Details of response with first-line gemcitabine and nab-paclitaxel therapy in patients with advanced pancreatic cancer

Background: No clinical trial has directly compared nab-paclitaxel/gemcitabine (nab-P/G) with FOLFIRINOX (fluorouracil/leucovorin/oxaliplatin/irinotecan) in metastatic or advanced pancreatic cancer (mPC or aPC). We conducted a systematic review of real-world studies comparing these regimens in the first-line setting. Methods: Embase and MEDLINE databases through 22 January 2019, and Gastrointestinal Cancers Symposium 2019 abstracts were searched for real-world, retrospective studies comparing first-line nab-P/G versus FOLFIRINOX in mPC or aPC that met specific parameters. Studies with radiotherapy were excluded. Study quality was assessed using the Newcastle–Ottawa Scale. Results: Of 818 records initially identified, 35 were duplicates and 749 did not meet the eligibility criteria, mostly because they were either not comparative ( n = 356) or not first line ( n = 245). The remaining 34 studies (21 mPC; 13 aPC) assessed >6915 patients who received nab-P/G or FOLFIRINOX. In the studies identified, the median overall survival (OS) reached 14.4 and 15.9 months with nab-P/G and FOLFIRINOX, respectively, and median progression-free survival reached 8.5 and 11.7 months, respectively. Safety data were reported in 14 studies (2205 patients), including 8 single-institutional studies. In most single-institutional studies that reported safety data, rates were higher with FOLFIRINOX versus nab-P/G for grade 3/4 neutropenia (five of six studies) and febrile neutropenia (all three studies), while rates of grade 3/4 peripheral neuropathy were higher with nab-P/G in four of seven studies. Conclusions: Although FOLFIRINOX was associated with slightly longer median OS in more studies, the differences, when available, were not statistically significant. Therefore, a randomized, controlled trial is warranted. Toxicity profile differences represent key considerations for treatment decisions.

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Meta-analysis of FOLFIRINOX regimen as the first-line chemotherapy for locally advanced pancreatic cancer and borderline resectable pancreatic cancer

Clinical and Experimental Medicine ◽

10.1007/s10238-018-0540-3 ◽

2018 ◽

Vol 19 (1) ◽

pp. 149-157 ◽

Cited By ~ 2

Author(s):

Xifeng Xu ◽

Qiong Wu ◽

Zhen Wang ◽

Song Zheng ◽

Ke Ge ◽

...

Keyword(s):

Pancreatic Cancer ◽

Meta Analysis ◽

Locally Advanced ◽

Advanced Pancreatic Cancer ◽

Locally Advanced Pancreatic Cancer ◽

First Line ◽

Resectable Pancreatic Cancer ◽

Borderline Resectable ◽

Borderline Resectable Pancreatic Cancer ◽

Line Chemotherapy

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Anlotinib Plus Toripalimab and Nab-Paclitaxel in Patients with Locally Advanced or Metastatic Pancreatic Cancer: Study Protocol for An Open-Label, Non-Randomized, Phase II Study (ATNPA)

10.21203/rs.3.rs-1076724/v1 ◽

2021 ◽

Author(s):

Jingwen Chen ◽

Yiqian Liu ◽

Yizhi Zhu ◽

Shiyun Cui ◽

Chongqi Sun ◽

...

Keyword(s):

