O85: ENSURE: EUROPEAN INVESTIGATION OF SURVEILLANCE AFTER RESECTION FOR ESOPHAGEAL CANCER

Abstract Presenting Author Email: [email protected] Research question Does intensive postoperative surveillance after planned curative resection for oesophageal cancer lead to increased detection of oligometastatic disease, facilitating increased use of tumor-directed therapy, hence improving overall survival? Background and aim Emerging data demonstrate long-term survival after salvage interventions for local or oligometastatic recurrence following planned curative resection for oesophageal cancer, providing rationale for postoperative surveillance. While meta-analyses confirm the survival benefit of chemotherapy (HR0.81, 0.71-0.92), and HER-2 directed therapy (HR0.75, 0.68-0.84) for patients with recurrent or metastatic oesophageal cancer, the effect of surveillance on oncologic outcome and health-related quality-of-life (HRQL) is unknown. There is currently no international consensus regarding the utility of surveillance following curative-intent treatment for oesophageal cancer, with divergent guidelines from ESMO, AUGIS and NCCN. A pilot study including 27 European centres (ENSURE-1) demonstrated wide variation in practice, with tumour markers, CT and PET-CT utilised in 4 (14.8%), 10 (37.0%) and 3 (11.1%), respectively. This multicenter collaborative project aims to determine the independent impact of intensive surveillance on recurrence patterns, oncologic outcome, and HRQL in survivorship, providing the first adequately powered study to address this critical research question. Patients A retrospective observational study of patients undergoing treatment with curative intent for oesophageal cancer at participating Centers from June 2009 to June 2015. Inclusion criteria 1. Age 18 years and above 2. Underwent surgery with curative intent for cTxNxM0 esophageal or esophagogastric junction (Siewert type I, II and III) cancer 3. Salvage surgery after failure of primary endoscopic or oncologic treatment will be included Exclusion criteria 1. Endoscopic therapy or definitive oncological treatment as sole therapy for esophageal cancer 2. Missing follow-up data Comparator Outcomes will be compared among patients managed with intensive surveillance (IS) compared with standard surveillance. IS will be defined as the routine use of CT/PET-CT for surveillance, at least annually, for at least the first three postoperative years. Each participating centre will be classified as undertaking IS or standard surveillance (SS) according to data submitted in the pilot study (ENSURE-1). Outcomes The primary endpoint of this study is: • Overall survival The secondary endpoints of this study are: • Disease-specific survival • Observed disease-free survival • HRQL o Prespecified EORTC QLQ-C30, QLQ-OG25 items • Recurrence patterns and treatment o Site of disease at initial recurrence o Oligometastatic disease at initial recurrence o Anastomotic disease at initial recurrence o Palliative chemotherapy, chemoradiation and radiation use o Treatment for oligometastatic and anastomotic recurrence (surgery, radiation, chemotherapy only) Study design Power calculation and sample size Power calculations are based on Sisic et al. demonstrating a 5% increase in 5-year overall survival with standardized follow-up in a propensity score matched analysis. Based on an initial feasibility survey of 18 Centers, current estimated number of cases per year for enrolled Centers is 885, therefore it is anticipated that the 5-year study period should capture approximately 4425 patients, of whom 31% undergo high intensity surveillance with cross-sectional imaging, with a minimum postoperative follow-up of 3 years. Using a log-rank analysis to detect a 5% difference in overall survival with sigma of 0.05, with 1371 of 4425 patients in the IS group, the study is powered to 90.4%, while accounting for a potential 20% exclusion rate, the study is powered to 83.1% with current enrolled Centers. Data collection and study definitions Where possible, data will be collected from prospectively maintained databases at participating Centers. Collected data will be entered into a standardized data collection spreadsheet “ENSURE Study - Datasheet” (attached). Variables will be coded at source by Co-Investigators according to standardized coding. Briefly, collected data will include: • Demographics • Co-morbidities and performance status • Histologic type • Tumor location • Clinical stage and grade • Pathologic stage, grade, treatment response and margins • Neoadjuvant therapy details • Operative details • Overall postoperative morbidity • Recurrence and associated treatment • Survival data • HRQOL o ENSURE database will be linked to include relevant HRQL data from a previous study (LASER) Registration The study has been registered on ClinicalTrials.gov (NCT03461341). Statistical Approach Data will be analyzed using SPSS® (v.23.0) software (SPSS, Chicago, IL, USA). For the multivariable analyses, all clinically relevant variables will be inputted into multivariable linear, logistic or Cox proportional hazards regression models. Team and infrastructure An international multidisciplinary collaborative team has been assembled via the Young Investigator Group of the European Society for Diseases of the Esophagus for the conduct of this study, with 27 centres signed up to participate in the pilot study to date. The study will be initiated from St. James's Hospital, Dublin, Ireland; the Karolinska Institute, Stockholm, Sweden; and Imperial College London, London, England. Steering committee: Jessie Elliott (Dublin), Fredrik Klevebro (Stockholm), Sheraz Markar (London), Lucas Goense (Utrecht), Melody Ni (London – statistician), Pernilla Lagergran (Stockholm – HRQL researcher) Supervisory committee: John V Reynolds (Dublin), Magnus Nilsson (Stockholm), George Hanna (London), Giovanni Zaninotto (Padova). Infrastructure: A dedicated biostatistician (Dr Melody Ni, Imperial College London) is a collaborator on the current project and will provide expertise with respect to design and data analysis. A researcher with expertise in HRQL assessment (Professor Pernilla Lagergren, Karolinska Institute) is also a named collaborator on the present project.

