Novel Use of FOLFIRINOX for Pancreatic Cancer

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In May 2011, Conroy and colleagues from the Eastern Cooperative Oncology Group published in the New England Journal of Medicine a multicenter randomized trial titled, FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer. In this study, they reported improvement in overall survival and progression-free survival when comparing FOLFIRINOX to gemcitabine in patients with metastatic pancreatic cancer (Stage IV). FOLFIRINOX is a combination of chemotherapy agents including: oxaliplatin, leucovorin, irinotecan, and fluorouracil.
The most interesting finding in this study was a significant improvement in response rate with FOLFIRINOX. In the phase 3 portion of the trial they reported:

The objective response rate was 31.6% (95% confidence interval [CI], 24.7 to 39.1) in the FOLFIRINOX group and 9.4% (95% CI, 5.4 to 14.7) in the gemcitabine group (P<0.001).

Basically, 3 out of 10 patients treated with FOLIRINOX had a response to chemotherapy versus 1 out of 10 patients treated with gemcitabine. This improvement in response rate has significant implications for locally-advanced pancreatic cancer. FOLFIRINOX may help control the disease and with adequate response enable pancreatic resection. Currently, it is unknown if FOLFIRINOX is an option for neoadjuvant (pre-surgery) chemotherapy.
Unfortunately, the impressive response rate associated with FOLRIRINOX comes with significant chemotherapy related side effects. Patients receiving FOLFIRINOX had significantly more hematologic (blood count) problems, specifically neutropenia (low white blood cell count). Other side effects included hair loss, diarrhea, and sensory neuropathy.
Today, I searched clinicaltrials.gov and identified the following 12 studies focused on the use of FOLFIRINOX in the treatment of pancreatic cancer. Although many of these trials are in the early stages and, in fact, not recruiting, it is exciting to see a steady advancement in the treatment options for pancreatic cancer.

Rank	Status	Study
1	Recruiting	Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer Conditions: Metastatic Pancreatic Cancer; Pancreatic Cancer Intervention: Drug: Folfirinox
2	Not yet recruiting	Phase I Study of Stereotactic Body Radiation Therapy and FOLFIRINOX in the Neoadjuvant Therapy of Pancreatic Cancer Conditions: Cancer of Pancreas; Cancer of the Pancreas; Neoplasms, Pancreatic; Pancreas Cancer; Pancreas Neoplasms Interventions: Drug: Folfirinox; Radiation: Stereotactic Body Radiotherapy (SBRT)
3	Recruiting	FOLFIRINOX Plus IPI-926 for Advanced Pancreatic Adenocarcinoma Conditions: Pancreatic Cancer; Adenocarcinoma; Pancreatic Neoplasms Intervention: Drug: FOLFIRINOX, IPI-926
4	Recruiting	Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer Condition: Stage IV Pancreatic Cancer Interventions: Drug: Gemcitabine; Drug: nab-paclitaxel; Drug: FOLFIRINOX; Genetic: Immunohistochemistry (IHC) Analysis; Drug: Metformin
5	Recruiting	LDE225 With Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan for Untreated Advanced Pancreatic Cancer Condition: Pancreatic Cancer Intervention: Drug: LDE225; Fluorouracil; Leucovorin; Oxaliplatin; Irinotecan
6	Not yet recruiting	Preoperative Folfirinox, Radiation Therapy for Resectable Adenocarcinoma of the Pancreas Condition: Pancreatic Cancer Interventions: Drug: Oxaliplatin; Drug: Irinotecan; Drug: 5-FU; Drug: Gemcitabine; Radiation: Radiation Therapy
7	Recruiting	FOLFIRINOX in Patients With Inoperable Pancreatic Cancer Condition: Adenocarcinoma of Pancreas Intervention: Drug: Irinotecan, Oxaliplatin, Leucovorin, 5-FU
8	Not yet recruiting	Chemotherapy for Patients With Locally Advanced Pancreatic Cancer (LAPC) With Additional Chemo-radiotherapy (CRT) for Patients With Borderline Resectable Tumours Condition: Pancreatic Cancer Intervention: Drug: Oxaliplatin, irinotecan, 5-FU & leucovorin
9	Recruiting	FOLFIRINOX Plus PF-04136309 in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma Condition: Pancreatic Neoplasms Interventions: Drug: oxaliplatin; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: fluorouracil; Other: laboratory biomarker analysis; Other: flow cytometry; Other: immunohistochemistry staining method; Other: pharmacological study; Drug: PF-04136309
10	Not yet recruiting	Combination Chemotherapy With or Without Ganitumab in Treating Patients With Previously Untreated Metastatic Pancreatic Cancer Condition: Pancreatic Cancer Interventions: Biological: ganitumab; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: oxaliplatin; Other: placebo; Other: questionnaire administration
11	Recruiting	Chemotherapy Selection Based on Therapeutic Targets for Advanced Pancreatic Cancer Condition: Carcinoma, Pancreatic Ductal Interventions: Drug: Targeted Therapy Tailored Treatment; Drug: Standard Chemotherapy
12	Recruiting	Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets Condition: Advanced Pancreatic Carcinoma Interventions: Drug: gemcitabine, or gemcitabine and capecitabine, or gemcitabine and erlotinib, or FOLFIRINOX, or FOLFOX, or FOLFIRI.; Drug: Gemcitabine, Gemcitabine-Capecitabine, Gemcitabine-Erlotinib, FOLFOXIRI, FOLFOX, FOLFIRI