Statement of the AGO Kommission Ovar, AGO Study Group, NOGGO, AGO Austria, Swiss AGO, BGOG, CEEGOG, GEICO, and SFOG regarding the use of hyperthermic intraperitoneal chemotherapy (HIPEC) in epithelial ovarian cancer. - 2024
Statement of the AGO Kommission Ovar, AGO Study Group, NOGGO, AGO Austria, Swiss AGO, BGOG, CEEGOG, GEICO, and SFOG regarding the use of hyperthermic intraperitoneal chemotherapy (HIPEC) in epithelial ovarian cancer.
[en] An international joint statement about the use of hyperthermic intraperitoneal chemotherapy (HIPEC) in ovarian cancer was published in 2016, warning about the uncritical use of HIPEC outside controlled studies. This statement has now been updated after the most recent literature was reviewed by the participating study groups and societies. HIPEC became a treatment option in patients with advanced colon cancer after positive results of a randomized trial comparing surgery and HIPEC versus palliative treatment alone. Although this trial did not compare the added value of HIPEC to surgery alone, HIPEC for the treatment of peritoneal metastases was in the subsequent years generalized to many other cancer types associated with peritoneal carcinomatosis including epithelial ovarian cancer (EOC). In the meantime, new evidence from prospective randomized trials specifically for EOC-patients emerged, with however contradicting results and several quality aspects that made the interpretation of their findings critical. Moreover, three additional trials in colorectal cancer failed to confirm the previously presumed survival benefit through the implementation of HIPEC in peritoneally disseminated colorectal cancers. Based on a still unclear and inconsistent landscape, the authors conclude that HIPEC should remain within the remit of clinical trials for EOC-patients. Available evidence is not yet sufficient to justify its broad endorsement into the routine clinical practice.
Disciplines :
Oncology
Author, co-author :
Harter, Philipp; Department of Gynecology & Gynecologic Oncology, Ev. Kliniken Essen-Mitte, Henricistrasse 92, 45136 Essen, Germany. Electronic address: p.harter@kem-med.com
Bogner, Gerhard; Department of Obstetrics and Gynecology, Paracelsus Medical University Salzburg, Salzburg, Austria
Chiva, Luis; Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, Madrid, Spain
Cibula, David; Department of Obstetrics and Gynecology, General University Hospital in Prague, First Faculty of Medicine, Charles University, Prague, Czech Republic
Concin, Nicole; Department of Gynecology & Gynecologic Oncology, Ev. Kliniken Essen-Mitte, Henricistrasse 92, 45136 Essen, Germany, Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria
Fotopoulou, Christina; Departments of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK
Gonzalez-Martin, Antonio; Medical Oncology Department Clínica Univerdad de Navarra, Madrid, and Program in Solid Tumours CIMA, Pamplona, Spain
Guyon, Frederic; Institut Bergonié, Bordeaux, France
Heinzelmann-Schwarz, Viola; University Hospital Basel, Basel, Switzerland
Kridelka, Frédéric ; Université de Liège - ULiège > Département des sciences cliniques > Gynécologie-Obstétrique
Mahner, Sven; Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Munich, Germany
Marmé, Frederik; Department of Gynecologic Oncology, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany
Marth, Christian; Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria
Morice, Philippe; Institut Gustave-Roussy, Villejuif, France
Novák, Zoltán; Department of Gynaecology, National Insitute of Oncology, Budapest, Hungary
Papadia, Andrea; Department of Gynecology and Obstetrics, Ospedale Regionale di Lugano EOC, Lugano, Switzerland, Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
Ray-Coquard, Isabelle; Centre Léon Bérard, Lyon, France
Redecha, Mikuláš; II. department of gynaecology and obstetrics, University Hospital Bratislava, Comenius University, Bratislava, Slovakia
Redondo, Andres; Medical Oncology Department, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain
Schwameis, Richard; Division of General Gynecology and Gynecologic Oncology, Department of Obstetrics and Gynecology, Gynecologic Cancer Unit, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria
Sehouli, Jalid; Department of Gynecology with Center of Gynecological Oncology,Charité, University Medicine of Berlin, Berlin, Germany
Undurraga, Manuela; University Hospital Geneva (HUG), Geneva, Switzerland
Van Gorp, Toon; Division of Gynaecological Oncology, University Hospitals Leuven, Leuven, Belgium
Vergote, Ignace; Division of Gynaecological Oncology, University Hospitals Leuven, Leuven, Belgium
Statement of the AGO Kommission Ovar, AGO Study Group, NOGGO, AGO Austria, Swiss AGO, BGOG, CEEGOG, GEICO, and SFOG regarding the use of hyperthermic intraperitoneal chemotherapy (HIPEC) in epithelial ovarian cancer.
Fujimoto, S., Shrestha, R.D., Kobayashi, K., et al. Combined treatment with surgery and intraperitoneal hyperthermic perfusion (IPHP) for far-advanced gastrointestinal cancer with peritoneal seeding. Acta Med Austriaca 16:3–4 (1989), 76–80.
