Phase II study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of 5-fluorouracil/leucovorin (GOFL) in advanced pancreatic cancer

Chang, Hui-Wen; Huang, Chien-Che; Wang, Hsiu Po; Shiah, Her Shyong; Chang, Ming Chu; Jan, Chang Ming; Chen, Jen Shi; Tien, Yu‐Wen; Hwang, Tsann Long; Lin, Jaw Town; Cheng, Ann‐Lii; Whang‐Peng, Jacqueline; Chen, Li Tzong

doi:10.1007/s00280-009-0980-2

Cited by 20 publications

(6 citation statements)

References 27 publications

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“…Baseline characteristics before starting nal-IRI + 5-FU/ LV were Eastern Cooperative Oncology Group performance score (ECOG PS) 0-1 in 32 (72.7%), presence of metastatic diseases in 39 (88.6%) with 56.8% exhibiting liver metastasis and failed to one prior chemotherapy in 32 (72.7%). The most common prior regimen was gemcitabine-based triplet therapy consisting of gemcitabine, oxaliplatin plus either 5-FU/LV or S-1/LV 14,15 in 24 (54.5%); while only 4 patients (9.1%) had prior exposure to irinotecan.…”

Section: Resultsmentioning

confidence: 99%

“…For its favorable safety profile, S-1 either alone or combining with gemcitabine are acceptable regimens for less fit, advanced PDAC patients in Japan 10,13 and for all comers in clinical practice before the reimbursement of FOLFIRINOX and the nab-paclitaxel in Taiwan. While biweekly triplet chemotherapy consisting of gemcitabine, oxaliplatin plus either infusion 5-FU/LV (the GOFL regimen) or oral S-1/LV (the SLOG regimen) that have been developed through a series of multicenter trials under the platform of Taiwan Cooperative Oncology Group (TCOG) are the favorable regimens in our institutional clinical practice 14,15 . In a single arm phase II trial, SLOG had 40.7% of overall response rate, and 7.6 and 11.4 months of median progression-free survival and overall survival, respectively, that are comparable with those achievable with FOLFIRINOX in ACCORD 11/0402 study 15 .…”

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confidence: 99%

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The Impact of Liposomal Irinotecan on the Treatment of Advanced Pancreatic Adenocarcinoma: Real-World Experience in a Taiwanese Cohort

Chiang

Tsai

et al. 2020

Sci Rep

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Liposomal irinotecan plus 5-fluorouracil/leucovorin (nal-IRI + 5-FU/LV) has shown to provide survival benefits for patients with gemcitabine-refractory metastatic pancreatic ductal adenocarcinoma (PDAC) in NAPOLI-1 trial, in which Asian patients experienced more hematological toxicity and subsequent dose modification. A retrospective chart review to investigate the administration pattern, therapeutic efficacy and safety profile of nal-IRI + 5-FU/LV in 44 consecutive patients with gemcitabine-refractory advanced PDAC treated between December 2016 and December 2018 in National Cheng Kung University Hospital, Taiwan. Most of them had metastatic diseases (88.6%), one-line of prior treatment (72.7%), ECOG PS 0-1 (72.7%) and starting dose of nal-IRI at 60 mg/m2 (≈52 mg/m2 irinotecan free-base) in 65.9%. The overall response rate was 9.1%. The median OS was 6.6 months for the entire cohort, and 7.8 and 2.7 months for patients of ECOG PS 0-1 and>2, respectively. The median OS of ECOG PS 0-1 patients with nal-IRI starting doses at 80 mg/m2 (≈70 mg/m2 irinotecan free-base, n = 13) and 60 mg/m2 (n = 19) were 7.5 and 8.4 months, respectively. Thirty-four percent of patients experienced manageable grade 3-4 hematological toxicity. Our results confirm the clinical benefit of nal-IRI + 5-FU/LV for patients of gemcitabine-refractory advanced PDAC with good performance status in a real-world setting.

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Section: Resultsmentioning

confidence: 99%

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confidence: 99%

The Impact of Liposomal Irinotecan on the Treatment of Advanced Pancreatic Adenocarcinoma: Real-World Experience in a Taiwanese Cohort

Chiang

Tsai

et al. 2020

Sci Rep

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“…In a randomized study comparing gemcitabine alone to gemcitabine combined with oxaliplatin, the group receiving the combination had a significantly better RR (26.8 vs. 17.3%, p = 0.04), progression-free survival (5.8 vs. 3.7 months, p = 0.04) and clinical benefit (38.2 vs. 26.9%, p = 0.03), but not OS benefit (9.0 vs. 7.1 months, p = 0.13) [17]. Although the RR of GOFL-treated patients with pancreatic cancer seems very promising [18], the current, still very limited, data do not indicate whether combining other drugs with gemcitabine can actually improve the outcome of this group [19]. However, a recent randomized trial demonstrated that metastatic pancreatic cancer patients receiving FOLFIRINOX (oxaliplatin, irinotecan and 5-FU) have a better RR, progression-free survival and OS than those receiving gemcitabine alone, indicating that a gemcitabine-based combination therapy may offer hope to this group of patients with a bleak prognosis [20].…”

