(Pancreatic Cancer) Efficacy of Abraxane + Gemzar?

• September 13, 2019
• Reading time: 2 minutes

At the ESMO World Congress on Gastrointestinal Cancer held in Barcelona, Spain from July 3–6, 2019, Michele Reni presented results from the APACT Phase III clinical trial evaluating adjuvant nab-paclitaxel plus gemcitabine as postoperative chemotherapy in previously untreated metastatic pancreatic cancer patients not eligible for FOLFIRINOX.

The APACT Phase III trial randomized patients to:

• Nab-paclitaxel + gemcitabine arm: nab-paclitaxel 125 mg/m² + gemcitabine 1000 mg/m², 6 cycles of 28 days
• Gemcitabine monotherapy arm: gemcitabine 1000 mg/m², 6 cycles of 28 days

Primary endpoint: disease-free survival (DFS) by independent review committee. Secondary endpoints: OS, safety, quality of life by EORTC QLQ-C30 and QLQ-PAN26.

Background: The 5-year survival rate in metastatic pancreatic cancer is only 20%, with poor prognosis — highlighting the need to improve adjuvant chemotherapy outcomes. In other trials, median OS with nab-paclitaxel + gemcitabine was 8.7 months versus 6.6 months with gemcitabine alone in metastatic pancreatic cancer, demonstrating significant improvement.

Results at median follow-up of 38.5 months:

6-cycle completion rate: 70% (nab-paclitaxel + gemcitabine 66% / gemcitabine monotherapy 71%).

DFS (Primary Endpoint) by Independent Review Committee: Median DFS: nab-paclitaxel + gemcitabine 19.4 months / gemcitabine monotherapy 18.8 months — no significant difference.

DFS by Investigator Assessment: Median DFS: nab-paclitaxel + gemcitabine 16.6 months / gemcitabine monotherapy 13.7 months. The nab-paclitaxel + gemcitabine arm showed an 18% reduction in progression risk (HR 0.82) — a significant improvement.

Overall Survival (Secondary Endpoint): Median OS: nab-paclitaxel + gemcitabine 40.5 months / gemcitabine monotherapy 36.2 months. The nab-paclitaxel + gemcitabine arm showed an 18% reduction in mortality risk (HR 0.82), suggesting a favorable trend, though data are not yet mature.

Safety:

Grade ≥3 adverse events: nab-paclitaxel + gemcitabine 86% / gemcitabine monotherapy 68%. Most common Grade ≥3 hematologic adverse event (neutropenia): 49% vs 43%. Most common Grade ≥3 non-hematologic adverse event (fatigue): 10% vs 3%.

Based on the APACT trial results, Michele Reni concluded that the primary endpoint of DFS by independent review committee was not met; however, nab-paclitaxel plus gemcitabine holds promise as a new treatment option for appropriate patients, pending mature OS data analysis.

Source: An international, randomized, open-label, phase III trial of adjuvant nab-paclitaxel plus gemcitabine vs gemcitabine alone for surgically resected pancreatic adenocarcinoma (APACT): primary analysis and quality of life outcomes (World Congress on Gastrointestinal Cancer 2019 Abstract #O-001)

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