HCG experience of modified FOLFIRINOX regimen in advanced pancreatic cancer

Introduction: FOLFIRINOX (FFX) regimen has changed the clinical practice in advanced pancreatic cancer. Improvement of Median overall survival (OS), progression-free survival (PFS), and objective responses were all superior with FFX when compared to Gemcitabine based combinations. Despite initial concerns over toxicity, many questions have arisen including the management of toxicities, the impact of frequent modifications, the optimal number of cycles, integration with other regimens and modalities in various geographical areas. There are hardly any publications from India regarding first line chemotherapy with FOLFIRINOX regimen in advanced pancreatic cancer. Hence this study was conducted to evaluate the efficacy and safety of a modified FOLFIRINOX regimen in advanced carcinoma of pancreas. Methods: We analyzed the patients with advanced pancreatic cancer who were treated with modified FOLFIRINOX regimen from Jan2014 to May 2016 in our center. The schedule of modified FOLFIRINOX was Oxaliplatin 85 mg/m2, Irinotecan 150 mg/m2, Leucovorin 400 mg/m2, and 5 fluorouracil 2000 mg/m2given as a 46-hour continuous infusion, every 2 weeks with PEG GCSF 6mg support. The efficacy and toxicity of above regimen were analyzed. Results: 32 untreated patients with advanced Pancreas and good ECOG Performance status who completed modified FOLFIRINOX regimen were enrolled. The median age was 53 (range 31 to 63 years). Male: female ratio was 1.9:1. The tumor marker CA19-9 was elevated at baseline in 68.75% of patients. The results of this regimen were as follows: Efficacy Modified Folfirinox regimen inEfficacy Locally advanced (n 10) vs Metastatic (n 22) were shown in the following order: Complete response (10%vs 0), Partial response (40% vs36.3%), Stable disease(30% vs31.8%), Progressive disease(20% vs 27.3%), Median PFS in months (6.5 vs4.5), Median OS in months(13m vs10m) and 1 year survival (50%vs 41%) respectively. Tumor marker response (CA 19-9) >50% reduction from baseline at 3months was seen 54.5% of patients. Hematological toxicity: Anemia (37.5%), Neutropenia (59.3%), Febrile neutropenia (15.6%), Thrombocytopenia (31.2%). Nonhematological toxicity: Nausea/vomiting 46.8%, Diarrhea 56.25%, Peripheral neuropathy (28.1%), Alopecia 90.6%, Mucositis 46.8%, Fatigue 62.5%, Median number of cycles completed by patients were 3.5 and dose reductions was required in 21.8%. Conclusion: A modified FOLFIRINOX is an effective, feasible and tolerable regimen with encouraging survival in advanced pancreatic cancer with good performance status. Further studies are required to compare with Gemcitabine based combinations.