Phase III randomised clinical trial comparing primary surgery versus neoadjuvant chemotherapy in advanced epithelial ovarian cancer with high tumour load (SCORPION trial): Final analysis of peri-operative outcome
| Autor: | Giovanni Scambia, Salvatore Gueli Alletti, Francesco Cosentino, Anna Fagotti, Gabriella Ferrandina, P.A. Margariti, Vito Chiantera, Valerio Gallotta, Francesco Fanfani, Barbara Costantini, Giuseppe Vizzielli, Lucia Tortorella |
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| Přispěvatelé: | Fagotti, A., Ferrandina, G., Vizzielli, G., Fanfani, F., Gallotta, V., Chiantera, V., Costantini, B., Margariti, P., Gueli Alletti, S., Cosentino, F., Tortorella, L., Scambia, G. |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Cancer Research
Carcinoma Ovarian Epithelial Randomised clinical trial Carboplatin Cytoreduction chemistry.chemical_compound Postoperative Complications 0302 clinical medicine Quality of life Antineoplastic Combined Chemotherapy Protocols Neoplasms Glandular and Epithelial Ovarian Neoplasms 030219 obstetrics & reproductive medicine Cytoreduction Surgical Procedures Middle Aged Debulking Oncology Chemotherapy Adjuvant 030220 oncology & carcinogenesis Female medicine.symptom Adult medicine.medical_specialty Adolescent Paclitaxel Nausea Operative Time Young Adult 03 medical and health sciences Ovarian cancer Body Image medicine Humans Progression-free survival Aged Analysis of Variance Advanced ovarian cancer Laparoscopy Peri-operative complications business.industry Perioperative Length of Stay Surgery Clinical trial Settore MED/40 - GINECOLOGIA E OSTETRICIA chemistry Peri-operative complication Complication business |
| Popis: | Objective To establishing whether neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) is superior primary debulking surgery (PDS) in terms of clinical outcome as well as peri-operative morbidity in advanced epithelial ovarian cancer (AEOC) endowed with high tumour load (HTL). Material and methods This is a single-Institution, superiority, randomised phase III trial enrolling supposed AEOC women. Patients considered pre-operatively eligible were triaged to staging laparoscopy to assess the predictive index (PI) of tumour load. All AEOC women with PI ≥ 8 or ≤ 12 (considered as HTL) were included. They were randomly assigned (1:1 ratio) to undergo either PDS followed by systemic adjuvant chemotherapy (arm A, standard ), or NACT followed by IDS (NACT/IDS) (arm B, experimental ). Co-primary outcome measures were postoperative complications (graded according to the Memorial Sloan Kettering Cancer Center surgical secondary events grading system) and progression free survival (PFS); secondary outcomes were overall survival, and quality of life (QoL). QoL was assessed using the EORTC QoL questionnaires. A sample size of 110 patients was required for the analysis of the first co-primary end-point (major peri-operative morbidity) whereas recruitment is still on-going to achieve the statistical power on PFS. Results Between October 2011 and November 2014, we registered 280 AEOC. Of the 110 eligible women, 55 were assigned to arm A and 55 to arm B. Despite different extension of surgery, rates of complete residual disease (residual tumour = 0 cm) were superimposable between the groups (45.5% versus 57.7%; p = 0.206). Twenty-nine patients (52.7%) in arm A experienced early grade III–IV complications versus three patients (5.7%) in IDS (p = 0.0001). The most common complication was grade III and consisted of symptomatic pleural effusion requiring thoracic drainage (17/55 women (30.9%) in arm A versus 1/52 (1.9%) in arm B, p = 0.0001). Three grade IV (5.4%) (i.e., two re-operations for postoperative haemorrhage and one septic multi-organ failure), and two grade V (3.6%) (two deaths for acute cardiopulmonary failure) early complications were observed in arm A only. Mean QoL scores of several scales/items were shown to ameliorate over time in both arms. Emotional functioning, cognitive functioning, nausea/vomiting, dyspnoea, insomnia and hair loss were statistically and clinically better in NACT/IDS compared to PDS arm. Conclusions Perioperative moderate/severe morbidity as well as QoL scores were shown to be more favourable in NACT/IDS arm than PDS in AEOC patients with very HTL. Completion of patient enrolment and analysis of survival data will clarify whether PDS with such a high rate of severe complications is an acceptable treatment in AEOC women with HTL. |
| Databáze: | OpenAIRE |
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