Gynecologic Cancers Research From ASCO20 Highlights Potential Benefits of Secondary Cytoreductive Surgery, Novel Combination Therapies

Author(s):  
Felipe Leonardo Estati ◽  
Rafaela Pirolli ◽  
Viviane Teixeira Loiola de Alencar ◽  
Adriana Regina Gonçalves Ribeiro ◽  
Maria Nirvana Formiga ◽  
...  

2020 ◽  
Vol 7 (4) ◽  
pp. 199-200
Author(s):  
Martin Pölcher

<b>Background:</b> The role of secondary cytoreductive surgery in recurrent ovarian cancer (ROC) has been under debate for decades. A recent trial in unselected patients (pts) failed to show an OS benefit. <b>Methods:</b> Pts with ROC and 1st relapse after 6+ months (mos) platinum-free interval (TFIp) were eligible if they presented with a positive AGO-score (PS ECOG 0, ascites ≤500 ml, and complete resection at initial surgery) and were prospectively randomized to second-line chemotherapy alone vs. cytoreductive surgery followed by the same chemotherapy; platinum combination therapy was recommended. OS was primary endpoint in this superiority trial. <b>Results:</b> 407pts were randomized 2010–2014. The TFIp exceeded 12 mos in 75% of pts. 206 pts were allocated to the surgery arm of whom finally 187 (91%) were operated. A complete resection was achieved in 75%; almost 90% in both arms received a platinum-containing second-line chemo. Primary endpoint analysis showed median OS of 53.7 mos with and 46.2 mos without surgery (HR 0.76, 95%CI 0.59–0.97, p = 0.03); median PFS was 18.4 and 14 mos (HR: 0.66, 95%CI 0.54–0.82, p &#x3c; 0.001), median time to start of first subsequent therapy (TFST) was 17.9 vs. 13.7 mos in favor of the surgery arm (HR 0.65, 95%CI 0.52–0.81, p &#x3c; 0.001). An analysis according to treatment showed an OS benefit exceeding 12 mos for pts with complete resection (CR) compared to pts without surgery (median 60.7 vs. 46.2 mos); pts with surgery and incomplete resection even did worse (median 28.8 mos). 60 d mortality rates were 0 and 0.5% in the surgery and no-surgery arm. Re-laparotomies were performed in 3.7% of operated pts. Further grade 3/4 adverse events did not differ significantly between arms. <b>Conclusions:</b> This is the first surgical study demonstrating a meaningful survival benefit in OC: Surgery in pts with first relapse and TFIp of 6+ mos and selected by a positive AGO-Score resulted in a significant increase of OS, PFS and TFST with acceptable morbidity and, therefore, should be offered to suitable pts. The benefit was exclusively seen in pts with CR indicating the importance of both the optimal selection of pts (eg. by AGO score) and of centres with expertise and a high chance of achieving a CR. Clinical trial information: NCT01166737.


2014 ◽  
Vol 134 (2) ◽  
pp. 257-261 ◽  
Author(s):  
M. Petrillo ◽  
L. Pedone Anchora ◽  
L. Tortorella ◽  
F. Fanfani ◽  
V. Gallotta ◽  
...  

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5558-5558
Author(s):  
Ioana Braicu ◽  
Wanja Nikolai Kassuhn ◽  
Hagen Kulbe ◽  
Pauline Wimberger ◽  
Cagatay Taskiran ◽  
...  

5558 Background: Complete resection at secondary cytoreductive surgery is associated with prolonged progression free and overall survival for patients with relapsed ovarian cancer. Secondary cytoreductive surgery has no impact on survival rates, if macroscopically tumor clearance cannot be achieved. Therefore, in order to avoid unnecessary perioperative morbidity and mortality, selection of patients who will undergo secondary tumor debulking is crucial. This study aims to improve upon the contemporary Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) score by including additional clinical variables like circulating HE4 and CA125 levels to predict surgical outcome at secondary cytoreduction. Methods: A total of 90 patients underwent secondary cytoreductive surgery and were retrospectively assigned a positive AGO score. Of those patients, 62 (68.9%) achieved optimal surgical outcome at secondary debulking with 28 (31.1%) patients retaining residual tumor mass ( > 0mm). Utilizing clinical variables including circulating HE4 and CA125 levels, we implemented a machine learning workflow to predict suboptimal surgical outcome in patients despite a positive AGO score. Results: We elucidated significantly lower levels of circulating HE4 (p = 0.0038) in patients with optimal surgical outcome compared to patients that retain macroscopic residual tumor at secondary cytoreductive surgery. Moreover, machine learning algorithms trained on clinical variables (e.g. serum HE4 level, serum CA125 level, age, Risk of Ovarian Malignancy Algorithmus (ROMA) score and occurrence of peritoneal carcinomatosis) achieved a mean area under the curve (AUC) of 78.4% based on 100 consecutive executions with randomized training and test sets. Conclusions: The application of machine learning allows to further improve the prediction of patients with high likelihood of achieving optimal surgical outcome at secondary cytoreduction. In turn, it might identify patients that would benefit from amplified treatment efforts. However, machine learning relies on large amounts of data to account for biological and clinical variation and produce predictions of sufficient/adequate quality. Given this limitation, we would validate this data within the prospective multicentric cohort of patients collected within NOGGO/ENGOT HELP_ER Trial.


Author(s):  
R. Harrison ◽  
I. Zighelboim ◽  
N.G. Cloven ◽  
J.Z. Marcus ◽  
R.L. Coleman ◽  
...  

2021 ◽  
Author(s):  
Min-Hyun Baek ◽  
Eun Young Park ◽  
Hyeong In Ha ◽  
Sang-Yoon Park ◽  
Myong Cheol Lim ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document