Neoadjuvant Chemotherapy for Newly Diagnosed, Advanced Ovarian Cancer
Publication Date: August 8, 2016
Last Updated: December 16, 2022
Assessment
All women with suspected stage IIIC or IV invasive epithelial ovarian cancer should be evaluated by a gynecologic oncologist prior to initiation of therapy to determine whether they are candidates for primary cytoreductive surgery (PCS). ( EB , H , B , M )
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A primary clinical evaluation should include a computed tomography (CT) scan of the abdomen and pelvis with oral and intravenous contrast and chest imaging (CT preferred) to evaluate the extent of disease and the feasibility of surgical resection. ( IC , H , H , M )
The use of other tools to refine this assessment may include laparoscopic evaluation or additional radiographic imaging (eg, [18F]fluorodeoxyglucose positron-emission tomography [FDG-PET] scan or diffusion-weighted magnetic resonance imaging [MRI]).
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Treatment
Women who have a high perioperative risk profile or a low likelihood of achieving cytoreduction to <1 cm (ideally to no visible disease) should receive NACT. ( EB , H , H , M )
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Decisions that women are not eligible for medical or surgical cancer treatment should be made after a consultation with a gynecologic oncologist and/or a medical oncologist with gynecologic expertise. ( IC , H , H , M )
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For women who are fit for PCS, with potentially resectable disease, either NACT or PCS may be offered based on data from phase III RCTs that demonstrate that NACT is noninferior to PCS with respect to progression-free and overall survival. ( EB , H , H , M )
NACT is associated with less peri- and post-operative morbidity and mortality and shorter hospitalizations, but PCS may offer superior survival in selected patients.
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For women with a high likelihood of achieving cytoreduction to <1 cm (ideally to no visible disease) with acceptable morbidity, PCS is recommended over NACT. ( EB , H , H , M )
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For women who are fit for PCS but are deemed unlikely to have cytoreduction to <1 cm (ideally to no visible disease) by a gynecologic oncologist, NACT is recommended over PCS. ( EB , H , H , M )
NACT is associated with less peri- and post-operative morbidity and mortality and shorter hospitalizations.
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Before NACT is delivered, all patients should have histologic confirmation (core biopsy preferred) of an invasive ovarian, fallopian tube, or peritoneal cancer. In exceptional cases, when a biopsy cannot be performed, cytologic evaluation combined with a serum CA-125 to carcinoembryonic antigen (CEA) ratio >25 is acceptable to confirm the primary diagnosis and exclude cancers that are not ovarian, fallopian tube, or primary peritoneal carcinomas. ( IC , H , H , M )
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For NACT, a platinum/taxane doublet is recommended. ( EB , H , H , M )
However, alternate regimens, containing a platinum agent, may be selected based on individual patient factors.
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RCTs tested surgery following three or four cycles of chemotherapy in women who had a response to NACT or stable disease. Interval cytoreductive surgery should be performed after ≤4 cycles of NACT for women with a response to chemotherapy or stable disease. ( IC , H , B/H , M )
Alternate timing of surgery has not been prospectively evaluated but may be considered based on patient-centered factors.
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Patients with progressive disease on NACT have a poor prognosis. Options include alternative chemotherapy regimens, clinical trials, and/or discontinuation of active cancer therapy and initiation of end-of-life care. In general, there is little role for surgery and it is not typically advised, unless for palliation (eg, relief of a bowel obstruction). ( EB , H , B , M )
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Recommendation Grading
Overview
Title
Neoadjuvant Chemotherapy for Newly Diagnosed, Advanced Ovarian Cancer
Authoring Organizations
American Society of Clinical Oncology
Society of Gynecologic Oncology
Publication Month/Year
August 8, 2016
Last Updated Month/Year
October 2, 2024
Supplemental Implementation Tools
Document Type
Guideline
External Publication Status
Published
Country of Publication
US
Document Objectives
To provide guidance to clinicians regarding the use of neoadjuvant chemotherapy and interval cytoreduction among women with stage IIIC or IV epithelial ovarian cancer.
Target Patient Population
Women with newly diagnosed or suspected stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Target Provider Population
Gynecologic and medical oncologists
PICO Questions
What clinical evaluations should be performed in all women with suspected or newly diagnosed stage IIIC or IV epithelial ovarian cancer?
Which patient and disease factors should be used as criteria for identifying patients who are not suitable for PCS?
How do NACT and PCS compare with respect to progression-free survival, overall survival, and perioperative morbidity and mortality in women with newly diagnosed stage IIIC or IV epithelial cancer who are fit for primary cytoreduction and have potentially resectable disease, and how should this information be used to select initial treatment?
What additional clinical evaluations should be performed in all women with suspected or newly diagnosed stage IIIC or IV epithelial ovarian cancer before NACT is delivered?
What is the preferred chemotherapy regimen for women with stage IIIC or IV epithelial ovarian cancer who will receive NACT?
Among women treated with NACT, does the timing of interval cytoreduction or the number of chemotherapy cycles after interval cytoreduction affect the safety or efficacy of treatment?
