Modified FOLFIRINOX Regimen With Improved Safety and Maintained Efficacy in Pancreatic Adenocarcinoma

Mahaseth, Hemchandra; Brutcher, Edith; Kauh, John S.; Hawk, Natalyn; Kim, Sungjin; Kooby, David A.; Maithel, Shishir K.; Landry, Jerome C.; El‐Rayes, Bassel F.

doi:10.1097/mpa.0b013e31829e2006

Cited by 176 publications

(188 citation statements)

References 6 publications

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“…(12) Median OS was 21.2 months in the study that did not give a bolus of 5-FU (20) and median OS was 26.0 months in the study with 80% dose intensity. (30) The median number of administered cycles was reported in nine of eleven studies and ranged from 3 to 11 cycles, where each cycle was 2 weeks.…”

Section: Survivalmentioning

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%

“…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%

“…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%

“…(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. The other seven studies determined LAPC based on multidisciplinary review board or retrospective evaluation of pretreatment imaging.…”

Section: Study Characteristicsmentioning

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: Survivalmentioning

confidence: 99%

Section: Survivalmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Studiesmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

See 3 more Smart Citations

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

et al. 2016

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Preoperative Modified FOLFIRINOX Treatment Followed by Capecitabine-Based Chemoradiation for Borderline Resectable Pancreatic Cancer

et al. 2016

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IMPORTANCE Although consensus statements support the preoperative treatment of borderline resectable pancreatic cancer, no prospective, quality-controlled, multicenter studies of this strategy have been conducted. Existing studies are retrospective and confounded by heterogeneity in patients studied, therapeutic algorithms used, and outcomes reported. OBJECTIVE To determine the feasibility of conducting studies of multimodality therapy for borderline resectable pancreatic cancer in the cooperative group setting. DESIGN, SETTING, AND PARTICIPANTS A prospective, multicenter, single-arm trial of a multimodality treatment regimen administered within a study framework using centralized quality control with the cooperation of 14 member institutions of the National Clinical Trials Network. Twenty-nine patients with biopsy-confirmed pancreatic cancer preregistered, and 23 patients with tumors who met centrally reviewed radiographic criteria registered. Twenty-two patients initiated therapy (median age, 64 years [range, 50–76 years]; 55% female). Patients registered between May 29, 2013, and February 7,2014. INTERVENTIONS Patients received modified FOLFIRINOX treatment (85 mg/m2 of oxaliplatin, 180 mg/m2 of irinotecan hydrochloride, 400 mg/m2 of leucovorin calcium, and then 2400 mg/m2 of 5-fluorouracil for 4 cycles) followed by 5.5 weeks of external-beam radiation (50.4 Gy delivered in 28 daily fractions) with capecitabine (825 mg/m2 orally twice daily) prior to pancreatectomy. MAIN OUTCOMES AND MEASURES Feasibility, defined by the accrual rate, the safety of the preoperative regimen, and the pancreatectomy rate. RESULTS The accrual rate of 2.6 patients per month was superior to the anticipated rate. Although 14 of the 22 patients (64% [95% CI, 41%–83%]) had grade 3 or higher adverse events, 15 of the 22 patients (68% [95% CI, 49%–88%]) underwent pancreatectomy. Of these 15 patients, 12 (80%) required vascular resection, 14 (93%) had microscopically negative margins, 5 (33%) had specimens that had less than 5% residual cancer cells, and 2 (13%) had specimens that had pathologic complete responses. The median overall survival of all patients was 21.7 months (95% CI, 15.7 to not reached) from registration. CONCLUSIONS AND RELEVANCE The successful completion of this collaborative study demonstrates the feasibility of conducting quality-controlled trials for this disease stage in the multi-institutional setting. The data generated by this study and the logistical elements that facilitated the trial's completion are currently being used to develop cooperative group trials with the goal of improving outcomes for this subset of patients. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01821612

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Palliative Chemotherapy for Advanced Pancreatic Cancer

2018

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Modified FOLFIRINOX Regimen With Improved Safety and Maintained Efficacy in Pancreatic Adenocarcinoma

Abstract: Modified FOLFIRINOX has an improved safety profile with maintained efficacy in metastatic PC. Modified FOLFIRINOX has promising activity in nonmetastatic disease.

Cited by 176 publications

References 6 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.

Preoperative Modified FOLFIRINOX Treatment Followed by Capecitabine-Based Chemoradiation for Borderline Resectable Pancreatic Cancer

Palliative Chemotherapy for Advanced Pancreatic Cancer

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