FOLFIRINOX for Locally Advanced Pancreatic Adenocarcinoma: Results of an AGEO Multicenter Prospective Observational Cohort

Marthey, Lysiane; Cunha, Antonio Sa; Blanc, Jean‐Frédéric; Gauthier, Mélanie; Cueff, A.; François, Ετιεννε; Trouilloud, Isabelle; Malka, David; Bachet, Jean‐Baptiste; Coriat, Romain; Terrebonne, Éric; Fouchardière, Christelle De La; Manfrédi, Sylvain; Solub, David; Lecaille, Cédric; Bidault, Anne Thirot; Carbonnel, Franck; Taı̈eb, Julien

doi:10.1245/s10434-014-3898-9

Cited by 152 publications

(141 citation statements)

References 24 publications

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“…After screening of the abstracts, 30 studies were selected for full text assessment, of which 13 studies fulfilled the inclusion criteria. (12,(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30) The excluded studies are presented in the webappendix, pages 2 and 3. Figure 1 presents the flowchart.…”

Section: Studiesmentioning

confidence: 99%

“…One study was a prospective non-randomized phase II study,(12) one was a prospective cohort study, (26) and the other eleven studies were retrospective cohort studies. (19)(20)(21)(22)(23)(24)(25)(27)(28)(29)(30) Three studies used the NCCN criteria (22,29,30), and three studies used the AHPBA/SSO/SSAT criteria (23,24,28) to define LAPC.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…The other seven studies determined LAPC based on multidisciplinary review board or retrospective evaluation of pretreatment imaging. (12,(19)(20)(21)(25)(26)(27) Only three studies presented a patient cohort including only LAPC patients. (22,26,30) None of the studies described a staging laparoscopy as part of the diagnostic work-up.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…A post hoc analysis including only the five studies with at least 20 LAPC patients found a median OS ranging from 21·1 to 26·0 months. (20,22,26,29,30) The median PFS ranged from 3·0 to 20·4 months across studies with a patient-level median PFS of 15·0 months [95% CI: 13·8 -16·2 months]. Figure 2 presents the survival curves of all individual studies as well as the pooled survival curves for OS and PFS.…”

Section: Survivalmentioning

confidence: 99%

“…(12,(20)(21)(22)(24)(25)(26)(27) Of those 368 patients, 269 (73·1%) received G-CSF. Four studies gave G-CSF as primary prophylaxis.…”

Section: Toxicity Datamentioning

confidence: 99%

See 4 more Smart Citations

A patient-level meta-analysis of FOLFIRINOX for locally advanced pancreatic cancer.

et al. 2016

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Section: Studiesmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Survivalmentioning

confidence: 99%

“…(12,(20)(21)(22)(24)(25)(26)(27) Of those 368 patients, 269 (73·1%) received G-CSF. Four studies gave G-CSF as primary prophylaxis.…”

Section: Toxicity Datamentioning

confidence: 99%

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A patient-level meta-analysis of FOLFIRINOX for locally advanced pancreatic cancer.

et al. 2016

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Evaluation of Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer After Neoadjuvant FOLFIRINOX Treatment

et al. 2020

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Outcomes of Primary Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma

et al. 2019

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IMPORTANCE Chemotherapy is the recommended induction strategy in borderline resectable and locally advanced pancreatic ductal adenocarcinoma. However, the associated results on an intention-to-treat basis are poorly understood. OBJECTIVE To investigate pragmatically the treatment compliance, conversion to surgery, and survival outcomes of patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma undergoing primary chemotherapy. DESIGN, SETTING, AND PARTICIPANTS This prospective study took place in a national referral center for pancreatic diseases in Italy. Consecutive patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma were enrolled at the time of diagnosis (January 2013 through December 2015) and followed up to June 2018. EXPOSURES The chemotherapy regimen, assigned based on multidisciplinary evaluation, was delivered either at a hub center or at spoke centers. By convention, primary chemotherapy was considered completed after 6 months. After restaging, surgical candidates were selected based on radiologic and biochemical response. All surgeries were carried out at the hub center. MAIN OUTCOMES AND MEASURES Rates of receipt and completion of chemotherapy, rates of conversion to surgery, and disease-specific survival. RESULTS Of 680 patients, 267 (39.3%) had borderline resectable and 413 (60.7%) had locally advanced pancreatic ductal adenocarcinoma. Overall, 66 patients (9.7%) were lost to follow-up. The rate of chemotherapy receipt was 92.9% (n = 570). The chemotherapeutic regimens most commonly used included FOLFIRINOX (fluorouracil, leucovorin, oxaliplatin, and irinotecan) (260 [45.6%]) and gemcitabine plus nanoparticle albumin-bound-paclitaxel (123 [21.6%]). Nineteen patients (3.3%) receiving chemotherapy died within 6 months, mainly for disease progression. The treatment completion rate was 71.6% (408 of 570). The overall rate of resection was 15.1% (93 of 614) (borderline resectable, 60 of 249 [24.1%]; locally advanced, 33 of 365 [9%]; resection:exploration ratio, 63.3%). Independent predictors of resection were age, borderline resectable disease, chemotherapy completion, radiologic response, and biochemical response. The median survival for the whole cohort was 12.8 (95% CI, 11.7-13.9) months. Factors independently associated with survival were completion of chemotherapy, receipt of complementary radiation therapy, and resection. In patients who underwent resection, the median survival was 35.4 (95% CI, 27.0-43.7) months for initially borderline resectable and 41.8 (95% CI, 27.5-56.1) months for initially locally advanced disease. No pretreatment and posttreatment factors were associated with survival after pancreatectomy. CONCLUSIONS AND RELEVANCE This pragmatic observational cohort study with an intention-to-treat design provides real-world evidence of outcomes associated with the most current primary chemotherapy regimens used for borderline resectable and locally advanced pancreatic ductal adenocarcinoma.

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FOLFIRINOX for Locally Advanced Pancreatic Adenocarcinoma: Results of an AGEO Multicenter Prospective Observational Cohort

Abstract: First-line FOLFIRINOX for LAPA seems to be effective and have a manageable toxicity profile. These promising results will have to be confirmed in a phase III randomized trial.

Cited by 152 publications

References 24 publications

A patient-level meta-analysis of FOLFIRINOX for locally advanced pancreatic cancer.

A patient-level meta-analysis of FOLFIRINOX for locally advanced pancreatic cancer.

Evaluation of Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer After Neoadjuvant FOLFIRINOX Treatment

Outcomes of Primary Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma

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