Penile cancer: a Brazilian consensus statement for low- and middle-income countries

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Abstract

Purpose

Penile cancer is highly prevalent in low- and middle-income countries, with significant morbidity and mortality rates. The first Brazilian consensus provides support to improve penile cancer patients’ outcomes, based on expert’s opinion and evidence from medical literature.

Methods

Fifty-one Brazilian experts (clinical oncologists, radiation oncologists, urologists, and pathologists) assembled and voted 104 multiple-choice questions, confronted the results with the literature, and ranked the levels of evidence.

Results

Healthcare professionals need to deliver more effective communication about the risk factors for penile cancer. Staging and follow-up of patients include physical examination, computed tomography, and magnetic resonance imaging. Close monitoring is crucial, because most recurrences occur in the first 2–5 years. Lymph-node involvement is the most important predictive factor for survival, and management depends on the location (inguinal or pelvic) and the number of lymph nodes involved. Conservative treatment may be helpful in selected patients without compromising oncological outcomes; however, surgery yields the lowest rate of local recurrence.

Conclusion

This consensus provides an essential decision-making orientation regarding this challenging disease.

Electronic supplementary material

The online version of this article (10.1007/s00432-020-03417-1) contains supplementary material, which is available to authorized users.

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Most cited references 98

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Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study.

Karim Fizazi, Michael Carducci, Matthew Smith … (2011)

Bone metastases are a major burden in men with advanced prostate cancer. We compared denosumab, a human monoclonal antibody against RANKL, with zoledronic acid for prevention of skeletal-related events in men with bone metastases from castration-resistant prostate cancer. In this phase 3 study, men with castration-resistant prostate cancer and no previous exposure to intravenous bisphosphonate were enrolled from 342 centres in 39 countries. An interactive voice response system was used to assign patients (1:1 ratio), according to a computer-generated randomisation sequence, to receive 120 mg subcutaneous denosumab plus intravenous placebo, or 4 mg intravenous zoledronic acid plus subcutaneous placebo, every 4 weeks until the primary analysis cutoff date. Randomisation was stratified by previous skeletal-related event, prostate-specific antigen concentration, and chemotherapy for prostate cancer within 6 weeks before randomisation. Supplemental calcium and vitamin D were strongly recommended. Patients, study staff, and investigators were masked to treatment assignment. The primary endpoint was time to first on-study skeletal-related event (pathological fracture, radiation therapy, surgery to bone, or spinal cord compression), and was assessed for non-inferiority. The same outcome was further assessed for superiority as a secondary endpoint. Efficacy analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00321620, and has been completed. 1904 patients were randomised, of whom 950 assigned to denosumab and 951 assigned to receive zoledronic acid were eligible for the efficacy analysis. Median duration on study at primary analysis cutoff date was 12·2 months (IQR 5·9-18·5) for patients on denosumab and 11·2 months (IQR 5·6-17·4) for those on zoledronic acid. Median time to first on-study skeletal-related event was 20·7 months (95% CI 18·8-24·9) with denosumab compared with 17·1 months (15·0-19·4) with zoledronic acid (hazard ratio 0·82, 95% CI 0·71-0·95; p = 0·0002 for non-inferiority; p = 0·008 for superiority). Adverse events were recorded in 916 patients (97%) on denosumab and 918 patients (97%) on zoledronic acid, and serious adverse events were recorded in 594 patients (63%) on denosumab and 568 patients (60%) on zoledronic acid. More events of hypocalcaemia occurred in the denosumab group (121 [13%]) than in the zoledronic acid group (55 [6%]; p<0·0001). Osteonecrosis of the jaw occurred infrequently (22 [2%] vs 12 [1%]; p = 0·09). Denosumab was better than zoledronic acid for prevention of skeletal-related events, and potentially represents a novel treatment option in men with bone metastases from castration-resistant prostate cancer. Amgen. Copyright © 2011 Elsevier Ltd. All rights reserved.

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Updates in the Eighth Edition of the Tumor-Node-Metastasis Staging Classification for Urologic Cancers

Mahul B Amin, Rodolfo Montironi, Donna Hansel … (2018)

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Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males.

Anna R Giuliano, Joel Palefsky, Stephen Goldstone … (2011)

Infection with human papillomavirus (HPV) and diseases caused by HPV are common in boys and men. We report on the safety of a quadrivalent vaccine (active against HPV types 6, 11, 16, and 18) and on its efficacy in preventing the development of external genital lesions and anogenital HPV infection in boys and men. We enrolled 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo-controlled, double-blind trial. The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18. Efficacy analyses were conducted in a per-protocol population, in which subjects received all three vaccinations and were negative for relevant HPV types at enrollment, and in an intention-to-treat population, in which subjects received vaccine or placebo, regardless of baseline HPV status. In the intention-to-treat population, 36 external genital lesions were seen in the vaccine group as compared with 89 in the placebo group, for an observed efficacy of 60.2% (95% confidence interval [CI], 40.8 to 73.8); the efficacy was 65.5% (95% CI, 45.8 to 78.6) for lesions related to HPV-6, 11, 16, or 18. In the per-protocol population, efficacy against lesions related to HPV-6, 11, 16, or 18 was 90.4% (95% CI, 69.2 to 98.1). Efficacy with respect to persistent infection with HPV-6, 11, 16, or 18 and detection of related DNA at any time was 47.8% (95% CI, 36.0 to 57.6) and 27.1% (95% CI, 16.6 to 36.3), respectively, in the intention-to-treat population and 85.6% (97.5% CI, 73.4 to 92.9) and 44.7% (95% CI, 31.5 to 55.6) in the per-protocol population. Injection-site pain was significantly more frequent among subjects receiving quadrivalent HPV vaccine than among those receiving placebo (57% vs. 51%, P<0.001). Quadrivalent HPV vaccine prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age. (Funded by Merck and others; ClinicalTrials.gov number, NCT00090285.).