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Prognostic Relevance of Celiac Lymph Node Involvement in Ovarian Cancer

International Journal of Gynecological Cancer ◽

10.1097/igc.0000000000000041 ◽

2014 ◽

Vol 24 (1) ◽

pp. 48-53 ◽

Cited By ~ 8

Author(s):

Alejandra Martínez ◽

Cristophe Pomel ◽

Thomas Filleron ◽

Marjolein De Cuypere ◽

Eliane Mery ◽

...

Keyword(s):

Ovarian Cancer ◽

Overall Survival ◽

Lymph Node ◽

Oncologic Outcome ◽

Progression Free Survival ◽

Disease Spread ◽

Short Term ◽

Free Survival ◽

Increased Risk

ObjectiveThe aim of the study was to report on the oncologic outcome of the disease spread to celiac lymph nodes (CLNs) in advanced-stage ovarian cancer patients.MethodsAll patients who had CLN resection as part of their cytoreductive surgery for epithelial ovarian, fallopian, or primary peritoneal cancer were identified. Patient demographic data with particular emphasis on operative records to detail the extent and distribution of the disease spread, lymphadenectomy procedures, pathologic data, and follow-up data were included.ResultsThe median follow-up was 26.3 months. The median overall survival values in the group with positive CLNs and in the group with negative CLNs were 26.9 months and 40.04 months, respectively. The median progression-free survival values in the group with metastatic CLNs and in the group with negative CLNs were 8.8 months and 20.24 months, respectively (P = 0.053). Positive CLNs were associated with progression during or within 6 months after the completion of chemotherapy (P = 0.0044). Tumor burden and extensive disease distribution were significantly associated with poor progression-free survival, short-term progression, and overall survival. In multivariate analysis, only the CLN status was independently associated with short-term progression.ConclusionsDisease in the CLN is a marker of disease severity, which is associated to a high-risk group of patients with presumed adverse tumor biology, increased risk of lymph node progression, and worst oncologic outcome.

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EWS-FLI1 fusion transcript structure is an independent determinant of prognosis in Ewing's sarcoma.

Journal of Clinical Oncology ◽

10.1200/jco.1998.16.4.1248 ◽

1998 ◽

Vol 16 (4) ◽

pp. 1248-1255 ◽

Cited By ~ 369

Author(s):

E de Alava ◽

A Kawai ◽

J H Healey ◽

I Fligman ◽

P A Meyers ◽

...