Möbus, V., Wandt, H., Frickhofen, N., Bengala, C., Champion, K., Kimmig, R., et al. Phase III trial of high-dose sequential chemotherapy with peripheral blood stem cell support compared with standard dose chemotherapy for first-line treatment of advanced ovarian cancer: intergroup trial of the AGO-Ovar/AIO and EBMT. J Clin Oncol 25:27 (2007), 4187–4193.
Colombo, N., Sessa, C., du Bois, A., et al. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease. Int J Gynecol Cancer, 2019, 10.1136/ijgc-2019-000308 [ijgc-2019-000308. Online ahead of print].
Armstrong, D.K., Bundy, B., Wenzel, L., et al. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med 354:1 (2006), 34–43.
Gore, M., du Bois, A., Vergote, I., Intraperitoneal chemotherapy in ovarian cancer remains experimental. J Clin Oncol 24 (2006), 4528–4530.
Walker, J.L., Brady, M.F., Wenzel, L., Fleming, G.F., Huang, H.Q., DiSilvestro, P.A., et al. Randomized trial of intravenous versus intraperitoneal chemotherapy plus bevacizumab in advanced ovarian carcinoma: an NRG oncology/gynecologic oncology group study. J Clin Oncol 37:16 (2019), 1380–1390.
Fujiwara K, Nagao S, Yamamoto K, et al. A randomized phase 3 trial of intraperitoneal versus intravenous carboplatin with dose-dense weekly paclitaxel in patients with ovarian, fallopian tube, or primary peritoneal carcinoma (a GOTIC-001/JGOG-3019/GCIG, iPocc trial). Presented at annual meeting of the Society of gynecologic oncology (SGO) in 2022.
Verwaal, V.J., van Ruth, S., de Bree, E., et al. Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer. J Clin Oncol 21:20 (2003), 3737–3743.
Quénet, F., Elias, D., Roca, L., et al. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol 22:2 (2021), 256–266.
Goéré, D., Glehen, O., Quenet, F., et al. Second-look surgery plus hyperthermic intraperitoneal chemotherapy versus surveillance in patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15): a randomised, phase 3 study. Lancet Oncol 21:9 (2020), 1147–1154.
Klaver, C.E.L., Wisselink, D.D., Punt, C.J.A., et al. Adjuvant hyperthermic intraperitoneal chemotherapy in patients with locally advanced colon cancer (COLOPEC): a multicentre, open label, randomised trial. Lancet Gastroenterol Hepatol 4:10 (2019), 761–770.
du Bois, A., Reuss, A., Pujade-Lauraine, E., Harter, P., Ray-Coquard, I., Pfisterer, J., Role of surgical outcome as prognostic factor in advanced epithelial ovarian cancer: a combined exploratory analysis of 3 prospectively randomized phase 3 multicenter trials: by the arbeitsgemeinschaft gynaekologische onkologie studiengruppe ovarialkarzinom (AGO-OVAR) and the Groupe d'investigateurs nationaux Pour les études des cancers de l'ovaire (GINECO). Cancer 115:6 (2009), 1234–1244.
Vergote, I., Tropé, C.G., Amant, F., et al. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med 363:10 (2010), 943–953.
Vergote, I., du Bois, A., Amant, F., Heitz, F., Leunen, K., Harter, P., Neoadjuvant chemotherapy in advanced ovarian cancer: On what do we agree and disagree?. Gynecol Oncol 128:1 (2013), 6–11.
Harter, P., Sehouli, J., Vergote, I., et al. Randomized trial of cytoreductive surgery for relapsed ovarian cancer. N Engl J Med 385:23 (2021), 2123–2131.
Querleu, D., Planchamp, F., Chiva, L., et al. European society of gynaecological oncology (ESGO) guidelines for ovarian cancer surgery. Int J Gynecol Cancer 27:7 (2017), 1534–1542.
Chiva, L.M., Gonzalez-Martin, A., A critical appraisal of hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of advanced and recurrent ovarian cancer. Gynecol Oncol 136:1 (2015), 130–135.
Spiliotis, J., Halkia, E., Lianos, E., et al. Cytoreductive surgery and HIPEC in recurrent epithelial ovarian cancer: a prospective randomized phase III study. Ann Surg Oncol 22 (2015), 1570–1575.
Harter, P., Reuss, A., Sehouli, J., Chiva, L., du Bois, A., Brief report about the role of hyperthermic intraperitoneal chemotherapy in a prospective randomized phase 3 study in recurrent ovarian cancer from spiliotis et al. Int J Gynecol Cancer 27:2 (2017), 246–247.
Sanz Rubiales, A., Del Valle, M.A., Survival analysis in a randomized trial of HIPEC in ovarian cancer. Ann Surg Oncol, 24(Suppl 3), 2017, 631.
