Publications by authors named "Marco Maruzzo"

49 Publications

Prognostic Stratification of Metastatic Prostate Cancer Patients Treated With Abiraterone and Enzalutamide Through an Integrated Analysis of Circulating Free microRNAs and Clinical Parameters.

Front Oncol 2021 16;11:626104. Epub 2021 Mar 16.

Oncology 1 Unit, Department of Oncology, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.

Androgen Receptor-Targeted Agents (ARTA) have dramatically changed the therapeutic landscape of metastatic Castration-Resistant Prostate Cancer (mCRPC), but 20-40% of these patients progress early after start of ARTA treatment. The present study investigated the potential utility of plasma cell-free microRNAs (cfmiRNAs) as prognostic markers by analyzing a prospective cohort of 31 mCRCP patients treated with abiraterone ( = 10) or enzalutamide ( = 21). Additional potential prognostic factors were extracted from clinical records and outcome was evaluated as overall survival (OS) and progression-free survival (PFS). cfmiRNAs were measured in plasma samples using quantitative real-time RT-PCR. Linear correlation among clinical factors and cfmiRNAs was assessed using the Spearman's rank correlation coefficient. The association with survival was studied using univariate and multivariate Cox proportional hazards models. Continuous variables were dichotomized with the cut points corresponding to the most significant relation with the outcome. Univariate analysis indicated that plasma levels of miR-21-5p, miR-141-3p and miR-223-3p, time to development of castration-resistance (tCRPC), and blood hemoglobin (Hb) levels strongly correlated with both PFS and OS. Multivariate analysis revealed that low plasma levels of miR-21, shorter tCRPC, and lower Hb values were independent factors predicting reduced PFS and OS. These findings suggest that the integrated analysis of cfmiRNAs, tCRPC, and Hb may provide a promising, non-invasive tool for the prognostic stratification of mCRPC patients treated with ARTA.
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http://dx.doi.org/10.3389/fonc.2021.626104DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8009625PMC
March 2021

Second medical opinion in oncological setting.

Crit Rev Oncol Hematol 2021 Mar 3;160:103282. Epub 2021 Mar 3.

Oncologia Medica, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, Verona, Italy. Electronic address:

Oncological patients increasingly require second medical opinions to feel more likely confident with their oncologists and treatments, although this could lead to wrong opinions and delay in the start of treatments. Second opinions can be required also by physicians to obtain advices, especially in case of rare tumors. The request of new opinions is documented in radiology and pathology settings too, with not negligible discrepancy rate. Conversely, the role in general medical/surgical conditions has not been well established. Literature is poor of studies relative to second opinions or they are more focused on patient's motivations. For these reasons, AIOM (Italian Association of Medical Oncology) and AIOM Foundation faced this topic during the 7th Annual Meeting on Ethics in Oncology (Ragusa, 4-5 t h May 2018). In this position paper we report reasons, limits, advantages and outcomes of second medical opinion and the respective Decalogue in the oncological setting.
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http://dx.doi.org/10.1016/j.critrevonc.2021.103282DOI Listing
March 2021

Clinical Outcomes of Metastatic Renal Carcinoma Following Disease Progression to Programmed Death (PD)-1 or PD-L1 Inhibitors (IO): A Meet-URO Group Real World Study (Meet-Uro 7).

Am J Clin Oncol 2021 03;44(3):121-125

Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.

Objectives: The aim of our study was to collect data about of the outcome of metastatic renal cell carcinoma patients who progressed after immune checkpoint inhibitors in order to enhance data about efficacy and safety of treatment beyond immune-oncology (IO).

Materials And Methods: A total of 162 eligible patients, progressing to IO, were enrolled from 16 Italian referral centers adhering to the Meet-Uro association. Baseline characteristics, outcome data and toxicities were retrospectively collected. Descriptive analysis was made using median values and ranges. Kaplan-Meier method and Mantel-Haenszel log-rank test were performed to compare differences between groups.

Results: A total of 111 patients (68.5%) were treated after IO progression. In all, 51 patients (31.5%) did not receive further treatment for clinical deterioration. Median IO progression free survival (PFS) was 4 months (95% confidence interval [CI]: 3.1-4.8). IO-PFS tends to be longer in patients reporting adverse events (AE) of any grade (5.03 [95% CI: 3.8-6.1] vs. 2.99 [95% CI: 2.4-3.5] months P=0.004). Subsequent therapies included cabozantinib (n=79, 48%), everolimus (n=11, 6.7%), and others (n=21, 12.9%).Median PFS post-IO was 6.5 months (95% CI: 5.1-7.8). Cabozantinib showed longer PFS compared with everolimus (7.6 mo [95% CI: 5.2-10.1] vs. 3.2 mo [95% CI: 1.8-4.5]) (hazard ratio: 0.2; 95% CI: 0.1026-0.7968) and other drugs (4.3 mo [95% CI: 1.3-7.4]) (hazard ratio: 0.6; 95% CI: 0.35-1.23). All grade AE were reported in 83 patients (74%) and G3 to G4 AE in 39 patients (35%). Target therapies post-IO showed median overall survival of 14.7 months (95% CI: 0.3-21.4).

Conclusions: In our real world experience after progression to IO, vascular endotelial groth factor-tyrosine kinase inhibitors, given to patients, proved to be active and safe choices. Cabozantinib was associated with a better outcome in terms of median PFS.
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http://dx.doi.org/10.1097/COC.0000000000000791DOI Listing
March 2021

Health-related quality of life 24-month after prostate cancer diagnosis: an update from the Pros-IT CNR prospective observational study.

Minerva Urol Nefrol 2021 Jan 13. Epub 2021 Jan 13.

Urology Unit, Azienda Socio-Sanitaria Territoriale Lariana, Sant'Anna Hospital, Como, Italy.

Background: This study analyzes patient health-related quality of life (QoL) 24-month after prostate cancer (PCa) diagnosis within the PROState cancer monitoring in ITaly from the National Research Council (Pros-IT CNR) study.