Keyword(s):

Overall Survival ◽

Multivariate Analysis ◽

Prognostic Factors ◽

Molecular Heterogeneity ◽

Curative Intent ◽

Adequate Treatment ◽

Fusion Transcripts ◽

Fusion Type

PURPOSE More than 90% of Ewing's sarcomas (ES) contain a fusion of the EWS and FLI1 genes, due to the t(11;22)(q24;q12) translocation. At the molecular level, the EWS-FLI1 rearrangements show great diversity. Specifically, many different combinations of exons from EWS and FLI1 encode in-frame fusion transcripts and result in differences in the length and composition of the chimeric protein, which functions as an oncogenic aberrant transcription factor. In the most common fusion type (type 1), EWS exon 7 is linked in frame with exon 6 of FLI1. As the fundamental pathogenetic lesion in ES, the molecular heterogeneity of these fusion transcripts may have functional and clinical significance. PATIENTS AND METHODS We performed a clinical and pathologic analysis of 112 patients with ES in which EWS-FLI1 fusion transcripts were identified by reverse-transcriptase polymerase chain reaction (RT-PCR). Adequate treatment and follow-up data were available in 99 patients treated with curative intent. Median follow-up in these 99 patients was 26 months (range, 1 to 140 months). Univariate and multivariate survival analyses were performed that included other prognostic factors, such as age, tumor location, size, and stage. RESULTS Among the 99 patients suitable for survival analysis, the tumors in 64 patients contained the type 1 fusion and in 35 patients contained less common fusion types. Stage at presentation was localized in 74 patients and metastatic in 25. Metastases (relative risk [RR] = 2.6; P = .008), and type 1 EWS-FLI1 fusion (RR = 0.37; P = .014) were, respectively, independent negative and positive prognostic factors for overall survival by multivariate analysis. Among 74 patients with localized tumors, the type 1 EWS-FLI1 fusion was also a significant positive predictor of overall survival (RR = 0.32; P = .034) by multivariate analysis. CONCLUSION EWS-FLI1 fusion type appears to be prognostically relevant in ES, independent of tumor site, stage, and size. Further studies are needed to clarify the biologic basis of this phenomenon.

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5-Year Results of Dose-Intensive Sequential Adjuvant Chemotherapy for Women With High-Risk Node-Positive Breast Cancer: A Phase II Study

Journal of Clinical Oncology ◽

10.1200/jco.1999.17.4.1118 ◽

1999 ◽

Vol 17 (4) ◽

pp. 1118-1118 ◽

Cited By ~ 37

Author(s):

C. Hudis ◽

M. Fornier ◽

L. Riccio ◽

D. Lebwohl ◽

J. Crown ◽

...

Keyword(s):

Breast Cancer ◽

Overall Survival ◽

Pilot Study ◽

Adjuvant Chemotherapy ◽

Disease Free Survival ◽

Free Survival ◽

Dose Dense ◽

Disease Free

PURPOSE: We conducted a phase II pilot study of dose-intensive adjuvant chemotherapy with doxorubicin followed sequentially by high-dose cyclophosphamide to determine the safety and feasibility of this dose-dense treatment and to estimate the disease-free and overall survival in breast cancer patients with four or more involved axillary lymph nodes. PATIENTS AND METHODS: Seventy-three patients received adjuvant treatment with four cycles of doxorubicin 75 mg/m2 as an intravenous bolus every 21 days, followed by three cycles of cyclophosphamide 3,000 mg/m2 every 14 days with granulocyte colony-stimulating factor support. RESULTS: Seventy-one patients were assessable, and all but two completed all planned chemotherapy. There was no treatment-related mortality. The most common toxicity was neutropenic fever, which occurred in 39% of patients. Median disease-free survival is 66 months (95% confidence interval, 34 to 98 months), and median overall survival has not yet been reached. At 5 years of follow-up, the disease-free survival is 51.7%, and overall survival is 60.0%. There is no long-term treatment-related toxicity, and no cases of acute myelogenous leukemia or myelodysplastic syndrome have been observed. CONCLUSION: Our pilot study of doxorubicin followed by cyclophosphamide demonstrates the safety and feasibility of the sequential dose-dense plan. Long-term follow-up, although noncomparative, is promising. However, this regimen is associated with a higher incidence of toxicity (and also higher costs) than the standard dose and schedule of doxorubicin and cyclophosphamide, and therefore it should not be used as conventional therapy in the absence of demonstrated improvement of outcome. Randomized trials testing the dose-dense approach have been completed but not yet reported. Because the sequential plan can decrease overlapping toxicities, it is an appropriate platform for the addition of newer active agents, such as taxanes or monoclonal antibodies.

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Age-Stratified Treatment-Modalities for Patients with Primary CNS Lymphoma: Results of a Phase II Study and Two Pilot-Studies.

