Modified FOLFIRINOX versus sequential chemotherapy (FOLFIRI/FOLFOX) as a second‐line treatment regimen for unresectable pancreatic cancer: A real‐world analysis

Introduction: Patients with advanced pancreatic cancer have a poor prognosis. FOLFIRINOX (FFX) and gemcitabine plus nab-paclitaxel (GnP) have been established as first-line treatment, but they have not been confirmed as second-line treatment after FFX. The aim of this study was to evaluate the safety and efficacy of GnP as second-line therapy after FFX in patients with unresectable pancreatic cancer. Methods: Twenty-five patients with unresectable pancreatic cancer were enrolled. The patients were treated with GnP after FFX between September 2015 and September 2019. Tumor response, progression-free survival (PFS), overall survival (OS), and incidence of adverse events were evaluated. Results: The response rate, disease control rate, median PFS, and median OS were 12%, 96%, 5.3 months, and 15.6 months, respectively. The common grade 3 or 4 adverse events were neutropenia (76%) and anemia (16%). Conclusions: GnP after FOLFIRINOX is expected to be one of the second-line recommendations for patients with unresectable pancreatic cancer.

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Real World First-Line Treatments and Outcomes of Nab-Paclitaxel Plus Gemcitabine, mFOLFIRINOX and GEMOX in Unresectable Pancreatic Cancer from a Chinese Single Institution

Current Oncology ◽

10.3390/curroncol28010023 ◽

2020 ◽

Vol 28 (1) ◽

pp. 209-219

Author(s):

Qi Quan ◽

Yixing Wang ◽

Fenghua Wang ◽

Dongsheng Zhang ◽

Xiuxing Chen ◽

...

Keyword(s):

Pancreatic Cancer ◽

Real World ◽

Objective Response ◽

Chinese Patients ◽

Cancer Center ◽

Unresectable Pancreatic Cancer ◽

Line Treatment ◽

First Line ◽

Real World Data ◽

First Line Treatment

Background: There have not been any head-to-head prospective studies to compare the effects of different chemotherapy regimens as first-line treatments for unresectable pancreatic cancer (UPC). We aimed to compare the effectiveness of nab-paclitaxel plus gemcitabine, mFOLFIRINOX and gemcitabine plus oxaliplatin (GEMOX) as first-line treatments by using real-world data from Chinese patients. Methods: We retrospectively included patients with UPC treated with nab-paclitaxel plus gemcitabine, mFOLFIRINOX or GEMOX as a first-line treatment at Sun Yat-sen University Cancer Center. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) were assessed. Results: A total of 117 patients were administered nab-paclitaxel plus gemcitabine (n = 62), mFOLFIRINOX (n = 30) or GEMOX (n = 25) as first-line chemotherapy. The median OS was 11.1, 10.1 and 10.2 months (p = 0.75) in the nab-paclitaxel plus gemcitabine, mFOLFIRINOX and GEMOX, respectively. The ORR was similar among the three groups (24%, 23% and 32%, p = 0.76) and the DCR was higher in the nab-paclitaxel-gemcitabine group (82%) than the other two groups (60% and 64%, p = 0.04). The most common adverse events of grade 3 or 4 were neutropenia (32%, 28% and 5%), peripheral neuropathy (13%, 16% and 0) and fatigue (9%, 16% and 5%). Febrile neutropenia occurred in 2%, 4% and 5% of the patients in the three groups. Conclusion: In the first line treatment of UPC, our results suggest that nab-paclitaxel plus gemcitabine was associated with a higher DCR than mFOLFIRINOX or GEMOX, while all groups demonstrated similar OS, PFS and ORR.

