A phase I and randomized phase II trial to evaluate the efficacy and safety of nab-paclitaxel (nab-P) in combination with gemcitabine (G) for the treatment of patients with ECOG 2 advanced pancreatic cancer (PDAC)

Hidalgo, Manuel; Pazo‐Cid, Roberto; Guillén‐Ponce, Carmen; Lopez, Rebecca; Vera, Ruth; Reboredo, Margarita; Muñoz, Andrés; Castro, Eva Martínez de; Beveridge, Robert Díaz; Casta, Adelaida La; Martin-Valades, Jose Ignacio; Cubillo, Antonio; Martinez-Galan, J.; Alés, Inmaculada; Sastre, Javier; Mercadé, T. Macarulla

doi:10.1093/annonc/mdx369.007

Cited by 5 publications

(4 citation statements)

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“…The European Society for Medical Oncology (ESMO) guidelines recommend patients with mPAC and European Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 receive first-line treatment with gemcitabine combined with albumin-bound paclitaxel (nab-paclitaxel), or with infusional 5-fluorouracil (5-FU), leucovorin/folinic acid (LV), irinotecan and oxaliplatin (FOLFIRINOX). Less fit patients (ECOG PS 2) should generally receive gemcitabine monotherapy, or best supportive care in those with worse PS or comorbidities,6 although certain patients with PS 2 may be able to receive gemcitabine+nab-paclitaxel if their poor performance status is due to a heavy tumour load 6 12…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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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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Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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“…The efficacy and safety of nab-paclitaxel combined with gemcitabine in fragile patients (Eastern Cooperative Oncology Group PS2) with advanced PDAC or metastatic PDAC were evaluated in the phase I/II FRAGANCE trial. 21,27 This trial showed a safety and efficacy profile consistent with the MPACT trial, suggesting that, even in a frail population, this doublet is of benefit. A limitation of this study was lack of assessment of PS by a second independent physician.…”

Section: Nanoformulated Paclitaxelmentioning

confidence: 58%

“…This study included only 8% of patients with Karnofsky performance-status score 70 (Eastern Cooperative Oncology Group PS2). The efficacy and safety of nab-paclitaxel combined with gemcitabine in fragile patients (Eastern Cooperative Oncology Group PS2) with advanced PDAC or metastatic PDAC were evaluated in the phase I/II FRAGANCE trial 21,27 . This trial showed a safety and efficacy profile consistent with the MPACT trial, suggesting that, even in a frail population, this doublet is of benefit.…”

Section: Standard Chemotherapy: Optimization With Nanotechnologymentioning

confidence: 99%

Emerging Treatment Strategies in Pancreatic Cancer

et al. 2021

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Pancreatic ductal adenocarcinoma (PDAC) is one of the main causes of cancer death in well-developed countries. Therapeutic advances in PDAC to date have been modest. Recent progress to understand the molecular landscape of the disease has opened new treatment opportunities for a small subset of patients, frequently those with KRAS wild-type disease. Novel treatment strategies in PDAC include, among others, the use of nanotechnology and metabolic reprogramming. In addition, new strategies are being investigated, which are designed to overcome the resistance to checkpoint inhibitors, targeting DNA repair pathways including mismatch repair, increasing antigen presentation through the use of vaccines, targeting various signaling pathways, and reprogramming the tumor microenvironment. Here, we review the landscape of PDAC treatment strategies and some of these new agents.

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“…Auf dem ESMO 2017 wurden nun die Ergebnisse einer randomisierten Phase-I/II-Studie mit ECOG-2-Patienten bei fortgeschrittenem Pankreaskarzinom (ca. 90 % UICC-Stadium IV) präsentiert [47].…”

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ASCO- und ESMO-Update 2017 – Neuigkeiten vom 53. Meeting der American Society of Clinical Oncology/ASCO 2017 und European Society for Medical Oncology/ESMO-Congress 2017

et al. 2018

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At ASCO 2017, and subsequently the ESMO congress 2017, a number of studies were presented which, in part, may change the present standard of therapy in gastrointestinal oncology. The German FLOT4 trial established perioperative Docetaxel, Oxaliplatin and 5-Fluorouracil (5-FU) as the new treatment standard for resectable adenocarcinoma of the gastroesophageal junction and the stomach. In hepatocellular carcinoma (HCC), two large studies did not show a survival benefit for selective internal therapy (SIRT), so an increasing use of SIRT in HCC is not recommended. On the other hand, the multityrosinekinase inhibitor Lenvatinib seems to be a promising alternative to sorafenib in first line treatment of metastatic HCC. In early colon cancer-following the data from the large IDEA initiative-three months of capecitabine and oxaliplatin is recommended for low-risk stage III cancers (T1 - 3, N1), while in high-risk stage III cancers (T4 or N2) patients should still receive six months of oxaliplatin and a fluoropyrimidine. Aside from regular exercise, one study found that regular intake of tree nuts (at least 2 servings per week), may decrease the risk of recurrence. In first line metastatic colorectal cancer (mCRC), SIRT should not be applied, whereas in BRAF mutant cancers, the combination of irinotecan, cetuximab and vemurafenib seems to be a promising second line treatment option. In biliary tract cancer, after curative resection, six months of capecitabine is considered the new treatment standard. Finally, in pancreatic cancer, targeting the tumor stroma with pegylated hyaluronidase (PEGPH20) may be a new treatment option that needs to be proven in phase 3 studies.

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A phase I and randomized phase II trial to evaluate the efficacy and safety of nab-paclitaxel (nab-P) in combination with gemcitabine (G) for the treatment of patients with ECOG 2 advanced pancreatic cancer (PDAC)

Cited by 5 publications

References 0 publications

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

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

Emerging Treatment Strategies in Pancreatic Cancer

ASCO- und ESMO-Update 2017 – Neuigkeiten vom 53. Meeting der American Society of Clinical Oncology/ASCO 2017 und European Society for Medical Oncology/ESMO-Congress 2017

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