Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup

González-Martín, Antonio; Mahner, Sven; Reuß, Alexander; Bois, Andreas du; Grimm, Christoph; Marth, Christian; Berger, Regina; Concin, Nicole; Chang, Ting‐Chang; Ochiai, Kazunori; Gebski, Val; Davis, Alison; Beale, Philip; Vergote, Ignace; Kridelka, Frédéric; Denys, Hannelore; Vandecaveye, Vincent; Reis, Francisco Jose Cancido dos; Diz, Maria Del Pilar Estevez; Stuart, Gavin; Mackay, Helen; Carey, Mark; Cibula, David; Dundr, Pavel; Dorigo, Oliver; Berek, Jonathan S.; O’Donnell, Dearbhaile M.; Saadeh, Feras Abu; Boere, Ingrid; Lok, Christianne; Coronado, Pluvio; Ottevanger, Nelleke; Tan, David Sp; Ng, Joseph; Martín, Antonio González; Oaknin, Ana; Poveda, Andrés; Fidalgo, Alejandro Perez; Rauh-Hain, Alejandro; Lu, Karen H.; López-Zavala, Carlos; Gómez-García, Eva; Ray-Coquard, I. L.; Paolettí, Xavier; Kurtz, Jean‐Emmanuel; Joly, Florence; Votan, Bénédicte; Bookman, Michael A.; Moore, Kathleen N.; Arend, Rebecca C.; Fujiwara, Keiichi; Fujiwara, Hiroyuki; Hasegawa, Kosei; Bruchim, Ilan; Tsoref, Dalia; Oda, Katsutoshi; Okamoto, Aikou; Enomoto, Takayuki; Michel, Dayana; Kim, Hee–Seung; Lee, Jung‐Yun; Mukhopadhyay, Asima; Katsaros, Dionyssios; Colombo, Nicoletta; Pignata, Sandro; Lorusso, Domenica; Scambia, Giovanni; Kohn, Elise C.; Lee, Jungmin; McNeish, Iain A.; Nicum, Shibani; Farrelly, Laura; Sehouli, Jalid; Keller, Maren; Braicu, Elena Ioana; Bjørge, Line; Mirza, Mansoor Raza; Auranen, Annika; Welch, Stephen; Oza, Amit M.; Heinzelmann, Viola; Gourley, Charlie; Roxburgh, Patricia; Herrington, C. Simon; Glasspool, Ros; Zang, Rongyu; Zhu, Jianqing

doi:10.1016/s1470-2045(22)00139-5

Cited by 61 publications

(42 citation statements)

References 53 publications

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“…15 In the recent consensus recommendations from the Gynecologic Cancer InterGroup (GCIG), it is recommended that for chemotherapy-resistant histologies such as low-grade serous ovarian cancer, primary cytoreductive surgery is preferred over neoadjuvant chemotherapy followed by interval cytoreductive surgery, even if a complete resection is questionable. 16 The authors of this article agree with the importance of maximal cytoreductive effort for this disease; however, it is reasonable to attempt neoadjuvant therapy in patients with extensive tumor burden in an effort to reduce significant morbidity. A pilot trial exploring an alternative neoadjuvant therapy with CDK4/6 inhibition and endocrine therapy will be addressed later in this article.…”

Section: Cytoreductive Surgerymentioning

confidence: 52%

Novel therapeutics in low-grade serous ovarian cancer

Cobb

Gershenson

2023

Int J Gynecol Cancer

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Low-grade serous ovarian cancer is a rare subtype of epithelial ovarian cancer clinically characterized by younger age at diagnosis, relative chemoresistance, and prolonged survival compared with its high-grade serous counterpart. It is molecularly characterized by estrogen and progesterone receptor positivity, aberrations in the MAPK (mitogen-activated protein kinase) pathway, and wild-typeTP53expression pattern. As research into low-grade serous ovarian cancer as a distinct entity has been able to accelerate independently, we have learned more about its unique pathogenesis, oncogenic drivers, and opportunities for novel therapeutics. In the primary setting, cytoreductive surgery in combination with platinum-based chemotherapy remain the standard of care. However, low-grade serous ovarian cancer has demonstrated relative chemoresistance in the primary and recurrent settings. Endocrine therapy is also commonly utilized in the maintenance and recurrent settings and is being evaluated in the adjuvant setting. Given the many similarities of low-grade serous ovarian cancer to luminal breast cancer, many recent studies have utilized similar therapeutic strategies including endocrine therapy combinations with CDK (cyclin-dependent kinase) 4/6 inhibitors. Additionally, recent trials have investigated combination therapies targeting the MAPK pathway, including MEK (mitogen-activated protein kinase kinase), BRAF (v-raf murine sarcoma viral oncogene homolog B1), FAK (focal adhesion kinase), and PI3K (phosphatidylinositol 3-kinase) inhibition. In this review, we will outline these novel therapeutic strategies for low-grade serous ovarian cancer.