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Paradigm Shifting of Systemic Chemotherapy for Unresectable Pancreatic Cancer in Japan

Journal of Clinical Medicine ◽

10.3390/jcm8081170 ◽

2019 ◽

Vol 8 (8) ◽

pp. 1170 ◽

Cited By ~ 2

Author(s):

Junji Furuse

Keyword(s):

Pancreatic Cancer ◽

Systemic Chemotherapy ◽

Locally Advanced ◽

Standard Of Care ◽

Phase Iii ◽

Unresectable Pancreatic Cancer ◽

Line Treatment ◽

Second Line ◽

Brca Mutations ◽

Line Chemotherapy

Systemic chemotherapy plays an important role in the treatment of pancreatic cancer, to improve the survival of patients with pancreatic cancer. Unresectable pancreatic cancer can be classified into three categories: metastatic, locally advanced, and hereditary pancreatic cancers. Furthermore, the second-line chemotherapy is required to prolong the survival. The combined regimens of oxaliplatin, irinotecan, fluorouracil and leucovorin (FOLFIRINOX) and gemcitabine plus nab-paclitaxel (GEM plus nab-PTX) have been recognized as the standard of care for advanced pancreatic cancer. However, the consensus of selection of the first-line chemotherapy still remains. Randomized controlled trials (RCTs) between FOLFIRINOX and GEM plus nab-PTX are ongoing for locally advanced and metastatic disease in Japan, respectively. Hereditary pancreatic cancer, especially associated with BRCA mutations, is responsive to platinum-containing regimens and/or poly (ADP-ribose) polymerase (PARP) inhibitors. It is becoming more important to examine the presence/absence of BRCA mutations to select the appropriate treatment strategy for individual patients. Although some S-1-based regimens have been investigated in the second-line treatment after GEM-based chemotherapy in Japan, no regime demonstrated survival benefit. Nanoliposomal irinotecan (nal-IRI) plus FF has been established as the standard of care in the second-line treatment in a global phase III trial (NAPOLI-1). A randomized phase II trial comparing FF plus nal-IRI with FF alone was also conducted in Japan to examine the efficacy and safety of the FF plus nal-IRI in Japanese patients.

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P201 Bezafibrate as second line treatment in patients with primary biliary cholangitis: a real world experience

10.1136/gutjnl-2020-bsgcampus.276 ◽

2021 ◽

Author(s):

Rebecca McCabe ◽

Martin Prince ◽

Shaun Greer ◽

Harpreet Dhaliwal

Keyword(s):

Real World ◽

Primary Biliary Cholangitis ◽

Line Treatment ◽

Second Line

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Second-line treatment efficacy in elderly vs. non-elderly advanced gastric cancer patients: an Italian multicentre real-world study

Annals of Oncology ◽

10.1093/annonc/mdx425.004 ◽

2017 ◽

Vol 28 ◽

pp. vi45

Author(s):

V. Fanotto ◽

M. Uccello ◽

L. Fornaro ◽

L. Rimassa ◽

F. Leone ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Cancer Patients ◽

Real World ◽

Treatment Efficacy ◽

Line Treatment ◽

Second Line ◽

Gastric Cancer Patients

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Assessing Type and Impact of Biases Potentially Occurring when Analyzing Real World Evidence: The Case of Second Line Treatment for Ovarian Cancer

Value in Health ◽

10.1016/j.jval.2018.04.1446 ◽

2018 ◽

Vol 21 ◽

pp. S213

Author(s):

F Kuehne ◽

M Arvandi ◽

LM Hess ◽

DE Faries ◽

R Matteucci Gothe ◽

...

Keyword(s):

Ovarian Cancer ◽

Real World ◽

Line Treatment ◽

Second Line ◽

Real World Evidence

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Real-world experience of everolimus as second-line treatment in metastatic renal cell cancer after failure of pazopanib

OncoTargets and Therapy ◽

10.2147/ott.s141260 ◽

2017 ◽

Vol Volume 10 ◽

pp. 4885-4893 ◽

Cited By ~ 1

Author(s):

Konstantinos Koutsoukos ◽

Aristotelis Bamias ◽

Kimon Tzannis ◽

Marta Espinosa Montaño ◽

Vasiliki Bozionelou ◽

...

