Comparing nab-paclitaxel and solvent-based paclitaxel in platinum-resistant ovarian cancer: evidence and perspectives.

OBJECTIVE

Paclitaxel is a standard therapy in platinum-resistant ovarian cancer, but nab-paclitaxel, a solvent-free formulation with a favorable toxicity profile approved in other tumors, has not been evaluated against solvent-based paclitaxel (sb-paclitaxel) in this setting. This study compares efficacy and safety of nab-paclitaxel to sb-paclitaxel monotherapy in platinum-resistant ovarian cancer to inform clinical decision-making and guidelines.

METHODS

A mixed-methods approach combined a systematic literature review with expert discussions. Study selection followed 2 sample frames: (1) randomized controlled trials for sb-paclitaxel monotherapy published after the Cochrane review (2022), and (2) randomized and observational studies for nab-paclitaxel monotherapy, identified through searches of major databases through October 2024. Findings were discussed in 2 inter disciplinary, patient-centered workshops. These workshops integrated trial data with real-world experience and expert judgment to evaluate treatment outcomes, safety, and research gaps.

RESULTS

The review identified no randomized head-to-head trials comparing nab-paclitaxel and sb-paclitaxel in platinum-resistant ovarian cancer. No new randomized trials of sb-paclitaxel were published since the Cochrane review. However, a related trial was identified comparing weekly with 3-weekly sb-paclitaxel. It reported improved survival and reduced hematologic toxicity with weekly dosing, although quality-of-life data were limited. Existing studies on nab-paclitaxel are limited to single-arm and combination trials with heterogeneous populations and treatment regimens. The experts agree that indirect evidence from other tumors (breast/gastric cancer), demonstrates comparable efficacy between the 2 formulations, with nab-paclitaxel showing a favorable safety profile by avoiding Cremophor® EL-related toxicities. The consensus was that nab-paclitaxel's tolerability allows higher dosing and may enhance quality of life. Regulatory and reimbursement challenges persist without approval for nab-paclitaxel monotherapy in platinum-resistant ovarian cancer.

CONCLUSIONS

Despite the absence of direct trials, experts considered evidence sufficient to support nab-paclitaxel as a viable alternative to sb-paclitaxel in platinum-resistant ovarian cancer with comparable efficacy, safety, and fewer hypersensitivity reactions. Additional randomized trials were not deemed necessary.