ASCO and SGO Release Clinical Practice Guideline on Neoadjuvant Therapy for Newly Diagnosed Advanced Ovarian Cancer
As reported by Alexi A. Wright, MD, MPH, of Dana-Farber Cancer Institute, and colleagues in the Journal of Clinical Oncology, ASCO and the Society of Gynecologic Oncology (SGO) have released a clinical practice guideline on neoadjuvant therapy for patients with newly diagnosed stage IIIC or IV epithelial ovarian cancer. The recommendations are based on expert panel systematic review of the literature, with four phase III trials providing the primary evidence base for the recommendations. The panel was co-chaired by Dr. Wright and Mitchell I. Edelson, MD, of Hanjani Institute for Gynecologic Oncology, Abington Jefferson Health, Abington, Pennsylvania. The key recommendations are summarized/reproduced here, with the type of recommendation, quality of evidence, and strength of recommendation shown in parentheses.
Key Recommendations
What clinical evaluations should be performed in all women with suspected or newly diagnosed stage IIIC or IV epithelial ovarian cancer?
- 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. (Type = evidence based, benefits outweigh harms; quality = intermediate; strength = 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 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; quality = intermediate; strength = moderate)
Which patient and disease factors should be used as criteria for identifying patients who are not suitable for primary cytoreductive surgery?
- 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 neoadjuvant chemotherapy. (Type = evidence based, benefits outweigh harms; quality = intermediate; strength = moderate)
- Recommendation 2.2. Decisions that women are not eligible for medical or surgical cancer treatment should be made after consultation with a gynecologic oncologist and/or a medical oncologist with gynecologic expertise. (Type = informal consensus, benefits outweigh harms; quality = intermediate; strength = moderate)
How do neoadjuvant chemotherapy and primary cytoreductive surgery compare with respect to progression-free survival, overall survival, and perioperative morbidity and mortality in women who are fit for primary cytoreduction and have potentially resectable disease, and how should this information be used to select initial treatment?
- Recommendation 3.1. For women who are fit for primary cytoreductive surgery, with potentially resectable disease, either neoadjuvant chemotherapy or primary cytoreductive surgery may be offered based on data from phase III randomized, controlled trials demonstrating that neoadjuvant chemotherapy is noninferior to primary cytoreductive surgery with respect to progression-free and overall survival. Neoadjuvant chemotherapy is associated with less peri- and postoperative morbidity and mortality and shorter hospitalizations, but primary cytoreductive surgery may offer superior survival in selected patients. (Type = evidence based, benefits outweigh harms; quality = intermediate; strength = moderate)
- Recommendation 3.2. For women with a high likelihood of achieving cytoreduction to < 1 cm (ideally to no visible disease) with acceptable morbidity, primary cytoreductive surgery is recommended over neoadjuvant chemotherapy. (Type = evidence based; benefits outweigh harms; quality = intermediate; strength = moderate)
- Recommendation 3.3. For women who are fit for primary cytoreductive surgery but are deemed unlikely to have cytoreduction to < 1 cm (ideally to no visible disease) by a gynecologic oncologist, neoadjuvant chemotherapy is recommended over primary cytoreductive surgery. Neoadjuvant chemotherapy is associated with less peri- and postoperative morbidity and mortality and shorter hospitalizations. (Type = evidence based, benefits outweigh harms; quality = intermediate; strength = moderate)
What additional clinical evaluations should be performed before neoadjuvant chemotherapy is delivered?
- Recommendation 4. Before neoadjuvant chemotherapy 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 CEA (carcinoembryonic antigen) ratio > 25 is acceptable to confirm the primary diagnosis and exclude a nongynecologic cancer. (Type = informal consensus, benefits outweigh harms; quality = intermediate; strength = moderate)
What is the preferred regimen for women who will receive neoadjuvant chemotherapy?
- Recommendation 5. For neoadjuvant chemotherapy, a platinum-taxane doublet is recommended. However, alternative regimens, containing a platinum agent, may be selected based on individual patient factors. (Type = evidence-based, benefits outweigh harms; quality = intermediate; strength = moderate)
Among women treated with neoadjuvant chemotherapy, does the timing of interval cytoreductive surgery or the number of chemotherapy cycles after interval cytoreductive surgery affect the safety or efficacy of treatment?
- Recommendation 6. Randomized controlled trials tested surgery following three or four cycles of chemotherapy in women who had a response to neoadjuvant chemotherapy or stable disease. Interval cytoreductive surgery should be performed after ≤ four cycles of neoadjuvant chemotherapy for women with a response to chemotherapy or stable disease. Alternative timing of surgery has not been prospectively evaluated but may be considered based on patient-centered factors. (Type = informal consensus, benefits outweigh harms; quality = insufficient; strength = weak)
What are the treatment options for patients with progressive disease on neoadjuvant chemotherapy?
- Recommendation 7. Patients with progressive disease on neoadjuvant chemotherapy 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 bowel obstruction). (Type = evidence-based, benefits outweigh harms; quality = intermediate; strength = strong)
Mitchell I. Edelson, MD, of the Hanjani Institute for Gynecologic Oncology, Abington, Pennsylvania, is the corresponding author of the Journal of Clinical Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