Methods: Pros-IT CNR is an ongoing, longitudinal and observational study, considering a convenience sample of patients enrolled at PCa diagnosis and followed at 6, 12, 24, 36, 48 and 60 months from the diagnosis. Patients were grouped according to the treatment received: nerve sparing radical prostatectomy (NSRP), non-nerve sparing radical prostatectomy (NNSRP), radiotherapy (RT), radiotherapy plus androgen deprivation (RT plus ADT) and active surveillance (AS). QoL was measured through the Italian versions of SF-12 and UCLA-PCI questionnaires at diagnosis and at 6-12 and 24-month. The minimal clinically important difference (MCID) was defined as half a standard deviation of the baseline domain.

Results: Overall, 1 537 patients were included in the study. The decline in urinary function exceeded the MCID at each timepoint only in the NSRP and NNSRP groups (at 24 months -14.7, p<0.001 and - 19.7, p<0.001, respectively). The decline in bowel function exceeded the MCID only in the RT (-9.1, p=0.02) and RT plus ADT groups at 12 months (-10.3, p=0.001); after 24 months, most patients seem to recover their bowel complaints. The decline in sexual function exceeded the MCID at each timepoint in the NNSRP, NSRP and RT plus ADT groups (at 6 months -28.7, p<0.001, -37.8, p<0.001, -20.4, p<0.001, respectively).

Conclusions: Although all the treatments were relatively well-tolerated over the 24 month period following PCa diagnosis, each had a different impact on QoL.
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http://dx.doi.org/10.23736/S0393-2249.20.04032-1DOI Listing
January 2021

Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG.

Ther Adv Med Oncol 2020 2;12:1758835920968463. Epub 2020 Nov 2.

Medical Oncology Unit, University Hospital of Parma, Parma, Italy.

Background: This prospective, multicentre, observational INVIDIa-2 study is investigating the clinical efficacy of influenza vaccination in advanced-cancer patients receiving immune-checkpoint inhibitors (ICIs), enrolled in 82 Italian centres, from October 2019 to January 2020. The primary endpoint was the incidence of influenza-like illness (ILI) until 30 April 2020. All the ILI episodes, laboratory tests, complications, hospitalizations and pneumonitis were recorded. Therefore, the study prospectively recorded all the COVID-19 ILI events.

Patients And Methods: Patients were included in this non-prespecified COVID-19 analysis, if alive on 31 January 2020, when the Italian government declared the national emergency. The prevalence of confirmed COVID-19 cases was detected as ILI episode with laboratory confirmation of SARS-CoV-2. Cases with clinical-radiological diagnosis of COVID-19 (COVID-like ILIs), were also reported.

Results: Out of 1257 enrolled patients, 955 matched the inclusion criteria for this unplanned analysis. From 31 January to 30 April 2020, 66 patients had ILI: 9 of 955 cases were confirmed COVID-19 ILIs, with prevalence of 0.9% [95% confidence interval (CI): 0.3-2.4], a hospitalization rate of 100% and a mortality rate of 77.8%. Including 5 COVID-like ILIs, the overall COVID-19 prevalence was 1.5% (95% CI: 0.5-3.1), with 100% hospitalization and 64% mortality. The presence of elderly, males and comorbidities was significantly higher among patients vaccinated against influenza unvaccinated (0.009, 0.0001, 0.0001). Overall COVID-19 prevalence was 1.2% for vaccinated (six of 482 cases, all confirmed) and 1.7% for unvaccinated (8 of 473, 3 confirmed COVID-19 and 5 COVID-like), 0.52. The difference remained non-significant, considering confirmed COVID-19 only (0.33).

Conclusion: COVID-19 has a meaningful clinical impact on the cancer-patient population receiving ICIs, with high prevalence, hospitalization and an alarming mortality rate among symptomatic cases. Influenza vaccination does not protect from SARS-CoV-2 infection.
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http://dx.doi.org/10.1177/1758835920968463DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7649863PMC
November 2020

Incidence and outcomes of severe acute respiratory syndrome coronavirus 2 infection in patients with metastatic castration-resistant prostate cancer.

Eur J Cancer 2020 11 20;140:140-146. Epub 2020 Oct 20.

Medical Oncology Department, ASST Cremona, Viale Concordia 1, 26100, Cremona, Italy.

Background: Patients with cancer are at increased risk of complicated severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection, but it is still unclear if the risk of mortality is influenced by cancer type or ongoing anti-cancer treatments. An interesting debate concerning the potential relationship between androgen deprivation therapy (ADT) and SARS-CoV-2 infection has recently been opened in the case of prostate cancer (PC), and the aim of this multi-centre cohort study was to investigate the incidence and outcomes of SARS-CoV-2 infection in patients with metastatic castration-resistant prostrate cancer (mCRPC).

Patients And Methods: We retrospectively reviewed the clinical records of patients with mCRPC who developed SARS-CoV-2 infection, and recorded their baseline clinical characteristics, their history of PC and SARS-CoV-2 infection, and their oncological status and treatment at the time of infection. The primary study end point was the death rate and the possible impact of the patients' PC-related history and treatments on mortality.

Results: Thirty-four of the 1433 patients with mCRPC attending the participating centres (2.3%) developed SARS-CoV-2 infection, 22 (64.7%) of whom were hospitalised. Most of the patients were symptomatic, the most frequent symptoms being fever (70.6%), dyspnoea (61.8%), cough (52.9%) and fatigue (38.2%). After a median follow-up of 21 days (interquartile range: 13-41), 13 patients had died (38.2%), 17 recovered (50.0%) and four (11.7%) were still infected. The number of treatments previously administered for mCRPC had a significant impact on mortality (p = 0.004).

Conclusions: Our findings contribute additional data to the current debate concerning the postulated protective role of ADT, which seems to be less in patients with metastatic PC.
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http://dx.doi.org/10.1016/j.ejca.2020.09.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7572507PMC
November 2020

Comprehensive geriatric assessment is an independent prognostic factor in older patients with metastatic renal cell cancer treated with first-line Sunitinib or Pazopanib: a single center experience.