Blood ◽

10.1182/blood.v108.11.4683.4683 ◽

2006 ◽

Vol 108 (11) ◽

pp. 4683-4683

Author(s):

Gerald Illerhaus ◽

Reinhard Marks ◽

Fabian Mueller ◽

Friedrich Feuerhake ◽

Christoph Ostertag ◽

...

Keyword(s):

Overall Survival ◽

Pilot Study ◽

Phase Ii ◽

Phase Ii Study ◽

High Dose ◽

Single Center ◽

Pilot Phase ◽

Multicenter Phase ◽

New Treatment

Abstract Background: Primary NHL of the CNS (PCNSL) are associated with a dismal prognosis despite initial response to steroids and radiotherapy (RT). Addition of high-dose methotrexate (HD-MTX) to RT has improved the prognosis of patients (pts) with PCNSL. However, the majority of pts eventually relapse. To improve survival we performed a multicenter phase II study with early high-dose chemotherapy (HDT) and autologous stem-cell transplantation (ASCT) followed by hyperfractionated whole-brain radiation (WBRT) for 30 pts under 65yrs. Five-year overall survival rates of 69% for all pts and 87% for 23 pts receiving HDT and ASCT could be reported (Illerhaus et al., J Clin Oncol. 2006). Purpose: Here we present the results of 1) a pilot study for HDT and ASCT with WBRT restricted to residual disease in pts ≤65 years; 2) a multicenter phase II study for MTX-based CT and 3) a pilot-study for chemo-immunotherapy in pts > 65 years. Methods and Results: New treatment regimen for pts ≤65 years: CT consists of 4 cycles HD-MTX (8g/m2), 2 cycles AraC (2×3g/m2) and thiotepa (40mg/m2) followed by HDT with BCNU (400mg/m2) and thiotepa (4×5mg/kg) before ASCT. To date, 12 pts have been treated in this single center pilot-study. After HDT and ASCT 7/10 pts (70%) responded with complete remission (CR), 2/10 pts with partial remission (PR), 1 pt showed progressive disease (PD) and died after refusing RT. The 2 pts with PR have been irradiated resulting in continuous CR. Two pts were off study due to refractory disease. After a median follow-up of 17 months (mo) (range 4–41) 9/12 pts are alive in continuous CR. One pt developed a systemic relapse and died 8 months after ASCT. Overall, the treatment was well tolerated without grade IV toxicity. Patients >65 yrs, MCP-protocol: Thirty-two pts (17 female, 15 male, median age 71 yrs, range 57–79y) were treated in a phase II trial with 3 repetitive cycles of HD-MTX (3g/m2, d1, 15, 30) combined with procarbazine (60 mg/m2 p.o., d1-10) and CCNU (110 mg/m2 p.o., d 1). There was no lower limit of Karnofsky Performance Status. Thirty-two pts received 1 cycle, 17 pts received 2 cycles and 10 pts received 3 cycles. Best documented response in 25 evaluable pts were CR in 13/32 (41%), PR in 7/32 (22%) and PD 5/32 (16%) pts. Five of 32 pts developed severe renal impairment after MTX and were treated off-study. One patient died due to neutropenic fever. With a median follow-up of 64 mo (range 0–82 mo), the 5-year overall survival probability currently is 30.5%, the median survival is 15 mo. As of July 2006 9/32 (28%) pts are alive, 8 without evidence for leukoencephalopathy. New treatment regimen for pts >65 years, R-MCP-Protocol: In a subsequent pilot-phase rituximab has been added before each MTX-application. In a single center pilot-phase, 9 pts were treated within the protocol. The response rates were CR in 4/7 (57%) evaluable pts, PR, SD and PD, each in one pt, respectively. One patient received only one dose of MTX due to liver toxicity and developed CR with rituximab as single agent. To date, after a median follow-up of 4 mo (range 0–11mo) 8 of 9 pts are alive. Conclusion: The protocols presented here are safe and show high efficacy in treating patients with PCNSL in both age-groups. The addition of rituximab to MTX-based chemotherapy is promising and warrants further investigation.

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Burden of metastatic hormone-sensitive prostate cancer to identify men more likely to benefit from early docetaxel.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.6_suppl.136 ◽

2017 ◽

Vol 35 (6_suppl) ◽

pp. 136-136 ◽

Cited By ~ 4

Author(s):

Gwenaelle Gravis ◽

Jean-Marie Boher ◽

Yu-Hui Chen ◽

Glenn Liu ◽

Karim Fizazi ◽

...

