Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer.

Stein, Stacey; James, Edward Samuel; Cong, Xiangyu; Deng, Yanhong; Salem, Ronald R.; Cha, Charles; Chang, Bing; Hochster, Howard S.; Doddamane, Indukala; Boustani, Annmarie; Patel, Vatsal; Kortmansky, Jeremy; Li, Jia; Staugaard, Carol; Lacy, Jill

doi:10.1200/jco.2016.34.4_suppl.395

Cited by 5 publications

(7 citation statements)

References 12 publications

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“…First, the current study included a relatively high population of patients with locally advanced pancreatic cancer, which might lead to the favorable OS when we compared all cohorts with previous studies using FOLFIRINOX. However, the median survival time of patients with metastatic PDAC (10.1 months) in this study was comparable to previous studies (Figure ). Therefore, we thought the SOXIRI regimen was not inferior to the original regimen.…”

supporting

confidence: 90%

“…Because of the high incidence of severe neutropenia and febrile neutropenia, the relative dose intensity of bolus 5‐fluorouracil (5‐FU) was only 15.9% . These significant toxicities in Japan, as well as in Western countries, resulted in modification of the FOLFIRINOX regimen; several studies using reduced irinotecan or omitting the bolus fluorouracil have been reported .…”

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confidence: 99%

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Phase II Study of the Triple Combination Chemotherapy of SOXIRI (S-1/Oxaliplatin/Irinotecan) in Patients with Unresectable Pancreatic Ductal Adenocarcinoma

et al. 2019

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Lessons Learned. The triple combination chemotherapy of SOXIRI (S‐1/oxaliplatin/irinotecan) in patients with unresectable pancreatic ductal adenocarcinoma was an effective treatment that appeared to be better tolerated than the widely used FOLFIRINOX regimen. SOXIRI regimen may provide an alternative approach for advanced pancreatic cancer. Background. In our previous phase I study, we determined the recommended dose of a biweekly S‐1, oxaliplatin, and irinotecan (SOXIRI) regimen in patients with unresectable pancreatic ductal adenocarcinoma (PDAC). This phase II study was conducted to assess the safety and clinical efficacy in patients with unresectable PDAC. Methods. Patients with previously untreated metastatic and locally advanced PDAC were enrolled. The primary endpoint was response rate (RR). Secondary endpoints were adverse events (AEs), progression‐free survival (PFS), and overall survival (OS). Patients received 80 mg/m 2 of S‐1 twice a day for 2 weeks in alternate‐day administration, 150 mg/m 2 of irinotecan on day 1, and 85 mg/m 2 of oxaliplatin on day 1 of a 2‐week cycle. Results. Thirty‐five enrolled patients received a median of six (range: 2–15) treatment cycles. The RR was 22.8% (95% confidence interval [CI]: 10.4–40.1); median OS, 17.7 months (95% CI: 9.8–22.0); and median PFS, 7.4 months (95% CI: 4.2–8.4). Furthermore, the median OS in patients with distant metastasis was 10.1 months, whereas that in patients with locally advanced PDAC was 22.6 months. Major grade 3 or 4 toxicity included neutropenia (54%), anemia (17%), febrile neutropenia (11%), anorexia (9%), diarrhea (9%), and nausea (9%). There were no treatment‐related deaths. Conclusion. SOXIRI is considered a promising and well‐tolerated regimen in patients with unresectable PDAC.

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confidence: 90%

mentioning

confidence: 99%

Phase II Study of the Triple Combination Chemotherapy of SOXIRI (S-1/Oxaliplatin/Irinotecan) in Patients with Unresectable Pancreatic Ductal Adenocarcinoma

et al. 2019

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“…Since the randomized controlled trial conducted by Conroy et al showed a survival benefit for FOLFIRINOX vs gemcitabine for metastatic pancreatic cancer, many case series were published that evaluated the survival effect of FOLFIRINOX for patients with LAPC . However, no randomized controlled trials have been published that confirm the survival benefit of FOLFIRINOX in LAPC patients.…”

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confidence: 99%

FOLFIRINOX and radiotherapy for locally advanced pancreatic cancer: A cohort study

