Impact of second-line treatment (2L T) in advanced pancreatic cancer (APDAC) patients (pts) receiving first line Nab-Paclitaxel (nab-P) + Gemcitabine (G): An Italian multicentre real life experience.

Giordano, Guido; Febbraro, Antonio; Milella, Michèle; Vaccaro, Vanja; Melisi, Davide; Foltran, Luisa; Zagonel, Vittorina; Zaniboni, Alberto; Bertocchi, Paola; Bergamo, Francesca; Passardi, Alessandro; Musettini, Gianna; Giommoni, Elisa; Iop, Aldo; Aloi, Maria Bernardetta; Vecchiarelli, Silvia; Vasile, Enrico; Re, Giovanni Lo; Marco, Mariacristina Di; Vita, Ferdinando De

doi:10.1200/jco.2016.34.15_suppl.4124

Cited by 11 publications

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“…The longest total OS values were observed in patients who received first-line nab -P/Gem followed by fluoropyrimidine-containing second-line regimens (n=132; median, 13.5 months); a small number (n=18) received second-line FOLFIRINOX and experienced a median total OS of 15.7 months 30. Another retrospective analysis from the previously described Italian registry (N=250) demonstrated similar findings, that is, a median OS of 13.5 months in patients who received second-line treatment after first-line nab -P/Gem (n=122) 31. More specifically, patients who received second-line FOLFOX/XELOX (n=56), FOLFIRI (n=24), and FOLFIRINOX (n=22) had median total OS values of 12.8, 13.2, and 13.8 months, respectively 31.…”

Section: Resultsmentioning

confidence: 68%

“… 30 Another retrospective analysis from the previously described Italian registry (N=250) demonstrated similar findings, that is, a median OS of 13.5 months in patients who received second-line treatment after first-line nab -P/Gem (n=122). 31 More specifically, patients who received second-line FOLFOX/XELOX (n=56), FOLFIRI (n=24), and FOLFIRINOX (n=22) had median total OS values of 12.8, 13.2, and 13.8 months, respectively. 31 Consistent findings have been observed in many other analyses, and the totality of data suggests that first-line nab -P/Gem followed by second-line therapy, particularly with regimens that contain a fluoropyrimidine, is feasible and beneficial to patients with advanced PC.…”

Section: Resultsmentioning

confidence: 99%

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nab-Paclitaxel for the treatment of pancreatic cancer

Kim¹

2017

CMAR

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BackgroundNanoparticle albumin-bound paclitaxel (nab-P) plus gemcitabine (Gem) became a standard treatment option for metastatic pancreatic cancer (MPC) following positive results from a global phase III trial (MPACT). A large number of studies have now published results on the use of nab-P/Gem to treat advanced and early-stage disease, warranting a comprehensive review. The main goal of this systematic review is to summarize the efficacy and safety data of nab-P/Gem for the treatment of pancreatic cancer (PC).MethodsThis systematic review includes results from studies that either published results in a peer-reviewed journal or presented the results at a major oncology conference.ResultsSixty-two studies were included (50 in the advanced/metastatic setting and 12 in the locally advanced setting). Most studies on the treatment of MPC were exclusively first line (33/50). Nevertheless, the studies in this review comprised a broad spectrum of patients, including those <65 and ≥65 years of age and those with a Karnofsky performance status of 70–100. Median overall survival (OS) in studies of nab-P/Gem in the advanced/metastatic setting ranged from 8.7 to 13.5 months. In addition, 15 studies of patients with advanced/metastatic PC examined nab-P/Gem as a backbone on which to add a variety of agents, including cancer stem cell inhibitors, stromal disrupting agents, and immune-modulating agents (median OS, 6.9–17 months). Ongoing trials are investigating nab-P/Gem with or without other agents across disease settings.DiscussionStudies conducted after MPACT have demonstrated that nab-P/Gem is an effective regimen for the first-line treatment of MPC for a wide range of patients. Regimens using nab-P/Gem as a backbone on which to combine additional agents are being studied actively, particularly in the advanced disease setting. Ongoing studies will yield valuable insights on the utility of nab-P–containing regimens to improve patient outcomes in PC in both earlier-stage and advanced disease.

