PMID- 38096656
OWN - NLM
STAT- MEDLINE
DCOM- 20240102
LR  - 20240102
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 197
DP  - 2024 Jan
TI  - SAKK57/16 Nab-paclitaxel and Gemcitabine in Soft Tissue Sarcoma (NAPAGE): a phase 
      I/II trial.
PG  - 113470
LID - S0959-8049(23)00772-4 [pii]
LID - 10.1016/j.ejca.2023.113470 [doi]
AB  - BACKGROUND: To determine whether the combination of nab-paclitaxel with 
      gemcitabine has activity in patients with pretreated soft tissue sarcoma (STS). 
      PATIENTS AND 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(2) in combination with gemcitabine 1000 mg/m(2) every two 
      weeks, until disease progression or unacceptable toxicity. This dose was 
      recommended for phase II (RP2D), as there was no dose limiting toxicity (DLT) or 
      discontinuations due to adverse events (AEs). The primary endpoint of the phase 
      II was progression-free rate (PFR) at 3 months (H0: 20%, H1:40%). The secondary 
      endpoints included progression free survival (PFS), overall survival (OS), AEs, 
      objective response and patient-reported outcomes (PRO). Efficacy analysis was by 
      intention to treat. 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: 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.
CI  - Copyright (c) 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Digklia, A
AU  - Digklia A
AD  - Department of Oncology, Lausanne University Hospital, University of Lausanne, 
      Lausanne, Switzerland. Electronic address: Antonia.digklia@chuv.ch.
FAU - Kollar, A
AU  - Kollar A
AD  - Department of Medical Oncology, Inselspital, Bern University Hospital, University 
      of Bern, Bern, Switzerland.
FAU - Dietrich, D
AU  - Dietrich D
AD  - Swiss Group for Clinical Cancer Research (SAKK) Competence Center, Bern, 
      Switzerland.
FAU - Kronig, M N
AU  - Kronig MN
AD  - Department of Medical Oncology, Inselspital, Bern University Hospital, University 
      of Bern, Bern, Switzerland.
FAU - Britschgi, C
AU  - Britschgi C
AD  - Department of Medical Oncology and Hematology, University Hospital Zurich, 
      Zurich, Switzerland.
FAU - Rordorf, T
AU  - Rordorf T
AD  - Department of Medical Oncology and Hematology, University Hospital Zurich, 
      Zurich, Switzerland.
FAU - Joerger, M
AU  - Joerger M
AD  - Department of Medical Oncology and Hematology, Kantonsspital St. Gallen, St. 
      Gallen, Switzerland.
FAU - Krasniqi, F
AU  - Krasniqi F
AD  - Department of Medical Oncology, University Hospital of Basel, Basel, Switzerland.
FAU - Metaxas, Y
AU  - Metaxas Y
AD  - Department of Medical Oncology, Cantonal Hospital, Grison Chur, Switzerland, now 
      at Cantonal Hospital Muensterlingen, Muensterlingen, Switzerland.
FAU - Colombo, I
AU  - Colombo I
AD  - Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale, 
      Bellinzona, Switzerland.
FAU - Ribi, K
AU  - Ribi K
AD  - International Breast Cancer Study Group IBCSG (IBCSG), Bern, Switzerland.
FAU - Rothermundt, C
AU  - Rothermundt C
AD  - Department of Medical Oncology and Hematology, Kantonsspital St. Gallen, St. 
      Gallen, Switzerland.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20231209
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (130-nm albumin-bound paclitaxel)
RN  - 0 (Albumins)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 0 (Gemcitabine)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Humans
MH  - Albumins
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - Deoxycytidine/therapeutic use
MH  - Gemcitabine
MH  - Paclitaxel/therapeutic use
MH  - *Pancreatic Neoplasms/drug therapy
MH  - *Sarcoma/drug therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chemotherapy
OT  - Gemcitabine
OT  - Nab-paclitaxel
OT  - Patient-reported outcome
OT  - Soft tissue sarcoma
COIS- 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.
EDAT- 2023/12/15 00:43
MHDA- 2024/01/02 11:42
CRDT- 2023/12/14 18:03
PHST- 2023/09/04 00:00 [received]
PHST- 2023/11/27 00:00 [revised]
PHST- 2023/11/29 00:00 [accepted]
PHST- 2024/01/02 11:42 [medline]
PHST- 2023/12/15 00:43 [pubmed]
PHST- 2023/12/14 18:03 [entrez]
AID - S0959-8049(23)00772-4 [pii]
AID - 10.1016/j.ejca.2023.113470 [doi]
PST - ppublish
SO  - Eur J Cancer. 2024 Jan;197:113470. doi: 10.1016/j.ejca.2023.113470. Epub 2023 Dec 
      9.