Morbidity of Surgery After Neoadjuvant Chemotherapy Including Bevacizumab for Advanced Ovarian Cancer

2013 ◽  
Vol 23 (7) ◽  
pp. 1326-1330 ◽  
Author(s):  
Elisabeth Chéreau ◽  
Eric Lambaudie ◽  
Gilles Houvenaeghel
Keyword(s):  
Ovarian Cancer ◽  
Postoperative Complications ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Ovarian Cancer ◽  
Median Number ◽  
Debulking Surgery ◽  
Surgical Safety ◽  
Computed Tomographic ◽  
Gynecology And Obstetrics ◽  
Grade 3

ObjectiveNeoadjuvant chemotherapy followed by interval debulking surgery is an alternative for the management of advanced ovarian cancer (AOC). Owing to unresectable disease at initial evaluation, some patients received bevacizumab in addition to neoadjuvant chemotherapy. The aim of this study was to evaluate the safety and postoperative course of patients who had received bevacizumab before debulking surgery for AOC.MethodsIn 2012, we identified all patients with AOC who had received neoadjuvant bevacizumab before debulking surgery. We recorded patients’ characteristics, surgical course, and postoperative complications.ResultsFive patients were identified, of whom 80% were International Federation of Gynecology and Obstetrics stage 4 at diagnosis. All patients underwent surgery after 6 courses of neoadjuvant chemotherapy with carboplatin, paclitaxel, and bevacizumab. The median number of bevacizumab injections was 3 (3–4), and the median time between the last injection of bevacizumab and surgery was 54 days (34–110 days). One patient had a grade 3 complication (lymphocyst with puncture under computed tomographic scans).ConclusionIn this preliminary study, debulking surgery after neoadjuvant chemotherapy that included bevacizumab did not increase the rate of postoperative complications when there was a reasonable interval between the last bevacizumab injection and surgery. Larger studies are warranted to assess surgical safety after antiangiogenic treatment in the neoadjuvant setting for advanced ovarian cancer.

The Role of HE4, a Novel Biomarker, in Predicting Optimal Cytoreduction After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer

2017 ◽  
Vol 27 (4) ◽  
pp. 696-702 ◽  
Author(s):  
Francesco Plotti ◽  
Giuseppe Scaletta ◽  
Stella Capriglione ◽  
Roberto Montera ◽  
Daniela Luvero ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Advanced Ovarian Cancer ◽  
Debulking Surgery ◽  
Gynecology And Obstetrics ◽  
Group A ◽  
Group B

ObjectivesThis study aimed to evaluate serum human epididymis protein 4 (HE4) changes during neoadjuvant chemotherapy (NACT) to establish HE4 predebulking surgery cutoff values and to demonstrate that CA125, HE4, and computed tomography (CT) taken together are better able to predict complete cytoreduction after NACT in advanced ovarian cancer patients.MethodsFrom January 2006 to November 2015, patients affected by epithelial advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage III–IV), considered not optimally resectable, were included in this prospective study. After 3 cycles of NACT, all patients underwent debulking surgery and were allocated, according to residual tumor (RT), into group A (RT = 0) and group B (RT > 0). Serum CA125, HE4, and CT images were recorded during NACT and compared singularly and with each other in term of accuracy, sensitivity, specificity, and positive and negative predictive value.ResultsA total of 94 and 20 patients were included in group A and group B, respectively. The HE4 values recorded before debulking surgery correlated with RT. The identified HE4 cutoff value of 226 pmol/L after NACT was able to classify patients at high or low risk of suboptimal surgery, with a sensitivity of 75% and a specificity of 85% (positive predictive value, 0.87; negative predictive value, 0.70). The combination of CA125, HE4, and CT imaging resulted in the best combination with a sensitivity of 96% and a specificity of 92% (positive predictive value, 0.96; negative predictive value, 0.94).ConclusionsThe novel biomarker HE4, in addition to CA125 and CT, is better able to predict the RT at debulking surgery and the prognosis of patients.

Efficacy and safety results from GEICO 1205, a randomized phase II trial of neoadjuvant chemotherapy with or without bevacizumab for advanced epithelial ovarian cancer

2019 ◽  
Vol 29 (6) ◽  
pp. 1050-1056 ◽  
Author(s):  
Yolanda Garcia Garcia ◽  
Ana de Juan Ferré ◽  
Cesar Mendiola ◽  
Maria-Pilar Barretina-Ginesta ◽  
Lydia Gaba Garcia ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Adverse Events ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Debulking Surgery ◽  
Randomized Phase Ii ◽  
Interval Debulking Surgery ◽  
Grade 3 ◽  
Macroscopic Response