J Geriatr Oncol 2021 Mar 21;12(2):290-297. Epub 2020 Sep 21.

Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy.

Background: There is poor data on the prognostic role of Comprehensive Geriatric Assessment (CGA) in older patients with metastatic renal cell carcinoma (mRCC) treated with first line Tyrosine Kinase Inhibitors (TKIs).

Materials And Methods: We retrospectively reviewed the clinical charts of mRCC patients older than 70 years treated at our Institute with first-line Sunitinib or Pazopanib for at least 6 months. Every patient received a CGA at baseline and was identified as fit, vulnerable or frail according to Balducci's Criteria. We then assessed the impact of CGA category on survival, disease control and tolerability of TKIs.

Results: We identified 86 eligible patients. Median age: 74.5 years, 56% males; 45.4% were fit, 37.2% vulnerable and 17.4% frail at CGA. There were no significant differences in the rate of Grade (G)1-2 and G3-4 toxicities, dose reduction rates, PFS and OS between Sunitinib and Pazopanib. Fit, vulnerable and frail patients achieved significantly different median PFS (18.9 vs 11.2 vs 5.1 months; p < 0.001) and OS (35.5 vs 14.6 vs 10.9 months; p < 0.001). Patients categorized as fit had higher chance of receiving a second-line treatment (66.6% vs 28.9% in vulnerable/frail; p = 0.002). The incidence of G3/4 events was significantly lower in the fit subgroup (19% vs 45% in vulnerable/frail; p = 0.0025).

Conclusions: In our retrospective single-center experience, CGA could accurately discriminate patients with higher risk of experiencing G3/4 toxicities, shorter PFS, and lower chance of receiving a second line treatment. CGA strongly impacted on OS, independently from International mRCC Database Consortium (IMDC) classification.
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http://dx.doi.org/10.1016/j.jgo.2020.09.009DOI Listing
March 2021

Fatal hyperprogression induced by nivolumab in metastatic renal cell carcinoma with sarcomatoid features: a case report.

Anticancer Drugs 2021 02;32(2):222-225

Oncology Unit 1, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, Padua.

In the past few years, the immune checkpoint inhibitor (ICI) nivolumab has become standard of care in the treatment of metastatic renal cell carcinoma (mRCC) progressing after antiangiogenic agents. To date, neither expression of programmed death ligand-1 (PD-L1) nor any other biomarker can be used to predict responses to ICIs, although intermediate-poor International Metastatic Database of Renal Carcinoma (IMDC) risk patients and those with sarcomatoid tumors appear to achieve superior benefit from immunotherapy. Paradoxically, ICIs may sometimes increase the speed of tumor growth. This rare phenomenon, called hyperprogression, has first been described in patients with melanoma and lung cancer treated with ICIs and is associated with poor survival. Here, we present the case of a patient affected by an intermediate IMDC risk mRCC with diffuse sarcomatoid features who achieved long disease control with first-line sunitinib and then started a second-line treatment with nivolumab. Unexpectedly, he experienced a dramatic acceleration of tumor growth and died soon after the third infusion of nivolumab. Then, we review the frequency of hyperprogression in mRCC and discuss the biological peculiarity of sarcomatoid RCC in terms of different responses to ICIs and antiangiogenic agents.
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http://dx.doi.org/10.1097/CAD.0000000000000991DOI Listing
February 2021

Management of Germ Cell Tumors During the Outbreak of the Novel Coronavirus Disease-19 Pandemic: A Survey of International Expertise Centers.

Oncologist 2020 10 18;25(10):e1509-e1515. Epub 2020 Sep 18.

Department of Clinical Medicine and Surgery, University of Naples "Federico II,", Naples, Italy.

Background: The coronavirus disease 2019 (COVID-19) pandemic has become a public health emergency affecting frail populations, including patients with cancer. This poses the question of whether cancer treatments can be postponed or modified without compromising their efficacy, especially for highly curable cancers such as germ cell tumors (GCTs).

Materials And Methods: To depict the state-of-the-art management of GCTs during the COVID-19 pandemic, a survey including 26 questions was circulated by e-mail among the physicians belonging to three cooperative groups: (a) Italian Germ Cell Cancer Group; (b) European Reference Network-Rare Adult Solid Cancers, Domain G3 (rare male genitourinary cancers); and (c) Genitourinary Medical Oncologists of Canada. Percentages of agreement between Italian respondents (I) versus Canadian respondents (C), I versus European respondents (E), and E versus C were compared by using Fisher's exact tests for dichotomous answers and chi square test for trends for the questions with three or more options.

Results: Fifty-three GCT experts responded to the survey: 20 Italian, 6 in other European countries, and 27 from Canada. Telemedicine was broadly used; there was high consensus to interrupt chemotherapy in COVID-19-positive patients (I = 75%, C = 55%, and E = 83.3%) and for use of granulocyte colony-stimulating factor primary prophylaxis for neutropenia (I = 65%, C = 62.9%, and E = 50%). The main differences emerged regarding the management of stage I and stage IIA disease, likely because of cultural and geographical differences.

Conclusion: Our study highlights the common efforts of GCT experts in Europe and Canada to maintain high standards of treatment for patients with GCT with few changes in their management during the COVID-19 pandemic.

Implications For Practice: Despite the chaos, disruptions, and fears fomented by the COVID-19 illness, oncology care teams in Italy, other European countries, and Canada are delivering the enormous promise of curative management strategies for patients with testicular cancer and other germ cell tumors. At the same time, these teams are applying safe and innovative solutions and sharing best practices to minimize frequency and intensity of patient contacts with thinly stretched health care capacity.
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http://dx.doi.org/10.1634/theoncologist.2020-0420DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543332PMC
October 2020

Cabozantinib After a Previous Immune Checkpoint Inhibitor in Metastatic Renal Cell Carcinoma: A Retrospective Multi-Institutional Analysis.

