1. Nab-paclitaxel plus gemcitabine improved overall survival, progression-free survival, and response rate compared to gemcitabine alone in advanced pancreatic cancer.
2. Combination therapy was associated with higher rates of reversible myelosuppression and peripheral neuropathy.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Despite recent progress, prognosis for metastatic pancreatic cancer remains poor. This phase 3 trial suggests that addition of nab-paclitaxel to standard gemcitabine therapy results in a clinically active regimen against pancreatic adenocarcinoma. The study authors cautioned that although the combined regimen had higher clinical activity, it was also associated with higher rates of adverse events, particularly neutropenia and peripheral neuropathy. As a result, not all patients may be eligible for this regimen, especially if the patient has underlying myelosuppression or neuropathy from other disease processes.
This large, multicentre trial included patients from North America, Europe and Australia. The combination regimen of nab-paclitaxel plus gemcitabine improved overall survival and response rates. Although combination therapy was associated with higher rates of adverse events, the rate of serious life-threatening events was not increased.
In-Depth [randomized, controlled trial]: This study analyzed the efficacy and safety of adding nab-paclitaxel (albumin-bound paclitaxel) to gemcitabine in treating metastatic pancreatic adenocarcinoma. The study randomly assigned 861 patients in a 1:1 ratio to receive nab-paclitaxel plus gemcitabine or gemcitabine alone. The primary endpoint was overall survival. Secondary endpoints included progression-free survival and overall response rate assessed by independent radiographic review.
The nab-paclitaxel-gemcitabine group had a median survival of 8.5 months (95% CI, 7.89 to 9.53) compared to 6.7 months (95% CI, 6.01 to 7.23; hazard ratio for death, 0.72) in the gemcitabine group. The combined regimen was associated with higher 1-year and 2-year survival rates. Nab-paclitaxel-gemcitabine was also superior to gemcitabine alone in progression-free survival, with a median of 5.5 months (95% CI, 4.5 to 5.9) versus 3.7 months (95% CI, 3.6 to 4.0; hazard ratio for progression or death, 0.69). The rate of progression-free survival at 1 year was 16% in the combined regimen group compared to 9% in the gemcitabine group. The response rate was higher in the nab-paclitaxel-gemcitabine group (23%; 95% CI: 19 to 27) compared to the gemcitabine group (7%; 95% CI: 5 to 10). In safety analyses, the combined regimen had a higher incidence of neutropenia (38% vs. 27%), fatigue (17% vs. 7%), and neuropathy (17% vs. 1%) compared to standard therapy.
By Xiaozhou Liu and Adrienne Cheung
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