BackgroundBevacizumab is an approved treatment after primary debulking surgery for ovarian cancer. However, there is limited information on bevacizumab added to neoadjuvant chemotherapy before interval debulking surgery.ObjectiveTo evaluate neoadjuvant bevacizumab in a randomized phase II trial.MethodsPatients with newly diagnosed stage III/IV high-grade serous/endometrioid ovarian cancer were randomized to receive four cycles of neoadjuvant chemotherapy with or without ≥3 cycles of bevacizumab 15 mg/kg every 3 weeks. After interval debulking surgery, all patients received post-operative chemotherapy (three cycles) and bevacizumab for 15 months. The primary end point was complete macroscopic response rate at interval debulking surgery.ResultsOf 68 patients randomized, 64 completed four neoadjuvant cycles; 22 of 33 (67%) in the chemotherapy-alone arm and 31 of 35 (89%) in the bevacizumab arm (p=0.029) underwent surgery. The complete macroscopic response rate did not differ between treatment arms in either the intention-to-treat population of 68 patients (6.1% vs 5.7%, respectively; p=0.25) or the 55 patients who underwent surgery (8.3% vs 6.5%; p=1.00). There was no difference in complete cytoreduction rate or progression-free survival between the treatment arms. During neoadjuvant therapy, grade ≥3 adverse events were more common with chemotherapy alone than with bevacizumab (61% vs 29%, respectively; p=0.008). Intestinal (sub)occlusion, fatigue/asthenia, abdominal infection, and thrombocytopenia were less frequent with bevacizumab. The incidence of grade ≥3 adverse events was 9% in the control arm versus 16% in the experimental arm in the month after surgery.ConclusionsAdding three to four pre-operative cycles of bevacizumab to neoadjuvant chemotherapy for unresectable disease did not improve the complete macroscopic response rate or surgical outcome, but improved surgical operability without increasing toxicity. These results support the early integration of bevacizumab in carefully selected high-risk patients requiring neoadjuvant chemotherapy for initially unresectable ovarian cancer.

Topotecan (T) and carboplatin (C) in the treatment of platinum sensitive relapsed ovarian cancer (ROC): Results of a multicenter phase I/II study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5089-5089
Author(s):  
D. Koensgen ◽  
A. Belau ◽  
P. Klare ◽  
T. Steck ◽  
O. Camara ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Phase I ◽  
Remission Rate ◽  
Primary Standard ◽  
Advanced Ovarian Cancer ◽  
Progression Free Survival ◽  
Median Number ◽  
Hematological Toxicity ◽  
Platinum Sensitive ◽  
Grade 3

5089 Background: Despite of the effectiveness of radical surgery and first-line chemotherapy, most patients (pts) with advanced ovarian cancer will relapse. Paclitaxel (P) in combination with C as second-line treatment improves the outcome of pts with platinum-sensitive ROC in comparison to C monotherapy. Due to polyneuropathy and alopecia this regimen can not be offered to all pts. Therefore, other platinum-combinations are required. We conducted a phase I/II study to define the dose limiting toxicities (DLT) and the tolerability of combination therapy with T and C. Methods: Pts with platinum-sensitive ROC and primary standard therapy were stratified according to treatment-free interval (TFI): 6–12 months (A) and ≥12 months (B). Following dose regimens were analysed: T 1mg/m2/d1–3 + C AUC5/d3 and T 0.75 mg/m2/d1–3 + C AUC5/d3, q21d. DLT was based on the first 4 courses and defined as: CTC grade 3/4 hematological and grade 2 non-hematological toxicity (excepted alopecia, vomiting), treatment delay >7d. Primary endpoints were DLT and tolerability. Secondary endpoints were remission rate (RR) and progression-free survival (PFS). Results: From 06/04 to 08/05, 28 pts were enrolled, 26 pts (A:13 pts, B:13 pts) were eligible. Median age was 61.5 years. A total of 141 cycles were analysed, median number of cycles was 6 (range A:2–8, B:1–10). DLTs were: leucopenia (n = 5) and thrombocytopenia (n = 1). MTD was reached at dose: T: 0.75mg/m2 and C: AUC5. Overall, grade 3/4 hematologic toxicities (in% of all cycles), for (A) and (B) respectively, were: anemia 4% vs. 4%, leucopenia 34% vs. 13%, neutropenia 30% vs. 31%, thrombocytopenia 7% vs. 6%. Febrile neutropenia 4.3% vs. 0%. Darbepoetin alfa was given in 13.5% of all cycles. Overall, grade 3/4 non-hematologic toxicities were infrequent (< 5%). Overall RR (95% CI) was 50% (29.7–70.1) [A: 30.8% (0.1–61.1), B: 69.3% (38.7–90.9)]. Median follow-up was 5.8 mo, median PFS (95% CI) was 7.7 mo (1.3–9.4) [A: 6.2 (1.3–7.2), B: 8.0 (7.3–9.4)]. Median overall survival was not reached. Conclusions: TC is a feasible and effective chemotherapy regimen for platinum sensitive ROC. Tolerability is not associated to TFI. The recommended dose for subsequent studies is T:0.75 and C:AUC5. No significant financial relationships to disclose.