Keyword(s):

Overall Survival ◽

De Novo ◽

Local Treatment ◽

Local Therapy ◽

High Volume ◽

Curative Intent ◽

Consistent Effect ◽

Visceral Metastases ◽

Definition Of

136 Background: Patients with a low burden of metastatic disease and who relapse after localized therapy with curative intent have a longer overall survival. It is unclear whether these patients benefit from early docetaxel (D). Methods: Patients in GETUG-AFU15 (N = 385, median follow-up 84 mo) and CHAARTED (N = 790, median follow up 54 mo) were randomized to ADT alone or ADT + D and outcomes described using the same definition of high volume (HV) and low volume (LV) disease. (HV: visceral metastases and/or 4 or more bone metastases with at least one outside the axis) and whether the patients had prior local therapy or not. Results: Table 1 details across both studies that de novo HV group treated with ADT alone has the shortest overall survival and D has a consistent effect in improving OS. In contrast, in both studies patients with LV disease had a much longer OS with no evidence that D improved OS. Conclusions: There was no apparent survival benefit in CHAARTED and GETUG-15 studies with D for LV whether patients had prior local treatment or not. Across both studies, early D had a consistent effect and improved OS in HV pts especially those with no prior local therapy. Partial Support and drug supply by Sanofi. Clinical trial information: NCT00104715, NCT00309985. [Table: see text]

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P-OGC56 Do patients presenting with obstructing oesophageal cancer have worse outcome?

British Journal of Surgery ◽

10.1093/bjs/znab430.184 ◽

2021 ◽

Vol 108 (Supplement_9) ◽

Author(s):

Siobhan Chien ◽

Khurram Khan ◽

Lewis Gall ◽

Colin MacKay ◽

Andrew Macdonald ◽

...

Keyword(s):

Oesophageal Cancer ◽

Performance Status ◽

Newly Diagnosed ◽

Ecog Performance Status ◽

Curative Intent ◽

Early Presentation ◽

Upper Gi ◽

The United Kingdom ◽

Treatment Intent

Abstract Background Oesophageal cancer carries a poor prognosis. Despite the availability of urgent Upper GI endoscopy in the United Kingdom, a substantial proportion of patients with newly diagnosed oesophageal cancer present late with near total dysphagia and an obstructing tumour at the index endoscopy. There is little data analysing the effect of obstructing oesophageal cancer at presentation on overall prognosis. The aim of the study was to analyse if patients presenting with obstructing oesophageal cancer have a worse outcome. Methods A retrospective cohort study of all newly diagnosed oesophageal cancers (adenocarcinoma and squamous cell carcinoma) and high grade dysplasia registered in a single UK Regional Upper GI MDT between October 2019 and September 2020 was performed. Electronic records were interrogated and patients dichotomised into two groups based on if they were obstructed endoscopically or not on the index endoscopy and the results were compared. Median follow up was 7 months. Results 243 patients (68 (28.0%) obstructed and 175 (72.0%) non-obstructed) with median age of 70 were identified. There were more females in the obstructed group (44.1% vs 25.7%, p = 0.005). ECOG performance status was worse in the obstructed group: ECOG-0 (30.9% vs 50.3%, p = 0.006). Adenocarcinoma was more common in non-obstructed group (69.1% vs 54.4%, p = 0.031). More patients in the obstructed group had a T4 tumour (38.2% vs 18.9%, p = 0.002), however, nodal and metastatic status were similar. Rates of curative intent treatment were similar. At median follow-up of 7 months (IQR 3-13), more patients in obstructed group were deceased (72.1% vs 49.7%, p = 0.002). Conclusions Obstructing oesophageal cancer at presentation is a marker of advanced disease and despite curative treatment intent, overall survival is worse compared to passable tumours. New screening techniques such as Cytosponge combined with public health interventions to encourage early presentation may enable earlier diagnosis and improved survival.

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Use of routinely collected health data in randomised clinical trials: comparison of trial-specific death data in the BOSS trial with NHS Digital data

Trials ◽

10.1186/s13063-021-05613-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Sharon B. Love ◽

Anna Kilanowski ◽

Victoria Yorke-Edwards ◽

Oliver Old ◽

Hugh Barr ◽

...