Target Oncol 2020 08;15(4):495-501

Genitourinary Cancer Unit, Dipartimento di Oncologia Medica, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.

Background: Angiogenesis has been recognized as the most important factor for tumor invasion, proliferation, and progression in metastatic renal cell carcinoma (mRCC). However, few clinical data are available regarding the efficacy of cabozantinib following immunotherapy.

Objective: To describe the outcome of cabozantinib in patients previously treated with immunotherapy.

Patients And Methods: Patients with mRCC who received cabozantinib immediately after nivolumab were included. The primary endpoint was to assess the outcome in terms of efficacy and activity.

Results: Eighty-four mRCC patients met the criteria to be included in the final analysis. After a median follow-up of 9.4 months, median overall survival was 17.3 months. According to the IMDC criteria, the rates of patients alive at 12 months in the good, intermediate, and poor prognostic groups were 100%, 74%, and 33%, respectively (p < 0.001). The median progression-free survival (PFS) was 11.5 months (95% CI 8.3-14.7); no difference was found based on duration of previous first-line therapy or nivolumab PFS. The overall response rate was 52%, stable disease was found as the best response in 25.3% and progressive disease in 22.7% of patients. Among the 35 patients with progressive disease on nivolumab, 26 (74.3%) patients showed complete/partial response or stable disease with cabozantinib as best response after nivolumab. The major limitations of this study are the retrospective nature and the short follow-up.

Conclusions: Cabozantinib was shown to be effective and active in patients previously receiving immune checkpoint inhibitors. Therefore, cabozantinib can be considered a valid therapeutic option for previously treated mRCC patients, irrespective of the type and duration of prior therapies.
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http://dx.doi.org/10.1007/s11523-020-00732-yDOI Listing
August 2020

Extraskeletal Myxoid Chondrosarcoma: Clinical and Molecular Characteristics and Outcomes of Patients Treated at Two Institutions.

Front Oncol 2020 16;10:828. Epub 2020 Jun 16.

Medical Oncology 1, Istituto Oncologico Veneto IRCCS, Padova, Italy.

Extraskeletal myxoid chondrosarcoma (EMC) is a rare subtype of STS, which usually arises in extremities. It carries reciprocal translocations involving the NR4A3 gene. It displays an indolent behavior, but studies with long follow-up showed a high proportion of local and distant recurrences. For patients with progressing metastatic disease anthracycline-based chemotherapy is the standard front-line regimen, though has limited activity. There is some evidence on possible activity of antiangiogenetics. This is a retrospective study conducted at Istituto Oncologico Veneto and at Institut Gustave Roussy. All patients with a confirmed diagnosis of EMC from January 1980 to December 2018 were extracted from a prospectively maintained database. 59 patients were identified, 37 male (62.7%) and 22 female (37.3%) with a M/F ratio of 1.7/1. We performed molecular analysis in 23 cases, all carried a EWSR1-NR4A3. Out of 49 patients treated with curative intent, 28.6% developed local recurrence and 40.8% patients developed metastases. In patients who had been radically resected (R0) local recurrence occurred in 7.6% of cases and metastases occurred in 15.4% of cases; in patients treated with R1 surgery, rates of relapse were higher. Twenty patients received chemotherapy for metastatic disease; best response was partial response with clinical benefit in 50% of patients. Fourteen patients received a second line of chemotherapy, with 46.1% disease control rate. A drug holiday was proposed to 8 patients with a mean duration of 22.8 months. Median overall survival was 180 months for the study population and 76 months for metastatic patients. No significant prognostic role was found for all studied variables, yet a trend of better survival for complete surgery, location in extremities of primary tumor and solitary lung metastases was observed. Chemotherapy for metastatic disease was negatively associated with survival. In this large retrospective cohort of patients with ECM, location of primary tumor and solitary lung metastases seem to be associated with better survival. Chemotherapy did not impact survival in unselected patients. Further research is necessary in order to identify more active regimens and to provide clinical and molecular factors to select patients that could delay systemic treatment for metastatic disease.
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http://dx.doi.org/10.3389/fonc.2020.00828DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7308468PMC
June 2020

Treatment Outcome of metastatic lesions from renal cell carcinoma underGoing Extra-cranial stereotactic body radioTHERapy: The together retrospective study.

Cancer Treat Res Commun 2020 29;22:100161. Epub 2019 Sep 29.

Radiotherapy Unit, University Hospital of Parma, Parma, Italy.

Objectives: stereotactic body radiation therapy (SBRT) use has increased overtime for the management of metastatic renal cell carcinoma (mRCC) patients, with a likely good control of irradiated lesions. We planned a retrospective multicenter Italian study, with the aim of investigating the outcome of treatment with SBRT for non-brain secondary lesions in mRCC patients.

Methods: all consecutive metastatic non-brain lesions from mRCC that underwent SBRT at nine Italian institutions from January 2015 to June 2017 were considered. The primary endpoint of the study was the lesion-PFS, calculated from SBRT initiation to the local progression of the irradiated lesion.

Results: 57 extracranial metastatic lesions from 48 patients with primary mRCC were treated with SBRT. At the median follow-up of 26.4 months, the median lesion-PFS was not reached (43 censored); 72.4% of lesions were progression-free at 40 months, with significantly better lesion-PFS for small metastatic lesions (<14 mm). SBRT was safe and the 1-year local disease control was 87.7%. After SBRT, 18 patients (37.5%) permanently interrupted systemic therapy.

Conclusions: consistently with the previous literature, our findings support the use of SBRT in selected mRCC patients.
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http://dx.doi.org/10.1016/j.ctarc.2019.100161DOI Listing
September 2019

Immunotherapy and urothelial carcinoma: An overview and future prospectives.

Crit Rev Oncol Hematol 2019 Nov 26;143:46-55. Epub 2019 Aug 26.

Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCSS, Padua, Italy.