Section: Discussionmentioning

confidence: 99%

Inferior Survival of Advanced Pancreatic Cancer Patients Who Received Gemcitabine-Based Chemotherapy but Did Not Participate in Clinical Trials

Kuo¹,

Tien²,

Hsu³

et al. 2011

Oncology

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Background: Advanced pancreatic cancer, even when treated, is highly lethal. The best choice of gemcitabine-based therapy and the prognostic factors affecting the success of treatment remain uncertain. Methods: We identified 159 of 1,475 patients with pancreatic cancer diagnosed in our institution and receiving gemcitabine-based chemotherapy between January 1995 and June 2007. Univariate and multivariate analyses were used to evaluate the prognostic significance of various clinical parameters for overall survival (OS). Results: The median survival after gemcitabine-based therapy was 5.4 months; 89.9% (n = 143) had ductal adenocarcinoma, 55.3% (n = 88) with stage IV. Gemcitabine alone was given to 60 (38%) patients, and gemcitabine with high-dose infusional fluorouracil (5-FU) with (n = 25) or without (n = 39) oxaliplatin was given to 64 (40%) patients. All regimens correlated with OS (p = 0.042) but not with the response rate (RR; p = 0.3). The overall RR was 11.1%, and all responders had a good performance status (PS). The RRs to gemcitabine with infusional 5-FU, and gemcitabine with oxaliplatin and infusional 5-FU were 5.3 and 20.8%, respectively. In a multivariate analysis, old age, advanced stage, poor PS and no enrollment in clinical trials were associated with inferior survival. Conclusions: The outcome for patients who did not participate in clinical trials, regardless of gemcitabine-based treatment, is still bleak.

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“…The results of multiple recent phase II studies provide some support for the 3 drug concept as combinations of gemcitabine, 5FU/capecitabine, and either oxaliplatin or docetaxel yielded response rates ranging from 33% to 41%, on par with FOLFIRNOX and clearly better than the 2 drug regimens 47–49 . However, the reported median OS between 7.8 and 9 months in these studies is worse than with FOLFIRINOX, despite a mixed population with 20–40% patients with locally advanced disease.…”

Section: Phase II Clinical Trials In Advanced Pancreatic Cancermentioning

confidence: 95%

Phase II clinical trials on investigational drugs for the treatment of pancreatic cancers

Kim¹,

Semrad²,

Bold³

2015

Expert Opinion on Investigational Drugs

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Introduction Despite some recent advances in treatment options, pancreatic cancer remains a devastating disease with poor outcomes. In a trend contrary to most malignancies, both incidence and mortality continue to rise due to pancreatic cancer. The majority of patients present with advanced disease and there are no treatment options for this stage that have demonstrated a median survival greater than 1 year. As the penultimate step prior to phase III studies involving hundreds of patients, phase II clinical trials provide an early opportunity to evaluate the efficacy of new treatments that are desperately needed for this disease. Areas Covered This review covers the results of published phase II clinical trials in advanced pancreatic adenocarcinoma published within the past 5 years. The treatment results are framed in the context of the current standards of care and the historic challenge of predicting phase III success from phase II trial results. Expert opinion Promising therapies remain elusive in pancreatic cancer based on recent phase II clinical trial results. Optimization and standardization of clinical trial design in the phase II setting, with consistent incorporation of biomarkers, is needed to more accurately identify promising therapies that warrant phase III evaluation.

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Phase II study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of 5-fluorouracil/leucovorin (GOFL) in advanced pancreatic cancer

Abstract: The triplet regimen is feasible and exhibits promising activity against APC, deserving further exploration.

Cited by 20 publications

References 27 publications

The Impact of Liposomal Irinotecan on the Treatment of Advanced Pancreatic Adenocarcinoma: Real-World Experience in a Taiwanese Cohort

The Impact of Liposomal Irinotecan on the Treatment of Advanced Pancreatic Adenocarcinoma: Real-World Experience in a Taiwanese Cohort

Inferior Survival of Advanced Pancreatic Cancer Patients Who Received Gemcitabine-Based Chemotherapy but Did Not Participate in Clinical Trials

Phase II clinical trials on investigational drugs for the treatment of pancreatic cancers

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