abstract
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.
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).
CONCLUSIONS:
Perioperative
moderate/severe morbidity as well as QoL scores were shown to be more
favourable in NACT/IDS
(neo-interval) arm than PDS
(primary) in AEOC patients with very HTL
(high tumuor load) .
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.
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
(plain english: make better) 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.
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