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Author and article information

Contributors

Andrey Soares:

ORCID: http://orcid.org/0000-0003-4980-6729

dr.andrey@uol.com.br

Journal

Journal ID (nlm-ta): J Cancer Res Clin Oncol

Journal ID (iso-abbrev): J Cancer Res Clin Oncol

Title: Journal of Cancer Research and Clinical Oncology

Publisher: Springer Berlin Heidelberg (Berlin/Heidelberg )

ISSN (Print): 0171-5216

ISSN (Electronic): 1432-1335

Publication date (Electronic): 26 October 2020

Publication date PMC-release: 26 October 2020

Publication date (Print): 2020

Volume: 146

Issue: 12

Pages: 3281-3296

Affiliations

[1 ]Department of Oncology, Centro Paulista de Oncologia-Oncoclínicas, Av. Brigadeiro Faria Lima, 4300, Vila Olímpia, São Paulo, SP 01452-000 Brazil

[2 ]GRID grid.413562.7, ISNI 0000 0001 0385 1941, Department of Oncology, , Hospital Israelita Albert Einstein, ; Av. Albert Einstein, 627, Morumbi, São Paulo, SP 05652-900 Brazil

[3 ]Latin American Cooperative Oncology Group, Porto Alegre, Rio Grande do Sul Brazil

[4 ]GRID grid.413562.7, ISNI 0000 0001 0385 1941, Department of Radiotherapy, , Hospital Israelita Albert Einstein, ; São Paulo, São Paulo Brazil

[5 ]Instituto Abathon, São Paulo, São Paulo Brazil

[6 ]Department of Urology, Hospital Ophir Loyola, Belém, Pará Brazil

[7 ]GRID grid.488456.3, ISNI 0000 0004 0577 2472, Department of Oncology, , Hospital Universitário da Universidade Federal do Maranhão, ; São Luís, Maranhão Brazil

[8 ]GRID grid.490183.7, ISNI 0000 0004 1783 540X, Department of Oncology, , Hospital São Domingos, ; São Luís, Maranhão Brazil

[9 ]GRID grid.477466.0, ISNI 0000 0004 0602 7861, Department of Radiotherapy, , Hospital Haroldo Juaçaba, ; Fortaleza, Ceará Brazil

[10 ]GRID grid.413471.4, ISNI 0000 0000 9080 8521, Department of Oncology, , Hospital Sírio-Libanês, ; São Paulo, São Paulo Brazil

[11 ]GRID grid.477466.0, ISNI 0000 0004 0602 7861, Department of Oncology, , Hospital Haroldo Juaçaba, ; Fortaleza, Ceará Brazil

[12 ]GRID grid.11899.38, ISNI 0000 0004 1937 0722, Medical Research Laboratory of the Discipline of Urology, Faculdade de Medicina da USP, ; São Paulo, São Paulo Brazil

[13 ]Department of Urology, Santa Casa de Misericórdia de Maceió, Maceió, Alagoas Brazil

[14 ]Department of Oncology, Hospital do Câncer Aldenora Bello, São Luís, Maranhão Brazil

[15 ]Department of Oncology, Hospital Adventista de Belém, Belém, Pará Brazil

[16 ]Department of Oncology, Centro de Tratamento Do Pará, Belém, Pará Brazil

[17 ]GRID grid.413320.7, ISNI 0000 0004 0437 1183, Department of Urology, , AC Camargo Cancer Center, ; São Paulo, São Paulo Brazil

[18 ]GRID grid.413320.7, ISNI 0000 0004 0437 1183, National Institute for Science and Technology in Oncogenomics and Therapeutic Innovation, , AC Camargo Cancer Center, ; São Paulo, São Paulo Brazil

[19 ]GRID grid.411204.2, ISNI 0000 0001 2165 7632, Department of Urology, , Hospital Universitário Presidente Dutra, UFMA, ; São Luís, Maranhão Brazil

Author information

Andrey Soares http://orcid.org/0000-0003-4980-6729

Icaro Thiago de Carvalho http://orcid.org/0000-0003-0607-7589

Carlos Heli Bezerra Leite http://orcid.org/0000-0003-2161-0222

Katia Ramos Moreira Leite http://orcid.org/0000-0002-2615-7730

Article

Publisher ID: 3417

DOI: 10.1007/s00432-020-03417-1

PMC ID: 7679332

PubMed ID: 33104884

SO-VID: a8cd49ee-6a1b-4053-9a4f-27ea654fa2a7

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 5 May 2020

Date accepted : 29 September 2020

Funding

Funded by: Latin American Cooperative Oncology Group – Genitourinary

Custom metadata

ScienceOpen disciplines: Oncology & Radiotherapy

Keywords: penile cancer,hpv cancer-related,cancer consensus,urologic malignancy

Data availability:

ScienceOpen disciplines: Oncology & Radiotherapy

Keywords: penile cancer, hpv cancer-related, cancer consensus, urologic malignancy

Penile cancer: a Brazilian consensus statement for low- and middle-income countries

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Abstract

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Karger: Oncology

Most cited references 98

Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study.

Updates in the Eighth Edition of the Tumor-Node-Metastasis Staging Classification for Urologic Cancers

Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males.

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