Suker

Nuyttens

Koerkamp

et al. 2018

Journal of Surgical Oncology

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IntroductionOne‐third of the patients with pancreatic cancer present with locally advanced unresectable pancreatic cancer (LAPC). Our aim was to determine survival outcomes and toxicity after FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin) followed by radiotherapy (RT) in biopsy‐proven patients with LAPC.MethodsWe analysed a cohort of biopsy‐proven patients with LAPC, who were eligible for induction FOLFIRINOX (eight cycles) and subsequent RT (30 fractions, 60 Gy). Eligible patients underwent a staging laparoscopy to detect occult metastasis before the treatment. The primary outcome was overall survival (OS), and secondary outcomes were progression‐free survival (PFS), treatment‐related toxicity, and resection rate.ResultsForty‐four patients were diagnosed with biopsy‐proven LAPC. Twenty‐five patients were eligible and all underwent staging laparoscopy before the treatment. In three (12%) patients occult metastases were found. Twenty‐two patients started induction FOLFIRINOX, 17 (77%) completed all cycles. Seventeen (77%) patients were treated with subsequent RT, with 16 (94%) receiving the full dosage. Three (14%) patients underwent a radical resection after the treatment. Median OS was 15.4 months (95% confidence interval [CI], 10.0‐20.7), median PFS was 11 months (95% CI, 7.7‐14.4).ConclusionsMedian OS after FOLFIRINOX and RT was 15 months in patients with LAPC. Toxicity remains severe, however, most patients completed all eight scheduled cycles of FOLFIRINOX and RT.

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“…The efficacy of FOLFIRINOX was confirmed in a phase II trial conducted in Japanese patients, but toxicities such as febrile neutropenia occurring in 22.2% of the patients posed a grave concern . To reduce these toxicities of FOLFIRINOX, trials of various modifications of FOLFIRINOX are currently under way in various countries . In Japan, a phase II trial was conducted of modified FOLFIRINOX, which consists of intravenous oxaliplatin 85 mg/m 2 , irinotecan 150 mg/m 2 , 5‐FU infusion 2,400 mg/m 2 over 46 h (no bolus 5‐FU) ; this regimen showed comparable efficacy in terms of the response rate, PFS and OS, and was associated with reduced hematological toxicities, especially febrile neutropenia, which was found to occur at a decreased rate of 8.7% in Japanese patients .…”

Section: Current Status Of Chemotherapy For Pancreatic Cancermentioning

confidence: 99%

Development of chemotherapy and significance of conversion surgery after chemotherapy in unresectable pancreatic cancer

Furuse

Shibahara

Sugiyama

2018

J Hepato Biliary Pancreat

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While surgery currently remains the only potentially curative treatment available for pancreatic cancer, only 20% to 30% of patients have resectable disease at diagnosis. Recently, with the introduction of intensive chemotherapy regimens such as oxaliplatin, irinotecan, fluorouracil plus leucovorin (FOLFIRINOX) and gemcitabine plus nab-paclitaxel, for the treatment of unresectable pancreatic cancer, the antitumor activity and overall survival in patients with pancreatic cancer have dramatically improved. These advances in intensive chemotherapy have led to the possibility of conversion of unresectable disease to resectable disease, and it has been reported that more than 20% of pancreatic cancer patients with unresectable locally advanced disease at diagnosis undergo successful conversion surgery after FOLFIRINOX therapy. In metastatic pancreatic cancer, resection for the primary lesion of pancreatic cancer may show some benefits for some patients with complete resolution of metastases by chemotherapy. Furthermore, surgical resection in some patients with only a few metastases, so-called oligometastases, have also been reported. Conversion surgery is becoming increasingly possible with the introduction of intensive chemotherapies, however, the actual clinical benefits of resection in such cases has not yet been sufficiently investigated. The long-term safety, feasibility and outcomes still need to be investigated in well-designed, multi-institutional studies on a large number of patients.

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Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer.

Cited by 5 publications

References 12 publications

Phase II Study of the Triple Combination Chemotherapy of SOXIRI (S-1/Oxaliplatin/Irinotecan) in Patients with Unresectable Pancreatic Ductal Adenocarcinoma

Phase II Study of the Triple Combination Chemotherapy of SOXIRI (S-1/Oxaliplatin/Irinotecan) in Patients with Unresectable Pancreatic Ductal Adenocarcinoma

FOLFIRINOX and radiotherapy for locally advanced pancreatic cancer: A cohort study

Development of chemotherapy and significance of conversion surgery after chemotherapy in unresectable pancreatic cancer

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