Neoadjuvant chemotherapy with six cycles of carboplatin and paclitaxel in advanced ovarian cancer patients not candidates for optimal primary surgery: Safety and effectivenes.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5540-5540
Author(s):  
Vanessa Costa Miranda ◽  
Angelo Bezerra de Sousa Fede ◽  
Carlos Henrique Dos Anjos ◽  
Juliana Ribeiro da Silva ◽  
Fernando Barbosa Sanchez ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Neoadjuvant Chemotherapy ◽  
Disease Progression ◽  
Advanced Ovarian Cancer ◽  
Length Of Hospital Stay ◽  
Complete Response ◽  
Debulking Surgery ◽  
Stage Iiic ◽  
Primary Debulking Surgery

5540 Background: Primary debulking surgery (PDS) has been considered the standard of treatment in advanced ovarian cancer, while neoadjuvant chemotherapy, three cycles followed by interval debulking (ID) surgery, is a valid treatment alternative for patients with non-resectable disease. This study aimed to show the efficacy and safety of six cycles of neoadjuvant chemotherapy (N-CT) followed by cytoreduction, a single institution experience. Methods: Aretrospective analysis was performed of all patients (pts) with advanced ovarian cancer treated with platinum based N-CT, between January/2004 and February/2012. Results: 97 pts underwent N-CT in our institution; 78.1% and 18.8% the patients had extensive stage IIIC or IV disease at diagnosis, respectively. Median age 60 years (36 – 82). Histologic types: serous 84.5%, adenocarcinoma not specified 11.3%, endometrioide 1.0%. A median of six cycles of chemotherapy were performed. Patients did not received chemotherapy after debulking surgery. During the treatment 31.4% had grade 3/4 toxicity, the most commonly observed toxicities were hematologic toxicities and nausea, four (4.1%) patients died during chemotherapy due to disease progression. After N-CT 24.7% achieved clinical complete response, 57.7% partial response and 12.4% disease progression. From this cohort 63.1% underwent a complete resection of all macroscopic and microscopic disease (R0). Median length of hospital stay and postoperative ICU stay was 5 and 0.8 days respectively, surgical complications were not common however five (7.1%) patients needed second surgery due to operatory complications and 19 pts (27.1%) needed blood transfusion after debulking. With a median follow up of 21.8 months (0.5-139.7), median overall survival and chemotherapy-free interval were 57,7 and 9,5 months, respectively. Conclusions: Six cycles of neoadjuvant carboplatin and paclitaxel is safe, effective and does not increase perioperative and postoperative complications for patients with stage IIIC-IV not candidates for optimal/R0 PDS. The overall survival of this cohort is higher than those treated with interval debulking surgery.

The evaluation of intra- and postoperative complications related to debulking surgery with bowel resection in patients with FIGO stage III–IV ovarian cancer

2007 ◽  
Vol 17 (5) ◽  
pp. 993-997 ◽  
Author(s):  
M. Bidzinski ◽  
P. Derlatka ◽  
P. Kubik ◽  
I. Ziolkowska-Seta ◽  
A. Dańska-Bidzinska ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Postoperative Complications ◽  
Cancer Patients ◽  
Bowel Resection ◽  
Intestinal Resection ◽  
Advanced Ovarian Cancer ◽  
Figo Stage ◽  
Hartmann’S Procedure ◽  
Debulking Surgery ◽  
Hartmann's Procedure

The surgical treatment of advanced ovarian cancer is based on the maximal debulking with widening the operation range to the infiltrated organs. The aims are as follows: (1) the assessment of the quantity and quality of intra- and postoperative complications in patients with advanced ovarian cancer in which partial bowel resection was performed and (2) the evaluation of intra- and postoperative complications related to surgery with bowel resection and anastomosis, compared to Hartmann's procedure. The analysis of debulking procedures with intestinal resection and postoperative period in 39 ovarian cancer patients, FIGO stage III–IV, was performed. During 39 operations, the most frequent type of resection was the sigmoidectomy or proctosigmoidectomy (29 patients). In the remaining patients, left- and right-side hemicolectomy or partial enterectomy was done. Twenty-four anastomosis and 15 Hartmann's procedures were performed. There were no differences between surgery with anastomosis and Hartmann's procedure in aspect of quantity of complications, blood loss, and the time of surgery. There were no statistically significant differences in overall survival and progression-free survival in both groups. We conclude that the percentage of complications related to debulking surgery with intestinal resection in advanced ovarian cancer patients might be accepted. The quantity of complications related to surgery with anastomosis and to Hartmann's procedure is similar. If possible, the surgery with anastomosis should be performed.

