AURELIA
AURELIA showed that adding bevacizumab to single-drug chemotherapy for ovarian cancer that has stopped responding to platinum doubled the time before the cancer grew again, from 3.4 to 6.7 months, and more than doubled the response rate, though it did not clearly lengthen life.
Overview
AURELIA was an open-label phase 3 trial in 361 women with platinum-resistant ovarian cancer randomised to the investigator's choice of weekly paclitaxel, pegylated liposomal doxorubicin or topotecan, alone or with bevacizumab. The primary endpoint was progression-free survival.
Median progression-free survival was 6.7 months with bevacizumab against 3.4 months with chemotherapy alone (hazard ratio 0.48), the response rate 27.3 against 11.8 percent and median overall survival 16.6 against 13.3 months (hazard ratio 0.85, not significant). Hypertension and proteinuria were more common with bevacizumab and gastrointestinal perforation occurred in 2.2 percent. The trial led to approval of bevacizumab with chemotherapy for platinum-resistant disease in the United States in November 2014, which is how the corpus's platinum-resistant ovarian cancer page cites it.
- Median 6.7 vs 3.4 months with Bevacizumab + single-agent chemotherapy compared with Single-agent chemotherapy; about 3.3 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 52 percent lower chance of the event at any given time (hazard ratio 0.48, likely range 0.38 to 0.6).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- Median 6.8 vs 3.4 months with Bevacizumab + single-agent chemotherapy compared with Single-agent chemotherapy; about 3.4 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 54 percent lower chance of the event at any given time (hazard ratio 0.46, likely range 0.366 to 0.577).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 27.3 vs 11.8 out of 100 had their tumour shrink with Bevacizumab + single-agent chemotherapy compared with Single-agent chemotherapy; 15.5 more per 100.
- Roughly one extra person helped for every 6 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- Median 16.6 vs 13.3 months with Bevacizumab + single-agent chemotherapy compared with Single-agent chemotherapy; about 3.3 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 15 percent lower chance of the event at any given time (hazard ratio 0.85, likely range 0.66 to 1.08).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 2.2 out of 100 people reached this endpoint with Bevacizumab + single-agent chemotherapy.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer after no more than two prior regimens: the investigator's single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin or topotecan) with or without bevacizumab, with progression-free survival as the primary endpoint. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
361 enrolled.
95% CI 5.62 to 7.79 · 95% CI 2.10 to 3.75
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Bevacizumab + single-agent chemotherapy | - | 6.7 months | 0.48 (0.38 to 0.6) | <0.001 | link |
| Single-agent chemotherapy | - | 3.4 months | ||||
| Progression-free survival (registry results, November 2011 cut-off) | Bevacizumab + single-agent chemotherapy | - | 6.8 months | 0.46 (0.366 to 0.577) | <0.0001 | link |
| Single-agent chemotherapy | - | 3.4 months | ||||
| Objective response rate (RECIST) | Bevacizumab + single-agent chemotherapy | - | 27.3% | - | 0.001 | link |
| Single-agent chemotherapy | - | 11.8% | ||||
| Overall survival | Bevacizumab + single-agent chemotherapy | - | 16.6 months | 0.85 (0.66 to 1.08) | 0.174 | link |
| Single-agent chemotherapy | - | 13.3 months | ||||
| Gastrointestinal perforation | Bevacizumab + single-agent chemotherapy | - | 2.2% | - | - | link |
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