Abstract B14: CA 19-9 levels in patients with metastatic pancreatic adenocarcinoma receiving first-line therapy with liposomal irinotecan plus 5-fluorouracil/leucovorin and oxaliplatin (NAPOX)

456 Background: The phase III MPACT trial was conducted to assess OS in patients with metastatic pancreatic adenocarcinoma (mPAC) receiving nab-paclitaxel (nab-P) 125 mg/m2 + gemcitabine (G) 1000 mg/m2 on days 1, 8, and 15 every 28 days. Due to reported increased incidence of adverse events (AEs) at this dose, practice at UC Health outside the setting of a clinical trial is to empirically dose reduce (EDR) nab-P to 100 mg/m2. This study is a review of the efficacy of EDR nab-P + G in patients with mPAC compared to MPACT data. Methods: This retrospective, single-center, cohort study included patients ≥18 years of age with mPAC (by biopsy) receiving first line therapy with EDR nab-P + G from January 1, 2012 to March 31, 2017. Primary outcome is OS. Secondary outcomes include PFS, CA19-9 percent reduction, incidence of grade ≥ 3 AEs. Results: See table. Conclusions: In patients with mPAC, EDR nab-P plus G demonstrated a median OS of 10 months and PFS of 5 months. 53% of patients had a 20% CA19-9 reduction from baseline with a 1 year OS rate of 45%. The incidence of grade ≥ 3 AEs appeared to be acceptable. [Table: see text]

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P-287 Nanoliposomal irinotecan (nal-IRI)-containing regimens versus nab-paclitaxel plus gemcitabine as first-line therapy in patients with metastatic pancreatic adenocarcinoma (mPAC): a randomized, open-label phase 2 study

Annals of Oncology ◽

10.1093/annonc/mdw199.277 ◽

2016 ◽

Vol 27 ◽

pp. ii84

Author(s):

Dean Andrew ◽

Ramanathan Ramesh ◽

Belota Brooke ◽

Belanger Bruce ◽

Adib Deyaa ◽

...

Keyword(s):

Pancreatic Adenocarcinoma ◽

Phase 2 ◽

First Line ◽

Open Label ◽

First Line Therapy ◽

Line Therapy ◽

Metastatic Pancreatic Adenocarcinoma ◽

Phase 2 Study ◽

Open Label Phase ◽

Nanoliposomal Irinotecan

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A phase II randomized study of cetuximab and bevacizumab alone or in combination with gemcitabine as first-line therapy for metastatic pancreatic adenocarcinoma

Investigational New Drugs ◽

10.1007/s10637-011-9691-8 ◽

2011 ◽

Vol 30 (4) ◽

pp. 1597-1606 ◽

Cited By ~ 34

Author(s):

Andrew H. Ko ◽

Hagop Youssoufian ◽

Jayne Gurtler ◽

Karel Dicke ◽

Omar Kayaleh ◽

...

Keyword(s):

Pancreatic Adenocarcinoma ◽

Phase Ii ◽

Randomized Study ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Metastatic Pancreatic Adenocarcinoma

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Nab-paclitaxel plus gemcitabine or plus simplified LV5FU2 as first-line therapy in patients with metastatic pancreatic adenocarcinoma: A GERCOR randomized phase II study (AFUGEM).

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.15_suppl.4120 ◽

2016 ◽

Vol 34 (15_suppl) ◽

pp. 4120-4120

Author(s):

Pascal Hammel ◽

Jean Baptiste Bachet ◽

Jérôme Desramé ◽

Aurelia Meurisse ◽

Benoist Chibaudel ◽

...

Keyword(s):

Pancreatic Adenocarcinoma ◽

Phase Ii ◽

Phase Ii Study ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Randomized Phase Ii ◽

Metastatic Pancreatic Adenocarcinoma

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First-line and second-line treatment of patients with metastatic pancreatic adenocarcinoma in routine clinical practice across Europe: a retrospective, observational chart review study

ESMO Open ◽

10.1136/esmoopen-2019-000587 ◽

2020 ◽

Vol 5 (1) ◽

pp. e000587 ◽

Cited By ~ 9

Author(s):

Julien Taieb ◽

Gerald W Prager ◽

Davide Melisi ◽

C Benedikt Westphalen ◽

Nathalie D'Esquermes ◽

...

