Clinical trial NCT04640935: Paclitaxel in Combination With Bevacizumab in Patients With Stage IV NSCLC.
Official title: Retrospective Multicenter Study of Paclitaxel in Combination With Bevacizumab in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: Non-small cell lung cancers
Paclitaxel
Bevacizumab
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
Collaborators: name: University Hospital, Grenoble
First posted: 2020-11-23
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include all eligible patients who started paclitaxel-bevacizumab between January 1, 2010 and May 1, 2018. The number of patients is estimated to be approximately 200.

Brief summary: The aim of the study is to evaluate the paclitaxel-bevacizumab combination retrospectively and multicenter in current practice, with subgroup analyses of the following patients: patients who have previously received immunotherapy, patients with an EGFR or ALK oncogenic addiction pathway, patients who have previously received taxanes or anti-angiogenic agents.

Detailed description: Lung and bronchopulmonary cancer is the leading cause of cancer death in France and worldwide. It is diagnosed at the metastatic stage from the outset in approximately 50% of cases. Non-small cell lung cancers (NSCLC) are the most frequent histological forms of lung cancer (approximately 85% of cases) with a predominance of the non-epidermal type.

The increase in the number of treatments available, improved supportive care and better patient selection have, in recent years, made it possible to expand the range of first-line chemotherapy treatments available at delà̀ and have contributed to the increase in overall survival (OS). As a result, nearly 80% of patients with metastatic NSCLC receive a second line of treatment. The main objective in these often symptomatic patients is a satisfactory tumor control rate with acceptable tolerability.

For a long time, the second-line reference chemotherapy has been docetaxel or pemetrexed as monotherapy with modest results. Alternative treatments such as the combination of paclitaxel (chemotherapy)-bevacizumab (anti-angiogenic monoclonal antibody) have been studied. Since 2010, by analogy with breast cancer and in the absence of therapeutic alternatives, the paclitaxel-bevacizumab doublet has been used in non-epidermal stage IV NSCLC in France. The value of combining taxane chemotherapy with an anti-angiogenic molecule has been demonstrated in two Phase 3 clinical trials. Thus, this combination is an integral part of the possible treatments in 2nd line and beyond, registered since 2016 in the treatment guidelines for non-epidermal NSCLC.

The first-line therapeutic strategy will also be redefined in 2019 with the use of immunotherapy for a majority of patients. Subsequent treatment lines will be modified, with a focus on chemotherapy, in particular the paclitaxel-bevacizumab combination.

As this combination has been used in current practice for several years, and in view of the upcoming changes to the first and second line of NSCLC treatment, data on the efficacy and tolerance of this combination in real life are needed to guide our practices. Recent studies are also looking at the efficacy of chemotherapy, particularly taxane chemotherapy associated with an anti-angiogenic agent after a previous line including immunotherapy, with a favorable signal.

The aim of the study is to evaluate the paclitaxel-bevacizumab combination retrospectively and multicenter in current practice, with subgroup analyses of the following patients: patients who have previously received immunotherapy, patients with an EGFR or ALK oncogenic addiction pathway, patients who have previously received taxanes or anti-angiogenic agents.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old;
* Histologically or cytologically confirmed diagnosis of non-epidermal NSCLC;
* Advanced stage IV disease at the start of treatment with paclitaxel-bevacizumab according to TNM 7/8th edition classification;
* Treatment with paclitaxel-bevacizumab received as second-line therapy or beyond, in a clinical trial or not;
* Alive patients not opposed to the use of their data

Exclusion Criteria:

* Patient under guardianship or curatorship at the date of the study ;
* Patients alive at the time of the study who are opposed to the use of their data
* Opposition to the use of their data expressed during the lifetime of patients who died at the time of the study.

Primary outcomes:
measure: Progression-free survival
timeFrame: Up to 12 months
Secondary outcomes:
measure: Drugs administration dosage description
timeFrame: Up to 12 months
measure: Objective response rate and control rate
timeFrame: Up to 12 months
measure: Overall survival Rate
timeFrame: Up to 12 months
measure: Objective Response Rate
timeFrame: Up to 12 months
measure: Progression-Free Survival Rate
timeFrame: Up to 12 months
measure: Disease Control Rate
timeFrame: Up to 12 months
measure: Overall Survival Rate
timeFrame: Up to 12 months
measure: Frequency of safety events
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Boulogne Billancourt
country: France
facility: Hôpital Ambroise Paré AP-HP
city: Brest
country: France
facility: Centre Hospitalier Universitaire Brest
city: Chambéry
country: France
facility: Centre Hospitalier Métropole Savoie
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles André Mignot
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Lyon
country: France
facility: Centre Léon Bérard Lyon
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Mantes-la-Jolie
country: France
facility: Centre Hospitalier François Quesnay
city: Metz-Tessy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Paris
country: France
facility: Institut Curie
city: Saint-Cloud
country: France
facility: Institut Curie Saint Cloud
city: Saint-Étienne
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: CH Annecy Genevois
name: Chantal Decroisette
role: PRINCIPAL_INVESTIGATOR
References: