Sarcoma European and Latin American Network (SELNET) Recommendations on Prioritization in Sarcoma Care During the COVID‐19 Pandemic

Abstract Background The COVID‐19 outbreak has resulted in collision between patients infected with SARS‐CoV‐2 and those with cancer on different fronts. Patients with cancer have been impacted by deferral, modification, and even cessation of therapy. Adaptive measures to minimize hospital exposure, following the precautionary principle, have been proposed for cancer care during COVID‐19 era. We present here a consensus on prioritizing recommendations across the continuum of sarcoma patient care. Material and Methods A total of 125 recommendations were proposed in soft‐tissue, bone, and visceral sarcoma care. Recommendations were assigned as higher or lower priority if they cannot or can be postponed at least 2–3 months, respectively. The consensus level for each recommendation was classified as “strongly recommended” (SR) if more than 90% of experts agreed, “recommended” (R) if 75%–90% of experts agreed and “no consensus” (NC) if fewer than 75% agreed. Sarcoma experts from 11 countries within the Sarcoma European‐Latin American Network (SELNET) consortium participated, including countries in the Americas and Europe. The European Society for Medical Oncology‐Magnitude of clinical benefit scale was applied to systemic‐treatment recommendations to support prioritization. Results There were 80 SRs, 35 Rs, and 10 NCs among the 125 recommendations issued and completed by 31 multidisciplinary sarcoma experts. The consensus was higher among the 75 higher‐priority recommendations (85%, 12%, and 3% for SR, R, and NC, respectively) than in the 50 lower‐priority recommendations (32%, 52%, and 16% for SR, R, and NC, respectively). Conclusion The consensus on 115 of 125 recommendations indicates a high‐level of convergence among experts. The SELNET consensus provides a tool for sarcoma multidisciplinary treatment committees during the COVID‐19 outbreak. Implications for Practice The Sarcoma European‐Latin American Network (SELNET) consensus on sarcoma prioritization care during the COVID‐19 era issued 125 pragmatical recommendations distributed as higher or lower priority to protect critical decisions on sarcoma care during the COVID‐19 pandemic. A multidisciplinary team from 11 countries reached consensus on 115 recommendations. The consensus was lower among lower‐priority recommendations, which shows reticence to postpone actions even in indolent tumors. The European Society for Medical Oncology‐Magnitude of Clinical Benefit scale was applied as support for prioritizing systemic treatment. Consensus on 115 of 125 recommendations indicates a high level of convergence among experts. The SELNET consensus provides a practice tool for guidance in the decisions of sarcoma multidisciplinary treatment committees during the COVID‐19 outbreak.

[1]  A. Dingemans,et al.  Impact of the COVID-19 pandemic on cancer treatment: the patients’ perspective , 2020, European Journal of Cancer.

[2]  D. Kerr,et al.  COVID-19 mortality in patients with cancer on chemotherapy or other anticancer treatments: a prospective cohort study , 2020, The Lancet.

[3]  J. Blay,et al.  Neoadjuvant Chemotherapy in High-Risk Soft Tissue Sarcomas: Final Results of a Randomized Trial From Italian (ISG), Spanish (GEIS), French (FSG), and Polish (PSG) Sarcoma Groups. , 2020, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[4]  I. J. Douglas,et al.  OpenSAFELY: factors associated with COVID-19-related hospital death in the linked electronic health records of 17 million adult NHS patients. , 2020, medRxiv.

[5]  I. Nagtegaal,et al.  Fewer cancer diagnoses during the COVID-19 epidemic in the Netherlands , 2020, The Lancet Oncology.

[6]  H. Kourie,et al.  Cancer patients and research during COVID-19 pandemic: A systematic review of current evidence , 2020, Critical Reviews in Oncology/Hematology.

[7]  S. Fröhling,et al.  Caring for patients with cancer in the COVID-19 era , 2020, Nature Medicine.

[8]  G. Curigliano,et al.  A Practical Approach to the Management of Cancer Patients During the Novel Coronavirus Disease 2019 (COVID‐19) Pandemic: An International Collaborative Group , 2020, The oncologist.

[9]  T. Burki Cancer guidelines during the COVID-19 pandemic , 2020, The Lancet Oncology.

[10]  C. Booth,et al.  Cancer, COVID-19 and the precautionary principle: prioritizing treatment during a global pandemic , 2020, Nature Reviews Clinical Oncology.

[11]  G. Putoto,et al.  COVID-19 in Italy: momentous decisions and many uncertainties , 2020, The Lancet Global Health.

[12]  Yong-tang Zheng,et al.  Elevated exhaustion levels and reduced functional diversity of T cells in peripheral blood may predict severe progression in COVID-19 patients , 2020, Cellular & Molecular Immunology.

[13]  P. Mehta,et al.  COVID-19: consider cytokine storm syndromes and immunosuppression , 2020, The Lancet.

[14]  Ruchong Chen,et al.  Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China , 2020, The Lancet Oncology.

[15]  Y. Hu,et al.  Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China , 2020, The Lancet.

[16]  M. Heinrich,et al.  INVICTUS: A phase III, interventional, double-blind, placebo-controlled study to assess the safety and efficacy of ripretinib as ≥ 4th-line therapy in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior anticancer therapies (NCT03353753) , 2019, Annals of Oncology.

[17]  K. S. Hall,et al.  Results of the first interim assessment of rEECur, an international randomized controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma. , 2019, Journal of Clinical Oncology.

[18]  J. Martín-Broto,et al.  Relevance of Reference Centers in Sarcoma Care and Quality Item Evaluation: Results from the Prospective Registry of the Spanish Group for Research in Sarcoma (GEIS). , 2018, The oncologist.

[19]  J. Blay,et al.  Efficacy and safety of regorafenib in adult patients with metastatic osteosarcoma: a non-comparative, randomised, double-blind, placebo-controlled, phase 2 study. , 2019, The Lancet. Oncology.

[20]  S. Sleijfer,et al.  Bone sarcomas: ESMO-PaedCan-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. , 2018 .

[21]  S. Sleijfer,et al.  Soft tissue and visceral sarcomas: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. , 2018, Annals of oncology : official journal of the European Society for Medical Oncology.

[22]  S. Sleijfer,et al.  Gastrointestinal stromal tumours: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. , 2018, Annals of oncology : official journal of the European Society for Medical Oncology.

[23]  S. Sleijfer,et al.  Corrections to "Soft tissue and visceral sarcomas: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up". , 2018 .

[24]  M. Stevens,et al.  Addition of dose-intensified doxorubicin to standard chemotherapy for rhabdomyosarcoma (EpSSG RMS 2005): a multicentre, open-label, randomised controlled, phase 3 trial. , 2018, The Lancet. Oncology.

[25]  S. Sleijfer,et al.  Prognostic factors for soft tissue sarcoma patients with lung metastases only who are receiving first‐line chemotherapy: An exploratory, retrospective analysis of the European Organization for Research and Treatment of Cancer‐Soft Tissue and Bone Sarcoma Group (EORTC‐STBSG) , 2018, International journal of cancer.

[26]  J Bogaerts,et al.  ESMO-Magnitude of Clinical Benefit Scale version 1.1 , 2017, Annals of oncology : official journal of the European Society for Medical Oncology.

[27]  J. Mora,et al.  GEIS-21: a multicentric phase II study of intensive chemotherapy including gemcitabine and docetaxel for the treatment of Ewing sarcoma of children and adults: a report from the Spanish sarcoma group (GEIS) , 2017, British Journal of Cancer.

[28]  H. Hoekstra,et al.  Adherence to Guidelines for Adult (Non-GIST) Soft Tissue Sarcoma in the Netherlands: A Plea for Dedicated Sarcoma Centers , 2017, Annals of Surgical Oncology.

[29]  J. Blay,et al.  Histotype-tailored neoadjuvant chemotherapy versus standard chemotherapy in patients with high-risk soft-tissue sarcomas (ISG-STS 1001): an international, open-label, randomised, controlled, phase 3, multicentre trial. , 2017, The Lancet. Oncology.

[30]  K. S. Hall,et al.  Prediction of long-term survival in patients with metastatic gastrointestinal stromal tumor: analysis of a large, single-institution cohort , 2017, Acta oncologica.

[31]  Robin L. Jones,et al.  Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial. , 2016, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[32]  Steven J Durning,et al.  Is There a Consensus on Consensus Methodology? Descriptions and Recommendations for Future Consensus Research , 2016, Academic medicine : journal of the Association of American Medical Colleges.

[33]  J. Blay,et al.  Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial , 2016, The Lancet.

[34]  M. Piccart,et al.  A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). , 2015, Annals of oncology : official journal of the European Society for Medical Oncology.

[35]  N. Araki,et al.  Trabectedin monotherapy after standard chemotherapy versus best supportive care in patients with advanced, translocation-related sarcoma: a randomised, open-label, phase 2 study. , 2015, The Lancet. Oncology.

[36]  P. Casali,et al.  Sorafenib and everolimus combination in non-resectable high-grade osteosarcoma progressing after standard treatment: a non-randomized phase II clinical trial from the Italian Sarcoma Group. Abstract , 2022 .

[37]  M. Cowie National Institute for Health and Care Excellence. , 2015, European heart journal.

[38]  P. Dileo,et al.  What is the role of routine follow-up for localised limb soft tissue sarcomas? A retrospective analysis of 174 patients , 2014, British Journal of Cancer.

[39]  Deepak Mittal,et al.  New insights into cancer immunoediting and its three component phases--elimination, equilibrium and escape. , 2014, Current opinion in immunology.

[40]  B. Feldman,et al.  Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. , 2014, Journal of clinical epidemiology.

[41]  B. Bui,et al.  Adherence to consensus-based diagnosis and treatment guidelines in adult soft-tissue sarcoma patients: a French prospective population-based study. , 2014, Annals of oncology : official journal of the European Society for Medical Oncology.

[42]  P. Rutkowski,et al.  What are the current outcomes of advanced gastrointestinal stromal tumors: who are the long-term survivors treated initially with imatinib? , 2013, Medical Oncology.

