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Postoperative treatment of pancreatic cancer with nab-paclitaxel (Abraxane) and gemcitabine improved survival by more than 4 months as compared with gemcitabine alone, long-term follow-up from a randomized trial showed.

Median overall survival (OS) was 41.8 months with the combination versus 37.7 months with single-agent gemcitabine. The combination led to a 7% absolute improvement in 5-year OS.

The survival advantage remained consistent across a prespecified subgroup analysis, reported Margaret A. Tempero, MD, of the University of California San Francisco, during the virtual . OS was a secondary endpoint of the randomized , which did not meet the primary endpoint of disease-free survival (DFS).

"The 5-year outcomes were consistent with those observed in both the primary analysis and the prior post hoc updated analysis for nab-paclitaxel plus gemcitabine versus gemcitabine alone," said Tempero. "Although APACT did not meet its primary endpoint of independently assessed disease-free survival in the primary analysis, these overall survival data suggest improved outcomes with nab-paclitaxel and gemcitabine."

The performance of nab-paclitaxel and gemcitabine compared favorably with previously reported studies of adjuvant therapy for resected pancreatic cancer, said Thomas Seufferlein, MD, of the University of Ulm in Germany. The control arm of single-agent gemcitabine achieved the highest 5-year OS of any prior studies (31% vs 10.4% to 27%).

"The conclusion for me is that the overall survival data suggest improved outcome with gemcitabine plus nab-paclitaxel compared to gemcitabine alone," said Seufferlein. "The median overall survival of 41.8 months was quite impressive. However, subgroups, like those with , were not evaluated. This matters particularly for gemcitabine/nab-paclitaxel combinations and substantially increases the benefit from this treatment if hENT1 expression is high."

"Already in the overall group the combination improves long-term survival, and I think it would be a useful addition to the armamentarium in the fight against pancreatic cancer recurrence, particularly in patients not being able to receive modified because we do increase the number of long-term survivors," he noted.

Looking ahead, he continued, neoadjuvant and perioperative regimens appear to be the future of systemic therapy for resectable pancreatic cancer. Studies in those settings have thus far shown no major differences between mFOLFIRINOX and gemcitabine/nab-paclitaxel.

The phase III, randomized, international APACT trial involved 866 patients with resectable pancreatic cancer. They were randomized to adjuvant treatment with gemcitabine alone or paired with nab-paclitaxel, and the primary endpoint was DFS by independent review. As Tempero previously reported, nab-paclitaxel did not significantly improve DFS in the primary analysis, although a of investigator-assessed DFS favored the combination over single-agent gemcitabine.

The primary analysis did reveal a trend toward better median OS with the combination (40.5 vs 36.2 months, P=0.045), as did a (41.8 vs 37.7 months, P=0.047).

Tempero reported the final OS analysis after a median follow-up of 63.5 months. The analysis yielded median values identical to those of the post hoc update, which translated into a 20% reduction in the survival hazard in favor of the combination (95% CI 0.678-0.947, P=0.0091). Median 5-year OS was 38% with gemcitabine/nab-paclitaxel and 31% with gemcitabine alone. The subgroup analysis produced hazard ratios of 0.73 to 0.94.

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