Background: Urothelial carcinoma (UC) is a common malignancy with a high mortality rate when metastatic. Traditionally, systemic therapy consisted in platinum-based regimens as first-line, with Taxanes or Vinflunine as further lines. Recently, checkpoint inhibitors (CPIs) immunotherapy has emerged as a new therapeutic option.

Methods: We searched in Medline, Pubmed and ClinicalTrial.gov databases for the relevant literature, reviewing the results of published trials and the design of ongoing studies involving CPIs in UC.

Result: Strong evidence supports the use of CPIs after failure of Cisplatin-based chemotherapy, although no predictive parameter is available so far. Expression of Programmed-Death-1-Ligand has given conflicting results, and is currently indicated only for the selection of Cisplatin-ineligible patients who should receive CPIs.

Conclusion: The therapeutic landscape of UC is rapidly changing due to the availability of CPIs. Neoadjuvant trials with CPIs and trials combining two CPIs are promising and will further expand the use of immunotherapy.
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http://dx.doi.org/10.1016/j.critrevonc.2019.08.005DOI Listing
November 2019

Trabectedin Drug Holiday and Rechallenge in Soft Tissue Sarcomas: Report of 4 Cases and Literature Review.

Front Oncol 2019 9;9:553. Epub 2019 Jul 9.

Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy.

Soft tissue sarcomas are rare neoplasms, with a high mortality rate. Few drugs are available for the treatment of patients affected by metastatic sarcomas, who still have a 5-years survival rate lower than 20%. However, some of the more recent therapies can obtain long lasting responses in a portion of patients, such as Trabectedin. We analyzed four such cases treated at our Institute after progression to an anthracycline based regimen. In each case a therapeutic pause was proposed after at least 6 months of therapy with Trabectedin and in three out of four patients a re-challenge was proposed at progression, achieving again disease control or response. In two cases oligo-progressive sites were treated with localized therapies as stereotactic radiotherapy, delaying the systemic treatment re-start. In this article the reports of the patients involved are presented with a concise review of the relevant literature. Our findings support the favorable safety profile of Trabectedin and the feasibility of drug holidays, which should be at least discussed with the patient.
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http://dx.doi.org/10.3389/fonc.2019.00553DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6629888PMC
July 2019

Prevalence of pain in patients with cancer aged 70 years or older: A prospective observational study.

J Geriatr Oncol 2019 07 25;10(4):637-642. Epub 2019 Jan 25.

Medical Oncology 1 Unit, Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.

Background: Pain is a common symptom among patients with cancer, yet pain prevalence and management in older cancer pts. are poorly known.

Methods: Patients aged ≥70 years referred to Istituto Oncologico Veneto IRCCS from January 2011 to December 2013 were evaluated with Comprehensive Geriatric Assessment (CGA). Pain was assessed by means of short form of McGill Pain Questionnaire (MPQ-sf), Brief Pain Inventory (BPI-sf), and numerical rating scale (NRS). Pts with completed CGA, no severe cognitive impairment and completed pain assessment were enrolled.

Results: Enrolled patients were 745; 51% male, median age 76 years, median ECOG Performance Status (PS) 1. Frail patients at CGA were 45.2%. Patients with pain were 266 (35.7%). Mean Average Pain Intensity (API) was significantly higher among females, patients fit at CGA, with advanced disease, poorer PS and more comorbidity. Pain was detected by the oncologist in 20.4% of cases and deemed cancer-related in 54.8%. Gender, PS, status of disease, stage, function disability, mood, cognitive functioning and frailty were significantly associated with reporting of pain. At BPI, moderate-severe pain was found in 81 patients. The degree of agreement between API and pain intensity evaluated by physician was minimal. Patients on pain medications were 184, with 113 patients reporting rates of pain relief ≥50%.

Conclusion: About one third of older patients with cancer report pain, which is not cancer-related in about half of cases. Female gender, fitness at CGA, advanced stage, poorer PS, higher number of comorbidities and primary site were associated with significant differences in pain reporting.
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http://dx.doi.org/10.1016/j.jgo.2019.01.005DOI Listing
July 2019

Results From a Large, Multicenter, Retrospective Analysis On Radium223 Use in Metastatic Castration-resistant Prostate Cancer (mCRPC) in the Triveneto Italian Region.

Clin Genitourin Cancer 2019 Feb 26;17(1):e187-e194. Epub 2018 Oct 26.

Medical Oncology Unit 1, Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.

Background: Radium 223 was introduced for metastatic castration-resistant prostate cancer based on the results of a randomized controlled trial showing risk reduction for death and skeletal events. Our aim was to evaluate the outcome of patients receiving radium 223 in a real-world setting.

Patients And Methods: We conducted a multicenter retrospective analysis in the Triveneto region of Italy.

Results: One hundred fifty-eight patients received radium 223 in our region. After a median follow-up of 9.5 months, 75 patients died. The median overall survival (OS) was 14.2 months, and the median progression-free survival (PFS) was 6.2 months. Seventy-one (45%) patients achieved progression as best response. Thirty-seven (23%) patients stopped the treatment early because of progression. Eastern Cooperative Oncology Group performance status was prognostic for OS (18.4 vs. 12.3 vs. 7.5 months; 0 vs. 1, P = .0062; 0 vs. 2, P = .0002), whereas previous prostatectomy or docetaxel exposure were not. A neutrophil to lymphocytes ratio ≥ 3 significantly impacted OS (18.1 vs. 9.7 months; P < .001) and slightly impacted PFS (6.6 vs. 5.6 months; P = .05). Patients with a baseline alkaline phosphatase (ALP) value ≥ 220 U/L had worse OS and PFS (24.1 vs. 10.5 months; 7.2 vs. 5.5 months; P < .001). Patients with changes in ALP value achieved better OS (P = .029) and PFS (P = .002). There was no difference according to the line of therapy (0 vs. ≥ 1; P = .490). The main grade 3/4 toxicities were anemia, asthenia, and thrombocytopenia.

