Advertisement


Jean-Marc Classe, MD, PhD, on Ovarian Cancer: New Data on Lymphadenectomy From the CARACO Trial

2024 ASCO Annual Meeting

Advertisement

Jean-Marc Classe, MD, PhD, of France’s Nantes Université, discusses phase III results showing that systematic lymphadenectomy should be omitted in patients with advanced epithelial ovarian cancer with clinically negative lymph nodes, as well as those undergoing neoadjuvant chemotherapy and interval complete surgery (LBA5505).



Transcript

Disclaimer: This video transcript has not been proofread or edited and may contain errors.
The CARACO trial is a trial about surgery for advance ovarian cancer patients. Advanced ovarian cancer patients are treated with complete surgery, with not residual, and the treatment could be primary surgery. If it is feasible to perform a primary complete surgery and then adjuvant chemotherapy, or if it's not possible, we can perform neoadjuvant chemotherapy, complete interval surgery. And then the other treatments. W. Hen you see some lymph nodes suspicious at the CT scan before surgery or during surgery, you must perform a lymphadenectomy. The question is not for this patient. The question is for patient with no suspicious lymph node at the CT scan before surgery or during surgery at the palpation of the peritoneum. And for this patient, you have already a study, a randomized study called the LION study. It was presented at the ESCO in 2017. The LION study was for primary surgery, advanced ovarian cancer patients with no suspicious lymph node treated by primary surgery. The LION trial demonstrates that it's not useful to perform an lymphadenectomy. So the remaining question is, what is the interest of lymphadenectomy for patients treated with neoadjuvant chemotherapy? And currently almost two thirds of the patients are treated with neoadjuvant chemotherapy. So it is an important question. So the CARACO trial, the design is inclusion criteria, epithelial ovarian cancer, primary treatments, no metastasis, but a FIGO stage three, no suspicious node at the CT scan before surgery. And a randomization complete surgery with lymphadenectomy compared with complete surgery with no lymphadenectomy. The results of this trial, if you consider just the morbidity, we observed statistically significant morbidity higher in the group of lymphadenectomy with more lymphedema, more re-intervention, more bleeding, transfusion, so more toxicity. The mortality rate was the same between the two arms, around 1 percent, no more. And if you consider the characteristics of the patients, you can observe a lot of complete surgery. 85 percent of complete surgery in both arms. In the lymphadenectomy arm we observed 28 median number of rejected lymph nodes, and 43 involvements, 43 involvements in the lymphadenectomy arm. And the significance is that these 43 lymph nodes involved remain in the patients in the new lymphadenectomy arm. And what is the result? To avoid a lymphadenectomy, the results of the CARACO trial is negative. What does it mean? It means that it's not useful to perform a lymphadenectomy in this patient with no suspicious lymph nodes before a treatment. So you are increasing the toxicity, but you're not increasing the survival. And it is true, for the primary endpoint, the disease-free survival, it is true for the secondary endpoint overall survival. And when you see subgroup analysis, you look at the results of the interval surgery, on the interval surgery, no difference. You look at the results of only high-grade serous carcinoma, no difference. So in conclusion, CARACO trial is a negative trial. So it means that for patients treated for an advanced ovarian cancer by primary surgery or neuro adjuvant chemotherapy, you don't have to perform a lymphadenectomy. We must talk about three limitations of the study. The first one is that we didn't include the right number of patients. We need 450 patients and we include a little less patients. But more important, we miss 22 events. We add only 320 events, and we missed 6 percent of the events required. But whatever happened to these 22 missing events, it is not possible that it could change the results. So we can say that the CARACO trial is a trial negative that demonstrates the not efficiency of the lymphadenectomy in the treatment of the patient with primary or with neuro adjuvant chemotherapy in case of no suspicious lymph nodes before surgery.

Related Videos

Breast Cancer

Sherene Loi, MD, PhD, on Early-Stage Breast Cancer: Weighing the Prognostic Value of ctDNA Detection

Sherene Loi, MD, PhD, of Peter MacCallum Cancer Centre, discusses a circulating tumor DNA (ctDNA) analysis from a cohort of patients with early-stage breast cancer who were enrolled in the monarchE trial. This large cohort was studied to look at the usefulness of a personalized tumor-informed assay for ctDNA detection in early stage high-risk patients (LBA507).

Prostate Cancer
Genomics/Genetics

Alicia Morgans, MD, MPH, and Susan Halabi, PhD, on Prostate Cancer: New Findings on Classifying Patients Into Risk Groups

Alicia Morgans, MD, MPH, of Dana-Farber Cancer Institute, and Susan Halabi, PhD, of the Duke Cancer Institute and Duke University School of Medicine, discuss a clinical-genetic model that identified novel circulating tumor DNA alterations that are prognostic of overall survival and may help to classify patients with metastatic castration-resistant prostate cancer into risk groups useful for selecting trial participants (Abstract 5007).

Kidney Cancer

Brian I. Rini, MD, on Renal Cell Carcinoma: Exploratory Biomarker Results

Brian I. Rini, MD, of Vanderbilt Ingram Cancer Center, discusses phase III findings of the KEYNOTE-426 study of pembrolizumab plus axitinib vs sunitinib for patients with advanced renal cell carcinoma. He details the exploratory biomarker results, including RNA sequencing, whole-exome sequencing, and PD-L1 (Abstract 4505).

Clifford A. Hudis, MD: A Message From ASCO’s CEO

Clifford A. Hudis, MD, of the American Society of Clinical Oncology (ASCO), talks about the 2024 Annual Meeting, and a focus on the compassionate side of cancer care.

Gynecologic Cancers

Yukio Suzuki, MD, PhD, on Endometrial Cancer: Long-Term Survival Outcomes With Hormonal Therapy in Reproductive-Age Patients

Yukio Suzuki, MD, PhD, of Columbia University College of Physicians and Surgeons, discusses data showing that reproductive-age patients with early-stage endometrial cancer who use fertility-preserving hormonal therapy seemed to have good overall survival after a 10-year follow-up (Abstract 5508).

Advertisement

Advertisement




Advertisement