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Section: Cytoreductive Surgerymentioning

confidence: 52%

Novel therapeutics in low-grade serous ovarian cancer

Cobb

Gershenson

2023

Int J Gynecol Cancer

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“…The consensus recommended that in randomized phase II trials that include a combination of agents, progression-free survival should be considered as the primary endpoint. 9 In phase III trials, progression-free survival assessed by an investigator and overall survival are the preferred primary endpoints (not necessarily dual). The consensus highlighted that when progression-free survival is chosen as primary endpoint this should be assessed by investigators (not centrally), irrespective of the blinding and placebo control.…”

Section: Reviewmentioning

confidence: 99%

Outcomes and endpoints of relevance in gynecologic cancer clinical trials

Madariaga

Sánchez-Bayona

Herrera

et al. 2023

Int J Gynecol Cancer

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Drug development is paramount to improve outcomes in patients with gynecologic cancers. A randomized clinical trial should measure whether a clinically relevant improvement is detected with the new intervention compared with the standard of care, using reproductible and appropriate endpoints. Clinically meaningful improvements in overall survival and/or quality of life (QoL) are the gold standards to measure benefit of new therapeutic strategies. Alternative endpoints, such as progression-free survival, provide an earlier measure of the effect of the new therapeutic drug, and are not confounded by the effect of subsequent lines of therapy. Yet, its surrogacy with improved overall survival or QoL is unclear in gynecologic malignancies. Of relevance to studies assessing maintenance strategies are other time-to-event endpoints, such as progression-free survival two and time to second subsequent treatment, which provide valuable information on the disease control in the longer term. Translational and biomarker studies are increasingly being incorporated into gynecologic oncology clinical trials, as they may allow understanding of the biology of the disease, resistance mechanisms, and enable a better selection of patients who might benefit from the new therapeutic strategy. Globally, the endpoint selection of a clinical trial will differ according to the type of study, population, disease setting, and type of therapeutic strategy. This review provides an overview of primary and secondary endpoint selection of relevance for gynecologic oncology clinical trials.

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“…However, the numbers are still increasing; more than 29.4 million cases of cancer may be estimated 20 years later [ 3 ]. Accordingly, efforts have been made to eliminate cancer through several strategies, including surgery, radiotherapy, chemotherapy, targeted therapy, and immunotherapy [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

Nanoparticle-Based Drug Delivery Systems Targeting Tumor Microenvironment for Cancer Immunotherapy Resistance: Current Advances and Applications

Han

Gong

et al. 2022

Pharmaceutics

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Cancer immunotherapy has shown impressive anti-tumor activity in patients with advanced and early-stage malignant tumors, thus improving long-term survival. However, current cancer immunotherapy is limited by barriers such as low tumor specificity, poor response rate, and systemic toxicities, which result in the development of primary, adaptive, or acquired resistance. Immunotherapy resistance has complex mechanisms that depend on the interaction between tumor cells and the tumor microenvironment (TME). Therefore, targeting TME has recently received attention as a feasibility strategy for re-sensitizing resistant neoplastic niches to existing cancer immunotherapy. With the development of nanotechnology, nanoplatforms possess outstanding features, including high loading capacity, tunable porosity, and specific targeting to the desired locus. Therefore, nanoplatforms can significantly improve the effectiveness of immunotherapy while reducing its toxic and side effects on non-target cells that receive intense attention in cancer immunotherapy. This review explores the mechanisms of tumor microenvironment reprogramming in immunotherapy resistance, including TAMs, CAFs, vasculature, and hypoxia. We also examined whether the application of nano-drugs combined with current regimens is improving immunotherapy clinical outcomes in solid tumors.

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Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup

Cited by 61 publications

References 53 publications

Novel therapeutics in low-grade serous ovarian cancer

Novel therapeutics in low-grade serous ovarian cancer

Outcomes and endpoints of relevance in gynecologic cancer clinical trials

Nanoparticle-Based Drug Delivery Systems Targeting Tumor Microenvironment for Cancer Immunotherapy Resistance: Current Advances and Applications

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