Abstract
BackgroundThis study aims to comprehensively summarize the currently available evidences on the efficacy and safety of gemcitabine plus erlotinib for treating advanced pancreatic cancer.Methodology/Principal FindingsPubMed, EMBASE, The Cochrane Library and abstracts of recent major conferences were systematically searched to identify relevant publications. Studies that were conducted in advanced pancreatic cancer patients treated with gemcitabine plus erlotinib (with or without comparison with gemcitabine alone) and reporting objective response rate, disease control rate, progression-free survival, time-to-progression, overall survival, 1-year survival rate and/or adverse events were included. Data on objective response rate, disease control rate, 1-year survival rate and adverse events rate, respectively, were combined mainly by using Meta-Analyst software with a random-effects model. Data on progression-free survival, time-to-progression and overall survival were summarized descriptively. Sixteen studies containing 1,308 advanced pancreatic cancer patients treated with gemcitabine plus erlotinib were included. The reported median progression-free survival (or time-to-progression), median overall survival, 1-year survival rates, objective response rates and disease control rates were 2–9.6 months, 5–12.5 months, 20%–51%, 0%–28.6% and 25.0%–83.3%, respectively. The weighted 1-year survival rate, objective response rate and disease control rate based on studies reporting robust results were 27.9%, 9.1% and 57.0%, respectively. According to the studies with relevant data, the incidences of total and severe adverse events were 96.3% and 62.9%, respectively. The most frequently reported adverse events were leucopenia, rash, diarrhea, vomitting, neutropenia, thrombocytopenia, anaemia, stomatitis, drug-induced liver injury, fatigue and fever. Compared with gemcitabine alone, the progression-free survival and overall survival with gemcitabine plus erlotinib were significantly longer, but there were also more deaths and interstitial lung disease-like syndrome related to this treatment.Conclusions/SignificanceGemcitabine plus erlotinib represent a new option for the treatment of advanced pancreatic cancer, with mild but clinically meaningful additive efficacy compared with gemcitabine alone. Its safety profile is generally acceptable, although careful management is needed for some specific adverse events.
Highlights
As a highly malignant disease, pancreatic cancer is the eighth, fourth and fifth leading cause of cancer-related deaths in the world, the United States and Europe, respectively [1,2,3,4,5]
There is a continuous need for more effective drugs that can be used alone or together with existing chemotherapies to further improve the prognosis of advanced pancreatic cancer (APC)
There existed significant heterogeneity in the overall meta-analyses of objective response rate and disease control rate, results from large prospective studies were consistent, which strengthened the robustness of our conclusion
Summary
As a highly malignant disease, pancreatic cancer is the eighth, fourth and fifth leading cause of cancer-related deaths in the world, the United States and Europe, respectively [1,2,3,4,5]. Gemcitabine (GEM), a nucleoside analog under the trade name ‘‘Gemzar’’, is effective in the treatment of APC in terms of both response rate and median overall survival [8] The benefit it brings is modest, and it does not improve the dismal prognosis much, with a median overall survival of less than 6 months [8]. Various cytotoxic chemotherapy drugs such as 5-fluorouracil, cisplatin, oxaliplatin, irinotecan, pemetrexed and capecitabine, in combination with GEM, have been investigated as alternative options for the treatment of APC They failed to improve the overall survival of patients significantly, the progression-free survival, time-to-progression and/or objective response rate could be increased to varying degrees [9,10,11,12,13,14]. This study aims to comprehensively summarize the currently available evidences on the efficacy and safety of gemcitabine plus erlotinib for treating advanced pancreatic cancer
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