Metastatic Pancreatic Adenocarcinoma Clinical Trial
Official title:
Phase II Study to Evaluatate the Efficacy of Gemcitabine Plus Erlotinib for RASH-positive Patients With Metastatic Pancreatic Cancer and Friendly Risk Circumstances
In the current study it is examined whether patients with good risk factors (age <75 years, total serum bilirubin < 1,5xULN, no history of cardiovascular diseases) treated with gemcitabine and erlotinib who developed skin rash of any grade during the first 4 weeks of treatment have a comparable outcome as patients who receive FOLFIRINOX.
The study by Burris et al. 1997 revealed a superiority of gemcitabine vs. 5-FU in terms of
improvement of general condition, pain symptoms and overall survival in patients with locally
advanced or metastatic pancreatic cancer. Subsequently, gemcitabine was established as a
standard treatment for locally advanced and metastatic pancreatic cancer.
In a series of studies gemcitabine was combined with other chemotherapeutic agents or
targeted therapies. For the first time, the PA.03 study showed a significant improvement of
overall survival. Patients who were treated with gemcitabine plus erlotinib had a survival of
6.24 months, compared with 5.91 months for those treated with gemcitabine plus placebo (HR
0.82, 95% CI 0.69-0.99, p=0.038). The one-year-survival rate was 23% for gemcitabine plus
erlotinib vs. 17% for gemcitabine plus placebo.
In a subgroup analysis of the PA.03 study, patients developing a skin rash NCI CTC ≥ grade 2
had an advanced survival (one-year-survival rate 43%) vs. those with grade 1 or 0
(one-year-survival rate 16% and 9%, respectively). Later studies confirmed the correlation
between skin rash and survival.
While patients developing a skin rash of any grade seem to profit most from treatment with
erlotinib, the prognosis for those without rash is rather dismal. In this population,
survival varied between 3.3 and 4.8 months in clinical trials (Verslype et al. 2009, Boeck et
al. 2010, Manzano et al. 2010). In this patients, a modification of the treatment strategy
should be considered. Which kind of treatment might lead to optimal results in these patients
is not yet clear.
In patients with excellent general condition complying with further prerequisits (age <75
years, total serum bilirubin < 1,5xULN, no history of cardiovascular diseases) the French
Prodige study-group could show a statistical superiority for the gemcitabine-free
FOLFIRINOX-scheme in terms of overall survival, progression free survival and response rate
compared to gemcitabine alone. However, this superiority was gained at the expense of
treatment tolerability. During treatment with FOLFIRINOX a grade 3-4 neutropenia was observed
in 5.4% and a grade 3-4 diarrhea in 12.7% of patients (Conroy et al. 2011). For patients who
comply with the above-named criteria FOLFIRINOX is considered an established standard of
care.
If a comparable efficacy of gemcitabine plus erlotinib with the published FOLFIRINOX data can
be seen in the selected population, this would favour, due to the worse tolerability of
FOLFIRINOX, the use of gemcitabine plus erlotinib.
In summary, the following selections are conducted during the study:
1. Selection due to the inclusion criteria for treatment with FOLFIRINOX provided by Conroy
et al.
2. Selection due to the development of a skin rash within four weeks of treatment
3. No signs of clinical tumour progression within the run-in phase within the first four
weeks of treatment
Patients who do not develope a skin rash of any grade should be treated with FOLFIRINOX. The
efficacy of FOLFIRINOX in rash-negative patients has not yet been investigated.
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