Conclusion: This large real-world report confirms comparable OS and PFS data when compared with the pivotal study, as well as the predictive role of ALP and neutrophil to lymphocytes ratio. The definition of the optimal position of radium 223 in the treatment of metastatic castration-resistant prostate cancer has still to be defined.
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http://dx.doi.org/10.1016/j.clgc.2018.10.013DOI Listing
February 2019

Safety and Efficacy of Pazopanib in First-Line Metastatic Renal-Cell Carcinoma With or Without Renal Failure: CORE-URO-01 Study.

Clin Genitourin Cancer 2019 Feb 10;17(1):e150-e155. Epub 2018 Oct 10.

Medical Oncology Unit, AUSL-IRCCS Reggio Emilia, Reggio Emilia, Italy.

Background: Pazopanib has been approved for first-line treatment of patients with metastatic renal-cell carcinoma on the basis of clinical trials that enrolled only patients with adequate renal function. Few data are available on the safety and efficacy of pazopanib in patients with renal insufficiency. This study investigated the effect of kidney function on treatment outcomes in such patients.

Patients And Methods: We retrospectively analyzed data of metastatic renal-cell carcinoma patients treated with pazopanib from January 2010 to June 2016 with respect to renal function. Patients with Modification of Diet in Renal Disease ≤ 60 mL/min/1.73 m (group A) were compared to patients with Modification of Diet in Renal Disease > 60 mL/min/1.73 m (group B) in terms of progression-free survival, toxicities, response rates, and overall survival.

Results: A total of 229 patients were included: 128 in group A and 101 in group B. Median progression-free survival was 14 months (95% confidence interval [CI], 9.4-18.5) and 17 months (95% CI, 11.4-22.8), and overall survival was 30.5 months (95% CI, 8-53) and 41.4 months (95% CI, 21-62) for group A and group B, respectively, with no significant difference (P = .6). No significant difference between the 2 groups was reported in the incidence of adverse events. Dose reductions were more frequent in group A patients (66% vs. 36%; P = .04).

Conclusion: Although the dose of pazopanib was reduced more frequently in patients with renal impairment, kidney function at therapy initiation does not adversely affect the safety and efficacy of pazopanib.
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http://dx.doi.org/10.1016/j.clgc.2018.10.001DOI Listing
February 2019

Autophagic Gene Polymorphisms in Liquid Biopsies and Outcome of Patients with Metastatic Clear Cell Renal Cell Carcinoma.

Anticancer Res 2018 10;38(10):5773-5782

Medical Oncology, Università Politecnica delle Marche, Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I, GM Lancisi, G Salesi, Ancona, Italy.

Background/aim: Autophagy has been shown to be involved in cancer development and response to cancer therapy. In this study, genotypes of autophagic genes were analyzed to assess their correlation with the risk of clear cell renal cell carcinoma (ccRCC) and the outcome of patients treated with pazopanib for metastatic ccRCC.

Materials And Methods: Single nucleotide polymorphisms (SNPs)were selected in the following genes: ATG4A (rs7880351), ATG4B (rs6709768), ATG4C (rs2886770, rs6670694, rs6683832), ATG5 (rs9373839, rs3804333, rs490010), ATG16L1 (rs6752107), ATG16L2 (rs10751215) and IRGM (rs10059011). The Kaplan-Meier method and log-rank test were used to evaluate differences between groups.

Results: Forty patients with metastatic ccRCC treated with pazopanib were included in the analysis. ATG16L2rs10751215 was significantly less frequent in patients with ccRCC compared to the general population, suggesting its potential protective role, while ATG4Ars7880351, ATG4C rs6670694 and rs6683832 and ATG5 rs490010 were correlated with the progression-free survival (PFS) of patients treated with pazopanib.

Conclusion: Our results suggest, for the first time, that autophagic gene SNPs are associated with ccRCC risk and patient outcome.
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http://dx.doi.org/10.21873/anticanres.12916DOI Listing
October 2018

The Role of Radiolabeled Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography for the Evaluation of Renal Cancer.

Eur Urol Focus 2020 01 16;6(1):146-150. Epub 2018 Aug 16.

Department of Surgery, Oncology, and Gastroenterology - Urology Clinic, University of Padua, Padua, Italy.

Context: Preliminary results have demonstrated that prostate-specific membrane antigen (PSMA) is highly expressed on the cell surface of the microvasculature of several solid tumors, including renal cell carcinoma (RCC).

Objective: To assess the role of PSMA positron emission tomography (PET)/computed tomography (CT) in RCC patients and to discuss its possible inclusion in the clinical management of these patients.

Evidence Acquisition: A systematic literature search was performed for studies on PET/CT in patients with RCC up to April 2018. MEDLINE databases, such as Pubmed, Web of Science, and Scopus were consulted using the following keywords: "Renal Cell Carcinoma" AND "PET/CT", "Renal Cancer" AND "PET/CT", "renal cancer" AND "PSMA PET/CT", and "renal cell carcinoma" AND "PSMA PET/CT".

Evidence Synthesis: Thirteen articles were retrieved from the available literature; the majority of them were relative to metastatic RCC (n=11/13, 85%) and eight of them were clinical cases, thus providing low-quality data. No diagnostic benefit of PSMA PET/CT was found in the evaluation of primary tumors. PSMA PET/CT may be a useful imaging modality in whole-body staging and restaging of patients with RCC and in the assessment of lesions that remained unclear on conventional imaging. Furthermore, PSMA PET/CT may predict the response to anti-angiogenic-targeted therapies.

Conclusions: The utility of PSMA-based PET imaging in the assessment of patients with RCC is encouraging. However, the available preliminary results will need to be addressed with larger prospective trials.

Patient Summary: In this mini-review, we evaluated the usefulness of an alternative imaging technique for patients with renal cell cancer. We found that this new imaging modality may indeed be useful. We conclude that the preliminary data should be assessed by larger studies.
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http://dx.doi.org/10.1016/j.euf.2018.08.004DOI Listing
January 2020

Prostate cancer imaging: when the game gets tough, the hard one gets done!

