Multicenter phase II trial of nintedanib plus docetaxel in second-line treatment in advanced non-squamous non-small cell lung cancer patients refractory to first-line platin-based chemotherapy (REFRACT GFPC 02–15 study)

Autor: Gwenaelle Le Garff, Margaux Geier, Lionel Falchero, Jean-Bernard Auliac, A. Bizieux, Alain Vergnenegre, Charles Ricordel, Florian Guisier, Laurent Greillier, Isabelle Monnet, R. Lamy, Refract Gfpc investigators, Christos Chouaid
Přispěvatelé: Service de Pneumologie [CHI Créteil], CHI Créteil, Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), Méthodes computationnelles pour la prise en charge thérapeutique en oncologie : Optimisation des stratégies par modélisation mécaniste et statistique (COMPO), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service d'oncologie multidisciplinaire innovations thérapeutiques [Hôpital Nord - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), L'Hôpital Nord-Ouest [Villefranche sur Saône], CHU de Saint-Brieuc, CH Bretagne Sud, Centre d'Investigation Clinique [CHU Rouen] (CIC Rouen), Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Clinical Epidemiology and Ageing : Geriatrie Soins Primaires et Santé Publique (CEpiA), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), CHU Limoges, Hôpital Charles Nicolle [Rouen]-CHU Rouen
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Male
Oncology
Cancer Research
Indoles
Lung Neoplasms
medicine.medical_treatment
MESH: Taxoids
Docetaxel
[SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract
chemistry.chemical_compound
Carcinoma
Non-Small-Cell Lung
Antineoplastic Combined Chemotherapy Protocols
Clinical endpoint
Prospective Studies
MESH: Treatment Outcome
MESH: Docetaxel
MESH: Indoles
MESH: Middle Aged
Middle Aged
MESH: Antineoplastic Combined Chemotherapy Protocols
Treatment Outcome
Second-line treatment
Taxoids
Nintedanib
medicine.drug
Pulmonary and Respiratory Medicine
medicine.medical_specialty
[SDV.CAN]Life Sciences [q-bio]/Cancer
Refractory
Internal medicine
Single-stage phase II study
medicine
Humans
Lung cancer
Chemotherapy
MESH: Humans
Performance status
business.industry
medicine.disease
MESH: Male
MESH: Prospective Studies
Discontinuation
MESH: Lung Neoplasms
chemistry
Non-squamous non-small cell lung cancer
business
MESH: Carcinoma
Non-Small-Cell Lung
Zdroj: Lung Cancer
Lung Cancer, 2021, 161, pp.122-127. ⟨10.1016/j.lungcan.2021.09.007⟩
Lung Cancer, Elsevier, 2021, 161, pp.122-127. ⟨10.1016/j.lungcan.2021.09.007⟩
ISSN: 0169-5002
Popis: Introduction Advanced non-squamous non-small cell lung cancer (NsqNSCLC) progressing at the induction of a first-line of platin-based chemotherapy is a subgroup of patients with poor prognosis and few second-line treatment options. Materials and Methods This single-stage phase II prospective multicenter open-label trial performed in platin-based refractory (i.e. progressing during induction phase of first-line platin-based chemotherapy) advanced NsqNSCLC assessed the efficacy of the nintedanib-docetaxel combination in second-line treatment. The primary endpoint was progression-free survival (PFS) rates at 12 weeks with a cut-off at 30% for ineffectiveness and 50% for minimal efficacy. Results A total of 59 patients from 23 centers were included (mean age, 58.5 years; male gender, 73.6%; performance status 0–1, 100%; former/current smokers, 92.5%; adenocarcinoma, 92.5%, median platin-based first-line chemotherapy, 2). Nintedanib-docetaxel combination was administered for a median of 4 cycles. The rate of PFS at 12 weeks was 39.6% (95% CI, 28.2–56.8). Median PFS was 2.7 (95% CI, 1.4–4.1) months and one-year PFS was 11.8% (95% CI, 4.8–22.2). Median overall survival (OS) was 6.9 (95% CI, 4.3–8.2) months and 12-month OS was 32.1% (95% CI, 19.8–45.0); 18-month OS was 27.6% (95% CI, 16,1–40.4). Twenty-nine (53.7%) patients reported at least one serious treatment-related adverse events leading to permanent discontinuation of at least one study drug in 12 (22.2%) patients. Conclusion The predefined minimal efficacy was not demonstrated. However, a number of NsqNSCLC patients refractory to first-line platin-based chemotherapy appeared to benefit from this combination.
Databáze: OpenAIRE
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