Chekerov 2017.
| Methods | Open‐label randomised multi‐centre phase II study of cytotoxic chemotherapy with vs without panitumumab | |
| Participants | Women 18 years of age or older with histologically proven epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Women must have pretreated platinum‐sensitive ovarian cancer with recurrence more than 6 months after completion of a platinum‐containing regimen and wild‐type KRAS status | |
| Interventions | Arm A (intervention): cytotoxic chemotherapy (carboplatin plus either gemcitabine or pegylated liposomal doxorubicin, specified by investigator before randomisation) plus panitumumab Arm B (comparison): cytotoxic chemotherapy (as per intervention arm) alone |
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| Outcomes |
Outcomes planned from clinicatrials.gov website Primary PFS rate after 12 months Secondary Duration of tumour response PFS at end of follow‐up (up to 1 year) Overall survival Toxicity Tumour response rate Outcomes reported in conference proceedings abstract in 2017 No update on clinicaltrials.gov website since 2013 despite anticipated completion date of 2014 102 participants randomised; 96 enrolled for final analysis Progression‐free survival in the intention‐to‐treat population (N = 96) was 9.5 months vs 10.7 months (HR 0.829, 95% CI 8.5 to 11.6 months vs 8.5 to 13.1 months) for experimental vs standard arm; P = 0.45 "Data of overall survival are not yet evaluable" Grade 3+ toxicities included Haematological toxicity (54%) Skin reactions (18%) Gastrointestinal events (16%) |
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| Notes | Other study ID numbers: GMIHO‐008/2009_AG56, 2010‐018849‐59 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Findings presented in abstract only ‐ no data provided |
| Allocation concealment (selection bias) | Unclear risk | Findings presented in abstract only ‐ no data provided |
| Blinding of participants and personnel (performance bias) Objective outcome measures (Overall Survival) | Unclear risk | Likely to be at low risk, as data unlikely to be affected by blinding. OS data not yet evaluable |
| Blinding of participants and personnel (performance bias) Subjective outcome measures (PFS; Toxicity; QoL) | High risk | Unblinded open‐label study |
| Blinding of outcome assessment (detection bias) Objective outcome measures (overall survival) | Unclear risk | Likely to be at low risk, as data unlikely to be affected by blinding |
| Blinding of outcome assessment (detection bias) Subjective outcome measures (PFS, Toxicity, QoL) | High risk | Unblinded open‐label study |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "102 participants were randomised and 96 enrolled for the final analysis" ‐ data in abstract only ‐ unclear if this constitutes a source of bias |
| Selective reporting (reporting bias) | Unclear risk | Abstract only presented, so incomplete data available at this stage; data not updated on clinicaltrials.gov website since 2013 |
| Other bias | Unclear risk | Abstract, so limited details for assessment |