Eur J Nucl Med Mol Imaging 2018 11 21;45(12):2032-2034. Epub 2018 Jul 21.

Oncology 1 Unit, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.

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http://dx.doi.org/10.1007/s00259-018-4092-2DOI Listing
November 2018

Negative prognostic factors and resulting clinical outcome in patients with metastatic renal cell carcinoma included in the Italian nivolumab-expanded access program.

Future Oncol 2018 Jun 18;14(14):1347-1354. Epub 2018 May 18.

IRCCS Policlinico 'S Matteo', Pavia, Italy.

Aim: We report the outcomes observed with nivolumab in metastatic renal cell carcinoma patients with poor prognostic features enrolled in the Italian expanded access program.

Patients & Methods: Nivolumab was available for patients who relapsed after at least one prior systemic treatment in the advanced or metastatic setting.

Results: Of 389 patients, 32 (8%) had brain metastasis, 129 (33%) had liver and 193 (50%) had bone metastasis. These subpopulations achieved a disease control rate of 53, 45 and 47%, respectively. Fifty-one patients had G4 tumor, and they showed 23% objective response rate. The safety profile of the subgroups was in line with the expanded access program population. No new safety signals were reported.

Conclusion: Patients with poor prognostic features may derive relevant benefits from nivolumab.
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http://dx.doi.org/10.2217/fon-2017-0570DOI Listing
June 2018

Outcome of oligoprogressing metastatic renal cell carcinoma patients treated with locoregional therapy: a multicenter retrospective analysis.

Oncotarget 2017 Nov 7;8(59):100708-100716. Epub 2017 Aug 7.

Campus Bio-Medico University of Rome, Department of Medical Oncology, Rome, Italy.

Locoregional treatment with radical intent should be considered during therapy with targeted agents in patients with metastatic renal cell carcinoma (mRCC) in order to achieve a complete response, especially in the setting of an oligo-progression in one or more metastatic sites. We retrospectively enrolled 55 patients who experienced a disease oligo-progression after at least 6 months from the beginning of first-line therapy in one or more metastatic sites radically treated with locoregional treatments. Post-first-oligo-progression overall survival (PFOPOS) and post-first-oligo-progression free survival (PFOPFS) were evaluated. The global median PFOPOS and PFOPFS were 37 months and 14 months respectively. Patients who continued the same therapy after a locoregional treatment on a site of progression had a significantly longer mPFOPOS compared to patients who changed therapy (39 11 months, =0.014). An advantage in mPFOPOS was also observed in patients with a Memorial Sloan-Kettering Cancer Center (MSKCC) good risk score compared to patients of the intermediate risk group (39 29 months, =0.036); patients with bone metastases had a longer mPFOPOS compared to those with visceral metastases (not reached 31 months, =0.045). The only independent predictor of poor prognosis, in terms of PFOPOS at multivariate analysis (=0.007), proved out to be change of treatment after first progression. In this paper we aim to illustrate that continuing the same systemic therapy, after a radical locoregional treatment on a site of progression, seems to be associated with a prolongation of mPFOPOS.
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http://dx.doi.org/10.18632/oncotarget.20022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5725056PMC
November 2017

Fluorocholine PET/CT predicts skeletal progression, skeletal event and cancer specific survival in patients with biochemical relapse for prostate cancer.

Clin Imaging 2017 May - Jun;43:110-116. Epub 2017 Feb 24.

Nuclear Medicine Unit, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.

Purpose: The aim of our study is to evaluate the prognostic impact of F-Choline (FCh) positron emission tomography (PET)/computed tomography (CT), CT alone and methylene diphophonate bone scan (MDP-BS) in prostate cancer (PCa) patients with biochemical relapse.

Methods: We retrospectively selected 58 patients who underwent, between June 2010 and February 2013, both FCh-PET/CT and MDP-BS within a maximum time interval of 5months. All patients had a biochemical PCa recurrence after radical prostatectomy and/or radiation therapy. Two independent observers reviewed FCh-PET/CT and MDP-BS images. The bone window of CT portion from FCh-PET/CT was separately assessed. Time to progression (TTP), skeletal event free survival (SES) and cancer specific survival (CSS) were defined as the length of time between imaging and progression of disease, skeletal related events and cancer specific mortality, respectively. A patient based and a K agreement analysis was used to compare the findings of all three imaging modalities. Kaplan-Meier and log-rank analysis were computed for survival assessment. A multivariate Cox regression analysis was used to identify the independent predictors for TTP.

Results: Bone metastases were detected in 22 (38%) patients at FCh-PET/CT, in 27 (47%) at MDP-BS and in 24 (41%) at CT. The agreement between FCh-PET/CT and MDP-BS, CT and MDP-BS, and FCh-PET/CT and CT were moderate/fair (respectively, k: 0.474, 0.267 and 0.424; all p<0.05). After 38months (IQR: 27-54months) of follow-up, 33 (57%) patients had a new recurrence of disease, 12 (21%) had skeletal related events and 19 (33%) died. Three subjects (5%) were lost during the observational period. At survival analyses, a worse TTP, SES and CSS were found in patients with a positive FCh-PET/CT at bone level than those with a negative scan (all p≤0.05). Conversely, any significant difference in TTP, SES and CSS was found for patients with both a positive MDP-BS and CT scan. At univariate analysis, a positive FCh-PET/CT at skeletal level was associated with all events (all p<0.05). However, only a positive FCh-PET/CT at any site was an independent prognostic variable of TTP (HR: 3.08; CI 95%: 1.85-9.05; p=0.04).

Conclusions: PET/CT should be preferred to CT and BS in patients with prostate cancer with bone metastasis because it allows a better stratification of TTP, SES and CCS compared to CT and BS.
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http://dx.doi.org/10.1016/j.clinimag.2017.02.003DOI Listing
November 2017

First-Line PAzopanib in NOn-clear-cell Renal cArcinoMA: The Italian Retrospective Multicenter PANORAMA Study.

Clin Genitourin Cancer 2017 08 29;15(4):e609-e614. Epub 2016 Dec 29.

