Limited Survival Benefit of Short-Course Neoadjuvant Gemcitabine Plus Nab-Paclitaxel for Resectable Pancreatic Cancer: A Prospective Phase II Study With a Propensity Score-Matched Analysis.

INTRODUCTION

The optimal duration and clinical benefit of neoadjuvant gemcitabine plus nab-paclitaxel (GnP) for resectable pancreatic cancer (RPC) remain uncertain.

METHODS

We conducted a prospective single-arm phase II study evaluating neoadjuvant GnP in RPC. The primary end point was 2-y relapse-free survival (RFS). Secondary end points included R0 resection rate, safety, overall survival, and the impact of treatment duration on survival outcomes. Survival outcomes were compared with those of a propensity score-matched historical cohort that underwent upfront surgery.

RESULTS

Twenty-eight patients were analyzed. The objective response rate was 17.9%, and curative resection was achieved in 85.7%. Grade ≥3 neutropenia occurred in 64.3% without febrile neutropenia, indicating manageable toxicity. The median RFS was 15.7 mo (95% confidence interval, 12.3-19.2), with a 2-y RFS rate of 29.9%, and the median overall survival was 32.9 mo (95% confidence interval, 30.0-38.8). Propensity score-matched analysis demonstrated survival comparable to historical controls treated with upfront surgery. However, patients who completed four cycles of GnP showed a trend toward longer survival than those receiving two cycles.

CONCLUSIONS

Neoadjuvant GnP provides acceptable safety and tumor control but limited survival benefit in RPC. Prolonged preoperative GnP may improve outcomes, suggesting that treatment duration may be a key determinant of efficacy.