scholarly journals Role of Lymphadenectomy During Interval Debulking Surgery Performed After Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Minjun He ◽  
Yuerong Lai ◽  
Hongyu Peng ◽  
Chongjie Tong
Keyword(s):  
Ovarian Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Residual Disease ◽  
Advanced Ovarian Cancer ◽  
Progression Free Survival ◽  
Debulking Surgery ◽  
Hazard Ratios ◽  
Significant Difference ◽  
Interval Debulking Surgery

ObjectiveThe role of lymphadenectomy in interval debulking surgery (IDS) performed after neoadjuvant chemotherapy (NACT) in advanced ovarian cancer remains unclear. We aimed to investigate the clinical significance of lymphadenectomy in IDS.MethodsWe retrospectively reviewed and analyzed the data of patients with advanced ovarian cancer who underwent NACT followed by IDS.ResultsIn 303 patients receiving NACT-IDS, lymphadenectomy was performed in 127 (41.9%) patients. One hundred and sixty-three (53.8%) patients achieved no gross residual disease (NGRD), and 69 (22.8%) had residual disease &lt; 1 cm, whereas 71 (23.4%) had residual disease ≥ 1cm. No significant difference in progression-free survival (PFS) and overall survival (OS) was observed between the lymphadenectomy group and the no lymphadenectomy group in patients with NGRD, residual disease &lt; 1 cm, and residual disease ≥ 1 cm, respectively. The proportions of pelvic, para-aortic and distant lymph node recurrence were 7.9% (10/127), 4.7% (6/127) and 5.5% (7/127) in the lymphadenectomy group, compared with 5.7% (10/176, P = 0.448), 4.5% (8/176, P = 0.942) and 5.1% (9/176, P = 0.878), respectively, in no lymphadenectomy group. Multivariate analysis identified residual disease ≥ 1 cm [hazard ratios (HR), 4.094; P = 0.008] and elevated CA125 levels after 3 cycles of adjuvant chemotherapy (HR, 2.883; P = 0.004) were negative predictors for OS.ConclusionLymphadenectomy may have no therapeutic value in patients with advanced ovarian cancer underwent NACT-IDS. Our findings may help to better the therapeutic strategy for advanced ovarian cancer. More clinical trials are warranted to further clarify the real role of lymphadenectomy in IDS.

TRAINING-Ovary 01 (connecTed pRehabiliAtIoN pelvIc caNcer surGery): multicenter randomized study comparing neoadjuvant chemotherapy for patients managed for ovarian cancer with or without a connected pre-habilitation program

2020 ◽  
pp. ijgc-2020-002128
Author(s):  
Eric Lambaudie ◽  
Cécile Bannier/Braticevic ◽  
Charlène Villaron/Goetgheluck ◽  
Christophe Zemmour ◽  
Jean-Marie Boher ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Primary Endpoint ◽  
Advanced Ovarian Cancer ◽  
Well Being ◽  
Phase Iii ◽  
Pelvic Surgery ◽  
Control Group ◽  
Gynecology And Obstetrics ◽  
Pelvic Cancer

BackgroundPatients undergoing neoadjuvant chemotherapy before surgery for advanced ovarian cancer may have impaired functional capacity, nutritional status, and emotional well-being.Primary objective(s)TRAINING-01 aims to determine if a connected pre-habilitation program during neoadjuvant chemotherapy for patients treated for an advanced ovarian cancer will improve physical capacity before major abdomino-pelvic surgery.Study hypothesisA pre-habilitation program during neoadjuvant chemotherapy will bring a fitter patient to surgery and will decrease treatment morbidity and improve oncological outcomes.Trial designThis study is a prospective, multi-center, phase III study. The pre-habilitation program consists of providing multi-dimensional support during neoadjuvant chemotherapy using connected devices. The control group will receive usual care.Major inclusion/exclusion criteriaEligible patients will be women with International Federation of Gynecology and Obstetrics stage III–IV advanced ovarian cancer undergoing neoadjuvant chemotherapy. Patients must be able to perform a cardiopulmonary exercise test.Primary endpoint(s)The primary endpoint will be the comparison of the variation in maximum oxygen uptake (VO2 max) between baseline and surgery in the pre-habilitation group and control groups.Sample size136 patients (68 per arm) will be recruited to demonstrate a medium standardized effect d=0.5 in the variations of VO2 max between baseline and surgery.Estimated dates for completing accrual and presenting resultsThe duration of the study includes 24 months of recruitment and 5 years of follow up. We anticipate reporting primary endpoint results in 2024.Trial registrationTRAINING-01-IPC 2018-039 (NCT04451369).

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