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. 2021 Feb 5;2021(2):CD005343. doi: 10.1002/14651858.CD005343.pub5

Chekman 2015.

Study characteristics
Methods Randomised trial, conducted in Algeria between 1 June 2008 and 31 April 2014.
Single‐centre study, single surgeon operated on all women in both groups.
Participants 90 women with FIGO stage IIIc ovarian carcinoma enrolled and underwent surgery. 82 women randomised, 41 to PDS and 41 to IDS
The diagnosis of stage IIIC ovarian carcinoma was confirmed by laparoscopy (78 cases) or laparotomy (3 cases)
A thoraco‐abdomino‐pelvic scan and tumour markers CA125 and CA19.9.
Interventions Primary complete cytoreduction surgery followed by chemotherapy (G1) or NACT chemotherapy followed by debulking surgery then further chemotherapy (G2).
Chemotherapy regimen used was Carboplatin ([AUC] 5) + Paclitaxel 175 mg/m², every 3 weeks
44% of women in IDS arm had 6 cycles of chemotherapy prior to debulking surgery, 10% had 4 cycles and 15% had 3 cycles.
In the PDS arm 78% of women had 6 cycles of chemotherapy after their surgery.
Outcomes Infra‐centimetimetric or complete resection, OS, recurrence‐free survival (RFS), morbidity and discuss the place of lumboaortic lymphadenectomy
Notes The trial was in abstract form only but Professor Chekman kindly provided us with the following information on request.
The mean operating time was 254.2min with (range 69 min to 480 min).
PDS (G1); mean operating time 273 min; (range 144 min to 480 min);
IDS (G2); mean operating time 233 min; (range 69 min to 360 min);
Average blood loss:
24 women (29%) were transfused; 13 women (16%) were transfused 1 unit; 9 women (11%) were transfused 2 units; 2 women (2.4%), were transfused 3 units.
PDS group: 15 women underwent blood transfusion (18%) versus IDS (G2): 9 women underwent blood transfusion (11%).
There were no postoperative deaths (0 to 30 days)
1 death recorded after the second cycle of NACT.
They performed 8 re‐operations (9.8%) mainly for abdominal and vascular complications: PDS group (G1) Six (7.3%); and IDS group (G2) two (2.4%).
R0 resection was achieved in 30 women: 16 in PDS group (G1); and 14 in IDS group (G2).
There were 36 recurrences:
20 women in the PDS group (G1); and 16 women in the IDS group (G2).
Another frequently recurring recurrence was abdominal‐pelvic lymph node recurrence with 19.4% of women relapsing in the total population. This concerns the same proportions in both groups. The other recurrences are localised, in order of frequency, in the hepatic (n = 6), pulmonary (n = 2), cerebral (n = 1) and inguinal (n = 2) levels (It should be noted that one or more sites may be affected by tumour recurrence).
Isolated biological recurrences (increase in CA‐125 without associated radiological evidence) were not recorded.
The average time between the end of initial treatment and the first recurrence is estimated at 13.15 months (95% CI 9.19‐17.10). In G1, it was 27.92 months [7 to 64] and 24.72 months [11 to 52] in G2.
In this trial, 22% of women had recurred before the first year, 38% between the first and second year, 25% between the second and third year and 13.8% beyond the third year. Thus most recurrences (86%) were recorded during the first three years and 15% after the third year (Time of occurrence of recurrence (P = 0.49)).
These recurrences benefited according to the type of either chemotherapy alone, or surgery associated with chemotherapy, or in case of cerebral metastasis of cerebral radiotherapy associated with chemotherapy. Surgery for recurrence only occurred in 19.4% of cases.
There were 24 deaths:
15 in the PDS group (G1); and 9 in the IDS group (G2).
Of the 12 remaining women who had a recurrence and remained alive, 5 were in the PDS group (G1) and 7 were in the IDS group (G2).
The mean PFS was 13.15 months (95% CI 9.19‐17.10).
In the PDS group (G1), mean PFS was 27.92 months [range 7 to 64] and in the IDS group (G2) mean PFS was 24.72 months [range 11 to 52].
Surgical management of recurrence occurred in 19.4% of cases.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The randomisation was performed in the operating room by random draw by someone other than the surgeon, once verification of inclusion criteria and resectability under laparoscopy or laparotomy had been confirmed. Histological confirmation of carcinomatosis of ovarian origin was by extemporaneous examination.
Allocation concealment (selection bias) Unclear risk Information lacking about the concealment process, but states 90 women underwent surgery and then 82 randomised to G1 or G2.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Minimal data provided regarding outcomes, only percentages provided for OS and PFS, no raw numbers, no confidence intervals or statistical calculations provided. Morbidity rate provided but unclear as to what specific morbidities this rate refers to.
Selective reporting (reporting bias) Unclear risk No information regarding why lumboaortic lymphadenectomy chosen as an outcome. No information regarding what constitutes morbidity data
Other bias Unclear risk Insufficient information to permit judgement