within the radiation field, seven outside the radiation field and two at the border. Median (IQR) time to recurrence was 24 (10–62) months. The 5-year overall survival was 74% and recurrence-free survival 70%. Conclusion Despite good overall survival, recurrence still occurred in 21% of patients. Most recurrences were distant, outside the radiation and surgical fields.

Robot-Assisted Versus Thoraco-laparoscopic McKeown Esophagectomy for Esophageal Cancer: a Propensity Score-Matched Study

2021 ◽  
Author(s):  
Lam Viet Trung ◽  
Nguyen Vo Vinh Loc ◽  
Tran Phung Dung Tien ◽  
Bui Duc Ai ◽  
Tieu Loan Quang Lam ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Propensity Score ◽  
Robot Assisted ◽  
Matched Study ◽  
Mckeown Esophagectomy
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