ALPACA: Promising results for dose de-escalated regimen of gemcitabine/nab-paclitaxel in metastatic PDAC

The results of the phase 2 ALPACA trial showed that alternating gemcitabine monotherapy with gemcitabine/nab-paclitaxel yields similar efficacy but with improved tolerability, compared with continuous gemcitabine/nab-paclitaxel, in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

Prof. Frank Kullmann (Hospital Weiden, Germany) and colleagues randomised 325 participants with metastatic PDAC 1:1 to continuous therapy with gemcitabine/nab-paclitaxel or to alternating cycles of gemcitabine/nab-paclitaxel and single agent gemcitabine [1]. The primary endpoint of ALPACA (NCT02564146) was overall survival (OS).

The median OS was 10.4 months in the continuous application arm and 10.5 months in the alternating application arm (HR 0.90; 95% CI 0.72–1.13; P=0.56). Similarly, no difference was seen in median progression-free survival between the 2 arms of the study (5.4 vs 5.5 months; P=0.18). However, there was a difference in tolerability: Grade ≥3 peripheral neuropathy (21.3% vs 14.1%) and grade ≥3 infections (20.0% vs 10.6%) occurred more frequently in the continuous application arm than in the alternating application arm.

“After 3 cycles of induction therapy with gemcitabine/nab-paclitaxel, treatment with alternating cycles of gemcitabine/nab-paclitaxel and single agent gemcitabine was associated with comparable survival times as therapy with continuous application of gemcitabine/nab-paclitaxel but with a clinically meaningful improvement in tolerability,” concluded Prof. Kullman.

1. Dorman K, et al. Alternating gemcitabine/nab-paclitaxel and gemcitabine versus continuous gemcitabine/nab-paclitaxel after induction treatment of metastatic pancreatic cancer: the randomized ALPACA trial (AIO-PAK-0114). Abstract 605, ASCO Gastrointestinal Cancers Symposium 2024, 18–20 January, San Francisco, CA, USA.

 

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Posted on 13 February, 202427 March, 2024