What are the treatment options for patients with progressive disease on NACT?
Inclusion Criteria
Female, Adult, Older adult
Health Care Settings
Ambulatory, Hospital, Outpatient
Intended Users
Nurse, nurse practitioner, physician, physician assistant
Scope
Treatment, Management
Keywords
neoadjuvant chemotherapy, Epithelial Ovarian Cancer, Advanced Ovarian Cancer, NACT
Source Citation
DOI: 10.1200/JCO.2016.68.6907 Journal of Clinical Oncology 34, no. 28 (October 01, 2016) 3460-3473.
Supplemental Methodology Resources
Methodology
Number of Source Documents
18
Literature Search Start Date
March 20, 2005
Literature Search End Date
March 20, 2015
Description of External Review Process
The ASCO Clinical Practice Guidelines Committee (CPGC), in collaboration with the SGO, convened an Expert Panel with multidisciplinary representation in medical oncology, gynecologic oncology, community oncology, patient/advocacy representation, and guideline implementation. The draft was submitted to two external reviewers with content expertise in medical and gynecologic oncology. Revisions made in response to the external reviews were reviewed and approved by the Expert Panel. No date was noted in the document.
Specialties Involved
Obstetrics And Gynecology, Oncology, Medical Oncology, Oncology
Description of Systematic Review
The Society of Gynecologic Oncology and the American Society of Clinical Oncology convened an Expert Panel and conducted a systematic review of the literature.
List of Questions
See full text
Description of Study Criteria
Articles were selected for inclusion in the systematic review of the evidence based on the following criteria:
Population: Women with newly diagnosed stage III or stage IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Study type: Evidence regarding the outcomes of NACT was drawn from published or presented phase III RCTs. Evidence regarding predictive and prognostic factors in advanced ovarian cancer was drawn from RCTs, multicenter cohort studies, meta-analyses, and population-based observational data. Inclusion of influential single-center cohort studies was made at the discretion of the panel.
Articles were excluded from the systematic review if they were editorials, commentaries, letters, news articles, case reports, narrative reviews, or published in a non-English language.
Description of Search Strategy
PubMed, the Cochrane Collaboration Library electronic databases, and meeting abstracts from ASCO, SGO, and ESMO were searched for evidence reporting on outcomes of interest.
The search terms is missing on page 12 in Data Supplement. Section 3. Overview of the Guideline Adaptation Process.
Description of Study Selection
Literature search results were reviewed and deemed appropriate for full text review by one ASCO staff reviewer in consultation with the Expert Panel Co-Chairs. Data were extracted by one staff reviewer and subsequently checked for accuracy through an audit of the data by another ASCO staff member. Disagreements were resolved through discussion and consultation with the Co-Chairs if necessary. Evidence tables are provided in the manuscript and in Data Supplements 1 and 2.
Description of Evidence Analysis Methods
The guideline recommendations were crafted, in part, using the GuideLines Into DEcision Support (GLIDES) methodology and accompanying BRIDGE-Wiz software.
Description of Evidence Grading
High: High confidence that the available evidence reflects the true magnitude and direction of the net effect (i.e., balance of benefits v harms) and that further research is very unlikely to change either the magnitude or direction of this net effect.
Intermediate: Moderate confidence that the available evidence reflects the true magnitude and direction of the net effect. Further research is unlikely to alter the direction of the net effect; however, it might alter the magnitude of the net effect.
Low: Low confidence that the available evidence reflects the true magnitude and direction of the net effect. Further research may change either the magnitude and/or direction this net effect.
Insufficient: Evidence is insufficient to discern the true magnitude and direction of the net effect. Further research may better inform the topic. The use of the consensus opinion of experts is reasonable to inform outcomes related to the topic.
Description of Recommendation Grading
Evidence Based: There was sufficient evidence from published studies to inform a recommendation to guide clinical practice.
Formal Consensus: The available evidence was deemed insufficient to inform a recommendation to guide clinical practice. Therefore, the Expert Panel used a formal consensus process to reach this recommendation, which is considered the best current guidance for practice. The Panel may choose to provide a rating for the strength of the recommendation (i.e., "strong," "moderate," or "weak"). The results of the formal consensus process are summarized in the guideline and reported in the Data Supplement (see the Supporting Documents" field).
Informal Consensus: The available evidence was deemed insufficient to inform a recommendation to guide clinical practice. The recommendation is considered the best current guidance for practice, based on informal consensus of the Expert Panel. The Panel agreed that a formal consensus process was not necessary for reasons described in the literature review and discussion. The Panel may choose to provide a rating for the strength of the recommendation (i.e., "strong," "moderate," or "weak").
No recommendation: There is insufficient evidence, confidence, or agreement to provide a recommendation to guide clinical practice at this time. The Panel deemed the available evidence as insufficient and concluded it was unlikely that a formal consensus process would achieve the level of agreement needed for a recommendation.
Description of Funding Source
ASCO provides funding for Guideline Development.
Company/Author Disclosures
Author Disclosures of Potential Conflicts of Interest are documented in the Guideline.
Percentage of Authors Reporting COI
100