Fagotti 2016.
| Study characteristics | ||
| Methods | Single institution (Italy) randomised phase III clinical trial, superiority trial (SCORPION) enrolled 280 women. | |
| Participants | Women aged 18 to 75 years with FIGO stage IIIc or IV ovarian, fallopian tube, or primary peritoneal cancer and histological confirmation of diagnosis. Histological sample obtained through staging laparoscopy and high tumour load calculated through laparoscopic predictive index (PI). PI between 8 and 12 without evidence of mesenteric retraction became inclusion criteria to go onto randomisation into the trial arms (110 randomised). | |
| Interventions | PDS + systemic adjuvant chemotherapy (arm A, standard) or to NACT + ITS (arm B, experimental) | |
| Outcomes | Co‐primary outcome measures were PFS and perioperative outcomes (early and late postoperative complications). Secondary outcomes were OS and QoL. Median number of chemotherapy cycles in both groups was 6; range 0 to 6 cycles in PDS arm and 3 to 6 in NACT arm. Women in NACT arm received a median number of four cycles prior to IDS. 3 women in the PDS arm progressed and did not receive chemotherapy. Chemotherapy schedule as were as follows: 3‐weekly carboplatin‐paclitaxel: 31 (60.8%) PDS arm versus 29 (55.8%) NACT arm (P = 0.691); 3‐weekly carboplatin‐paclitaxel‐bevacizumab: 14 (27.4%) PDS arm versus 20 (38.5%) NACT arm (P = 0.296); weekly carboplatin‐paclitaxel: 5 (9.8) PDS arm versus 3 (5.7%) NACT arm (P = 0.444); weekly carboplatin: 1 (1.9%) PDS arm versus 0 (0%) NSACT arm (P = 0.310). Median duration of treatment (randomisation to completion): 38 weeks for PDS (range 17 to 45 weeks) and 28 weeks for NACT arm (range 16 to 34 weeks). This was largely due to increased time to start/restart chemotherapy after surgery: median time after PDS was 40 days (range 17 to 120 days) versus 27 days after IDS (range 16 to 37 days) (P = 0.001). |
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| Notes | Trial registered on ClinicalTrials.gov (No. NCT01461850) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A centrally performed, computer‐generated list for block randomisation (1:1 ratio) was used. Women randomly (max allowable percentage deviation = 10%) allocated to PDS + systemic adjuvant chemotherapy (arm A, standard) or to NACT + IDS (arm B, experimental) |
| Allocation concealment (selection bias) | Unclear risk | Randomisation was done centrally by an independent DMC (CUSH‐CTC), however there is no mention of whether the sequence was protected prior to assignment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind participants or personnel to interventions in the trial. It is unclear what impact this will have in terms of bias, although it does carry a high risk |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. Blinding of outcome assessors not important for OS but crucial for assessment of disease progression. Also may be quite important for QoL outcomes as well |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Substantial missing data for QoL outcomes. Survival outcomes only partially reported as part of conference proceedings, no peer‐reviewed publication of survival outcomes, as yet |
| Selective reporting (reporting bias) | High risk | Relative results (HRs) for OS were not presented in the ASCO abstract and we were unable to obtain effect estimates. PFS was reported as part of conference proceedings, QoL and perioperative morbidity and mortality outcomes in the published article |
| Other bias | High risk | The authors state that the types of surgery performed on women in each arm of the study were significantly different. In women in the PDS arm, upper abdominal surgical procedures were performed in all women compared to 42.3% of women in the IDS arm.
Median duration of entire treatment from randomisation to completion of medical treatment was also longer in the PDS arm (38 weeks versus 28 weeks). This was due to statistically significant difference in time to start post‐surgery chemotherapy (median time post PDS 40 days, median time post IDS 27 days) No discussion of funding. No conflict of interest declared |