Bevacizumab Plus Paclitaxel–Carboplatin Adds To Recurrent Ovarian Cancer Options

Ovarian cancer patients with platinum-sensitive recurrence may benefit from a bevacizumab regimen given alongside paclitaxel and carboplatin

medwireNews: Results from the GOG-0213 study add to evidence for the use of bevacizumab alongside chemotherapy in patients with platinum-sensitive recurrent ovarian cancer.

The open-label study included 674 women with epithelial ovarian, primary peritoneal or fallopian tube cancer who had achieved a complete response to primary platinum-based chemotherapy and had been disease-free for at least 6 months before developing recurrence.

Participants were assigned to receive six cycles of paclitaxel plus carboplatin alone or alongside bevacizumab 15 mg/kg every 3 weeks, followed by maintenance bevacizumab at 3-week intervals.

In addition, eligible candidates were randomly assigned to receive one of these two regimens with or without cytoreductive surgery. The results of this surgical objective will be published at a later date, the researchers explain.

The primary endpoint of intention-to-treat overall survival (OS) did not show a statistically significant difference between the 377 patients given the bevacizumab regimen and the 337 controls, at a median of 42.2 versus 37.3 months.

However, Robert Coleman, from the University of Texas MD Anderson Cancer Center in Houston, USA, and co-investigators found that 7% of patients in the study had incorrect treatment-free interval stratification data; sensitivity analysis adjusting for this error gave a significant hazard ratio (HR) for OS of 0.823 in favour of the anti-Angiogenesis regimen.

“The difference in median overall survival (5 months) is clinically meaningful and is bolstered by a significant increase in both progression-free survival [PFS] and objective and complete responses in the bevacizumab group”, the researchers add in The Lancet Oncology.

Specifically, median PFS was 13.8 months for the bevacizumab-treated patients and 10.4 months with chemotherapy alone, giving a significant adjusted HR of 0.628 for progression or death. An objective response was achieved by 78% and 59%, respectively, with a complete response achieved by 32% and 18%.

Serious adverse events were more common with bevacizumab plus chemotherapy, reported for 28% of patients versus 11% of those given chemotherapy alone. The most common grade 3 or more severe toxicities were abdominal pain (12 vs 0%), nausea (9 vs 3%), small bowel obstruction (6 vs 3%), hypertension (6 vs 0%), proteinuria (6 vs 0%) and dyspnoea (6 vs 0%).

But Robert Coleman et al observe that “[i]mportantly, toxicity was not associated with diminution of patient-reported outcomes.”

Although both patient groups showed a decrease in Function Assessment of Cancer Therapy–Ovary trial outcome index scores during treatment, the reduction in quality of life was not considered to be clinically meaningful at any timepoint and patient scores were above the baseline values 6 months after beginning treatment.

Philipp Harter, from Kliniken-Essen-Mitte in Germany, notes in a linked comment that the findings support those of the OCEANS trial, which led to European approval of carboplatin–gemcitabine plus bevacizumab in patients with a first platinum-sensitive relapse.

If bevacizumab given with carboplatin–paclitaxel is also approved in Europe, this would provide another option for this population, he writes.

“Doctors could counsel patients regarding the activity and side-effects (eg, Alopecia, neurotoxicity) of two different platinum plus bevacizumab-based regimens so that patients can choose their preferred regimen.

“Furthermore, this combination is a new option in the USA, where bevacizumab has only been approved for platinum-resistant disease.”

And he adds: “The results of the surgical objective, which—together with the AGO-DESKTOPIII trial – will provide a definitive answer regarding the role of surgery in [recurrent] ovarian cancer, are eagerly awaited.”

References

Coleman RL, Brady MF, Herzog TJ, et al. Bevacizumab and paclitaxel–carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol; Advance online publication 21 April 2017. DOI: http://dx.doi.org/10.1016/S1470-2045(17)30279-6

Harter P. A new standard of care or just another option for patients with relapsed ovarian cancer? Lancet Oncol; Advance online publication 21 April 2017. DOI: http://dx.doi.org/10.1016/S1470-2045(17)30253-X

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