Pancreatic Cancer ◽

Maintenance Therapy ◽

Kinase Inhibitor ◽

Locally Advanced ◽

Advanced Pancreatic Cancer ◽

Metastatic Pancreatic Cancer ◽

Second Line ◽

First Line ◽

Open Label ◽

Combination Strategy

Abstract Background There have not been standard second-line or maintenance regimens with definite survival benefits so far for patients with pancreatic carcinoma who have lost the opportunity of curable resections or failed first-line chemotherapy. Anlotinib, a potent small-molecule tyrosine kinase inhibitor, exhibits anti-angiogenic and anti-tumour effects by specifically binding to multiple targets such as VEGFR, FGFR, PDGFR, c-Kit and Ret. Toripalimab, a novel anti-PD-1 mAb, has been proved to significantly prolong progression-free survival (PFS) and overall survival (OS) in various solid tumours with manageable toxicities when combining with cytotoxic chemotherapy. We design this study to assess the combination of anlotinib, toripalimab and nab-paclitaxel as a second-line or maintenance therapy for locally advanced pancreatic cancer (LAPC) or metastatic pancreatic cancer (MPC). Patients and Methods: This is an open-label, non-randomized, single-arm phase Ⅱ study, aimed at evaluating the efficacy and safety profile of the above-mentioned combination strategy in first-line therapy-failed LAPC or MPC. Totally 53 patients are to be enrolled and receive anlotinib (12 mg, po. qd.) plus toripalimab (240 mg, ivgtt. q3w.) and nab-paclitaxel (125 mg/m2, ivgtt, d1, d8) every 3 weeks as a cycle until disease progression or intolerable adverse events. The primary endpoint is PFS. Secondary end points include OS, disease control rate (DCR), object response rate (ORR), quality of life (QoL) and safety. Enrollment started in April 2021, and follow-up will be finished in April 2023. Discussion and Significance: Combination of anlotinib, toripalimab and nab-paclitaxel may promote vessel normalization and drug delivery, and activate the immune response, thus exerting synergistic anti-tumour effects and counteracting the immunosuppressive microenvironment of pancreatic cancer. As the first intending to assess this combination in pancreatic cancer, this study will provide comprehensive evidence for second-line or maintenance therapy of LAPC and MPC. Trial registration: ClinicalTrials.gov: ATNPA, NCT04718701. Registered January 22, 2021. (https://clinicaltrials.gov/ct2/show/NCT04718701?term=NCT04718701&draw=2&rank=1)

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First-Line FOLFIRINOX chemotherapy in initially unresectable locally advanced pancreatic cancer: retrospective clinical data analysis from a single HPB center

European Journal of Surgical Oncology ◽

10.1016/j.ejso.2018.10.252 ◽

2019 ◽

Vol 45 (2) ◽

pp. e68

Author(s):

V. Lazarou ◽

A. Petrou ◽

C. Charalambous ◽

G. Astras

Keyword(s):

Pancreatic Cancer ◽

Data Analysis ◽

Clinical Data ◽

Locally Advanced ◽

Advanced Pancreatic Cancer ◽

Locally Advanced Pancreatic Cancer ◽

First Line ◽

Clinical Data Analysis

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Resection of Locally Advanced Pancreatic Neoplasms after Neoadjuvant Chemotherapy with Nab-Paclitaxel and Gemcitabine following FOLFIRINOX Failure

Case Reports in Gastroenterology ◽

10.1159/000478722 ◽

2017 ◽

Vol 11 (2) ◽

pp. 422-427 ◽

Cited By ~ 3

Author(s):

Sarah Hahn ◽

Ahmet Ayav ◽

Anthony Lopez

Keyword(s):

Pancreatic Cancer ◽

Pancreatic Neoplasms ◽

Locally Advanced ◽

Advanced Pancreatic Cancer ◽

Response Rates ◽

Vascular Involvement ◽

Hematologic Toxicity ◽

First Line ◽

The Past ◽

Single Center Experience

The incidence of pancreatic cancer has dramatically increased over the past years, but the prognosis has not improved. Between 30 and 40% of tumors are considered locally advanced, essentially due to vascular involvement. In recent years, new chemotherapy protocols with high response rates have been developed. FOLFIRINOX seems to be an interesting option in this situation, but hematologic toxicity could be an obstacle to its prescription. Nab-paclitaxel and gemcitabine offer significant response rates with a reasonable safety profile. We report here a single-center experience of 2 cases with a locally advanced pancreatic cancer initially considered unresectable, progressive after first-line neoadjuvant FOLFIRINOX chemotherapy, and then treated with second-line nab-paclitaxel/gemcitabine chemotherapy.

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