Keyword(s):

Overall Survival ◽

Clinical Trials ◽

Oesophageal Cancer ◽

Health Data ◽

Digital Data ◽

Phase Iii ◽

Specific Data ◽

Routinely Collected Health Data ◽

Death Data

Abstract Background A promising approach to reduce the increasing costs of clinical trials is the use of routinely collected health data as participant data. However, the quality of this data could limit its usability as trial participant data. Methods The BOSS trial is a randomised controlled trial comparing regular endoscopies versus endoscopies at need in patients with Barrett’s oesophagus with primary endpoint death. Data on death and cancer collected every 2 years after randomisation (trial-specific data) were compared to data received annually (all patients on one date) from the routinely collected health data source National Health Service (NHS) Digital. We investigated completeness, agreement and timeliness and looked at the implications for the primary trial outcome. Completeness and agreement were assessed by evaluating the number of reported and missing cases and any disparities between reported dates. Timeliness was considered by graphing the year a death was first reported in the trial-specific data against that for NHS Digital data. Implications on the primary trial outcome, overall survival, of using one of the data sources alone were investigated using Kaplan-Meier graphs. To assess the utility of cause of death and cancer diagnoses, oesophageal cancer cases were compared. Results NHS Digital datasets included more deaths and often reported them sooner than the trial-specific data. The number reported as being from oesophageal cancer was similar in both datasets. Due to time lag in reporting and missing cases, the event rate appeared higher using the NHS Digital data. Conclusion NHS Digital death data is useful for calculating overall survival where trial-specific follow-up is only every 2 years from randomisation and the follow-up requires patient response. The cancer data was not a large enough sample to assess usability. We suggest that this assessment of registry data is done for more phase III RCTs and for more registry data to get a more complete picture of when RCHD would be useful in phase III RCT. Trial registration ISRCTN54190466 (BOSS) 1 Oct 2009.

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Effect of Margin Status on Survival After Resection of Hilar Cholangiocarcinoma in the Modern Era of Adjuvant Therapies

The American Surgeon ◽

10.1177/0003134820973401 ◽

2020 ◽

pp. 000313482097340

Author(s):

Michael D. Watson ◽

Maria R. Baimas-George ◽

Michael J. Passeri ◽

Jesse K. Sulzer ◽

Erin H. Baker ◽

...

Keyword(s):

Overall Survival ◽

Hilar Cholangiocarcinoma ◽

Demographic Data ◽

Locally Advanced ◽

Resection Margins ◽

R0 Resection ◽

Complication Rates ◽

Curative Intent ◽

Adjuvant Therapies

Introduction Studies have shown that for patients with hilar cholangiocarcinoma (HC), survival is associated with negative resection margins (R0). This requires increasingly proximal resection, putting patients at higher risk for complications, which may delay chemotherapy. For patients with microscopically positive resection margins (R1), the use of modern adjuvant therapies may offset the effect of R1 resection. Methods Patients at our institution with HC undergoing curative-intent resection between January 2008 and July 2019 were identified by retrospective record review. Demographic data, operative details, tumor characteristics, postoperative outcomes, recurrence, survival, and follow-up were recorded. Patients with R0 margin were compared to those with R1 margin. Patients with R2 resection were excluded. Results Seventy-five patients underwent attempted resection with 34 (45.3%) cases aborted due to metastatic disease or locally advanced disease. Forty-one (54.7%) patients underwent curative-intent resection with R1 rate of 43.9%. Both groups had similar rates of adjuvant therapy (56.5% vs. 61.1%, P = .7672). Complication rates and 30 mortality were similar between groups (all P > .05). Both groups had similar median recurrence-free survival (R0 29.2 months vs. R1 27.8 months, P = .540) and median overall survival (R0 31.2 months vs. R1 38.8 months, P = .736) with similar median follow-up time (R0 29.9 months vs. R1 28.5 months, P = .8864). Conclusions At our institution, patients undergoing hepatic resection for HC with R1 margins have similar recurrence-free and overall survival to those with R0 margins. Complications and short-term mortality were similar. This may indicate that with use of modern adjuvant therapies obtaining an R0 resection is not an absolute mandate.

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