[43]  J. Blay,et al.  Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial , 2013, The Lancet.

[44]  W. Tap,et al.  Long‐term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high‐grade, operable osteosarcoma , 2012, Cancer.

[45]  J. Blay,et al.  Randomized multicenter and stratified phase II study of gemcitabine alone versus gemcitabine and docetaxel in patients with metastatic or relapsed leiomyosarcomas: a Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) French Sarcoma Group Study (TAXOGEM study). , 2012, The oncologist.

[46]  M. Stevens,et al.  Randomized comparison of intensified six-drug versus standard three-drug chemotherapy for high-risk nonmetastatic rhabdomyosarcoma and other chemotherapy-sensitive childhood soft tissue sarcomas: long-term results from the International Society of Pediatric Oncology MMT95 study. , 2012, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[47]  David Goldstein,et al.  Complete Longitudinal Analyses of the Randomized, Placebo-Controlled, Phase III Trial of Sunitinib in Patients with Gastrointestinal Stromal Tumor following Imatinib Failure , 2012, Clinical Cancer Research.

[48]  J. Blay,et al.  Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial , 2012, The Lancet.

[49]  Aki Vehtari,et al.  One vs three years of adjuvant imatinib for operable gastrointestinal stromal tumor: a randomized trial. , 2012, JAMA.

[50]  J. Maurel,et al.  Randomized phase II study comparing gemcitabine plus dacarbazine versus dacarbazine alone in patients with previously treated soft tissue sarcoma: a Spanish Group for Research on Sarcomas study. , 2011, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[51]  A. Ferrari,et al.  Prolonged 14‐day continuous infusion of high‐dose ifosfamide with an external portable pump: Feasibility and efficacy in refractory pediatric sarcoma , 2010, Pediatric blood & cancer.

[52]  K. Sepkowitz,et al.  Nosocomial infections in patients with cancer. , 2009, The Lancet. Oncology.

[53]  Paul A Meyers,et al.  Osteosarcoma: the addition of muramyl tripeptide to chemotherapy improves overall survival--a report from the Children's Oncology Group. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[54]  P. Thall,et al.  Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: results of sarcoma alliance for research through collaboration study 002 [corrected]. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[55]  P. Thall,et al.  Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: results of sarcoma alliance for research through collaboration study 002 [corrected]. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[56]  Xin Huang,et al.  Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial , 2006, The Lancet.

[57]  N. Jaffe,et al.  High‐dose ifosfamide in relapsed pediatric osteosarcoma: Therapeutic effects and renal toxicity , 2005, Pediatric blood & cancer.

[58]  I. Ray-Coquard,et al.  Conformity to clinical practice guidelines, multidisciplinary management and outcome of treatment for soft tissue sarcomas. , 2004, Annals of oncology : official journal of the European Society for Medical Oncology.

[59]  S. Donaldson,et al.  Addition of ifosfamide and etoposide to standard chemotherapy for Ewing's sarcoma and primitive neuroectodermal tumor of bone. , 2003, The New England journal of medicine.

[60]  Sigrid Stroobants,et al.  Safety and efficacy of imatinib (STI571) in metastatic gastrointestinal stromal tumours: a phase I study , 2001, The Lancet.

[61]  M Bonetti,et al.  Adjuvant chemotherapy for adult soft tissue sarcomas of the extremities and girdles: results of the Italian randomized cooperative trial. , 2001, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[62]  A. Rydholm,et al.  Monitoring referral and treatment in soft tissue sarcoma: Study based on 1,851 patients from the Scandinavian Sarcoma Group Register , 2001, Acta orthopaedica Scandinavica.

[63]  R. Souhami,et al.  A phase II study of cisplatin, ifosfamide and doxorubicin in operable primary, axial skeletal and metastatic osteosarcoma , 1999 .

[64]  M. van Glabbeke,et al.  A phase II study of cisplatin, ifosfamide and doxorubicin in operable primary, axial skeletal and metastatic osteosarcoma. European Osteosarcoma Intergroup (EOI). , 1999, Annals of oncology : official journal of the European Society for Medical Oncology.

[65]  A. Antón,et al.  Phase II trial of first-line high-dose ifosfamide in advanced soft tissue sarcomas of the adult: a study of the Spanish Group for Research on Sarcomas (GEIS) , 1998, Annals of oncology : official journal of the European Society for Medical Oncology.

[66]  H. Avet-Loiseau,et al.  Ifosfamide and etoposide in childhood osteosarcoma. A phase II study of the French Society of Paediatric Oncology. , 1997, European journal of cancer.

[67]  A. Giuliano,et al.  Adjuvant chemotherapy for osteosarcoma: a randomized prospective trial. , 1987, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[68]  E. Mindell,et al.  cis-Dichlorodiammineplatinum (II) in advanced osteogenic sarcoma. , 1978, Cancer treatment reports.

[69]  R. Benjamin,et al.  Adriamycin: a new effective agent in the therapy of disseminated sarcomas. , 1975, Medical and pediatric oncology.