ALPACA Trial: Alternating Chemotherapy Strategy Improves Tolerability in Metastatic Pancreatic Cancer
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ALPACA Trial: Alternating Chemotherapy Strategy Improves Tolerability in Metastatic Pancreatic Cancer
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ALPACA Trial: Alternating Chemotherapy Strategy Improves Tolerability in Metastatic Pancreatic Cancer
Pancreatic cancer, often referred to as the “king of cancers,” is one of the deadliest malignancies, expected to become the second leading cause of cancer-related deaths by 2030.
Most patients with pancreatic cancer are diagnosed at an advanced stage when the disease has already metastasized, with systemic chemotherapy being the standard treatment.
A common first-line therapy involves combining gemcitabine with nab-paclitaxel, though this combination has a higher incidence of adverse events compared to gemcitabine monotherapy.
To prioritize patient safety, clinicians may opt to reduce the dosage in combination therapy, but a standardized dose-reduction strategy has yet to be established.
Recently, the results of the ALPACA Phase 2 trial were published in The Lancet Gastroenterology & Hepatology.
The study revealed that for patients with metastatic pancreatic cancer who underwent three cycles of standard-dose gemcitabine combined with nab-paclitaxel, an alternate strategy using single-agent gemcitabine or nab-paclitaxel led to similar overall survival rates but with improved tolerability.
The study suggests that for patients with stable disease after three cycles of standard treatment, switching to an alternate treatment strategy may be considered.
Study Details:
ALPACA is a randomized, open-label, Phase 2 clinical trial conducted across 29 medical centers in Germany. The study included 325 patients with metastatic pancreatic ductal adenocarcinoma, all of whom met the following criteria: 1) age ≥ 18 years; 2) histologically or pathologically confirmed metastatic pancreatic ductal adenocarcinoma; 3) no prior relevant treatments.
All patients received three cycles of induction therapy with standard doses of gemcitabine combined with nab-paclitaxel prior to randomization. The specific regimen consisted of 28-day cycles, with gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) administered on days 1, 8, and 15 of each cycle. Following the induction phase, 167 patients were randomized in a 1:1 ratio into two groups: the continuation of standard therapy group (79 patients) and the alternate therapy group (88 patients), with treatments as follows:
- Continuation of Standard Therapy Group: Continued with the same regimen.
- Alternate Therapy Group: Treated with either gemcitabine or nab-paclitaxel as a single agent.
In cases of toxicity, dose adjustments were allowed in both groups, with the first reduction lowering gemcitabine to 800 mg/m² and nab-paclitaxel to 100 mg/m², and the second reduction lowering gemcitabine to 600 mg/m² and nab-paclitaxel to 75 mg/m². Further dose reductions led to study discontinuation.
Key Findings:
The median overall survival was similar between the two groups, with 10.4 months for the continuation group and 10.5 months for the alternate therapy group (HR = 0.90, 80% CI: 0.72–1.13, P = 0.56). Secondary outcomes, including progression-free survival, objective response rate, and disease control rate, were also comparable.
Regarding safety, common adverse events such as peripheral neuropathy (62% vs. 74%) and fatigue (52% vs. 54%) were observed less frequently in the alternate therapy group compared to the continuation group. Moreover, serious adverse events occurred in 33% of patients in the alternate therapy group and 50% in the continuation group. Notably, two patient deaths were reported, both in the continuation group. The incidence of grade 3 or higher adverse events was lower in the alternate therapy group.
In conclusion, the ALPACA study demonstrates that after three cycles of induction therapy, an alternate treatment strategy with single-agent gemcitabine or nab-paclitaxel for metastatic pancreatic cancer results in similar overall survival but with better tolerability. This study establishes a new treatment approach that aims to reduce drug toxicity while maintaining efficacy and preserving the quality of life for patients.
ALPACA Trial: Alternating Chemotherapy Strategy Improves Tolerability in Metastatic Pancreatic Cancer
References:
(source:internet, reference only)
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