Keyword(s):

Chart Review ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Treatment Choices ◽

First Line Therapy ◽

Line Therapy ◽

Metastatic Pancreatic Adenocarcinoma ◽

Review Study ◽

The Uk

BackgroundTreatment of metastatic pancreatic adenocarcinoma (mPAC) relies on chemotherapeutic regimens. We investigated patterns of first-line and second-line treatment choices, their geographical variation between European countries, and alignment with current European recommendations.MethodsThis retrospective, observational chart review study was conducted between July 2014 and January 2016. Physicians were recruited from nine European countries. Patient data were collected in electronic patient record forms (PRFs) by physicians managing patients with mPAC. Patients with a current mPAC diagnosis aged ≥18 years old who had completed first-line therapy during the study period were included.ResultsParticipating physicians (n=225) completed 2565 PRFs. The vast majority of PRFs were from France, Germany, Italy, Spain and the UK. Most patients (86.6%) had stage IV disease at diagnosis. The most common first-line treatments were FOLFIRINOX (5-fluorouracil, leucovorin/folinic acid, irinotecan and oxaliplatin) (35.6%), gemcitabine+nab-paclitaxel (25.7%) and gemcitabine monotherapy (20.5%). Physicians in France and the UK prescribed FOLFIRINOX more frequently than gemcitabine+nab-paclitaxel. Gemcitabine-based therapies were more widely used at second-line, although 5-fluorouracil-based therapies were preferred in Italy and Spain, where gemcitabine-based treatments were more frequently selected for first-line. For patients receiving first-line modified FOLFIRINOX, second-line gemcitabine monotherapy was preferred in the overall population (45.9%).ConclusionAlthough treatment choices for patients with mPAC varied between countries, they align with current European guidelines. Factors including drug availability, reimbursement, patient characteristics, physician preference and prior first-line therapy affect treatment choices. Approved, recommended therapies for patients who progress following first-line treatment are lacking. These findings may influence the development of effective treatment plans, potentially improving future patient outcomes.

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RESILIENT part II: an open-label, randomized, phase III study of liposomal irinotecan injection in patients with small-cell lung cancer who have progressed with platinum-based first-line therapy.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.tps9081 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. TPS9081-TPS9081

Author(s):

Luis G. Paz-Ares ◽

David R. Spigel ◽

Yuanbin Chen ◽

Maria Jove ◽

Oscar Juan-Vidal ◽

...

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Small Cell ◽

Symptom Improvement ◽

Small Cell Lung ◽

First Line ◽

Open Label ◽

First Line Therapy ◽

Line Therapy ◽

Liposomal Irinotecan

TPS9081 Background: Although small cell lung cancer (SCLC) is often sensitive to established first-line therapies, many patients relapse and develop drug resistance, and second-line therapies are limited. RESILIENT (NCT03088813) is a two-part phase 2/3 study assessing the safety, tolerability, and efficacy of liposomal irinotecan monotherapy in patients with SCLC who progressed with platinum-based first-line therapy. Preliminary data from the dose-ranging part of the study (part 1) showed that liposomal irinotecan 70 mg/m2 administered every 2 weeks was well tolerated and had promising antitumor activity (Paz-Ares et al. ASCO 2019; poster 318). Here, we present the design of the second, larger part of the study, which will evaluate the efficacy and safety of liposomal irinotecan versus topotecan in the same patient population. Methods: Part 2 of RESILIENT is a phase 3, open-label study with a planned sample size of 450. Patients are randomly allocated 1:1 to intravenous liposomal irinotecan or intravenous topotecan. Liposomal irinotecan is administered every 2 weeks at 70 mg/m2 (free-base equivalent) and topotecan is administered for 5 consecutive days every 3 weeks at 1.5 mg/m2. As of January 2020, 80 patients have been enrolled in part 2 of the trial. Tumor assessments are performed using the Response Evaluation Criteria in Solid Tumors version 1.1 and the Response Assessment in Neuro-oncology criteria for CNS lesions; symptom improvement is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Safety assessments include monitoring for adverse events. The primary endpoint is overall survival (OS) and secondary endpoints are progression-free survival (PFS), objective response rate, and proportion of patients reporting symptom improvement. Patients will continue study treatment until disease progression, unacceptable toxicity or study withdrawal and will then be followed for survival until death or study end (when all patients have died, withdrawn consent or are lost to follow-up). Clinical trial information: NCT03088813.

