for the main comparison.
| PLD/carbo compared with PAC/carbo for platinum‐sensitive relapsed ovarian cancer | ||||||
|
Patient or population: women with platinum‐sensitive relapsed ovarian cancer Settings: inpatient or outpatient setting Intervention: PLD/carbo Comparison: PAC/carbo | ||||||
| Outcomes | Illustrative comparative survival or risk rates* (95% CI included for RR) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| PAC/carbo | PLD/carbo | |||||
| Progression‐free survival | Median PFS¹ = 40 weeks (9 months) | Median PFS¹ = 48 weeks (11 months) | HR 0.85 (0.74 to 0.97) | 1164 (2) | ⊕⊕⊕⊕ high | P value 0.01. Low statistical heterogeneity between studies. |
| Overall survival | Median OS¹ = 141 weeks (33 months) | Median OS¹ = 132 weeks (31 months) | HR 1.01 (0.88 to 1.17) | 1164 (2) | ⊕⊕⊕⊝ moderate | P value 0.85. Low statistical heterogeneity between studies. We downgraded this evidence due to post‐study treatment differences between the groups in the CALYPSO 2010 study which may have impacted the results in the direction of the PAC/carbo arm. |
| SAE ‐ Hand‐foot syndrome (grade 3) | 3 per 1000 | 13 per 1000 (3 to 60) |
RR 4.30 (0.92 to 20.15) | 1140 (2) |
⊕⊕⊕⊝ moderate | P value 0.06. We downgraded the quality of this evidence due to the rarity of grade 3 events in these two studies. |
| SAE ‐ Hair loss (grade 2)² | 840 per 1000 | 76 per 1000 (50 to 126) |
RR 0.09 (0.06 to 0.15) | 1140 (2) |
⊕⊕⊕⊕ high | P < 0.00001. |
| Discontinuation due to toxicity | 144 per 1000 | 55 per 1000 (37 to 82) | RR 0.38 (0.26, 0.57) | 1150 (2) | ⊕⊕⊕⊕ high | P < 0.00001. Low statistical heterogeneity between studies. |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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; RR: risk ratio; HR: hazard ratio; PFS: progression‐free survival; OS: overall survival; PLD: pegylated liposomal doxorubicin; PAC: paclitaxel; carbo: carboplatin | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
The basis of the assumed risk was the median control group risk across studies, and the corresponding risk (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), unless otherwise noted.
¹ These illustrative values, rounded to the nearest week and month, are taken from CALYPSO 2010.
² Grade 2 is the highest grade of alopecia according to the CTCAE 2006.