A Phase III Trial Comparing Folfirinox Versus Gemcitabine for Metastatic Pancreatic Cancer

Singhal, Mukesh Kumar; Kapoor, Anu; Bagri, Puneet Kumar; Narayan, Samir; Singh, Deepak; Nirban, R.K.; Singh, Gagandeep; Maharia, S.; Kumari, Poonam; Jakhar, Shankar Lal; Beniwal, Surender; Sharma, Neeraj; Harsh, Kamlesh Kumar; Kumar, H.S.; Sharma, Anupama; Bardia, Megh Raj

doi:10.1093/annonc/mdu334.3

Cited by 22 publications

(16 citation statements)

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“…While, general pain, fatigue, weight loss, and dissatisfaction with their appearance were more prevalent in patients of Gem group, due to its severe toxicity profile. These results are also supported by other studies on similar program of therapy, [15,[25][26][27][28] for the efficacy Fol therapy in improving the overall QOL and psychological distress.…”

Section: Discussionsupporting

confidence: 82%

“…Also in accordance with other studies. [15,[25][26][27][28][29]31,32] Otherwise, of our findings, there are other studies [24,30] who have concluded that Fol significantly reduces QOL impairment in patients with metastatic pancreatic cancer, because of the increased toxicity of Fol.…”

Section: Discussionmentioning

confidence: 59%

“…[23] Singhal et al concluded that median overall survival was 10.8 months in the Fol group as compared with 7.4 months in the Gem group (P < 0.001). [26] The findings in this study show that the clinical effect of Fol compared with Gem may improve the QOL of patients with pancreatic cancer. This is also in accordance with other studies, [15,[25][26][27][28][29] which show beneficial effects of Fol versus Gem in overall QOL and psychological distress.…”

Section: Discussionmentioning

confidence: 66%

“…Even though there are differences in the above studies, [19][20][21][22][23][24][25][26][27][28][29][30][31][32] most of them conclude that Fol compared to Gem improves the overall QOL.…”

Section: Discussionmentioning

confidence: 99%

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Murtezani

2017

AJP

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Objective: The aim of this study is to assess the clinical effectiveness of folfirinox (Fol) compared with gemcitabine (Gem) on quality of life (QOL) that predicts survival in patients with Stage IV of pancreatic cancer. Materials and Methods: A total of 34 patients suffering from metastatic pancreatic adenocarcinoma were randomized into two groups, the Gem group (n = 17) and Fol group (n = 17). The first group was treated with Gem in a dose of 1000 mg/m 2 once weekly for 7 weeks, followed by 1 week of rest during the first cycle and subsequently 1000 mg/m 2 once weekly for 3 weeks followed by 1 week of rest. The second group was treated with Fol (oxaliplatin 85 mg/m 2 , irinotecan 180 mg/m 2 , leucovorin 400 mg/m 2 , and fluorouracil 400 mg/m 2 bolus, followed by 2400 mg/m 2 on 46-h continuous infusion) once every 2 weeks. The QOL was measured by the functional assessment of cancer therapy (FACT)-hepatobiliary cancer scale. Results: Thirty-four of randomized patients completed the study, and there were no significant differences among the two groups at baseline demographic characteristics. Overall QOL, P value shows the significance of correlation for components of FACT in all scales between Fol-group and Gem-group. Median survival time for the entire cohort was 14.1 months for Fol-group compared to Gem-group which was 9.2 months. P value shows the significance of the correlation between survival rate and stage of tumor, in Fol-group versus Gem-group (P = 0.0001). Conclusions: We conclude that Fol significantly improves QOL, physical functioning and survival time in advanced pancreatic cancer patients in comparison with Gem.

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Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 59%

Section: Discussionmentioning

confidence: 66%

“…Even though there are differences in the above studies, [19][20][21][22][23][24][25][26][27][28][29][30][31][32] most of them conclude that Fol compared to Gem improves the overall QOL.…”

Section: Discussionmentioning

confidence: 99%

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Murtezani

2017

AJP

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“…9 The main results from a confirmatory phase III trial performed in India with the same study design are available as an abstract. 10 A total of 310 patients with an ECOG PS score of 0 or 1 were randomized to receive either FOLFIRINOX or gemcitabine using the Burris schedule. They reported a median OS of 10.8 months in the FOLFIRINOX group compared with 7.4 months in the gemcitabine group (HR, 0.48; p < 0.001).…”

Section: Introduction: Actual Situationmentioning

confidence: 99%

Current status on the place of FOLFIRINOX in metastatic pancreatic cancer and future directions

Lambert

Gavoille

Conroy

2017

Therap Adv Gastroenterol

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Pancreatic cancer (PC) incidence rates are rapidly increasing in developed countries, with half the patients being metastatic at diagnosis. For decades, fluorouracil, then gemcitabine regimens were the preferred palliative first-line options for fit patients with metastatic PC. FOLFIRINOX (a combination of bolus and infusional fluorouracil, leucovorin, irinotecan and oxaliplatin) was introduced to clinical practice in 2010 due to the results of the phase II/III trial (PRODIGE 4/ACCORD 11) comparing FOLFIRINOX with singleagent gemcitabine as first-line treatment for patients with MPC. Median overall survival, progression-free survival, and objective response rate were superior with FOLFIRINOX over gemcitabine and there was prolonged time to definitive deterioration in quality of life. Although FOLFIRINOX was also associated with increased toxicity, mainly febrile neutropenia and diarrhea, there has been rapid uptake of this regimen. This review closely examines optimal management and prevention of toxicities, international recommendations for firstline treatment, and use of modified FOLFIRINOX protocols. In this review, we also look at the potential benefit of FOLFIRINOX in selected groups of patients: second-line therapy, adjuvant chemotherapy, induction therapy in patients with borderline resectable and locally advanced PC. Robust validation of the FOLFIRINOX regimen in these settings requires confirmation in further randomized trials.

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Chemotherapy and radiotherapy for advanced pancreatic cancer

Chin

Nagrial

Sjoquist

et al. 2018

Cochrane Database of Systematic Reviews

102

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Combination chemotherapy has recently overtaken the long-standing gemcitabine as the standard of care. FOLFIRINOX and gemcitabine plus nab-paclitaxel are highly efficacious, but our analysis shows that other combination regimens also offer a benefit. Selection of the most appropriate chemotherapy for individual patients still remains difficult, with clinicopathological stratification remaining elusive. Biomarker development is essential to help rationalise treatment selection for patients.

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A Phase III Trial Comparing Folfirinox Versus Gemcitabine for Metastatic Pancreatic Cancer

Cited by 22 publications

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Current status on the place of FOLFIRINOX in metastatic pancreatic cancer and future directions

Chemotherapy and radiotherapy for advanced pancreatic cancer

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