A retrospective study of neoadjuvant FOLFIRINOX in unresectable or borderline-resectable locally advanced pancreatic adenocarcinoma

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Abstract

Background

5-fluorouracil, leucovorin, irinotecan and oxaliplatin (FOLFIRINOX) is superior to gemcitabine in patients with metastatic pancreatic cancer who have a good performance status. We investigated this combination as neoadjuvant therapy for locally advanced pancreatic cancer (LAPC).

Methods

In this retrospective series, we included patients with unresectable LAPC who received neoadjuvant FOLFIRINOX with growth factor support. The primary analysis endpoint was R0 resection rate.

Results

Eighteen treatment-naïve patients with unresectable or borderline resectable LAPC were treated with neoadjuvant FOLFIRINOX. The median age was 57.5 years and all had ECOG PS of 0 or 1. Eleven (61 %) had tumors in the head of the pancreas and 9 (50 %) had biliary stents placed prior to chemotherapy. A total of 146 cycles were administered with a median of 8 cycles (range 3-17) per patient. At maximum response or tolerability, 7 (39 %) were converted to resectability by radiological criteria; 5 had R0 resections, 1 had an R1 resection, and 1 had unresectable disease. Among the 11 patients who remained unresectable after FOLFIRINOX, 3 went on to have R0 resections after combined chemoradiotherapy, giving an overall R0 resection rate of 44 % (95 % CI 22–69 %). After a median follow-up of 13.4 months, the 1-year progression-free survival was 83 % (95 % CI 59-96 %) and the 1-year overall survival was 100 % (95 % CI 85-100 %). Grade 3/4 chemotherapy-related toxicities were neutropenia (22 %), neutropenic fever (17 %), thrombocytopenia (11 %), fatigue (11 %), and diarrhea (11 %). Common grade 1/2 toxicities were neutropenia (33 %), anemia (72 %), thrombocytopenia (44 %), fatigue (78 %), nausea (50 %), diarrhea (33 %) and neuropathy (33 %).

Conclusions

FOLFIRINOX followed by chemoradiotherapy is feasible as neoadjuvant therapy in patients with unresectable LAPC. The R0 resection rate of 44 % in this population is promising. Further studies are warranted.

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Most cited references 6

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Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial.

Patrick Loehrer, Yang Yu Feng, Higinia R. Cardenes … (2011)

The purpose of this trial was to evaluate the role of radiation therapy with concurrent gemcitabine (GEM) compared with GEM alone in patients with localized unresectable pancreatic cancer. Patients with localized unresectable adenocarcinoma of the pancreas were randomly assigned to receive GEM alone (at 1,000 mg/m(2)/wk for weeks 1 to 6, followed by 1 week rest, then for 3 of 4 weeks) or GEM (600 mg/m(2)/wk for weeks 1 to 5, then 4 weeks later 1,000 mg/m(2) for 3 of 4 weeks) plus radiotherapy (starting on day 1, 1.8 Gy/Fx for total of 50.4 Gy). Measurement of quality of life using the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire was also performed. Of 74 patients entered on trial and randomly assigned to receive GEM alone (arm A; n = 37) or GEM plus radiation (arm B; n = 34), patients in arm B had greater incidence of grades 4 and 5 toxicities (41% v 9%), but grades 3 and 4 toxicities combined were similar (77% in A v 79% in B). No statistical differences were seen in quality of life measurements at 6, 15 to 16, and 36 weeks. The primary end point was survival, which was 9.2 months (95% CI, 7.9 to 11.4 months) and 11.1 months (95% CI, 7.6 to 15.5 months) for arms A and B, respectively (one-sided P = .017 by stratified log-rank test). This trial demonstrates improved overall survival with the addition of radiation therapy to GEM in patients with localized unresectable pancreatic cancer, with acceptable toxicity.

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Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies.

E Alexandre, Pascal Hammel, Frédéric Selle … (2007)

The management of locally advanced (LA) pancreatic cancer patients remains controversial. To select patients who could benefit from chemoradiotherapy (CRT), the therapeutic strategy used by the Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR) consisted of initial chemotherapy (CT) for at least 3 months. The decision to administer CRT or continue CT in nonprogressive patients was the investigator's choice. Retrospective analysis of outcome in 181 patients with LA pancreatic cancer (76 women and 105 men; mean age, 61 years; range, 37 to 85 years) enrolled onto prospective phase II and III GERCOR studies was performed to compare the survival of patients who received CRT with that of patients who continued CT alone. Median progression-free survival (PFS) and overall survival (OS) times for the 181 patients were 6.3 and 11.4 months, respectively. Fifty-three patients (29.3%) had metastatic disease after 3 months of CT and were not eligible for CRT. Among the 128 remaining patients (70.3%) who had no disease progression and who were, therefore, eligible for CRT, 72 (56%) received CRT (group A), whereas 56 (44%) continued with CT (group B). The two groups were balanced for initial characteristics (performance status, sex, age, and type of CT), as well as for induction CT results. In groups A and B, the median PFS times were 10.8 and 7.4 months, respectively (P = .005), and the median OS times were 15.0 and 11.7 months, respectively (P = .0009). These results suggest that, after control of disease by initial CT, CRT could significantly improve survival in patients with LA pancreatic cancer compared with CT alone. A prospective phase III study is ongoing to evaluate this strategy.

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A phase II study of gemcitabine in combination with radiation therapy in patients with localized, unresectable, pancreatic cancer: a Hoosier Oncology Group study.

Higinia R. Cardenes, Annette Moore, Cynthia S Johnson … (2011)

A Phase II study was conducted at Indiana University to evaluate the safety and efficacy of combined weekly Gemcitabine (GEM) with external beam radiotherapy (RT) in unresectable, locally advanced pancreatic cancer (LAPC). Eligible patients had biopsy-proven LAPC without evidence of metastatic disease. In part A of the treatment plan, patients received GEM 600 mg/m(2) IV weekly, with concurrent RT (50.4 Gy in 28 fractions, 1.8 Gy/d, 5 days per week). Part B of the treatment plan began approximately 4 weeks after completing part A: patients without disease progression received weekly GEM 1000 mg/m(2) on days 1, 8, and 15 of a 28-day cycle for 6 cycles or until disease progression. From April 2001 to June 2003, of 28 patients evaluated, 24 (86%) completed part A. About 22 patients had grade 3 toxicities, primarily hematologic (43%) and gastrointestinal (36%). Three patients (11%) had grade 4 toxicities (one each for hyperbilirubinemia, infection, and dyspnea). The median follow-up was 10 months (1-63 months) for all enrolled patients. Six patients (21%) had a radiologic partial response, 16 (57%) had stable disease, 5 (18%) had progressive disease, and 1 patient (4%) had an unevaluable response at last follow-up. Four patients (14%) underwent surgical resection (2 with R0 resection). Median time to progression was 6 months (0-36 months). Median survival time was 10.3 months (95% confidence interval, 7.9-14.6 months). The 1- and 2-year actuarial survival rates were 30% and 11%. At last analysis, all but 2 patients died. The activity and toxicity profile of combination GEM and RT indicates that this can be safely administered for patients with LAPC.

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Author and article information

Journal

Journal ID (nlm-ta): BMC Cancer

Journal ID (iso-abbrev): BMC Cancer

Title: BMC Cancer

Publisher: BioMed Central

ISSN (Electronic): 1471-2407

Publication date Collection: 2012

Publication date (Electronic): 29 May 2012

Volume: 12

Page: 199

Affiliations

[1 ]Department of Medicine, Division of Hematology/Oncology, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL, USA

[2 ]Institution: Department of Medicine, Division of Hematology/Oncology, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL, USA

[3 ]Advanced Oncology Center of Hospital São José, São Paulo, Brasil

[4 ]Department of Medicine, Division of Hematology/Oncology, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL, USA

[5 ]Department of Medicine, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL, USA

[6 ]Department of Medicine, Division of Hematology/Oncology, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL, USA

[7 ]Department of Radiology, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL, USA

[8 ]Department of Medicine, Division of Gastroenterology, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL, USA

[9 ]Department of Radiation Oncology, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL, USA

[10 ]Department of Medicine, Division of Hematology/Oncology, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL, USA

[11 ]Department of Surgery, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL, USA

[12 ]Department of Medicine, Division of Hematology/Oncology, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL, USA

Article

Publisher ID: 1471-2407-12-199

DOI: 10.1186/1471-2407-12-199

PMC ID: 3404979

PubMed ID: 22642850

SO-VID: 425ceb48-90f4-4f8b-a51c-bc5a1a4c1129

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

A retrospective study of neoadjuvant FOLFIRINOX in unresectable or borderline-resectable locally advanced pancreatic adenocarcinoma

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Abstract

Background

Methods

Results

Conclusions

Related collections

Karger: Oncology

Most cited references 6

Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial.

Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies.

A phase II study of gemcitabine in combination with radiation therapy in patients with localized, unresectable, pancreatic cancer: a Hoosier Oncology Group study.

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