Keyword(s):

Renal Cell Cancer ◽

Real World ◽

Renal Cell ◽

Cell Cancer ◽

Line Treatment ◽

Second Line ◽

Metastatic Renal Cell Cancer

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Second-line treatment efficacy and toxicity in older vs. non-older patients with advanced gastric cancer: A multicentre real-world study

Journal of Geriatric Oncology ◽

10.1016/j.jgo.2018.11.009 ◽

2019 ◽

Vol 10 (4) ◽

pp. 591-597 ◽

Cited By ~ 1

Author(s):

Valentina Fanotto ◽

Lorenzo Fornaro ◽

Roberto Bordonaro ◽

Gerardo Rosati ◽

Lorenza Rimassa ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Real World ◽

Treatment Efficacy ◽

Older Patients ◽

Line Treatment ◽

Second Line

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Modified FOLFIRINOX as a second-line therapy following gemcitabine plus nab-paclitaxel therapy in metastatic pancreatic cancer

10.21203/rs.3.rs-18686/v4 ◽

2020 ◽

Author(s):

Masashi Sawada ◽

Akiyoshi Kasuga ◽

Takafumi Mie ◽

Takaaki Furukawa ◽

Takanobu Taniguchi ◽

...

Keyword(s):

Pancreatic Cancer ◽

Prognostic Factors ◽

Prognostic Model ◽

Prognostic Score ◽

Objective Response ◽

Metastatic Pancreatic Cancer ◽

Line Treatment ◽

Second Line ◽

Second Line Therapy ◽

Line Therapy

Abstract Background There is no established second-line treatment after failure of gemcitabine plus nab-paclitaxel (GnP) therapy for metastatic pancreatic cancer (MPC). This study aimed to evaluate the efficacy and tolerability of the modified FOLFIRINOX (mFFX) as a second-line therapy for MPC and investigate prognostic factors for survival. Methods From 2015–2019, we retrospectively reviewed the medical records of patients receiving mFFX for MPC after failure of GnP therapy. Patients were treated every 2 weeks with mFFX (intravenous oxaliplatin 85 mg/m 2 , intravenous irinotecan 150 mg/m 2 , and continuous infusion of 5-fluorouracil 2,400 mg/m 2 for 46 hours without bolus infusion) until disease progression, patient refusal, or unacceptable toxicity. Results In total, 104 patients received mFFX. The median overall survival (OS) was 7.0 months (95% confidence interval [CI]: 6.2-9.8) and the progression-free survival (PFS) 3.9 months (95% CI 2.8-5.0). The objective response rate was 10.6% and the disease control rate 56.7%. The median relative dose intensities of oxaliplatin, irinotecan, and infusional 5-FU were 80.0% (range 21.5-100%), 77.2% (range 38.1-100%), and 85.9% (range 36.9-100%), respectively. Grade 3-4 toxicities were reported in 57 patients (54.8%), including neutropenia, leukopenia, anemia, febrile neutropenia, and peripheral sensory neuropathy. Glasgow prognostic score and carcinoembryonic antigen level were independently associated with survival. Our prognostic model using these parameters could classify the patients into good (n = 38), intermediate (n = 47), and poor (n = 19) prognostic groups. The median OS and PFS time was 14.7 (95% CI 7.6-16.3) and 7.6 months (95% CI 4.1-10.5) for the good prognostic factors, 6.5 (95% CI 5.5-10.0) and 3.6 months (95% CI 2.7-4.8) for the intermediate prognostic factors and 5.0 (95% CI 2.9-6.6) and 1.7 months (95% CI 0.9-4.3) for the poor prognostic factors, respectively. Conclusions The mFFX showed to be a tolerable second-line treatment for MPC after GnP failure. Our prognostic model might be useful for deciding whether mFFX is indicated in this setting.

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