Santa Chiara Hospital, Medical Oncology, Trento, Italy.

Introduction: Pazopanib is a standard first-line treatment for metastatic clear-cell renal cell carcinoma (ccRCC). Very few data on its activity in non-clear-cell renal cell carcinoma (nccRCC) are currently available. The aim of this study was to retrospectively analyze efficacy and toxicity of pazopanib in nccRCC patients.

Patients And Methods: Records from advanced nccRCC patients (consecutive sample) treated with first-line pazopanib between 2010 and 2015 at 17 Italian centers were reviewed. Response rate, progression-free survival (PFS), and overall survival (OS) were evaluated. Univariate and descriptive analyses were performed.

Results: Thirty-seven patients with nccRCC were treated with first-line pazopanib; 51% had papillary histology, 24% chromophobe, 22% unclassified, and 3% had Xp11.2 translocation. Dose reductions/temporary interruptions for toxicity were required in 46% of cases. Grade (G) 3/4 toxicity was seen in 32%, G1/2 in 89% of cases; 81% achieved disease control, with 10 partial responses (27%) and 20 cases of stable disease (54%); 16% of patients had disease progression as best response. Median PFS and OS were 15.9 and 17.3 months, respectively. In univariate analysis, nephrectomy (P = .020), Memorial Sloan Kettering Cancer Center (MSKCC) score (P < .001), basal neutrophil/lymphocyte ratio (NLR; P = .009) and performance status (PS) (P = .001) were associated with PFS; MSKCC score (P < .001), International Metastatic Renal Cell Carcinoma Database Consortium score (P = .003), PS (P < .0001), nephrectomy (P = .002), histology (P = .035), dose reductions/interruptions (P = .039), best response to treatment (P < .001), and NLR (P = .008) were associated with OS.

Conclusion: In nccRCC patients, treatment with pazopanib was effective and feasible; dose reductions required for toxicity were similar as expected in ccRCC.
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http://dx.doi.org/10.1016/j.clgc.2016.12.024DOI Listing
August 2017

Prognostic Value of Plasma and Urine Glycosaminoglycan Scores in Clear Cell Renal Cell Carcinoma.

Front Oncol 2016 24;6:253. Epub 2016 Nov 24.

Department of Biology and Biological Engineering, Chalmers University of Technology , Göteborg , Sweden.

Background: The prognosis of metastatic clear cell renal cell carcinoma (ccRCC) vastly improved since the introduction of antiangiogenic-targeted therapy. However, it is still unclear which biological processes underlie ccRCC aggressiveness and affect prognosis. Here, we checked whether a recently discovered systems biomarker based on plasmatic or urinary measurements of glycosaminoglycans (GAGs) aggregated into diagnostic scores correlated with ccRCC prognosis.

Methods: Thirty-one patients with a diagnosis of ccRCC (23 metastatic) were prospectively enrolled, and their urine and plasma biomarker scores were correlated to progression-free survival (PFS) and overall survival (OS) as either a dichotomous ("Low" vs. "High") or a continuous variable in a multivariate survival analysis.

Results: The survival difference between "High"- vs. "Low"-scored patients was significant in the case of urine scores (2-year PFS rate = 53.3 vs. 100%,  = 3 × 10 and 2-year OS rate = 73.3 vs. 100%,  = 0.0078) and in the case of OS for plasma scores (2-year PFS rate = 60 vs. 84%,  = 0.0591 and 2-year OS rate = 66.7 vs. 90%,  = 0.0206). In multivariate analysis, the urine biomarker score as a continuous variable was an independent predictor of PFS [hazard ratio (HR): 4.62, 95% CI: 1.66-12.83,  = 0.003] and OS (HR: 10.13, 95% CI: 1.80-57.04,  = 0.009).

Conclusion: This is the first report on an association between plasma or urine GAG scores and the prognosis of ccRCC patients. Prospective trials validating the prognostic and predictive role of this novel systems biomarker are warranted.
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http://dx.doi.org/10.3389/fonc.2016.00253DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5121125PMC
November 2016

Extranodal Extension of Nodal Metastases Is a Poor Prognostic Indicator in Gastric Cancer: a Systematic Review and Meta-analysis.

J Gastrointest Surg 2016 10 13;20(10):1692-8. Epub 2016 Jul 13.

Department of Diagnostics and Public Health, University and Hospital Trust of Verona, Piazzale Scuro, 10, 37134, Verona, Italy.

Introduction: The extranodal extension (ENE) of nodal metastases (the extension of neoplastic cells through the nodal capsule into the perinodal soft tissue) is a histological feature that has been considered a prognostic factor in several cancers, but the role in gastric cancer was not yet investigated. We aimed to investigate the prognostic role of ENE in patients affected by gastric cancer through a systematic review and meta-analysis.

Material And Methods: Two independent authors searched major databases until 09/30/2015 to identify studies providing data on gastric cancer patients' prognostic parameters and comparing patients with ENE (ENE+) vs intra-nodal extension (ENE-). The data were summarized using risk ratios (RRs) for the number of deaths/recurrences and hazard ratios (HRs) with 95 % confidence intervals (CI), adjusted for potential confounders.

Results: Nine studies followed up 3250 patients with gastric cancer (1064 ENE+ and 2186 ENE-). ENE+ was associated with a significantly higher risk of all-cause mortality (RR = 1.70; 95 % CI: 1.43-2.03, I (2) = 66 %; HR = 2.14; 95 % CI: 1.66-2.75, I (2) = 0 %), cancer-specific mortality (RR = 1.59; 95 % CI: 1.42-1.79; HR = 1.52; 95 % CI: 1.19-1.96), and disease recurrence (RR = 3.43, 95 % CI: 1.80-6.54, I (2) = 0 %).

Discussion: Judging from our results, ENE in gastric cancer patients should be considered for prognostic purposes from the gross sample to the pathology report.
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http://dx.doi.org/10.1007/s11605-016-3199-7DOI Listing
October 2016