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Section: Resultsmentioning

confidence: 68%

Section: Resultsmentioning

confidence: 99%

nab-Paclitaxel for the treatment of pancreatic cancer

Kim¹

2017

CMAR

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“…The longest total OS values were observed in patients who received first-line nab-Paclitaxel/GEM followed by fluoropyrimidine-containing second-line regimens (median, 13.5 months); the small number who received second-line FOLFIRINOX reached a median total OS of 15.7 months [ 18 ]. Another retrospective analysis led to similar findings, with a median OS of 13.5 months in patients who received second-line treatment after first-line nab-P/Gem (with a benefit with the FOLFIRINOX regimen, 13,8 months of total OS, versus 13,2 with FOLFIRI and 12,8 with FOLFOX/XELOX regimen) [ 19 , 20 ].…”

Section: Discussionmentioning

confidence: 67%

Second-line chemotherapy for the treatment of metastatic pancreatic cancer after first-line gemcitabine-based chemotherapy: a network meta-analysis

et al. 2018

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Guidelines for treatment of metastatic pancreatic cancer recommend a second line based on Fluoropyrimidine (FP) alone or in combination with Oxaliplatin (OXA) or Irinotecan (IRI) after a first line treatment based on Gemcitabine (GEM). We conducted a Bayesian network meta-analysis to compare currently available therapies to treat metastatic pancreatic cancer in the second line, considering as efficacy measures overall survival (OS) and progression free survival (PFS). Published randomized trials were identified using electronic databases (MEDLINE, PubMed, https://clinicaltrials.gov/ and American Society of clinical oncology). 8 studies met the inclusion criteria for a total of 1,587 patients and 7 different therapeutic schemes. The results suggested that the use of IRI-FP-Folinic Acid scheme in the second-line treatment of metastatic pancreatic cancer may offer a benefit in terms of OS and PFS for patients not previously treated with these drugs.

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“… 14 The feasibility and benefit of first-line nab -paclitaxel plus gemcitabine for the treatment of advanced pancreatic cancer among patients in Europe are in agreement with outcomes reported elsewhere. 15 A retrospective analysis of several centers in Italy revealed that the majority of patients with advanced pancreatic cancer (122 [55%]; total N=221 patients) treated with first-line nab -paclitaxel plus gemcitabine were able to receive a second line of therapy, and the median OS among these patients was 13.5 months (95% CI: 12.66–14.34).…”

Section: Discussionmentioning

confidence: 99%

nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial

Tabernero

Kunzmann

Scheithauer

et al. 2017

OTT

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PurposeThe global Phase III MPACT trial demonstrated superior efficacy of nab-paclitaxel plus gemcitabine over gemcitabine alone as first-line treatment for metastatic pancreatic cancer. Region was a randomization stratification factor in the MPACT trial. This subgroup analysis of MPACT examined efficacy and safety of patients treated in Western Europe.Patients and methodsPatients received nab-paclitaxel plus gemcitabine or gemcitabine alone as first-line treatment for metastatic pancreatic cancer as previously described. A total of 76 patients were included in this analysis (n=38 for each arm).ResultsDifferences between the overall Western European cohort and the intention-to-treat population included lower percentages of male patients (46% and 58%, respectively) and patients with biliary stents (8% and 17%), and higher percentages of patients with Karnofsky performance status of 90–100 (78% and 60%) and primary tumors in the body of the pancreas (48% and 31%). The median overall survival was 10.7 months with nab-paclitaxel plus gemcitabine vs 6.9 months with gemcitabine alone (hazard ratio [HR]: 0.82 [95% confidence interval (CI): 0.48–1.40]; P=0.471). Median progression-free survival was 5.3 vs 3.7 months, respectively (HR: 0.70 [95% CI: 0.37–1.33]; P=0.277). The independently assessed overall response rate was 18% vs 5% (response rate ratio, 3.50 [95% CI: 0.78–15.78]; P=0.076). The most common grade ≥3 adverse events with nab-paclitaxel plus gemcitabine and gemcitabine alone were neutropenia (46% vs 33%, respectively), leukopenia (35% vs 19%), anemia (22% vs 0%), asthenia (21% vs 6%), thrombocytopenia (14% vs 3%), and peripheral neuropathy (13% vs 3%).ConclusionAlthough a statistically significant difference between the treatment arms was not reached for efficacy endpoints, this study does report treatment benefit and a manageable safety profile associated with nab-paclitaxel plus gemcitabine in patients treated in Western Europe with metastatic pancreatic cancer.

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Impact of second-line treatment (2L T) in advanced pancreatic cancer (APDAC) patients (pts) receiving first line Nab-Paclitaxel (nab-P) + Gemcitabine (G): An Italian multicentre real life experience.

Cited by 11 publications

References 0 publications

<em>nab</em>-Paclitaxel for the treatment of pancreatic cancer

<em>nab</em>-Paclitaxel for the treatment of pancreatic cancer

Second-line chemotherapy for the treatment of metastatic pancreatic cancer after first-line gemcitabine-based chemotherapy: a network meta-analysis

<em>nab</em>-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial

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