SAKK57/16 Nab-paclitaxel and Gemcitabine in Soft Tissue Sarcoma (NAPAGE): a phase I/II trial.
Chemotherapy
Gemcitabine
Nab-paclitaxel
Patient-reported outcome
Soft tissue sarcoma
Journal
European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373
Informations de publication
Date de publication:
09 Dec 2023
09 Dec 2023
Historique:
received:
04
09
2023
revised:
27
11
2023
accepted:
29
11
2023
medline:
15
12
2023
pubmed:
15
12
2023
entrez:
14
12
2023
Statut:
aheadofprint
Résumé
To determine whether the combination of nab-paclitaxel with gemcitabine has activity in patients with pretreated soft tissue sarcoma (STS). NAPAGE is a phase Ib/II clinical trial investigating the combination of nab-paclitaxel (nab-pc) with gemcitabine employing two cohorts. One of a dose-de-escalation phase and one of expansion. In phase I, nab-pc was given at 150 mg/m The 3-month PFR was 56.4% (95% confidence interval CI: 39.6-72.2%). The 3-month and 6-month PFS were 58.4% (95% CI: 41.3-72.1%) and 44.6% (95% CI: 28.4-59.5%), respectively. Median PFS was 5.3 months (95% CI: 1.4-8.2) and median OS was 12.8 months (95% CI: 10.5-39.2). The most common treatment-related grade ≥ 3 AE were neutropenia (18%), followed by anemia (2.6%), hypertension (2.6%) and alanine aminotransferase increase (2.6%). Grade 1 and grade 2 peripheral sensory neuropathy (PNP) occurred in 15.4% and 20.5%, respectively. No grade 3-4 PNP was reported. Combining nab-pc and gemcitabine is safe. Promising activity is observed in pretreated STS patients with manageable toxicity. This regimen should be considered for further exploration.
Sections du résumé
BACKGROUND
BACKGROUND
To determine whether the combination of nab-paclitaxel with gemcitabine has activity in patients with pretreated soft tissue sarcoma (STS).
PATIENTS AND METHODS
METHODS
NAPAGE is a phase Ib/II clinical trial investigating the combination of nab-paclitaxel (nab-pc) with gemcitabine employing two cohorts. One of a dose-de-escalation phase and one of expansion. In phase I, nab-pc was given at 150 mg/m
RESULTS
RESULTS
The 3-month PFR was 56.4% (95% confidence interval CI: 39.6-72.2%). The 3-month and 6-month PFS were 58.4% (95% CI: 41.3-72.1%) and 44.6% (95% CI: 28.4-59.5%), respectively. Median PFS was 5.3 months (95% CI: 1.4-8.2) and median OS was 12.8 months (95% CI: 10.5-39.2). The most common treatment-related grade ≥ 3 AE were neutropenia (18%), followed by anemia (2.6%), hypertension (2.6%) and alanine aminotransferase increase (2.6%). Grade 1 and grade 2 peripheral sensory neuropathy (PNP) occurred in 15.4% and 20.5%, respectively. No grade 3-4 PNP was reported.
CONCLUSIONS
CONCLUSIONS
Combining nab-pc and gemcitabine is safe. Promising activity is observed in pretreated STS patients with manageable toxicity. This regimen should be considered for further exploration.
Identifiants
pubmed: 38096656
pii: S0959-8049(23)00772-4
doi: 10.1016/j.ejca.2023.113470
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
113470Informations de copyright
Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest AD reports honoraria and/or consulting fees from and has served on advisory boards for F. Hoffmann-La Roche Ltd, Pharmamar, Incyte, and AstraZeneca (via institution). MJ. reports honoraria and/or consulting fees for Bristol Myers Squibb, Pfizer, Merck Sharp & Dohme, Bayer, Debiopharm, Novartis, Basilea Pharmaceutica, Sanofi (via institution). CR reports honoraria and/or consulting fees for Bristol Myers Squibb, Pfizer, Merck Sharp & Dohme (via institution). AK, DD, MNK, CB, TR, FK, YM, IC,KR have declared no conflicts of interest.