GOG-218: What the Ovarian Cancer Trial Found

In brief

GOG-218 asked whether adding bevacizumab, a drug that blocks the blood vessels feeding a tumor, to standard chemotherapy would help women with advanced ovarian cancer. Published in 2011, the answer was split. Bevacizumab delayed cancer growth by close to four months when continued after chemotherapy. It did not help women live longer, and eight more years of follow-up did not change that.

Trial at a glance

Field	Detail
Trial	GOG-218 (GOG-0218)
Identifier	NCT00262847
Phase	Phase 3
Design	Randomized, double-blind, placebo-controlled
Cancer type	Advanced epithelial ovarian, fallopian tube, primary peritoneal
Comparator	Carboplatin and paclitaxel plus placebo
Primary endpoint	Progression-free survival
Enrollment	1,873 women

Who took part

The trial enrolled 1,873 women with newly diagnosed stage III disease that surgery could not fully remove, or stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer. All had already had surgery to remove as much tumor as possible, and all were still reasonably active (performance status 0 to 2). Anyone with a history of clinically significant vascular events, or evidence of bowel obstruction, was excluded, because bevacizumab raises the risk of bleeding, clotting and bowel injury.

What the trial found

Everyone received six cycles of carboplatin and paclitaxel. One group added placebo; a second added bevacizumab during cycles 2 to 6 only; a third added bevacizumab during chemotherapy and continued it for up to 22 cycles.

Median progression-free survival was 10.3 months with chemotherapy alone, 11.2 months with the short bevacizumab course, and 14.1 months with bevacizumab continued afterward. Only the continued group beat chemotherapy alone: hazard ratio 0.717 (95% CI, 0.625 to 0.824; P<0.001). The short course did not (hazard ratio 0.908; 95% CI, 0.795 to 1.040; P=0.16).

Overall survival is the part that matters most and the part that did not move. At the first report, 76.3% of patients were alive, with no significant differences among the three groups. The final protocol-specified analysis, published in 2019 after a median follow-up of 102.9 months, found a hazard ratio for death of 1.06 (95% CI, 0.94 to 1.20) for the concurrent group and 0.96 (95% CI, 0.85 to 1.09) for the concurrent-plus-maintenance group. Disease-specific survival was not improved in any arm.

The added treatment had costs. Hypertension of grade 2 or higher occurred in 7.2%, 16.5% and 22.9% of the three groups; gastrointestinal wall disruption in 1.2%, 2.8% and 2.6%.

What changed in practice

Bevacizumab entered first-line ovarian cancer treatment on the strength of the progression-free survival result. The National Cancer Institute lists it as approved with carboplatin and paclitaxel and then alone in patients with stage III, stage IV or recurrent disease following surgery. The European ICON7 trial landed in a similar place: restricted mean progression-free survival at 36 months of 21.8 months with bevacizumab versus 20.3 months without (hazard ratio 0.81; 95% CI, 0.70 to 0.94; P=0.004).

What this story cannot tell you

• It cannot tell you that bevacizumab will help you live longer with advanced ovarian cancer. Across nearly nine years of follow-up, GOG-218 found no overall survival difference. A longer time before scans show growth is a real thing, but it is not the same thing.
• It does not apply to early-stage ovarian cancer, to stage III disease that surgery removed completely, or to women with recent vascular events or bowel obstruction, who were kept out of the trial.
• A longer median survival appeared in the stage IV maintenance group (42.8 versus 32.6 months) in 2019, but that was one subgroup inside an overall negative trial, and subgroup findings raise questions rather than settle them.
• Front-line treatment has changed since 2011. The 2019 analysis found that BRCA1/2 and homologous recombination repair mutations affected prognosis but did not predict who benefited from bevacizumab; its authors concluded that testing for them is essential. Decisions today involve options this trial never tested.

Questions worth asking

• Given my stage and what surgery removed, what would bevacizumab realistically change for me?
• Are we aiming to delay progression or to extend life, and which does the evidence support?
• What genomic testing should I have before we choose maintenance treatment?

Sources

This article was written from the sources below, which were checked on the source-check date shown above.

• NEJM: Incorporation of Bevacizumab in the Primary Treatment of Ovarian Cancer (GOG-218) (primary)
• JCO 2019: Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer (primary)
• ClinicalTrials.gov: NCT00262847 (registry)
• NCI: Bevacizumab (reference)
• NEJM: A Phase 3 Trial of Bevacizumab in Ovarian Cancer (ICON7) (supporting)

Related reading: ovarian cancer and its treatment.

How this article was prepared

Prepared by Cancer Explained's AI-assisted editorial system and checked against the sources listed above. This article has not been reviewed by a healthcare professional unless a named reviewer is specifically shown.

Cancer Explained is published by the National Cancer Information Foundation as a nonprofit-oriented public-interest education project. It is not a diagnostic service, does not recommend treatments, and is not for emergencies.

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