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Nab-paclitaxel plus gemcitabine or plus simplified LV5FU2 as first-line therapy in patients with metastatic pancreatic adenocarcinoma: A GERCOR randomized phase II study (AFUGEM).

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.4_suppl.350 ◽

2017 ◽

Vol 35 (4_suppl) ◽

pp. 350-350 ◽

Cited By ~ 2

Author(s):

Olivier Dubreuil ◽

Jean Baptiste Bachet ◽

Pascal Hammel ◽

Jerome Desrame ◽

Aurelia Meurisse ◽

...

Keyword(s):

Pancreatic Adenocarcinoma ◽

Progression Free Survival ◽

Phase Iii ◽

First Line ◽

Eligibility Criteria ◽

First Line Therapy ◽

Metastatic Pancreatic Adenocarcinoma ◽

Third Line ◽

Metastatic Sites ◽

Ecog Ps

350 Background: Nab-paclitaxel plus gemcitabine regimen (NABGEM) became a standard in first-line patients (pts) with metastatic pancreatic adenocarcinoma (mPAC). The AFUGEM trial evaluated the efficacy and safety of nab-paclitaxel plus simplified LV5FU2 (NABFU). Methods: Main eligibility criteria were: untreated mPAC, ECOG PS≤2. Pts received nab-paclitaxel (125 mg/m2 on d1, 8 and 15) plus gemcitabine (1000 mg/m2 on d1, 8 and 15) or plus simplified LV5FU2 (leucovorin 400 mg/m2, 5FU bolus 400 mg/m2 followed by 2400 mg/m2 given as a 46-hour continuous infusion on d1 and 15), one cycle every 4 weeks in both arms, ratio 1:2, respectively. The primary end point was observed progression-free survival (PFS) rate at 4 months (m). A Fleming 2-stage design was used with a targeted (H1) 4m-PFS rate of 50% in NABFU arm and an uninteresting 35% rate (H0, unilateral alpha of 5% and power of 80%). Results: 114 pts were included: NABGEM n=39, NABFU n=75. Baseline characteristics were well balanced: median age 66 years (45-86), ≥2 metastatic sites 36.8%, ECOG PS 0-1 84.2% and 2 15.8%, at the exception of pain more frequent in the NABFU arm (38.5% vs 56.0%). In mITT population, the observed 4m-PFS rates were of 55.4% [95% CI, 45-63] in NABFU Vs 53.9% [95% CI, 39.6-67.7] in NABGEM. Disease control rates were 65% (95% CI, 53-76) and 62% (95% CI, 45-77) respectively. After a follow-up of 24.3m, median PFS were 5.9 [95% CI, 3.6-7.4] v 4.9 months [95% CI, 2.1-7.7] [HR=0.79, 95% CI: 0.52-1.20]. Grade 3-4 adverse events were more frequent in NABGEM (77% v 87%). At tumor progression, in the NABFU arm, 50 patients (66%) and then 13 patients (17%) received a second and third line of chemotherapy respectively, versus 22 patients (56%) and 6 patients (15%) in the NABGEM arm. Median OS were 11.4 [95% CI, 8.8-16.5] v 9.2 months [95% CI, 6.0-13.6] [HR=0.61, 95% CI: 0.40-0.95], respectively. The 12 and 18-months OS rates in NABFU vs NABGEM arm were 48% Vs 41% and 34% Vs 13%, respectively. Conclusions: Nab-paclitaxel plus simplified LV5FU2 appears at least as active as gemcitabine plus nab-paclitaxel in mPAC. The toxicity profile is safe and tolerable. This regimen deserves evaluation in a phase III trial. Clinical trial information: NCT01964534.

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