OV21/PETROC: a randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer

Provencher, Diane; Gallagher, Chris; Parulekar, Wendy R.; Ledermann, Jonathan A.; Armstrong, Deborah K.; Brundage, Michael; Gourley, Charlie; Romero, Ignacio; González-Martín, Antonio; Feeney, Mark; Bessette, Paul; Hall, Marcia; Weberpals, Johanne I.; Hall, Geoff; Lau, Susie; Gauthier, Philippe; Fung-Kee-Fung, Michael; Eisenhauer, Elizabeth; Winch, Chad; Tu, Dongsheng; Mackay, Helen

doi:10.1093/annonc/mdx754

Cited by 57 publications

(33 citation statements)

References 22 publications

(28 reference statements)

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“…The biologic, molecular, physical, and mathematical basis of this would suggest that, for an IP therapy to be effective, it should be given when the residual postsurgical disease volume is small (<1 cm) and ideally microscopic at individual sites. Several randomized trials have demonstrated significant improvements in PFS and OS with the administration of IP therapy . These IP trial designs varied, as many allowed additional dose/intensity in the IP arm, which has impeded conclusions on IP or IV administration, dose for dose.…”

Section: Treatment Of Ovarian Cancer—surgery Systemic Therapy and Rmentioning

confidence: 99%

Epithelial ovarian cancer: Evolution of management in the era of precision medicine

Lheureux

Braunstein

Oza

2019

CA A Cancer J Clinicians

981

867

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Ovarian cancer is the second most common cause of gynecologic cancer death in women around the world. The outcomes are complicated, because the disease is often diagnosed late and composed of several subtypes with distinct biological and molecular properties (even within the same histological subtype), and there is inconsistency in availability of and access to treatment. Upfront treatment largely relies on debulking surgery to no residual disease and platinum‐based chemotherapy, with the addition of antiangiogenic agents in patients who have suboptimally debulked and stage IV disease. Major improvement in maintenance therapy has been seen by incorporating inhibitors against poly (ADP‐ribose) polymerase (PARP) molecules involved in the DNA damage‐repair process, which have been approved in a recurrent setting and recently in a first‐line setting among women with BRCA1/BRCA2 mutations. In recognizing the challenges facing the treatment of ovarian cancer, current investigations are enlaced with deep molecular and cellular profiling. To improve survival in this aggressive disease, access to appropriate evidence‐based care is requisite. In concert, realizing individualized precision medicine will require prioritizing clinical trials of innovative treatments and refining predictive biomarkers that will enable selection of patients who would benefit from chemotherapy, targeted agents, or immunotherapy. Together, a coordinated and structured approach will accelerate significant clinical and academic advancements in ovarian cancer and meaningfully change the paradigm of care.

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Section: Treatment Of Ovarian Cancer—surgery Systemic Therapy and Rmentioning

confidence: 99%

Epithelial ovarian cancer: Evolution of management in the era of precision medicine

Lheureux

Braunstein

Oza

2019

CA A Cancer J Clinicians

981

867

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“…However, these data have not been replicated in other studies that incorporate different patient populations, adjustments in the dosing regimens to allow for outpatient therapy, and the use of bevacizumab (GOG 252 trial). Because of the positive outcomes in the adjuvant setting, a phase 2 RCT investigated the role of intraperitoneal chemotherapy after interval debulking (OV21/PETROC trial) 48 . Although the regimen with intraperitoneal cisplatin was poorly tolerated despite the dose being decreased to 75 mg/m 2 , the intraperitoneal carboplatin regimen was well tolerated and demonstrated a trend toward fewer recurrences at 9 months.…”

Section: Principles Of Intraperitoneal Chemotherapymentioning

confidence: 99%

“…Although the regimen with intraperitoneal cisplatin was poorly tolerated despite the dose being decreased to 75 mg/m 2 , the intraperitoneal carboplatin regimen was well tolerated and demonstrated a trend toward fewer recurrences at 9 months. It is important to note, however, that the study design and endpoints of this trial were changed midway because of poor accrual, and despite the aforementioned findings, it is not considered a positive trial 48 …”

Section: Principles Of Intraperitoneal Chemotherapymentioning

confidence: 99%

The Chicago Consensus on peritoneal surface malignancies: Management of ovarian neoplasms

