Summary of findings 2. EGFR tyrosine kinase inhibitor (TKI) plus chemotherapy compared to chemotherapy alone for the treatment of relapsed epithelial ovarian cancer.
| EGFR tyrosine kinase inhibitor (TKI) plus chemotherapy compared to chemotherapy alone for the treatment of relapsed epithelial ovarian cancer | ||||||
| Patient or population: treatment of relapsed epithelial ovarian cancer Setting: hospital outpatient treatment of women with relapsed ovarian/fallopian tube/primary peritoneal cancer Intervention: EGFR tyrosine kinase inhibitor (TKI) plus chemotherapy Comparison: chemotherapy alone | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with chemotherapy alone | Risk with EGFR tyrosine kinase inhibitor (TKI) plus chemotherapy | |||||
| Overall survival | Median OS for chemotherapy alone was 18 months compared to 14 months in the chemotherapy plus EGFR TKI arm. | HR 1.25 (0.80 to 1.95) | 129 (1 RCT) | ⊕⊕⊝⊝ LOWa,b | Outcome unlikely to be affected by blinding. due to the way HRs are calculated, the assumed and corresponding risks were not estimated. | |
| Progression‐free survival | Median PFS for chemotherapy only was 3.5 months compared to a median PFS of 3.0 months in the chemotherapy plus EGFR TKI arm. | HR 0.99 (0.69 to 1.42) | 129 (1 RCT) | ⊕⊝⊝⊝ VERY LOWc | due to the way HRs are calculated, the assumed and corresponding risks were not estimated. | |
| Toxicity: grade 3 or 4 rash Assessed with National Cancer Institute Common Toxicity Criteria version 3 (CTCv3.0) or CommonTerminology Criteria for Adverse Events (CTCAE) | Study population | RR 13.63 (0.78 to 236.87) | 125 (1 RCT) | ⊕⊝⊝⊝ VERY LOWc | ||
| 1 per 100 | 11 per 100 (1 to 100) | |||||
| Toxicity: grade 3 or 4 nausea ± vomiting Assessed with National Cancer Institute Common Toxicity Criteria version 3 (CTCv3.0) or Common Terminology Criteria for Adverse Events (CTCAE) | Study population | RR 0.63 (0.16 to 2.52) | 125 (1 RCT) | ⊕⊝⊝⊝ VERY LOWc | ||
| 8 per 100 | 5 per 100 (1 to 20) | |||||
| Toxicity: grade 3 or 4 fatigue Assessed with National Cancer Institute Common Toxicity Criteria version 3 (CTCv3.0) or Common Terminology Criteria for Adverse Events (CTCAE) | Study population | RR 0.87 (0.28 to 2.72) | 125 (1 RCT) | ⊕⊝⊝⊝ VERY LOWc | ||
| 9 per 100 | 8 per 100 (3 to 26) | |||||
| Toxicity: cardiac toxicity (any grade) | Study population | RR 5.24 (0.26 to 107.02) | 125 (1 RCT) | ⊕⊕⊝⊝ LOWb | ||
| 16 per 1000 | 82 per 1000 (4 to 1000) | |||||
| Quality of life: not measured | ‐ | ‐ | ‐ | ‐ | ‐ | No QoL data included in the publication |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; CTCAE: Common Terminology Criteria for Adverse Events; EGFR: epidermal growth factor receptor; HR: hazard ratio; PFS: progression‐free survival; QoL: quality of life; RCT: randomised controlled trial; RR: risk ratio; TKI: tyrosine kinase inhibitor | ||||||
| GRADE Working Group grades of evidence High‐certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate‐certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low‐certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low‐certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
aOutcome unlikely to be affected by lack of blinding. bDowngraded by two levels due to imprecision (one small study, wide confidence intervals that cross zero, and too few events for adequate power). cDowngraded by three levels due to risk of bias (blinding absent or unclear); imprecision; and inability to assess inconsistency (one small study, wide confidence intervals that cross zero, and too few events for adequate power).