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 This is an original JCO publication from 2016. Please visit the JCO website to access the full article.


Neoadjuvant Chemotherapy for Newly Diagnosed, Advanced Ovarian Cancer: Society of Gynecologic Oncology and American Society of Clinical Oncology Clinical Practice Guideline

 

 Authors

Alexi A. Wright, Kari Bohlke, Deborah K. Armstrong, Michael A. Bookman, William A. Cliby, Robert L. Coleman, Don S. Dizon, Joseph J. Kash, Larissa A. Meyer, Kathleen N. Moore, Alexander B. Olawaiye, Jessica Oldham, Ritu Salani, Dee Sparacio, William P. Tew, Ignace Vergote, and Mitchell I. Edelson

THE BOTTOM LINE

Neoadjuvant Chemotherapy for Newly Diagnosed, Advanced Ovarian Cancer: Society of Gynecologic Oncology and American Society of Clinical Oncology Clinical Practice Guideline

Guideline Question

To provide guidance to clinicians and patients regarding the use of neoadjuvant chemotherapy (NACT) and interval cytoreduction among women with advanced epithelial ovarian cancer.

Target Population

Women with newly diagnosed or suspected stage IIIC or IVepithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Target Audience

Gynecologic and medical oncologists and women with advanced ovarian cancer.

Methods

An Expert Panel was convened to develop clinical practice guideline recommendations based on a systematic review of the medical literature.

Key Points

Recommendation 1.1. 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). (Type: evidence based; benefits outweigh harms; evidence quality: intermediate; strength of recommendation: strong.)

Recommendation 1.2. 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. 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]). (Type: informal consensus; benefits outweigh harms; evidence quality: intermediate; strength of recommendation: moderate.)

Recommendation 2.1. 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. (Type: evidence based; benefits outweigh harms; evidence quality: intermediate; strength of recommendation: moderate.)

Recommendation 2.2. 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. (Type: informal consensus; benefits outweigh harms; evidence quality: intermediate; strength of recommendation: moderate.)

Recommendation 3.1. For women who are fit for PCS, with potentially resectable disease, either NACTor 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. NACT is associated with less peri- and postoperative morbidity and mortality and shorter hospitalizations, but PCS may offer superior survival in selected patients. (Type: evidence based; benefits outweigh harms; Evidence quality: intermediate, Strength of recommendation: moderate)

Recommendation 3.2. For women with a high likelihood of achieving cytoreduction to < 1 cm (ideally to no visible disease disease) with acceptable morbidity, PCS is recommended over NACT. (Type: evidence based; benefits outweigh harms; evidence quality: intermediate; strength of recommendation: moderate.)

Recommendation 3.3. 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. NACT is associated with less peri- and postoperative morbidity and mortality and shorter hospitalizations. (Type: evidence based; benefits outweigh harms; evidence quality: intermediate; strength of recommendation: moderate.)

Recommendation 4. 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 a nongynecologic cancer. (Type: informal consensus; benefits outweigh harms; evidence quality: intermediate; strength of recommendation: moderate.)

Recommendation 5. For NACT, a platinum/taxane doublet is recommended. However, alternate regimens, containing a platinum agent, may be selected based on individual patient factors. (Type: evidence-based, benefits outweigh harms; evidence quality: intermediate; strength of recommendation: moderate.)

Recommendation 6. 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. Alternate timing of surgery has not been prospectively evaluated but may be considered based on patient-centered factors. (Type: informal consensus; benefits outweigh harms; evidence quality: insufficient; strength of recommendation: weak.)

Recommendation 7. 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). (Type: evidence-based; benefits outweigh harms; evidence quality: intermediate; strength of recommendation: strong.)

Additional Resources

More information, including a Data Supplement with additional evidence tables, a Methodology Supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources, is available at www.asco.org/NACT-ovarian-guideline and www.asco.org/guidelineswiki. Patient information is available at www.cancer.net.

ASCO and SGO believe that cancer clinical trials are vital to inform medical decisions and improve cancer care and that all patients should have the opportunity to participate.

SUMMARY OF RECOMMENDATIONS

Clinical QuestionRecommendationEvidence Rating
What clinical evaluations should be performed in all women with suspected or newly diagnosed stage IIIC or IV epithelial ovarian cancer?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 PCS.

Type: evidence based; benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

A primary clinical evaluation should include a CT 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. The use of other tools to refine this assessment may include laparoscopic evaluation or additional radiographic imaging (e.g., FDG-PET scan or diffusion-weighted MRI).

Type: informal consensus; benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

Which patient and disease factors should be utilized as criteria for identifying patients who are not suitable for PCS?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.

Type: evidence based; benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

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.

Type: informal consensus; benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

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 ovarian cancer who are fit for primary cytoreduction and have potentially resectable disease, and how should this information be used to select initial treatment?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 non-inferior to PCS with respect to progression-free and overall survival. NACT is associated with less peri- and postoperative morbidity and mortality and shorter hospitalizations, but PCS may offer superior survival in selected patients.

Type: evidence based; benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

For women with a high likelihood of achieving a cytoreduction to < 1 cm (ideally to no visible disease) with acceptable morbidity, PCS is recommended over NACT.

Type: evidence based; benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

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. NACT is associated with less peri- and post-operative morbidity and mortality and shorter hospitalizations.

Type: evidence based; benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

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?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 CA125 to CEA ratio > 25 is acceptable to confirm the primary diagnosis and exclude cancers that are not ovarian, fallopian tube, or primary peritoneal carcinomas.

Type: informal consensus; benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

What is the preferred chemotherapy regimen for women with stage IIIC or IV epithelial ovarian cancer who will receive NACT?For NACT, a platinum/taxane doublet is recommended. However, alternate regimens, containing a platinum agent, may be selected based on individual patient factors.

Type: evidence based; benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

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?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. Alternate timing of surgery has not been prospectively evaluated but may be considered based on patient-centered factors.

Type: informal consensus; benefits outweigh harms

Evidence quality: insufficient

Strength of recommendation: weak

What are the treatment options for patients with progressive disease on NACT?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 (e.g., relief of a bowel obstruction).

Type: evidence based; benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

 

ASCO Guideline Disclaimer: The clinical practice guidelines and other guidance published herein are provided by the American Society of Clinical Oncology, Inc. (“ASCO”) to assist practitioners in clinical decision making. The information therein should not be relied upon as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. With the rapid development of scientific knowledge, new evidence may emerge between the time information is developed and when it is published or read. The information is not continually updated and may not reflect the most recent evidence. The information addresses only the topics specifically identified therein and is not applicable to other interventions, diseases, or stages of diseases. This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating physician, as the information does not account for individual variation among patients. Recommendations reflect high, moderate or low confidence that the recommendation reflects the net effect of a given course of action.  The use of words like “must,” “must not,” “should,” and “should not” indicate that a course of action is recommended or not recommended for either most or many patients, but there is latitude for the treating physician to select other courses of action in individual cases. In all cases, the selected course of action should be considered by the treating physician in the context of treating the individual patient. Use of the information is voluntary.  ASCO provides this information on an “as is” basis, and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information or for any errors or omissions.


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