Hoppenot¹,

Schuitevoerder²,

Izquierdo³

et al. 2020

Cancer

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The Chicago Consensus Working Group provides multidisciplinary recommendations for the management of ovarian neoplasms specifically related to the management of peritoneal surface malignancy. These guidelines are developed with input from leading experts, including surgical oncologists, medical oncologists, gynecologic oncologists, pathologists, radiologists, palliative care physicians, and pharmacists. These guidelines recognize and address the emerging need for increased awareness in the appropriate management of peritoneal surface disease. They are not intended to replace the quest for higher levels of evidence. Cancer 2020;126:2553-2560. Communication 2554Cancer June 1, 2020 seeding and upstaging of a potentially early-stage cancer. The most common histologic diagnosis is high-grade serous cancer (66% of EOCs), with mucinous cancer, endometrioid cancer, and carcinosarcoma each accounting for about 10%. Clear cell carcinoma and low-grade serous carcinomas are less frequent, accounting for less than 5% of the remaining cancers, and have a strong association with endometriosis and borderline tumors, respectively. Pathological diagnosis should be verified by an experienced gynecologic pathologist and confirmed by immunohistochemical markers that can help to distinguish ovarian cancer from cancers metastatic to the ovary (eg, CK7, CK20, CA125, CEA, WT1, PAX8, p53, estrogen receptor/progesterone receptor). Accurate identification of low-grade serous carcinomas is See companion articles on pages

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“…Although 3 randomized trials using cisplatin showed a survival benefit from ip chemotherapy for optimally debulked patients with stage III ovarian cancer, 15 it has not been accepted as standard therapy, mainly because it has not been shown that ip administration of carboplatin is more efficacious than iv administration. 17 Although the OV21 study showed significant improvement in the progression-free rate at 9 months, 17 another large-scale, randomized, phase 3 study (GOG 252) failed to show a survival benefit of ip carboplatin when bevacizumab was integrated into the ip arm. 16 The OV21 trial was a 3-arm, phase 3 study designed to compare and evaluate 2 ip regimens against standard iv carboplatin/paclitaxel chemotherapy.…”

Section: Intraperitoneal Chemotherapymentioning

confidence: 99%

“…Nevertheless, in addition to the promising efficacy data, the ip carboplatin-based regimen was well tolerated with no reductions in quality of life or increases in toxicity in comparison with iv administration alone. 17 Although the OV21 study showed significant improvement in the progression-free rate at 9 months, 17 another large-scale, randomized, phase 3 study (GOG 252) failed to show a survival benefit of ip carboplatin when bevacizumab was integrated into the ip arm. 18 In the GOG 252 trial, eligible patients were randomly assigned to 1 of 3 arms: 1) the iv carboplatin arm (6 cycles of weekly iv paclitaxel at 80 mg/m 2 with iv carboplatin at AUC 6 every 3 weeks), 2) the ip carboplatin arm (weekly iv paclitaxel at 80 mg/m 2 with ip carboplatin at AUC 6), or 3) the ip cisplatin arm (iv paclitaxel at 135 mg/m 2 over 3 hours on day 1 every 3 weeks, ip cisplatin at 75 mg/m 2 on day 2, and ip paclitaxel at 60 mg/m 2 on day 8).…”

Section: Intraperitoneal Chemotherapymentioning

confidence: 99%

Landscape of systemic therapy for ovarian cancer in 2019: Primary therapy

Fujiwara

Hasegawa

Nagao

2019

Cancer

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According to the statement from the 5th Ovarian Cancer Consensus Conference in 2015, the primary systemic chemotherapy for advanced ovarian cancer is a combination of paclitaxel plus carboplatin administered every 3 weeks (PCq3w). Optional alternatives include weekly dose-dense paclitaxel, in combination and maintenance therapy with bevacizumab, and intraperitoneal chemotherapy. Since then, in addition to the PCq3w strategy, there has been emerging new evidence, especially for poly(adenosine diphosphate-ribose) polymerase inhibitors. Moreover, there are multiple randomized, phase 3 trials testing the addition of antiangiogenic and/or immune checkpoint inhibitors in this patient population. In this article, current and future perspectives of systemic chemotherapy for advanced ovarian cancer are discussed. Cancer 2019;125:4582-4586.

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OV21/PETROC: a randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer

Abstract: clinicaltrials.gov, NCT01622543.

Cited by 57 publications

References 22 publications

Epithelial ovarian cancer: Evolution of management in the era of precision medicine

Epithelial ovarian cancer: Evolution of management in the era of precision medicine

The Chicago Consensus on peritoneal surface malignancies: Management of ovarian neoplasms

Landscape of systemic therapy for ovarian cancer in 2019: Primary therapy

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