Batista, T.P., Comment on: surgery and hipec in recurrent epithelial ovarian cancer: a prospective randomized phase III study. Ann Surg Oncol, Dec;24(Suppl 3), 2017, 630.
van Driel, W.J., Koole, S.N., Sikorska, K., et al. Hyperthermic intraperitoneal chemotherapy in ovarian cancer. N Engl J Med 378 (2018), 230–240.
Spriggs, D.R., Zivanovic, O., Ovarian cancer treatment – are we getting warmer?. N Engl J Med 378 (2018), 293–294.
Fotopoulou, C., Sehouli, J., Mahner, S., et al. HIPEC: HOPE or HYPE in the fight against advanced ovarian cancer?. Ann Oncol 29:8 (2018), 1610–1613.
Vergote, I., Harter, P., Chiva, L., Is there a role for intraperitoneal chemotherapy, including HIPEC, in the management of ovarian cancer?. J Clin Oncol 37:27 (2019), 2420–2423.
Lim, M.C., Chang, S.J., Park, B., et al. Survival after hyperthermic intraperitoneal chemotherapy and primary or interval cytoreductive surgery in ovarian cancer: a randomized clinical trial. JAMA Surg 157:5 (2022), 374–383.
Lim, M.C., Chang, S.-J., Yoo, H.J., et al. Randomized trial of hyperthermic intraperitoneal chemotherapy (HIPEC) in women with primary advanced peritoneal, ovarian, and tubal cancer. J Clin Oncol, 35, 2017 [https://meetings.asco.org/abstracts-presentations/153316. suppl; abstr 5520].
Oza, A.M., Cook, A.D., Pfisterer, J., et al. Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial. Lancet Oncol 16:8 (2015), 928–936.
Harter, P., Mouret-Reynier, M.A., Pignata, S., et al. Efficacy of maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed, advanced ovarian cancer in the phase III PAOLA-1/ENGOT-ov25 trial PAOLA 1. Gynecol Oncol 164:2 (2022), 254–264.
Antonio, C.C.P., Alida, G.G., Elena, G.G., et al. Cytoreductive surgery with or without HIPEC after neoadjuvant chemotherapy in ovarian cancer: a phase 3 clinical trial. Ann Surg Oncol 29:4 (2022), 2617–2625.
Chiva, L., Harter, P., Boria, F., Ramirez, P., A comment on a recent failed HIPEC trial. Ann Surg Oncol 29:5 (2022), 3359–3360.
Carneiro, V.C.G., Ramalho, N.M., Letter to the Editor: comment on “cytoreductive surgery with or without HIPEC after neoadjuvant chemotherapy in ovarian cancer: a phase 3 clinical trial”. Ann Surg Oncol 29:5 (2022), 3351–3352.
Raghavan, S., Patel, S., Prem, A., Pandey, D., Enigma of hyperthermic intraperitoneal chemotherapy with interval cytoreduction surgery: need to push more boundaries!. Ann Surg Oncol 29:5 (2022), 3355–3356.
Noiret, B., Bakrin, N., Eveno, C., Combining HIPEC to interval surgery in ovarian cancer? One step forward with a second randomized study: comment on “cytoreductive surgery with or without hipec after neoadjuvant chemotherapy in ovarian cancer-a phase 3 clinical trial”. Ann Surg Oncol 29:5 (2022), 3357–3358.
Paulino, E., Melo, A.C., The debatable role of HIPEC in ovarian cancer. Ann Surg Oncol 29:5 (2022), 3353–3354.
Zivanovic, O., Chi, D.S., Zhou, Q., et al. Secondary cytoreduction and carboplatin hyperthermic intraperitoneal chemotherapy for platinum-sensitive recurrent ovarian cancer: an MSK team ovary phase II study. J Clin Oncol 39:23 (2021), 2594–2604.
Vergote, I., Gonzalez-Martin, A., Lorusso, D., et al. Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup. Lancet Oncol 23 (2022), e374–e384.
Moore, K., Colombo, N., Scambia, G., et al. Maintenance Olaparib in patients with newly diagnosed advanced ovarian cancer. New Engl J Med 379 (2018), 2495–2505.
Gonzalez-Martin, A., Pothuri, B., Vergote, I., et al. Niraparib in patients with newly diagnosed advanced ovarian cancer. New Engl J Med 381 (2019), 2391–2402.
Ray-Coquard, I., Pautier, P., Pignata, S., et al. Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. New Engl J Med 381 (2019), 2416–2428.
Harter, P., Mahner, S., Hilpert, F., et al. Statement by the Kommission OVAR of the AGO study group on the use of HIPEC (hyperthermic intraperitoneal chemotherapy) to treat primary and recurrent ovarian cancer. Geburtshilfe Frauenheilkd 73:3 (2013), 221–223.
Harter, P., du Bois, A., Mahner, S., et al. Statement of the AGO Kommission Ovar, AGO study group, NOGGO, AGO Austria and AGO Switzerland regarding the use of hyperthermic intraperitoneal chemotherapy (HIPEC) in ovarian cancer. Geburtshilfe Frauenheilkd 76:2 (2016), 147–149.