Maintenance therapy with paclitaxel or paclitaxel poliglumex (PP) does not improve overall survival (OS), when compared with surveillance, in patients with ovarian, peritoneal, or fallopian tube cancer, according to a phase 3 trial published in the Journal of Clinical Oncology.
Despite the lack of improvement in OS, patients assigned to paclitaxel maintenance did have a significant improvement in progression-free survival (PFS), but the difference in PFS between PP and surveillance was not significant. In addition, taxane maintenance was associated with greater toxicity.
This study (ClinicalTrials.gov Identifier: NCT00108745) included 1157 patients with stage III-IV ovarian, peritoneal, or fallopian tube cancer who had achieved a clinical complete response to first-line platinum-taxane therapy.
The patients were randomly assigned 1:1:1 to surveillance (n=386), maintenance with paclitaxel (n=384), or PP maintenance (n=387). Both taxanes were given once every 28 days for 12 cycles.
The study’s primary endpoint was OS. There was no significant difference in OS between the arms at a median follow-up of 8.1 years.
The median OS was 58.3 months with surveillance, 56.8 months with paclitaxel (hazard ratio [HR], 1.091; 95% CI, 0.991-1.307; P =.343), and 60.0 months with PP (HR, 0.1.033; 95% CI, 0.862-1.239; P =.725).
The median PFS was 13.4 months with surveillance, 18.9 months with paclitaxel (HR, 0.801; 95% CI, 0.684-0.938; P =.006), and 16.3 months with PP (HR, 0.854; 95% CI, 0.729-1.00; P =.055).
“The decision to use OS rather than PFS as the primary outcome was controversial, and in retrospect, considering the evolution of drug approval/registration to include PFS, a primary end point of PFS could have been considered,” the researchers wrote. “To date, it is important to note that most maintenance trials have demonstrated improved PFS but not OS.”
Adverse events were more common with taxane maintenance than with surveillance. Grade 3 or higher adverse events that occurred more often in the PP and paclitaxel arms than in the surveillance arm included:
- Neutropenia — 21.6%, 16.6%, and 0.5%, respectively (P <.01)
- Sensory neuropathy — 10.0%, 5.4%, and 0.8% (P <.001)
- Hypokalemia — 2.4%, 0.5%, and 0% (P =.001)
- Joint, bone, or muscle pain — 8.2%, 4.8%, and 2.9% (P =.004).
There were no treatment-related deaths.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Copeland LJ, Brady MF, Burger RA, et al. Phase III randomized trial of maintenance taxanes versus surveillance in women with advanced ovarian/tubal/peritoneal cancer: A Gynecologic Oncology Group 0212:NRG Oncology study. J Clin Oncol. Published online June 27, 2022. doi:10.1200/JCO.22.00146